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John W. Hubbard, Ph.D.
Title: President and CEO
Education: Ph.D., Physiological Psychology and Physiology, University of Tennessee
Family: Wife of 36 years
Hobbies: Martial Arts, 3rd Degree Black Belt and senior instructor, international travel, home improvements, and gardening
Bucket List: Achieving his 4th Degree Black Belt — Master Level and continuing to travel around the world learning about different cultures
Awards/Honors: Fellow, American College of Clinical Pharmacology (1994); Accomplished Alumni Award, University of Tennessee (2009); Distinguished Alumnus Award, Department of Psychology, Commencement Speaker, University of Tennessee College of Arts & Sciences (2012); Fred J. Epstein M.D., Lifetime Achievement Award, 11th Annual Dream & Promise Awards Benefit, Children’s Brain Tumor Foundation (2013); University of Tennessee Alumni Professional Achievement Award (2014); Award in Appreciation for your Commitment to Pfizer Quality, (2014)
Associations: American College of Clinical Pharmacology; American Association for the Advancement of Science; American Society of Clinical Pharmacology and Therapeutics; Drug Information Association; Society of Sigma Xi
Breaking Down Barriers to Innovation
Since taking the helm as Bioclinica’s president and CEO in January 2015, John Hubbard, Ph.D., has dramatically changed the company under his leadership and is bringing transformative solutions to the industry.
With extensive insight into the complexities inherent in the drug development process, Dr. Hubbard has created an agile organization committed to surfacing — and realizing — new possibilities within R&D. To this end, his strategic vision centers on simplifying the drug development process, shortening cycle times, and reining in rising costs. He believes more needs to be done to break down the barriers across the industry and improve collaboration with patients, investigators, regulators, payers, service providers, and the industry.
“Despite years of trying, we still have an industry with multiple siloes — from research, through development and commercialization,” he says. “This challenge is now amplified due to extreme commercial pressures across the biopharmaceutical and healthcare ecosystem and the need to accelerate the development of more effective therapies.”
Under Dr. Hubbard’s stalwart leadership, Bioclinica has grown from its original two divisions to three business segments comprising a total of nine divisions. He expanded the company’s solution sets, once focused on eClinical and imaging, into adjacent areas through strategic acquisitions of leading providers in the areas of patient recruitment-retention, postapproval research, clinical site network, safety and regulatory, and financial lifecycle solutions.
In addition to his talent at delivering growth in alignment with industry needs, Dr. Hubbard is equally passionate about innovation and encourages every team member to pursue finding new ways to address the industry’s challenges each and every day.
Dr. Hubbard has a history of breaking down the barriers to innovation.
While at Pfizer as senior VP and worldwide head of development operations, Dr. Hubbard directed and oversaw trial operations and management of more than 450 clinical projects a year and spearheaded initiatives to improve the efficiency and productivity in pharma R&D.
He served on the executive taskforce that redesigned Pfizer’s R&D organization, which ultimately led to a significant improvement in quality and increase in productivity from 2010 to 2014. The challenges Pfizer faced were the need to reduce enterprise R&D costs by $2 billion, resolve a clinical warning letter, improve GCP data quality, transition from multiple functional service providers to two global CROs, and deliver the development portfolio on time and on budget.
“This was one of the most challenging positions and assignments I have ever had in my 30-year career,” he says. “I also found it extremely rewarding working with a great team to achieve these results.”
During Dr. Hubbard’s more than 11 years as group president of ICON’s global clinical research services business, the CRO’s largest business division, he achieved a consolidated annual growth rate of 25% to 35%, and revenue grew from $85 million in 1999 to just under $1 billion by the end of 2010.
Dr. Hubbard measures success by his influence on the industry, both through the people he has worked with and the results achieved to bring new innovative drugs to the market.
A trusted, well-liked, and respected leader, Dr. Hubbard leads by empowering team members to achieve beyond what they think is possible. Motivation, he believes, comes from enjoying what you do, but also from interactions with others.
“We sometimes forget the impact we have on people, both through the work we do to bring new drugs to market, but also in our daily interactions,” Dr. Hubbard says. “Progress is achieved, when people have the freedom to make mistakes and learn through the process. In the long-term, career achievements are about a mix of impact on industry and on people. I would like to be remembered as an innovator and calculated risk-taker who brought improvements to the clinical development process. I would also like to be remembered as a good leader and mentor.”
Company: Daiichi Sankyo
Education: MBA, Loyola Marymount University
Family: Wife, Barb
Hobbies: Running; going to gym; crying over NY Knicks
Bucket List: Hike Moab
Awards/Honors: Amgen’s First Impact Award; 2nd Most Inspiring Award
Stepping up to the Challenge
Ken Keller doesn’t shy away from a challenge. Rather he leans into it, keeping the big picture front and center and owning problems with others.
Mr. Keller joined Daiichi Sankyo in the middle of 2014 as president, taking on responsibility for leading the administrative and commercial organization. It was just as the company was about to sail into a perfect storm of challenges.
First, the company was facing the loss of patent exclusivity on its two major franchises, including Benicar, the hypertension treatment whose patent is slated to expire next year and which brings in about 27% of annual revenue. Second, a new blood thinner, a product developed internally launched just after Mr. Keller’s arrival, which was expected to help soften the blow, but the label was challenged relative to the competitors in its class, resulting in a product launch that ended up being “tough sledding.”
As a result of the combination of these factors he inherited, Mr. Keller has had to right-size the organization, shedding a large number of jobs.
He has moved aggressively to license a late-stage product, execute a co-promotion agreement with AstraZeneca’s Movantik, a treatment of opioid-induced constipation, and create a new, highly energized culture of a company that was on the ropes. With Movantik, Daiichi Sankyo is implementing innovative programs in multi-channel marketing, along with a number of beyond-the-pill offerings, and the company has been effective at generating growth and maximizing potential for the franchises facing the loss of patent exclusivity.
Mr. Keller is not afraid to take a risk, saying companies can’t innovate without being willing to tolerate failure.
But he recognizes that organizations can suffer from PTSD from such challenges, which can cause the culture to erode. Therefore, he has worked hard to make sure this does not happen on his watch.
The “new DSI” has an energy and passion that is palpable among its employees. Results and growth have been highly positive, the P&L of the business has been re-engineered, and the company has a number of exciting projects in the pipeline.
Mr. Keller measures success by achieving more than one thought was possible, and doing it in a way that he can be proud and that others also feel a sense of pride.
Before joining Daiichi Sankyo, Mr. Keller was executive VP and chief operating officer at Spectrum Pharmaceuticals, and before that he was VP and general manager of the bone health business unit at Amgen.
Mr. Keller cites as his greatest career highlight the launch of Amgen’s Neulasta, indicated to treat neutropenia, an initiative he says spanned from cultivating the concept to $3 billion in revenue.
Success aside, it’s the people that matter most to Mr. Keller who says helping people improve themselves and become more successful is how he would like to be remembered. When it comes to delivering financial results, few will care 10 years from now, so he focuses on being an excellent and dependable leader for today.
“I would like to be remembered as someone who made a huge impact to many others as they achieved their own breakthrough success,” he says.
Michael C. Kaufmann
Title: Chief Financial Officer
Company: Cardinal Health
Education: BA, Ohio Northern University
Family: Wife, Linda; four children
Hobbies: Fishing, cooking, movies
Bucket List: Take a family vacation to a new destination every year
Awards/Honors: Distinguished Alumni, Ohio Northern University, 2016; Guys Who Get it Award, Institute for Women’s Leadership 2014; Honorable Mentor, Healthcare Businesswomen’s Association, 2012
Associations: Ohio Northern Board of Trustees; Red Oak Sourcing executive board; Healthcare Distribution Management Association (former executive committee member); National Association of Chain Drug Stores Association (former executive committee member)
Chief Diversity Champion
Mike Kaufmann’s contributions to the success of Cardinal Health over the past 25 years or so have been substantial. Mr. Kaufmann started his career at the healthcare services company in finance and quickly realized he wanted to expand his experiences. After success in sales, general management, and procurement, Mr. Kaufmann served as group president of the medical business, overseeing the all aspects of the unit. He quickly moved into the CEO role of Cardinal’s pharmaceutical segment where he was responsible for the direction of the $80 billion business and overseeing 16 business units that ranged from pharmacy distribution to nuclear pharmaceuticals. He also led the team that negotiated the joint venture with CVS Health to form Red Oak Sourcing. The 50/50 stand-alone joint venture is the largest sourcer of generic pharmaceuticals in the United States.
“I thrive knowing that we are making a difference for healthcare providers taking care of patients,” Mr. Kaufmann says.
In November 2014, Mr. Kaufmann was named chief financial officer of Cardinal Health, providing executive oversight for all of the financial and procurement activities of the company as well as helping to set the strategic direction of the company.
“Success for me is about solving the tough problem, building lasting relationships, and surrounding myself with great team members who have the opportunity to take their careers and the company to the next level,” he says.
His demonstration of extraordinary leadership in support of women and their career development sets him apart. He is considered the quintessential sponsor and mentor and is the executive sponsor of the Cardinal Health Women’s Initiative Network (WIN).
“This stands out as one of my most challenging roles,” he says. “When I first started, I thought I knew a lot about gender partnership. What I learned relatively quickly was that I didn’t know as much as I thought. I can’t tell you how many a-ha moments I’ve had with WIN.”
As the executive sponsor of WIN, he demonstrates his passion for gender partnership internally and externally; he is a much-sought after speaker on the topic. Colleagues say he not only talks the talk but he walks the walk.
His efforts have not gone unnoticed. In 2012, the Healthcare Businesswomen’s Association (HBA) named Mr. Kaufmann its Mentor of the Year.
More recently, Mr. Kaufmann was awarded the Guys Who Get it Award from the Institute for Women’s Leadership. The institute was founded by Rayona Sharpnack to innovate in the areas of gender partnership in addition to growing and developing women.
“Professionally, my involvement with WIN has been one of the most amazing experiences in my recent career history,” he says. “WIN has challenged me to learn and find my blind spots with respect to gender partnership. More importantly, it has made me a better parent, partner, and leader.
“I want Cardinal Health to make a difference in healthcare,” Mr. Kaufmann continues. “I also want to make a difference in gender partnership because I think we all win when everyone can bring 100% of themselves every day to work.”
Men and women admire him and thank him for his generosity for helping them reach their potential through mentoring and sponsorship, even when they didn’t see what they could accomplish themselves. He asks the hard questions and provides honest feedback allowing his teams to learn new skills and experience new career opportunities.
“The idea of sponsoring is really powerful,” he says. “It means they give 110% and make me and the company look good, and in return I promote them for stretch assignments and sometimes provide air-cover when things aren’t perfect. Sponsorship is how we will ultimately build a more diverse workforce.”
Mr. Kaufmann is not only creating a more diverse workforce he has created an environment where there is diverse thought.
“As a leader, I have to create an environment where people have permission to fail,” he says. “Without permission to fail people won’t feel empowered to try new things.”
Mr. Kaufmann encourages his people to know their own personal brand and make sure their actions reflect that brand.
And for him his brand is a focus on three things: speed, grit and getting lost in team.
“I’d like to be the guy that our customers want to do business with because they trust me; and because I treat them and everyone I work with the way they want to be treated and the way I’d want to be treated,” he says.
Ms. Sharpnack’s organization got it right; Mr. Kaufmann is a guy who gets it.
Mary Manna Anderson
Company: Ogilvy CommonHealth Medical Education and SCI Scientific Communications & Information, both Ogilvy CommonHealth Worldwide companies
Education: BA, Journalism/Economics, New York University
Family: Husband, Jeff; children, Moriah, 22, and Jeremy, 16
Hobbies: Hiking, cooking, gardening
Bucket List: A culinary tour of the continents, including cooking classes in major cities around the world to become more familiar with the cuisine styles of the non-Western World
Awards/Honors: Healthcare Businesswomen’s Association (HBA) Rising Star
Associations: HBA, various community organizations, including chorus
Pushing the Medical Education Envelope
Combining unsurpassed knowledge in medical education with vision and pursuit of excellence in client service, Mary Anderson has helped to drive innovative approaches in medical education.
Throughout her nearly 30-year career, Ms. Anderson has been focused on educating healthcare professionals around the world on the clinical benefits and risks associated with their treatment decisions. In doing so she has built one of the industry’s broadest and deepest medical director communities that ensures education platforms are built with the scientific rigor that the industry demands.
Ms. Anderson is a forward thinker who is always looking to push the envelope with innovative strategies. She has a clear understanding of the drivers in the medical marketplace and an ability to seamlessly translate these insights into scientific communications and strategies.
She is laser-focused on goals and measures success by what she has achieved. Her brand, she says, is built for distance.
About 10 years into her career she and a partner started a medical education company, which they ran successfully for five years until 9/11 and several other factors pressed a decision to move on.
“This helped me build the entrepreneurial skills, financial acumen, and grit that comes in handy every day,” Ms. Anderson says.
She later joined Ogilvy and set a goal to manage a unit to success, taking a step back from managing her own company to demonstrate what she could do. The gamble paid off and she reached her goal within three years.
Ms. Anderson has led Ogilvy CommonHealth Medical Education for eight years and during her tenure, she has transformed the operating model and grown revenue by more than 30%. Soon after becoming president, she created SCI, which is focused on the specific needs of medical affairs and R&D teams in pharma, biotech, and device manufacturing.
She consistently challenges her teams to uphold the highest quality standards in Ogilvy’s scientific communications and constantly strives for more innovative ways to deliver educational content. Examples of innovations that Ms. Anderson has delivered include: thought leader content co-creation platforms, behavior change-based clinical decision making models, data visualization and comprehension techniques, and scientific narratives informed by lexical analysis.
She has built up an impressive and diverse group of medical directors, Ph.D.s, account and project managers, medical writers, publication planners, and program directors, who bring unique, specialized expertise in science and adult learning. She has harnessed the collective power of talent in both the N.Y. and N.J. Ogilvy offices, enhancing the ability to service clients and develop talent in the organization. Through her leadership, this team has grown to be one of the most robust in the industry.
Ms. Anderson garners respect from her team and clients alike. She creates a positive work environment while challenging her team to always think differently and provide new ideas to clients.
She practices what she preaches, modeling positive approaches and with a belief that there is always a solution. When challenges arise she has a simple approach: tell a joke, buy lunch, and figure it out.
Those who work with Ms. Anderson feed from her energy, resourcefulness, and pursuit of perfection as she motivates, drives, and inspires her team.
