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Dr. Vas Narasimhan
For His Vision to Impact Global Health
Education: BA, Biology, University of Chicago; MPP, Harvard’s John F. Kennedy School of Government; MD, Harvard Medical School
As the new CEO of Novartis, Vas Narasimhan, M.D., has a clear objective: to positively impact the state of global health. He recognizes that to reach this goal, the company and industry must embrace digital technologies.
He has long championed a digital-first approach, making major investments in the latest medical technologies, aiming to alter the process of drug discovery and development. In particular, he has spearheaded the adoption of artificial intelligence and machine learning to improve Novartis’ strong but scattered data collection processes. These investments paved the way for what a global pharmaceutical company could become, and cemented Novartis as a leader in digital health. “I’m constantly looking at how we can push existing boundaries through science and technology to truly bend the curve of life,” he says.
Dr. Narasimhan has signaled his intention to further Novartis’ commitment to digital health, with the goal of achieving a “productivity revolution” to get important treatments to patients in need, faster.
Only one month into his tenure, Novartis announced two partnerships with technology companies: Science 37, a leader in decentralized clinical trial technology and design, and Pear Therapeutics, a digital therapy company. Dr. Narasimhan will also continue to prioritize the company’s commitment to tackling the greatest healthcare challenges of our time, including cardiovascular diseases, cancer, and Alzheimer’s. Novartis recently announced a deal to divest its stake in its consumer healthcare joint venture to GlaxoSmithKline, which will allow for an increased focus on these and other core businesses.
Dr. Narasimhan began his career at Novartis in 2005, where he was instrumental in developing the company’s pipeline, which today at any given time boasts more than 200 projects. In 2016, Dr. Narasimhan was appointed the first-ever head of global drug development and chief medical officer of Novartis. Under his leadership, the global drug development team received 11 development approvals and completed 13 major submissions, including Kymriah, which broke ground as the first CAR-T cell therapy approved anywhere in the world.
Dr. Narasimhan began his career at Novartis in 2005, where he was instrumental in developing the pharma giant’s pipeline, which today at any given time boasts more than 200 projects. In 2016, Dr. Narasimhan was appointed the global head of drug development and chief medical officer of Novartis. Under his leadership, the global drug development team received 11 development approvals and completed 13 major submissions, including Kymriah, which broke ground as the first CAR-T cell therapy approved anywhere in the world.
Dr. Narasimhan has deftly navigated his career by choosing a myriad of seemingly dissimilar roles, from working on the ground with communities in India, Africa, and Peru, to time spent as a consultant, extending his management knowledge during a three-year stint with McKinsey, not to mention a variety of positions within Novartis.
Innovation is driven by culture, Dr. Narasimhan believes, and he says it’s vital for all companies to break down silos, embrace agile mindsets, and foster bold new ideas in the pursuit of innovation.
“At Novartis, and in our industry, smart risk-taking within R&D is encouraged,” he says. “We can’t fear failure because without it, we won’t learn. Each small failure in science brings us one step closer to a groundbreaking discovery for medicine.”
He is eager to change the view of the pharma industry, which he says has lost its connection to society somewhere along the way. “In the 1980s and 1990s, pharma was one of the most respected industries in the world,” Dr. Narasimhan says. “It was known as the industry that brought forward the vaccines that enable millions of disease-free childhoods, and for the breakthroughs in CVD, neuroscience, and more.”
To get back to that point, Dr. Narasimhan says he constantly asks himself what he and others in the industry are doing to define the next chapter of the pharma journey.
“Are the projects we pursue going to help improve, and even save people’s lives?” he asks. “Our responsibility is to pursue the highest standards of transformative innovation and better the lives of patients around the globe.”
He is optimistic about the potential to achieve transformational innovation, advances that will challenge established medical paradigms, and therapies that dramatically improve quality of life, cure disease outright, and make it possible to intervene earlier than ever before, and even prevent diseases in the first place.
He says as CEO of one of the world’s largest pharmaceutical companies, he comes to work every day looking to inspire Novartis’ people to think differently and to embrace change because each person in the organization plays a crucial role in the mission: to improve and extend people’s lives.
With unlimited resources, Dr. Narasimhan would be focused on curing diseases before they start. “We’re already on our way, thanks to novel technologies that allow us to look at diseases in completely new ways,” he says. (PV)
For Having The Right Stuff
Title: Chairman of the Board and CEO
Company: Merck & Co. Inc.
Education: BA, The Pennsylvania State University; JD, Harvard Law School
Family: Wife Andrea; son, James and daughter, Lauren
Hobbies: Watching baseball and football, running and reading, particularly history and biographies
Awards/Honors: Ronald H. Brown American Journey Award, 2018; Time 100, 2018; Fortune’s World’s Greatest 50 Leaders, 2018; National Minority Quality Forum’s Lifetime Achievement Award, 2017; The Bloomberg 50, 2017; BioPharma Dive, Executive of the Year, 2017; Grace Award, 2017
Associations: Boards of PhRMA, Weill Cornell Medicine, Exxon Mobil Corporation, and Cornerstone Christian Academy; member of the American Academy of Arts and Sciences, the American Philosophical Society; The Business Council, the Council of the American Law Institute, the American Bar Association
Personal Brand: Seek Adventure
Ken Frazier, chairman of the board and CEO at Merck & Co., has made a habit of making tough decisions that have wide-reaching impact. You could say he has made history several times over, such as last year, when he was the first chief executive to resign from President Trump’s presidential advisory council in response to his public remarks after the “Unite the Right” rally, which was sponsored by neo-Nazis, the Ku Klux Klan, and other white supremacist groups.
Ken stated: “As CEO of Merck and as a matter of personal conscience, I feel a responsibility to take a stand against intolerance and extremism.”
As one of the nation’s most powerful black CEOs, Ken’s position created a symbolic statement not only within the pharmaceutical industry, but across other industries, and the country at large. His resignation prompted a number of other CEOs to resign from the council and eventually forced the White House to disband the council.
“CEOs need to be very thoughtful and sober about the positions that they take publicly,” Ken said in an interview with the New York Times. “Ultimately, if you believe strongly in something, you ought to say it, and you ought to say it in a very clear way.”
Before joining Merck, Ken was a partner with the law firm Drinker Biddle & Reath. He was drawn to that particular firm because it had a reputation of doing pro bono work. In one of his pro bono cases, he represented James Willie “Bo” Cochran, a man who spent nearly 20 years on death row and faced execution for a crime he did not commit. Ken worked to overturn the decision and won Bo his freedom. Ken says this was the high point of his professional law career. He was drawn to a career in law due to the potential to affect social change, and credits his childhood hero Thurgood Marshall for inspiring him.
In 1992, he joined Merck as general counsel of the company’s joint venture with Astra AB. He then became general counsel of Merck in 1999. In his role, he had to defend the company against lawsuits involving Vioxx. Ken remembers that the litigation argument was that the company put profit before patient safety. At the time he said: “There was no way that we could allow that story to be unchallenged. We did not want Vioxx to become a verbal shorthand, like an Enron or something of that nature, for corporate wrongdoing. The most important role of a leader is to safeguard the heritage and values of the company.”
Ken continues to safeguard the heritage and values of the company that has one of the best reputations in the pharmaceutical industry. Under Ken’s watch, Merck has substantively increased its investment in research, including early research, while refocusing the organization on the launch and growth of key products that provide benefit to society. He has also led the formation of philanthropic and other initiatives that build on Merck’s 125-year plus legacy.
“We continue to push the boundaries of science with the hope and expectation that our innovative solutions will lead to better health for generations to come,” Ken says. “That same commitment to overcoming the world’s greatest health challenges extends to how we operate as a responsible company — building a sustainable business that contributes to a healthier world.”
Before becoming CEO and chairman in 2011, Ken’s 26-year career at Merck took him across divisions and areas of specialty. He was VP of public affairs in 1994, and in 1997, was also named assistant general counsel. In 1999, Ken was promoted to general counsel of Merck.
From 2007 to 2010, he served as president of global human health, Merck’s sales and marketing division. In 2010, he was named president of the global pharmaceutical company.
“Very early on in my tenure there was a lot of pressure being put on pharmaceutical CEOs to cut their research budgets,” Ken says. “And we value R&D as a company. It’s who we are. It’s the core of what we do. I made the decision that I wasn’t going to cut our R&D budget, and that had some short-term negative consequences in terms of share price. But by taking those actions I think we were able to show that we really did care about what we said we were about as a company.”
Members of the global Merck organization can’t say enough about his leadership style, and ability to execute against the company’s core values and vision to deliver innovative life-saving medicines and vaccines as well as long-term and sustainable value to its multiple stakeholders. (PV)
For Combining Order and Disorder for Brand Creativity
Title: Managing Partner, Chief Strategy Officer
Education: BA Sociology, Kent State University; MA Sociology, San Diego State University
Family: His ever-supportive wife Kristina, his tolerant kids Owen and Oliver, his loving mother Willa, and his oblivious dogs Ynez and Gus
Hobbies: Reading, skateboarding, rock climbing
Awards/Honors: Two Clios; MedAdNews Agency of the Year, 2018
For more than 20 years, Garth McCallum-Keeler has marshaled deep scientific, product, customer, and even societal knowledge to help healthcare companies and brands chart, and then follow, the most productive paths forward.
He relishes his role as chief strategy officer to help build and reinforce Calcium’s position as a “go-to” agency for those who crave strategy and creative that make a difference.
A strategist by name and title, Garth is always in learning mode. Indeed, he describes himself as paradoxical — energized by both order and disorder.
“A belief that ‘we know exactly how to do this’ is a sure sign that an organization has stopped seeking and has become leaden,” he says.
While he respects the patterns and viewpoints that governed the past, he’s even more interested in the ideas and behaviors driving the future. Garth’s academically sharp, inquisitive mind combines perfectly with a marketer’s aspirational sense of what’s achievable.
“Innovation arises at Calcium by understanding customer needs; addressing those needs from within the brand strategy yielding solutions that are situated to succeed,” he says.
Garth understands that in the relatively imprecise field of marketing and an overly dynamic market means that the creative and strategic process is never really over. “There are always assumptions to re-visit, approaches to re-consider, and choices to re- examine,” he says.
Garth brings extensive experience working in U.S. and global biotech/specialty markets. His range of expertise extends from pipeline work to in-line marketing efforts. He brings industry-side experience to his agency role, having held director-level marketing positions at Genzyme, Insmed, and Dey Pharma. He has worked in numerous therapeutic categories, including oncology, dermatology, renal, rheumatology, endocrinology, pulmonology, and genetic disorders. In all of these disciplines, Garth has demonstrated a special ability to master both the scientific intricacies as well as the big picture landscape. From p-values to broad issues of healthcare practice and technological change, nothing of substance escapes Garth’s probing intellect. If it matters to a client or brand, it matters to him.
He would like to be remembered as someone who is committed to the brands as well as to client partners.
Given Garth’s passion for gaining insights into human and customer behavior, it’s not surprising that he began his career as a sociologist. His skills for delivering ideas and information, telling a coherent story, and captivating audiences were clearly honed in the classroom, where he taught undergraduate courses. The field of sociology also equipped Garth with the strong analytical and data-related skills that are vital to his strategist role.
Above all, he succeeds at elevating the dialogue and making a difference. Colleagues say Garth leads with grace, humility, warmth, and respect, even as he pushes them further to understand clients’ businesses better and more completely.
As healthcare has become more complex, ideators such as Garth are even more inspiring for the way they distill complexity into simplicity and generate solutions that are both elegant and effective. (PV)
For Advancing the Agency Model
Title: President & CEO
Education: BA, Bates College
Family: His mom, dad, wife, and children — behind any success in life there is strong support
Hobbies: Cycling, skiing, and golfing
Awards/Honors: PM360 Elite 100; Best Places to Work in CT, 2015, 2016, 2017, 2018; Inc 5000 Fastest Growing Companies, 2017, 2018; When Work Works, 2017
Associations: Pacific House
Personal Brand: It is always Day 1
In a time when agency churn is a real thing, and people often feel like a number, Matt Schecter has managed to do the impossible. He has created an agency based on a 21st century business model, one that values people first — clients and employees. Starting Lockwood on his own in 2007, he sought to create a new type of medical communications agency and lured initial team members to join the company.
Matt upended the traditional agency work environment. He was able to employ some of the best and brightest strategists and creative talent by providing flexibility and a virtual-work environment by providing them with the equipment to work from home. VOIP phones, cloud computing, and instant messaging all sounded like futuristic jargon back then, but Matt held tight to his conviction that “work is something you do, not somewhere you go.”
Now 11 years later, Lockwood has more than 180 team members, including more than 60 advanced-degreed, full-time scientific team members; generates more than $40 million in revenue; and is averaging 40% growth per year.
Matt’s consistent focus on employee-engagement and satisfaction keep his teams working at a high level to deliver great work to clients.
He describes his approach to building Lockwood as going against what most business schools would teach and what his competitors are doing. “Without understanding the why and having employees buy into the value we deliver, people are not motivated to think outside the box,” he says.
His goal is to improve the lives of patients and their caregivers through education by creating an environment that fosters true partnerships with Lockwood’s clients. Matt says when clients see Lockwood as an extension of their team it means he and his team are maximizing their opportunity to make a difference in the lives of people who need all of their help.
Running an agency is not an easy task, but Matt tackles challenges by keeping things in perspective and he has confidence that he and his colleagues can solve whatever problems they face. “Maybe it’s my confidence that motivates people or maybe I’m confident because my team is always motivated to find the solution when we’re faced with challenges,” he says.
Matt says he surrounds himself with capable people, gives them the tools they need to get their job done, and then lets them decide how they need/want to include him to get things done.
Believing his team members are his most important asset and the key to over-delivering to clients in a demanding industry, Matt invests in his people to keep them connected, engaged, and happy. For the past 11 years, he starts the year by flying the entire agency to an annual year beginning meeting structuring the days to allow for a balance of learning and fun. He hosts the entire agency and their guests in a suite at baseball games in Chicago and New York/New Jersey every summer, supports charitable giving through local and remote-based events and a matching program, and holds regular one-on-one meetings with senior team members to stay connected into the business.
He encourages empowerment throughout the organization. And he is realistic and forgiving about mistakes because he knows there is something to be learned from every miscue.
“I believe this approach of empowerment and forgiveness encourages people to take measured risks and inspires them to do their best work,” Matt says. “I believe if you create an environment where your employees can be successful and want to come to work, they will exceed client expectations every time.”
Team members say Matt is compassionate, understanding, and genuinely cares about them. Just a few examples of his people-first approach include reassuring a team member who had to relocate outside the United States due to a spouse’s deployment that there would always be a job for them upon their return in a few years, granting a team member unlimited time off to work through an unexpected terminal diagnosis for a family member, and giving parents all the flexibility they need when dealing with sick children.
At the end of the day, Matt would like to be remembered as someone who cared about the work the industry is doing, the clients the agency is serving, and the people who are making Lockwood a tremendous success.
“The work we’re doing at Lockwood is pretty special and I am grateful to be part of it every day,” he says. “I like to work and knowing that we’re improving the lives of patients and their caregivers as well as helping our clients achieve their goals is all the motivation I need.” (PV)
For Being an RNAi Champion
Company: Alnylam Pharmaceuticals
Education: BS, Industrial Engineering, University of Pittsburgh
Family: Grandparents, Lew and Ann Greene, Al and Eva Kober; even as a young adult, he and his wife enjoyed their unmitigated love, they saw their energy, drive, integrity, and sense of family; parents, Ken and Ellen Greene; they instilled in him a sense of family, community, the importance of Judaism, integrity, and hard work; wife, Natalie; she is his rock who makes him better every day; children: Harley and Sydney, they make him deeply proud and happy; and extended family — Greene Party of 13
Hobbies: Triathlons, yoga, water sports, surfing, sailing Hobie Cats, wine lover
Awards/Honors: Albert Einstein Award; 2008 Pharmaceutical Executive 45 Under Forty Five; 2008 The 11th Annual Myer Saxe Award from the Alzheimer’s Association; 2010 Women Unlimited, Inc. You Make the Difference Recognition; Alzheimer’s Association 2010 Century Award
Associations: Acorda Pharma Board of Directors; Karyopharma Board of Directors; Hope for the Harbor Event Committee for Alzheimer’s Association
Personal Brand: Yes We Can
Alnylam President Barry Greene has played a pivotal role in leading the company’s 15-year journey to translate the raw and Nobel Prize-winning science of RNA interference (RNAi) into a clinically validated platform and a potential new class of medicines. During his time at Alnylam, Barry has led every aspect of the business. Currently responsible for the company’s commercialization activities, Barry played an instrumental role in Alnylam’s decision to invest in early technologies and rigorous R&D to develop and evolve RNAi. With this singular focus, Alnylam has been able to stay one step ahead of the rest of the world, standing behind the platform even when faith and funding in RNAi began to falter with the 2007 global recession and despite the challenges associated with safely delivering RNAi drugs to humans.
With passion, urgency, and persistence, Barry and Alnylam leadership team inspired employees to continue to fight for the potential of RNAi and accept the challenges inherent in scientific discovery. Because of these efforts, Alnylam is now gearing up to launch, patisiran for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis), the first-ever RNAi therapeutic on a global scale, heralding a new class of innovative medicines that may have the potential to transform the lives of patients who have limited or inadequate treatment options.
In June of this year, the FDA granted orphan drug designation to follow-on molecule, Alnylam’s ALN-TTRsc02, an investigational RNAi therapeutic for the treatment of transthyretin-mediated amyloidosis (ATTR amyloidosis). ALN-TTRsc02 has the potential to be a once-quarterly, low-volume, subcutaneously administered RNAi medication in the management of this serious disease.
“This whole new class of medicines has the potential to have an immense impact on the industry by providing new options for many diseases that were once considered untreatable, and give hope to patients around the world,” Barry says.
Barry has been a key driver in creating Alnylam’s open, collaborative culture, and he is dedicated to making Alnylam a great place to work for all employees. Employees say he is an extremely approachable leader and his door is always open. Everyone he passes in the hallway is greeted with “hey dude” or an enthusiastic fist pump. He goes out of his way to connect with people at every level of the company, hosting new hire breakfasts and meetings to ensure employees are engaged with the team and meeting their career goals. As the co-executive sponsor of Alnylam’s diversity and inclusion initiative, he’s helped spearhead programs such as unconscious bias training to empower employees to act with an inclusive mindset.
In addition to playing an important role in creating the company’s culture, Barry also has created business success. The analyst firm Zacks named Alnylam one of the best-performing biotech stocks in 2017 after its stock price skyrocketed more than 200%. With Barry’s strategic guidance, Alnylam has grown from 60 employees in 2004 to more than 800 employees across North America, Europe, and Japan in 2018. The company continues to expand, ramping up commercial, supply chain, manufacturing, and medical affairs capabilities globally and investing in a $300 million manufacturing facility in Norton, Mass., that will bring more than 150 jobs to the community.
Success for Barry is not measured by dollars and stock prices, no matter how impressive. He is committed to bringing new and innovative medicines to market that can not just improve lives of patients but be life-saving. “Bottom line, it’s not about the dollars, it’s about the patients,” he says.
Barry is a well-respected 30-plus year industry veteran. Before joining Alnylam, he served as general manager of oncology at Millennium Pharmaceuticals, where he led the company’s global strategy and execution for its oncology business, including strategic business direction and execution, culminating in the successful approval and launch of Velcade in mid-2003.
Barry regularly contributes to industry forums, including BIO International 2018, Xconomy’s What’s Hot in Boston Biotech, lectures at Duke, MIT, and Harvard.
“I have always looked to work on amazing change-the-world opportunities, with great people where I can have a genuine impact,” he says. “There is nothing better than developing innovative medicines that save lives. I always tell myself that patients are waiting — what we do is personal and every day matters.” (PV)
Alex von Plato
For Fearlessly Taking Risks
Company: Publicis Health
Personal Brand: Happily unsatisfied
Fearlessly taking risks has been a hallmark of Alex von Plato’s career. As Publicis Health’s first female CEO, Alex leads with an infectious vision and passion that inspires people to push their own boundaries.
First named as a PharmaVOICE 100 in 2013, she compares her role as CEO with being the organization’s compass and Sherpa, pointing the way and doing her best to ensure her team reaches its goals together.
“I always ask myself, ‘What’s the worst that can happen?’” Alex notes. “If you’re unwilling to take big risks, you’ll never know what you can accomplish.”
She believes leaders need to make sure people are given the support to try, fail, learn, and grow.
Alex describes herself as “unsettled,” saying creative people often possess a certain restlessness and rarely ever feel fully satisfied in their work.
“I believe that good work could always be better and great work is never done,” she says. “Something that J&J Chairman and CEO Alex Gorsky said at the Healthcare Businesswomen’s Association’s annual Woman of the Year event sticks with me, ‘We can be pleased, but never satisfied.’ ”
Those who meet Alex are immediately taken by her warmth and straightforward approach to work, life, and motherhood. She is a gifted collaborator who believes leadership starts with a genuine appreciation for the contributions of others and the desire to inspire people to go farther, be better, and accomplish more than they thought possible.
“Leadership is not about expecting respect from others,” she says. “If anything, leadership is about serving others, earning respect, and doing your best to help the people who work with you to be their best.”
She believes that inspiring team members starts with making sure she does the hard work of keeping herself inspired. Alex thinks inspiration is a sport and intellectual curiosity is a muscle that one needs to constantly build.
Mentoring is important to Alex, who considers it a critical part of her job and life. “Mentorship is a two-way street, giving me the opportunity to learn from someone, while hopefully helping them to discover things about themselves, what they want, and what they are capable of,” she says.
