NOTE: The content below contains the first few paragraphs of the printed article and the titles of the sidebars and boxes, if applicable.
Creating Opportunities out of Obstacles
Company: hVIVO plc
Awards/Honors: Entrepreneur of the Year UK category winner for Healthcare, Ernst & Young; Female Executive of the Year in Europe, the Middle East and Africa, Gold Award, Women in Business Stevie Awards; Mayor of London’s Business Advisory Board
Associations: BioIndustry Association (BIA)
Kym Denny brings a powerful combination of passion, confidence, and practicality to everything she does. She has a unique talent for converting her vision into an achievable plan, providing a clear path to success that staff, collaborators, and investors can relate to and follow.
Since becoming CEO in 2010 of hVIVO, she has led the evolution of the company (formerly Retroscreen Virology) from research services to building a pioneering human-based analytical platform to accelerate drug discovery and development, focusing on respiratory and infectious diseases. This shift in direction included leading the organization’s transition from private to public in 2012, resulting in one of the most successful IPOs in AIM history.
hVIVO is a UK-based specialty biopharma company with discovery and clinical testing capabilities. The company has created a technology platform that uses human disease models to study new drugs and investigate disease in a safe, controlled environment.
Colleagues say Ms. Denny is passionately committed to creating opportunities out of obstacles. She led the diversification of hVIVO in response to a period of downturn in research services to build commercial capabilities to sustain the business for the long term.
Ms. Denny’s ability to think outside of the box and pioneer new paths led to the introduction of concepts that focus on trying to solve the fundamental issues that contribute to the burden of drug development: long development timelines, high costs, and high failure rates.
Using her clinical development site management skills, she worked with UK investigator sites and pharma affiliates to substantially increase the allocation of sites in the UK that would be tapped for international studies compared with those in Eastern Europe.
Her experience led to the creation of a comprehensive international course in managing drug development across different cultures, which she has run multiple times and which has been adapted to different industries.
Under Ms. Denny’s leadership, hVIVO saw revenue growth of 539% in her first three years with the company. hVIVO also began to build its commercial infrastructure to fuel the company’s products and support new, more collaborative client relationships. In the past two years, Ms. Denny has identified and acquired significant stakes in three clinical-stage assets that have the potential to disrupt the standard-of-care in important disease. These assets include a novel antiviral prophylactic (PrEP-001) through a partnership with PrEP Biopharm, a universal flu vaccine (FLU-v), and a mosquito-borne illness vaccine platform (AGS-v) for diseases such as Zika, malaria, dengue fever, and West Nile fever, through a joint venture with Imutex.
In 2015, Ms. Denny positioned the company to prove hVIVO model’s potential with its own drug through the acquisition of PrEP-001. hVIVO has subsequently completed a proof-of-concept and three Phase IIa challenge studies.
Colleagues say Ms. Denny’s confidence and enthusiasm have fueled internal talent programs as well. She implemented staff experience and values initiatives built from the ground up, leveraging an employee-driven approach that has brought people together.
She defines leadership as helping others through periods of change and ambiguity.
“The essential characteristic of leadership is defining a path forward when there isn’t one, to rally the organization around the ultimate goal, and getting the teams excited to embrace that goal as their own,” she says. “It’s essential to make the change relevant and paint the vision, bringing the rest of the organization/team with you and celebrating successes along the way.” (PV)
Lynn O’Connor Vos
A Leader for All Occasions
Lynn O’Connor Vos
Company: ghg | greyhealth group
Education: BS, BSRN, Alfred University
Family: Husband, children
Hobbies: Tennis, traveling, reading, politics
Bucket List: Have more impact on health; worldwide travel
Awards/Honors: Woman of the Year, Healthcare Businesswomen’s Association; Corporate Achievement Award, The Jed Foundation; Academy of Women Achievers, NY YWCA; PM360 Elite; MM&M Healthcare Transformer; MM&M Hall of Femme
Associations: Women Business Leaders (WBL); Healthcare Businesswomen’s Association; W.O.M.E.N. in America
Tweet at: @lynnvos
With patients increasingly turning to the Web for health advice, Lynn O’Connor Vos saw the potential to impact outcomes and change patients’ lives by enhancing the healthy conversations taking place online. For the past decade, Ms. O’Connor Vos has been a pioneer for the power of the digital conversation to address changing dynamics in consumer access and trust.
As the CEO of ghg | greyhealth group, a health communications firm owned by WPP, she is credited with helping transform the marketing of pharmaceutical brands. And she is the first woman to develop and run a global health communications enterprise.
Under her leadership, ghg has become an advocate of using technology to improve public health, and she believes ghg partnerships with media, technology, pharma, and healthcare delivery companies could solve some of the industry’s biggest challenges. In fact, ghg was the first healthcare agency to partner with IBM Watson. Ms. O’Connor Vos has also led the investment by WPP into partnerships in the EHR and e-Rx space that have positioned the agency to take clients to the next level in point-of-care solutions.
Not only did she found ghg and create an industry leading agency brand, she has secured brand leadership for clients across digital and traditional channels, and she continues to innovate, build, and acquire companies that have expanded ghg’s global footprint.
If she were a brand, Ms. O’Connor Vos says her tagline would be: Relentless pursuit of new ideas. She believes that continuous reinvention is crucial to success in today’s ever-changing health and technology landscape. She holds herself and her team to exacting standards for relentless re-education and improvement of the latest communications strategies, and more importantly, to anticipate what clients will need to meet the marketplace imperatives almost before they do.
She cultivates a diverse group of executives — many of whom are physicians, pharmacists, nurses, vets, and top creative and digital talent — to create something great every day.
In addition to leading ghg, Ms. O’Connor Vos believes in investing her time and expertise for the public good. She was a founding board member of the Jed Foundation, a leading mental health nonprofit organization, as well as the Multiple Myeloma Foundation.
Most recently, Ms. O’Connor Vos has become a member of the Kraft Precision Medicine Accelerator at Harvard Business School, where her mission is to help bring the promise of precision medicine to more cancer patients by addressing the current crisis in cancer communication.
At ghg, Ms. O’Connor Vos has cultivated an eco-system in which women assume key leadership roles. Not only has she mentored individuals who have gone on to successful careers leading organizations outside ghg, but she has also provided rich opportunities for leadership within the organization. Most recently, she participated in the Fortune and U.S. State Department’s Global Women’s Mentoring Partnership, in which she mentored an entrepreneur from Argentina. She is also a member of W.O.M.E.N. in America, a mentoring program.
Colleagues say she is an inspiration to countless professional women, both at ghg and beyond.
Ms. O’Connor Vos says one of her career highlights was being named Woman of the Year by the Healthcare Businesswomen’s Association. Another highlight was creating Text4Baby, an initiative that uses technology and community to educate women in underserved populations to care for their babies before and after they are born.
“This program is an example of using simple communication to dramatically advance the public health,” she says. “We need more collective impact in the nonprofit world to improve outcomes. If I had unlimited resources, I would pool funds and gain consensus among oncology nonprofits to promote the key messages for getting the best cancer care.”
She says she is motivated to go to work every day because there is always something new to invent and always something new to learn. (PV)
A Catalyst for Success
Company: Cardinal Health Specialty Solutions
Education: BS, Marketing, Rutgers University; MBA, Pharmaceutical Chemical Studies, Fairleigh Dickinson University
Family: Wife, Renee; two children, Joseph and Nikki
Hobbies: Golfing, fishing
Awards/Honors: Chairperson, Bay Area Leukemia and Lymphoma Light the Night Walk Company
Associations: BioNJ, Healthcare Businesswomen’s Association, Cardinal Health WIN Steering Committee, International Society for Pharmacoeconomics and Outcomes Research
For the past 27 years, Joe DePinto has been focused on bringing life-saving specialty drugs to market and helping patients with complex diseases gain access to advanced care.
Mr. DePinto began his career as a sales representative at Upjohn Pharmaceuticals, and then moved to Ortho Biotech, an oncology-focused biotech company owned by Johnson & Johnson before serving as VP of the global hematology marketing for J&J, where he directed promotional efforts that touched patients throughout the world. Over the course of his career at J&J, he helped the company bring key specialty drugs, such as Procrit and Dacogen, to market.
In 2008, he joined Imclone Systems as VP of commercial operations, where he led all aspects of commercial planning and management for the pipeline and existing products, ultimately supporting the sale of the company to Lilly for $6.5 billion. Next, he took on executive leadership roles at two growing biotechnology companies.
Mr. DePinto says he was fortunate during his career to work in oncology and commercializing some blockbuster drugs and from a drug development standpoint lead the strategic and clinical development of an FDA-approved product for non-small cell lung cancer.
Today, as president of Cardinal Health Specialty Solutions, Mr. DePinto leads one of the fastest-growing businesses within Cardinal Health, which has grown from $5 billion in revenue in 2015 to more than $10 billion in 2016.
Since joining Cardinal Health in 2015, Mr. DePinto has led the integration of Metro Medical’s specialty pharmaceutical distribution business, which was acquired by Cardinal Health that same year. He has also overseen the opening of a new 300,000-square-foot third-party logistics warehouse in Nashville, Tenn., and directed the acquisition of RainTree Oncology Services, a physician-owned group purchasing organization specializing in oral oncologic products.
In 2016, he led the expansion of two new offices in Cambridge, Mass., and Houston, moves that put Cardinal Health closer to key customers and support strategic growth initiatives.
Mr. DePinto is also steering the business to broaden its services to biopharma manufacturers with expanded offerings in regulatory sciences, health economics and outcomes research (HEOR), third-party logistics, and patient access.
He is committed to always positioning patients as being the most important part of the equation.
His toughest assignment came early in his career when he was given the opportunity to lead a low-performing team. After making changes to the strategy, execution, and personnel, the team became one of the top-performing units in the company.
“I didn’t realize it, but after that I was characterized as the ‘fix-it’ guy and often was given the turnarounds or challenging jobs,” he says. “Turnarounds don’t always work, but the learnings along the way are invaluable.”
He says he has learned from mentors that helping people explore the options to problems empowers them, helps them grow, and may even identify that there really isn’t a problem.
Fear of failure and limited resources prevent innovation, and Mr. DePinto believes it’s better to make a wrong decision than no decision at all — and learn from mistakes to avoid future missteps.
Colleagues say Mr. DePinto inspires them to think differently, to be creative, and not be afraid to take risks. He considers himself a catalyst to innovation and urges people to be creative and think differently.
He and his team work together by identifying solutions, debating options, aligning the best ideas, and moving forward as a team. Mr. DePinto challenges his team to buck the status quo in their pursuit of organizational results.
He is courageous, authentic, unwavering in what he stands for, and he is appreciative — never failing to recognize and thank the people surrounding him.
In addition to his business accomplishments, Mr. DePinto has dedicated himself to building and mentoring the next generation of leaders and inspiring his teams to reach higher level of success.
In 2017, Mr. DePinto was appointed as the first man to serve on the national board of directors for the Healthcare Businesswomen’s Association, where he serves as a staunch advocate for the development and promotion of women in the healthcare industry. He also serves on the advisory committee for Cardinal Health’s Women’s Initiative Network, an employee group that helps women build strong career paths. He also serves on the board for Viking Scientific, a drug delivery platform company.
In addition, Mr. DePinto has served as a volunteer and supporter of the Leukemia and Lymphoma Society and CancerCare. (PV)
A Leader of Leaders
Company: Healthcare Businesswomen’s Association
Education: BS, Microbiology, University of Maryland; Post-undergraduate degree, Pharmacy, University of Washington; Masters, Software Engineering Management, University of Luton; licensed Pharmacist, Certified Association Executive
Family: Husband, who is her best friend and stalwart support; son, who has taken up her gauntlet of service; and daughter, who has taken her leadership advice to successfully navigate her own career
Hobbies: Movies, eating out, pets, and cruising
Bucket List: Building a dream tiny house; take an African safari, explore the Galapagos Islands, and visit the Taj Mahal
Awards/Honors: PharmaVOICE 100, 2011; American Society for Association Executives (ASAE) Mentor of the Year
Associations: Healthcare Businesswomen’s Association; Forum of Executive Women of Philadelphia; American Society of Association Executives; UUCDC Leaders’ Community (Nominating Committee Chair); Philly Hunger Task Force; Women Business Leaders of the U.S. Health Care Industry Foundation
Tweet at: @)_lcooke9_
Since taking the helm of the Healthcare Businesswomen’s Association (HBA) as CEO a dozen years ago, Laurie Cooke has consistently, passionately, and purposefully steered the global nonprofit organization to new heights in pursuit of its core purpose: to further the advancement and impact of women in the business of healthcare.
This egalitarian leader is selfless in her willingness to provide counsel, support, mentorship, and advice to the many member leaders who reach out to her, as well as the growing staff of association professionals.
Ms. Cooke says growing the HBA’s community to more than 25,000 — women and men who take part in the association’s more than 300 in-person and virtual events — is a career highlight.
“I dedicate my efforts in my personal and professional life to support others to be the best they can be and measure my accomplishments by the number of people who I am able to help advance,” she says.
Ms. Cooke is also the steward of the association’s strategic plan, and in partnership with the board of directors of the organization, she is creating an architecture for sustainable and long-term success that includes: a refreshed brand, global expansion, new products and services designed to meet the needs of individual members as well as the HBA’s corporate partners and sponsors, and a focused and deliberate approach to tackle head on the paucity of women leaders at the highest levels throughout the life-sciences and healthcare industries.
While others may crack under the weight of such an awesome responsibility, Ms. Cooke performs her many duties with grace, equanimity, and good humor.
Colleagues and peers say Ms. Cooke is approachable and equally at ease with the CEOs and executive leaders who she meets at the many functions she attends representing the HBA as she is with women and men new to the industry.
And she offers this advice to those who are just starting their careers: pay attention to office politics, which are incredibly important and can help you to understand your organization and position yourself effectively; get experience early on leading people, managing a P&L, and work on an international project to gain global perspectives; find sponsors in your company who can advocate for you when promotions or high-potential roles are discussed; join an association to secure hands-on skills and knowledge; and build your network inside and outside your company to expand your perspectives.
As the HBA ramps up its call for more diversity at the highest levels of leadership, Ms. Cooke is delivering the HBA’s vision — to be a united force for change — with increasing frequency to a wide variety of interest groups.
“We connect diverse groups of both women and men, across all healthcare and life-sciences disciplines,” Ms. Cooke says, quoting the HBA’s refreshed value proposition. “By taking focused action to advance our mission, we’re creating a powerful movement that drives professional opportunity and corporate growth. We believe that by joining forces in the relentless pursuit of gender parity, we are doing more than uniting individuals — we are strengthening the business of healthcare.”
She measures success by the number of staff team members, volunteers, and members who have advanced in their skills and career opportunities. And she would be gratified to be remembered for helping women and men across the industry feel more empowered and successful because of the HBA’s work.
“I am committed to redefining the definition of a leader so we can highlight how many of the skills that are needed in today’s world are ‘feminine’ leadership skills,” she says.
Colleagues note that Ms. Cooke is a rare breed of leader, one who is generous with encouragement and inspires others to reach beyond what they believe is within their grasp.