She was selected as an HBA Rising Star in 2011, and is presently a mentor for the HBA’s mentoring program. In her life, she works informally to mentor young women.
She says she would be liked to be remembered as a person who saw what was coming around the corner and was ready before it happened.
Nancy S. Berg
Title: CEO and Executive Director
Company: International Society for Pharmacoeconomics and Outcomes Research (ISPOR)
Education: BA, University of Michigan
Family: Her parents, grandparents, husband
Hobbies: Cycling, currently training for long ride charity events, and beach lover
Bucket List: Completing America’s Most Beautiful Bike Ride around Lake Tahoe for the Leukemia and Lymphoma Society; participating in an archeology dig; being a spectator at the Tour De France; and a two-week vacation would also be nice, not practical, but nice
Awards/Honors: 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: American Society of Association Executives; Council for Engineering and Scientific Society Executives
Driving Change Through Collaboration
Forward-thinking, strategic, and transparent, Nancy Berg is enabling the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) to position itself as a leader in the field of health economics and outcomes research (HEOR).
One of her first tasks when assuming the role of CEO and executive director of ISPOR in 2014 was a revamp of the organization’s strategic plan, including the mission, vision, and pillars upon which it functions.
Any change in leadership comes with new processes, new systems, and new perspectives — the type of change that typically makes employees and members a bit uncomfortable. But the mark of a true leader is revealed in her skill in guiding everyone through the transition so that they not only feel comfortable with the changes, but also begin to fully appreciate how necessary those changes are for growth.
Ms. Berg’s ability to deal with these challenges head on through open communication is extraordinary. She leads by example by encouraging her team to think creatively and strategically, and empowering them to take ownership and make independent decisions.
Her approach has been to combine a respectful honoring of the history and past success of the association but with a consistent application to new ways of thinking.
Under Ms. Berg’s leadership, a collaborative team of board members, thought leaders, and cross-functional staff teams developed and implemented a new strategic plan that cements ISPOR’s position as a global leader in HEOR. Ms. Berg’s collaborative process has resulted in the strategic plan being an owned as well as a living document to align the organization for the future.
Membership, meeting attendance, and revenue are up, and the visibility and international profile of the organization have been elevated through the creation of strategic partnerships and collaborations around the world.
In 2015, ISPOR welcomed more than 18,000 attendees from more than 90 countries to its global conferences.
Ms. Berg is committed to a business culture founded on the inclusion of multiple perspectives in decision-making processes. As a leader, she makes a personal commitment to provide constructive feedback, mentoring, and development opportunities to all staff.
Ms. Berg moved into healthcare after her husband was diagnosed with non-Hodgkin’s lymphoma. Through his successful battle and recovery in 2009, she grew acutely aware of the critical role healthcare research plays in the lives of patients and caregivers.
Before joining ISPOR, she was responsible for transformational change as CEO of the International Society for Pharmaceutical Engineering (ISPE), the world’s largest professional society in the field.
At ISPE, Ms. Berg worked to bring together diverse groups of pharmaceutical industry stakeholders.
Early in her career, she served as executive director of the Society of Manufacturing Engineers (SME) where she became the youngest person ever to head a global engineering/technical organization.
“Today I have an opportunity to apply that experience in managing the growth of ISPOR,” she says. “The situation is similar. I am working with some of the world’s brightest people to produce meetings, publications, and tools to advance the field of health economics and outcomes research, which is not only extremely rewarding, but critical as medical decision making becomes more complex.”
The team is vital to success, Ms. Berg notes, saying the most critical decisions a leader makes are around assessing, shaping, and developing the team. She measures success by the accomplishments of her team.
“Many people who have worked for me have gone on to lead other scientific societies, or to be executives in science or technology-based companies, so part of my success lies in my ability to spot talent,” she says.
Stepping back, she would like to be remembered as someone who saw potential and possibilities, who listened in order to learn and who stretched those around her.
“Above all, I would like to be remembered as grateful,” she says.
Julie Ann Ross
Company: Advanced Clinical LLC
Education: BS, Nuclear Medicine; University of Wisconsin, Lacrosse
Family: Husband, Steve Ross; children, Steven, Anna, Nick, and Tony; Parents, Mike and Judy; in-laws, Bill and Janet
Hobbies: Kayaking, boating, fishing, and spending time in Northern Wisconsin and shopping with her daughter
Bucket List: Being in Time’s Square on New Year’s Eve and a trip to Alaska with all of her children
Awards/Honors: PharmaVOICE 100 honoree, 2014
Associations: Healthcare Businesswomen’s Association, DIA, GRACE
Bridging the Talent Gap
With a clear focus on mapping a path forward, Julie Ross is committed to solving each hurdle that the life-sciences industry faces. Ms. Ross, president of Advanced Clinical, has been a thought leader and innovator within the pharma, clinical, and biotech space for more than 25 years.
Ms. Ross has mastered the skills necessary for helping pharmaceutical and clinical organizations achieve success, growing vertical organizations from $20 million to billion-dollar entities. She led the successful transition of a site management organization into a full-service contract research organization that grew from nothing to $50 million in revenue in about five years before a successful sale.
Her impact on driving industry-leading change has been profound, and as a leader she has developed and groomed tomorrow’s top pharmaceutical professionals.
Her vision and leadership have guided Advanced Clinical to become one of the strongest and most-effective CRO, staffing, and consulting organizations in the pharmaceutical space.
Recognizing the need for continuous innovation and industry improvement, Ms. Ross has been a champion for new initiatives, including risk-based monitoring, electronic trial master filing, and streamlining FDA-compliance automation.
Her expertise and ability to diagnose next-generation solutions within clinical areas are sought out by professional organizations across the United States.
One of the most recent examples of her leading-edge thinking is the development of a program to help bridge the significant talent gap facing the clinical and pharmaceutical industry. Under Ms. Ross’s leadership, Advanced Clinical developed and launched a new program aimed at accelerating and promoting new clinical research associates entering the field. Working with leading U.S. universities, the program is a catalyst for maximizing new graduate experience and complements the real-world skills necessary to be successful in the field.
She says the “war on talent” keeps her up at night as the clinical research industry is evolving quickly and reaching the tipping point where many senior leaders will retire, and yet the industry finds it difficult to attract younger, less experienced people.
Ms. Ross cites her toughest assignment was selling the CRO she was responsible for building. While it was the right business decision, the transaction came with a great deal of change — i.e. culture, roles and responsibilities, processes, systems, loss of a few positions, integration hurdles, etc. — for many. Leading her team through the sale and integration, while ensuring client programs were not affected was a critical initiative, she says.
Helping to advance others’ careers is a priority for Ms. Ross, who would like to be remembered as a servant leader, a person who made a difference in the lives of many through personal and professional coaching, and through her innovative ideas and programs.
She is a mentor and board director for the Healthcare Businesswomen’s Association. Mentoring is critically important for her, as she says it is a way for her to give back and grow the future of the industry.
“I am motivated by the opportunity to make this a better world by innovating within the drug development industry and through coaching and mentoring people to be better versions of themselves,” Ms. Ross says.
She leads by example, respecting individual value systems, challenging people to be their best, and offering encouragement.
“Life is a journey with ups and downs but when I reflect back, the most difficult of times can be the most rewarding in terms of lessons learned spiritually, emotionally, and intellectually,” she says.
Brian Nightengale, Ph.D.
Education: Bachelor of Pharmacy, University of Oklahoma; Ph.D., Pharmaceutical Sciences, University of South Carolina
Family: Wife, Jennifer; children Camden, Alex, Jack, and Anna, and parents
Hobbies: Fishing, playing guitar, cycling
Bucket List: Landing a 400-lb blue marlin; spending two weeks in the Holy Land
Awards/Honors: Top Places to Work in Tampa Bay
Associations: International Society for Pharmacoeconomics and Outcomes Research, Academy of Managed Care Pharmacy, University of Oklahoma College of Pharmacy National Board of Directors
Empowering Success One Passion at a Time
People are the inspiration for Brian Nightengale, Ph.D., and as president of Xcenda he is focused on empowering them, connecting with their passion to drive the business vision and mission, and creating opportunities.
“When smart people are empowered to reach their full potential and to pursue their passion, and when that passion is aligned with a purposeful strategy, great things happen,” Dr. Nightengale says.
Dr. Nightengale leads a variety of teams and experts in projects that are critical to the pharmaceutical product commercialization journey.
Xcenda, part of AmerisourceBergen, is a strategic consultancy that applies real-world expertise in health economics and outcomes research, reimbursement, stakeholder insights, and market access consulting and communications.
As a leader, Dr. Nightengale and his team have driven Xcenda’s global expansion. In 2014, Xcenda acquired Herescon, a leading research and consulting firm based in Hannover, Germany. This acquisition positioned the company to more fully address the growing needs of its clients for health technology assessment, global market access, scientific communications, and related global services in Western Europe. The company maintains a network of key opinion leaders around the world and regularly exhibits at international conferences to ensure it can provide market-by-market commercialization insights to customers. Under his leadership, Xcenda has become a thought leader in the big data arena, helping pharmaceutical manufactures understand and apply data to supporting better patient adherence and outcomes.
Success for Dr. Nightengale is measured by the level of engagement of the company’s associates and customer satisfaction and accolades.
“When our customers win big awards, we love to celebrate behind the scenes,” he says.
He is considered an expert in collaborating with the company’s pharmaceutical partners, providing them with excellent customer service, strategic insights, and solutions. Dr. Nightengale ensures that trust and communication are integral parts of Xcenda’s culture.
His leadership, business acumen, and professional ethics are valued throughout the organization and with the executive leadership team. The company culture, which he helped to shape, regularly earns one of the highest employee engagement scores in the field helping retain and attract the finest and brightest talent, an accomplishment Dr. Nightengale regards as a career highlight.
He is also proud of the fact that Xcenda has been selected as Best Places to Work both times the company was eligible.
He regards his colleagues as family and says because of the trust built over the years, when challenges arise it’s natural for them to come together as a dedicated team, with no personal agendas, to come up with a response and solution to address the issue. His primary goal is to empower others to succeed beyond even their current goals.
“I love to solve problems and fully believe that an engaged and empowered group of experts, aligned on a common strategy can drive and shape the future of healthcare,” he says.
Dr. Nightengale says if he isn’t mentoring he’s failing in his job, and he seeks to be more of a coach, mentor, and colleague versus being a manager. He was also an early sponsor of the company’s Women in Leadership initiative.
“Mentorship is incredibly important because that is what builds and perpetuates a culture of collaboration, growth, and success,” he says. “I believe that the most important impact of effective mentorship is passing along the lessons that come from past failure, for that is the birth of wisdom.”
To him, leadership comes down to three simple but powerful themes: engage, empower, and unleash.
“I hope to be remembered as a coach and mentor who made a difference in the lives of the people who I work with, and because of that, collectively, that Xcenda is viewed as the best-in-class essential partner versus a vendor by our customers,” Dr. Nightengale says.
Editor’s Note: As of press time, Dr. Nightengale has been named president of Good Neighbor Pharmacy, a network of independent pharmacies.
Education: MS, Business Administration, ICHEC Brussels Management
Family: Wife, Genevieve, and twins, Alix and Aymeric
Hobbies: Movies, music, DIY projects
Bucket List: Drive a Formula 1 car; skydive; become a business angel
Awards/Honors: Scrip Award 2014
Revolutionizing Statistical Monitoring
CluePoints CEO Francois Torche is set to disrupt the traditional thinking regarding risk-based monitoring and data quality oversight.
CluePoints is a central statistical monitoring solution that employs unique statistical algorithms to determine the quality, accuracy, and integrity of clinical trial data. By identifying anomalous data and site errors, corrective actions can be taken to ensure data quality and a reduction in overall regulatory submission risk. Aligned with guidance from the FDA and EMA, CluePoints is deployed to support traditional on-site monitoring and can be implemented as the engine to drive a risk-based monitoring strategy.
Mr. Torche has been at the heart of the company’s cloud-based software, which works by harnessing a unique, patent-protected engine comprising a comprehensive suite of statistical algorithms to ensure that no stone is left unturned in surfacing potential issues in both clinical and operational data. This advanced data analytics solution significantly reduces the risk of regulatory submission failure, while complying with current regulatory guidance and achieving higher quality data at the end of the study. As the complexity, size, and costs of clinical trials continues to increase, there is no doubt that this technology represents a major step forward for the industry and will lead to tangible benefits.
Mr. Torche’s passion and expertise have helped frame the industry’s discussion on operational quality management and he is encouraging organizations to rethink their approach to centralized monitoring techniques as they seek to implement risk-based monitoring.
Colleagues view Mr. Torche as a visionary who has been instrumental in this revolution. Possessing a rare combination of technical ability and an appreciation for the subtleties of running clinical trials, he is able to identify how CSM technology can help study teams maintain greater and more efficient oversight of patient safety and improve overall data quality.
His entrepreneurial mindset enables the company to be as nimble as possible and respond quickly to customer and partner requests as well as evoking a spirit where everyone is able to put forward new ideas and change the plans if appropriate. The ability of being able to make a decision in the morning and implement it in the afternoon is what makes Mr. Torche’s leadership at CluePoints so inspiring for those who work there.
This ability to deliver innovative solutions that match customer requirements is a recipe for great success. Many companies develop what they think is needed and then wonder why it doesn’t fly off the shelves, but Mr. Torche listens to what customers really need and how they need it to be done.
“We talk and we work together on the challenge,” he says.
Using an agile product development methodology, he ensures solutions are developed and implemented in record time.
He has created a company culture that has allowed for its ranks to expand from five to 30 employees in three years, and being appointed CluePoints CEO is by far his most challenging assignment to date. He shares his enthusiasm and passion for the work and enjoys interacting with others, initiating discussions about a certain topic, and sharing a diversity of thoughts.
Mr. Torche is as passionate about his family as he is about his work, and as the father of twins, he may have a tougher job at home than at work.
Colleagues tell us that he spends what little spare time he has at the beach with his family and is a keen kite-surfing enthusiast. He can talk for as long about that pastime as he can about SAS programing.
Education: BS, Business Communications, Bentley University
Family: Husband, Garrett Morgan and two sets of twins — Evelyn and Lexi, 6, and Owen and Josie, 4
Hobbies: Arts and crafts with the kids; reading, traveling
Bucket List: Travel twice a year to a new place — one trip with the kids and one without
Awards/Honors: 40 under 40, Orange County
Associations: Healthcare Businesswomen’s Association, Bentley Executive Club
Blazing a Trail
There is a saying that leaders shine in times of crisis or conversely that crises make a leader. Carolyn Morgan has proven her mettle time and again on both fronts.