With an uncanny ability to bring out the best in her team, she ensures that those around her always feel as if they have skin in the game. She says being part of a team of passionate, talented, and generous people who genuinely care about the work and each other is what inspires her to be her best.
Alex’s colleagues say she is a leader who takes bold action and expects excellence from herself and those around her. She’s been a pioneer of digital communications and healthcare marketing for years. Others say she is the type of leader who other leaders aspire to be — authentic, honest, and brave.
A rare creative/business hybrid, before taking the top job at Publicis Health, Alex served in various leadership roles at Publicis Health, including global group president, global chief creative officer, and president and global chief creative officer at Digitas Health. She has served as jury president at Cannes, as Champion of Hope for the Leukemia and Lymphoma Society, and was named an HBA Luminary. She is the proud mother of three amazing kids. (PV)
For Breaking Barriers
Company: Boston Biomedical Inc.
Education: MBA, University of Michigan; BA, Brown University
Family: Husband, Michael, who is always there for her
Awards/Honors: Industry Explorers Blaze On
Associations: Life Sciences Cares’ Board of Advisors
Personal Brand: Today is a good day
Since assuming her role as CEO of Boston Biomedical in April 2017, Pat Andrews has taken the company forward by prioritizing its clinical activities, focusing its efforts on a handful of critical success factors and staffing the company with exceptional talent.
One of a growing number of female CEOs in the biopharmaceutical field, Pat is a trailblazer in the industry. She is the first female CEO of a business under the corporate umbrella of Sumitomo Dainippon Pharma, Boston Biomedical’s parent company. As the first chief commercial officer at Incyte, she established the commercial organization and launched the company’s first product, a first-in-class, first-in-disease treatment for people with myelofibrosis. Though preparing for launch, she also led a team on multiple business development transactions, including one of the largest biotech licensing deals of 2009. Before Incyte, Pat was the first head of the U.S. oncology business unit at Pfizer, and had other positions of increasing responsibility over her 17 years with the company.
During her two decade career, Pat has gained a diverse experience set, including commercialization, business development, finance, and strategic planning. This experience created the strong foundation from which she leads Boston Biomedical today. Pat has transformed the company’s culture to embrace transparency, collaboration, and an open exchange of ideas. Overall, she inspires people to come to work every day by clearly communicating her vision: to work collaboratively and efficiently to make a true difference in the lives of people with cancer.
Innovation, she believes, is often stifled by the fear of a small likelihood of success on something truly innovative versus the comfort of a reasonable likelihood of success on something incremental. And she believes healthcare still has a long way to go to meet the boundary-pushing advancements other industries are achieving, such as zero-emissions electric cars.
Within the workplace, Pat has instilled a powerful value system in employees, encouraging them to question how decisions will affect patients and what it takes to do the best that can be done.
“I help colleagues succeed by recognizing their strengths and giving them the opportunity to show what they can do,” she says. “I like to know people’s stories and their perspectives.”
When it comes to defining her leadership style, she cites President Eisenhower with “It is the art of getting other people to do what you want them to do because they want to do it.” She couples that thought with the Cheshire Cat’s warning to Alice: “If you don’t know where you are going, any road will get you there.” She believes clear articulation of concrete goals is a prerequisite for achieving rapid progress through collective efforts on what matters most.
She is an empowering mentor who brings strong business acumen and personal compassion to the team she leads at Boston Biomedical. She gives everyone she works with, no matter their seniority, the chance to have ownership of projects and to use their own judgment to learn while still providing oversight and guidance on what is truly doable.
Colleagues credit her down-to-earth, humble approach to putting employees at all levels at ease, and that encourages them to voice their ideas and viewpoints.
She has always had a passion for innovation and science. Just ask her about her childhood hobby of raising mice, and the “orange” one that almost was. (PV)
Dr. Chris Gibson
For Adding AI to Biology to Shake up Discovery
Title: Co-Founder and CEO
Company: Recursion Pharmaceuticals
Education: BS, Rice University; BA, Rice University; PhD, University of Utah
Family: His father, mother, and brother, each of whom has taken a big entrepreneurial risk or two, and their courage emboldened him to do the same; his wife, who as a neurologist and ALS researcher, has been an incredible inspiration to him, as well as a fantastic supporter; his children
Hobbies: Salt water reef keeping, cycling
Awards/Honors: Endpoints’ Under 40 Pharma Innovators; Fierce Innovation Award, 2016; Fierce 15 Award Winner, 2017; Women Tech Council 2018 Shatter List
Associations: BIO; BioUtah; IRDiRC — International Rare Diseases Research Consortium
Personal Brand: Just do it
With a goal to fundamentally improve the lives of tens of millions of people, Chris Gibson, Ph.D., founded Recursion Pharmaceuticals on three big principles: biology, automation, and artificial intelligence. He is building a technology and a team capable of bringing effective and safe therapies to patients in need at an order of magnitude more efficiently and at greater scale than ever before.
“I know that our mission is ambitious enough that there is a chance we might fail,” he says. “At the same time, success is also a real possible outcome. We could help millions of people, and that is what keeps me pushing the limits.”
Dr. Gibson developed the technology and approach underlying Recursion as part of his M.D./Ph.D. graduate work in the lab of co-founder Dr. Dean Li at the University of Utah. In fact, Dr. Gibson left medical school, where he was working toward his dream of being a cardiothoracic surgeon, to pursue Recursion, recognizing that he had the potential to positively impact millions of lives more if the company was successful than as a physician.
In less than five years, Dr. Gibson has built Recursion into a leading biotech company combining experimental biology and AI to disrupt the drug discovery process. Recursion generates more than 20 terabytes of cellular image data every week and, with more than 1 petabyte of cumulative data already generated, the company is well on its way to its goal of building the first map of human cellular biology. This map would not only enable the rapid and efficient discovery of additional treatments, but it would allow the testing of innumerable hypotheses using the enormous dataset of biological image data that Recursion is in the process of acquiring.
“Machine learning will transform most areas of R&D, and especially those where large useful and complicated datasets are prevalent, within the next decade,” Dr. Gibson says.
The company now has 100 employees, has raised more than $75 million in funding, and its high-throughput-screening platform interrogates more than 100 diseases a year. Dr. Gibson and his team have orchestrated multiple drug discovery partnerships with top 20 pharmaceutical companies in addition to developing their own therapeutics in the rare genetic space.
“We’re innovating around the discovery space to industrialize the process to identify potential therapies with a higher likelihood of being efficacious, and simultaneously identifying liabilities such as various toxicities as early as possible in the process using our data set and algorithmic approach,” he says.
He measures success by the number of lives improved through Recursion’s work — both those of employees and of future patients. And he is relentless in his objective, with little patience for anything that gets in the way of the company’s vision or slows him and his colleagues down.
Dr. Gibson puts culture at the center of everything the company does and is constantly pushing Recursion team members to set aspirational goals that force them to think in new, disruptive ways. “As an innovator, I want to get smart people together in a room and ask why to everything,” he says.
Recursion is recognized for its commitment to inclusiveness. The company has been named to Women Tech Council’s 2018 Shatter List; for its innovation, it received multiple Fierce 15 awards; and for its technology, it has been recognized by the Salt Lake City tech community.
He has also contributed to enhancing Salt Lake City and Utah’s reputation as a tech hub, in part via the recent announcement that Recursion will be moving to the thriving downtown arts, culture, food and drink where they are taking over a former Dick’s Sporting Goods space. Recursion’s new headquarters will have capacity for 300 skilled employees.
In addition, he serves as a board member for multiple patient advocacy groups and foundations, such as CureHHT, a patient advocacy group for hereditary hemorrhagic telangiectasia, the Rare and Undiagnosed Network, and Utah Rare.
He also mentors young, promising leaders. His advice: “Don’t be afraid to wander a bit. You will feel tempted to drive as straight a path as possible, but sometimes it is the unexpected beyond the beaten path that will lead to your greatest joys and successes.” (PV)
For Linking Like-Minded Individuals
Company: Skipta LLC
Education: BA, Government, Harvard
Family: Jill Ciccio, his mother; Aliza Ciccio, his wife
Hobbies: Watching and playing sports, traveling, investing
Awards/Honors: PM360 ELITE winner, 2018
Under John Ciccio’s leadership, Skipta has evolved from a startup company to an efficient well-oiled machine that successfully provides services to the majority of top pharmaceutical manufacturers in the country.
To get the company to this point, John has focused on the organizational hierarchy and structure, employee development, improved pipeline management, and campaign execution processes resulting in cost savings and efficiency, ultimately reaching profitability and the sale of the company to a billion-dollar global organization.
John joined Skipta as chief operating officer, tasked with implementing structure, refining business operations, bolstering culture, and optimizing productivity. Within a short time, he was promoted to the role of president overseeing the sales operations, technology, finance, client solutions management, analytics, and marketing departments.
John is driven to take on new challenges, thanks to a high level of intellectual curiosity and constant desire to learn. Skipta was founded as a place where like-minded verified healthcare professionals could communicate and collaborate on patient cases across the country. Skipta’s first community, Pharmacist Society, was established for credentialed practitioners in 2009.
Since then, the Skipta network has grown to comprise more than 30 specialized online medical communities, and continues to grow based on healthcare professional demand.
In his role at Skipta, John brings a wealth of knowledge from various leadership positions, including director of business analytics and development, VP of new product development and most recently, VP of product commercialization at Adheris.
John has successfully launched superior digital product offerings and led efforts to eclipse strategic business goals, including facilitating the growth of a former company from $18 million to $70 million in annual revenue.
Colleagues say one key element to John’s success is his leadership style and ability to positively influence and motivate a diverse team with locations spanning both U.S. coasts and across seven states.
He maintains that most of the skills and experiences he draws on today were born out of some obstacle he faced when he was younger, so it’s important to think of every challenge and difficulty as an opportunity to learn.
John is not afraid to make difficult decisions, carefully but objectively weighing all sides with the outcome always in the best interests of the company.
He leads by example, demonstrating transparency, a strong work ethic, and sound decision-making, grounded by data and with a Skipta-first mindset. His direct reports look to him for guidance and are inspired to achieve the same level of excellence that he demonstrates, with a commitment to collaborative success.
Across all levels of the organization, he supports an open work environment where team members of all levels are encouraged to challenge each other to foster creative solutions and enable growth for the betterment of themselves and the company.
“I’d like to be remembered as someone who helped my colleagues develop and grow in their professional lives and who worked to bring innovative ideas to life,” he says.
Success for John is less about the numbers, and more about the tangible ways he can positively affect the company’s culture, work quality, and collective professional growth of its people.
“Organizations often fail to look ahead and anticipate change when the status quo is working,” he says. John sees opportunity to push boundaries in areas such as personalized medicine, virtual reality, connected health tracking apps, and professional social media.
Colleagues say working with John has helped them to become better leaders and stronger contributors to the company’s success because of his commitment, passion, and accountability.
For John, leadership is about the ability to rally people around a common goal through motivation and exemplification of the values and principles that generate success.
He takes mentoring those who work with him very seriously.
“I think we all need people who are willing to invest time and attention in us in order to fully reach our potential as employees and as leaders,” he says. “I enjoy being able to be part of that development process for my team members.” (PV)
For Connecting Technology, People, and Processes
Title: Chief Operating Officer
Company: Cenduit LLC
Education: Lesley College
Family: Her husband of 28 years Eric; 26-year-old daughter, who is working in pediatric oncology
Hobbies: Exploring nature, traveling to as many places as she possibly can; and football — she is a huge fan, and you’ll find her in front of the TV even on the nicest fall afternoon of the year
Awards/Honors: Women in Leadership contributor and an Executive Representative to a Leadership and Diversity program in the EU
Associations: Women in Leadership (Linkage Institute), Healthcare Businesswomen’s Association
Jennifer Aquino is helping to make clinical trials more flexible and nimble, especially in the interactive response technology (IRT) space, with a differentiated approach to client delivery, leadership, and putting the voice of the patient first. As chief operating officer of Cenduit, she is helping the company to find new ways of improving clinical trials and connecting technology, people, and processes to better serve patients.
Jennifer has extensive experience developing systems and operational teams that support digital health solutions, including ePRO/eCOA, EDC, CTMS, and regulatory submissions at both sponsor and CRO organizations. Before rejoining Cenduit, she was a compliance lead at Shire, supporting the company’s R&D group. She also held senior leadership roles at Parexel in the United States and in Europe, where she had general manager responsibility for its largest IRT delivery center.
She rejoined Cenduit as chief operating officer in 2017 and has put new structures in place to continually improve technology delivery and customer service. In less than a year, she’s built a completely refreshed and revamped approach to form teams around customers and market segments.
Jennifer says her current role has had some large but remarkably rewarding challenges after having spent the first half of the year focusing on industrializing operational and service delivery capabilities. “This process has enabled us to create a high-quality service to handle the pressures of business scale and the complexity and change we’re seeing in study trial designs,” she explains.
Colleagues say Jennifer is known for her ability to quickly assimilate the right team, get to the root of the problem, and quickly drive solutions resulting in positive outcomes for her customers and teams. “When I commit to a goal or a project I’m laser-focused and determined to complete it successfully,” Jennifer says. “Many of the projects on which we work are incredibly challenging. Staying the course and keeping all the stakeholders engaged is key.
There are some cases where accomplishing a goal isn’t possible but I think that’s a rarity.
Determination and hard work will almost always bring you over the goal line if you have the right plan and the right team. And if you aren’t willing to take a risk you’ll rarely do anything special.”
Among her many passions is her devotion to empowering women in biotechnology.
Throughout her career Jennifer has developed and supported programs to empower women in leadership and to promote inclusion and diversity around the globe, and she continues to drive this commitment among her client delivery teams, and in the culture she’s shaping at Cenduit.
“The work we do has a profound impact on people,” she continues. “It’s important to focus not only on sponsors and patients but also on our internal teams. We need compassion in this business. As leaders we are constantly called on to make difficult decisions, but when given the choice we must put our employees first. We need to treat our teams well — they are our most important asset, and they allow us to create an environment where we can deliver for clients so that they can bring new therapies to patients.”
She says a career highlight — an experience that continues to shape her leadership view — occurred while at a previous company where she had the opportunity to get deeply involved in its diversity and inclusion program.
“In addition to being an advocate in this area within the organization, I participated in coursework and training that changed the way I think about building an organization, which has become a passion within my role at Cenduit,” she says. Jennifer admits that while it’s natural to want to surround yourself with people who think and solve problems like you do, this approach can limit what you accomplish. “It takes a globally diverse team with different backgrounds — cultural, educational, and experience, working styles, and values to identify and create solutions that challenge the status quo,” she adds.
She would like her legacy to reflect her passion about fostering a globally inclusive, collaborative, and innovative environment that helps her teams achieve their goals and become leaders who make a difference.
Jennifer is also passionate about programs and educational initiatives that support the well-being of at-risk youth. “We have to do all we can to give every child the opportunity to attend school, nurture their dreams, and create the life they deserve,” she says. “Providing this foundation to our world’s youth is incredibly important and critical to our future. Being a part of the pharma and healthcare industry has also made me keenly aware of the importance of helping to improve the overall health and welfare within our society as a whole — and I’m very passionate about how the work we do in our industry is contributing to that broader world impact.” (PV)
For Transforming ISPOR
Education: University of Michigan
Family: Husband Tim, and parents who each added to her values
Hobbies: Cycling, traveling
Awards/Honors: PharmaVOICE 100, 2016, 2017; Multiple Stevie Awards for Women in Business: Mentor or Coach of the Year-Gold, 2017; Woman of the Year-Silver, 2017, Female Executive of the Year-Silver, 2017, 2016, Female Innovator of the Year-Bronze, 2017, Most Innovative Woman of the Year-Bronze, 2017
Associations: American Society of Association Executives, Healthcare Businesswomen’s Association, ISPOR
Personal Brand: I want it all, but in reasonable proportions
In her four years at ISPOR — the Professional Society for Health Economics and Outcomes Research — Nancy Berg has taken an already successful organization to new heights. She has drawn on a confident but thoughtful, fair-minded leadership style to help ISPOR become a top-tier scientific organization in the healthcare world.
A transformative leader, Nancy has a clear vision for the role ISPOR can, and should, play in healthcare and she is helping the organization to find its voice in the healthcare space. For her efforts, she has been recognized twice before as a PharmaVOICE 100 honoree in 2016 and 2017.
She approached ISPOR acknowledging the successes already achieved: a profitable organization with growing membership and event participation, in a field that had a wealth of opportunities. But she also saw the immediate threats to the organization, including a lack of understanding of the competition, antiquated systems and processes, mission creep, and limited resources.
Nancy realized that the initial growth of ISPOR had created both needs and opportunities.
Founded in 1995, ISPOR has grown and today has more than 20,000 individual and chapter members. ISPOR was no longer a small organization that could be run without specialized internal expertise, particularly in the financial, communication, and scientific areas. She created lead positions in each area, providing anchor points for the membership and staff. In addition, she quickly instituted numerous reforms to increase transparency and accountability within governance structures to give members a greater sense of ownership as well as an opportunity to lead. She has actively worked to establish key collaborations with other healthcare organizations to expand the influence of ISPOR and health economics and outcomes research (HEOR).
She hired ISPOR’s first chief science officer and then worked to introduce a number of new strategic initiatives, including ISPOR/ISPE Initiative on Real-World Evidence, Women in Health Economics and Outcomes Research, Initiative on US Value Assessment Frameworks, and a new ISPOR Health Technology Assessment Central.
She says her most challenging assignment has been managing the total turnaround of outdated enterprises and team norms. “Change comes slowly but it is worth it,” she says.
By continuing to augment staff in key areas, Nancy has enabled the organization to further grow its membership offerings. She also devoted much-needed resources to the staff by providing opportunities for improvement, including a tuition reimbursement program, performance-related bonuses, and training opportunities.
She also recognized that the IT platform that ISPOR had been using was no longer sufficient for the organization and received board support for a major overhaul to upgrade the system.
These updates include an association management system; a financial management system; a new website with a content management system; a taxonomy for all ISPOR’s reports, tools, and resources; a learning management system; and a collaboration/community platform.
To better engage membership at all levels, she has driven a more inter-connected approach to ISPOR’s leadership councils and scientific groups, as well as an overarching assessment of how its major conferences are structured and managed.
By being a key resource in an area of expanding importance, ISPOR continues to attract members, increasing its membership at least 25% to more than 20,000 and growing revenue more than 50% during Nancy’s tenure. She consistently works to advance ISPOR’s mission of making HEOR science more accessible to healthcare stakeholders, such as decision makers and patients, through several initiatives, including the publication of ISPOR 2018 Top 10 HEOR Trends, a new report directed to the media and non-scientific decision makers who would benefit from a better understanding on how HEOR can affect decisions involving new therapies, use of new technology, and medical advancements.
With the patient at the core of what she does, ISPOR also formed the Patient Council to raise awareness and education. In addition, she supported the critical mission of building capacity globally by establishing health technology assessment and HEOR training programs and roundtables around the world.
She strives to innovate by being the chief collaborator and communicator, setting the vision, and creating possibilities. Nancy takes a hands-on approach to leadership and provides mentorship and guidance to her staff. She is a high energy and active leader, always ready to roll up her sleeves and dive into the discussion.
Despite a busy schedule, Nancy prioritizes staff development and engagements, personal mentorship, and informal discussions.
Her greatest concerns are to maintain balance in her life so she can be valuable to others, helping her staff avoid burnout, and remembering there are only 24 hours in a day. (PV)
For Having an Unassailable Commitment to the Brand
Title: Chief Creative Officer
Education: MA, Emerson College
Family: Her sisters, Judi and Patricia, who make her laugh, keep her sane; her daughters, Iona and Charlotte, who are growing into two completely different awesome women
Hobbies: Cooking, traveling, walking and hiking, reading, knitting
Awards/Honors: Many, most proud of James E. Burke Award, 2005, for Johnson & Johnson recognizing an ad they created for the plastic surgery franchise as the best ad of the year; Employee of the Year, precisioneffect
Associations: Lifebox, Kraft Harvard Business School Precision Medicine Accelerator
Personal Brand: This is a project. I need a couple of weeks, some internal reviews. I’d want to work with an art director to develop the logo. This is the soul of the work we do every day. I can’t rush it.
Described by colleagues as a one-woman launching pad for marketing talent, Deborah Lotterman can boost professional fortunes. As chief creative officer at precisioneffect, Deborah’s strategic vision has also been a platform for dozens of brands. She has played an integral role in the agency’s creative work that has helped win awards, secure new business, and grow sales.
Most important to her colleagues, in addition to her official role as chief creative officer, Deborah is the agency’s unofficial chief empowerment officer. Colleagues say people shuffle into her office hunched over, buckled by uncertainty, and float out unencumbered by gravity.
She looks at every brand and every situation with fresh eyes, learning about clients’ brands from the ground up rather than taking the easy approach of simply pushing forward solutions that worked elsewhere. Often audacious in her approach, Deborah says someone has to set a mark at the outer limits, then everything else looks moderate and do-able.
Managing the significant growth of the agency while continuing to do stellar work and creating an environment where her team can do that stellar work can be a challenge. “It’s hard, but absolutely critical that we maintain our standards and culture,” she says. “It’s what our clients are buying.”
Deborah can always be counted on to bring energy and optimism and she takes great pride in the work she and her colleagues are doing. Of particular note is the work the agency is doing with Exact Sciences to promote Cologuard noninvasive screening for colon cancer.
“The Cologuard broadcast spot and the campaign have won a lot of awards, but most importantly the ads are getting people to screen for colon cancer,” Deborah says. “More than 40% of those using Cologuard have never been screened for colon cancer. It’s early days, but Cologuard is really changing the standard of care.”
Refreshingly direct, honest, and fair, Deborah is someone others can learn from. She gives those around her the confidence to make decisions, and she has taught colleagues never to undervalue or niche themselves.