“I inspire others by the use of stories of how others have found success, encourage them to learn through their adversities, and provide active listening to mirror back to them what they want to accomplish versus what others have defined as success,” Ms. Cooke says. “I create a vision, I provide a clear line of sight to teams to see how they’re achieving this vision, and celebrate how much progress they’re making.” (PV)
Reaching the Future First
Company: Heartbeat a member of Publicis Health
Education: BA, Rutgers College; Henry Rutgers Scholar, Glasgow University
Family: His wife of 19 years, Barrie Gillies, whose humor and tolerance have helped him succeed; 12-year-old son, Will, whose lack of sentimentality keeps him honest
Hobbies: Photography; binge-watching high-quality TV series; screaming inappropriately during Little League Baseball games; spelunking
Bucket List: Travel to exotic destinations: Rangoon, Kuala Lumpur, Staten Island; visit every Major League Baseball park with his son; bring friends and family together for a celebration at a castle in Ireland
Awards/Honors: PharmaVOICE 100, 2017, 2015, 2008; Innovation Catalyst, MM&M Magazine; DTC Hall of Fame; Heartbeat has won more than 200 industry awards; Volunteer awards, The Hole in the Wall Gang Camp
Associations: National MS Society; Google Healthcare Advisory Board; Digital Scholar, Digital Health Coalition; advisory board member, Pharmaceutical Executive; mentor, Blueprint Health
Tweet at: @drumbeat
Bill Drummy has been catalyzing change and inspiring innovation for the healthcare marketing industry both as an entrepreneur and industry thought leader for the better part of two decades.
He has worked tirelessly to illuminate stagnant practices while calling for antiquated thinking to be vaulted into modern times by showing the industry a clear path toward the future.
Mr. Drummy started what was then Heartbeat Digital, now part of Publicis, in 1998, building it up to become an industry leader with 200 employees.
But the journey wasn’t without its challenges. The 2008 Wall Street crash required Mr. Drummy and his team to stay calm and manage their way through the crisis. This included making some very tough decisions, including buying out a lease he had signed the day the market crashed, spinning off a division, and making the re-captured equity available to his senior leadership team, which led to a long string of growth and success.
“What followed might not have happened had we not been shocked into a fundamental reconsideration of the business,” he says.
Today, Mr. Drummy serves as chairman, having recently ceded day-to-day management responsibilities to longtime colleagues and Heartbeat partners, Nadine Leonard and James Talerico.
His focus as chairman is ensuring Heartbeat’s long-term success as the agency moves into being a much more significant player in the industry. He is going about this by focusing on developing new client relationships, counseling long-standing Heartbeat clients on business innovation, and providing provocative, culture-shifting insight into the healthcare industry.
With Heartbeat now part of Publicis, Mr. Drummy says the challenges of succeeding as a larger agency are much different from the challenges of a smaller, early-stage agency.
“We have to make sure that we are set up structurally and culturally to thrive in this rarified atmosphere,” he says.
Reluctant to give up on achieving something once his mind has been set, Mr. Drummy has been described as relentless by others for years — a description he says is either a compliment or a complaint. Mr. Drummy describes himself as hypercritical of everything.
“I have always been that way; in some ways, it can be a useful trait,” he says. “It can also drive people crazy. Being regularly dissatisfied with the state of things leads to frustration, but it also drives the desire to make things better.”
Mr. Drummy passionately encourages his teams to seek out and employ the latest technologies and leading-edge solutions for a myriad of marketing challenges.
Success for Mr. Drummy can be described in three ways: the hard-financial measures of growth and profitability; the human equation, which might be measured by low turnover rates and high marks in employee surveys; and a tonal indication, by which he means the vibe that a place emits.
“The latter may be difficult to quantify, but it’s just as real, and far more predictive of success, than the other measures,” he says.
Learning from others is important to Mr. Drummy, who says partners, clients, and colleagues have taught him how to handle stress and manage a crisis.
“I know people who never lose their cool no matter what the emergency; I admire them and I try to emulate them,” he says.
Which makes his comment on managing challenges even more amusing:
“I scream and yell and blame everyone for screwing things up,” he says. “Either that, or I try to keep an even keel and break down problems into manageable, achievable steps. One of those two.”
Inspiration is hard to quantify and Mr. Drummy says he never claims to inspire anyone directly, but rather has the guts to “be emphatically myself,” to misquote Ralph Waldo Emerson. He never hesitates to say things he believes in passionately.
Motivation comes from the prospect of continuing to grow something healthy, and to do stimulating work with exceptional people. Mr. Drummy drives innovation by pushing people to take on activities that are difficult, but desirable and just barely possible, and giving them permission to pursue things that excite them.
Mr. Drummy derives great satisfaction from mentoring, including start-up companies associated with Blueprint Health, a healthcare startup accelerator, as well as people in Heartbeat and the wider Publicis world. (PV)
Dr. Andreas Koester
Passionate About Transforming Clinical Trials
Title: Global Head, R&D Operations
Company: Janssen Pharmaceutical companies of Johnson & Johnson
Education: MD, Leipzig Medical School; PhD, Humboldt University, Berlin
Hobbies: Photography, tennis
Bucket List: Seeing a polar bear in the wild before they have all been killed
Awards/Honors: Medicine Maker Top 100, 2015; Pioneer Award Partnership in Clinical Trials for Investigator Databank, 2014
Tweet at: @andreas_koe
Development of new therapies has never been more challenging. It takes longer to recruit patients, trial complexity is increasing, and trial design is antiquated, costly, and inefficient.
Andreas Koester, M.D., Ph.D., has become a prominent voice for improving clinical trial design as a means to reduce drug development costs and create higher quality of life for patients. As global head, R&D operations innovation at Janssen, he has advanced promising technologies while also introducing innovative trial designs that put the patient at the center.
“It’s important to treat patients as partners in clinical trials,” he says. “Their participation is vital to the pharma industry’s ability to bring new medicines to the market. Sponsors can do a better job listening to patients and addressing their needs to improve clinical trial experiences.”
To do this, Dr. Koester leads a team that is rethinking the entire clinical trial process and driving change through a suite of smart technologies and process initiatives.
Dr. Koester has more than 20 years of experience designing and managing clinical trials for pharmaceutical companies and contract research organizations, and he plays a central role in industrywide efforts to modernize clinical trials by leading the charge of prioritizing the patient experience.
At Janssen, Dr. Koester is leading the creation of iSTEP (Integrated Smart Trial & Engagement Platform) to address the industry’s need for transformative solutions. iSTEP aims to replace many paper-based procedures with smart technologies that automate record-keeping and provide personalized medication reminders, drug information, and communication between patients and clinicians. Release 1.0 of the platform will be available later in 2017, ready to be used in patient trials.
Additionally, Janssen, as one part of its patient engagement initiatives, is working on ways to provide patients with access to their data during every part of trial: before, during, and after. Dr. Koester says the company is piloting its first program to enhance patient data access in a large-scale, multinational Phase III trial. This will help give patients actionable healthcare information, moving them beyond the traditional role as “subjects” in trials toward treating them as true partners.
Colleagues say Dr. Koester’s fierce commitment to helping patients, drug developers, and the healthcare industry overall has brought together some of the world’s most respected drug developers, clinicians, and scientific advisors to collaborate on efforts to enhance and optimize the clinical trial process.
“I am driven to innovate by dissatisfaction with the status quo,” he says.
Dr. Koester is an oversight committee member of TransCelerate BioPharma representing Janssen, a founding member of the consortium. This is a collaborative effort to develop shared industry R&D solutions to simplify and accelerate the delivery of innovative products to patients.
Before the formation of TransCelerate, he was instrumental in the creation of the Cross-Pharmaceutical Investigator Databank, established in collaboration with Merck and Lilly, to reduce the administrative burden for investigators and streamline the site selection and start-up process.
Five years later, the investigator databank, now investigator registry, has been joined by the majority of large pharma companies and serves as the backbone for TransCelerate’s site investigator portal.
Dr. Koester believes closer and more efficient industry cooperation, such as the TransCelerate CTTI, MRCTI and other initiatives, is the key to address the challenges of the clinical trial enterprise.
Looking back at his career, developing drugs for Alzheimer’s, HIV, and tuberculosis and co-creating the investigator databank were career highlights he cherishes.
Dr. Koester’s positive impact is felt by his peers, his company, and the industry at large and he would like to be remembered as someone whose work helped to lift all boats by making clinical trials better for patients and investigators and as a result can bring novel medicines to patients faster.
“I try to inspire others by giving them the room and safety net to be their best,” he says. (PV)
Meeting Need with Strategy and Urgency
Company: Immunovaccine Inc.
Education: BSc, Biology; Master’s, Management, Université d’ Angers
Family: He is very grateful to his wife and kids, who have been very supportive and accepting of his extremely busy schedule; and his parents, who instilled strong values in him early on
Hobbies: Running marathons, hiking, skiing, playing guitar
Bucket List: Running the Boston marathon
Since being named CEO in 2016, Frederic Ors has led Immunovaccine on a journey of extraordinary progress, taking it from an early-stage biotechnology company with novel science to a biopharma organization with three promising clinical candidates and several more poised to enter human testing. He has crystalized the company’s strategic development plan and brought clear focus and prioritization to the pipeline.
In that short time, the team has grown from 20 to 30-plus members, attracting new investors and more funds. Mr. Ors has also been instrumental in establishing several crucial partnerships with industry leaders, including Merck, Incyte, Dana-Farber Cancer Institute, Leidos, and UConn Health.
He describes getting up in front of the board at the annual general meeting and recapping, with a sense of shared pride, the transformational successes of the past year.
Mr. Ors says he is acutely aware of the multitude of urgent, unmet medical needs plaguing today’s treatment landscape. He believes passionately in the potential of his team and the company’s technology to help address some of these needs through the development of novel therapies.
He inspires his team by reminding them of the urgent need patients face, in some of our most vulnerable patient populations, including patients battling ovarian cancer or respiratory syncytial virus (RSV).
“We are in a position to positively impact these patients because of what our people do day in and day out,” he says. “We see the need, we harness the hope, and inspiration is the inevitable result.”
For Mr. Ors, biotech is an amazing industry, operating on the edge of innovation and risk. Investing the right resources at the right time in the right place is challenging, but he sees the opportunity to do important and meaningful work.
He leads by fostering a shared sense of purpose and teamwork. He also views it as his job to have the courage to do the right thing, stick to the values of ingenuity and collaboration on which Immunovaccine was founded, and encourage his team to deviate from the status quo.
“At Immunovaccine, we’ve seen what strong collaborations with academia can do to transform a scientific or technical concept into a clinical program,” he says. “We’ve also benefitted from biotech and pharma partnerships that can move candidates through the clinic and toward commercialization.”
According to Mr. Ors, his role is to bring together people with the complex set of skills needed to create breakthroughs and to respect the insights they bring to the team. He respects and is grateful for the expertise of his senior leadership team, the board of directors, new hires, veteran scientists, and consultants.
“Innovation takes courage, and people should not be afraid to make mistakes,” he says, adding that having a strong team with good judgment ensures the right level of caution will be inherent in their work.
“For my part, I work hard to instill a shared sense of purpose in my team, give them an outlet to direct their knowledge and skills, and then to get out of the way, giving them the room to do what they do best,” Mr. Ors says. “I ask a lot from my team, and our business partners, because we need to bring together a substantial set of skills and resources to come through for our patients, our investors, and our people.”
He maintains that innovation thrives where there are good people, open communication, mutual respect, groundbreaking science, and strong business acumen. Dreaming big is important, and Mr. Ors would tell his younger self that boldness has genius, power, and magic in it, and never to forget the power of engagement. (PV)
Thinking Big and Getting It Done
Title: Chief Operating Officer
Company: Alamo Pharma Services
Education: BS, Business and Finance, San Diego State University
Family: Parents for showing him the importance of faith and family; his dad for showing him how to lead with a personality; his sister and brothers for instilling a competitive spirit in him at an early age; his wife and children for keeping him focused on what is really important in life.
Hobbies: Golfing, attending live sporting events and concerts, traveling
Bucket List: Travel to Australia, see more of Europe, get a hole in one, golf at the top 10 golf courses in the world, write a book or two with a national lecture tour
Awards/Honors: CMR Institute Board Of Directors, 2001; American Red Cross Training Advisory Board, 2000; PharmaVOICE 100, 2017 and 2009; Editorial Advisory Board, Pharmaceutical Rep Magazine; Top 100 People in Learning and Development, Leadership Excellence Magazine, 2008; Training Magazine Top 125, 2005, 2006, 2007, 2008, 2009, 2010
Through strong leadership, Pete Marchesini has helped build a company that is regarded as a true partner to its clients. As chief operating officer of the contract sales organization Alamo Pharma Services, Mr. Marchesini is building teams that embody trust, accountability, and spirit.
When Alamo was founded in 2011, Mr. Marchesini along with Terry Herring (2017 Red Jacket honoree) identified talented individuals to join the organization, taking into consideration each person’s strengths, varied professional backgrounds, what motivates them, their intrinsic values, and their commitment to success.
As Alamo continues to develop and grow, Mr. Marchesini has fostered a company energy that is based on brainstorming sessions where teams decide what the next steps to success will be. He consistently challenges colleagues to look back and self-assess what the company should continue to do, stop doing, and start doing. He also inspires his company leaders to always look for the greatest return on their clients’ investment.
Taking Alamo Pharma Services from an idea to a successful company is a career highlight for Mr. Marchesini.
He credits his time at inVentiv Health from 2002 to 2010 as a defining period, which required prioritization of initiatives while still being a service organization. He and his colleagues were part of a monumental evolution of a company, which was growing rapidly through acquisitions and organic growth.
“I learned much of what I know about this industry from a group of individuals that built the company, and ultimately have moved on to find that entrepreneurial spirit again,” he says.
His goal is to build Alamo to the right size, ensuring it has the revenue it needs, the profits desired, the customers he and his colleagues love, and the people they want to work with each day.
He would like to be remembered as someone who built up people and companies.
Mr. Marchesini inspires by helping individuals see their strengths and positioning them to be successful. He works beside his colleagues whenever possible. He is motivated by the need to exceed the expectations of his senior leadership and above all his customers. And he is driven by the need for better answers to address challenges related to people, processes, time, and budget.
Customer service is paramount in Mr. Marchesini’s view, and he says expectations are being set from outside the industry, driven by the speed that people are able to get the answers they need in their personal life.
Products and businesses such as Alexa, Siri, and Amazon have set the bar high in terms of what a timely response is in the mind of a customer.
Clients say Mr. Marchesini has built a company that acts as a partner in every way. He asks questions, listens, and always has suggestions ready during calls and meetings. He thinks big and delivers bigger.
As issues and challenges come up, Mr. Marchesini is always finding solutions and connecting clients with experts throughout the industry to help with a range of areas. Where some may see a roadblock, Mr. Marchesini envisions a set of concepts and solutions that succeed.
Mr. Marchesini exhibits three characteristics that make success happen. First, he is available and responsive. Second, he is creative in developing solutions drawing on his extensive salesforce experience as well as less obvious ideas. And third, he is true to his word, always responding and following up with clients and colleagues as agreed.
Those who have worked with him describe him as a collaborative, positive, smart, enthusiastic, even-keeled leader who is outstanding to work with and who does what he says he is going to do.
Mr. Marchesini also is a thought leader and acts as a mentor for the next generation.