At the age of 32, and three years into her employment at LehmanMillet, Ms. Morgan became managing director of the West Coast office, where she tripled billings, grew the staff from 12 to more than 40, and was named to Southern California’s 40 under 40 list of top leaders.
In June 2013, she returned to Boston to take over as president of the entire organization, a promotion she describes as both awesome and humbling.
Ms. Morgan continued to grow the firm at a rate in excess of the industry average, then managed it through a change in ownership, and positioned the newly rebranded agency as precisioneffect, part of Precision Medicine Group, to ascend to the top of the advertising industry along a nontraditional path.
Ms. Morgan has boldly repositioned the agency to seek out, engage, and catapult clients that are changing the standard of care to the top. And she has restructured the team to assure that the right talent is in place to address the dynamic healthcare marketplace to provide sound and top creative executions around the agency’s roster of innovative companies to create new positioning in a competitive healthcare landscape.
Her goal is to continue to hone and refine the agency’s craft, add talent everyone can learn from, and help launch or rebrand game-changing products that make a difference in patients’ lives.
She makes sure that everyone keeps up with literature both on therapeutic innovations as well as new marketing technologies that she and her team should be mastering.
“There are new and exciting things to learn every single day,” she says.
Ms. Morgan says managing an influx of work while taking care of her team and clients is a balancing act, and knows that great work and a happy team are hugely essential for long-term growth and stability.
She is also committed to lessen the divide between industry and society through impactful communications.
“So many amazing things are being done every day by extraordinary people and yet the focus remains on things that are perceived as negative — like the cost of drugs,” she says. “It would be great to highlight the unsung heroes and moments within the industry in an earnest and authentic way. In addition, there are underserved patient populations that need resources and attention, especially in ultra-rare diseases. It would be great to develop a coalition to support underfunded populations.”
Ms. Morgan is an inspiration to her peers and partners in the pharmaceutical and biotech industries. She has built an agency culture focused on fairness, integrity, and winning.
Internally, she makes everyone at the agency feel appreciated and important. Externally, she makes it a point to contribute to every account that comes through the agency’s doors.
She measures success by the amount of laughter she hears on a daily basis and the retention of her agency colleagues and repeat business that comes from the trust she builds with clients.
She has a tremendous warmth that is infectious and unifies those around her, which is especially important as she makes decisions, takes risks, and moves the business forward. She empowers people to leverage the skills at which they are great. She knows when to step in and solve problems, and more importantly, how to ask the right questions to help her teams solve problems on their own.
She weaves the perfect blend of intelligence, empathy, positivity, and vision into her everyday interactions with the entire agency.
Ms. Morgan devotes her time to individual development by listening, asking questions, and maximizing every minute. She genuinely cares about her employees and wants to make sure that people are happy with what they are doing. She inspires those around her through her sheer determination, leading by example, and ensuring a strong work/life balance.
She is a mentor to many other agency and client side talent and has kicked off a new Women in Life Sciences executive program with local Boston partners to further connections, mentorship, and knowledge share.
“Being a mentor is one of the most rewarding parts of my day,” she says. “I love to guide, encourage, and challenge. Our industry never stops.
Helping people to focus on themselves and tackle and complete a new challenge is essential to growth and so fun to watch.”
And she manages all of this with two sets of twins under the age of 6.
Title: President and CEO
Company: iCardiac Technologies Inc.
Education: BS, Cornell University; Master’s, University of Oxford; JD, American University
Family: Wife, Katie; two children, Marina and Max
Hobbies: Hiking, reading (everything), movies, travel, creative writing, and spending time on their hobby farm
Awards/Honors: Science Coalition 100 and Top Workplaces of Rochester twice; Leadership Excellence Award
Optimizing Clinical Trial Efficiency
A lawyer, a boxer, and a writer walk into a company to develop innovative ways for cost-effective safety testing for drugs with an entrepreneur. A joke? No, the lawyer, boxer, writer, and entrepreneur are all the same person: Alex Zapesochny.
The president and CEO of iCardiac Technologies has many diverse talents, and one of them is using technology to disrupt the way cardiac safety and respiratory assessment studies are conducted.
The former New York City prosecutor and attorney for technology companies started iCardiac with two others in 2006, with an exclusive license agreement with the University of Rochester Medical Center.
Under Mr. Zapesochny’s leadership, iCardiac Technologies performs advanced research studies that help pharmaceutical companies and regulators determine if new medicines that are being developed may potentially have lethal cardiac side effects.
The company has pioneered a number of key innovations in cardiac safety that are being widely used by numerous drug developers and sponsors.
iCardiac conducts cardiac safety and respiratory assessment studies worldwide and works with numerous pharmaceutical and biotechnology companies, including eight of the 10 largest global pharmaceutical companies.
Co-founding iCardiac and growing it into a 170-plus person company has been Mr. Zapesochny’s biggest career highlight. The most challenging assignment has been discovering and validating a methodology for more precise measurements in the context of cardiac safety studies, which represents a significant improvement in the cardiac safety industry.
Using the scientific evidence, Mr. Zapesochny’s team was able to convince preeminent thought leaders that through data from a unique ECG analysis methodology, it was possible to get definitive information from routine Phase I studies.
He has rallied the company around the technology that has resulted in it becoming an accepted strategy by regulators, which is unprecedented in the industry. And, in spite of industry criticism, Mr. Zapesochny worked with a discreet group of stakeholders to position iCardiac as the leading service provider behind this approach.
Colleagues describe Mr. Zapesochny as a pioneer and a disrupting force within the industry. His entrepreneurial skills are founded on his grasp of scientific concepts and how to make them valuable in a business context.
He possesses a pragmatic, effective approach, and always keeps one eye on the bottom line while pushing new ideas forward for top line growth and innovation.
An intuitive leader, Mr. Zapesochny has the ability to work with a wide range of people from academics to industry professionals; his unusual combination of analytical and emotional intelligence has enabled the technology and the organization to succeed. His leadership style epitomizes the belief that innovation, technology, and a committed workforce are keys to future success.
His first development at iCardiac was High Precision QT testing, which was focused on reducing costs and increasing precision using state-of-the-art software and digital signal processing algorithms.
Today, he and his team are focused on looking for ways of applying new technologies to additional areas, both currently in the clinical trial industry, but also methods that could be used in the broader healthcare industry.
It is no secret that drug development needs better methods so that sponsors can make clinical trials more efficient, affordable, and accurate, and iCardiac, under Mr. Zapesochny’s leadership, has done exactly that. The exciting thing is that colleagues say he always saw the mission of the organization as going beyond building a viable company to being an entity with a broad societal impact.
One of Mr. Zapesochny’s professional goals is to continue to grow iCardiac into the industry’s largest centralized core lab offering an array of best-of-breed service offerings.
“I hope iCardiac continues to be known as an organization that introduces technological innovations that serve to optimize drug development efficiency, and as a modern-age company with a culture characterized by respect, teamwork and autonomy,” he says. “I love to work on and implement new ideas with regard to technology, business models, and company culture.”
Jules Mitchel, Ph.D.
Company: Target Health Inc.
Education: BS, Biology, Queens College; MS, Biology, University of Oregon; MBA, Pace University; Ph.D., Biology, New York University
Family: Wife and life partner, Joyce
Hobbies: Walking in Central Park
Bucket List: Personally — go to the Galapagos Islands; professionally — see the adoption of paperless and standardized clinical trials to accelerate safe and effective drugs to the market
Awards/Honors: Small Business Global Trade Award from World Trade Week NYC 2016; Certificate of Appreciation in Recognition of Outstanding Service and Contributions on Behalf of CTTI (Clinical Trials Transformation Initiative); Sponsor of the Year (Center for Dermal Research; Leaders Society (Dermatology Foundation)
Associations: CTTI, ASCO, AAD, AUA, ACRP, DIA
Trailblazing for Electronic Clinical Trial Efficiency
The move away from the dependence on paper in clinical trials can’t happen soon enough for Jules Mitchel, Ph.D. Trying to get the life-sciences industry to embrace the transition to paperless clinical trials remains his toughest challenge.
“I’d like to be remembered as the guy who helped to transform clinical trials from the Dark Ages where paper dominated and time was not of the essence, to the Modern Age where we all use 21st century thinking and cutting-edge technology,” Dr. Mitchel says.
Dr. Mitchel has been a trailblazer in developing and using electronic source solutions to impact the clinical research enterprise, including clinical research sites, patients, regulators, as well as CRAs, project, safety, and data managers within drug and device companies.
He started Target Health with his wife and business partner, Joyce Hays, and the two along with a talented team have built the company into an internationally recognized full-service CRO with expertise in clinical research, regulatory affairs, biostatistics, data management, Internet-based clinical trial electronic data-capture (EDC, paperless), software development, drug and device development.
From early on, he had the insight to recognize the potential of the Internet to save time and money in clinical trials, as well as to increase efficiencies and have validation software far exceeding the accuracy of human review.
He blends technologies with expertise in clinical research while maintaining a regulatory perspective to facilitate efficient clinical trials that can lead to smooth regulatory reviews and ultimately marketing approvals.
Success for him happens each time a client hits a key milestone, such as a successful outcome of an FDA meeting, a successful clinical trial, obtaining an orphan drug designation, and of course a marketing clearance of a drug, biologic, or device.
A career highlight for Dr. Mitchel was the first-ever marketing approval of an investigational product that used direct entry of patient data at the time of the office visit for a trial using Target Health’s proprietary EDC system, Target e*CRF integrated with Target’s e-clinical trial record e-source system, Target e*CTR. This was followed by a new drug application (NDA) with seven studies that used the same software and where all five clinical research sites had flawless FDA pre-approval inspections.
Indeed, Target Health’s technologies have not only been accepted by the FDA, but in fact, have become the new industry standard held by regulators.
A collaborative thinker, Dr. Mitchel recognizes and leverages the creative and technological resources of his clients to optimize each interaction whether with the FDA or coordinating activities with other regulatory agencies.
His expertise has earned him an impressive client list; he currently represents more than 45 pharmaceutical and biotech companies at the FDA and more than 150 companies since Target Health was founded.
He has been a leader within the industry on multiple fronts: using MedDRA within the EDC environment; creating behind-the-scenes datasets consistent with CDISC; creating pharmacovigilance within the EDC environment, which eliminates reconciliation work; blending the eSource with the EDC using technology, all the while protecting the ownership by the site of the source documents and the ownership by the sponsor for the EDC data.
In addition, Dr. Mitchel has been actively involved in the FDA Clinical Trial Transformation Initiative (CTTI) as a member of the executive and steering committees.
Ideally, Dr. Mitchel would have all clinical trials for a given disease in the cloud so that all a researcher would have to do is add a new treatment to an existing protocol. Further, he believes the pharmacy industry could become an integral part of postmarketing surveillance as all prescriptions are now electronic so it is easy to track fulfillment and renewals.
Critically important is how a company treats its employees and structures itself for employee growth. Dr. Mitchel elevates talent-development to a new level with his more than 65 employees by having regularly scheduled company gatherings, which acknowledge individual achievement, attainment of group goals, and excellence in recruitment and retention.
Dr. Mitchel inspires his employees by engaging all staff members no matter where they sit in the company’s hierarchy.
“I share my passion for science and the industry and how working at Target Health can make a difference,” he says.
Title: Chief Operating Officer
Company: MedNet Solutions
Education: BS, Biology
Family: Her parents, both deceased, who provided her with a strong core and moral foundation; two siblings
Hobbies: Gardening; she can grow almost anything; watching college sports of any kind; and supporting the Kansas City Royals, Sporting KC, and the Kansas City Chiefs
Bucket List: Travel to Anguilla and the Maldives; a vacation on a boat with a captain in the West Indies; owning a business
Awards/Honors: PRA President’s and Chairman’s Club awards
Associations: DIA, SCDM, Founding Member, Women’s Capital Connection, Mid America Angel Investors, Hebron Board of Directors
Going the Extra Mile
Everything Clareece West does is directed toward a very clear goal: benefitting patients. Ms. West is driven by delivering technologies properly married to science to improve and advance devices and therapies for all patients.
Ms. West is an energetic, passionate, and experienced industry leader dedicated to corporate and individual success, as well as improving the life-sciences community on a personal and professional level.
Ms. West has an incredible track record. A career highlight for her was joining the team of a relatively small company, contributing to its growth year after year, and eventually taking it public. Another accomplishment was taking a company that was hugely revenue concentrated with one client representing more than 85% of the business, and helping it to diversify its client portfolio and revenue across more than 50 new clients.
“In both cases, I was fortunate to have fantastic teams,” she says. “That’s where real success happens.”
In addition, Ms. West was directly involved with all hepatitis/HIV products brought to market between 1984 and 1998 by supporting three of the top diagnostic companies worldwide.
Ms. West joined MedNet Solutions as chief operating officer at a crucial time in the company’s history. Specifically, MedNet had just received the first major outside financing in the company’s history, and its leadership team was looking for expert assistance in taking the organization to the next level of growth, building on the company’s solid eClinical products, and furthering its excellent customer service reputation.
Since joining, Ms. West has helped to reorganize MedNet’s departments to increase efficiency and productivity. She has hired experienced personnel to strengthen internal capabilities and knowledge and she has spearheaded initiatives to expand MedNet’s global footprint. In 2015, MedNet experienced record growth, including iMedNet eClinical sales growth of 98% from 2014; iMedNet eClinical backlog growth of 91% from 2014; record R&D spending, a 46% increase from 2014; significant employee hiring growth, more than 30%; and inbound prospective customer inquiry growth of 40% from 2014.
Her goal is to help drive and influence better cures, while improving the products and devices in development.
“I hope to continue leading industry companies toward growth, goals, and better quality results,” she says.
Ms. West loves what she does, knowing that every computer click, data entry, monitoring trip, medical review can make a difference in overall patient care. She is excited by the opportunities technology brings to the industry by creating a more universal mindset that allows the industry to draw patients into clinical trials from around the globe.
She believes success should be measured by the performance of those who work for her. She constantly challenges herself by asking: “Are they motivated? Do they care and want to achieve more? Do I provide the right strategy and goals for them to succeed? What did I learn?”
Ms. West motivates team members to achieve the highest level of excellence in everything they do by modeling this behavior every day herself.
She seeks to inspire teams through push and drive and helping her teams achieve what they want long term.