Colleagues and clients love the fact that she is never caught flat-footed by a question from a client, doesn’t speak in clichés, and is perceptive, articulate, and succinct.
Her goal is to create a legacy as someone who always pushed to do the best work, the right work, the work that is built on a true insight and executed with empathy and exceptional creativity.
To continue to make a difference, Deborah says it’s important to stay flexible, adaptable, and be constantly learning.
“The bar for great marketing communications is completely different than it was five years ago; it will be completely different in another five,” she says.
Success, she believes, is measured by being able to answer several key questions: “Are we proud of the work? Did it make a difference? Were we able to motivate new behaviors with physicians and patients?”
She mentors many informally, saying it is great fun and an honor to help smart people move forward.
Colleagues are inspired by her energy, optimism, and the undying belief that this one — this client, this brand, this project — is the opportunity to do amazing work. And when challenges arise, she helps colleagues realize that it will work out and that as a team they will figure it out.
Beyond the agency, Deborah is on the board of Lifebox, a nonprofit organization dedicated to making surgery safer in low-resource countries. Lifebox was established by a group of dedicated surgeons and anesthesiologists, who began by creating a low-cost, highly rugged pulse oximeter to monitor anesthesia. As a result, more than 10 million lives have been impacted. In the years since, the organization has created a probe for infants (in association with the Bill & Melinda Gates foundation), has worked with partners in-country to establish local protocols to prevent surgical site infection, and has begun work on a low-cost headlamp that will light the surgical field in conditions where brownouts are commonplace.
“It is a critical, creative, and very exciting organization,” Deborah says. (PV)
For Putting Neglected Diseases on the Map
Title: CEO and President
Company: PaxVax Inc.
Education: AB, Stanford University; MBA, Harvard Business School
Family: His parents Bijan and Shahrzad, who were both pioneers in Silicon Valley, and his wife, Christine who puts up with him every day
Hobbies: Skiing, travel, and watching Stanford football
Awards/Honors: 2013 Emerging Pharma Leader (Pharmaceutical Executive); Best Early Stage Vaccine Company (2016, Vaccine Industry Excellence Awards); 2016 Rising Star Award, California Life Science Association
PERsonal Brand: Make a difference. Every day.
At a time when global infectious diseases are on the rise, vaccination standards are being questioned, and the race to develop innovative preventative solutions is relentless, Nima Farzan has remained steady in his vision: transform the world with novel specialty vaccines.
Nima is admired for his innate ability to push industry boundaries, strive for achievements, and steer PaxVax headfirst into commercialization — all of which have been the foundation of his success since taking the reins of PaxVax as president and CEO in early 2015 at a time when the company needed to raise substantial capital to complete the development and prepare for the launch of Vaxchora.
The company needed to identify and bring on new investors who could provide capital for the next stage of its growth and financing was certainly not guaranteed, a challenge for the first-time CEO. This task was compounded by the significant consolidation that was happening in the vaccines business at the time; at one point there were only five companies that were globally commercializing vaccines themselves. Under Nima’s leadership PaxVax realized an opportunity to carve out and build a business, going up against the major players, and emerging as a small, fully integrated specialty vaccines company.
Working with Cerberus Capital Management, Nima secured $105 million in funding to help solidify the long-term trajectory for the company. The company acquired Vivotif, a typhoid vaccine as well as the manufacturing facility in Switzerland.
In 2016, the company achieved a significant milestone when it received approval for and launched Vaxchora, the only FDA approved cholera vaccine and the only single dose vaccine for cholera worldwide. Vaxchora was developed from IND to BLA approval in less than five years after a clinical development program with more than 3,000 patients.
Nima’s relationship with the Coalition of Epidemic Preparedness Innovations (CEPI), a public-private alliance designed to prevent public health emergencies and contain global epidemics, propelled the company to join the ranks of the most valued organizations, including the Bill & Melinda Gates Foundation and the Wellcome Trust. He was able to bring PaxVax to the table, demonstrating the company’s thought leadership and commitment to bringing forth vaccines for endemic infectious diseases and ensuring increased access to these vaccines for the people who need them most.
Most recently, Nima led 12 members from the PaxVax team from Switzerland, San Diego, and Redwood City on a volunteer mission to Haiti to experience firsthand the human impact caused by limited access to clean water, nutrition, and basic healthcare. This opportunity was an extremely memorable and rewarding experience for the team, and it humanized the impact that infectious diseases have on those in the developing world and helped bring the company’s social mission to life.
He draws on his knowledge of the vaccines business from his previous role as VP of marketing at Novartis Vaccines USA, where he was responsible for marketing, market access, and the launch of multiple vaccines.
Going to work is easy for Nima, because he loves what he does particularly given the potential impact the company is making.
He is a strategic leader who draws out the best talent of his people. Nima strives to keep the team focused on the mission as he works to drive new models in funding and deliver innovation. When challenges arise, he seeks to motivate others by being honest while remaining optimistic.
“It’s important to recognize the challenge otherwise you will lose credibility,” he says. “At the same time as a leader you have to remain confident in your and your team’s ability to pull through.”
He inspires others by letting people know what the company is trying to accomplish and why. “I find nothing builds trust better than honesty and transparency,” he says. “And when people trust you it’s easier to inspire them.”
Nima formally mentors several employees at PaxVax and previously he mentored MBAs at Harvard Business School. “Being a mentor helps give you perspective as well,” he says. “You get as much as you give.” (PV)
Dr. Lee Fraser
For Connecting Science With Storytelling
Title: Executive VP, Chief Medical Officer
Company: Digitas Health
Education: BSc, MSc, PhD, Queen’s University
Family: His mother who always supported everything he ever wanted to do and his grandfather who told the best stories ever
Hobbies: Hockey, golfing, cycling, skiing
Lee Fraser, Ph.D., executive VP, chief medical officer at Digitas Health, has a solid background in science augmented by an inspirational marketing flair that brings both scientific and promotional heat to projects that stimulate success for clients and team members alike. He has a wide arsenal of clinical expertise across many therapeutic areas as well, which allows him to make the most complex science understandable.
Colleagues admire his talent for being able to identify the scientific story and turn the opportunity for the brand to be relevant to patients.
Many in a similar role may over index on the science side, meaning they fully understand therapeutic categories, MOAs, and the HCP mindset but are unable to effectively tell the brand story. Dr. Fraser, on the other hand, is a business strategist who truly leads teams to develop groundbreaking ideas that will not only differentiate clients in their sector, but drive true business outcomes.
Dr. Fraser’s talent is a rare and highly sought-after skill in the industry. His ability to bring his personality and intellect to bear in the telling of a single-minded, strategic, and simple brand story is inspiring to watch, colleagues say. He can seamlessly pivot from science to marketing to creative and back again, while never losing sight of the strategic “reason why” for a brand.
If you ask Dr. Fraser what his job is, he’ll humbly say it is to infuse Digitas’ innovations with clinical and medical relevance. “My motivator is helping patients and doctors achieve better healthcare and this helps to ensure our innovations are valuable, not simply innovative,” he says.
However, demonstrating the value of differentiated medicines to patients, physicians, and health systems is a crucial part of health sciences, and Dr. Fraser plays a central role as a leader in this field.
Often called “scary smart,” he brings a unique perspective and ability to simplify the complex. He can easily translate complicated scientific concepts into effective communications capable of reaching broad audiences. He has made the science more accessible, impactful and ultimately more critical to the success of the agency.
Dr. Fraser thrives in the complexity of oncology, rare disease, and biologics, and he has the capacity to digest clinical data and find new ways of interpreting information, unlocking pathways for commercialization no one else sees.
On the medical side, colleagues say Dr. Fraser has an amazing gift of being able to distill the complexities of cancer medicine, and he presents the information in an interesting and easy-to-digest manner for busy professionals and anxious patients alike. This means that at the moment of truth when physician and patient sit face-to-face, the doctor is confident in what he or she says, and the patient is equally confident in what he or she hears.
Dr. Fraser is noted as being a trusted collaborator who has helped build brands across the development life cycle, integrating high science and clinical insights into all aspects of the business on brands such as Promacta, Opdivo, Sprycel, Empliciti, Imlygic, Gleevec, Dymista, and InnoPran XL. “I think it all comes back to my science training — keep calm, dissect the problem, and think through the solutions,” he says. “Nothing is ever as hard as it seems in the moment.” (PV)
For Defining Commercial Leadership
Title: Executive VP, Chief Commercial Officer
Company: Publicis Health Solutions
Education: BS, Biology, Marshall University; Master’s of Biological Science, Concentration Microbiology
Family: Mother and father, who taught him that hard work and persistence are the key ingredients to overcoming life’s challenges and being successful; Wife, who has supported him and their family over the past 30 years and through six company relocations
Hobbies: Traveling with friends on vacation (the Caribbean is a favorite), basketball, racquetball, and reading nonfiction
Awards/Honors: Pharmacia Premier Award Winner, Rated the No. 1 Sales Director, Pharmacia; Recognized for new business development in the areas of oncology, oncology diagnostics, rare disease, and biosimilars
Associations: Bio New Jersey; Mass Bio; Life Sciences PA; Healthcare Businesswomen’s Association
Personal Brand: Trusted Performance
Archie Robinson, executive VP and chief commercial officer, has helped grow and transform Publicis Health Solutions (PHS) to meet the evolving needs of today’s market. Highly respected throughout the industry, Archie has been instrumental at Publicis Health in bringing client programs to fruition that positively impact the health of patients. He is proficient in finding the right talent, mentoring and managing the teams, and providing overall direction and guidance to his GMs, NAMs, DMs, and regional leads. He is laser-focused on providing service to his clients, his teams, and ultimately patients. Archie has a passion for creating and providing best-in-class patient-support services, and he is always finding new and creative ways to elevate those services.
Before joining PHS in 2011, he was VP, sales and marketing, at Intercell Inc., where he led the commercialization of the company’s first vaccine. Archie started his career as a pharmaceutical sales representative at Pharmacia and spent 18 years there in roles of increasing responsibility, culminating in a role as senior director of strategic operations.
Archie’s expertise in the pharmaceutical industry and his understanding of the commercial services industry is a true asset to the company and his colleagues. He has implemented tremendous changes and the expansion of resources that PHS has to offer to clients and has helped PHS stand out as one of the most prominent commercial solutions provider companies for more than five years.
Further, he has been at the forefront of shifting Publicis Health Solution’s focus into rare disease, biologics, biosimilars, and other specialty markets. Archie says one of his biggest challenges, and one that confronts all leaders, is uncovering the best way to achieve short-term goals while simultaneously transforming the organization for the future.
Colleagues say without his foresight to stay ahead of market dynamics, the company would not have had as much success as it has over the past two years.
Archie’s leadership and vision have enabled PHS to continue to be a marketplace leader in a category that is rapidly changing. His innovative approaches to designing customized in-field and inside salesforces for a veritable who’s who of pharmaceutical companies have made him the go-to-guy in the business. Many colleagues say they still rely on Archie’s sound advice even after they have amassed their own years of experience.
Archie possesses the uncanny ability of identifying the best solutions for his clients, as well as always doing what’s right for his teams. He creates win-win scenarios for everyone within his orbit, colleagues say.
During periods of transformation, he provides continuity of vision, clarity of organizational focus, and directional guidance for all business leaders within the organization, as evidenced by the success.
Always a visible and vocal champion of diversity and inclusion, he has long been active as a mentor and supporter of company and industry initiatives aimed at equality and gender parity. Archie is an active believer in corporate social responsibility and giving back to the community in which he works. He serves on multiple committees, including as an executive sponsor of VivaWomen of Color at Publicis and a supportive ally to the local chapter of Egalite, its LGBT employee group.
He serves as a mentor to numerous colleagues within the organization, as a coach, and as a leader in the industry at large. He strives to give personal attention to colleagues, regardless of their role and level. Archie is an approachable communicator, and his encyclopedic knowledge of the pharmaceutical market add up to qualities that make for a great mentor. His ability to competently integrate company values and growth objectives is in part what makes him a true leader within the Publicis family and its focus on improving and sustaining patient lives.
Colleagues are confident that Archie’s leadership will be a part of PHS’s long-standing legacy within the commercial solutions industry. (PV)
Dr. Maria Fardis
For Evolving TIL Technology
Title: President and CEO
Company: Iovance Biotherapeutics
Education: MBA, Golden Gate University; PhD, University of California at Berkeley
Family: Husband and children, who have been absolutely wonderful in supporting her career; her open-minded parents to whom she is grateful
Hobbies: Painting, cooking, hiking
Awards/Honors: Multiple educational awards, including Bronze tablet (University of Illinois in Champaign-Urbana); 2008 Outstanding Graduate Student MBA Award from Golden Gate University; multiple company awards at Gilead
Associations: SITC, ASCO, Spark advisor (Stanford University School of Medicine)
Community associations: San Carlos Educational Fund
Personal Brand: Play to Win
When Maria Fardis, Ph.D., of Iovance Biotherapeutics took over as CEO two years ago, she didn’t anticipate making many drastic changes. But soon she recognized the company needed a clear vision and a strategic path forward and she set about creating both to drive Iovance to long-term success.
She established key partnerships with CMOs; entered into agreements with leading cancer research centers, including MD Anderson and Moffitt; initiated several clinical trials; and increased the company’s market capitalization more than six-fold. Dr. Fardis has big plans for Iovance and intends to take advantage of the significant opportunities ahead. She is committed to bringing Iovance’s first product to market and expanding on the potential impact of its innovations by moving into different indications and commercializing globally.
Under Dr. Fardis’ leadership, Iovance has transformed the cutting-edge technology and process related to tumor infiltrating lymphocytes (TIL) manufacturing, which was previously only practiced in an academic setting, and embarked on the path toward commercialization.
Iovance’s TIL technology leverages and enhances the body’s natural defenses against cancer and is designed as a highly personalized therapy that overcomes certain adverse effects seen with other cell therapies, including CAR-T. Currently, the company has a pipeline platform technology, allowing it to treat a variety of cancers, including melanoma, cervical, ocular, ovarian, and pancreatic.
Dr. Fardis wakes up every morning with a purpose, and she inspires the Iovance team to operate with intent to know where they are going and how to get there. She leads by example and demonstrates how hard work can lead to superior results. Her leadership approach has promoted a culture of continuous improvement and execution.
Employees know they can make a positive difference in the lives of cancer patients and they know what they need to do to get there. She has an open-door policy and makes a point of knowing everyone in the organization by first name to the degree possible.
Building successful teams at Iovance as well as at prior companies has been one of the biggest highlights of her career. Under her guidance, teams have been able to execute a clear drug development plan, which has led to the successful launch of multiple drugs, including Imbruvica and Calquence.
Dr. Fardis is first and foremost a scientist at heart who has found her way from the lab to the C-suite. She held several key scientific and management roles at Gilead Sciences where she was involved with multiple therapeutic areas, including antivirals, oncology, and cardiovascular therapeutics, and she worked on the development and life-cycle management of Letairis. Next, she was the chief of oncology operations and alliances at Pharmacyclics, where she oversaw development of the ibrutinib (Imbruvica), and was involved in development of abexinostat (HDAC inhibitor), and the FVIIa inhibitor programs. Dr. Fardis then moved to Acerta Pharma where she was chief operating officer and worked on the development of acalabrutinib until the company was acquired by AstraZeneca for up to $7 billion.
Her track record of achievement is built on the foundation of a strong work ethic, a passion to help patients, and a genuine love for science.
As evidenced through her professional experience, Dr. Fardis is tenacious in her approach to drug development and has the goal of getting the drug to market to improve the lives of patients. “One has to be tenacious in drug development,” she says. “The field is full of disappointments and one has to have a strong drive for success to not get disappointed or give up.”
Dr. Fardis is a well-respected leader in the healthcare industry, and the influence of her actions has driven positive change within Iovance, the sector, and the larger healthcare community. She inspires those around her to tirelessly work to further innovation and create lasting change for the benefit of the patient.
With all this success behind and ahead of her, Dr. Fardis still has some words of wisdom she would tell her younger self. “Think out of the box more often,” she says. “Career paths are to be defined by you and not by others.” (PV)
For Empowering Programmatic Health Technology
Education: BA, Clark University; JD, Syracuse University
Awards/Honors: Smart CEO Future 50, 2017; Crain’s NYC Top 100 Companies to Work for, 2016, 2017; Inc 5000 Fastest Growing Private Companies, 2015, 2016, 2017; Deloitte Fast 500, 2016, 2017, 2018
As CEO of PulsePoint, Sloan Gaon brings powerful outside-in thinking to the healthcare industry, helping to unlock new ideas and promote quantum change. In the process, he aims to improve the lives of millions of patients using emerging technologies in new and sophisticated ways.
At PulsePoint, Sloan is pioneering the use of programmatic health technology to make targeted health solutions available to consumers and their healthcare providers.
As Sloan studied the way health products and services have historically been marketed to consumers, he was struck by the internal inconsistency he saw in the industry. While, health is intensely personal, health marketers also have to cast a wide net through broad reach media to ensure they connect enough audiences to their messages.
To address this inconsistency, Sloan has worked to enhance PulsePoint’s core technology and data insights to help health marketers reach volumes of patients in personal ways. In so doing, marketers could reach many people by running campaigns of one but still remain profitable.
“I believe that through the power of technology and data, personalized healthcare can become a reality,” he says. Ideally, Sloan would like to provide a single application for consumers to own their own health data.
Sloan has taken programmatic health technology to the next level, empowering marketers to get more specific than ever in delivering the right message to the right audience at the right time in the right format, and giving them the ability to sequence these personalized interactions to meet customers’ needs.
Sloan also championed the formation of the Programmatic Health Council, an advocacy group comprised of programmatic and healthcare advertising experts committed to advancing programmatic technologies across health brands, agencies, and publishers.
Under Sloan’s direction, PulsePoint is expanding globally through the acquisition of Vitality Ad Lab, a digital health advertising team with deep-rooted relationships and innovative market-specific solutions in Europe.
Sloan is skilled at identifying emerging trends, and mobilizing people — employees and clients — to listen, and get on board. As a result, under his leadership over the past six years PulsePoint has posted triple-digit revenue growth.
Among his future goals, he would like to add health-specific data partners, publisher partners, safety standards, intellectual property and CRM capabilities to enable a deeply specialist approach to clinical trial recruitment, healthcare provider engagement, and direct-to-consumer advertising.
Sloan is tapping into his experience with companies that he successfully built and sold, including DotMenu, which was acquired by GrubHub, and MIVA, acquired by Adknowledge, to identify whitespace in the marketplace to build new products and offerings that go beyond what can be seen at the present. He continuously looks for the next big step and where it could take PulsePoint.
Sloan inspires his teams as a leader, noting that he builds a positive work environment, establishes a shared sense of purpose through transparent communication, and cultivates a “have fun or go home” culture. Teams are encouraged to take pride in the work they do, and they are excited to come to work every day. His teams describe him as a prodigious thinker who encourages every individual to push the boundaries and think big.
Each year, he leads a company retreat where everyone coalesces around a specific business problem, such as ways to disrupt clinical trial recruiting.
PulsePoint team members are divided into randomized teams, and each team works over the course of a month to develop a solution that they present at the retreat. The winning idea is then taken to the market.
He says leaders need to do two things: coach people on the “what” and inspire them on the “why.”
“To be a great leader, you have to do both in every engagement,” Sloan says.
Writing code, selling product, and delighting customers are the result, but people are central to everything Sloan does in business.
To put his people-centric mentality into action, Sloan has created a strong set of core values that are enforced across virtually every aspect of the company. (PV)
For Making Business Personal
Company: J. Knipper and Company Inc.
Education: Honorary Degree, Ph.D., Business, Georgian Court University Education; BS, Chemistry, University of Scranton; MBA, Pharmaceutical Sciences, Fairleigh Dickinson University; MA, Theology, Georgian Court University
Family: His wife of 28 years, Teresa, his four sons, Tim, Jon, Peter and Jake, and his two grandsons, Bodhi and Julian
Hobbies: Paddle boarding, traveling,
Awards/Honors: PharmaVOICE 100 — 2009; Corporate Citizen of the Year Award, Georgian Court University; Light of Hope Award, Catholic Charities of the Diocese of Trenton; Honorary Doctorate in Business, Georgian Court University
Personal Brand: Nothing is impossible
The greatness of a company is defined by its people. That’s the guiding principle that has helped Jim Knipper, CEO, grow his company and ensure continued innovation in the area of product sample management services. In fact, at J. Knipper and Company, they call it “The Art of Samplicity.”
“Our mission is to work with our clients to create solutions that are strategically designed, faithfully executed, and driven by market insight and data to ensure maximum return on our clients’ investment, and ultimately to improve people’s lives,” Jim says.
At a time when technology and economics often place the emphasis of success on automation over craftsmanship and the strip mining of commercial assets through M&A, Jim has taken a very different approach. Despite a challenging economy and three competitor acquisitions within four years, the emphasis has remained on finding and retaining talented people who are committed to excellence and demonstrate the company’s values in everything they do. Unlike most acquirers, a primary objective of each J. Knipper acquisition has been to retain the people and to blend the best of the cultures from each organization. One of his most important acquisitions was actually re-acquiring his own company from McKesson in 2002 and guiding its 400% growth over the decade.
Employees are accustomed to Jim talking about the layers of the company and its culture, and how those layers create a stronger and more versatile team.
There is no doubt that new technologies and improved processes are important contributors to the success of any company, and J. Knipper invests a great deal in both. However, it’s Jim’s firm commitment to the founding principles he and his father built the company on that continue to inspire all who work for him. Those principles have been memorialized in the company’s core values known as CHART, an acronym for caring, honesty, accountability, respect, and trust.