He speaks at various industry conferences about salesforce effectiveness, product launches, and developing commercialization teams.
Through his teaching role at Rutgers University, Mr. Marchesini advises students on how to get their first job in the industry or to move ahead in the industry.
“The value of this time spent not only grounds you in the basics but gives you an appreciation of the opportunities you were both given and/or you took,” he says. (PV)
Succeeding Through Optimism
Company: Altasciences Clinical Research
Education: BSc (Hons) Applied Biology, Bradford University, 1975
Family: Girlfriend of 20 years
Hobbies: Brewing, knife making, and biking
Bucket List: Motorcycle and camp across the western U.S.; build a hot rod; eat Jamon Ibérico ham in the Iberian Peninsula where the black pigs are raised on acorns
Awards/Honors: CRO Leadership Award, Life Science Leader, for the fourth consecutive year; Best Contract Research Organization – Niche, 12th Annual Scrip Awards, 2016; Best Full Service Early Stage Clinical Research Provider – Canada, Global Health & Pharma’s Biotechnology Awards, 2016; Outstanding Performance, 31st Annual Canada Awards for Excellence, 2015
With a good plan and good people, there’s very little that can’t be overcome — it just takes time. This optimism is how Chris Perkin leads his company, Altasciences Clinical Research, and its employees to success.
Mr. Perkin has enabled Altasciences to become one of the leading early-stage clinical research organizations — all within seven years.
In 2015, as the industry faced volatility, Mr. Perkin inspired his multi-site teams to think outside of the box and face challenges head on. He recognized it was time to take the integration of the company’s three sites — Montreal, Kansas, and Fargo — to the next level and to accelerate harmonization of best clinical and operational practices. In January 2016, the company shared its new harmonized look and messaging for its three sites with the industry, allowing sponsors worldwide to better view the sites as one unified company, but with a flexible and customized approach.
Mr. Perkin has been in the industry for more than 40 years and during this time, he has evolved from entry-level scientist to inspirational leader, guiding his teams to success through his exemplary motivational style.
He views leadership as the ability to persuade, encourage, and guide groups of people to work together for a common goal, to overcome obstacles and to believe in the journey and destination.
Mr. Perkin has thoroughly enjoyed moving from a large company to become CEO of a smaller one, and attracting a team of talented managers.
Mr. Perkin, a three-time PharmaVOICE 100 honoree, believes inspiration is a product of culture plus management style, noting that an environment where information is shared, teamwork and cross-department collaboration are encouraged and valued, individual responsibility and accountability is freely given, support is always available, and regular feedback is provided, is one that leads to inspired performance and the achievement of high goals.
Mr. Perkin instills trust in his staff, noting that the fastest and most effective way to grow talent is to allow people to take on responsibilities and tasks that stretch their abilities. With support rather than oversight, Mr. Perkin believes they will almost always exceed expectations.
By creating an environment that removes the fear of failure and encourages and respects new ideas and solutions, Mr. Perkin motivates his team to innovate.
He is grateful to have had a senior executive coach and mentor at each of the four companies he has worked, and while the relationships weren’t formalized, there was a mutual recognition of similar values and work ethic.
As for returning the favor, Mr. Perkin subscribes to the philosophy that good managers and supervisors at all levels provide guidance, time, understanding, and advice to their staff.
“I am not sure that any manager is qualified to credibly describe his or herself as a mentor as I believe it is a title that can only be bestowed by others,” he says.
Employees describe Mr. Perkin as approachable and a great listener, which encourages them to speak openly and honestly to him about anything. He makes them feel valued, always checking in to ensure they are happy with their job and role.
He sees his employees as his main source of growth. He openly shares his vision on where the organization stands, and speaks transparently to all employees. He listens humbly, without rushing or interrupting. (PV)
Shaping the Healthcare Evolution
Title: President and CEO
Company: Zephyr Health Inc.
Education: BA, Biology, Baylor University; MBA, Texas A&M University
Family: Wife, Susan; daughters, Sophia and Ava
Hobbies: Tennis, fitness, travel
Associations: HealthTech Capital
After a long career in the pharmaceutical industry, Lance Scott realized there was another way to help life-sciences companies achieve their goals: developing technology that helps companies make smart decisions using reliable data insights.
Today, instead of searching for that signal within the data noise to help a brand, he is now providing the technology that connects data and delivers dynamic insights for life-sciences teams tasked with creating go-to market strategies for new brands.
Because Mr. Scott spent most of his career on the pharma and medical device side, he is uniquely qualified to not only understand the frustrations many marketing and sales teams have in defining a strategy based on data insights, but offer his new company perspective on what life-sciences teams are searching for.
As CEO of Zephyr Health, he is focused on applying his operational experience, leadership, and expertise in influencing the evolution of healthcare through further integration of innovative technology.
Building Zephyr Health and defining a new product category motivates Mr. Scott daily.
“I think about the clients counting on us to help them succeed and the members of the Zephyr Health Team counting on me to ensure we are focused on the right priorities to ensure our success,” he says.
The challenge for the industry, he says, is to rapidly integrate technology solutions that provide data-driven, actionable insights that can optimize go-to-market strategies.
With more pharma companies partnering directly with patients to improve early disease detection and management, patient programs are growing and generating lots of data. Getting this data integrated into provider outreach, however, or even other internal systems is still a challenge. Mr. Scott understood that by linking these data points, life-sciences companies would gain a richer understanding of the provider’s treatment approach and the type of patients being treated.
In 2016, Mr. Scott led the launch of Zephyr Illuminate’s Referral Analytics to highlight the importance of the patient’s connection with the provider, enabling life-sciences commercial teams to better understand who is managing target patients on an ongoing basis, as well as better understand referral dynamics and the relationship between the primary care and specialty physician.
Across all areas of healthcare and life sciences, Mr. Scott believes opportunity lies in utilizing data-driven insights to improve decision making for commercial success.
Before Zephyr, Mr. Scott spent 25 years at Abbott in various sales and marketing executive positions in both the pharmaceutical and medical device units and has experienced first-hand how the lack of cogent data can affect confidence in making business decisions.
Mr. Scott knew there had to be a better way to leverage data and gain confidence in what the information was telling him and in a way that would allow his team to be responsive in real time.
Over the course of his career, he has been involved in the launch of several new products, including TriCor, which established a new category of dyslipidemia therapy, and Xience V, an innovative drug-eluting stent (DES) that became the world’s leading DES.
His most intense role was leading the integration of Kos Pharmaceutical acquired by Abbott in 2006. The goal for completing the integration was 90 days. With the support of a talented and dedicated integration team, Mr. Scott and his colleagues completed the integration on schedule and well below expected costs.
As a leader, Mr. Scott notes that although quantifiable measures of success are important — sales, margin, etc. — he also places emphasis on the success of individuals with which he works.
“I feel a significant responsibility to ensure that I play a meaningful role in partnering with members of my team to ensure they grow professionally and achieve their goals,” he says. “That may be a more lasting legacy than achieving financial targets.”
Mr. Scott maintains that the way to get the most out of a team is to be candid in terms of the opportunities and challenges facing the business and the role each member of the team plays in contributing to the success of the business.
The role of the leader is to provide a clear vision of the goal for the organization and then create an environment where team members can apply their talent, experience, and insights to best achieve that goal, he says.
Mr. Scott understands the value of teamwork. He has encouraged engineers to work side by side with other team members in developing new capabilities.
Life requires balance, and Mr. Scott would advise his younger self to be diligent about consistently balancing time and effort across professional and personal priorities. (PV)
The Caring Warrior
Title: Chairman and CEO
Company: Agile Therapeutics Inc.
Education: BS, Drexel University; MBA, Rider University
Family: Wife, Chris; children, Alison and Claire; son-in-law Jay; grandfather, Antonio
Hobbies: Traveling, sports
Bucket List: Too many places still to see
Awards/Honors: Hall of Fame Father Judge High School, 2017; Hall of Fame, Drexel 100, 2017; CEO of the Year, Finance Magazine, 2016; Father of the Year, American Diabetes Association, 2015; CEO of the Year, New Jersey Technology Council, 2014; PharmaVOICE 100, 2007, 2017
Associations: TASK Trenton Area Soup Kitchen (Vice Chair); Advisory Board, Drexel University
Tweet at: @alaltomari
As Chairman, President, and CEO Al Altomari is taking Agile Therapeutics to great heights and moving it closer to the goal of being a leading women’s healthcare company.
After a distinguished career at Johnson & Johnson, Mr. Altomari served as CEO of Barrier Therapeutics, where he began blazing his own trail in pharmaceuticals, launching, developing, and commercializing innovative women’s healthcare and dermatology products.
Sometimes, rather than creating entirely new entities, entrepreneurial enterprises innovate by leapfrogging old technology, and sometimes, by leaping ahead of their past endeavors. Agile rallied its capital and resources around developing products in the almost-abandoned field of women’s health related to contraception, starting with a lower-dose, more convenient alternative to the only existing birth-control patch on the market.
Agile’s initial NDA for its lead product caused the FDA to issue a complete response letter that sent the company back to the drawing board in late-stage development. Then-chairman Mr. Altomari took over the CEO role and assembled new management, organized a confirmatory Phase III trial of the company’s new contraceptive patch, and raised much needed-capital by taking the company public in 2014.
Because of his inspired leadership and motivating actions, the company received a second chance.
An exemplary leader, Mr. Altomari always seeks to do the right thing and is selfless in his contributions to both the business and his employees. He inspires with passion, energy, and caring. He fosters innovation by letting people make mistakes and by laughing at his own blunders.
Mr. Altomari takes the idea of making a difference in people’s lives seriously, and says he is driven to innovate by a combination of patients and competition.
He encourages others to think outside of the box and provides the guidance and support necessary for his teams to reach new levels. Colleagues say he has the rare ability to listen to various opinions and always welcomes a thought different from his own.
Mr. Altomari says he would like to be remembered for two things: being resilient and being a mentor. Mentoring, he says, keeps him young. He is a true champion of supporting and developing others for success whether it’s internal or external constituents, with no expectation or desire for personal recognition and is a strong advocate of growing opportunities for women in industry leadership positions.
Active with Drexel University, Mr. Altomari serves on the President’s Leadership Council, is vice chair of the LeBow College Dean’s Advisory Board, and serves on the advisory board of the Charles D. Close School of Entrepreneurship.
He has been instrumental in supporting the advancement of educational programs, including the MBA internship program at Drexel’s LeBow College of Business. As a result of his tireless commitment, Mr. Altomari was inducted into the Drexel 100, the University’s Alumni Hall of Fame in May 2017. He is also being inducted to the Father Judge High School Hall of Fame for his efforts and contributions in the support of achieving academic excellence and providing educational opportunities to deserving children.
In 2016, he was named Father of the Year by the American Diabetes Association (ADA) for his continued support, efforts, and ongoing commitment to the association. Having lost his mother to diabetes, Mr. Altomari has been committed to the efforts of the ADA and finding a cure for diabetes. His caring extends into the community, and he also serves on the board of the Trenton Area Soup Kitchen (TASK).
This is Mr. Altomari’s second recognition as a PharmaVOICE 100, having been named to the list in 2007. (PV)
Dr. Keith Bradley
Teach and They Will Come
Title: Founder, CEO, Chief Medical Officer
Company: National Alliance of Research Associates Programs (NARAP)
Education: BS, University of Notre Dame; MD, Tulane University School of Medicine
Family: Wife, five children, and five grandchildren
Bucket List: The continued success of NARAP
Associations: American College of Emergency Physicians (ACEP); Society for Academic Emergency Medicine (SAEM); National Association of Advisors for the Health Professions (NAAHP); North East Association of Advisors for the Health Professions (NEAAHP)
For the past 23 years, Keith Bradley, M.D., has been working to change healthcare by bringing together clinical research, patients, emergency departments across the country, and pre-med students.
In 1994, while working as an emergency room physician, Dr. Bradley brought pre-health professional students from local colleges and universities to Lincoln Hospital in the South Bronx. Under his guidance, these students, called research associates (RAs) engaged directly with patients and their families to conduct clinical research in the emergency department.
After years of testing and refining the concept, in 2009 Dr. Bradley founded the National Alliance of Research Associates Programs (NARAP), a nonprofit, 501(c)(3) national organization. Since then, large-scale affordable healthcare research is now possible through the coordination, standardized training, and rigorous processes created by NARAP.
It’s been a lot of work to develop NARAP into an organization that can have a positive impact on healthcare, and it required sound financial backing to fulfill its potential.
As an expanding consortium of hospitals, universities, doctors, and pre-health professional students, the all-volunteer NARAP model has successfully demonstrated it can positively impact health concerns with large-scale studies in smoking, breast cancer, cervical cancer, prostate cancer, domestic violence, and across a broad range of clinical issues in emergency medicine.
“Our consortium of affiliate hospitals continually expands and since 2009, 140,000 emergency department patients and visitors have participated in clinical research studies and received invaluable healthcare screening and prevention information,” Dr. Bradley says.
The need for an organization like NARAP, which establishes a research model, infrastructure, and proof-of-concept for health professionals, is great. In fact, at that first orientation session at Lincoln Medical and Mental Health Center in the South Bronx, Dr. Bradley expected 10 students to show up, instead, 75 did. And, Dr. Bradley took them all on.
His goal is to continue the success of NARAP as a national organization. More than 10,000 students have volunteered over the past 23 years in the NARAP Research Associates Program learning the fundamentals of interacting with patients as well as the disciplines of clinical research.
Dr. Bradley measures success in increments, by the impact of NARAP’s clinical research, by the primary healthcare screening facilitated, and by the success of thousands of students as research associates.
Working together with a strong group of visionary people is what enables NARAP to jump hurdles and keep the motivation for its mission strong.
He says it’s important to get across the importance of face-to-face interactions, realizing that medicine is personal, not digital.
Dr. Bradley seeks to mentor research associates, particularly chief research associates, on their paths to career discernment, qualification, and personal development.
“As the Latin root for doctor is docere, to teach, they are the multiplier effect I hope to have far into the future of healthcare,” he says. (PV)
Leading Through Growth
Title: Chief Operating Officer
Education: BS, Accounting & Finance, St. Joseph’s University; MBA, Corporate Finance & Entrepreneurship, New York University
Family: Wife, Laura, and two children, Samantha and Tyler, for being so supportive of his career; parents for showing him what it takes to start and grow a business and create opportunities for others
Hobbies: Golf, basketball
Bucket List: Drive cross-country; play every golf course on the top 100 list; learn to play the saxophone
Awards/Honors: Philadelphia Business Journal Forty Under 40
Associations: Life Science Angel Network
Tweet at: @jpwoodland
Jim Woodland receives high praise from his colleagues noting an impressive list of attributes, and those are almost as impressive as one that isn’t in his job description: a knack for listening.
Apparently, everything Mr. Woodland, chief operating officer, at CMI/Compas does, he does well, including growing CMI/Compas to a thriving business, and being named to the Philadelphia Top 40 Under 40.
In 2016, CMI/Compas grew more than 30% in revenue, 12% in staff, and the planning arm, CMI, was acquired by WPP. The company publicly took on accountability for the success of its clients, to the tune of several billion dollars in client revenue growth. Mr. Woodland’s strong leadership in strategic thinking and in pushing pharmaceutical marketing beyond traditional boundaries are keys to the company’s success. Externally, he focuses all his effort to the community of clients. He has pushed the organization to leverage the company’s assets of AdMission, Adapt focused Media Buying, Drive, Advanced Analytics, and ByDoctor platforms to increase clients’ ROI each year.