Ms. West consistently shares her knowledge and expertise with the life-sciences community through her leadership roles in various industry-related organizations and events. For example, she has served in multiple lead speaking and moderating roles at DIA events, both within the United States and abroad.
She devotes countless hours of her personal time to multiple community initiatives that are near and dear to her heart. For example, she is passionate about helping small businesses attain the funding they need to achieve their dreams and is a founding member of the Women’s Capital Connection, a regional angel investment group, and is an active member of the Mid America Angel Investors network.
She is also committed to healthcare-related not-for-profit organizations in her community. After a coworker was diagnosed with breast cancer, Ms. West became a member of the Ribbons of Pink Foundation, an organization dedicated to finding a cure.
She has also served seven years on the board of the Kansas City Eye Bank, and four years as president. She served as the chairperson for the Kansas City Memory Walk for Kansas City Hospice House.
Ms. West also volunteers for Kansas City Hospice and she is currently president of the board for Hebron Cemetery.
Title: US, Managing Director
Company: Chandler Chicco Agency, inVentiv Health
Education: Journalism, University of Kansas
Associations: Healthcare Businesswomen’s Association
There’s no such thing as “we can’t do that” for Julie Adrian. With an imaginative approach to problem-solving, Ms. Adrian looks beyond the predictable to make solutions a reality.
Ms. Adrian brings passion, creativity, and inspiration to everything she touches. She is able to adapt to any client situation, contribute to and win new business, drive strategic discussions, and do it all with pep and determination.
A charismatic, creative, and inspirational leader, she has more than 25 years of experience in the development and execution of healthcare marketing communications programs.
She joined Chandler Chicco Agency (CCA) in 2003, chosen by industry veterans Bob Chandler and Gianfranco Chicco, to establish CCA’s West Coast presence. A dedicated visionary, she built the West Coast operation from scratch, and it now includes more than 30 communications professionals representing a range of biotech, pharma, and device companies. She took the office to the next level, helping it to become the hub of inVentiv Health’s West coast operations, defining new approaches, and being a model for the integrated service model.
Since becoming the leader of the Chandler Chicco Agency U.S. in 2015, she has focused on unifying three offices: New York, Los Angeles, and Washington, D.C. She has redefined how each group works together while fostering vision and creativity in each of the offices.
Ms. Adrian has embraced being part of inVentiv Health and finds ways to cross-collaborate with sister agencies: Palio, Medical Communications, GSW, Managed Markets, among others. She leverages expertise across the inVentiv Health network to infuse broader thinking into the communications approach for clients.
At the same time, she has not lost sight of CCA’s legacy and what makes it unique: a no-walls, no-titles culture that promotes collaboration and rewards innovation.
She strikes the right balance of experience, knowledge, energy, and a single-minded goal to deliver the highest quality work.
A relationship builder, Ms. Adrian’s clients are dedicated to her while her competitors admire her.
She understands the regulated environment the industry works in, and how to be innovative and cutting-edge while always staying compliant.
And she does so while always keeping front and center that everything both the agency and its clients do ultimately touches the lives of patients, their families, and caregivers, and therefore must be authentic, motivating, and relevant.
Whether she is providing strategic counsel to facilitate effective change management between companies experiencing a merger, helping a brand establish its voice, or developing a compelling, authentic narrative that will ultimately have a positive business impact, Ms. Adrian’s pursuit of excellence is relentless.
A recent example of her ability to bring fresh thinking to business challenges is her work supporting the primary screening indication for the cobas HPV test. This was a huge PR opportunity for the agency. Because the test was a critical screening option for women, it was essential that CCA deliver a high-impact PR program that supported an advisory committee and FDA approval. Not only did she deliver outstanding results, she also parlayed this success into a PR education project for CCA’s internal business partners.
Ms. Adrian brings learnings borne from years of helping companies tell their stories and engage with stakeholders in meaningful ways that have a positive impact on the business.
Her energy and positive attitude are infectious in the office. She empowers her team to think outside-of-the-box to deliver results-oriented programs to healthcare clients to ultimately improve patients’ lives.
“Considering the patient voice very early in the life cycle of a product or service — even when choosing to develop a compound — will do more to change the way we make decisions than any other shift in recent years,” she says.
She inspires through words and deeds, noting that inspiration is part motivation and part action.
“It’s important to give people the right direction, help them see how to feel good about what they are doing, and why they are doing it,” she says. “But it’s equally important to show them you are fully vested in their success, and seeing leaders follow through on what they say is highly motivating.”
Her commitment to supporting women who are passionate about healthcare communications extends beyond working with CCA employees. As the current president of the Southern California chapter of the Healthcare Businesswomen’s Association, she is directly involved in shaping the next generation of women in healthcare.
Title: Group President
Company: Publicis Health
Education: BS, University of Delaware
Family: Partner, Ralph Bassett
Hobbies: Running, house renovation
Bucket List: Trip to the Maldives
Awards/Honors: PharmaVOICE 100 2014, 2015, 2016; MM&M Agency Marketer of the Year, Silver 2014; Ad Age Best Places to Work 2015
Associations: Big Brothers Big Sisters Independence Region, Board of Directors, Vice Board Chair, Chairmen of Marketing Committee, Secretary Philadelphia Interactive Marketing Association, Founding Member Egalite, Publicis Group’s network for gay, lesbian, bisexual, and transgender professionals and allies
Creating Powerful Connections
Three-time PharmaVOICE 100 honoree Matt McNally gives 100% to everything he does.
“If I am not 100% committed and involved, I can never expect my teams to be,” Mr. McNally says. “My team sees my passion and dedication to them, and they give it right back to me.”
Mr. McNally consistently shows passion for his people, his clients, and the media world. He has pioneered many new initiatives over the years that have benefited patients, the media industry, and his healthcare clients.
His advocacy for pharma marketing goes beyond branding and delivers real value: education, awareness, and value beyond the pill.
One of the leading innovators in the intersection of media and marketing in healthcare, Mr. McNally’s vision and skill as a media pioneer and marketing expert has set the pace for the transformation of pharmaceutical marketing from static creative metaphors, to real-time engagement through content and interactivity. From building the first-ever integrated media capability at Digitas Health, to leading the successful launch and expansion of Publicis Health Media (PHM), Mr. McNally has demonstrated his ability to seize on emerging trends and lead in uncharted and exciting new territories.
He has moved PHM into a leadership position within the health and wellness media space within three years of the agency being established.
Last year, Mr. McNally was promoted to group president of Publicis Health, and in addition to leading PHM, he was tasked with overseeing Razorfish Health.
“This experience taught me how to build and optimize teams that I did not create, and reposition the Razorfish Health brand in the marketplace,” he says. “This responsibility reinforced the power of team, and how to make decisions quickly to drive change.”
In taking over responsibility of Razorfish, Mr. McNally is helping to connect the dots between technology, content, creative, and media and driving continued innovation and evolution within the healthcare media and digital space. He sees exciting opportunities in developments such as marketing automation platforms, business programmatic ad buying, and patient and healthcare practitioner data driving marketing decisions and performance.
He has a vision for how his clients can use data to drive better user experience and better ROI and has built an industry-leading business intelligence function that enables advertisers to deliver more effective campaigns.
Always on point with his industry knowledge, clients describe Mr. McNally’s business acumen and attention to detail in his relationship with them as extraordinary. He challenges clients and colleagues to not think like marketers, sales executives, or publishers, but like a patient. He eschews terms like “targets,” saying people are individuals with fears, hopes, desires and needs.
“We need to move from simply selling products to servicing distinct individual needs in a more inspiring, personalized, and compelling way,” he says.
While he is at the forefront of digital media innovation, he never speaks in terms such as digital or mobile or social; for him it’s all about optimal branding and exposure for a brand’s message and creating engagement.
Clients, peers, partners, and colleagues respect Mr. McNally. His energy and drive are limitless and only matched by his desire to meet and exceed expectations of his clients and his teams.
Mr. McNally has a quote above his desk: “a smooth sea never made a skilled sailor.” Challenges, he says, help people grow and develop.
He has an exceptional ability and interest in mentoring younger generations of marketers to help prepare them as future leaders.
“I feel I get more out of our time together than they do,” he says. “I love seeing how younger colleagues view challenges and more importantly their thoughts on solving them.”
As committed as Mr. McNally is to leading a motivated and happy agency, he is just as focused on positively impacting at-risk children in the Greater Philadelphia area. He joined the governing board of directors of Big Brothers Big Sisters Independence Region in January 2015 and has been instrumental in starting a Beyond School Walls program, allowing adult volunteers from his company to mentor youth from a local high school during the work day. He also chairs the newly created marketing and communications committee, serves on a fundraising committee, and provides facilities for the agency to host meetings with community members and supporters.
Title: Chief Operating Officer
Company: ProSolus Inc.
Education: BS, Chemical Engineering, University of Florida
Family: Wife Angela; daughters Michelle and Nichole
Hobbies: Golf, basketball, and traveling
Bucket List: Experience the way other societies deal with life’s challenges
Awards/Honors: Twenty-three patents and several special recognitions for bringing facilities and projects to fruition
Associations: AAPS, CRS, AICHE
The Art and Heart of Transdermal Development
Juan Mantelle’s career epitomizes the history of innovation in transdermal patches. Described as a transdermal genius, his approach to transdermal drug delivery is unique and innovative. Colleagues call Mr. Mantelle, chief operating officer at ProSolus, the guru of the transdermal drug delivery arena.
Mr. Mantelle has devoted the past three decades to perfecting transdermal drug development and delivery, and he openly passes his knowledge along to the next generation of scientists. His strong passion for his work and the positive impact his innovations bring to patients inspires countless others to continue to develop this unique combination of art and science delivery.
Those who have worked with him say that transdermal development and formulation is truly an art and he is a skilled artist. The product designs he comes up with require both a creative mind and the scientific ability to turn an idea into a unique and effective transdermal delivery product. To figure out how to deliver just the right amount and level of drug through the skin, a natural protective barrier to the body, to treat the patient in a positive way takes this skill, and he uses his creativity to improve the wearability of patches, creating more desirable, smaller sizes that stay in place even while the patient is exercising, bathing, or swimming.
For example, transdermal patches need great adhesion without skin irritation. The product must also wear well for the full duration of therapy and not lose skin contact halfway through treatment. Mr. Mantelle can create patches that accomplish these goals all while meeting the stringent regulatory requirements. Few individuals or formulation teams in the transdermal world can do what Mr. Mantelle can, according to colleagues.
A chemical engineer by training, he doesn’t just formulate a patch; he thinks about everything, especially patients, when developing a new and better product. He’s not just a scientist, he is also a marketer and applies this to the art of patch design.
As ProSolus has grown over the past five years, Mr. Mantelle wears many hats; business partners say he near-singlehandedly and successfully manages all of the business processes — human resources, accounting, etc. — while simultaneously leading his R&D team to develop generic and over-the-counter (OTC) transdermal products. Showing sharp business acumen, he adjusted the company’s direction, realizing that expanding into manufacturing was a very real source of income. For example, the company’s Miami facility doubled its expansion into manufacturing.
Recently, Mission Pharmacal Company acquired ProSolus, and Mr. Mantelle was able to return to his passion: the development of products with unique market potential and great therapeutic value.
As a recognized innovator and leader, Mr. Mantelle has more than 20 patents to his credit and is a sought-after speaker at symposia and conferences worldwide. Two examples of his success include Daytrana (methylphenidate transdermal system, Noven Pharmaceuticals), and CombiPatch (estradiol/norethindrone acetate transdermal system, Noven).
The six-foot, four-inch baritone of Belgian and French descent is a passionate yet pragmatic, artistic and theoretical leader who is loyal to his team. Mr. Mantelle leads a growing team of 20 — up from 12 just a year ago — from 30,000 feet, yet understands all of the minor details.
He’s equally at home at his laboratory bench as he is in front of the packaging line. He does all this with honesty, commitment, and heart.
Education: BA, Economics, BS, Physics, George Washington University
Family: His parents, both teachers, who always encouraged him to try challenging new things and find a way to succeed
Hobbies: Sailing, photography
Bucket List: Learn to scuba dive
Inspiring Patient Connections
A pioneer in developing healthcare social networks, Brian Loew created Inspire, an online support community comprised of some 850,000 patients and caregivers. His goal has long been to accelerate medical research through the use of safe, trusted online social networks and create a world of connected patients and caregivers.
“We help bring the experiences and perspectives of patients, in numbers too large to ignore, to scientists, policymakers, and the industry,” he says.
Inspire’s clients include all of the top 10 pharmaceutical companies, and most of the top 25. Inspire partners with 100 nonprofit patient advocacy organizations, providing them with free online support communities for their members.
Just as important is the response from patients for whom Inspire has provided a forum for knowledge and hope. Inspire connects people or their loved ones who are experiencing the same disorders, which enables them to share stories, provide guidance, and supply support.
Mr. Loew communicates with members on a personal level as well; his work has helped provide support to thousands of patients through no-cost online communities, and helped many of those patients increase their access to clinical research.
Through Mr. Loew’s leadership, Inspire is partnering on new research on patient safety topics such as improving pharmacovigilance through patient insights from healthcare social networks.
“Increasingly, patients are taking a lead in their own health management, enabled by key technology developments,” Mr. Loew says. “The plummeting costs of quantified self-glucose monitoring devices and genetic testing are two different examples that are making it possible for patients to rapidly learn about themselves and play a patient-centric role in medical innovation.”
Innovation thrives in an environment with important problems to solve and where curiosity is celebrated, experiments are encouraged, and failure is not fatal, Mr. Loew says.
Mr. Loew says if he had the wherewithal to mandate it, patients’ perspectives would be required when designing healthcare solutions across the continuum. While attending the recent Cancer Moonshot Summit in Washington, D.C., he was heartened by Vice President Biden recommending greater participation by patients in the stages of clinical trial design.
“This would help pave the way for more patient-initiated medical research and faster medical progress,” he says.
He motivates his colleagues by describing the purpose of what Inspire does, showing them what’s possible, and always being optimistic.
Challenges are met and overcome by staying focused on the goal and using creativity to solve every problem. He makes sure his team has the tools they need to do their work and listens to the larger community on ideas to improve the Inspire framework and more.
Mr. Loew has long been an Internet entrepreneur. In 1994, he founded worldweb.net, a content management software company that created and launched more than 100 websites for major publishers. He is always ready to provide help to other entrepreneurs in any way he can. He is an international author and speaker on topics related to e-health, digital pharma, patient empowerment, and healthcare social media.