Jim’s philosophy regarding people is apparent even in the language he uses. While most companies refer to employees, Jim calls them contributors. And his contributors are motivated by Jim’s personal and work ethic and the care he shows for others, his professionalism, ethical behavior, and a sense of being present for other people.
“I would like to be remembered as a leader who was honest and ethical in all that I did and treated each person with respect,” Jim says.
He works alongside his team, helping them to overcome challenges by reminding them that the company is best when everyone works together. Leadership, he says, is about setting a goal and empowering the team to use their skills, within the context of the organization’s vision and mission, to execute both as individuals and as a group.
This “people-first” approach has led the company to sustained growth throughout its three plus decades in business, having started as a small shop with 23 employees in 1987 that was focused on direct mail and sampling. Today, J. Knipper is a market segment leader with more than 600 employees and multiple distribution centers. Most recently, the company has expanded into the specialty pharmacy arena with its new affiliate, KnippeRx, which operates out of the new Midwest distribution center.
“The greatest professional mentor I have ever had was my father, Joe Knipper,” Jim says. “We worked together from 1981 until his death in 2008 and he taught me so many lessons in how to run a business, but more importantly how to lead in an honest and ethical way. He defined what it means to take the high road in all that you do, especially in growing a business and caring for those who work with you.”
Jim is focused on helping the organization to innovate by looking forward, setting new goals, ensuring proper resources are available, and ensuring all operations fall within the organization’s mission.
Jim, who was also recognized as a PharmaVOICE 100 in 2009, carries his people-first approach into other parts of his life as an ordained deacon for St. Paul Catholic Church, Princeton, N.J., where he spends time preparing couples for marriage and serving the people of the parish. In addition, Jim heads head up a small publishing company — Clear Faith Publishing — whose proceeds go to feeding the hungry, clothing the naked, and welcoming the stranger.
Jim draws his inspiration from a Jesuit priest who has worked with LA gang members for the past 34 years. “He realized that you have to replace a bullet with a job and thus started Homeboy Industries, which employees more than 1,000 former gang members,” he says. “He comments that we need to reach out to those on the margins, not so that we make a difference but so that those living on the margins make us different.” (PV)
For His Deep Commitment to Creating Clinical Excellence
Title: Founder and Board Chair
Education: MBA, Kellogg Graduate School of Management, Northwestern University
Family: His wife and three children for their love and support, and his dog for constantly reminding him to find joy in every moment
Hobbies: Hiking, cycling, rowing, playing and performing music, learning about music history and American history
Awards/Honors: DIA Fellow Inductee, DIA Outstanding Service Award, ACRP European Outstanding Leadership, ACRP Innovation Leadership, Lifetime Achievement award from the Institute of International Research, Neal Award Finalist in Publishing; University Distinguished Service Nominee
Associations: DIA, ACRP, ISPE, ISPOR
Personal Brand: Aspiring for informed purpose and relevance
Across the industry, Ken Getz’s name is synonymous with clinical research. He is one of the most visible, committed, well-respected, and influential leaders in the industry. As the founder of the Center for Information and Study on Clinical Research Participation (CISCRP), and as an associate professor at Tufts University, he has been instrumental in helping to raise awareness and to educate and inform stakeholders throughout the clinical research enterprise.
“One of my proudest achievements is establishing and growing the nonprofit organization CISCRP, which is dedicated to providing public and patient outreach and educational programs and helping professionals improve their patient engagement capabilities,” he says.
(CISCRP does not conduct, promote, or recruit for clinical trials and remains a neutral and unbiased source for information and education.)
Under Ken’s guidance, CISCRP has become well-known for providing free clinical research education to the public, patients, and underserved minority populations through its flagship AWARE for All program that is being implemented in various cities all over the world. Since its inception in 2003, AWARE for All has amassed an impressive track record of engagement in more than 60 cities, including Baltimore, Boston, Dallas, Los Angeles, and Philadelphia. The program is also prominent in the Research Triangle area — Raleigh, Durham, and Chapel Hill, N.C.
Ken and CISCRP have coined the term Medical Hero to recognize those who give the gift of participation in clinical trials. CISCRP hosts Medical Hero Appreciation events, such as 5K walks/runs, publishes Medical Hero Spotlight stories and newsletter features, and has run a successful Medical Heroes in Everyday Places TV and radio campaign. CISCRP is also dedicated to helping sponsor companies return plain language clinical trial results summaries to study volunteers. More than 40 companies have now engaged CISCRP in this important endeavor.
Ken volunteers his time as founder and board chair of CISCRP and is closely involved in all the educational and outreach programs that CISCRP develops each year. For example, he led CISCRP in creating a new public service message on the importance of clinical trials in developing new medications for pharmacy shelves. The public service initiative, called the MT Pharmacy, set up in a community in Newark, N.J., and showed the public what pharmacies — with empty shelves and barren displays — would look like without clinical trials. “The idea is to bring home the message that without clinical trials, there would be no medicines or therapies to ease or treat illness and disease,” he says.
Colleagues say Ken’s approach to facing challenge is a team effort, and that his thoughtful and informed insights often lead to new solutions. “It’s critical that we put in the effort to gather the right evidence, to listen and learn, to not be afraid to fail or to push, and change our way of thinking,” he says.
In addition to his role at CISCRP, he is an associate professor conducting grant-funded research and an entrepreneur, having founded, invested, and sold several ventures.
He measures success by the number of patients and professionals who have found value and relevance in the projects and the initiatives in which he is involved. He draws inspiration from the many people with whom he has had the privilege to work with, as well as from the clinical trial volunteers who are on the front lines of clinical research. Mentoring staff and students is, for Ken, an essential way to share his experiences and knowledge and assist in the professional development of others.
He inspires others through his actions and ideas, which are drawn from evidence and information gathered over the years.
Ken is also highly respected throughout the academic industry. He generously shares his time, expertise, and insights speaking at hundreds of industry meetings, symposium, corporate events. He is also a prolific author, having published more than 200 articles and chapters in peer-reviewed journals, books, and in the trade press. He is the author of two nationally recognized books — Informed Consent: A Guide to the Risks and Benefits of Volunteering for Clinical Trials and The Gift of Participation — for patients, their families, and advocates.
“I wear so many hats simultaneously — as the founder of a nonprofit assisting patients and the public; as an associate professor conducting grant funded research; and as an entrepreneur — I truly enjoy what I’m doing,” he says. “I can’t think of another profession I would like to attempt.” (PV)
For Being an Innovative Force
Company: Inception Digital
Education: BA, Ramapo College,
Family: Wife, partner, and friend of 29 years, Colleen — she’s the glue that holds his Popsicle sticks together; three strong, smart, and beautiful daughters, as well as (currently) two not-so-smart Labrador retrievers
Hobbies: Fly-fishing, acoustic guitar, skiing
Awards/Honors: Coalition for Healthcare Communications, board chair, 2013–2015; MM&M/PRWeek Health Influencer 50 (#5), August 2016; MM&M Advertising Marketer-of-the-Year nominee, October 2015; PM360 Transformational Leader, July 2015; MedAdNews Advertising Person-of-the-Year, April 2011; DTC Perspectives Inaugural DTC Hall of Fame Inductee, December 2008; PharmaVOICE 100 — 2005; MM&M Master of Medical Advertising, July 2003
Associations: Board chair, founding board member, CharityNavigator.org, 2002-present
Personal Brand: Authentic Intensity
Matt Giegerich, CEO of Inception Digital, made his first appearance on the PharmaVOICE 100 list in 2005, and he has been gracing our pages ever since, providing insightful thought leadership that made his name synonymous with Ogilvy CommonHealth for more than 20 years.
“Taking the helm of CommonHealth at the age of 35 was enormously challenging,” Matt says. “It was a time of great change in the agency and the industry and I spent a lot of time learning from my mistakes.”
Today, Matt has a new role in a new company, and a brand new focus. He has taken on an exciting and challenging opportunity; Inception is a leading provider of video production, interactive visual solutions, broadcast and webcast platforms for virtual meetings and audio/visual/meeting support. Comprised of Inception Digital, Kampfire, and Inception Visual, the company delivers state-of-the-art TV-style technology to clients in the healthcare, financial services, and technology sectors.
The common denominator between his past career and his new one is that the work in both is innovative and ground breaking.
In his early days as a marketer, he drove the startup and growth of two of the first-mover agencies into direct-to-consumer Rx advertising and CRM-based loyalty and adherence initiatives. His marketplace firsts include the first mass media use of a celebrity spokesperson, which was Joan Lunden for Claritin and partnerships with MLB (Schering/Claritin) and the NFL (GSK/Levitra).
Overseeing the development of Pando, Inception’s interactive, production-quality meetings platform is just as cutting edge. Unlike anything else currently on the market, Pando brings a live studio production together with up to 60 remote on-camera participants and virtually unlimited off-camera participants anywhere in the world. They are connected through the camera on their computers and displayed on a 40-foot Pandorama video wall creating an interactive experience.
“Deciding to leave the ad agency business after 30 years and making the leap into a smaller, more entrepreneurial and technology-driven organization has been hugely challenging and rewarding,” Matt says.
Some may wonder how Matt could transition from his long tenure as CEO of Ogilvy CommonHealth to that of a small digital company, however, colleagues say he is the perfect fit, and his vision for Inception is right on.
An energetic, creative, results-oriented leader with extensive experience building and growing marketing agencies and brands in the health and wellness and life-sciences space, Matt has an innate ability to prioritize, connect, and drive all elements critical to success: talent, innovative and creative work, clients/brands, and business results.
“I like building things and serving people — helping both colleagues and clients along the way,” Matt says.
According to colleagues, he is a genuine, one-of-a-kind leader. Although he expects his teams to deliver, he gives them the room to do so without being overbearing or controlling.
“Leadership can be a single thing — like vision, inspiration, courage, or empathy, but it’s usually a combination of these things that clears the path forward and motivates others to follow,” Matt says.
Colleagues say he is generous in his acknowledgments, which make them want to do more for him. He is appreciative. He never loses the opportunity to recognize someone, to thank someone, or to encourage someone. It is very important to him to create a work environment where people want to be, want to contribute, and want to bring value to the clients they serve.
Matt believes context and perspective are the best tools-of-the-trade. One of his mentors used to say the key to success is to be both caring and acting like your life depends on every single thing you do, all the while knowing that most things matter very, very little in the grand scheme of things. He says keeping those two thoughts simultaneously alive and present at all times can be a challenge in itself, but it can also be the key to a balanced, purposeful, authentic, and happy life.
“I try to inspire by being authentic, vulnerable, and owning the decisions I make when confronted with choices or problems and how I keep true north in focus,” Matt says. “I also use language — both spoken and written — as best I can to emote and engage others. The ‘power of the pen’ seems to be a fading skill, but it has always been my secret weapon.” (PV)
For Being a Leadership Trailblazer
Company: AIT Bioscience LLC
Education: BS, Pharmacy, Rutgers College of Pharmacy; MBA, Pace University
Family: Husband of more than 30 years, Rich Pascarelli; daughter, Liz Pascarelli, a strong professional woman in her own right, currently living and working in Australia
Hobbies: Traveling; family time; spending time near the beach/water
Awards/Honors: Healthcare Businesswomen’s Association (HBA) STAR (Strategic Transformation Achievement Recognition), 2018; HBA President’s Award, 2010; HBA STAR Volunteer, 2004; President’s Model of Excellence Award, AstraZeneca, 2010; AZCE Cardiovascular Excellence Award, AstraZeneca, 2010; Special Achievement Award, multiple awards, Roche Pharmaceuticals; Vice President’s Award, Boehringer Ingelheim; Previous volunteer work recognized by the United Way (including as a company campaign chair) for work in Connecticut, Maryland, and Indiana and for volunteering with the American Heart Association; recognized as a business leader by Leadership Howard County (Maryland) and Leadership Maryland; Recognized and selected by Rotary International, Connecticut USA for professional business exchange program with Rotary International, state of Victoria, Australia; Recognized by the Connecticut Jaycees with the state’s John H. Armbruster Keyman Award (state Jaycee of the Year), 1988
Associations: Strategic planning committee, Women Business Leader’s of the U.S. Healthcare Industry (WBL); Chair Emeritus, HBA; BioCrossroads, Indiana Life Sciences; Indiana Health Industry Forum (IHIF); Chair, Board of Visitors (Dean’s Advisory Board), Butler University College of Pharmacy and Health Sciences, Indianapolis; Former Board member; American Heart Association, United Way; Brookfield Jaycees and Connecticut Jaycees
Personal Brand: Go where there is no path and leave a trail
In this time of heightened awareness of the need for gender parity in the life-sciences industry and more women leaders in the C-suite, it is with great pleasure that we introduce to you a woman who has been blazing that trail for more than 25 years.
Terri Pascarelli, CEO of AIT Bioscience, is currently holding her third position as an entrepreneurial company CEO or president. She joined AIT Bioscience as CEO in December 2014.
Her leadership has put AIT Bioscience on Inc. Magazine’s list of fastest-growing private companies two times in the past three years, once ranking on the Inc. 500 list and once on the Inc. 5000 list.
Prior to AIT Bioscience, Terri was VP, client development, at YourEncore Inc., which is a leading advisory and execution services firm serving many of the largest bio/pharmaceutical companies along with leading clients in consumer, nutrition, and food.
Terri’s healthcare industry experience ranges across start-up and Fortune 500 firms. She has held leadership roles in strategy, sales and marketing management, managed markets, R&D, and commercial operations roles at Boehringer Ingelheim Pharmaceuticals, Roche Pharmaceuticals, and AstraZeneca.
Fittingly, Terri is a long-standing member of the Healthcare Businesswomen’s Association (HBA). She was a founder of the Indiana chapter and she has continued to serve the global HBA board of directors in a number of capacities for more than 15 years. In 2013, she was elected to serve as chair of the HBA’s corporate board of directors, a global position. She currently serves the HBA as an advisory board member, and is a member of the Indiana chapter’s executive advisory council. Terri was recognized with the 2018 Strategic Transformation Achievement Recognition (STAR) award by HBA. This award honors a volunteer who stands apart as a truly exemplary role model and who has demonstrated a long-term commitment to furthering the HBA’s strategic goals.
Colleagues describe her as a servant leader, portraying a leadership philosophy that shares power, puts the needs of others first, and helps people develop and perform as highly as possible. In this regard, Terri is unfailingly generous in terms of giving those around her the space to lead even when it means taking a step back. She is empathetic, smart, and considerate. Many of her professional and HBA colleagues note that when Terri talks with you, she makes you feel as though you are the most important person in the room. She is greatly admired for her steady, thought-provoking, courteous, and considerate behavior toward others.
She takes time to invest in her employees as well as her HBA colleagues and she cares about the success they bring to the company and the association and she genuinely cares for their individual professional development.
In addition to finding time to mentor and guide the careers of so many, Terri maintains a steady hand on the tiller of AIT Bioscience’s business goals. She is measured in her decision making, contemplative of risk and reward, and unflappable. Focused on keeping the company on track for growth, she is not reactive to the changes in the industry, and doesn’t let AIT Bioscience get caught up in disruptions that detract from the company’s overall business objectives.
“No matter how much we’re getting done, it seems that there are big challenges ahead,” she says. “We need company leaders, employees, investors, and even our customers to align on what’s important and try even harder to move the needle higher and faster.”
Terri’s efforts are shaping the careers of future innovators, as well as her employees and the industry as a whole, as she blazes new trails for not only women, but for everyone. (PV)
For Uniting Communications
Title: Chief Growth Officer, Syneos Health Communications
Company: Syneos Health
Education: BA, Communications, Villanova University
Family: Her sweet and spirited children, Daisy and Chance; and her sensationally smart and supportive husband, Bill
Hobbies: Travel, reading, cooking, beaches, walking
Awards/Honors: 2015 Healthcare Businesswomen’s Association Luminary
Personal Brand: This will be funny later
Leader, collaborator, teammate, innovator, mentor, and role model — all of these words define Amy Hutnik, chief growth officer at Syneos Health Communications, the communications group of the merged entity of inVentiv Health and INC Research. In this role, she oversees business development for a $300 million communications offering made up of a number of advertising, medical communications, and public relations agencies in the pharma and healthcare space.
In early 2017, Amy was tasked with creating a common backbone for the company’s 12 communications agencies within the Syneos Health Communications network. The vision was to fuel a growth engine with centralized resources driving prospecting, customer development, and the evolution of capabilities, including data science, insights, and innovation to the collection of interconnected healthcare agencies. The goal was to foster knowledge-sharing across entities that were previously accustomed to operating independently and to drive accelerated growth.
To ensure a successful launch of the new entity, Amy brought the teams together to identify and prioritize opportunities for collaboration and to brainstorm solutions to shared issues. By engaging participants across functions, Amy created buy-in for the concept of shared growth excellence, starting with a solution to the agencies’ most pressing problem: quickly gathering insights from across the company and using it to differentiate Syneos Health agencies. Her pioneering efforts led to an industry-leading platform for connectivity across divisions that allows Syneos to integrate a full suite of outsourced commercial services in turnkey fashion for small, emerging, mid, and large pharmaceutical and biotechnology company partners.
Amy oversees a team of a few dozen professionals who prospect leads, develop relationships, manage an overwhelming RFP process, and assist agencies with pitches and anything and everything related to business development. On a daily basis, the teams may be involved with 20 to 30 pitches in various stages that she and her team manage, with a hit rate of 65% to 70%.
With more than 20 years in marketing, operations, and strategy that span consumer and healthcare markets, Amy knows the business, the players, the companies, and the brands inside and out. Colleagues say she has an innate ability to see around corners, and she delivers results. Most importantly, they say she does it all with a collaborative spirit and selflessness that is rare in the agency business.
“My whole job is about what’s next: how our teams grow together,” Amy says. “That means constantly searching for how we’ll level up and up and up. It’s constantly refreshing our expectations and making sure our growth team has the same mentality — as soon as we establish a new process, product or growth trajectory, we take about a minute to feel great about it, and then we start to think how to measure it and improve it.”
Always curious, Amy wants to understand how and why, and — her favorite — why not. She is committed to continuing to find ways to pave the way forward for tomorrow’s success in a complicated, dynamic industry.
“Healthcare communications is well-understood as a service partnership, yet it will evolve dramatically and quickly in the next few years,” she says. “I am constantly thinking about the steps we need to take right now; preparing us for the next horizon of innovation is what I love to think about.”
Believing that innovation is iterative, she says that if organizations are planning for a single, gigantic innovation moment, they may be missing the opportunity to make 10 smaller decisions that drive change in manageable increments.
Amy drives with purpose and thoughtfulness and makes everyone around her want to strive to do their best too. She hopes she is known as someone who advocates for the teams and structures that make a difference in the work, in the experience people have, and in the positive health outcomes that her colleagues and clients are all dedicated to.
“There are people who make the journey enjoyable and rewarding and people who make it hard,” she says. “I hope I’m the former.”
Her advice to her younger self would be to take the work seriously, not yourself. “And don’t think of a career like a ladder — it’s so much more fun if you follow your curiosity. Thinking of it as a straight vertical path can be limiting,” she says. (PV)
For Delivering the First Digital Therapeutic
Title: President and CEO
Company: Otsuka North America Pharmaceuticals
Education: MBA, INSEAD; MA, Math, University of Cambridge
Associations: NJ BioPharma Networking Group
Kabir Nath, president and CEO of Otsuka North America Pharmaceuticals, believes patient solutions need to be lifestyle solutions, developed with a deep understanding of a patient’s behavior and environment. Kabir assumed the role of president and CEO of Otsuka North America Pharmaceuticals in March 2016.
“Novel solutions need to fit into patients’ lives in order to succeed,” he says. “An app that takes 20 minutes to interact with is not going to work.”
In November 2017, Otsuka received FDA approval of Abilify MyCite, the first digital medicine approved by the regulatory body. This drug delivery system is designed to support patients, their physicians, and care providers in treating serious mental illness in a new and innovative way by helping to track medication adherence. Kabir is leading the company’s development, delivery, and market access of advanced therapeutics, such as Abilify, with the backing of advanced data and analytic tools that are helping change the patient-care paradigm. Building on the decades-long leadership of Otsuka in innovating treatments for serious mental illness, Kabir is leading Otsuka to explore new drug delivery platforms and other elements of care, such as long-lasting injectables and advanced data collection and analytics, which will help address issues and barriers facing patients in novel, impactful ways.
Recognizing that developing and gaining approval for the first FDA-approved digital medicine system is not the end of the journey, he is leading Otsuka to help break down barriers to treatment, which includes engaging payers and physicians on the value of technology-enabled innovative approaches to care, adherence, and outcomes measurement.
With more than 25 years of broad international biopharma and devices experience — before Otsuka, he was senior VP of virology US pharmaceuticals for Bristol-Myers Squibb — Kabir has shaped strategy and delivered results in complex, challenging business environments at country, regional, and global levels. His strategic and outcomes-oriented vision and leadership is nowhere more in evidence than in his current role at Otsuka. Kabir is shaping access and innovation for some of the most-advanced and never-before-seen platforms that treat serious diseases, particularly in mental healthcare.
“At Otsuka, we believe in challenging the norm and taking innovative approaches to creating new medicines,” he says. “As a senior leader at Otsuka, I am committed to providing innovative solutions for people affected by mental health disorders and their families.”
This effort has led to two new drug approvals, a pipeline of investigational therapies, and resources to address serious mental illness, as well as Alzheimer’s disease, autosomal dominant polycystic kidney disease (ADPKD), and an emerging oncology portfolio.
“In all of our activities, we’re driven by a commitment to improve the lives of people globally,” he says. Through his leadership, Kabir is helping not only to shape the culture, commitment and success of Otsuka, he is also helping to usher in advances that will add value to all aspects of the healthcare ecosystem.