Mr. Woodland also worked to re-define the agency-client relationship by introducing a partnership plan for clients that allowed the media agency to take a more strategic role and be accountable for the business growth of clients, including introducing technologies built around how clients do business today, better engagement of physicians and consumers, harnessing data for marketing, and completely changing the way media planning is done.
Colleagues call him a terrific leader who is smart, collaborative, insightful, and genuinely passionate about the business. The direction he has provided to the team at CMI has catapulted the agency to the top of the ranks, his team members say.
Mr. Woodland possesses excellent business acumen, and cares deeply for his employees.
Although CMI has grown exponentially and is now part of WPP, Mr. Woodland ensures the company remains true to its family-first roots. He has a clear vision and engaging demeanor that inspires both staff and clients. In the office, he is the “go-to” guy. As a beacon of knowledge and experience, all levels of staff turn to him for guidance, inspiration, and at times even an ear. “Let’s see what Jim thinks,” is often heard at CMI/Compas.
Mr. Woodland also inspires those around him by encouraging and challenging staff to think differently. In times of change, he is always a constant. He has overseen adding three office locations in under four years.
Mr. Woodland would like to be remembered in the industry not as a singular person but through the organizations he contributes to and what they collectively achieve and represent.
“I want our staff to feel they worked at the best possible place to advance their careers in the industry,” he says. “I want our clients to know they hired the best partner to grow their business.”
Mr. Woodland can be seen on just about any day taking time just listening — to his colleagues, to clients, to supplier partners — a true rarity in any business setting today. (PV)
Making Good Things Happen
Title: Managing Partner, Chief Operating Officer
Company: Calcium USA LLC
Education: BS, Marketing/Management, Siena College
Family: Children, who are a constant reminder of what is important in life; husband, her life partner; parents, who made her who she is
Hobbies: Yoga, running, weight training, cheering son’s basketball games, watching her youngest play tennis, homework helper, master scheduler, and spending time with family
Bucket List: Write a book, teach a class, travel
Awards/Honors: PharmaVOICE 100, 2009 and 2017; PM360 Elite award; Crains 40 under 40, 1998; President’s Club Top Sales Awards, Marion Merrell Dow,1989 and 1990; Managers Performance Awards, 1988, 1989, 1990; Siena College President’s Award for Service to the Community, 2012; Stack Center Entrepreneur of the Year Award, 2016
Associations: Siena College Board of Trustees, Epiphany Community Nursery School Board, Promise Project Board
Judy Capano’s potential was apparent at the age of 9. Too young to earn money from a paper route, instead she devised a plan to collect the used papers in the neighborhood and recycle them for cash. At $1 for every hundred pounds of paper, she made $84 that year.
Similarly, in her first industry job as a sales rep at Marion Merrell Dow, colleagues report that she applied her business acumen and her systematic approach to strategy, and her commitment to supporting her colleagues, which resulted in her receiving the President’s Club Top Sales award two years in a row.
From there, she moved to the agency world, starting her journey at Harrison & Star, where she was director of client services. Her next career step was to the McCann healthcare network, where she led the global operations group and built the McCann global network to more than 50 offices. Ms. Capano then moved to the position of managing partner, chief strategy officer, at Wishbone, where she remained until its acquisition by Rosetta. Today, she is co-founder, managing partner, and chief operating officer, at Calcium. Her work remains focused on the creation and nurturing of healthcare brands and businesses. She is also keenly interested on generating a positive impact on both individuals and society.
Throughout the many phases of her life and career, Ms. Capano has been successful at making good things happen, turning challenges into opportunities, and generating positive results.
In the past 12 months, Calcium has demonstrated significant growth, fueled in large part by her strategic stewardship of a number of key accounts. In all cases, she has ensured that Calcium’s clients appreciate that the company sees itself as less of an agency and more of a group of individuals who care deeply about their brands. Her tireless energy in doing the absolute best for clients is fundamental to the company’s culture, actions, and success.
On both a personal and professional level, Ms. Capano is a thoughtful person: she cares for those in the work place with much of the same focus, energy, and passion that she brings to her family life. She is very active in various educational and philanthropic initiatives, serving on the boards of Siena College; the Promise Project, which provides support to children with learning disabilities; and the Epiphany Community Nursery School.
In all of her endeavors, Ms. Capano is driven to seek the most productive path forward and to deliver the most positive outcomes. She is by nature highly collaborative, but she can also assert a strong independence when the situation warrants it. She is a leader who speaks with authority and credibility, and whose voice is heeded by all.
One trait that also stands out is her clarity of thought and action. In this complicated, hyperactive age, coherence is something that’s often in short supply. There is a certain tendency to equate complexity with sophistication and intelligence, as if the right answers to important questions need to be, on some level, difficult to grasp.
When Ms. Capano is leading a group discussion, there is never a fog of vagueness pervading the room; rather, colleagues say insights, ideas, and directives are marshaled crisply and effectively. In an industry that can get bogged down in its own complexity and subjectivity, her voice is unabashedly clear and carries an eloquence that is born out of a deep appreciation for concreteness, practicality, and the attainment of real results.
“My motto is: seek first to understand then be understood,” she says. “This has served me very well in business because by taking a moment to ask questions and learn the other person’s position helps you gain insight into how to better manage the situation. It also comes in pretty handy in parenthood.” (PV)
Dr. Greg Koski
Transforming the Clinical Trial System
Title: President, CEO, Co-founder
Company: ACRES (Alliance for Clinical Research Excellence and Safety)
Education: AB, MD, and PhD, Harvard
Family: His loving and fiercely independent wife, Linda Ann Powers; children, Jessica, Hannah, and Jared who are making the world a better place; mother and father who taught him that any job worth doing is worth doing right and that one should always aim high
Hobbies: Sailing, cooking, playing guitar and singing, hiking, and cycling
Bucket List: Cruise the world aboard his beloved Veneeni, a Lord Nelson 41 bluewater sailing vessel, with friends and family; to get good enough with the guitar to do a Thursday night performance at King Eider’s Pub in Damariscotta, Maine
Awards/Honors: Superior Service Award from the Department of Health and Human Services; Special Recognition Award from Public Responsibility in Medicine and Research (PRIM&R); Lifetime Membership Awards from the Association of Clinical Research Professionals (ACRP) and the Academy of Pharmaceutical Physicians and Investigators (APPI); Special Recognition from the Center for Information and Study of Clinical Research Participation (CISCRP); Honorary Doctor of Science degree from Albany Medical College
Associations: Association of Clinical Research Professionals; Academy of Physicians in Clinical Research; SAFE Biopharma Association Board of Trustees; BlueCloud Global Advisory Board; Seven Seas Cruising Association; Bluewater Sailing Club; U.S. Sailing
Few others have contributed more to the positive reform and professionalization of clinical research globally than Greg Koski, M.D., Ph.D.
In 1999, after the death of Jesse Gelsinger in the highly publicized gene-transfer study at the University of Pennsylvania, the internationally recognized leader in clinical research was recruited by then Secretary of Health and Human Services, Donna Shalala, to establish a new Office for Human Research Protections.
“This was an opportunity that forever changed my life and surely many others as we promoted a culture of conscience and commitment in human subjects research — doing the right thing because it is the right thing to do,” Dr. Koski says.
Dr. Koski also led the successful push for an independent accrediting body for human research protection programs. Now as president, CEO, and co-founder of ACRES, he is continuing to transform clinical research and development enterprise to become a safer, more efficient, and more effective system up and down the line.
Under Dr. Koski’s leadership ACRES, the Alliance for Clinical Research Excellence and Safety, is a global, nonprofit public-interest, system-focused multi-sector collaborative shaping the dialogue for the future of the industry, stressing the need for greater collaboration and developing and applying systems approaches to provide the connectivity and interoperability needed to transform the clinical research endeavor on an international level.
Dr. Koski has a vision of implementing global standards in clinical research. This would be translated into an increase in quality in research worldwide, more accurate data, and faster results for the pharmaceutical industry.
Through his leadership, ACRES has established a model for site accreditation and a global IT platform — ACRES Blue Cloud, which facilitates international site set up as well as novel initiatives in patient engagement, quality management, systems science, and the supply chain.
“The opportunity to lead a global multi-stakeholder effort to transformatively change the global ecosystem for clinical innovation through the application of systems thinking is not a minor undertaking, but with support from hundreds of committed friends, colleagues, and organizations around the world, we are moving forward, and the benefits to everyone, including patients, will be enormous,” he says. “Having enjoyed a wonderful career that has encompassed essentially every aspect of medicine, science, ethics, regulatory science, information technology, quality management, and patient care, my goal is to see it all come together in the form of a comprehensive, integrated global system that benefits all of the stakeholders and help make the world a better place.”
His work with ACRES has inspired researchers all over the globe to set standards for researchers and education for all involved in drug development.
Those who know Dr. Koski says he is a man who is passionate about his current venture, and he is an inspiring, thoughtful, and compassionate individual who recognizes that the discovery, learning, and sharing of knowledge are all critical for the advancement of society.
He says he can’t help but share his excitement about the work being done at ACRES, and this rubs off on the people he talks with about systems thinking.
“I encourage others to get involved, to accept the challenge of doing something really big and bold that will be a real game changer and help people,” he says. “And when they get excited too, I recognize it and share their excitement.
“I hope that I may be remembered as someone who was willing to undertake the challenge of ensuring all people have access to safe, effective, dependable, and affordable medical treatment, medicines, and devices become a reality by sharing that vision and bringing together a group of like-minded people and organizations to make it happen,” he concludes. (PV)
Title: President and General Manager
Company: Aqua Pharmaceuticals, an Almirall Company
Education: BS, Villanova University, 1988; MBA, St. Joseph’s University, 1994
Family: His father who has always modeled the way for him; his mom who has instilled caring and humility in him
Hobbies: Golfing, college football and basketball, going to the beach
Bucket List: Play Augusta National; save more lives with National Bone Marrow Foundation
Awards/Honors: Corporate Culture Award for Customer Affinity, Almirall, 2015; PharmaVOICE 100, 2010, 2017; Fastest Growing Company in Philadelphia Business Journal
Since taking the helm of Aqua Pharmaceuticals five years ago, Ted White has led the company to double-digit growth every year. During that same period, Aqua has acquired and launched four new products and manufactured its first product. And the sales team has grown from 40 representatives to more than 150.
When asked to comment on the company’s growth, Mr. White says it’s consistency that matters.
“It is not difficult to win an award here and there; what’s difficult is achieving success year after year at a high level,” he says.
And Mr. White believes spending time in the field to better understand the needs of customers and patients is the path to innovation and sustainable success.
He is committed to continuing the company’s growth and expanding into other areas of dermatology outside of prescription products.
Colleagues say he has a knack for addressing the challenges of running a business with a personal touch, which has allowed him to attract and retain top-flight individuals to continue the organization’s upward trajectory.
He is focused on advancing future leaders at the company, noting developing leaders allows Aqua to become a better, more productive, and more profitable organization.
He has a knack for identifying great people and the commitment, tenacity, and loyalty to build great relationships.
In his time at Aqua, two significant programs have been established within the company that provide opportunities for advancement. The first, Progressions, allows for both representatives and managers to achieve different levels within their current roles at the company.
The second program, the Aqua Leadership Academy is open to all employees. Those accepted into the program are given different assignments, meetings, collaborations, and other monthly tasks to prepare them to take on more of a leadership role within the company.
Seeking to model the way for others, Mr. White believes it’s important to learn what drives others and to create a “we” mentality since developing solutions to challenges is done by getting people to work together.
Mr. White always looks at the business decisions he makes through the eyes of a sales representative. He has never lost sight of what it’s like to carry a bag.
He would like to be remembered as someone who was results-oriented, consistent, fair, and left a positive impact on employees’ lives.
His father taught him from an early age that hard work is the only way to achieve results, or as he puts it: “unless you fill the bucket up with sweat you will never achieve true success.” (PV)
Dr. Sy Pretorius
Creating New Paths in Drug Development
Title: Senior VP and Chief Scientific Officer
Company: Parexel International Corp.
Education: MBChB, University of the Free State, South Africa; MMedSc, Clinical Pharmacology, University of the Free State, South Africa; MBA, North-West University; MS, Management of Drug Development, University of Southern California; FFPM (Hon) – Fellow of the Faculty of Pharmaceutical Medicine
Family: Wife, Surene; two sons, Christiaan and Daniel; parents and siblings
Bucket List: His current role is to assist clients in getting their drugs developed and approved; one day, his dream is to develop and bring his own drug to market
Sy Pretorius’ deep scientific expertise, inclusive leadership style, and passion and commitment to improving the lives of patients inspire all who work with him.
What has made Dr. Pretorius so successful in his role as senior VP and chief scientific officer at Parexel International is his drive to innovate by using science and data to make better decisions in planning and conducting clinical research.
He collaborates closely with biopharmaceutical and medical device clients in designing and optimizing drug/device development strategies and plans, simplifying their journey between science and new treatments.
He has championed the industry’s shift toward using data, technology, and process to optimize clinical trials. By using an analytical approach, and by applying his vast expertise and experience, Dr. Pretorius breaks down barriers to conducting smarter planning and creating more effective and efficient optimized clinical trials.
Colleagues describe Dr. Pretorius as warm, humble, caring, with an engaging personality.
He is driven to innovate and he leads by example, which inspires others to think differently. His passion translates to employees and clients, and positively impacts everyone who works with him.
According to colleagues Dr. Pretorius’ approachable demeanor makes a significant difference to those who look to him for guidance. He approaches things from different angles and helps people to think in novel ways. In addition, he has an incredible and unique grasp of both science and of business.
These qualities have allowed Dr. Pretorius to help the biopharmaceutical services provider become a true partner in the drug development journey. One example of his leadership was a turnaround of Parexel’s early-phase business several years ago. At the time, the early-phase business was in an environment of chronic overcapacity in the industry, creating substantial profitability challenges. Dr. Pretorius and his team developed and executed a successful turnaround that has provided substantial benefit to the company.
Dr. Pretorius also led a team responsible for the creation of Parexel’s Quantitative Clinical Development Services, which combines clinical pharmacology modeling and simulation with clinical pharmacokinetics/pharmacodynamics and pharmacometrics. This service offers valuable drug development insights and better trial design with the potential to reduce the time and cost of bringing drugs to the market. Additionally and with the help of colleagues, he created Parexel’s Genomic Medicine Services, which helps clients integrate genomic research into their global drug development programs and meets a growing industry need.
He is committed to innovation, and chairs a companywide Innovation Forum, which aims to funnel and nurture new ideas. Dr. Pretorius’ passion for and commitment to bringing new medicines to patients in need is evident.
“Patients’ lives are at stake,” he says. “Paying attention to details is critically important, and can often be the difference between life and death for a patient, or success and failure for a new drug. My area of work is essentially about people and patients.”