Title: Principal, Chief Client Officer
Education: BS, Advertising/Communications, University of Illinois
Family: Wife of 33 years, four children, one grandchild, parents
Hobbies: Reading short fiction, claiming he will one day write short fiction, taking vicious swings at golf balls, and running as much as he can Awards/Honors: INC. 500 fastest growing private business four years in a row; Crain’s Chicago as a Chicago Fast Fifty company; Chicago Area Entrepreneurial Hall of Fame in 2015, along with his business partner Mark Goble
Associations: Vistage CEO peer group board president, The Cancer Support Center of Chicago Co-Chair, Dean’s advisory board; University of Illinois College of Media
Ahead of the Curve
Combining caring, character, and commonsense, Joe Kuchta is leading Sandbox and changing what “good enough” is when it comes to how an agency should support and partner with its clients. As a founding partner and chief client officer of Sandbox, Mr. Kuchta strives to help people understand why the company doesn’t fit into any current, preconceived notion of an agency.
He and business partner Mark Goble made the decision for GA Communication Group to become a founding member of Sandbox in order to create greater opportunity for clients and employees by expanding capabilities and talent pool. The move brought together five independently successful agencies, with deep cross-industry experience and wide-ranging expertise.
Mr. Kuchta operates with an authenticity and integrity that is inspiring. He leads by making clients, the agency’s people, and their work the priority. He demonstrates every day that leadership is a privilege that is earned, an attitude that inspires absolute loyalty in employees and utter trust from long-term clients.
When a start-up medical devices company with limited resources sought his advice, he worked tirelessly to provide the necessary resources to support and build the company from the ground up, providing everything from corporate and product logos, the website, product branding and the strategic and tactical planning to enable the company to successfully launch a medical device product into the very complex healthcare market. He also was instrumental in helping to attract and convince educated investors to help fund the company.
Innovation happens where people have freedom of thought and permission to imagine what could be versus what people often get stuck in every day. That’s particularly true in the highly regulated life-sciences space, where it is too easy — though not entirely wrong — to feel restricted in being innovative.
He describes himself as impulsive, because he always wants to get to the bottom line; get to the solution; get to the point, which means he and his colleagues aren’t afraid to make decisions or try new things.
Being considerate is integral to who Mr. Kuchta is, and it stems from being raised in a large family with nine siblings by parents who set the foundation for caring about others. This family-esque culture is how he and his partners have led their agency for the past 20 years.
While building a successful business is important for Mr. Kuchta, even more important is that people truly enjoy being part of the agency.
“Life is too short to hate where you work or who you work with,” he says. “My goal for our agency has always been and will continue to be to create an environment where people can use their talent and have as much fun as possible doing so.”
Success, he says, is measured by the satisfaction of clients and employees.
“Our business is ultimately successful and thrives when both are happy,” he says. “It takes an awful lot of work to achieve that, but that is the true measure of success in my experience.”
He mentors not necessarily by sharing some infinite wisdom or teaching the ways of the world, but in helping others discover what they are capable of and what they can accomplish when they don’t think they are, or can.
Inspiration, he believes, comes more from action than words, or fiery rhetoric, or wise old sayings. He motivates by reminding everyone that as tough as things can get sometimes, “we don’t shed blood, there are no lost limbs, and this perspective is everything.”
If he could step back with some sage advice for a younger Joe Kuchta it would be to not take everything so seriously and recognize as soon as possible that there are six sides to every story and very few things in life are definitively black and white.
Taking a big-picture perspective of the industry, Mr. Kuchta says the high costs of the entire system are making care unattainable to too many people in too many ways, which has led to a dismal overall perception of the healthcare industry to the general public.
“It’s disheartening when you see so many people and so many companies making such an impact on life,” he says. “How did it get this bad, and how, as an industry, do we change this?”
Mr. Kuchta is president of the board of directors for the Cancer Support Center, which provides much needed support and services to those impacted by cancer and their families free of charge. His leadership has helped to ensure that the center not only thrives operationally and financially, but continues to increase the number of participants it serves.
Title: Managing Partner, Chief Creative Officer
Education: BA, Brown University
Family: Wife, Laurie; children, Rebecca and Jared
Hobbies: Playing guitar, fly fishing, audio
Bucket List: Fly-fishing in Alaska and New Zealand; culinary tour of Italy
Evolving Imagination into Action
The pharmaceutical marketing environment changes and evolves at a moment’s notice, and Steve Hamburg, managing partner and chief creative officer at Calcium, is just the man to keep pace with it. The idea maker’s creative reputation is larger than life, due in part to his constant determination to create impact in all of his endeavors.
“I’m always searching for new things and the right answers,” he says. “I’m driven to see and understand the truths that lie deeper.”
With more than 25 years of creative and strategy experience, Mr. Hamburg has been strongly focused on those big, transformative ideas, the ones that are surprising, inventive, and disruptive; and the ones that, by igniting interest and engagement, can actually improve the uptake of content. His priorities are content, data, and technology, and he believes that in the information-saturated world, where content pours into every waking moment, that ideas have the unique capacity to penetrate hearts and minds and change the way people think, feel, and act.
The second-time PharmaVOICE 100 honoree brings a strong mix of strategic, creative, scientific, and digital skills to every marketing challenge.
By blending these skills together in a holistic way, Mr. Hamburg is able to generate ideas and solutions that are themselves holistic, as opposed to one dimensional, which can improve impact and effectiveness.
In practicing this kind of idea-fueled engagement, he has been able to help generate significant growth and success for many brands and businesses across a wide span of healthcare categories, including oncology, cardiovascular, rare diseases, CNS, allergy/respiratory, pain, dermatology, and others.
Mr. Hamburg has produced award-winning work throughout his career, when he was the chief creative officer at LLNS/Omnicom, Rosetta, Wishbone (creatively focused, Agency of the Year winner), and roles within the Publicis companies. At all these agencies, he has made it his priority to mentor talent, foster creative innovation and risk taking, and make collaboration an important organizational imperative.
“My career highlights have involved helping small agencies become big agencies through the delivery of excellence in all dimensions, but especially through consistently outstanding creative work,” Mr. Hamburg says. “A truly collaborative culture can significantly enhance both the work and the work experience.”
Colleagues describe Mr. Hamburg as a dynamic leader who brings out the best in his staff, especially during high-pressure situations. He has the rare knack to keep work fun but highly focused, and consistently sets the stage for inspiring creative. They say his insights help them to take their skills to new levels and that anyone who is lucky enough to work for Mr. Hamburg will expand their creative repertoire and be ready to meet new challenges.
Mr. Hamburg says his professional aim is to foster agency growth and happiness through the generation of remarkable ideas and he would like to be remembered as someone who drove healthcare advertising to be something more than data and information-focused, and who understood that vibrant creativity could actually engage and activate healthcare audiences.
Mr. Hamburg wants every campaign that comes out of his agency to resonate for both clients and the consumers they are trying to reach. He measures success by the ability to generate powerful ideas that move clients, move audiences, and move the needle on business success.
He has always strived to create something wonderful and memorable out of words and images, and in his earlier days his career ambition was to be a poet.
Mr. Hamburg also enjoys the creativity of music, especially playing guitar, of which he owns many.
Mike Wilkinson, Ph.D.
Title: Executive VP and Chief Information Officer
Education: BS, Ohio University; MS, Penn State University; Ph.D., Indiana University
Family: Wife of 43 years, Carolyn
Hobbies: Family, four kids and 10 grandkids; golf; movies; reading
Bucket List: Be CEO of a small company; hike the Appalachian Trail; play with his great grandkids; drive a dog-sled in Alaska; participate in a long bike ride for charity; snow mobile in Yellowstone; sail from island to island in the Caribbean
Associations: UDT/SEAL Association
Digging Deep for Clinical Innovation
Recognized by those who know him well as a true leader, Mike Wilkinson, Ph.D., is driving technological innovation to transform clinical trials.
As executive VP and chief information officer of PPD, he is advancing the company’s strategy of bending the cost and time curve of drug development to help biopharmaceutical customers deliver therapies to patients more quickly and to improve the productivity of their R&D investments.
He provides strategic direction for PPD’s development and deployment of innovative ideas and technology. Dr. Wilkinson knows that technology is only as good as the implementation and the people behind it. While technology is an enabler, it’s not the complete answer, he says.
Equally important are the processes, the training, and the people.
He joined PPD in 2008 as executive VP of global clinical development, bringing more than 25 years of project management experience to the role. He is passionate about being in the healthcare industry and the role PPD plays in helping customers bring life-changing therapies to patients in need.
Since moving into the CIO role, Dr. Wilkinson has been a driving force for PPD business innovations. Mobile health and Preclarus, PPD’s comprehensive clinical data solution that consolidates and standardizes data from multiple sources to give PPD teams and clients transparent, real-time access to all clinical trial operations and patient data, are two significant technologies that Dr. Wilkinson has played a pivotal role in bringing to the forefront of the business. In addition to these innovations, Dr. Wilkinson has championed industry recognitions and PPD has received several awards for the most innovative use of technology for process excellence and for its training, its training developers, and its trainers.
He describes his current role as his greatest career challenge.
“Since I’m from clinical operations and not a technologist, I had a lot to learn and also had to trust those around me to help me make the best decisions,” he says.
Committed to being engaged and involved, if something is not in his area of expertise he will research it, get experts to the table, and help move them toward good decision making.
He is recognized for his skill at building and leading successful project teams, and he builds strong communications across his organization, working to empower his staff, not just his direct reports. Dr. Wilkinson created an advisory committee of managers, and he regularly meets with these advisors to exchange ideas.
Without micromanaging, Dr. Wilkinson empowers his organization to think creatively. He acknowledges that even employees who are doing the right things for the right reasons will still occasionally make mistakes, and he says the important lessons to be learned from missteps outweigh the side effects of failure.
He engenders trust and has a true passion for providing opportunities for others, and is always looking for talent. For example, he started a program that supported those who wanted to enter project management not through the typical path. Many of them are now VPs.
He inspires by creating a clear vision or path to success and then helping people find their inner motivation to make it happen.
“I try to keep others focused on the mission or the outcome, rely on their teammates, and ensure they also take time to enjoy the challenges, learn from them and remember that it’s a journey,” he says.
Described by colleagues as an authentic leader, Dr. Wilkinson articulates his vision and empowers his team to achieve the vision.
Dr. Wilkinson’s vibrant career includes serving as a Navy SEAL, an aviation physiologist, the White House liaison for Marine One Executive Transport, a director of operations for the Joint Special Operations Medical Training Center, and the chief operational test director for the V-22 Osprey military aircraft.
In 2011, North Carolina’s governor appointed Dr. Wilkinson to serve on the committee responsible for the stewardship of the highly decorated World War II battleship the U.S.S. North Carolina. Anchored across the river from downtown Wilmington, N.C., the iconic battleship is visible from his office in PPD’s worldwide headquarters.
Udit Batra, Ph.D.
Title: Member, Executive Board, Merck KGaA, Darmstadt, Germany, and CEO, MilliporeSigma
Education: BChE, Chemical Engineering, University of Delaware; Ph.D., Chemical Engineering, Princeton University
Awards/Honors: Chairman’s Award, Novartis, 2009; scholarships and multiple academic awards
Solving the Toughest Life-Sciences Problems
When Udit Batra, Ph.D., became head of EMD Millipore in March 2014, he immediately saw an opportunity to expand the company’s offerings and reach. He quickly developed a transformative business strategy that included the Sigma-Aldrich acquisition. The deal was announced just six months later.
This achievement is but one example of Dr. Batra’s breakthrough strategic leadership and ability to implement change decisively.
In April 2015, Dr. Batra was named CEO-elect of the combined EMD Millipore and Sigma-Aldrich businesses. MilliporeSigma is the life-sciences business of Merck KGaA, Darmstadt, Germany, in the United States and Canada.
In his new role, Dr. Batra sponsored a joint integration team that laid the foundation for a seamless transition once the deal closed. This work included creation of a new customer-focused organizational design and leadership structure, and integration of all critical systems. Throughout the integration, which is ongoing, the business continued to deliver strong growth, a credit to the priority Dr. Batra places on excellence in customer service and employee engagement.
The 2015 combination of EMD Millipore and Sigma-Aldrich is the largest deal ever in the history of Merck KGaA, Darmstadt, Germany, and one of the largest in the life-sciences industry. Together, the life-sciences business of Merck KGaA has a portfolio of more than 300,000 products, providing end-to-end tools and solutions from discovery and development through manufacturing and diagnostics.
Under Dr. Batra’s leadership, the business is expanding life-science innovation globally, and deepening the industry’s ability to treat disease and improve human health. In recognition of his leadership, Dr. Batra was recently named to the executive board of Merck KGaA.
Dr. Batra is a champion of collaborative creation to develop innovative products and solutions to help customers solve the toughest life-sciences problems. He is committed to inspiring new ways of working with customers to meet their unique needs, such as the newly relaunched M Lab Collaboration Centers. These state-of-the-art “labs” allow real-time, co-creation with customers to develop new solutions. He is also the executive sponsor of the business’ Innovation Board, which brings together a diverse group of scientists from each business segment to help solve a wide range of R&D challenges.
Throughout the business, Dr. Batra is fostering a culture that places a premium on diversity of thinking and bringing together different backgrounds to create new ideas. A chemist, for example, doesn’t have to be the person to solve a chemistry question. Maybe it’s a computational data engineer who thinks about a problem differently. Small, diverse teams are charged with creating a hypothesis and then working with customers to create a new product or program.
For Dr. Batra, practical curiosity is essential to solving tough problems.
“I like to ask ‘why,’ and then ask ‘why’ again and again, to discover insights that can be applied to deliver new solutions,” he says. “I want people to have the ability to explore problems, the resources to develop the insight, and the freedom to execute.”
In addition to the recognized factors of teamwork, collaboration, and diversity of thinking, Dr. Batra believes that innovation requires one factor that is rarely spoken about: dissent.
“My goal is to foster an obligation to dissent, no matter where you sit in the hierarchy,” he says. “It takes courage, but it’s important because it forces people to explore many angles of a problem. It creates better problem-solving and often, game-changing solutions.”
By having the courage to dissent, employees are better able to identify the right problems and solve them better and faster than they would with conventional thinking found in a typical hierarchal organization.
“As part of this process, we must first identify a worthwhile problem and understand the status quo, have the curiosity to question it, and then place constraints to ensure a pragmatic and successful implementation,” he says.