Kabir recently served as chair of the 29th Annual Lifesavers Gala. Each year, the American Foundation for Suicide Prevention holds the Lifesaver’s Gala, to honor individuals and organizations that have made a substantial contribution to suicide prevention. From scientists to public policy advocates, Gala honorees have gone above and beyond in drawing attention to the cause, elevating public discourse around mental health and suicide. (PV)
For Being a Med-Tech Problem Solver
Title: Chairman and CEO
Company: InCube Labs
Education: BS, Electrical Engineering, Rutgers University; MS, Bioengineering, Rutgers University
Family: His wife for putting up with him; his son who is playing a critical role at his company, and his four daughters who are absolutely amazing
Hobbies: Reading history, collecting antique instruments and machines
Awards/Honors: Fellow National Academy of Engineers; Fellow National Academy of Inventors; Top 50 Medical Device Inventors of All Time by QMed; Rutgers Hall of Distinguished Alumni, 2009; Rutgers University Distinguished Engineer Award, 2005
Associations: National Academy of Engineers, National Academy of Inventors
Personal Brand: Fearlessly push boundaries
With an unbridled curiosity and a deep commitment to solving big problems, Mir Imran has spent the last almost 40 years creating and commercializing breakthrough medical innovations. Now as chairman and CEO of InCube Labs, he is focused on developing breakthrough technology that could potentially disrupt the pharmaceutical industry by converting injectable medications into pills.
Even as a child, Mir was interested in understanding how things work. His mother would buy him mechanical toys in pairs, one of which he’d break down to figure out how it operated. As a high school student, he took night classes in radio making, then sold his creations to friends, ultimately using his profits to subsidize his tuition at Rutgers University.
During his undergraduate years, Mir spent a summer working at The Matheney School, which specialized in treating children with cerebral palsy. While there, he invented a communication device that translated children’s facial expressions into pre-recorded phrases. The immense satisfaction of using his inventive mind to address a medical problem set him on the path that would define his future.
After three years of medical school, Mir yearned to break away from the practical aspects of a career in medicine, so he focused his energy on creation and innovation.
During his storied med-tech career, Mir has founded more than 22 companies and has more than 400 patents to his name. He has invented dozens of medical devices, including: the first FDA-approved automatic implantable cardioverter defibrillator (ICD) at Intec Systems; a cooled RF ablation catheter for the treatment of ventricular arrhythmias at Cardiac Pathways; a low-pressure balloon and aspirator system for catheter-based interventions at Percusurge; the EEG monitoring sensor array used by astronaut John Glenn on his last space mission; and a new implantable treatment for chronic pain at Spinal Modulation, which was recently acquired by St. Jude Medical, now Abbott.
His most recent invention is the RaniPill capsule, which has the potential to be the next breakthrough in oral drug delivery, by both extending the lifecycle of existing medications and becoming the go-to delivery platform for new biologics.
This innovative delivery system is a “robotic” pill that is able to navigate through the stomach and enter the small intestine. The patient takes what appears to be an ordinary capsule, but this capsule passes through the gut and delivers an intestinal injection without exposing the drug to digestive enzymes. This sophisticated device is being developed by Rani Therapeutics, an InCube spin off. The technology has potential applications for injected drugs that treat a range of diseases, such as diabetes, rheumatoid arthritis, Crohn’s disease, and psoriasis. The company plans to conduct clinical trials with octreotide for acromegaly.
Mir says the development of the RaniPill capsule has been his most challenging technical problem to solve. “This is a problem that has eluded a solution for decades,” he says.
He is unfazed by the challenges of developing new innovations to solve some of the industry’s most pressing unmet needs to help patients. Mir plans to continue to innovate until he dies. “I am passionate about changing healthcare and coming up with new solutions that will impact the lives of millions of patients.” It is this passion for turning innovations into clinical success that motives him to come to work every day.
Mir believes success is a process and a way of life. “It’s not an event,” he says.
Colleagues are inspired by his commitment to solving the problem of delivering healthcare to all patients across the globe in an efficient and cost-effective manner. Mir has also drawn industrywide accolades for his efforts, having been named as one of the “Top 50 Medical Device Inventors of All Time,” recognized as a National Academy of Inventors (NAI) fellow in 2015, and elected to the National Academy of Engineers in 2017, a high honor in engineering. (PV)
For Focusing on Rare Disease
Title: Executive VP and Chief Commercial Officer
Company: Horizon Pharma
Education: MBA Kellogg School of Management, Northwestern University
Family: His top priority
Hobbies: Golfing, hanging out with his family, enjoying fine wine
Awards/Honors: President’s Club
Associations: Board member of Arthritis Foundation, Chicago chapter; Mentor, CIM (Chicago Innovation Mentors)
Personal Brand: No Patient Left Behind
Vikram Karnani is a leader who tackles any challenge with an open mind and quickly finds a solution, so it didn’t take long for him to have an impact on Horizon Pharma when he joined the company in 2014 as VP and general manager.
Three years and three promotions later, it’s no surprise to those who work with Vikram that he is credited as one of the individuals responsible for leading Horizon’s transformation from a company focused on primary care products to one that is dedicated to bringing to market products to address the many rare diseases without any therapies.
Upon arriving at Horizon as VP of the rheumatology business, he expanded the team from 40 people to 160 and increased revenue from $20 million in 2014 to $200 million in 2017. He achieved this by bringing together all of the elements of strategy, sales, marketing, patient services, etc.
Committed to continual improvement, Vikram is visible with Horizon’s customers and community, learning and listening to enhance the services the company offers and the way it does business.
As the chief commercial officer, he is incredibly focused on numbers, metrics, and performance, but colleagues say although these things are important, Vikram looks at his role through the lens of helping patients and making a positive impact on them and their families.
While many people know about Vikram’s leadership and motivational skills, few people know that the foundation for this talent is his belief in helping all people succeed, and as a result, bringing forth the best medicines to relieve the pain of others.
Colleagues credit his success on his ability to see the big picture and to take on and complete large projects and break new ground. For example, when Horizon faced a set of challenges with a business unit that was less profitable than anticipated, Vikram quickly decided to launch one of the company’s products into a new specialty. This was a decision that resulted both in addressing an unmet patient need and delivering unprecedented quarter over quarter growth on a product that had been on the market for several years. Analyzing issues, bringing people together, and influencing them to pursue optimal solutions is in his DNA.
“It helps to have a plan,” Vikram says. “If a plan is well-thought out, based on real data, then temporary challenges are just speed bumps.”
He is deeply committed to bringing life-enhancing and in some cases lifesaving medicines to patients. Vikram’s patient-first approach is driven in part by his upbringing in India. His mom was a doctor, and she instilled in him intellect and compassion.
With more than 15 years of cross-functional expertise across a multitude of industries, including medical devices, management consulting, semiconductors, and cellular telecommunications, Vikram brings a unique perspective and skill set to Horizon, which is much-appreciated by his colleagues and team members.
An inclusive leader, Vikram strives to be transparent and authentic when sharing or seeking information and he is known for providing consistent and clear direction about expectations.
He is solutions-oriented and encourages outside-of-the-box thinking to get the job done efficiently and compliantly.
Vikram encourages innovation and trusts his teams, allowing them to flourish and grow in their roles, which leads to retention of top talent.
Mentoring is important to Vikram. “There isn’t a book that teaches you about life lessons; you can only learn those from mentors,” he says.
He credits Horizon CEO, Tim Walbert, and Fenwal CEO Ron Labrum as two people who have provided him with mentorship. (PV)
Dr. Nuala Murphy
For Raising the Bar on Clinical Performance
Title: President, Clinical Research Services
Company: ICON plc
Education: BSc, Biochemistry, Trinity College Dublin; PhD, Neuropharmacology, University of Leeds
Awards/Honors: One of Ireland’s Top 25 most powerful women, business leader category, Women’s Executive Network WxN, 2017; Under her leadership — Clinical Research Team of the Year, Care Awards, 2018, Best Partnership in Clinical Research, PharmaTimes, 2017
Nuala Murphy, Ph.D.’s success in clinical operational delivery and raising the bar in project success is achieved through an unwavering passion to offer the best possible services to clients. As president, clinical research services, ICON, she oversees the largest multidisciplinary division with employees spanning across 38 countries. She has executive responsibility for driving excellence in global operational performance and delivering industry-leading metrics that support pharma, biotech, and medical device companies.
At the end of 2017, her division had responsibility for overseeing more than 340 active studies with 8,500 active sites, and 39,500-plus active patients. She is particularly proud of her group’s industry leading metrics; under her leadership, ICON has been able to deliver locked databases within 20 days of last patient out, exceeding industry standards by as much as 60%. “Ultimately, it’s about how well our team can support our customers to gain approval from the regulators to bring new treatment options to patients,” she says.
With a focus on market leading innovation, her group expanded into the field of adaptive trial design, post-acquisition of Aptiv Solutions in 2014, while expanding its Japanese footprint in oncology.
Those who work with Dr. Murphy say she is a truly inspirational leader and drives performance and relationships through engagement and development of her teams. She brings vision — the opportunity to make a difference in unmet medical needs by transforming the way clinical research is conducted — to the organization and provides motivation across multiple groups and functions to drive and execute on that vision. She questions the status quo internally and engages her pharma and biotech client counterparts in conversations on how to work together to really transform the way clinical research can be conducted not just in the future but in real terms, today.
“I am passionate about supporting our clients to make a difference in patient lives,” she says.
Fostering collaboration is an important factor to great leadership, and one of Dr. Murphy’s strengths is her ability to build teams based on collective strengths with the dynamic of achieving more as a team than on an individual level. She excels in identifying high potential leadership talent and in nurturing and developing that talent. She continually encourages her leaders and business partners to step into the limelight and she supports them as they try to reach their full potential. In so doing she builds long-term trusted relationships with her extended team to drive organizational success.
Dr. Murphy says she and her teams are driven to always find a better way to support clients to reduce time and increase quality in clinical development. “Innovation is at the core of what we do, every day,” she says. “We work together to ensure that new technologies and processes are seamlessly integrated into our delivery processes to minimize disruption and optimize outcomes — we make innovation happen.”
Our industry, Dr. Murphy points out, is highly regulated and therefore can be very conservative in approach to ensure compliance. “The safety of the patient is and always will be paramount in clinical trials, but to transform, we must push the boundaries to improve patient care. Maintaining the balance is always the challenge.”
Leading a globally dispersed team, Dr. Murphy focuses on the benefits that diversity and engagement can bring to the organization. Over the last five years, she has driven increased employee engagement, reflected by survey scores, and takes meaningful actions to support continuous improvement in this area to create a positive working environment for her people.
Her own leadership team mirrors the diversity of the company from a gender and regional representation and many of the senior leaders have been mentored and coached by her and benefited from her industry insight and leadership style.
“I encourage my senior leadership team to take an active role in the development of coaching and mentorship programs that support ongoing professional development and long term succession planning for the company,” she says.
Dr. Murphy is committed to developing people and in particular is passionate about the next generation of scientists, believing that they will play a critical role in the evolution of transformative trial execution. She has shown this passion through her leadership in developing and embedding the graduate program and Clinical Research Associate Academy at ICON, an initiative that is very close to her heart. (PV)
For Challenging the Healthcare Status Quo
Education: BA, Political Science and International Relations, West Virginia University
Family: Husband, Jeff Bresch; children, Chloe, Madeline, Kelsey, and Jack
Hobbies: Fitness zealot, closet chef
Awards/Honors: #31 in Fortune magazine’s 50 Most Powerful Women list, 2014; EY Global Impact of the Year Award, 2014; Albert Schweitzer Leadership Award honoree, 2017
Associations: Chair, Association for Accessible Medicines, 2016, 2005, and 2004; vice chair 2003 and 2006
personal Brand: Work Hard
Mylan CEO Heather Bresch is no stranger to publicity. Her frequent appearances in major business magazines and newspapers, as well as on TV and radio, might make her one of this year’s most visible PharmaVOICE 100 honorees.
As the first woman to run a Fortune 500 pharmaceutical company, and the daughter of a politician — former West Virginia Governor and current U.S. Senator Joe Manchin — she is aware that every move she makes is under scrutiny. But that doesn’t stop her from taking on the challenges set forth by the nature of the industry, the healthcare system, or any alleged gender bias in the STEM field.
In 1992, Heather started working as a clerk in a factory owned by Mylan fresh out of college. According to Heather, she almost didn’t accept that first job, but her father encouraged her to try it for one year. She took his advice, and has been there ever since.
Throughout her nearly 30-year career at Mylan, Heather has provided passionate global leadership on key healthcare and pharmaceutical issues. Among her policy priorities is ensuring that everyone living with HIV/AIDS has access to high-quality, affordable drugs and advocating for treatment soon after diagnosis to produce better health outcomes, reduce HIV transmission, and create long-term cost savings.
Heather also has been a leading advocate for global competitiveness and quality standards and was instrumental in developing the Generic Drug User Fee Act (GDUFA), which aims to hold all drugs sold in the United States, to one quality standard. She actively advocates for the implementation of a viable abbreviated approval pathway for safe and effective generic versions of biologic drugs, which will provide patients with access to lower-cost versions of these life-saving products.
Early in her career, Heather played a vital role in the passage of the 2003 Medicare Modernization Act, a congressional revision to the Hatch-Waxman Act of 1984, which created Medicare Part D, a prescription-drug benefit.
In 2006 Heather testified before the U.S. Senate Special Committee on Aging to lobby for changes to the law that would prevent pharma companies from raising challenges to the introduction of generic competitors by filing citizen’s petitions with the FDA, which would prevent pharma companies from undercutting the profits of generic companies by making deals to introduce authorized generics.
Looking toward the future, Heather is pushing for an accelerated pathway for a generic version of biologic drugs to provide patients with access to lower-cost versions of these life-saving products. An example of Heather’s commitment in this realm includes the December 2017 FDA approval of Mylan and Biocon’s Ogivri, which potentially will make Mylan the first company to provide patient access to a biosimilar to Herceptin for the treatment of HER2-positive breast cancer.
Heather oversees a workforce of about 35,000 people, a global research platform, a geographically diverse manufacturing footprint, and a portfolio of more than 7,500 products marketed in more than 165 countries and territories.
Heather inspires her colleagues and teammates with her infectious passion about cost-savings to patients and the healthcare system, and under her leadership, Mylan is one of the largest generic drug suppliers in the world.
She is one of only 24 female CEOs of Fortune 500 companies in 2018, and Heather hopes her performance as CEO is evaluated on her accomplishments and not on her gender. She is outspoken about empowering women to aim for C-suite jobs and to choose degrees in STEM. She encourages a diverse board and environment at Mylan, believing that diversity brings a rounded approach; Mylan’s board is 36% women. (PV)
For Lifting eCOA to New Heights
Title: President, eCOA, Patient Engagement
Company: mProve, a Bracket company
Education: Masters, International Management, Thunderbird School of Global Management; BA, International Relations and Spanish, Bucknell University
Family: His parents, Bob and Sandy, who passed away within 30 days of each other, which was also the same month his first child was born in 2010 — this dreadful experience inspired him to direct his career interests toward mobile health
Hobbies: Flying — the private aviation kind, not just traveling for work
Awards/Honors: Best Patient-Focused Technological Development for ePRO/Patient Engagement offering, Clinical & Research Excellence Awards; a Health 2.0 Developer Challenge winner
Associations: DIA, Mindshare, a DC-area CEO group
Personal Brand: What you see is what you get
With a belief in the power of mobile technology to improve the quality and efficiency of data collection, Jeff Lee founded mProve Health in 2010 to build solutions that deliver an outstanding user experience, transforming the way patients participate in clinical research.
His devotion to instigating real change and inspiring the industry to rethink the way it interacts with millions of patients, has earned him a reputation as one of the most influential technology leaders across the pharmaceutical and clinical trial sectors.
Without outside financial backing, Jeff co-founded mProve Health — with his business partner, Denis Curtin — with grit, determination, and a conviction that he could rewrite the rules. “The company managed to compete against larger, better funded companies, while remaining profitable and innovative,” he says.
The first step at mProve was using SMS messaging to improve the patient experience. “When smartphone penetration was nearing 50% in developed countries, we launched a first-of-its-kind patient engagement app to optimize and create the best possible patient experience,” he says.
So often, technology companies are focused on building solutions that they think meet customer needs, but colleagues and competitors say Jeff has an innate ability to understand what can make data collection better in trials for both sponsors and patients. Jeff’s passion for driving the industry’s shift toward higher quality data and improved patient engagement in clinical trials is inspiring.
“It’s crucial to be able to put yourself in the mindset of the patient, the research site, the client, employees, or even business partners — this allows for insights and collaboration that many people just don’t unlock,” he says. “Empathy is a secret weapon for success.”
One example of his innovative thinking was his entering and winning the Health 2.0 ADHD App Developer Challenge, sponsored by Shire. The resulting app, Traxion, is a virtual coach built for the needs of patients with ADHD during a critical and highly dynamic period in their lives. The app helps schedule tasks and events, and reminds users to complete specific activities, while supporting and encouraging them along the way as kids transition into adults.
He also has been instrumental in helping pharma companies adopt ePRO, eCOA, and patient-centric data solutions, helping to improve the pathway to market for many medicines.
As a non-native to the life-sciences field — having worked in strategic consulting for organizations such as EY — Jeff is not burdened by the way things have always been done. He came to the field ready to innovate and serve up processes that challenge the norms. At the same time, he has gained a rich global vision and in-depth understanding of how the industry works, as well as how it can work for the better.
Having been one of the first advocates of the bring-your-own-device (BYOD) methodology in clinical trials, Jeff has been instrumental in helping many of the industry’s sponsors and CROs to make the leap toward a patient BYOD experience. “It’s taken years for mature organizations in the eCOA field to stop resisting BYOD,” he says. “The resistance is not really based on unsolvable concerns about BYOD, it’s more based on vested interests in the established ePRO model.”
Like a true advocate, Jeff stays abreast of all of the industry’s developments and is a provocative voice in the on-going conversation regarding the use of mobile in clinical trials.
He would like to be remembered for breaking new ground and constantly trying to rethink the patient experience, and for being a straight-shooter. Colleagues admire Jeff for his urgency to sustain the pace of innovation, for his vision, his energetic, yet friendly and approachable style, as well as his sense of humor — all of which have earned him much-deserved respect from the industry.
His sense of adventure and willingness to take risks have helped to define his approach to leadership and to challenge the status quo in today’s clinical trials. Eager to share his insights and ideas with the wider industry, he maintains an active presence at industry conferences where he presents his approach to implementing mobile in clinical trials, and particularly BYOD.
“The ability to bring ideas to life in ways that can materially help people is really gratifying,” he says.
Jeff’s enthusiasm is infectious with both the team at Bracket — Bracket bought mProve in October 2017 — and with clients. He, in turn, is inspired by the ingenuity of his team members.
He wants to be a force that connects software developers and business problems. “By helping channel the talents of gifted software developers, I believe that I can make a difference in our industry,” he says. (PV)
For Taking Data Science to the Next Level
Title: Chief Data Officer
Company: Medidata Solutions
Education: BS, Biometry and Statistics, Cornell University; MA, Statistics, Columbia University
Family: Wife, Miyoung; children, Nathaniel and Amilia Rose; parents, Daniel and Anna
Hobbies: Reading, soccer, and table tennis
Awards/Honors: Best Tech Innovation in Clinical Trials — Sponsor Focused, Scrip Award, 2017; PM360 Innovators, 2017; Medidata Innovator Award Winner, 2014; SAS Enterprise Excellence Award, 2012
In what might seem like an unlikely transition, David Lee, chief data officer of Medidata Solutions, took his 15 years of experience as a data scientist in insurance and consulting and translated it into near instant success at Medidata by providing vision and leadership for initiatives related to advanced analytics and big data.
Since joining the company four years ago, he has grown the data science department by more than 500%, created several new data-driven solutions for life-sciences companies that have received industry awards, and been published in Nature Reviews Drug Discovery, American Society of Clinical Oncology, and Joint Statistical Meetings.
Straight out of grad school in 2004, David was offered the chance to be the first-ever predictive modeler for the insurance company AIG. Back then, data science was not even a term yet, but AIG senior management knew that certain hedge funds were gaining an information advantage through predictive modeling. AIG wanted to access that advantage too. David saw this as a great opportunity to identify massive operational and informational inefficiencies that could negatively affect the company and figure out how to solve them.
“What attracted me to that job was the opportunity to use historically collected data through predictive models, instead of just intuition, to vastly improve future underwriting decisions and business results,” he says.
After one year working on the predictive modeling project, David deployed a highly accurate predictive model into the underwriting production process. As more people realized its value, David’s solution transformed that business from the biggest money loser to the biggest moneymaker.
When David joined Medidata, he was a newcomer to the life sciences, but biostatistics and clinical trials were in his academic DNA. He looked forward to the challenge and his bringing the perspective that proved successful at AIG. Medidata’s data assets were an information gold mine waiting to be tapped. The move proved to be a smooth transition for him because just like insurance, pharma is a business of risk and he was used to the high stakes.
Since joining Medidata, David and his team have been innovating and reshaping the world of clinical development: a new tool that mitigates the risk in go/no-go decisions after early phase trials and another solution that uses machine learning to streamline and automate genomic biomarker discovery. A third creation quantifies operational performance metrics to help pinpoint inefficiencies in clinical trials across thousands of studies for hundreds of sponsors.
David built a 60-plus member team that includes former FDA reviewers, Ph.D. biostatisticians, genomicists, predictive modelers, and data wranglers. These team members are inspired by his unique problem-solving mentality, his collaborative bent, and his logical and inquisitive nature.