Dr. Pretorius says he would like to be viewed as a knowledgeable and creative drug developer who played a role in bringing new therapies to patients and as a leader who inspired people and made a difference in their lives. His colleagues would say he has already achieved that goal. They look to him for guidance, strategy, and his absility to link science, clinical practice, and business together. (PV)
A Strategic Transformer
Title: CEO and Executive Director
Company: ISPOR (International Society for Pharmacoeconomics Outcomes Research)
Education: BA, University of Michigan
Family: Parents, grandparents, siblings, and her husband who puts up with travel, stress, and lots of time away from home
Hobbies: History, visiting Charleston, S.C., beach time, spending time with family
Bucket List: Doing a century cycling event
Awards/Honors: PharmaVOICE 100, 2016, 2017; PM360 Elite 100 award for transformational leadership, 2016; Silver Stevie award for women in business, 2016; Top 100 Most Influential Women by Crain’s Detroit Business, 2004; Michigan’s Top 50 Women by Corp Magazine, 2004; Women of Achievement Award, Business & Industry by the YWCA of Western Wayne County, MI; 40 Under 40 by Crain’s Detroit Business
Associations: Healthcare Businesswomen’s Association
Tweet at: @nbergberg
From the moment Nancy Berg joined the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), she set her sights on transforming the organization to become the leading educational and scientific resource for health economics and outcomes research (HEOR).
She recognizes the importance of ISPOR’s mission to advance HEOR excellence toward the goal of improving decision-making for health globally.
Ms. Berg rapidly began working with ISPOR’s board of directors to implement a new strategic plan for the society. To date, she has made great progress in executing this plan and has actively begun involving more healthcare stakeholders in
ISPOR’s mission and in elevating the society, which now has more than 20,000 individual and chapter members.
Under Ms. Berg’s guidance and expertise, ISPOR has reached many milestones: educational offerings were expanded to include essential in-person trainings; the ISPOR New Professionals Network was launched to develop future HEOR leaders; ISPOR Career Center, specializing in HEOR talent, was redesigned and relaunched; and a new initiative for U.S. value assessment frameworks was kicked off. In addition, the society’s peer-reviewed journal, Value in Health Regional Issues, was selected for inclusion in Medline/PubMed.
At every point, Ms. Berg recognizes ISPOR’s members as the life of the organization and it is through them that ISPOR is able to have an influential voice in healthcare decisions today.
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.
She has achieved all this and more while respectfully honoring the history and past success of the association.
There have been many highlights in Ms. Berg’s career, including mentoring others and watching them achieve more than they imagined they could, seeing former employees become CEOs, leading successful turnarounds, and now, inspiring ISPOR to evolve and change. She continues to set those goals for herself: to be a role model, build a world-class, cohesive team, and make a real difference in the association.
Colleagues say she has made a significant impact in the workplace, empowering her staff to think, explore, analyze, and implement against the vision she has so successfully put forward. She is committed to a business culture founded on open, honest communications, and the inclusion of multiple perspectives in decision-making processes. As a leader, Ms. Berg is confident and thoughtful, fair-minded and business-oriented, relaxed and friendly.
Through Ms. Berg’s leadership, there are more training and professional development opportunities for all staff members as well as a tuition reimbursement program.
Mentoring matters to Ms. Berg, who counsels people across several industries.
“I learn from them every time we meet,” she says. “I really appreciate having mentee relationships outside of the pharma industry; this gives me a different perspective and helps me continue to learn.”
Success for Ms. Berg can be measured in meeting goals. She is grateful to the people she has around her — her staff and her board of directors. She trusts those she works with to do what is right, and she helps them to realize the vision and understand their own contribution to the association’s mission.
Ms. Berg is admired for her transparency, candor, and for being a servant-leader.
“Innovation is realizing what we can’t even imagine is possible,” she says. “Innovation requires openness, feedback, energy, and a willingness to take risks.”
Ms. Berg has a personal commitment to the mission of promoting HEOR excellence. Her husband was diagnosed with non-Hodgkin’s lymphoma. His successful recovery made Ms. Berg acutely aware of the critical role healthcare research plays in helping patients.
Outside of ISPOR, Ms. Berg provides pro bono strategic planning and branding consultation support to help transform nonprofit organizations and churches. She has served on the board of National Science Foundation-sponsored educational coalitions, as well as other boards and committees. She also supports the Healthcare Businesswomen’s Association by bringing ISPOR in as a new corporate partner. (PV)
The Right Advice
Company: KPMG LLP
Education: BEng, Electrical and
Electronics Engineering, University of Michigan
Family: His wife, Danielle, who is his backbone and supports him in every aspect of his life; two daughters, who motivate him to help build a better tomorrow; father, who taught him the value of hard work and a strong sense of justice; mother, who has passed away, for giving him confidence
Hobbies: Skiing, jogging, reading, spending time with family
Awards/Honors: Breath of Life Award, Cystic Fibrosis Foundation, 2012
With a commitment to driving meaningful innovation that improves the lives of patients, Mark Ginestro has become a trusted advisor to life-sciences companies around the world.
“Our industry needs to remember who we’re working to help: patients,” Mr. Ginestro says. “With a greater patient focus, I’d like to see all stakeholders get together and figure out a path to collaborate that is beneficial to all.”
As an advisor, Mr. Ginestro says his role is to bring an outside perspective to problems a group has either been trying to solve or would like to solve.
“Being an outsider, I am able to cut across political structures and reporting lines and be honest about what I see in a situation and share how other organizations have solved a similar problem,” he says. “My role is also to bring people together when there are differing views and competing incentives.”
Early in his career, he focused on life-sciences operations, putting him at the center of some of the most urgent manufacturing, quality, and regulatory challenges. Perhaps the most notable example of his contributions involved a situation where there was a devastating shortage of flu vaccine in the United States, putting millions of lives at risk. The shortage was caused by a manufacturing facility that was shut down due to various quality issues. Over a roughly a six-month period, Mr. Ginestro led a team that supported the company to methodically address the issues and bring the facility back online.
He also spent two years living and working in India where he led the opening of a consulting office to serve clients in that market.
More recently, Mr. Ginestro has been advising life-sciences companies on commercial strategies, product launches, and product development process improvement. His counsel has helped companies make objective choices between investment and portfolio options, allowing for increased focus and greater likelihood of success. He has also been an adviser to many companies on the development of the biosimilars market, writing extensively on the topic and supporting companies in their efforts to bring the first biosimilars to market.
Mr. Ginestro has been a leader in helping companies improve their innovation processes, including streamlining translational medicine techniques, seeking root cause issues for inefficiencies, and, ultimately, reducing product development time to market. He has also advised early-stage companies in building out their first commercial launch strategy, which requires thoughtful, cross-functional planning to determine best sequence of geography launches and the organizational capabilities needed at each point.
Mr. Ginestro says working as an advisor to multiple companies globally requires adaptability to culture and norms, balanced by a strong sense of self and point of view to be effective in those environments.
Time is precious, Mr. Ginestro says, and so he ensures he stays focused on the most important task, regularly assessing and reassessing goals and priorities.
He inspires his colleagues through honest and constructive feedback, and when coaching others he tries to take himself out of the role of supervisor and colleague to provide career advice.
“This honesty to inspire also applies to being transparent with people in difficult situations,” he says. “People appreciate knowing what the real story is or being told certain information can’t be shared.”
He believes that innovation must be set from the top and leaders must stress that it’s okay to fail.
“Living in San Francisco, I often get asked, particularly from those outside of the U.S., why Silicon Valley is so innovative,” he says. “I always tell them that it’s because failure is not only accepted, it’s often celebrated.”
In addition, Mr. Ginestro is on the board of directors of the California Life Sciences Association, and has been a key advocate for policies that develop a community of life-sciences innovators. For the past 10 years, he has served on the board of directors of the Cystic Fibrosis Foundation of Northern California. (PV)
Dr. Michael Murphy
A Visionary Leader and Mentor
Title: Chief Medical and Scientific Officer
Company: Worldwide Clinical Trials
Education: MD, PhD, board-certified in psychiatry, doctorate in pharmacology, Tulane University; Psychiatry Residency Program, Stanford University School of Medicine; Psychiatry Residency Program, Mt. Sinai School of Medicine of New York University
Family: Catherine Murphy, wife; Francis Murphy Jr., father
Hobbies: The study of 19th-century American history, computers
Bucket List: Experience the Southern Literary Trail car tour in a 1950s classic convertible
Awards/Honors: Clinical Research & Excellence (CARE) Lifetime Achievement Award, 2017; the Michael F. Murphy Clinical Research Methodology Fellowship Program, Worldwide Clinical Trials
Associations: Founder, Research & Development Editor, American Health & Drug Benefits; Center for Experimental Pharmacology and Therapeutics, Harvard-MIT Division of Health Sciences and Technology
Known for his dedication and passion to drive innovation, Michael Murphy, M.D., Ph.D., is a true visionary in the clinical trials industry. He possesses an unwavering commitment to integrating scientific acumen with operational excellence across studies for all parties involved.
Since Worldwide Clinical Trials (WCT) was initially established as a global CRO in 1995, Dr. Murphy has worked tirelessly to develop the company’s strategic value added approach for protocol and program design and clinical operations. As chief medical and scientific officer, he has been instrumental in crafting the company’s committed approach toward executive oversight for the execution, analysis, and interpretation of clinical trials across multiple therapeutic areas.
Dr. Murphy’s passion, hard work, and unwavering commitment inspire those around him to do the same. His inspired leadership led WCT to recently create the Michael F. Murphy Clinical Research Methodology Fellowship Program. The program offers scientists hands-on clinical research experience working alongside Dr. Murphy and other WCT experts to support the increasingly complex clinical trials of tomorrow.
Those who have participated in the fellowship program are grateful to Dr. Murphy for taking them on and diligently teaching them the clinical development ropes. Although frequently characterized by innovative challenges with difficult deadlines they say he always makes time to answer any questions, shows great patience in mentoring, tests skills, and capacities while kindly guiding them to a successful completion of the project.
Dr. Murphy also is a lecturer within the Center for Experimental Pharmacology and Therapeutics, Harvard-MIT Division of Health Sciences and Technology (HST), and he has contributed to the curriculum for a two-year Clinical Investigator Training Program.
“I estimate that it is been my professional privilege to assist in the training of more than 250 board qualified or board certified physicians in clinical research methodology over the last 20 years,” Dr. Murphy says. “Mentoring and teaching obligations have helped to define me professionally, provided innumerable insights regarding cutting-edge technology in the context of patient care, and have enabled me to influence the professional development of colleagues far beyond the immediacy of any task.”
He says his most challenging assignment was when he served as president of a highly diverse CRO integrated under the umbrella of the UnitedHealth group, in which legacy organizations had remarkably different pedigrees, business objectives, professional backgrounds, and visions for the direction and method in which clinical research services should be developed.
“This assignment helped me to realize that there was much more to pharmaceutical development than simply demonstrating the attributes of the next novel chemical or biological entity,” he says. “Our task is to simultaneously demonstrate the value of the innovation recognizing the challenges of transformative technologies in an complex healthcare environment. It is the facilitation of linkages across functional groups , incorporating the perspective of multiple stakeholders, to which every manager aspires.”
Dr. Murphy says it is the industry’s responsibility to facilitate the delivery of patient care in the context of evaluating innovative clinical technologies, i.e., small molecules, biologicals, and devices. If he had unlimited resources, he would facilitate a dynamic and practical professional collaboration between academia, the pharmaceutical industry, the healthcare delivery system, and regulatory scientists to achieve his vision.
“This would be an activity that would represent the highest expression of the art of clinical development, and perhaps the most significant professional legacy,” he says. (PV)
Keeper of the Craft
Title: Global Chief Creative Officer
Company: Digitas Health
Education: BA, Ealing Art School
Family: Wife, Jac, who makes him a thousand times the person he would be without her
Hobbies: Art, any kind of live music
Bucket List: Learn to play the piano and accordion
Awards/Honors: Multiple awards from Cannes Lions, Clio, D&AD, Epica, Globals, MM&M, One Show, Webbys
Associations: D&AD, One Show
Thirty years ago, Graham Mills left art school to become an advertising copywriter in London. This included stints at agencies such as Lowe Howard Spink, TBWA, and Delaney Fletcher Delaney. Since then, he has helped form a radio writing company, worked with an improv comedy troop, co-wrote a book on architecture, and created advertising, direct, digital and social campaigns for both national and international clients. For the last 18 years he has built and led agencies in the United Kingdom and the United States, including Ogilvy, Wunderman, Arc Worldwide, and Digitas, and was one of the founders of Digitas Health in 2007.
He assumed his current role as global chief creative officer in 2015 and is responsible for multiple agencies in the network: Digitas Health, Publicis LifeBrands, Publicis Health Media, and Razorfish Health.
Mr. Mills is a true “creative,” who has never let convention stand in his way. Colleagues call him “a keeper of the craft.” He is a throwback in that he ensures that every element of every deliverable is incredibly well done. To him, it’s the craft that matters.
Mr. Mills brought his knowledge of digital marketing to the pharma stage and demonstrated healthcare marketing as it should be: “helping not selling.” He has been at the forefront of digital marketing and helped transform the industry, making it more relevant to healthcare professionals, patients, and consumers.
Mr. Mills receives glowing endorsements from clients, including EMD Serono, for his work revamping the brand Rebif. He proposed to bring Rebif, a mature brand, into the new digital age and redefined its marketing to be a two-way communication. An eco-system of digital channels was developed allowing the brand to provide relevant information that resonates with patients, and allow patients to communicate directly with the brand. His next step in the revamp plan was a global campaign for HCPs.
Mr. Mills’ work has earned awards that span the gamut from best creative for TV, digital, consumer, multi-media, unbranded disease awareness, branded, and CRM. Some specific examples include: The Chantix “Real People, Real Stories.” This social campaign was launched in Times Square New Years Eve in 2009 — an industry first. The campaign was based on the insight that when people tell the world they will quit smoking they are more likely to actually achieve quitting. He was the architect of the first open-commenting pharma campaign on Facebook — the currently running Rebif/MS Lifelines page, which recently overtook the National MS Society page for engagement. This is the first time in any category that a branded property beat an advocacy property for engagement. When Abilify was facing the challenge that two-thirds of patients on primary anti-depressants were still experiencing symptoms, but didn’t tell their physician, Mr. Mills helped drive the animated multi-channel campaign “Me and My Depression.” The premise was based on the famous insight from Winston Churchill that “my depression is like a black dog.”
Mr. Mills’ vision for the new Digitas Health is also unconventional. He identifies the agency’s teams as “pirates” as they are composed of smart, passionate, hungry creatives who didn’t have pharmaceutical experience.
He also brought media into the creative department and formed a process called “CREAM” — creative and media — which at the time, was a truly unique offering as digital and social media were rapidly changing.
Colleagues say Mr. Mills has been an inspiration and game changer in the space since he entered it. He has always challenged clients and teams to think beyond perceived constraints.