As Dr. Batra notes, “This type of problem-solving is incredibly important to our customers, many of whom are working to bring new therapies to market, from novel gene therapies to treat cancer to vaccines that help eradicate the deadliest viruses of the 21st century.”
Robert G. Urban, Ph.D.
Title: Global Head, Johnson & Johnson Innovation Centers
Company: Johnson & Johnson
Education: Ph.D., Microbiology and Immunology, University of Texas System
Family: Wife; three sons
Hobbies: Distance running, hiking; dog training
Bucket List: Summit Mt. Aconcagua
Awards/Honors: McLaughlin Fellowship, University of Texas Irvington; Fellow, Harvard University; Top 100 Visionaries in Biotechnology, Scientific American
Removing Barriers to Innovation
With a personal motto of “Together, We can,” Robert Urban, Ph.D., has played a key role in helping entrepreneurs and scientists develop medical devices and diagnostic technologies, consumer healthcare products, and pharmaceuticals. As global head, Johnson & Johnson Innovation Centers, he oversees the company’s externally facing innovation agenda — a vast investment team and toolkit that provide scientists, entrepreneurs, and emerging companies with one-stop access to the broad resources of the Johnson & Johnson family of companies and incubators called JLABS. Dr. Urban has made exceptional contributions to the life-sciences through his central role in building a Johnson & Johnson Innovation Center in the Boston region from the ground up.
Before being promoted to lead the organization globally, Dr. Urban was recruited from MIT in 2013 to build Boston Innovation Center, which began the task of finding the right talent, employees, and business models. The center’s goal is to drive biotech innovation in both the life-sciences hotspot of Boston and East Coast region overall by building relationships and collaborating with regional startups across the biotech, device, and consumer health sectors, entrepreneurs, academia, and others in the overall innovation community, ultimately helping fill J&J’s pipeline.
Dr. Urban has played a key role in every single one of the 88 early-stage collaborations signed through the Boston Innovation Center across a variety of therapeutic areas and life-sciences sectors. Most of the partnerships have involved pharmaceuticals, but are increasingly focused on medical device and consumer healthcare products.
He has dedicated his life to using his skills to help other people and ensure that life-changing companies thrive, not only through his work in science healthcare, but as an innovation leader and an inspiring colleague.
Dr. Urban says a career highlight has been working alongside remarkable teams translating diverse discoveries into high-impact products.
“I remind my teams to imagine the possibilities and to remain highly resilient and grounded in humility,” he says.
Colleagues say Dr. Urban is uncommonly modest and accessible to his team at all times. He literally removes barriers to innovation. At the Boston Innovation Center, he has chosen to not have a dedicated office, instead he participates in a rotational seating scheme in an open-office floor plan. n. This enables him and the whole team to be hyper-available and constantly interacting with different members of the inter-disciplinary team. Dr. Urban believes that it most often organic, casual conversation and iterative exploration that most effectively advances the best ideas.
Dr. Urban says what motivates him is the privilege of having the ability to make meaningful differences in the lives of individuals all over the world.
“I provide a culture and environment in which risk, failure, and imagination are mingled and celebrated,” he says. “It’s important to understand — and embrace — the difficultly of the undertaking. It will be hard, if not impossible, but the journey is worth it.”
Dr. Urban’s colleagues frequently express how selfless and caring he is when it comes to the team, sharing countless examples of how he has helped colleagues advance professionally and/or pursue their passion, work-related or not. Two years ago, he started a program in Boston, which has now extended across the J&J organization, to do just that. The program, One Amazing Thing Leads to Another, seeks to stimulate personal growth beyond objectives set in the workplace. The program focuses on three areas: mind, body, and soul. For the past two years, J&J employees across the globe have participated in the program, resulting in amazing personal accomplishments, ranging from completing a MBA program to learning to swim. While the typical completion rate for similar programs is 10%, 65% of participants completed their goals.
Title: President, Communications Business
Company: inVentiv Health
Education: MA, Technology and Communication, University of North Carolina, Chapel Hill
Family: Husband, Bob; sons Scott, 17; Luke, 14; Dean, 10
Hobbies: Exercising; reading; skiing; exploring — traveled to more than 20 countries visiting numerous cities in each
Bucket List: To parachute out of an airplane; rent a house in a different country every summer to immerse in another culture once retired
Awards/Honors: Luminary Award, Healthcare Businesswomen’s Association, 2014; inVentiv Health Circle of Excellence Winner, 2009; Rising Star Award, Healthcare Businesswomen’s Association, 2005
Associations: Healthcare Businesswomen’s Association
Transforming Marketing Communications
In her role as president of inVentiv Health Communications, which includes the company’s advertising, public relations, and medical communications operations, Lisa Stockman works with an alchemy of communications disciplines matching each client’s need to the best mix of talent to drive the optimal solution.
Her mantra, “We Can Do It,” drives her teams to work together to create solutions that drive more efficient and effective outcomes for clients.
Not only does she refuse to take a one-size-fits-all approach knowing that what is best for one client may not work for another, she has 1,600 communications professionals ready, willing, and able to form nimble networks to best serve client needs. Ms. Stockman’s vision allows her to know what clients will need next, and she makes sure the communications group is ready to provide it. That is no small feat with 11 healthcare communications agencies with offices across multiple geographies.
Ms. Stockman began her career as a founding member of the Chandler Chicco Agency, which trail-blazed the healthcare PR industry with highly effective, award-winning campaigns. As Chandler Chicco evolved to launch complementary sister agencies, she led Biosector 2, where she drove significant growth anchored in groundbreaking educational campaigns.
Chandler Chicco was grounded in the idea that integrated thinking was tantamount for client success. The agency was the first to eliminate titles and walls that proved to be a barrier to collaboration and the best work. Ms. Stockman was the first employee to be brought on board by the founding partners of that agency and no one will argue that she helped to make much of the magic happen. The firm went on to win multiple accolades in the industry, and when the firm was acquired by inVentiv Health, it had year-over-year double-digit growth with more than 400 employees and offices across the United States and Europe.
Her inspirational leadership carried the organization through the acquisition, and in 2015 Ms. Stockman assumed leadership of all inVentiv public relations agencies, including Chandler Chicco, Biosector 2, Chamberlain PR, and Allidura Consumer. Her success in growing these brands and leveraging integration across the various inVentiv clinical and commercial offerings led to her being named president of inVentiv Health Communications, which includes healthcare advertising and branding agencies GSW, Palio, Navicor, and Addison Whitney.
Ms. Stockman’s creativity and pragmatic approach to problem solving is also leading the evolution of integrated marketing. Her team delivers sophisticated multi-disciplinary solutions, infused with clinical development insights, to enhance biopharmaceutical clients’ ability to bring therapies to those who need them most. For example, innovative patient engagement strategies, grounded in communications disciplines such as advocacy relations, are now accelerating trial completion times through more targeted recruitment and retention strategies.
Ms. Stockman believes in a dynamic organization, built to respond to the changing needs of the marketplace. She is a transformational leader who has the ability to speak to individual needs as well as company priorities within the same heartbeat, capturing the key levers of mutual benefit. She masters the art of balancing client engagement and industry thought leadership, through the creation of inspired partnerships internally and externally.
Over the years, Ms. Stockman has grown in breadth and depth of experience, but she has remained unchanged in terms of her focus on supporting colleagues in doing great work that matters. According to a colleague who knew her then and now, she still delivers strategy; she creates brilliant concepts that support business objectives; and she forces clients to think. Her work is steeped in research, tied to client needs, and flawlessly executed.
Title: Chief Operating Officer
Company: Evoke Health LLC
Education: BS, Kutztown University
Family: Husband Kevin, three children
Hobbies: Cooking with and for her family, supporting her children’s sporting activities, reading a good book
Bucket List: Visit Japan, wineries in Tuscany, and African safari
Relentlessly Collaborative and Innovative
Since joining Evoke as the chief operating officer, Heather Torak has been instrumental in the growth of the agency and building a world-class, scalable process. This has enabled Evoke’s expansion into several new geographies, while maintaining the integrity of the agency’s brand, work, and culture.
Central to this is the environment of collaborative partnership that Ms. Torak has built. Whether between different disciplines, entry-level and executive-level staff, agency and client teams, finance and procurement, she has set the standard for open, trusting relationships, whereby all team members can mutually benefit from shared knowledge and operational gains.
Ms. Torak has helped to drive a company with differentiated offerings, value-added services unique to the group, and proven partnership processes that clients have adopted. This has helped to create an emboldened agency group that thrives on innovative solutions.
Her guidance and acuity have cultivated a healthy, sustainable, and scalable organizational framework adept at balancing agency financial and operational success, and maintaining a progressive and encouraging internal culture.
Ms. Torak says 2015 was a remarkable year for both the company and her, since Evoke not only experienced revenue growth of almost 30%, but organizationally her team worked to open a West Coast location — the company’s fourth office — and added two new companies under the Evoke Group umbrella.
Resilience in an industry where change is the one constant is essential, Ms. Torak believes.
“Pharma DTC and digital everything is still new and constantly evolving,” she says. “Rules and regulations change, and brands and clients change. Our job is to adapt and prepare for this change, and resilience is key to accepting — or perhaps welcoming — this constant change.”
Ms. Torak’s goal is to continue to contribute to Evoke Group’s growth by adding new disciplines, capabilities, partnerships, and offices. She thrives in a high-growth organization because she’s always learning and is relentless in her desire to do more.
“I’m driven to try new things, figure out a way to succeed, and learn from my mistakes,” she says. “If I can successfully navigate the process, I’m happy.”
She is motivated by the work the agency and industry does, and loves solving problems, working out a plan, and seeing it through.
“At its most basic level, I love the process of teasing out an issue and customizing a solution,” she says. “I leave the office most days feeling like I truly made a difference.”
Every agency Ms. Torak has worked at has benefited from her ability to build processes and strong operational teams.
She says in the long run, she would like to be remembered as a solution-focused, honest partner.
She says she enjoys creating innovative solutions driven by clients’ toughest challenges and by creating an environment where all employees are empowered to think and speak up and share their ideas.
A supportive teacher, Ms. Torak offers sound advice with just enough room for interpretation, fostering individual ideas and growth. She is a confident and knowledgeable leader who constantly challenges her own expertise, striving for new learnings, and is able to admit when she has made a mistake and laugh at herself.
A fair and approachable colleague, Ms. Torak is willing to work with and learn from anyone.
She says having the opportunity to mentor colleagues, share her knowledge and perspective, and see them benefit from her experiences is very rewarding, not only for that individual but for herself and the organization she works for. Ms. Torak empowers others to believe in their abilities, inspiring them to think differently, encouraging them to be solutions-oriented, and trusting others to make difficult decisions.
“I’d like to think I inspire those around me to be true to themselves,” she says. “I’m driven, direct, and quick to jump in and offer solutions but I also laugh easily. I’m approachable and I haven’t always taken the easy road. That’s who I am, and I like others in the organization — especially young women — to see there isn’t just one mold you have to fill to be successful. Be yourself.”
Fred Petito, J.D.
Title: Chief Behavioral and Engagement Officer
Company: Guidemark Health
Education: BA, SUNY Albany; JD, Brooklyn Law School; Doctoral Candidate (Marketing), Pace University
Hobbies: Skiiing, golf, tennis, cross-training
Father of Praedicis
Fred Petito, chief behavioral and engagement officer for Guidemark Health, is a seasoned digital and multichannel marketer with almost 20 years of experience planning and implementing communications programs for clients in a range of industries and at agencies such as Ogilvy, Grey, R/GA, and Young & Rubicam. He is an expert in designing high-impact marketing campaigns that integrate behavioral insights, analytics, and emerging media into brand experiences.
He has been at Guidemark in his relatively new role for roughly 18 months, and colleagues say he has a natural curiosity that drives him and his team to continually explore and learn about target audiences like they have never seen before.
“Once I identify something that I think is innovative or opportunistic I will pursue opportunities to exploit it with drive and energy,” Mr. Petito says.
Under Mr. Petito’s leadership, the agency launched Praedicis, a proprietary methodology that draws on decades of research from the social, cognitive, and decision sciences to more deeply understand the factors influencing health decisions and behaviors. The methodology digs deep into understanding the behaviors that drive both rational and irrational health decisions across all audiences, bringing a better understanding of their behavior, which allows Guidemark to deliver inspiring brand ideas, innovative engagement strategies, and extraordinary content that will deliver meaningful healthcare engagements that change lives for the better.
“We are leveraging 40 years of academic research to gain a deeper understanding of what influences behavior,” Mr. Petito says. “Then we’re designing interventions using adult learning principles and user experience design to modify those behaviors.”
His extensive knowledge of consumer psychology and behavioral economics theory allows him to often frame the problem and the solution in a way that is distinctive. These deeper insights and the supportive theory often allow for a more effective strategy and tactical execution.
Through his insights, Mr. Petito has brought a new dynamic to the agency, and colleagues says he has been tremendous in driving new thinking for both launch and established brands.
Being part of the leadership team at Guidemark Health, he has encountered many challenges from creating a brand, establishing process, hiring and training people, and winning and servicing clients. Mr. Petito plans to continue to grow the Guidemark Health business, expand his expertise in behavioral insights in healthcare, as well as integrate his commercial work with behavioral insights with academic research. As a doctoral candidate in marketing at Pace University, he is conducting research into the factors affecting how consumers set and attain health- and wellness-related goals.
A firm believer that behavioral insights are crucial to a successful marketing program, Mr. Petito calls out three valuable benefits of using behavioral insights when planning a campaign. First, they provide validated models for better predicting human behavior, as opposed to personal opinions or guesswork. Second, they reveal how nonrational and nonconscious factors influence decisions and behaviors. Third, they provide a conceptual basis for developing campaigns that have the potential to deliver better results and outcomes.
Mr. Petito has played an instrumental role in delivering strategic solutions across a broad range of therapeutic categories for many tier-one healthcare companies, including AbbVie, AstraZeneca, GSK, and Johnson & Johnson, Merck, Otsuka, Novartis, and Zoetis.
He would like to be remembered for innovating on how to use behavioral insights in healthcare marketing and communications, and to mentoring members of his team.
“I like to teach and coach people to be better marketers and storytellers,” he says. “It gives me pleasure to improve someone’s skill set, competence, and confidence in their profession.”
Mr. Petito draws inspiration from his father, who worked hard all his life and rose to a very senior level position at a company he worked at for 35 years.