In 2017, on behalf of his team, David accepted the Scrip Award for Best Technology Development in Clinical Trials Sponsor Focused for Medidata’s Synthetic Control Arm. Often in serious diseases, such as oncology, it’s considered unethical to require a control arm in early phase trials. But single arm trials result in scientific difficulty for pharma companies when making go/no-go decisions, since a control group is not available as a baseline. Incorrect decisions contribute to the high late-phase failure rate, and these failures might often be predictable and avoidable if a control arm — synthetic or actual — was available. Medidata’s Synthetic Control arm can help avoid late-phase trial failure while achieving a higher level of ethics.
“We’re constantly figuring things out in the life sciences,” David says. “We don’t always have all of the variables, data are often siloed, and we know that no model is perfect. This all part of the challenge and fun.”
He feels that while biostatistics and experimental design have gotten the industry far already, there is more to do, and the life-sciences industry will benefit from taking a page from other industries that have embraced data science. “Being data-driven is a key to further advancement,” David says. “If we stand on the shoulders of the many giants in data science fields, just like Netflix has done in entertainment, we can harness these powerful capabilities to solve life-science problems differently.” (PV)
For Driving Research Into Blinding Retinal Diseases
Title: Chief Operating Officer
Company: Foundation Fighting Blindness
Education: BA, Communication, Oakland University
Family: His wife, Leanne, who is the catalyst to his whole career and inspires him daily; his three children, parents, brothers, and sister
Hobbies: Travel; doing things around the house, especially landscaping and gardening; golf, although he is not sure yet if he loves it or hates it
Awards/Honors: Ophthalmic Brand Champion Award, PM360, 2014; Finalist for Unbranded Campaign of the Year for Sjogren’s Syndrome campaign, PM360, 2014; Finalist for Medical Device Brand Campaign, Sjo, Med Ad News, 2013; Finalist for Medical Device Brand Campaign, AdenoPlus, Med Ad News, 2012; One of the 50 outstanding innovators in Pharma, PM360, 2012; Winner of the Professional Brand Campaign of the Year, AzaSite, PM360, 2010; multiple President’s clubs, Circle of Excellence’s, and CEO awards
Personal Brand: Work Hard. Be Real. Do Good.
It doesn’t surprise people who know Jason Menzo that he would take his 15 years of experience and become a patient advocate. After Jason spent the bulk of his career as a marketing, sales, and operations executive with ophthalmic pharmaceutical and medical device companies, in March 2018 he was named chief operating officer of Foundation Fighting Blindness.
“My passion fuels me and I hope, in turn, inspires my teams,” Jason says. “I love what I do. I love leading people and inspiring them to do great things with their talents. I love creating brands that help people. I love the missions that the organizations I’ve been a part of stand for. I consider myself fortunate to have had so much fun doing what I love for a living.”
Now in his current role at the Foundation Fighting Blindness, a source of research funding for preventions, treatments, and cures for retinal diseases, Jason is able to use his marketing prowess to help those struggling with retinal diseases.
“My new role has exposed me to dozens of massively inspirational people, from Gordon and Lulie Gund, Bradford and Bryan Manning (from Two Blind Brothers, a clothing company in New York), Ben Yerxa, who is leading this organization into a new chapter with brilliance and grace and David Brint, who I learn something from nearly every time I interact with him,” he says. “I am passionate about our mission of driving research to find treatments and cures for the range of blinding retinal diseases that affect tens of millions of individuals worldwide,” Jason says. “We are the leading organization in this space and are making great strides toward our mission with almost 30 clinical-stage programs worldwide.”
Those who know him say Jason is a visionary marketer and passionate leader, and as a result of his dedication and expertise, brands under his stewardship have been awarded many industry accolades and honors.
Jason says he wants to be remembered by the impact he has made on his team first and foremost. He believes the culture of an organization is a reflection of the people that comprise it. A great place with a great culture starts with the team, he says.
“I hope everyone who has worked on my team looks back and thinks of our time together as the highlight of their careers,” he says. “I hope they had the most professional growth, the most fun, and that the experience defined their career expectations.”
Jason says the highlight of his career to date has been being a part of the launch of Sun Ophthalmics. The organization started with four people and a vision to build a world-class company in the ophthalmic market. In two years, the company had grown to more than 120 people, launched its first product, and had a 20% plus market share.
As VP, sales and marketing at Sun Ophthalmics, his team encompassed sales, marketing, training, sales operations, and professional relations, and they adopted a “concierge service” mindset to engage the professional audience. The company’s first product, BromSite, is the first ophthalmic NSAID indicated for prevention of pain and controlling inflammation in patients undergoing cataract surgery.
“I hope that the work accomplished had a meaningful impact on the patients we’ve served and the marketplace,” he says.
Patients are a key focus of Jason’s vision of success, which he also defines as progress.
“Whether looking at the performance of a brand, a business, or a career, I try to measure success in the incremental steps of progress,” he explains. “Sometimes we only look for the big milestones to define success, but I feel that success is like a fledgling campfire, and the baby steps of progress are like kindling.”
Having had dozens of mentors in his life, which is why mentoring is so important to him today, he would like to highlight a few individuals who helped change the trajectory of his career and life, one being Jerry St. Peter, who is now the CEO of Eyevance Pharmaceuticals. “Along the way I met another great friend and mentor Jason Werner,” he says. “Like Jerry, Jason and I have built businesses side by side, and I have learned literally volumes of knowledge from him. I also am lucky to count another PharmaVOICE 100 as a mentor and friend — Frank Powers. Frank has taught me so much about brand building, positioning, and how to build iconic brands.”
When it comes to paying it forward, Jason and his family are involved with local and national organizations that are focused in the area of autism, including Autism Speaks and Camp Bluebird. His wife Leanne writes a weekly blog on Autism and as a family they are passionate about raising awareness and acceptance of those affected. “Our youngest daughter, Addie is affected with autism, which has propelled our family to get involved.” (PV)
For Leading a Digital Revolution
Title: Chief Digital Officer — Health & Wellness
Family: Wife, three sons, they are the reason he does what he does
Hobbies: Soccer once a week; Radio show once a week, both passions
Awards/Honors: Clio Award for the best use of Social Media in Pharmaceutical, 2011
Associations: Asthma and Allergy Foundation of America Board; Advisor to Pebblepost, a programmatic direct mail company; Adviser to Medable, a healthcare platform company
Personal Brand: Imagination and Integrity
Ritesh Patel, chief digital officer, health and wellness, at Ogilvy, has been pioneering the use of digital, social, and mobile in healthcare for years, and has cultivated a presence both on and offline that rivals omnipotence. A speaker, digital evangelist, consultant, and innovator, Ritesh daily proselytizes the digital future of healthcare. His energy and enthusiasm are larger than life, and his influence is felt across the industry.
His storied career started at Chandler Chicco, where he established the digital and social media practice. First came the digital and social ecosystem for DRIVE4COPD, a highly successful campaign for Boehringer Ingleheim to raise awareness of COPD that used Facebook, Twitter, YouTube, Twibbon, and a custom Windows-based mobile app to screen potential patients at NASCAR events. He then waded into digital waters neck deep by convincing the brand manager for tobramycin at Novartis to create a Facebook page for patient outreach work. He won a Clio award for that initiative and the tobramycin Facebook page is still active today.
More recently, Ritesh worked with the digital team at Ogilvy CommonHealth Worldwide (OCHWW) to create the industry’s first marketing cloud that enables clients to truly have a 360-view of their HCP customers. He also led the team that successfully created an EHR practice enabling the manufacturer to directly message HCPs on an EHR platform. The majority of OCHWW client brands now use this innovative solution.
Additionally, he championed the OCHWW Innovation Lab, which is central to all the work conducted at OCHWW. The Lab is responsible for showcasing to clients the art of the possible.
Voice-activated systems such as Alexa and Google Home, connected homes, wearables, chatbots, and AI are the subjects Ritesh and the Lab are focused on so that OCHWW is better able to showcase how these tools and technologies have and will continue to impact healthcare for clients in the not-too-distant future.
His recent move to Ogilvy sees him working with many senior pharma clients as they begin the digital transformation of their business. From social business, to innovation and working with stratups, Ritesh is an outspoken digital evangelist who has lent his expert opinion in a variety of forums over his career.
He is passionate about educating both peers and clients about what the future of digital looks like for healthcare. In addition to all the innovations he’s been responsible for bringing forward, he has taken his missions on the road and he has been a keynote speaker at a wide variety of digital and healthcare-centered events all across the world.
Ritesh has a proven history of bringing to life programs and practices others have never dreamed of — or if they dreamed them, they didn’t dare take them on. Colleagues say there really isn’t anyone else like him — with his inspirational vision, passion, visibility, and drive — in the industry.
And we’d be remiss if we didn’t mention that Ritesh has accomplished all these achievements with little formal education. He quit the Trinity School for Boys at age 15. (PV)
For Serving Patients in a Meaningful Way
Title: Senior VP and Chief Financial Officer, Ipsen North America
Education: BBA, Pace University; MBA, Lehigh University
Family: His wife, Rosemary, and four children — Jillian, Tara, Haley Rose, and Brendan
Hobbies: Running and exercising, boating, following NY Giants
Associations: NY State Society of CPAs, AICPA, and CPA New York State
Personal Brand: Make it happen
Harry O’Grady is a 30-year veteran of the life-sciences industry and he remains energized by the work he and his team members do every day at Ipsen to serve patients and make a meaningful difference in their lives.
Toward the end of 2017, Harry stepped up to serve as interim president, commercial operations, of Ipsen North America. He helped to steer the organization during the integration and manage the transition to new leadership.
“My interim role as president, commercial operations, for Ipsen North America required strong and steady leadership and ensuring business continuity as the company underwent a series of changes, which was a career highlight and challenge, he says.
Harry’s colleagues admire his determination and pursuit of excellence. He is committed to making sure the company’s operations are based on objective business discussions, which ensure joint ownership and accountability to all stakeholders, and successfully promote teamwork and transparency. This business focus and working style allow for the marketing and sales teams to function at a higher level with the goal of better serving patients.
While his unique combination of financial, operational, strategic, and sales expertise create and develop high-performing teams driven to achieve top and bottom-line results for Harry, the true success is measured in patients’ lives impacted.
“As a member of the life-sciences community, the patients we serve always are an inspiration to the work I do,” he says. “Hearing their stories as they struggle with difficult-to-treat diseases and learning how Ipsen medicines may help them drives me to continue succeeding in my role.”
He also has been instrumental in the growth of the Ipsen U.S. business, serving as a key leader in the integration of the acquisition of an important pancreatic cancer therapy from Merrimack Pharmaceuticals.
Part of driving success is being willing to take risks and learn from failure. “If a company and its leaders are not willing to explore the unknown, and look at opportunities for innovation, they will never know how far they can go as a business,” Harry says.
One of the biggest concerns for industry leaders, he adds, is the time it takes to bring a drug to market. “We need to ask ourselves if we are doing enough and what more can be done to bring solutions to patients faster,” he adds. “That is why at Ipsen, we have made a bold promise to bring one new indication or molecular entity to market every year.”
Passionate about what the company is doing in the areas of oncology, neuroscience, and rare diseases, he strives to ensure everyone knows — and understands — why it’s so important. “Our focus is and always will be our patients, and the opportunity to make a difference in their lives,” he says. “Through any challenge that arises, this is what motivates us — the fact that our patients cannot wait.”
Harry openly invites ideation from his team members and then uses fact-based data to move programs forward. He supports professional development and empowers those who work for him to achieve greater heights in both their careers and personal lives.
Leadership can be many things but to Harry it’s mostly about inspiring, empowering, and developing others, and about being able to see challenges as opportunities — both personally and professionally.
“I try my best to lead by example and to listen,” he says. “That’s incredibly important and can help steer others on a better path.”
He is a mentor and role model for many in the finance function and across the company as a member of the North American Leadership Team, and he is always happy to serve as a sounding board for ideas.
“To me it’s important to try to help people, but also to learn from them — so mentoring and being mentored, and learning from listening are extremely valuable,” he says.
Throughout his career, Harry would like to be viewed as a strong and compassionate leader who lives with integrity and treats people with respect. (PV)
For Serving In-Need Communities
Title: President and CEO
Company: Strongbridge Biopharma plc
Education: BS, Central Michigan University; MBA, Central Michigan University; JD, Michigan State University College of Law
Family: His mother, Pamela Pauls McCaffrey, who passed away on May 28, 2016, from glioblastoma multiforme and was one of the best people he ever met; his grandfather, William Walsh, who passed away on Oct. 29, 2017, and was a tremendous role model for him in so many ways; his son, Chandler Fraser-Pauls, 25
Hobbies: Running, biking, basketball, acoustic guitar playing
Awards/Honors: EY Entrepreneur of the Year Finalist — Greater Philadelphia, 2016; PM360 Trailblazer Specialty Pharma/Biotech Company of the Year, 2017; Marcom Gold Award Winner, 2018
Associations: Life Sciences PA, Healthcare Businesswomen’s Association (HBA), NORD, Global Genes
Personal Brand: The Underdogs — don’t ever count us out
When selecting a mascot for Strongbridge Biopharma, the 1960s cartoon character Underdog struck a chord with Matt Pauls, not only because it reflected the company’s small size in comparison with its bigger peers, but more importantly it symbolized the company’s desire to serve communities that are often overlooked and underserved in the drug development and commercialization process.
Since becoming CEO in 2014, Matt has been instrumental in attracting industry-leading talent who have rare disease expertise and growing the number of employees in the United States from three to more than 100 by the end of 2018. He navigated the company through a difficult IPO market in 2015, while helping Strongbridge Biopharma to realize significant market capitalization growth during the past 15 months — from about $85 million to over $300 million.
In addition, Matt moved the company from Sweden to Ireland and rebranded the firm from Cortendo AB to Strongbridge Biopharma. The evolution of the new brand was guided by Matt’s vision to create a new identity that better reflected the company’s strength and commitment to connecting or bridging treatment gaps as rapidly as possible.
Colleagues applaud him for creating a patient-driven culture, one that is fueled by performance, precision, and a united purpose to remove the barriers and isolation associated with rare diseases to connect patients with life-enhancing treatment options.
People and patients are at the heart of what drives Matt in both his personal and professional life. He has a genuine desire to make a lasting impact on the community around him, an important goal for someone leading a company focused on addressing the needs of people with rare or ultra-rare diseases.
“Over the last 10 years, I have helped run a nonprofit youth basketball program that has helped numerous young people — many of them from underprivileged home situations — find a path to a college education via basketball,” he says. “And along the way I have probably learned more from the incredible young people I have worked with than they have from me.”
This same commitment to the rare disease community is evident in every move Matt makes to move the company forward, including the acquisition of its first rare disease commercial product — Keveyis — in late 2016 and more recently its second product Macrilen. Keveyis, granted an orphan drug designation, is the first and only FDA-approved treatment for hyperkalemic, hypokalemic, and related variants of primary periodic paralysis (PPP) — an ultra-rare neuromuscular disorder. Macrilen, a new prescription oral drug that has been granted orphan drug designation in the United States, is the first and only FDA-approved oral growth hormone secretagogue receptor agonist indicated for the diagnosis of adult growth hormone efficiency (AGHD), a rare endocrine disorder. The Strongbridge team are also anxiously awaiting the mid-year 2018 results of the SONICS Phase III clinical trial of Recorlev in Cushing’s syndrome.
Under Matt’s leadership, Strongbridge is bringing awareness, education, and resources to niche communities. For example, the company recently launched Uncovering Periodic Paralysis, a no-cost periodic paralysis gene panel testing program offered in partnership with Invitae. The program aids physicians in making an earlier and more accurate diagnosis for PPP, which can sometimes take up to 20 years to diagnose. Since launching the program, there have been a meaningful number of new and confirmed diagnoses and the company continues to build a database that may allow it to identify additional genetic causes of PPP.
Matt has positioned the company to commercialize its products efficiently using small, experienced, and focused sales teams. Colleagues say Matt’s steady leadership and determined focus lead to successful outcomes.
“Success can be measured objectively by delivering what you say you are going to do,” Matt says, adding that success is measured subjectively by asking if people do better when working with you or get better based on the product you and your colleagues develop.
He cares about his staff and their families and reinforces the company’s guiding principles of focus and commitment. Strongbridge offers employees benefits and policies that recognize work-life balance, thereby allowing employees to focus on the important business of serving rare disease patients.
He inspires his teams by setting the bar high, always telling the truth, and placing value on authenticity. “It’s all about people,” he says. “People help organizations be innovative. Culture equals people, people, people.” (PV)
For Focusing on Early-Stage Drug Development
Education: BSc, University of Bradford
Family: His mother and father, for the source of his values, principles, curiosity, and work ethic
Hobbies: Brewing, anything mechanical, playing with electronics
Awards/Honors: PharmaVOICE 100 — 2015, 2016, 2017, 2018; International Gamechanger of the Year, 2018; Best Early Phase CRO in North America as part of the Global Health & Pharma’s Biotechnology Award, 2018; International Full Service Early Stage Clinical Research Provider of the Year, 2018; CRO Leadership Award by Life Science Leader Magazine, 2017; Best Contract Research Organization – Niche, 12th Annual Scrip Awards, 2016; Montreal site was named Best Full Service Early Stage Clinical Research Provider – Canada by Global Health & Pharma’s Biotechnology Awards, 2016; recognized at the 31st Annual Canada Awards for Excellence ceremonies for outstanding performance, 2015; Grands Prix Québécois de la qualité, 2014
Personal Brand: It does what it says on the box
A true leader. A visionary. A clear and transparent communicator. A down-to-earth and caring executive. All of these inspirational notations and more from his colleagues sum up Chris Perkin, CEO of Altasciences.
Over the past few years, Chris has overseen the positioning of Altasciences Clinical Research as a midsize contract research organization that encompasses Algorithme Pharma in Montreal, Canada, Vince & Associates Clinical Research in Overland Park, Kan., and Algorithme Pharma USA in Fargo, N.D., with an overall company focus on supporting early-stage drug development.
Under Chris’ direction, the goal is to provide the best quality early-stage clinical development services to an international base of biopharmaceutical companies with a focus on customer service. Colleagues say he continuously looks for new ways to improve customer relationships and the range of services offered by the company. They also say Chris has created a culture that allows employees to grow and stretch their skill sets, which leads to increased value for customers and return for shareholders. Analytical by nature, Chris bases his decisions on facts and data, not on perceptions, and he encourages those around him to look at the business horizontally and not just vertically. Chris started his career in the life sciences as a smallpox and rabies research technician; over the next 40 years he has become an inspirational leader, guiding his teams to success.
“I encourage innovative thinking, and I want our people to be able to link different skills and experience to evaluate a process,” he says.
It’s the continual small victories that keep the business growing and innovating, the variety of each day, and engaging the energy of others that keep him motivated.
Chris never talks about problems, only solutions. His team members note that he continually offers guidance, which enables them to meet their objectives. Chris sets a clear vision and can transform massive amounts of information into concrete projects with clarity on how they lead to the end goal. He is open to all ideas and always involves others to increase the chance of success. More importantly, his folks say he delivers on his promises.
Chris believes in encouraging his team to stay the course when problems arise and to resist the temptation to change direction. He believes if the plan is solid and good, then that is the right direction.
Success for Chris is multi-factorial. It’s about creating value for investors; seeing individuals develop their skills and confidence; and having customers return regularly and recommending the company’s services to others.
His transparency, honesty, and leadership have led the organization to continue to grow and evolve with the changing industry climate.
Chris translates ideas into action by fully engaging key individuals around him, and he seeks to engage people at all levels and give them a voice as the business expands.
He drives success and truly demonstrates Altasciences’ values every single day. And he leads in a way that motivates people to be a part of the mission. Chris inspires those around him to improve where and when necessary to drive growth for the company.
“I do my best to lead by example and assume that everyone is doing their best,” he says. “I share as much information about the company and the business as possible and I talk continually about our vision for the future.”
Colleagues says that in an industry that has its ups and downs, it’s comforting to know that Chris is at the helm.
As a CEO, one would imagine that making time for employees is impossible, but that’s not the case for Chris. He has an open-door policy where if employees have questions, concerns, and/or feedback, he is there to listen no matter how busy his day is. His monthly blog keeps the entire company well-informed about the direction of the business, and he further ensures everyone is kept up to date with quarterly town hall meetings.
A willing guide, Chris takes time to work closely with many managers to guide them to achieve their full potential. “I do not claim to be their mentor but I do try to be a good manager,” he says.
A four-time PharmaVOICE 100, Chris’ legacy as a leader with strong values and ethics and inspiring visionary is well-grounded. (PV)
Dr. Gisela Schwab
For Following the Science to Drive Patient Outcomes
Title: President, Product Development and Medical Affairs, Chief Medical Officer
Company: Exelixis Inc.
Education: MD, University of Heidelberg, board certified in hematology and oncology
Family: Her husband, who has been and continues to be incredibly supportive throughout her career
Hobbies: Art, travel, exercise, playing with her two Golden Retrievers
Associations: ASCO, ASH, AACR
Personal Brand: Focus and never
For more than a decade, Gisela Schwab, M.D., has been dedicated to an important product franchise that has the potential to improve care and outcomes for people with cancer. Driven by the needs cancer patients have for new treatment options, Dr. Schwab is committed to overcoming the many obstacles to drive product development forward.
As president of product development and medical affairs and chief medical officer for Exelixis, Dr. Schwab has devoted her attention to the Cabometyx (cabozantinib) franchise, which has celebrated several recent successes, with approvals for multiple indications as well as forward movement in a number of clinical trials. Most recently, the FDA approved Cabometyx as a first-line treatment in advanced renal cell carcinoma (RCC), and Exelixis submitted an sNDA for cabozantinib for previously treated patients with advanced hepatocellular carcinoma (HCC), following highly encouraging data coming from a Phase III pivotal trial. Her work leading the highly skilled and committed team who developed this product for RCC patients has been a career highlight for Dr. Schwab.