He also fills the roles of mentor, friend, boss, creative North Star, copywriter in a pinch, judge, foodie, British historian, eye doctor, tech nerd, pub mate, and storyteller for his colleagues. (PV)
Title: CEO, TBWA\WorldHealth and Chief Client Officer, Omnicom Health Group
Company: TBWA\WorldHealth and Omnicom Health Group
Education: BA, Wheaton College
Family: Her two sons, Ben, 15, high school sophomore and basketball star, and Henry, 20, who just finished his junior year at Indiana University
Hobbies: Home renovations, yoga, be more disciplined about exercise, making jewelry, but most of the time you can see her cheering in the stands at her son’s basketball games
Bucket List: Yoga retreat in Bali, achieve her ideal weight, thank everyone who was ever kind to her, write a book, take a pottery class, live in Provincetown for an entire summer
Awards/Honors: Women’s Venture Fund Highest Leaf Award, 2014; HBA Star Volunteer, 2006
Associations: Healthcare Businesswomen’s Association (president in 1997 and 2005, Metro Chapter Advisory Board, several board positions since 1989); Board of Arthritis Foundation; Women Against Alzheimer’s; The Women’s Venture Fund; OmniWomen, founding member of Omnicom’s women’s leadership group; OPEN Pride, founder of Omnicom’s LGBTQ employee organization; Coalition for Healthcare Communications, Chair 2016-2017, first woman chair
Tweet at: @SharonFCallahan
In April 2016, Sharon Callahan and a group of like-minded people launched TBWA\WorldHealth, combining two iconic Omnicom healthcare agencies — LLNS and Corbett — and built a new company based on a strong vision of collaboration.
Her dynamic leadership style catapulted the agency into the spotlight, transforming the way clients are served and racking up success after success. Ms. Callahan and her colleagues at TBWA believe that disruption is a catalyst for creative thinking and ideas that can change the world of healthcare.
“The healthcare industry is in great need of disruptive thinking to create business-building ideas that challenge the conventions of our business,” she says.
As CEO, Ms. Callahan is committed to the disruption methodology developed by Jean-Marie Dru to push against conventions, define an unreasonable vision, and find a disruptive idea that will move each client’s business forward in a different way than before.
She is committed to transforming the way clients are served, stripping away the complications and making it all about their needs.
In addition to her TBWA\WorldHealth duties, Ms. Callahan does this on a broader stage as the chief client officer for Omnicom Health Group, where she leads a team of client-dedicated stewards who serve Omnicom’s biggest healthcare clients.
A visionary leader, Ms. Callahan’s teams say she embodies bravery; she leads by example; and she is able to take an obstacle and overcome it with gusto. Rather than fixing a problem, she is revered for identifying what the bigger issue might be and finding multiple solutions. Ms. Callahan is known and respected across Omnicom, and she knows the dozens of great agencies that make up Omnicom Health Group. She’s a natural at assembling the best and brightest to serve the group’s consolidated clients, such as Pfizer, Merck, Takeda, and J&J.
“Frankly, if we had to reinvent the way that healthcare is delivered, we’d never do it the way that we do now,” she says. “There are lots of visionaries out there who are reinventing the status quo.”
Colleagues say Ms. Callahan’s unique perspective and innovative approach to creating the agency of the future is her legacy. She is valued for her ability to stay ahead of the curve in health and well being as well as for empathetic leadership and vision.
Ms. Callahan believes innovation thrives when leaders are curious, open-minded, mindful, empathetic, nonjudgmental, and are committed to becoming better critical and innovative thinkers and egoless, constructive collaborators.
For Ms. Callahan, breakthroughs come from being committed to a goal even if the path is unclear.
Equally, it’s important to have a steady stream of the best thinkers to replenish the talent pool as products become more specialized and complex. Colleagues say she is brilliant at finding individuals who are at the cusp of being ready for the next level and she generously guides them to take that leap.
Ms. Callahan says leadership is about having the courage to be vulnerable.
“Real leaders are willing to acknowledge that they need help and are brave enough to ask for it,” she says.
Ms. Callahan is inspired by the people she works with and the possibilities of the drugs and devices the agency represents, which will have a deep impact on people’s lives.
She mentors others, empowers them, champions her team members to further their individual careers, and guides them toward a fulfilling and successful professional life. Ms. Callahan says Peter Frishauf, founder of Medscape, has been her most meaningful mentor.
“He always had the innate ability to assemble an A-team of the best talent in the industry; people were inspired by his outstanding dedicated leadership, personal integrity, and authenticity in everything he did,” she says.
She would like to be remembered as someone who was happy, who lived a life well lived, and who couldn’t wait to wake up in the morning to meet the day’s challenges.
“And I’d want people to know that there was a lot of hard work along the way and a commitment to try to do better every single day,” she says. (PV)
Digital Health Pioneer And Innovator
Company: Healthware International
Education: Istituto Universitario Suor Orsola Benincasa di Napoli, Marketing Communications; magna cum laude, Università degli Studi di Napoli Federico II, Medicine
Family: Wife, Alessandra; dog, Arturo
Hobbies: Sailing, sports, especially soccer and basketball
Bucket List: Take a few trips in and around nature
Awards/Honors: Best Industry Leader at The Health 2.0 Ten Years Global Retrospective Awards, September 2016; PM360 ELITE Awards, May 2017; MMM Top 50 Agency; PM360 Innovators; Webby Awards; W3 Awards; The Global Awards; MM&M Awards; Web Health Awards; Rx Club Awards; Web Award, European Excellence Awards; IKA – Interactive Key Award; IN-AWE Award; ADI Design Index; Best Practices for Innovation Award; SMAU Mobile App Award; European eContent Award
Associations: Frontiers Health Conference, chairman
Tweet at: @RobertoAscione
Roberto Ascione is a pioneer in digital health and a recognized thought leader, serial entrepreneur, and global manager.
His passion for medicine, computer science, and human-technology interactions have led to his life-long commitment and dedication to the advancement of digital healthcare and wellness. He holds a strong belief that digital innovations and technology will be the most impactful drivers of change in healthcare — disrupting the healthcare-related industries along the way.
With a passionate and fierce entrepreneurial spirit, Mr. Ascione founded in 1996 his first company, which provided health informatics services.
Being a pioneer in the field even as early as the 1990s, when digital was still in its infancy, was not without its challenges and opportunities.
Those inspirational years that followed witnessed a group of young and brave people led by Mr. Ascione who anticipated the future. They designed a full range of services and applications in healthcare across Europe leading to the foundation of the first Healthware company and to the partnership with Saatchi & Saatchi Health, thereafter merged into Healthware Group a pioneering, digital-first, agency anticipating today’s digital health scenario.
In the first 10 years, Healthware faced an exponential growth of its business, expanding into the European markets with innovative solutions in many areas ranging from the very first integrated disease awareness programs powered by search marketing to patient-centric interactive services. Mr. Ascione and his colleagues were also ahead of the curve in defining the foundational basis for closed loop marketing concept and distributed data-driven collaboration networks for physicians, which is still cutting-edge today.
In 2007, Healthware was acquired by Publicis Groupe and rebranded Publicis Healthware International (PHI) and Mr. Ascione was appointed managing director of the brand.
Between 2007 and 2012, Mr. Ascione successfully led the integration of several long-standing digital agencies across multiple countries — eHealth Solutions and iMed Studios in the United States, NUATT in Spain, Digital District in Germany, and Elevator in the United Kingdom — which strengthened capabilities in several areas such as KOL management, visualization, social, digital branding, and strategy.
Under Mr. Ascione’s leadership as global president, the resulting entity reached an unparalleled breadth and depth of services with substantial geographical reach.
In 2012, Publicis Healthware International and Razorfish Health, also a member of Publicis, were merged as Razorfish Healthware resulting in one of the largest global healthcare digital agency players active in 10 markets with more than 300 professionals worldwide.
Since June 2015, he has been leading the spin out of the original Healthware team, serving as global CEO. In February 2017, Healthware made a further step into cross-agency collaboration by building a joint venture with U.S.-based Intouch Solutions. The agencies have implemented special teams to provide a joint solution to global clients, and the long-term plan is to have a dedicated Intouch Solutions International team comprised of employees from both companies. Intouch and Healthware have a combined 800 employees in Kansas City, Chicago, New York, London, Milan, Rome, and Salerno.
In the meantime, Healthware formed a new division, HealthwareLabs, focusing on providing services to digital health startups and delivering open innovation projects and solutions to pharmaceutical and device companies.
Naturally, he remains committed to his vision and demonstrates this via his contributions to several research organizations and start-up accelerators. He offers his unique outlook on the evolving digital health landscape by chairing the Frontiers Health conference and offering mentorship for start-ups based on his own outstanding entrepreneurial journey. All these are done in the efforts to challenge the status quo and promote brave new innovative thinking in this field.
Mr. Ascione is a true champion when it comes to business transformation and innovation in health and wellness. His vision of how digital will drive healthcare transformation has proven true over the decades.
“If a dream seems achievable, the bar has probably been set too low, so go for the sky,” he says. (PV)
Title: Chief Business Officer
Company: Mersana Therapeutics
Education: BA, University of Virginia; Master’s Health Science, Johns Hopkins University
Family: Parents, who stressed the importance of education and encouraged her as she pursued the different paths her career has taken her
Hobbies: Paddle boarding; running; travel, hiking; skiing
Bucket List: Learn how to do a headstand on a paddle board; continue to explore the world
Awards/Honors: Honorable Mention, WEST Giving Back Awards
Associations: Springboard Enterprises, member of the Life Sciences Council
Tweet at: @emj01bos
Eva Jack may be the chief business officer of Mersana Therapeutics, but her impact is felt way beyond that title. Colleagues say along with a wealth of financial and business development expertise, she brings equal parts science, passion, and commitment to her position.
There is fierce competition among the scores of companies all vying to develop and commercialize therapeutics for patients who are afflicted with a host of common or rare cancers. The drug development landscape may be competitive, but it is collaborative as well. Mersana seeks partnering opportunities with established pharmaceutical and emerging biotech companies to push its programs forward so that patients in need of therapies can benefit from its proven next-generation antibody drug conjugates (ADC) therapies. For three years, Ms. Jack has led this charge for Mersana and she has been incredibly productive on the partnering front. She has structured strategic and transformative partnerships with Takeda Pharmaceuticals, EMD Serono, and Asana Biosciences, allowing these companies to leverage Mersana’s Fleximer technology to generate ADCs. Since 2013, when Ms. Jack joined the company as chief business officer, she has become a key contributor in helping establish the company among the industry leaders in ADC development.
Within the capacity of her involvement, Ms. Jack and her development team have integrated the process and/or prospect of partnering into each professional area of the company, from the CEO and chief medical officer, to chemistry and manufacturing. As an early-stage biotechnology company, Mersana is clearly driven by its ability to identify and partner with companies that may have development programs and assets that are strategic as well as compatible with its platform and emerging pipeline.
“I really enjoy being part of a small company, participating in its growth, helping to establish a culture that fosters scientific rigor to bring therapies to the patients who are in need of new therapies all while having fun at work,” Ms. Jack says.
Ms. Jack provides the necessary due diligence and leadership in ensuring that these deals get done, as there is no telling when the next strategic alliance may uncover a breakthrough medicine for cancer patients.
Leadership seems to come easily to Ms. Jack and she has strong skills in directing and managing critical business development and corporate initiatives including the completion of Mersana’s recent $75 million initial public offering. In fact, prior to 2015, when CEO Anna Protopapas joined the company, Ms. Jack was part of executive leadership that effectively ran the company in the absence of a true chief executive. During this time, she exhibited uncanny leadership acumen by being both strategic and thoughtful and showing the ability to make the tough decisions necessary for a company’s growth, particularly at those early stages.
Perhaps the truest barometer of the passion and humanity she brings to her position at Mersana is her long-time dedication to training and caring for service dogs. She serves as a volunteer puppy raiser for Canine Companions for Independence, a nonprofit organization that enhances the lives of people with disabilities by providing trained assistance dogs.
Ms. Jack is also a member of the life sciences council of Springboard Enterprises, an organizational network of innovators, investors, and influencers who are dedicated to building high-growth companies led by women in the life-sciences and high-tech industries.
Her commitment to others is part of Ms. Jack’s DNA. Whether she is engineering scientific collaborations that may have the potential to develop and bring new medicines forward, or raising a young puppy that will help enrich the life of a person with disabilities, she is equally at home doing her best to touch others. (PV)
Navigating Toward Success
Title: President, Navicor
Company: INC Research/inVentiv Health
Education: BS, Hillsdale College
Family: Wife, Tami, who is understanding of the late nights/weekends/travel his job requires, while also maintaining her own career as an educator and mother
Hobbies: Watching daughter’s horse shows and sporting clays
Bucket List: Travel Europe and South America with wife; drive an 18-wheeler across the country
Awards/Honors: MedAd News Agency of the Year, 2013, 2017
Tweet at: @dquerry
Dave Querry’s father owned a tool and die company, and growing up he learned to build dies and machining fixtures and to drive the company truck.
“I always loved driving — the bigger the truck the better,” he says, adding he would like to drive an 18-wheeler across country for fun. However, driving a truck will have to wait, because right now Mr. Querry is very busy driving 50% business growth for Navicor, now a part of INC Research/inVentiv Health.
Navicor has seen double-digit year-over-year growth since Mr. Querry took the reins in 2013. Colleagues say he has created a collaborative, client-driven agency that delivers groundbreaking work to help patients who are dealing with cancer.
As president of Navicor, he leads two growing offices with clients that span global large pharma clients to emerging drug develpers bringing their first assets to market. His authentic leadership style is a blend of strategic vision and compassion. He is always searching for better ways to communicate in the oncology space. For example, recently he worked with behavioral scientists to better understand how to connect with non-small cell lung cancer patients. He is also pioneering integrated marketing for clients, leading teams that work across advertising, public relations, and medical communications.
Colleagues say Mr. Querry combines a unique skill set of deep scientific, advertising, marketing, and brand strategy, and is a strong leader with a great drive, innovation, and care for his co-workers. His 25-plus years of brand building coupled with an approach where he is deeply connected to the work, his clients, and most importantly his staff, make him unlike any other leader.
Mr. Querry is noted for his extraordinary integrity, integration skills, and ability to bridge gaps. In addition to making business development a critical and daily part of the company’s focus, Mr. Querry has built charitable efforts and corporate responsibility into the fabric of the Navicor culture. A day doesn’t go by that the team is not encouraged to remember that improving patient outcomes is the ultimate goal in and outside of work.
Mr. Querry has fostered support of the Leukemia & Lymphoma Society, the Pancreatic Cancer Action, and St. Jude Children’s Hospital. These efforts are not one-off efforts, but a continuous cycle of contributing to patients, caregivers, and research. The team participates in walks and runs, and has even held chili cook offs to raise money for these organizations, and contributed almost $10,000 alone in 2016. In fact this year, the Columbus, Ohio, team was one of the top donators to the Columbus Light the Night walk, just one of the efforts the team works on.
When the agency expanded to Philadelphia with a new office, within months team members were pounding the pavement at the St. Jude 5k at the Philadelphia Zoo.
Scrolling through the Navicor Facebook page, there is post after post illustrating the company’s contributions to its communities and patients. The reason is because for Mr. Querry cancer is more than a therapeutic category. His philosophy has clearly permeated the Navicor team and lives at the heart of this successful business.
Colleagues say Mr. Querry believes in a hug before a handshake. He has a contagious enthusiasm for helping turn hopeful oncology patients into extraordinary survivors and he is completely committed to the work Navicor does to connect difficult marketing situations of orphan diseases with the strategies necessary to move markets. (PV)
Overcoming Counterfeiting Through Transformative Change
Title: President and CEO
Education: BA, Computer Science, Boston University
Awards/Honors: TraceLink, one of the Top Places to Work in Massachusetts in the Boston Globe, 2016; MassEcon Economic award winner, 2016
Associations: Healthcare Distributors Alliance (HDA), GS1 US Health, MassBIO, and the Open Serialization Communication Standard (Open-SCS) group of the pharmaceutical industry
For more than a decade, Shabbir Dahod has dedicated himself to pharmaceutical supply chain integrity, making it his mission to protect patients around the world.