Title: President, Managing Partner
Company: The Bloc
Education: BA, English Literature, College of the Holy Cross
Family: Her parents, husband, and children
Hobbies: Cooking for family and friends
Bucket List: Learn Italian; go on a pilgrimage; see New Zealand
Awards/Honors: Golden Arrow for best Team Lead, 2001, Wunderman; Healthcare Businesswomen’s Association Rising Star, 2009
Champion of Innovation
For almost a decade, Jennifer Matthews has been the transformational leader of one of the largest independent healthcare agencies in the world.
As president and managing partner at The Bloc, she has demonstrated an uncanny ability to spot not just what’s around the corner, but what’s five years ahead. In today’s environment of dramatic and disruptive change in healthcare, she sees only opportunity, and her visionary leadership has inspired a fundamentally different way of thinking about the business, priming it to meet the rapidly evolving needs of clients and their customers.
Ms. Matthews started The CementBond in 2007, growing it into a successful company from the ground up, attracting a remarkable talent base, with many people joining her from previous agencies. The CementBond and The CementWorks converged to form a larger agency — The CementBloc, now The Bloc.
Ms. Matthews was appointed managing partner and led the agency successfully through the transition. Her future-focus set the stage for The Bloc to become the full-service, multi-stakeholder company it is today and helped to innovate and create the consumer, digital, and relationship marketing practices.
A champion of innovation, Ms. Matthews invests in ideas supporting The Bloc’s industry-first initiatives, including HealthWellNext, HealthAwareNext, Happy Fuel, and Caregivers Speak Up.
Ms. Matthews draws on her deep roots in digital and relationship marketing and strong consumer experience from her work on flagship brands across multiple verticals, including AT&T and American Express.
Over the years, she has built deep and lasting relationships with her clients. She understands their opportunities, feels their pain, and always operates with transparency, and they know it. As a result, in 2015, the agency’s partnerships grew with AstraZeneca, Merck, Zoetis, Novartis, and BMS.
In all, the agency won 33 new assignments across existing and new client partners. During her tenure, the organization’s revenue has grown 264%, with the digital capability she established accounting for 50% of revenue in 2015. In addition, The Bloc has brought home numerous accolades. In 2014, the agency was recognized as the No. 3 agency worldwide by Advertising Health at the inaugural Lions Health Festival in Cannes.
A restless individual in the best sense of the word, Ms. Matthews is always looking ahead to what she, and the agency, can be doing better. In 2015, she determined that greater integration and sharper focus areas were required to realize The Bloc’s mission of delivering innovation and operational efficiencies.
She established five key teams across the agency with clear charters: the business team optimizes client partnerships; the strategy team integrates the agency’s bench in customer, clinical, and channel to ensure that deep insights drive ideas; the creative team integrates the creation of content and design; the new growth team proactively drives revenue opportunities and develops innovative products and services; and the operations team is tasked with flawless delivery across clients, teams, and geographies.
When the agency moved in 2015 to expanded, state-of-the-art flagship premises, Ms. Matthews pre-empted concerns by establishing The Bloc Move Crew, a multi-functional, multi-level team of Bloc influencers who provided weekly updates to provide information and create excitement ahead of the move — from estimated commute times and dry cleaner locations to downtown tours and bar recommendations — which ensured a smooth transition to the agency’s new home with zero IT or office services hitches.
A powerful role model, Ms. Matthews encourages women to lean in, take risks, and thrive as leaders. The leadership team she has put in place is a remarkable example: 75% of the partners at The Bloc are female, and women make up 71% of the senior VP leadership roles. Additionally, 66% of the creative leaders on Ms. Matthew’s team are women, compared with the 3% industry average.
With a focus on building talent, Ms. Matthews led the development of two key initiatives. Building Blocs is a performance management program that starts on day one of an employee’s tenure, centering on collaborative, action-oriented goal-setting toward individual success metrics.
Cementorship matches employees with mentors, and supports their partnership and mutual growth.
In addition, Ms. Matthews has championed progressive policies that provide practical support for sustainable work-life balance for all employees.
She is deeply respected by colleagues past and present for her vision, her leadership, and her compassion.
Title: President, Americas Operations
Company: Astellas Pharma US Inc.
Education: BS, Marketing, DePaul University
Family: Two daughters
Hobbies: Golf, running, and reading
Bucket List: Run the 2016 Chicago Marathon, become a strong swimmer, and start a foundation
Awards/Honors: PharmaVOICE 100, 2015; Astellas named as one of America’s top workplaces by Forbes magazine in 2015 and 2016, and one of the top 20 in Chicago by Chicago Tribune
Associations: Chairman of the Pharmaceutical Research and Manufacturers of America (PhRMA) State Committee; BioScience council member at ChicagoNEXT; Board of directors, member at MATTER; Member of The Commercial Club of Chicago
Collaboration is integral to success and to innovation, according to Jim Robinson. It’s collaboration — extending past the usual business boundaries — that allows companies to be flexible and nimble enough to adapt to change, which is essential in the healthcare environment.
“Great ideas come from many places — internally and externally,” he says. “I believe that collaboration with stakeholders across the spectrum — patients, providers, payers, regulators, policy makers, biopharmaceutical companies, and academicians — empower higher-quality work.”
By making sure that the right people are working on the right project in the right place, at the right time, and creating an environment that is flexible, open to change, and nimble, innovation can thrive, Mr. Robinson is inspiring and motivating Astellas’ more than 3,000 employees in the Americas’ region.
For Mr. Robinson, the focus is all about the patient and ensuring everyone at Astellas knows that no matter what their job function, they make a difference in patients’ lives.
“Three things keep me motivated: patients, the reason for what we do; our people, who the company is; and performance, maintaining a culture that drives success,” he says.
Astellas continues to enjoy huge success under Mr. Robinson’s leadership. In the past year, the company enjoyed growth of almost 16%, an achievement he attributes to an incredible team. In his new role as president of the Americas at Astellas, Mr. Robinson is expanding his focus beyond the United States to Canada and Latin America.
“Accordingly, my professional goals include continuing to pursue operational excellence and successfully building the Astellas presence throughout the region,” he says.
There are many ways to measure success, but for Mr. Robinson there’s only one: “The Astellas Way.”
“Our success is based on how we live our core values — the impact we have on patients, the variety of challenges we own, our results, our openness to communicating, and the way in which we take responsibility for our actions,” he says. “Our continued success will be fueled by our ability to keep these core values in mind and respond intelligently, responsively and swiftly to an ever-changing healthcare landscape.”
He is focused on thinking about whether the organization is meeting unmet patient needs and the steps the organization needs to take to bring science and advancements to patients.
“Another challenge is business sustainability and how we can continue seeking financial, environmental, and social opportunities,” he says.
For Mr. Robinson, personalized medicine is one of the most important innovations in healthcare today. The concept of personalizing treatment options to fit and cater to patients will ultimately lead to better care and decrease risk and prevalence, he maintains.
“What better way to put the patient at the center than to understand the exact treatment each individual needs?” he says.
Among the initiatives Mr. Robinson has helped to spearhead is the Guiding Coalition at Astellas, which was specifically designed to empower employees to take action and accelerate innovative solutions that have the potential to maximize impact.
He has been instrumental in the launch of several new products in the U.S. market since he joined the company in 2005 as the VP of health systems and established the managed markets, reimbursement strategy, government affairs, and government accounts teams. He then took on the role of senior VP for sales and marketing and president of the US business at Astellas before being named president of the Americas in April 2016.
A 2015 PharmaVOICE 100 honoree, Mr. Robinson inspires others by seeking to understand what matters the most to them, then he connects with them on a real level.
He encourages his teams to innovate by stepping into a challenge, embracing it, demystifying it, and then leading through it.
Outside of Astellas, Mr. Robinson is on a number of committees, including PhRMA’s state committee; ChicagoNEXT, a private-public partnership dedicated to expanding Chicago’s business climate and driving growth in science, tech and entrepreneurship; the Commercial Club of Chicago; and MATTER, a group of leaders passionate about creating products and services that advance healthcare.
Title: Chief Commercial Officer, Clinical Division
Company: inVentiv Health
Education: BS, Biology, Temple University
Family: Wife, Fara; daughters, Kendall, Reese, Reagan
Hobbies: Tennis, golf, ice hockey
Bucket List: Cage diving with great white sharks
Awards/Honors: MVP, Partnerships in Clinical Trials Meeting
Associations: Linking Leaders
Pushing the Development Process Foward
Greg Skalicky is fully vested in everything he does in life — from clinical research to professional growth, both personal and other’s growth.
Colleagues say the chief commercial officer for inVentiv Health’s clinical division has the unique ability to forge life-long relationships in a 10-minute time span. He has boundless energy and operates at warp speed.
He has a positivity and sense of humor that make people want to sit next to him. Mr. Skalicky’s perspective, informed by practical experience, is driven by a passion to motivate and empower those around him.
He creates an environment that puts the client first and holds people to a level of excellence. And colleagues say Mr. Skalicky has the sincere ability to dig out the positive of any situation and use it as the springboard for success. This is why he inspires such loyalty from those who elect to work for him and with him. His no-nonsense hyper-focus on business results is balanced with integrity, acumen, and a sincere interest in delivering for his clients and his team. This makes him endearing and fun to be around but also creates an environment ripe for developing innovative strategic solutions where even crazy ideas are brought to the table and are considered, tossed around, and looked at from every angle.
“I inspire others by challenging them to put themselves in the shoes of their clients and proactively create solutions to potential obstacles our clients may be facing,” he says.
Mr. Skalicky says his most challenging assignment to date was the integration, restructuring, and continuation of four disparate sales organizations as the company acquired PharmaNet, i3 Research, and K-Force within a two-year time period.
The vast majority of his sales organization supported his effort and vision for over a decade and remains stalwart in support of his values and allegiance toward their careers as well as individual growth.
He is working to move the industry forward via a combined clinical and commercial offering that will save cost and time during the clinical development process. His passion toward making this vision a reality is in full flight as he is orchestrating several strategic engagements with an array of pharmaceutical organizations. The core focus of this vision is bringing better opportunity and support to patients through the masses of data available from the commercial landscape.
He is dedicated to driving better and more efficient practices in support of the conduct of clinical trial execution.
“Creative thinking and promoting a thought process geared toward developing better practices to achieve a primary objective can foster innovation,” he says.
Throughout his 16-year tenure at inVentiv, Mr. Skalicky has been an influential leader who continues to drive the company forward with his effective approach of leading by example while empowering those around him.
“I deliver as promised and keep people informed along the way,” he says. “I believe there are tangible advantages to encouraging transparency internally among teams as well as in our client relationships.”
Mr. Skalicky says one of the biggest industry challenges is patient/site enrollment in clinical trials.
“The industry faces two major problems: not enough patients to participate in clinical trials as a result of there not being enough investigative sites,” he says. “I firmly believe that if we take 10% of existing physicians and train them to participate in clinical trials we can increase the number of patients overnight.”
Title: CEO and Founder
Company: Exco InTouch Ltd.
Education: BSc, Microbiology and Biotechnology, University of Sheffield
Bucket List: Complete the Ride 25, a 25-stage ride right from the UK all the way to Australia; travel, particularly to Asia Pacific — Thailand, Malaysia, Indonesia, Australia
Awards/Honors: PharmaVOICE 100, 2013; Digital Health 100, 2014 and 2015; Sunday Times HiscoxTechTrack100, an annual list of the fastest growing privately owned technology companies in the UK; and 6th in the 2016 Northern Tech listing, which recognizes the Top 50 Fastest Growing Technology Companies in the North of the UK
Associations: ePRO consortium Fast Growth Icons
A Patient-Centered Approach to Technology
Tim Davis is forever pushing the company forward. As the CEO and founder of Exco InTouch, he leads a company that has since its inception in 2004 aimed to change the way clinical trials are conducted by using technology to improve the way patients are supported.
A commitment to continual innovation, combined with the desire to improve the clinical and healthcare experience for patients, means Mr. Davis and Exco InTouch have an impressive record of firsts in the industry.
Having been first to introduce the use of mobile phone technology into clinical trials, Mr. Davis helped to create the patient engagement industry, which is improving patient compliance to trial protocols and reducing the percentage of patients lost-to-follow-up. From this strong start it was a natural progression to use this conduit into patient’s lives to collect simple data, and he created the first-ever mobile phone eDiary in 2005 for a Phase IV hemophilia study.
Exco InTouch continues to innovate in the clinical trial space. In January, the company launched Gather, a new way to manage stakeholder engagement in clinical trials. It is specifically designed to simplify and connect the traditionally independent technology systems used in clinical trials. The product suite offers engagement for all participants in clinical studies, from design through to completion.
Although Exco InTouch has gone on to create a whole suite of seminal technologies, Mr. Davis is keen to keep the focus on improving life for patients; he is adamant his company remains a patient engagement company at its heart.
As an example of this commitment, earlier this year the company launched TARGET My Hives (target-community.com), a new digital health community network that aims to bring together everyone impacted by chronic urticaria. Ultimately, TARGET My Hives seeks to improve patient outcomes by also integrating physicians and patient associations in the network.
“Patients now have a community where they can come together to connect with others to share their experiences and connect with clinical specialists who may have information that may help them better manage their condition and improve their health outcome and their quality of life,” he says.
Those who work with Mr. Davis says he is not someone who just talks about patient centricity, but he is someone who considers the value and impact of a new technology on patients.
Mr. Davis says he is most excited about a new generation of health programs that are more like social networks for health where patients can share experiences and learn from each other.
Colleagues say he is a strong leader, who is down to earth and approachable and someone who inspires creativity.
Mr. Davis says he aims to inspire people by engaging them, encouraging them to think about how their visions impacts others, and helping them understand the possibilities they have in front of them. Mentoring is important to him. He supports Founders4Schools, a U.K.-based organization whose mission is to improve the life chances of students by giving them access to inspiring business leaders in their community and help them discover the skills and pathways that will be relevant when they leave school.
He is motivated to go to work every day because there is always something exciting on the horizon, whether it’s a new technology or new project.
“I’d like to think I’d be remembered as someone who saw an opportunity to improve the clinical trial and the healthcare experience for patients, and who wouldn’t give up until we got it right,” he says.
Title: CEO U.S.
Education: BSc, Honors, Economics, University of Birmingham
Family: Wife, Michelle; parents; three sons
Hobbies: Playing golf, cooking, tennis
Bucket List: Master a good brisket; travel to South America
Associations: Special Olympics NJ, certified soccer, tennis, basketball coach
A Transformational Leader
Creativity and thinking beyond the norm are two things that Andy Woolf believes help foster innovation. And he has applied these attributes to the company he founded, McCallan Health, which sold in 2015 to the company he now runs, Bionical.