In addition, she has overseen a broad clinical development program for cabozantinib as a single agent and in combination with immune check point inhibitors, encompassing Exelixis trials as well as studies funded by NCI-CTEP and independent investigators.
She has focused on following the compound where the science points and understanding how the drug can be applied to diseases for improved patient outcomes, whether it be as an individual agent or in combination with other oncology therapies. To that end, Dr. Schwab has played a crucial role in pursuing and facilitating several clinical development collaborations, including clinical collaborations with Bristol-Myers Squibb and Roche to pair cabozantinib with immuno-oncology agents.
Beyond cabozantinib, Dr. Schwab has also supported the process by which Exelixis is bringing new therapies into its pipeline, including the recent exclusive licensing agreements with both StemSynergy Therapeutics and Invenra for the discovery and development of novel anticancer therapies.
The cabozantinib development hasn’t been without challenges, including the need to reduce the workforce after a late-stage clinical trial failure in prostate cancer in 2014. In response, Dr. Schwab helped to refocus Exelixis’ work, ultimately leading to clinical trial successes in advanced RCC and HCC for cabozantinib. When such challenges arise, colleagues say Dr. Schwab helps the team to stay focused on the overall goal, encourages efforts to jointly address and resolve issues as possible, and keeps an open mind about revising plans as necessary.
She leads by setting the direction and goals, and encouraging innovation at all levels of product development. To do that, she says, we need to make sure that we hire the skilled and motivated people and enable them to be efficient and effective.
As a female chief medical officer in an industry dominated by male executives, Dr. Schwab understands her unique position as a role model for other women in the industry and the opportunity it presents to empower those around her. She attributes her successful career to role models and mentors in her past and is committed to paying it forward by supporting and mentoring those in her field and helping to remove obstacles they may face.
She hopes her legacy will be two-fold: making a meaningful difference in drug development that ultimately results in improved outcomes for cancer patients and supporting the career development of her team members. “I try to support and mentor my team members,” she says. “Much of learning is really learning on the job and collaboration along with effective mentorship is critical to success.” (PV)
For Taking Patient Engagement to New Heights
Title: President, Patient Engagement Division, WCG; CEO, ThreeWire Inc.; and CEO, MedAvante-ProPhase
Company: WIRB-Copernicus Group (WCG)
Education: BA, English Literature, University of Michigan; TOPGUN — Navy Fighter Weapons School (graduated top of class)
Family: His parents and his wife who have been constant sources of support and inspiration
Hobbies: Experimenting with different styles of homebrewed beer
Awards/Honors: Two patents on direct-to-patient marketing and clinical trials recruitment methods; Ernst & Young, Entrepreneur-of-the-Year Finalist, 2017; Alcon Laboratories — Marketing Director of the Year, 1993, Product Manager of the Year, 1991, Division Sales Manager of the Year, 1989; CooperVision — Territory Manager of the Year, 1988, Rookie of the Year, 1988, President’s Club, 1987 and 1988; American V. Mueller — Sales Specialist of the Year, 1985 and 1986; United States Navy — Pacific Fleet Pro of the Week (two awards); Navy Fighter Weapons School — TOPGUN Award (top of graduating class), 1980
Associations: Medical Alley Twin Cities Minnesota Clinical Research Hub, Military Officers Association of America, University of Michigan Alumni Association, Trinity Church Wayzata, Minn.
PeRsonal Brand: Never give up
It’s quite a journey from flying F-14 Tomcats in the U.S. Navy and being a TOPGUN graduate — top of class — to focusing on patient engagement for clinical trials, but Mark Summers is executing new approaches to solve one of the industry’s most persistent challenges with the same discipline and call- to-action he learned in the Navy. He is also unflappable in a crisis — Mark made the first-ever gear-up landing in an F-14 at night after a mechanical malfunction.
Mark’s measured outlook — essential in all Navy flyers — has stood him in good stead throughout his career and is contributing to his success in managing a new trio of senior executive positions at WIRB-Copernicus Group (WCG) as president of patient engagement, CEO of MedAvante-ProPhase, and CEO of ThreeWire.
As the electronic clinical outcomes assessment piece of WCG’s business, MedAvante-ProPhase provides services and technologies that improve the quality of clinical trial data collection and analysis.
Mark’s naval background continues to resonate in many ways. ThreeWire, for example, was named for the third of four wires on an aircraft carrier’s flight deck that catches the airplane’s tailhook on landing, it’s also the nickname for a perfect landing.
After leaving the Navy, Mark set his sights on a sales job at a Fortune 500 company and after several offers he decided to join American Hospital Supply Corp., his first foray into the world of healthcare. After serving in a number of leadership roles at several different companies in a diverse number of healthcare sectors, Mark founded ThreeWire so that he could employ a direct-to-patient marketing platform he developed. While the idea was ahead of its time, it became clear that the technology and service platform he had invented could be used very effectively for patient recruitment. Before long, he had a rapidly growing business, focused on patient recruitment services for the early-stage medical device industry.
When the recession hit in 2008, he had to either close the company’s doors or change direction. He steered ThreeWire through that difficult period by shifting the company’s focus to the pharmaceutical industry, and finding a niche providing support to investigator sites.
Getting through that tough period was all about resilience, learning perseverance, adapting to changing conditions, and managing some very difficult financial times.
It paid off and ThreeWire now works with most of the top 20 pharma companies and manages a large number of studies going on simultaneously. Including its personnel working onsite at investigator sites, the company has expanded its geographic footprint across North America, Europe, and Asia. In 2017, ThreeWire was acquired by WCG. Mark is proud of having built the company from the ground up.
And while being at the helm of three thriving entities is time consuming, Mark still regularly calls clients and visits sites. Even though other members of his team could make those calls, he loves to meet with study managers, coordinators, and investigators to find out about the challenges they are facing.
He also enjoys hearing from patients to find out what attracts them to a clinical research study and what barriers they have to overcome, mental or otherwise, to participate.
Mark is very quick to give credit to his colleagues for his successes, which is just one of the reasons why he is so well liked. Colleagues say he is also humble, intellectually curious, and open to hearing everyone’s opinion. “As a senior executive, who has spent 35 years in the pharma and medical device industries, I now focus on the leadership of those who are managing the businesses,” he says.
Colleagues are inspired by Mark’s desire to help them succeed, his ability to persevere when things get tough, and how he is always looking for ways to improve himself and the business. They also say Mark expects just as much out of himself as he does them. “I challenge others to never accept the status quo,” he says. “I believe that the more people say an idea won’t work, the more likely it is that we are onto something potentially special.
“Our goals are to exceed clients’ expectations and to help get new therapies onto the market for patients who need them earlier than expected,” he continues.
And Mark has the mettle and intelligence to make it all happen. (PV)
Dr. Helen Torley
For Launching Meaningful New Drugs
Title: President and CEO
Education: Bachelor of Medicine and Bachelor of Surgery degrees — MB, ChB, MRCP, University of Glasgow
Family: Her husband, Alain, whose love, support, and advice have inspired her for the last 30 years; her daughters, Kate and Julie, who inspire her and make her proud, and who are charting their own successful paths, on their terms
Hobbies: Basketball (Go Warriors); golfing; painting
In 2014, Dr. Helen Torley took the helm of the San Diego biotech company Halozyme at a critical time in the organization’s history — very little revenue was being generated from its core technology and resources were spread thin among a variety of disparate programs. In the four years since becoming CEO, she has almost doubled the market value of Halozyme and dramatically increased revenue to more than $300 million in the most recently reported fiscal year. In doing so, she has built a strong team and has earned the respect and admiration of her colleagues, employees, and the biotechnology community at large.
From a business perspective, one of the first priorities Dr. Torley undertook was to establish a strategic focus. At the time, the company worked in the broad areas of a delivery technology, diabetes, cosmetic therapies, and oncology. Following a strategic evaluation, she decided to focus exclusively on cancer and Halozyme’s Enhanze drug delivery technology and discontinue work in all other areas.
With its new focus, Halozyme moved forward its lead drug candidate, pegvorhyaluronidase alfa, which is now in a global Phase III study in pancreas cancer, with data anticipated in 2019. Additionally, demand for the Enhanze technology increased significantly, culminating with three new collaboration agreements in 2017 with Bristol-Myers Squibb, Roche, and Alexion. As of March 2018, Halozyme is partnering with eight pharmaceutical companies, and there are now three commercialized products that use the Enhanze technology.
Dr. Torley is admired as much for her drive to realize results as she is for her supportive nature, desire to bolster team development, recognition of the benefits of diverse teams, and her sponsorship and people development.
As a physician, she holds patients as the priority for every decision she and her teams make. She wants everyone at Halozyme to understand and share in the company’s mission of transforming and enhancing patients’ lives.
Before Haloyzme, Dr. Torley was instrumental in bringing several significant new therapies to market, including Prolia for osteoporosis, Sensipar for secondary hyperparathyroidism, and Kyprolis for multiple myeloma. “I am proud to have played a key role in gaining approvals and successfully launching new drugs or new indications that helped many people and today are highly successful commercially,” she says.
She has made substantial investments to foster a culture that embraces collaboration, innovation, and career development. “One of the best business books I have read is Patrick Lencioni’s The Five Dysfunctions of a Team,” Dr. Torley says. “When teams truly collaborate remarkable results occur.”
She has sponsored and coached multiple individuals who are now in leading roles at multinational biopharma organizations. As one example of her investment in development, Dr. Torley promotes and uses sponsorship — a step up from a mentorship program — designed to identify talented employees and work with them to stretch their skills. She frequently acknowledges that without active sponsorship from her prior managers and senior colleagues she wouldn’t be where she is today.
“When people ask me about having a mentor or a sponsor, I say ideally have both,” she says. “I have seen personally how mentoring can help by providing an outside perspective on a career or business challenge. I am happy to be that sounding board. I also advise people to seek a sponsor: someone within the company who can create a developmental stretch assignment.”
Dr. Torley says she is huge believer in developmental rotations. “I did a developmental rotation as a sales regional business director, overseeing a team of more than 160 representatives,” she says. “This was hard because I did not have the immediate skills and knowledge to direct the team in all aspects of their role. I quickly identified how and where to apply my strengths and how to leverage the skills and talents of team members.”
Her culture- and talent-building efforts extend beyond the walls of Halozyme.
The company is the primary sponsor of PurpleStride in six U.S. cities, an annual walk focused on ending pancreatic cancer, a cause for which she has personally raised significant funds.
Halozyme also sponsors STEM In Your Backyard, a community-based STEM initiative that advances science awareness and education in San Diego schools and neighborhoods. Dr. Torley also leads BIO’s efforts to improve the diversity of biotech senior leadership and boards as chair of the Workforce Development, Diversity and Inclusion Committee and member of the BIO board of directors. (PV)
Dr. Neal Walker
For Driving Advancements in Dermatology
Title: Founder, President, and CEO
Company: Aclaris Therapeutics
Education: BA, Biology, Lehigh University; MBA, Wharton School, University of Pennsylvania; DO, Philadelphia College of Osteopathic
Family: His parents Dr. JDA Walker and Elizabeth Walker, his wife Christy Walker, his brother James Walker, and his children Jake and Madison
Hobbies: Ice hockey, sports car racing
Awards/Honors: Frank Baldino Bioscience CEO of the Year Award, 2016, Ernst & Young Entrepreneur of the Year Greater Philadelphia Award, 2016, Aclaris Therapeutics Best Places to Work, Best IPO of 2015 from a return perspective
Associations: Advancing Innovation in Dermatology, Dermatology Summit, Fellow of the American Academy of Dermatology, American Osteopathic College of Dermatology- Fellow: FACOD, American Medical Association
Personal Brand: Relentless persistence
With a passion for people and innovation, Neal Walker, D.O., co-founded Aclaris Therapeutics in 2012 to identify, develop, and commercialize innovative therapies to address significant treatment gaps in dermatology.
His commitment to innovation is driven by the great need in dermatology for advanced therapies to treat patients suffering from difficult-to-treat dermatological conditions where no good therapies exist.
Dr. Walker has worked tirelessly to raise capital and assemble a high-performing, industry leading team to navigate the IP, formulation, regulatory, and clinical hurdles required to bring advanced treatments to market for patients with psychologically devastating conditions such as alopecia areata — an autoimmune skin disease that causes hair loss on the scalp, face, and body — and vitiligo.
Taking the company from a startup to a fully integrated biopharmaceutical company with a commercial product has been a challenge but his efforts and those of his colleagues are paying off. A career highlight for Dr. Walker was taking Aclaris public on the NASDAQ exchange; Aclaris was the top performing IPO in 2015 from a return perspective.
In 2017, Aclaris acquired Confluence Life Sciences to become a fully integrated biopharmaceutical company with in-house capabilities in discovery, development, and commercialization. This year, Aclaris will launch the first FDA-approved treatment for raised seborrheic keratoses.
Among his many achievements has been to exclusively license a patent portfolio from Columbia University that uses JAK inhibitors for the treatment of alopecia areata. Aclaris also acquired Vixen Pharmaceuticals, a startup focused on developing drugs for hair loss.
Among his many achievements has been to acquire Vixen which owned the exclusive license to a patent portfolio from Columbia University that uses JAK inhibitors for the treatment of alopecia areata and other forms of hair loss.
Aclaris was not Dr. Walker’s first entrepreneurial foray. Recognizing an opportunity to partner with another clinician, Dr. Stuart Shanler, and address a common clinical problem in patients, the redness of rosacea, he formed Vicept Therapeutics, raised funding, and hired a small drug development team, all while continuing to see patients. Vicept was later acquired by Allergan. The fruits of his creative drug development strategy are benefiting patients today, with commercially available Rhofade cream.
In addition, he co-founded Octagon Research Solutions with his twin brother and fellow 2010 PharmaVOICE 100 James Walker, which was acquired by Accenture, and Trigenesis Therapeutics Inc., which was acquired by Dr. Reddy’s Laboratories Ltd.
Dr. Walker has a deep appreciation of translational research in skin diseases, the process of applying discoveries about the pathophysiology of disease generated in the laboratory to the development of trials, and studies of new compounds in humans.
Coming from a background as a practicing dermatologist, Dr. Walker realized in practice he could only help the patients that he saw, but his impact could be much broader if he served all dermatology patients by spurring the development of innovative therapies.
In research involving Bio Med Sciences and Pfizer, Dr. Walker served as lead investigator on a study involving the application of silicone gel sheets to hypertrophic scars and keloids in patients with various types of scars. This ultimately led to the commercialization of the silicone sheets as an OTC treatment for scars, which were commercially available as Neosporin Scar sheets.
Colleagues have benefited from Dr. Walker’s investment in mentoring talented people in the dermatology and the life science space broadly for several decades, launching and advancing many careers and several companies. While assembling high-performing, empowered teams, he remains personally involved and attentive to the key decisions and milestones.
“I enjoy passing on what I have learned to new entrepreneurs to give back to the ecosystem that provided so much to me in the early days,” he says.
Dr. Walker co-founded and serves on the board of directors of the Dermatology Summit, the Dermatology Innovation Forum, and Advancing Innovation in Dermatology (AID), which is dedicated to catalyzing science-based product innovation by bringing together key ecosystem stakeholders, including scientists, clinicians, patient advocates, business partners, and others who share a strong interest in advancing to market new dermatology products that substantially improve skin health.(PV)
Dr. Thomas Bramley
For Championing Health Economics
Company: Lash Group
Education: BS, Pharm, Drake University; PhD, University of South Carolina
Family: Wife, Krista Larsen
Hobbies: Running, skiing, biking, hiking
Awards/Honors: American College of Gastroenterology Governor’s Award for Excellence in Clinical Research at the 2005 conference; Vision Award Winner
Associations: Academy of Managed Care Pharmacy; International Society of Pharmacoeconomic and Outcomes Research
Personal Brand: Curious
Thomas Bramley, Ph.D., earned accolades for his hard work, dedication, and passion. In his position as president with Lash Group, which he assumed in October 2017, Dr. Bramley is leveraging his insights on population health to strengthen patient services and to improve patient-health management. He is leading a team of more than 3,000 associates as they improve patient access, affordability, and adherence services to help patients start and stay on therapy to optimize health outcomes.
Dr. Bramley joined Lash Group, a patient support services company and part of AmerisourceBergen, after 16 years at Xcenda, which is also an AmerisourceBergen business unit, where he most recently served as president. While at Xcenda, a strategic consulting company focused in health economics, outcomes research, reimbursement, market access and staffing, he guided a team of more than 500 consultants who shaped manufacturers’ development process and early stage commercialization strategies. Under his leadership, the team also provided strategic guidance on hundreds of outcomes research engagements with clients and generated data-driven evidence required for successful market launches.
He has deep compassion for patients, which makes him a very successful leader. Part of his compassion comes from being a patient himself. From a very early age as a child with asthma, he understood the value of medicine and the positive impact it could have on patients. He saw the role the community pharmacist had on people’s lives, and he wanted to be part of an industry that had a positive impact. As his academic career progressed, he recognized that through the study and application of health economics, his influence could be much broader and such began his HEOR career and his opportunity at Xcenda, his first job in the industry.
Over his career, he has consulted with major pharmaceutical and biotechnology firms, as well as small pharmaceutical and medical device firms, to help them prove the value of their products and maximize their ability to provide access to therapy for patients — always striving to keep the patients who need life-saving medicines at the top of his mind when leading these projects.
“Knowing the work I do helps patients access therapies leading to better, healthier lives motivates me every day,” Dr. Bramley says.
Since becoming Lash Group’s president, Dr. Bramley has been instrumental in supporting the launch of Fusion, a technology ecosystem that helps patients gain faster access to their medications, improves patient and healthcare provider experience, and enhances patient outcomes.
Lash Group also launched a new solution for electronic benefit verification. Powered by SmartPoint, a proprietary artificial intelligence technology, the solution will accelerate speed to therapy and improve the care delivery experience for patients and providers.
Colleagues are moved by Dr. Bramley’s innovative spirit and his desire to optimize healthcare delivery, advance patient care, and improve patient outcomes. They also note that he is a tremendous and impassioned leader, an inspiring colleague, and a valued friend.
“I would like to be remembered as improving health outcomes and advancing patient access across the globe,” he says.
In addition to his professional accomplishments, Dr. Bramley is deeply dedicated to making an impact on the communities in which he works and serves. In 2016, he climbed Mt. Kilimanjaro while committing to raise and donate $10,000 for Kupenda for the Children, a charity group that supports children with disabilities in Africa.
In 2017, he ran the Boston Marathon in support of Family Reach, a national nonprofit dedicated to eliminating the financial burden of cancer for patients and their families. Running on behalf of two Family Reach grant individuals — both teenagers diagnosed with a rare cancer — Dr. Bramley and a running companion raised $20,000 to help defray everyday expenses these children and their families face. (PV)
Dr. Kinnari Patel
For Being a Rare Disease Champion
Title: Chief Operating Officer and Head of Development
Company: Rocket Pharma
Education: BS, Biology and Pharmacy Doctorate, University of Sciences, Philadelphia; Executive MBA, NYU Stern School of Business
Family: Her husband for being her best friend and rock; her parents, who have been phenomenal role models as community volunteer/leaders, and teaching her the value of education, passion, and a strong work ethic
Awards/Honors: Recognition for mentoring Rutgers University post-doctoral fellows, increasing awareness of rare disease drug development and teaching as guest lecturer at pharmacy schools; company awards ranging from leadership, mentoring and achieving product milestones; HBA Metro Chapter Volunteering Award
Associations: American Society of Gene & Cell Therapy, European SCGT, Drug Information Association, Regulatory Affairs Professionals Society, Healthcare Businesswomen’s Association, American Society of Clinical Oncology, American Society of Hematology
Kinnari Patel, PharmD, exemplifies authentic and natural pharmaceutical/biotech industry leadership — combining a passion and commitment to patients with a talent for rare disease drug development anchored in an instinctive grasp of the global business and regulatory landscape.
Kinnari’s expertise in rare diseases spans her 15-year career working at leading pharmaceutical companies, including AstraZeneca, Bristol-Myers Squibb, Novartis, Hoffmann-La Roche, and Pfizer, and across R&D, regulatory, pharmacovigilance, policy, and quality compliance. She has led both small molecule and biologic development programs from Phase I through Phase IV across multiple therapeutic areas, including immuno-oncology, oncology, respiratory, virology, transplantation, and metabolism. Kinnari worked on the Phase I through BLA filings for Opdivo for treating metastatic melanoma, renal cell carcinoma, and non-small cell lung cancer as well as Myalept for treating an ultra-rare lipodystrophy disease. She also submitted the Valcyte NDA for the prevention of cytomegalovirus disease in pediatric kidney and heart transplant patients.
Leading the Myalept BLA submission and approval process, including supporting an FDA AdCom, was one of her most challenging experiences to date. It required helping align stakeholders from three different companies — BMS, AstraZeneca, and Amylin — with regard to the product’s benefit/risk profile. “This was my most rewarding career experience to date, as together we were able to overcome numerous challenges in bringing a novel therapy to patients with a rare disease where there was an unmet medical need,” Kinnari says. “Meeting the patients treated on this therapy and having them thank researchers, clinicians, and the industry for our persistence in bringing this therapy to market after more than a decade of clinical development was inspiring.”
In early 2016, Kinnari joined Rocket Pharma, a New York-based multi-platform gene therapy company focused on first-in-class treatments for rare and devastating pediatric diseases, as VP, head of regulatory, pharmacovigilance, and quality. At that point the company had only just completed series A financing. In her first year at Rocket, Kinnari helped galvanize the team to put five first-in-class rare disease assets on a regulatory path to the clinic. The first one, a gene therapy for treating Fanconi anemia, has now achieved clinical proof of concept and is headed toward potential global registration planning. While anchored in drug development and regulatory science, Kinnari’s role was also fundamental in establishing and developing Rocket’s team and culture, as well as putting together critical company procedures and policies in place to ensure corporate and quality compliance.