As a true visionary, Mr. Dahod recognized early on where and how traceability technology could be used to strengthen the life-sciences supply chain and make a significant impact on saving lives, years before the United States and nearly 50 other countries around the world began mandating a tightening of the drug distribution system.
In the early 2000s, while working with MIT Auto-ID Labs, he was alerted to a series of incidents where counterfeit drugs made their way to unsuspecting patients across the United States.
Recognizing the importance of safeguarding the supply chain, Mr. Dahod had the idea to lift the journey of a pharmaceutical product up into the cloud so its footprint could be managed digitally, thereby securing the movement of safe medicines.
In 2003, he started what was then SupplyScape, which engineered a software solution to safeguard the supply chain by creating a pedigree for each drug product. Mr. Dahod and his partners were invited a year later by the FDA to demonstrate the SupplyScape software to pharmaceutical industry CEOs at a meeting in Washington, D.C. It was here that the concept of a digital pharmaceutical supply chain was disclosed to industry.
In 2005, SupplyScape launched an ePedigree compliance solution, delivering end-to-end track-and-trace capabilities for states such as California, Florida, and Nevada. Ensuring drug supply throughout the supply chain at the state level helped blaze the track-and-trace trail by setting the course for how the Drug Supply Chain and Security Act (DSCSA) would later work at the federal level.
Next, he transitioned SupplyScape to TraceLink while keeping the core team members as well as customers to build a new cloud-based network architecture that is now the world’s largest track-and-trace network for the life-sciences supply chain.
“Those three pillars, our core leadership team, long-term support from our customers, and our disruptive technology are the foundation of TraceLink’s success today,” he says.
His passion for cutting-edge technology and business model innovation was the driving force behind what is now the de-facto industry standard for protecting patients from the threat of counterfeit medicines.
Innovation is vital in a company like TraceLink, and Mr. Dahod encourages all employees to submit ideas and ask questions about all aspects of the business to ensure innovations are pursued in all parts of the organization.
In 2016, Mr. Dahod and TraceLink unveiled the first Global Drug Supply, Safety, and Traceability report, with insights from 331 pharmaceutical manufacturers, wholesale distributors, hospitals, and retail pharmacies, revealing the complexity of the pharmaceutical supply chain and the importance in understanding the complicated movement of pharmaceutical products in the supply chain, to prevent counterfeiting.
Mr. Dahod has worked to maintain the company culture as the employee base grows around the world with the diversity of many regional cultures that serve the different segments of the supply chain.
Mr. Dahod’s commitment to educating the life-sciences community in creating business value while protecting supply channel integrity and patient safety drove the idea of Nexus, an annual gathering of stakeholders from across the supply chain to share ideas on tackling global traceability challenges and supply chain value beyond compliance.
With a focused approach, Mr. Dahod is committed to understanding customers, products, technology, and markets at a deeper level to create value and efficiency in execution.
He takes lessons from other industries and solutions and looks at ways to apply them to the challenges facing the supply chain.
Mr. Dahod believes leadership is best portrayed through influence and transparency, and strongly credits passion as the primary driver for employee engagement.
There is much that motivates Mr. Dahod: patient outcomes, customer success, team culture, product ideas, and innovation. (PV)
Dr. Kathy High
Creating a Spark of Gene-Inspired Innovation
Title: Co-founder, President and Chief Scientific Officer
Company: Spark Therapeutics Inc.
Education: AB, Chemistry, Harvard University; MD, University of North Carolina School of Medicine; MA, University of Pennsylvania.
Family: Husband of 33 years, three children
HobbIes: Reading, swimming, dining with friends, falling asleep on her husband’s sailboat
Bucket List: Take a sabbatical in Freiburg or Vienna; become fluent in German; become as good a sailor as her husband
Awards/Honors: Scientific Achievement Award, Pennsylvania BIO, 2016; elected to the Faculty of Pharmaceutical Medicine of the Royal College of Medicine (London), 2015; Innovation of the Year Award for SPK-RPE65, presented by Genetic Rx, 2016; National Hemophilia Foundation Researcher of the Year; Foundation Fighting Blindness Directors Award; Election to the American Academy of Arts and Sciences; Election to the National Academy of Medicine
Associations: American Society of Gene and Cell Therapy; American Society of Hematology; American Society of Clinical Investigation; Association of American Physicians
Kathy High, M.D., has dedicated her career of more than 30 years to advancing gene therapy. Before co-founding Spark Therapeutics, Dr. High was a long-time member of the faculty at the University of Pennsylvania and on the medical staff at Children’s Hospital of Philadelphia, where she was also an investigator at the prestigious Howard Hughes Medical Institute.
Dr. High is motivated personally by her experience as a young hematology attending physician in the mid-1980s, at the height of the blood supply crisis, when she was caring for many men with hemophilia who contracted AIDS from a blood transfusion. Even then, she saw potential in gene therapy as a conduit for unlocking a new future for people not only with hemophilia, but also with a range of genetic diseases that could be addressed through gene therapy.
With a determination to break barriers, Dr. High has been an inspiration to those who know her. Colleagues say Dr. High is a brilliant scientist, driven to do what had not yet been done — bring gene therapies for genetic disease to patients in the United States and around the world.
Dr. High co-founded Spark Therapeutics in March 2013 as a result of the technology and know-how accumulated over two decades at the Children’s Hospital of Philadelphia (CHOP), as a publicly traded, late clinical-stage gene therapy company.
At Spark, Dr. High has led two clinical development programs that have earned breakthrough therapy designation from FDA, in a rare form of congenital blindness and in hemophilia B. Due in large part to Dr. High’s perseverance and scientific leadership, Spark is now poised to bring the first-ever gene therapy for a genetic disease to patients in the United States.
This represents the culmination of a quest three decades in the making, and the platform she helped build is being used to expand Spark’s reach into other therapeutic areas, including CNS disorders and diseases that can be addressed by targeting the liver. The company is now working to achieve licensing of AAV vectors for gene therapy. If successful, this would be the first licensed AAV therapy in the United States.
Fostering innovation, Dr. High says, requires a high level of talent, freedom from bureaucratic constraints, the right physical environment for reflection and discussion of ideas, and time set aside to do these. But she says, too much emphasis on saving money at the expense of investing in R&D can stop an organization from being innovative.
“I worked on gene therapy for genetic disease for many years before the work came to fruition,” she says. “My most exciting career highlight to date has been the work we have done at Spark in developing a gene therapy approach for hemophilia.
Because I am a hematologist, I have a deep appreciation of the challenges of current therapeutic approaches. It has meant a great deal to me to participate with the group here at Spark, and our clinical collaborators in the United States and abroad, to establish a strong basis for an entirely different approach to hemophilia treatment.”
Dr. High would like to be remembered for helping to establish a new class of therapeutics, gene therapy. She is motivated everyday by the efforts to improve life for people who need help to enjoy the things that most of us take for granted. When challenges arise, she reminds her colleagues of the reasons they are doing what they do.
Mentoring is important for Dr. High, who says she had many professional mentors during her career.
“The best aspect of what I have done through the years has been the opportunity to work closely with the leaders of the next generation of innovators,” she says.
Dr. High has received numerous awards and accolades for her work. Recently, Dr. High was voted one of the most influential women in cell and gene therapy by Phacilitate. And in 2016, the Pennsylvania Biotechnology Industry Organization, now Life Science Pennsyvlania, honored her with its Scientific Achievement Award. Additionally, Dr. High has been elected a fellow of the American Association for the Advancement of Science based on “distinguished contributions in the field of human gene therapy.” (PV)
The Rare Disease CEO
Company: Retrophin Inc.
Education: BS, Biology, University of Notre Dame
Family: Parents who encouraged him to get a high-quality education and follow his passion; wife, Cindy, and three daughters, who have supported him over the years
Hobbies: Fishing and a rare round of golf
Bucket List: Explore National Parks, especially Yellowstone and Glacier
Awards/Honors: American Kidney Fund Corporate Honoree, 2016
Associations: Biotechnology Innovation Organization (BIO); BioCom – Life Sciences Association of California; California Life Sciences Association (CLSA)
Retrophin wouldn’t be where it is today without the leadership of CEO Stephen Aselage. Under Mr. Aselage’s leadership, Retrophin is primed to make a difference in the lives of thousands of rare disease patients.
The company has accomplished impressive clinical feats within the last year alone and is looking forward to more developmental successes. In 2016, the company completed the largest ever clinical trial for focal segmental glomerulosclerosis (FSGS), a rare kidney disorder. The Phase II trial reported promising data and as a result, the company plans to kick off a Phase III study of its investigational candidate, sparsentan, for the treatment of FSGS.
Additionally, the company expects to soon start the FOsmetpantotenate Replacement Therapy (FORT) study, a global, pivotal clinical trial evaluating fosmetpantotenate (RE-024), the company’s novel replacement therapy for the treatment of pantothenate kinase-associated neurodegeneration (PKAN), a genetic neurological disorder causing severe movement disorders.
Under the guidance of Mr. Aselage, Retrophin has advanced fosmetpantotenate through the U.S. regulatory pathway, reaching an agreement with the FDA under its Special Protocol Assessment (SPA) process, for the FORT study of RE-024 in PKAN. In the United States, the study also has FDA fast track status, which speeds up the review process so a drug can potentially reach patients earlier.
After experiencing some unique challenges in the early years, Mr. Aselage is proud to say all Retrophin team members have rallied around the company’s mission to deliver life-changing therapies to people living with rare diseases who have few, if any, treatment options, as well its values: integrity, accountability, compassion, teamwork, scientific excellence, and entrepreneurial spirit.
With a sound, strategic direction, the company and its almost 150 team members are dedicated to developing first-in-class therapies and ensuring that the patients Retrophin serves with its current commercial portfolio have broad access to the medications and free support services to achieve the best possible therapeutic outcomes.
“In the biopharmaceutical industry you often face challenging or unpredictable situations; it is in the DNA of drug development,” he says. “The company’s culture, entrepreneurial spirit, willingness, and ability to look at opportunities from unique perspectives, as well as rewarding success, have helped to foster innovation that will bring long-term value to patients and stakeholders.”
Mr. Aselage has spent more than 40 years in the biopharmaceutical industry doing his part to help people living with rare diseases ultimately receive much-needed therapies.
He says he is motivated by having the opportunity to make a difference for thousands of people living with rare diseases and that is also the epicenter of the company’s motivation. He would like to see Retrophin continue to grow and be recognized as a leader in the rare disease community as a result of the pipeline’s advancement to commercialization.
“We have continued to increase support and resources for our research and development functions to give us the best chance of creating first-in-class therapies for patients,” Mr. Aselage says.
His dedication to bettering the rare disease community goes well beyond Retrophin’s pipeline. He makes it a priority to attend patient conferences and other gatherings supported by advocacy groups. Mr. Aselage also remains in touch with the community by attending caregiver advisory boards and focus groups across all therapeutic areas the company touches. While other C-suite executives may consider these forums to be tactical, he finds these interactions to be invaluable, because they help him keep the patient perspective at the forefront of his mind as he guides Retrophin toward a new chapter in its history.
He also finds the time to provide his expertise on the board of directors for Acer Therapeutics and Patara Pharma, in addition to serving on the advisory council for the department of science at the University of Notre Dame, his alma mater. (PV)
Dr. Evan Demestihas
A Medical Affairs Visionary
Title: Worldwide Head
Company: The Medical Affairs Company
Education: BS, Pharmacy, Long Island University School of Pharmacy; MD, SUNY at Buffalo
Family: Wife, Joyce, who has provided the bedrock and foundation for his entire family; they’ve been together since their early teens and are celebrating their 40th year of marriage this year; four children, five grandchildren
Hobbies: Competitive ballroom dancing
Bucket List: Another trip to space; he is No. 59 on the list for a 2018-19 World View Voyage trip to near space; in 2004, he did an “Edge of Space” adventure in Russia where he flew in a MiG-25 to nearly 90,000 feet at over 2,000 mph
Awards/Honors: PharmaVOICE 100, 2006, 2017; Dean’s Award, Mercer University, School of Pharmacy & Health Sciences, 2012
Known as an outside-the-box thinker, innovator, and entrepreneur, Evan Demestihas, M.D., created the first outsourced MSL team 20 years ago and founded The Medical Affairs Company (TMAC) as an organization solely dedicated to medical affairs. In 2017, Dr. Demestihas spearheaded the acquisition of TMAC by Parexel to expand the company’s services to better meet the needs of current and future clients. He says his present-day challenge is guiding the company through the acquisition.
“Post-acquisition, the challenge is to guide an integration within the Parexel organization that both keeps the distinct identity and brand presence of TMAC in the marketplace, yet takes full advantage of and leverages the broader footprint of our new parent organization,” he says. “At this stage of my career, guiding the successful reinvention of TMAC is a very clear professional goal. Medical affairs has come to play such a central role in the commercialization of biopharmaceuticals that solidifying the positioning of TMAC as the preeminent global provider of outsourced medical affairs services is paramount to me.”
TMAC remains a distinct entity within Parexel with the advantage of a larger scope of services for clients.
Dr. Demestihas would like to be remembered as a pioneer in the medical affairs sector, as a trailblazer in the outsourcing of field medical personnel, and as a valued partner and colleague, not merely a service provider, by clients.
The industry, he says, needs to better showcase the value that companies’ investments have in affecting the health of individuals and the quality of their lives.
“While, of course, rules are important, knowing when and how to challenge existing norms and being open to new ideas is critical to innovation and ultimately success,” he says.
Industry leaders need to be more in the public view for the good their companies do, and not only when called to answer for the occasional negative publicity.
“As an industry, we collectively suffer from a poor image problem, despite the fact we invest billions annually to help patients live longer, healthier, and more productive lives,” he says.
Those who work with Dr. Demestihas say he has created an environment that rewards hard work within a team atmosphere. He hosts company outings and events on a regular basis that build camaraderie, allowing employees to have fun outside the office, which has proven successful by the low attrition rate of TMAC staff over the years.
Colleagues say Dr. Demestihas promotes work-life balance and growth opportunities among his employees. In fact, he says he tries to inspire others by setting an example and expectation of hard work but also ensuring a good work life/home life balance. He is active in community and enjoys travel, competitive ballroom dancing with his wife, and spending quality time with his children and grandchildren.
Space travel always fascinated him, and in 2004 he did an “Edge of Space” adventure in Russia where he flew in a MiG-25 to nearly 90,000 feet at more than 2,000 mph. He is now scheduled to be on an early flight of a World View Voyage capsule (2018-19) where he will spend six hours at more than 100,000 feet, catching the sun rise over planet earth and marveling at the planet.
“I’m one of about 2,500 humans to have ever reached this altitude,” Dr. Demestihas says. (PV)
The Persistent Entrepreneur
Title: Chairman and CEO
Company: Amicus Therapeutics Inc.
Education: BS, Foreign Service, Georgetown University; JD, University of Notre Dame Law School; MBA, Harvard
Family: Wife, Aileen; three children John, Megan, and Patrick
Hobbies: Cross-fit, biking, swimming
Awards/Honors: BIONJ Dr. Sol J. Barer Annual Award for Vision & Leadership, 2011; Make A Wish Foundation Humanitarian of the Year, 2009; University of Notre Dame Family Exemplar Award, 2011
Associations: BIO, BIONJ, Global Genes
The story of John Crowley and his children has been told numerous times via speeches, articles, books, and even a Hollywood movie. He is a father so determined to help his children that he founded a biotech company focused on developing therapies for the rare disease afflicting them — Pompe disease.
He began his career in the industry at Bristol-Myers Squibb, and after two of his three children were diagnosed with Pompe disease, a rare inherited disorder that causes muscle weakness, he left BMS to start Novazyme. Novazyme’s charge was to find a treatment for Pompe disease. Novazyme was eventually acquired by Genzyme, which received FDA approval for Lumizyme, an enzyme replacement therapy for Pompe.
Mr. Crowley continues his dedication to developing therapies for rare diseases at Amicus Therapeutics, where he is chairman and CEO. And he is persistent in this pursuit.
“Drug development rarely works, and when it does it’s not usually a linear path to success,” he says. “I’ve learned to keep at it even when faced with multiple challenges along the way. Our initial drug to receive EU approval at Amicus, our precision medicine Galafold, is a great example.”
Galafold is a first-line treatment for Fabry disease — Fabry disease is a rare genetic disease with a deficiency of an enzyme called alpha-galactosidase A — that was approved in the EU May 2016 and launched there in February 2017.
He says his biggest career highlight has been taking Amicus from an idea, to a molecule to an approved medicine, while building a deep pipeline in orphan and rare diseases and with what he believes to be one of the very strongest and most passionate teams in all of the industry.
“I measure success by the number of lives we can impact,” he says. “This is the vision at Amicus, to measure our success by the number of patients on an Amicus product, either in clinical studies or on marketed products. And if we can develop treatments that have a meaningful impact on patients, we can also create very substantial shareholder value.”
Mr. Crowley says the race against time is always the most challenging assignment, particularly in rare disease drug development. Too many patients and their families are waiting, and many of them will progress in their disease or die before a treatment becomes available. When challenges arise, he reminds people of the some of the greatest biotech success stories, which faced years and even decades of initial setbacks.
“I’ve often told the story of a retired biotech pioneer who reminded me that his stock was ‘stuck at two bucks a share for more than a decade,’ ” he says. “At first I didn’t know if that was supposed to inspire me, or prepare me, but then he added ‘If you believe in the science, then push it as far as you can for patients.’ That pioneer was Dr. Sol Barer, Celgene’s founder.”
Mr. Crowley encourages his teams to think differently, take smart risks, and design drugs and develop studies that are in the best interest of patients and that can truly transform people’s lives.
“We are not interested in making small differences,” he says “We have the obligation to keep investing in our disease areas, to make our own technologies obsolete, and to continue to deliver better medicines for patients for many years to come.”
Despite the challenges of drug development, Mr. Crowley believes he is in the right profession.
“As a biotech CEO I can accomplish much of what I hope to achieve for the rare disease community broadly,” he says. “Throughout my earlier career path I had the opportunity to work in different industries and to gain a unique set of experiences. For the past 12 years, I had the chance to serve as a commissioned officer in the Navy Reserve. That was the greatest honor of my life.”
Every day, Mr. Crowley says he gets calls from parents who have a child or children who have just been diagnosed with a rare genetic disease.
“I listen and share my personal experience, give them advice on how to get involved with the patient organizations or industry, and try to provide some measure of hope,” he says. “Having been through the same experience, I think it’s valuable to remind these families to advocate for themselves, get connected with the community, and never give up hope. Many of these people have gone on to start their own companies or patient organizations.” (PV)
A Revolutionary in the Fight Against Addictions
Company: FORCE (Female Opioid Research and Clinical Experts)
Education: BS, Neuroscience, University of Rochester
Family: Husband and soul-mate, Lance Sheldon; children Ryan, Kaitlin, and Jack
Hobbies: Cooking, swimming, gardening, reading
Awards/Honors: Bronze Winner, Best Female Executive of the Year, American Business Awards (Stevie Awards), 2016; Medical Marketing & Media’s (MM&M) Top 40 Healthcare Transformers; Winner for Executive of the Year for Best in Biz; a finalist for Ernst & Young (EY) Entrepreneur of the Year, NJ
Associations: Opioid Addiction Prevention and Treatment; Child Abuse Prevention
Behshad Sheldon is leading a revolution in treatment for serious neurological and psychiatric disorders, including opioid addiction. As former president and CEO of Braeburn Pharmaceuticals, she brought a novel buprenorphine implant, Probuphine, through FDA approval and to the market for long-term maintenance treatment of opioid addiction.
Now as founder and chairwoman of the nonprofit organization FORCE, Female Opioid-addiction Research and Clinical Experts, she aims to reduce the stigma and treatment barriers that people with opioid addiction face. FORCE, formed in June of 2016, is an alliance of women with scientific, health policy, and medical expertise in opioid addiction.
Ms. Sheldon wants to be remembered for making a dent in the opioid epidemic. She works tirelessly to destigmatize and evolve the way society treats people struggling with neurological diseases, entrenching her as an industry thought leader and change maker.
“In doing so, I hope to inspire more leaders to understand that opioid addiction is a disease, not a choice,” she says.
Colleagues say she is an inspired leader who has stood steadfast in the face of adversity. When challenges arise, like they often do, it’s not in Ms. Sheldon’s DNA to give up.
“I push myself and my entire team to continuously think of alternative ways we can achieve our goals,” she says.
Ms. Sheldon says her biggest career highlight — as well as her most challenging assignment — was the approval of Probuphine.
“Securing FDA approval for Probuphine did not come without experiencing significant, unexpected setbacks,” she says. “There was a very real possibility that Probuphine would never make it to patients. We believed in the value proposition of this medicine and weren’t ready to give up. Our plea to conduct another clinical trial was approved, leaving myself and a few colleagues with a great opportunity, but one which would require each of us wearing 10 hats. We took on the challenge, enrolling the trial in record time.”
Colleagues say Ms. Sheldon is driven by a deep commitment to social justice. She believes that the easy path is not necessarily the right one and she always strives to do better for her company or organization, for herself and for patients. She has immersed herself in the patient experience to understand unmet needs.
She tries to inspire others by striving to connect every day work to the team’s shared mission to improve the lives of patients and by holding herself accountable just as she holds others accountable. She is motivated by the work she is doing to make a difference, both for people living with opioid addiction and the people who love them and wants nothing more than to see them stay in long-term treatment and lead a productive, healthy and meaningful life.
Ms. Sheldon says her father has served as an inspiration to her.
“My father, Dr. Bahram Dowlatshahi, came to the United States as a young physician for a cardiology residency program,” she says. “He chose to start over again in the United States despite a decade of experience. He taught his daughters the value of resilience and inspired us to never give up or be afraid of starting over.”
Ms. Sheldon believes the industry needs to better communicate that while companies are for-profit businesses, each saves and improves lives every day through the products they bring to society.
“We need to join forces to eliminate stigma of diseases that harm clinical outcomes,” she says. “We need to collaborate with payers to ensure the right medicines are available to every patient. And we need to collaborate with the government (NIH) to make sure their research projects turn into medicines.” (PV)
Born to Transform
Title: Chairman, President, and CEO
Education: BA, Economics, East Asian Studies, University of Pittsburgh; JD, Law, Temple University; MBA, Temple University
Family: Wife, two children
Hobbies: Golfing, basketball
Regarded by many as one of the biggest dealmakers in the industry, Brent Saunders, chairman, president, and CEO is also known for transforming Allergan into a leader in what he calls “growth pharma.”
Mr. Saunders has overseen the transformation of Allergan, which has included 16 stepping-stone deals to transform the company’s pipeline and product portfolio, as well as the sale of Allergan’s generic drug business to Teva for $40.5 billion in 2015.
His astute business nature extends back to the age of 13 when he set up a business cutting lawns in his local neighborhood with his identical twin brother, Wayne. The business grew into a landscaping operation with more local boys brought into the fold. The brothers put their earnings toward college and a few trips before selling the business to a professional landscaper.
Mr. Saunders later tapped into his entrepreneurial skills when he came to the Thomas Jefferson University Health System, where he helped to institute a compliance program — a first for the industry. Next, at PricewaterhouseCoopers, he became a partner in the compliance business advisory services group.
In 2003 Fred Hassan, who had been tasked with turning around Schering-Plough, brought Mr. Saunders on as senior VP of global compliance and business practices. There he helped the company resolve its legal issues before taking on the role of president of consumer health at Schering-Plough. In that role, Mr. Saunders helped the business unit grow globally. He played led the integration of Dutch biotech Organon BioSciences into the Schering-Plough fold, and when Merck acquired Schering-Plough, he was asked to lead the integration team.
His first CEO role was at Bausch & Lomb in 2010, where he built his reputation, helping to rebuild the company, its team, and its strategy before the company’s sale to Valeant Pharmaceuticals.
His next CEO role was at Forest Laboratories and before too long he had acquired Aptalis to expand Forest’s GI presence. He then helped to bring about the sale of Forest to Actavis and was asked to take on the role of CEO of the combined company. It was there that the move to Allergan began. At the time, Allergan faced a hostile takeover by Valeant, but working with Allergan’s then CEO David Pyott, Mr. Saunders and Actavis stepped in as a white knight, winning the bidding and acquiring Allergan.
As a business leader, colleagues say Mr. Saunders is committed to the company’s three main constituents: the patients and customers it serves, its shareholders, and its employees. Doing well by patients and customers means doing well by shareholders and employees, Mr. Saunders believes.
That approach also means a commitment to what he calls a “social contract with patients,” keeping pharmaceutical price rises at close to the rate of inflation levels and condemning price gouging.
Mr. Saunders works hard to unite the workforce behind this mission of doing well by doing good.
He is focusing the company and its 2,000 scientists on drug development and building a strong pipeline, and is looking externally to smaller companies for the discovery side of the business — a model Allergan calls “Open Science.” Acquisitions include companies focused on depression, aesthetics, glaucoma, gastrointestinal conditions and eye diseases among others.
Colleagues say he is a truly present leader, preferring face-to-face meetings with customers and front-line colleagues to a never ending parade of meetings in the office.
With a view to reaching out to employees and stakeholders more generally and authentically, Mr. Saunders launched a blog in 2016 and manages his own Twitter account, using the channels to weigh in on important issues for the broader healthcare system. (PV)
Dr. Leen Kawas
Transforming Therapy for Neurodegenerative Diseases
Title: President and CEO
Company: M3 Biotechnology Inc.
Education: PhD, Washington State University; PharmD, University of Jordan; Executive Training Certificate, University of Washington Foster School of Business
Family: Parents, siblings
Hobbies: Hiking, swimming, exploring new places and food
Bucket List: Get a drug approved; see more of the world; start a family
Awards/Honors: BIO International Convention – Buzz of Bio Finalist, 2017; Forbes – What Happens When Women Dream Big And Act Boldly?, 2017; Association of Washington Business – Entrepreneur of the Year, 2016; EY Entrepreneurial Winning Women 2016 – Entrepreneurial Winning Women, 2016; EY Entrepreneur of the Year 2016 – Finalist as EY Entrepreneur of the Year in the Pacific Northwest Award, 2016; GeekWire Awards 2016 – Finalist as GeekWire Young Entrepreneur of the Year Award, 2016; Life Science Leader – Hot New Therapeutics MOAs Versus Neurodegenerative Diseases, 2016; Forbes.com – Meet the Millennial CEO Taking Bold Steps to Cure Billion-Dollar Diseases, 2016; The Montgomery Summit – The Rise of the Female Entrepreneur, 2016; GeekWire – M3 named one of Seattle’s Top 10 Hottest Startups, 2016; Puget Sound Business Journal – CEO Leen Kawas honored as 40 under 40, 2016
Associations: Alzheimer’s Association, regional board member; Alzheimer’s Drug Discovery Foundation, scientific advisory board member; Life Science Washington, board member; Community Development Round Table, member; Association of Washington Businesses, board member; Governor’s Life Science Advisory Board, member
Tweet at: @leenkawas; @m3biotechnology
Leen Kawas, Ph.D., dedicated herself to making a difference in healthcare after losing her mother to a neurodegenerative disease when she was 18. Just 10 years later, she became CEO of a start-up company designed to discover therapies to reverse the course of an array of neurological diseases, such as Alzheimer’s, Parkinson’s, multiple sclerosis, and amyotrophic lateral sclerosis.
Becoming a CEO was a move she hadn’t planned on, but it’s a move that is paying off in a big way for M3 Biotechnology.
Her capabilities became know to her Ph.D. adviser at Washington State University (WSU) who suggested that Dr. Kawas become involved in commercializing research from WSU on treatments for Alzheimer’s disease, and eventually M3 Biotechnology was born.
“I started a company, learned about entrepreneurship, helped to grow the company, and soon we will start our clinical trials,” she says. “I did not listen to what people thought of a 28-year-old Jordanian woman trying to start a company and resolve Alzheimer’s disease.”
She says moving from academia to being an entrepreneur was the best move she could have made for herself and her biggest career highlight to date.
According to colleagues, Dr. Kawas handles “firsts” with aplomb and no fear. Moving to America at 21, she overcame many challenges, and now as a female, millennial, first-generation American, and first-time CEO, she has defied stereotypes and faced discrimination head-on from established technology investors in the Pacific Northwest. However, Dr. Kawas developed her entrepreneurial muscle, persevered, and succeeded.
At 30, she completed more than 100 investor meetings before closing an oversubscribed $12 million Series A funding from Washington State regional venture funds, Dolby Family Ventures, and the Alzheimer’s Drug Discovery Foundation (ADDF), as well as private investors, all in one year. As one of the first investors in M3, the ADDF helped validate the therapeutic potential of M3’s drug candidate for Alzheimer’s disease. With a second investment of $1.4 million recently, the ADDF has now provided key funds to support the launch of human trials this year.
While current drugs for Alzheimer’s disease only provide symptomatic relief, M3’s small molecule therapeutics have the potential to be truly disease-modifying. By re-establishing lost connections between brain cells, these therapies may halt the course of the disease. M3 is now in the process of planning a first-in-humans Phase Ia clinical trial for its lead candidate, NDX-1017, to evaluate its safety and determine optimal dosing range.
Driven to innovate by not accepting the status quo, Dr. Kawas is a natural born leader and disrupter. Dr. Kawas takes time to pay-it-forward and mentors aspiring entrepreneurs frequently.
Her intense creativity and lack of fear when facing the difficult tasks of running a company focused on developing breakthrough therapies to meet crucial medical needs creates a motivational and passionate workplace. Colleagues say her deep reservoir of courage is contagious.
Dr. Kawas stays motivated and calm during the chaos, and open to meeting challenges and changing courses if needed.
“If it was easy everyone would do it,” she says. “Challenges spur creativity and innovation. We take challenges head on and always come out better informed and prepared for the next challenge.”
With more than 25 industry recognitions and awards to her name to date, we think her record speaks for itself. (PV)