In her second year at Rocket, she was promoted to senior VP, global program head, for the company’s lentiviral gene therapy platform. She supported company financing efforts through series B financing, and her work was instrumental in preparing Rocket to be a publicly traded company.
In just three years, she has helped Rocket grow from three employees working out of a conference room in its founding investment firm’s office (RTW investments) with just one development program to now being a public company with five innovative gene therapy programs in development globally, more than 30 full-time employees, and100-plus associates engaged as partners in development.
In January 2018, Kinnari was voted in unanimously by the board as chief operating officer and head of development. Her goal in her new role is to create organizational efficiency and support exponential growth of the company in a way that maintains its culture and momentum. She is focused on bringing personalized medicines to market, such as the company’s ex-vivo lentiviral gene therapy and AAV therapies, and making these medicines accessible to patients from a cost perspective.
“It will take a new healthcare ecosystem to make these therapies cost-effective for every patient and available for every disease,” she says.
With all these accomplishments, the activity that Kinnari perhaps enjoys the most is educating and mentoring the next generation. “I’ve had the opportunity to start PharmD post-doctoral fellowship programs at AstraZeneca and BMS for regulatory affairs as well as global safety,” she says. “I’ve really enjoyed mentoring pharmacy and MBA students from NYU, Rutgers University, and Philadelphia College of Pharmacy. I’ve also had the pleasure of mentoring through the Healthcare Businesswomen’s Association and various companies I’ve worked for in the past.” (PV)
Dr. Shannon Dahl
For Breaking Bioengineering Ground
Title: Chief Scientific Officer
Company: Cell Care Therapeutics
Education: BS, Materials Science and Engineering, Massachusetts Institute of Technology; Ph.D., Biomedical Engineering, Duke University
Family: Husband, son, and daughter
Hobbies: Family ski trips, visits to national parks
Awards/Honors: Humacyte, CNBC Disruptor 50 company for ability to advance a first-in-class product, 2016; Popular Mechanics Breakthrough Awards, Brilliant Innovators, 2011
With a clear goal set for herself, Dr. Shannon Dahl is dedicated to advancing new medical therapies that improve patient care and reduce healthcare costs. “This goal requires building successful businesses and teams, clarifying ambiguities, and establishing the path forward in collaboration with regulators,” Dr. Dahl says. “I’m proud of the progress we’ve made at Humacyte and I am excited to advance another regenerative medicine technology platform and company, which is now the focus of my new role as chief scientific officer at Cell Care Therapeutics.”
One of three co-founders of Humacyte back in 2000, Dr. Dahl has been a driving and influential force for the regenerative medicine company, bringing deep healthcare bioengineering expertise to prepare Humacyte’s clinical products for commercialization. To create the economic case for the company’s innovative products and how they could translate to significant cost savings, Dr. Dahl made sure to develop strong working relationships between Humacyte and government agencies and regulators.
Her rich scientific experience has contributed to developing and acquiring the research and preclinical data to advance Humacyl, an award-winning biologic. With her assistance, the company and product received the first ever Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, expediting Humacyl’s evaluation for vascular access in performing life-sustaining hemodialysis. Before the FDA’s establishment of RMAT designation, she helped Humacyte gain an FDA fast track designation.
Under Dr. Dahl’s leadership, Humacyte successfully initiated multiple clinical trials on Humacyl in an effort to make bioengineered human organs a reality in this lifetime. She spearheaded early research and foundational product development of Humacyl, and helped design the early clinical investigations for the treatment of patients with ESRD, who require dialysis and are not candidates for fistula.
Likewise, Dr. Dahl was integral in helping to expand the opportunity for broader applications of the Humacyte platform.
“Advancing a first-in-class regenerative medicine product from academia to late-stage clinical trials is an accomplishment that has been deeply rewarding — it is rare to have the chance to contribute meaningfully along the entire development path of a product, to co-found and build a leading regenerative medicine company, and to set precedents for the field as we advanced the technology and company,” Dr. Dahl says. “It’s exciting to see the groundbreaking milestones Humacyte continuously makes, such as receiving the first FDA RMAT designation, as well as completing enrollment of the first-ever Phase III trial to investigate a bioengineered tissue in a life-sustaining use.”
In addition to her contributions to Humacyte and her new role at Cell Care Therapeutics, Dr. Dahl also consults with businesses and individuals on development, regulatory, and reimbursement strategies to advance new medical therapies. For example, Dr. Dahl serves as a lead mentor at Stanford StartX Med, a medical vertical of StartX focused on accelerating the development of Stanford’s top medical entrepreneurs through experiential education and collective intelligence. As a lead mentor, Dr. Dahl enjoys sharing her key learnings with other healthcare focused entrepreneurs and industry leaders on topics spanning cell therapy, cancer immunotherapy, diagnostics, and medical devices. Dr. Dahl has also held an adjunct faculty position in surgical research at Duke, and has previously performed research in orthopedic surgery at the prestigious Harvard Medical School.
Colleagues are inspired by her drive and focus and her view of innovation encompassing both developing new products and developing a clear path to market.
“Innovation requires comfort with leaning into ambiguity in both areas, and focus to define a reasonable path forward,” she says. “Not all organizations or people are comfortable with ambiguity.”
Dr. Dahl is an inventor and holds 20 issued patents and is a highly respected researcher, in addition to being the author of 17 peer-reviewed publications. She has been featured in high-profile interviews with top tier publications, including The Economist, BBC Radio, USA Today, and Technology Review among others. (PV)
Susan Flinn Cobian
For Shattering Preconceptions
Company: HYC Health
Education: BA, Kenyon College
Family: Her amazing, loving, supportive, and patient husband, Randy Robert Cobian; her phenomenal circle of girlfriends who keep her sane
Hobbies: Golf and restoring her great-grandmother’s 100-year-old house
Awards/Honors: DMN Hall of Femme, 2018, MM&M Hall of Femme, 2017, PM360 ELITE – Transformational Leader, 2017, Chicago Business Journal Woman of Influence, 2017; PM360 ELITE – Entrepreneur, 2016, Chicago Business Journal Woman of Influence, 2017, PharmaVOICE 100, 2016
Associations: HBA, Bright Pink, She Runs It, Board of Directors Chikaming Country Club, Lakeside Association
Personal Brand: Go heavy or go home
For nearly three decades, Susan Flinn Cobian has been showing colleagues what best practices in pharmaceutical advertising looks like.
Susan started at the bottom and worked her way up, shattering that proverbial glass ceiling. She has built two agencies from scratch and rebuilt three others through her brand strategy expertise, incredible network, and ability to lead tight-knit teams who innovate at every turn.
She grew the Chicago office of a large New York agency with nothing but her Rolodex it into a multimillion-dollar business in just eight months.
“I achieved this by rebranding and restructuring the company and driving revenue through numerous project wins and sustainable organic growth,” she says. “I eventually grew the office from a single-person start up to a 35-person agency with annual revenue of $15 million and average gross margins of 36% — all in less than three years.”
She is driven by the thrill of achieving the unachievable and shattering preconceptions. “One of my favorite quotes — and essentially my personal mantra — comes from the inestimable Milton Berle: ‘If opportunity doesn’t knock, build a door’,” she says.
In Susan parlance, this also means not being afraid to speak up or challenge conventional thinking.
“Being innovative means being disruptive and disruption often has a negative connotation,” she says. “But the only way to truly innovate is to try something new, and different, and that’s never been done before, or that’s been done in a different way.”
For Susan, breakthroughs happen when people take an approach of “what if” instead of “we can’t” or “I’m not allowed.”
Until recently, Susan ran HYC Health, a 25-person ad agency specializing in pharmaceuticals, medical devices, diagnostics and emerging healthcare categories. Under her leadership, the company grew into a multimillion-dollar company with four new business wins in 2017 and more than 45 creative awards on its shelves. The initial challenge was to pitch and win the agency’s first true healthcare account and then use that core business to build a new complementary agency focused solely on healthcare — pharma, medical devices, diagnostics, etc. The founders had the foresight to recognize that healthcare business would drive growth for the entire company, but firmly believed the business could be staffed with consumer advertising professionals.
“It took me eight excruciatingly painful months to convince them that wasn’t a smart plan,” she says. “Eventually, I was given the green light to hire experienced healthcare agency folks — many of whom I have worked with before — and we more than quadrupled the business as a result.”
Susan has delivered multimillion-dollar revenue growth to countless clients, but what really sets her apart is her vision for always doing better, and her fierce loyalty and passion for helping people achieve greater success than they ever imagined. She is known for building and nurturing relationships that last a lifetime.
Her legacy, she hopes, will be recognition for the true entrepreneur that she is; for not just shattering the glass ceiling, but all ceilings; for bucking the system to build something out of nothing; for showing that it is possible to do the impossible; and for never saying never.
Susan approaches her work with the same passion she approaches everything in her life. Her never-say-never attitude is backed by a magnetic, larger-than-life personality that instills a sense of loyalty and an unwavering desire to go above and beyond.
She gathers all the information she can and comes up with a strategy for success. To do this, Susan leverages every one of her many great leadership qualities. She is admired for creativity, honesty, and intuitiveness. She is an inspirational force grounded in a true belief in the abilities of others.
Susan encourages people to push boundaries and think independently. She instills a sense of ownership and accountability that makes people want to go above and beyond. People are exceedingly loyal to her and she develops genuine, lifelong partnerships due to her “tell it like it is” style.
The words “not my job” are anathema to Susan, who has always been a hands-on leader who will work alongside her staff at all levels.
“I share with them my belief that perseverance and hard work can solve any issue,” she says. “I may set high standards for my team, but they always see me as a fair, consistent, and supportive leader.”(PV)
Editor’s Note: At press time, Susan left HYC to pursue a new opportunity. Stay tuned, wherever she lands it will be with gusto.
For Changing the Oncology Game
Title: President and CEO
Company: ImmunoGen Inc.
Education: BS, Northeastern University; JD, Harvard Law School
Family: Wife Nancy and sons Michael and David
Hobbies: Sports car racing
ImmunoGen CEO Mark Enyedy has set out a clear vision for the company: positively transform, improve, and extend the lives of patients diagnosed with cancer.
The biotech company specializes in the development of targeted cancer therapies called antibody-drug conjugates (ADCs), and Mark is positioning ImmunoGen to be at the forefront of developing breakthrough treatments for patients with difficult-to-treat cancers.
He is a strategic, thoughtful leader who has transformed the 35-year old biotech company since taking the helm of the organization as CEO in May 2016, shifting its internal mindset from a research-based organization to one that is committed to bringing its first product to market in about two years. In June 2018, the FDA granted fast track approval for mirvetuximab soravtansine in patients with platinum-resistant ovarian cancer. This is the first ADC to receive such a designation for ovarian cancer.
Mark brought to his role as CEO more than 25 years of experience in general management, business development, and legal counsel.
He has led the company through several key inflection points resulting in ImmunoGen’s market cap almost tripling and value creation increasing that has been recognized by the investment community. Upon his arrival, he executed a difficult, yet necessary, comprehensive review of ImmunoGen’s core functions and prioritization of the portfolio, which has strengthened the organization and set the company on a path toward long-term value and growth. The initiative created a leaner, more agile company better positioned to achieve its mission of delivering innovative ADC therapies that disrupt the progression of cancer and offer patients more good days.
Team members say what defines Mark’s leadership style is not only his ability to inspire and mobilize the troops, but his willingness to continually challenge the status quo. For example, he recognized that ImmunoGen, which has a strong heritage in ADC research but no marketed products, had the potential to become a leader in its field.
He successfully led the turnaround of the business and made it one of the most watched companies in the oncology space. In just a short time, he has led the company through several clinical trial initiations, received key data readouts, led the sale of noncore assets to Sanofi and Debiopharm, and created high-value collaborations with other companies in the industry, including Jazz Pharmaceuticals and CytomX.
Taking a patient-first approach, Mark continually encourages and motivates his team to focus on what’s important.
With the goal of securing FDA approval for mirvetuximab by 2020, Mark continues to champion a diverse pipeline of innovative therapies for diseases such as acute myeloid leukemia (AML), B-cell acute lymphocytic leukemia (ALL), and other hematological malignancies.
His management philosophy is to provide strategic direction — tell people where they need to go; delegate effectively — give people the tools they need to get there; and coach — provide the support and feedback they need for the ride.
Mark’s leadership has promoted a corporate culture of not only achieving results, but one of inclusiveness, where employees feel valued for their contributions and are proud to come to work each day. He believes when people understand the objectives they are empowered to act.
Mark’s experience in oncology goes back to his days at Genzyme, where he worked directly with biotechnology legend Henri Termeer, who he cites as one of the people who has been a mentor to him during his career. He held several roles of increasing responsibility during his 15 years at Genzyme, including president of the transplant, oncology, and multiple sclerosis divisions. While at Genzyme he executed the company’s strategy to enter the oncology market, overseeing the launch of two new products and managing a global business generating more than $675 million in revenue with operations in more than 50 countries. He counts this achievement as a career highlight.
Outside of his day-to-day role at ImmunoGen, Mark serves on the board of directors of Keryx Biopharmaceuticals and the American Cancer Society (Northeast Region), which further demonstrates his commitment to helping guide companies to develop next-generation medicines for patients with serious diseases.(PV)
For Connecting Talent with Bold Ideas
Title: Chief Innovation Leader
Company: LevLane Advertising Inc.
Education: Smeal College of Business, Penn State University
Family: His father who was also his hero, his mentor, and his best friend; his mother, the one who also taught him it is more important to give than receive; his sister who guides him when he needs it, which is often; and Betsy, who gets him, which is not easy
Hobbies: Golf, running, movies, reading motivational and business books, fashion, enjoying a good glass of red wine
Awards/Honors: PharmaVOICE 100, 2012 and 2018; PM360 2017 Elite Award Winner; University of the Sciences, Remington Award; Star Group, Person of the Year, 2012
Associations: Smeal College of Business Alumni Society Board; Penn State Hammond Society, Smeal College of Business, Penn State; Executive Director, New Leadership, State of Israel Bonds; Board of Directors — Convenient Care Association; Board of Visitors, Samson College of Health Sciences, University of the Sciences; Board of Directors, Wanamaker House Condominium Association
Personal Brand: Do what you love, love what you, and deliver more than you promise
Throughout his career, Timmy Garde has led the way in terms of innovative thinking, strategic guidance, and thought leadership. Customer-centric and values-driven, Timmy understands how to give life to brands and communicate energetically about the benefits of new innovations.
Innovative transformation is what he does, wrapping his arms around insights garnered from a keen understanding of the trends of a changing world and the market environments.
Colleagues say he has perfected insight mining and mastered the ability to thoughtfully look at his pallet and paint a landscape of trends impacting clients’ brands. Timmy is admired for being able to dissect and understand root causes of issues and then offer opportunities for realistic implementable solutions.
“As chief innovation leader, I set the pace for creating innovative approaches to business relationships, models, and initiatives,” he says. “At the same time, it’s important to develop the strengths of people and encourage decision-making without fearing failure and being transparent all of the time because, after all, that is how you build trust.”
And after years in the industry, Timmy knows convincing clients to do something bold requires lots of confidence, trust, and nurturing.
Timmy says he wanted to learn the craft of advertising from the top down, so he started out in the industry as the owner of a boutique agency in Philadelphia.
He has a knack for encouraging transformation by engaging and integrating myriad credible external experts and resources and inserting them into the solution mix. From his time at Vox Medica to his role at Star Life Sciences/Calcium and now as chief innovation leader at LevLane, Timmy knows when to bring in world-class thinkers to instill confidence and trust then build the decision bridge.
He has an impressive network and engages with the best of technology giants, scientists, physician leaders, health plan executives, corporate executives, entrepreneurs, strategic thinkers, and leadership giants. He collaborates with them to come up with solutions to challenges that are realistic, within resources, and that can be executed.
And while he is laser-focused on customer and brand successes, he never leaves patient centricity behind. Colleagues note Timmy has a unique way of presenting both the opportunity and the risk so that everyone understands that bold moves are not done without some level of uncertainty.
Colleagues and clients alike trust Timmy and appreciate his sense of humor. He is always willing to share his knowledge and expertise with both leadership as well as the team members who support them.
He looks for strength in others and encourages decision-making without fearing failure, and he is transparent with colleagues and clients alike. When challenges arise, he takes a positive approach and seeks advise from others, because “that is what a good leader does.”
With a willingness to pay it forward, Timmy has opened agency experiences to select graduate students, who have ultimately gone on to become valued assets for agencies. He is a mentor par excellence and likes to give back what he has learned and share his knowledge with those entering the marketplace. To that end, he has created scholarship programs for students seeking rewarding life-science careers.
He is committed to putting the smartest people together under one umbrella to drive positive results for clients and employees alike.
“Never make a business decision based on emotion, never ever leave anywhere on a bad note, and be the first person to say good morning,” he adds.
His advice is to surround yourself with smart people who have vision, to do the best you can, and learn from your mistakes. (PV)
For Addressing Genetic Diseases
Title: President, North America
Education: BSc, Biology, Tel-Aviv University; MBA, Rekanati Business School, Tel-Aviv University
Family: His wife Iris and three kids: Yuval, Amit, and Carmel
Hobbies: Snowboarding, running, traveling
Since being named president of Sobi North America in 2014, Rami Levin has built the company into a team of nearly 70 employees and brought important medicines to patients — making it the most profitable affiliate in Swedish Orphan Biovitrum AB’s (Sobi) global portfolio.
Sobi is a pioneer in biotechnology with world-class capabilities in protein biochemistry and biologics manufacturing. In 2014, Sobi opened its North American offices in Waltham, Mass., to mainly focus on inflammatory, genetic, and metabolic diseases. Earlier that same year, Sobi assumed direct responsibility for the commercialization of its proprietary product, Orfadin in North America. Orfadin is the only FDA approved therapy for use as an adjunct to dietary restriction of tyrosine and phenylalanine for the treatment of hereditary tyrosinemia type 1 (HT-1).
Rami led the company’s efforts to get HT-1 added to newborn screening in all 50 states, and launch a patient-support program to help patients and caregivers by providing access to nurse advisors, help navigating insurance and financial needs, developing low-protein recipes and meal-planning tools, and much more. As patients began to approach adulthood, the company introduced larger doses and once-daily formulations, and just last year it launched a peer-to-peer support network. Rami has also led Sobi in gaining FDA approval for Kineret (anakinra) for the potentially life-threatening rare genetic disease neonatal onset multisystem inflammatory disease (NOMID). Kineret had previously been approved in rheumatoid arthritis, but when a group of NIH specialists reached out with a desperate plea on behalf of a handful of patients suffering from this severe form of an exceedingly rare disease — cryopyrin associated periodic syndrome (CAPS) — Rami answered the call. Working with the FDA to collect data and achieve FDA approval — and unknowingly at the time, becoming a case study for the Open Act legislation, which is intended to encourage more companies with drugs for com
mon diseases to expand into the orphan space — Rami and his team members blazed a new trail.
Colleagues admire Rami’s determination in leading the organization to help patients suffering from rare and difficult-to-treat diseases. Rami works to recruit the best talent, to build Sobi’s footprint, to break down barriers to access, and to find new ways the organization can support patients and caregivers.
“My team and I recognize that patients’ needs change significantly from infancy through adulthood,” he says. “One of our core focus areas for innovation is to understand patients’ changing needs and to innovate to address them. That innovation can take many forms: new therapies, dosing flexibility, different delivery systems, patient support services, and more, there are many ways we can think innovatively to solve an issue for patients.”
Though passionate about achieving outcomes, he doesn’t allow that passion to interfere with the job at hand. Instead, he draws on his experiences, he analyzes data and details, he uses the talents of his team, and he takes each step with precision and intention.
In addition to opening the Waltham location, Rami was instrumental in establishing a Canadian affiliate, and built all of the key functions needed in a pharmaceutical company, including sales, marketing, medical, operations and access, HR, legal, regulatory, finance, and communications.
“Like my peers in the life-sciences community, improving the lives of patients is my No. 1 concern every day,” he says. “While many patients are fortunate to have access to appropriate treatments and quality medical care, there’s still so much work to do. There are 7,000 identified rare diseases, and fewer than 600 of these have approved treatments, so there is tremendous unmet need in rare diseases. Even when treatments exist, gaining access to specialty medications is often more complex than it should be. That’s why we’re working here in the United States and Canada, and with our colleagues internationally, to ensure patients around the world get timely and sustainable access to our treatments.”
He is motivated to keep Sobi moving forward to address the unmet needs of so many rare disease patients.
“I am constantly impressed by the resilience and strength of the patients, families, and caregivers who are impacted by rare diseases,” he says. “I often hear stories about the work our dedicated team is doing to make a positive difference in their lives: whether that means staying on the phone with FedEx all weekend to ensure an emergency shipment of medicine is delivered, or helping a growing patient to maintain access to his or her medicine while transitioning between pediatric and adult physicians. My team and I work hard every day to support the patients and communities we serve. Their stories are what get me out of bed in the morning.”
Spending his formative years as a competitive swimmer and later in the Israel defense force, he learned firsthand the importance of persistence, determination, and finding that balance between the heart and the mind, the place where passion and reason intersect.
“I would like to be remembered for my ability to bring together the best people, in the right environments, to help meet the changing needs of those who are living with rare diseases,” Rami says. “I don’t just mean by exploring treatment and delivery options, but also by creating tailored programming and communities where patients and families feel supported, informed, and empowered, despite the challenges they face.” (PV)