Mr. Woolf founded McCallan and has spent the last 12 years growing the organization into a highly effective company with a team that strived to break barriers in its approach in providing creativity in marketing and consulting services. The company created MED Select, an engagement platform that allows sales representatives and healthcare providers to build customized content specific to physicians’ needs.
A few years into his new venture, he realized that the traditional business model of medical education through reminder advertising had to change. He completely transformed and reinvented the business.
His vision is now centered on improving patient care and, ultimately, improving patient outcomes. Using engagement as a core driver of innovation, he has now overseen the building of a new team delivering creative educational solutions. Additionally, he has added skilled clinical specialist teams enabling patients to play a more active role in improving their health. The end result: tools and systems to help pharmaceutical companies build better relationships with doctors.
“We strive to be a company that offers transformational not transactional solutions,” he says. “While that sounds like management speak, we want to create change for our clients. Consequently, we have a number of innovative ideas that would, for example, help bridge the gap between commercial and clinical activity. I would like to see those solutions particularly help in the area of rare disease.”
Under Mr. Woolf’s leadership, Bionical is creating innovative, customized quality patient education products that allow dynamic engagement between sales and marketing organizations and physicians, as well as between physicians and their patients.
He says the acquisition by Bionical, a U.K.-based company, was a career highlight.
“No acquisition is ever plain sailing, but we have been able to bring all teams together and not lose a single person in the process,” he says.
Colleagues say he is a thoughtful and caring individual. With an unwavering moral compass, Mr. Woolf is always concerned with doing what’s right, regardless of his personal benefit.
“I would hope that any inspiration can come from decisive leadership built on consensus,” he says. “The overall objectives have to be clear whether that’s coaching soccer or at Bionical. This may also sound wishy-washy but I think there’s an innate ability to simply tell if someone is inspired or not by the look in their eyes, and if you have reached them they are engaged. One also has to accept there is no magic bullet to inspire everyone.”
Colleagues say he is not only an effective leader, he is also a dynamic part of the overall team. His dedication to the business and, most importantly, staff, shows in their commitment to their work and the organization.
While not officially a mentor, he says he hopes that everyday he can show examples of strong customer service, which will set the standard for teams to follow.
Beyond work, Mr. Woolf has built strong relationships with the surrounding community and has taken a role as a soccer, basketball, and tennis coach for the Special Olympics. He volunteers countless hours to help the young athletes compete.
“Working closely with the Special Olympics provides a rich vein of inspiration from athletes who achieve so much,” he says.
Clive A. Meanwell, M.D.
Company: The Medicines Company
Education: MD, MBChB, Birmingham
Awards/Honors: E&Y Entrepreneur of the Year; Sol Barrer Award for Innovation; AI Dealmaker of the Year; CFO Magazine CEO of the Year
Associations: PhRMA, BIO, EFPIA
2015 was a milestone year for Clive Meanwell, M.D., and The Medicines Company, which he founded in 1996. He won the prestigious NJBio Sol J. Barer Award for Vision, Innovation, and Leadership, which was established by the BioNJ board of trustees in 2008 as an annual award to recognize the outstanding research and business leaders who have made and continue to make significant contributions to the growth of the biosciences in New Jersey and around the world. And under his leadership and guidance, The Medicines Company received approval for four drugs in the United States and four in Europe: Kengreal, the first and only intravenous, reversible P2Y12 platelet inhibitor with an immediate onset of action for patients undergoing PCI; Raplixa and the RaplixaSpray device to provide adjunctive hemostasis for mild to moderate bleeding in adults undergoing surgery; Ionsys, the first needle-free, patient-controlled, pre-programmed fentanyl delivery system, for the short-term management of acute post-operative pain; and a new formulation of Minocin for injection for the treatment of infections. In Europe, the company received approval for Kengreal (named Kengrexal in that region), Raplixa, Ionsys, and Orbactiv, a drug for superbug bacterial infections which had been approved in U.S. in 2014. The company also announced promising new clinical data from its four major research and development programs.
“We had a big year in 2015 during which five products in all were approved in the United States and/or Europe, four potential blockbuster products emerged from our R&D pipeline, our lead product became an authorized generic, and we launched a new corporate strategy to focus on our most promising development programs,” Dr. Meanwell says. “We have a strong execution focus and guided by that strategy we have made significant R&D progress, we have divested six in-market products to raise up to $1.2 billion in non-dilutive capital, and we strengthened our balance sheet. These moves enable us to invest aggressively in Carbavance, which recently showed very positive Phase III data in treatment of complicated urinary tract infections, and our other three potential blockbuster R&D programs that are our PCSK9 synthesis inhibitor for LDL lowering in atherosclerotic cardiovascular disease; MDCO-216, which is targeted for arterial plaque regression; and our investigational intravenous anesthetic and sedation agent ABP-700.”
He is professionally and personally invested in saving lives, alleviating suffering, and improving the economic outcomes of healthcare delivery.
“I have a relentless commitment to creating healthcare value through and with multidisciplinary scientific and commercial teams,” Dr. Meanwell says. “And for me, success is measured by how our products impact health outcomes — both clinical and economic.”
Colleagues and peers have noted that Dr. Meanwell is a visionary leader who is not afraid to challenge the status quo; likewise he is not afraid to challenge “myths” within in his company.
“Others have said innovation begins with the criticism of myths,” Dr. Meanwell says. “It follows that innovation in our highly successful industry may be stifled by an over-emphasis on established edicts, methods, and measures of success.”
Always ready and willing to look at the future, likewise he challenges his teams to imagine what’s possible in health and drive to make things happen in the delivery of improved health with ever greater economic efficiency. Since starting the company in 1996, Dr. Meanwell has shaped The Medicines Company into an innovative and collaborative entity, known for developing products that have been dubbed potentially game-changing in terms of serious infectious disease care, acute cardiovascular care, and surgery and perioperative care.
Self-identified as an unternehmengeist, or loosely translated as entrepreneurial spirit, Dr. Meanwell has built a company culture that encourages and rewards leaders to think big in a collegial atmosphere.
“As an industry, we sometimes isolate specialist knowledge and skills and focus on short-term financial measures that may not create long-term value for customers and shareholders,” he says. “Achieving the right balance is challenging.”
The Medicines Company’s mission is to take on challenging health problems. And there is no higher priority than improving outcomes for patients in ever more cost-effective ways.
He is a leader who knows how to get the job done and how to inspire a team to travel that road with him.
“I go all-out asking talented people to align motives, skills, activities, and understanding,” he says. “When this works, we see force multiplied and dramatic progress — and that’s what it takes to improve healthcare significantly over the coming years.”
Shideh Sedgh Bina
Title: Founding Partner
Education: BSE, Multinational Marketing & Managament, University of Pennsylvania — The Wharton School
Family: Mom, husband, sons, Kavian, Carey, and Kian
Hobbies: International travel, reading, poker, cooking
Bucket List: Live long enough to see her grandchildren grow; travel to Iceland, the Galapagos Island, Xian (the Terra-cotta Army); get to the final table at a WSOP event; write a book
Awards/Honors: Healthcare Businesswoman’s Association’s 2014 Woman of the Year; 40 prominent business leaders under 40 in the Philadelphia tri-state area – 1995, Wharton; Outstanding Young Women of America, 1985; acknowledged as a significant business leader by the Philadelphia Business Journal in its book Business Leaders of Philadelphia; Philadelphia Business Journal listed High Performance Consulting as one of the fastest-growing privately held companies in the Philadelphia area for three years running; acknowledged in David Logan’s book The Three Laws of Performance
Associations: NACD (National Association of Corporate Directors), Trustee Committee for Economic Development (CED), Healthcare Businesswomen’s Association, Forum of Executive Women, Union League of Philadelphia
Shideh Sedgh Bina’s success at driving transformation comes from the fact that she lives it every day. For more than 28 years, Ms. Sedgh Bina, co-founder of Insigniam, has been leading the company’s efforts to deliver breakthrough methodologies to the pharmaceutical and other healthcare industries.
“We are committed to transforming the practice of management and leadership to unleash the power of inspired human performance and a new level of unprecedented results,” she says.
Across health systems, medical device and biotech companies, as well as big pharma companies, Ms. Sedgh Bina has had extraordinary success in supporting senior executives in mobilizing leaders, setting disruptive strategies, defininting their organization models and creating a culture that will deliver breakthrough business results. She has worked with tens of thousands of people throughout the world, and she is as adept at working with C-level teams as she is at being a great team member herself. At a time of great and rapid change in healthcare, Ms. Sedgh Bina is a passionate believer that people and companies create their own futures and that we have the opportunity to make a long-lasting social impact as we transform our healthcare models.
She is known to be a breakthrough thinker, leads by example, listens and responds to what she hears from others, and looks for the potential in everyone she encounters.
To share her vision and commitment to transformation, in 2013 she launched the company’s thought leadership magazine, Insigniam Quarterly, which is distributed to more than 50,000 executives around the world.
Ms. Sedgh Bina personifies the American success story. She and her family immigrated to the United States from Iran when she was very young. She has inspired and moved both small and large groups with her story and the possibility of accomplishing something that seems beyond one’s reach.
For Ms. Sedgh Bina, innovation thrives when there is a supportive culture, a leadership mandate, increased creativity, and an investment in resources. It struggles where there is corporate myopia, an enterprise immune system, and corporate gravity.
As a coach and mentor, Ms. Sedgh Bina enables her team members to see their own leadership potential. Her ability to discuss both her successes as well as her mistakes and even failures establishes a connection with people that leads to their own willingness to pursue their dreams and to be their very best.
She is a steadfast champion of women as leaders in all levels and advocates for women in the C-suite and on boards. The majority of the partners and employees at Insigniam are women, and half of the company’s executive committee members are women.
She was honored as the Healthcare Businesswomen’s Association’s Woman of the Year in 2014, is a trustee of the Committee for Economic Development, and is a member of the Forum of Executive Women.
She also makes pro bono work a priority, from ending sex trafficking, to reducing recidivism (The End Violence Project), building leadership among American youth (Boy Scouts), and accelerating progress for women through workplace inclusion (Catalyst).
Smart and multi-talented, Ms. Sedgh Bina’s brand — “Shideh Happens” — sums who she is and what she stands for.
“I do everything from work, to love, to play with all of my heart, mind, and spirit,” she says.
Donald A. Deieso, Ph.D.
Title: Chairman and CEO
Company: WIRB-Copernicus Group (WCG)
Education: BSME, Mechanical Engineering, Manhattan College; MS, Ph.D., Environmental Science, Rutgers University
Hobbies: Music, having studied trumpet for 15 years with the leading faculty member at Julliard; high-performance cars
Bucket List: Attending performances of Verdi opera at the leading opera houses of Europe
Awards/Honors: Top 20 Innovators Changing the Face of the Clinical Trials Industry, CenterWatch Monthly, 2013; Ernst & Young Entrepreneur of the Year finalist, New Jersey, 2010; Deloitte Fastest Growing Companies in the US
Associations: Chairman, Certara, BioreclamationIVT, and TractManager; operating partner and co-lead, Arsenal Capital Partners’ healthcare team
Tweet at: @WCGClinical
WIRB-Copernicus Group (WCG) Chairman and CEO Donald Deieso, Ph.D., is a smart, charismatic leader who not only has a big picture view of the industry but someone who also pays attention to the details that impact his teams and the patients his company serves.
During the past four years, he has led WCG to acquire 11 companies, and succeeded in building an entirely new type of organization in the biopharmaceutical industry — a clinical services organization (CSO).
He also never forgets to send personal thank you notes and is always the first to hold the door open and welcome visitors to his company’s headquarters.
Colleagues say if you are an operational genius, a powerful strategic thinker, and have a character that is based on core, inalienable principles, then your name is Don Deieso.
WCG’s rapid growth, which is due in large part to Dr. Deieso’s commitment to a well-defined vision, has not gone unnoticed throughout the clinical space.
The company now has more than 600 full-time employees, 14 IRB panels that meet daily, and 11 offices throughout the country. Furthermore, its IRBs reviewed 40 of the 45 drugs approved by the FDA in 2015, and by eliminating unnecessary administrative redundancies, WCG has helped its clients to shorten their timelines by months, not days. And thanks to Dr. Deieso’s vision, WCG now has partnerships with more than 1,500 institutions in the United States alone, ranging from small community hospitals and research sites to large academic medical centers and universities.
“I have a talent for seeing the big picture and being able to envision how clinical trial processes can be improved on both a macro and micro level,” Dr. Deieso says. “I am fortunate to be a part of a great team of leaders who are passionate about solving the important problems of our time.”
Not content to solve just the problems within his company, he has a personal mission to do what he can to help find a cure for cancer. The theme for WCG’s “party with a purpose” at last year’s DIA Annual Meeting was “Mission Possible: Curing Cancer in Our Lifetime,” and he says he intends to help make that dream a reality.
He is quite comfortable handling big challenges, as is illustrated throughout his career. One of the largest hurdles he faced was serving as the assistant commissioner in the N.J. Department of Environmental Protection working to clean up the local environment.
“This was at a time when environmental issues were front page stories in every newspaper nationally,” he says. “I was proud of our accomplishments in clean air, water, and solid waste matters in our state.”
His biggest career highlight to date has been his work at WCG, where he envisioned how the company could accelerate the clinical trial process while maintaining the highest quality protections for human volunteers, and then built the WCG family of companies to make that vision a reality.
Dr. Deieso attributes his ability to manage so many high-powered roles to following a simple ethos: he focuses on hiring talented people who are passionate about finding a better, smarter way to do things.
“I have learned to appreciate the power of a collaborative management style,” he says. “I endeavor to hire the best people and empower them to think bigger. We learn from each other all the time.”
Having run a multitude of companies, and as a former lecturer at Rutgers University, Dr. Deieso calls himself a “teacher of life,” and puts energy into mentoring younger managers to become the best leaders they can be.
A talented and passionate man, Dr. Deieso never does anything in half measures, no pun intended, as he also has a musical side and is a talented trumpeter who once considered a music career.
Colleagues agree they are glad he chose instead to orchestrate a better clinical research industry.
Lorence Kim, M.D.
Title: Chief Financial Officer
Company: Moderna Therapeutics
Education: MBA, Wharton School of the University of Pennsylvania; M.D., University of Pennsylvania School of Medicine
Family: Wife; three children
Hobbies: Skiing the deep stuff in the trees; ice hockey with the over-the-hill crowd at Chelsea Piers; watching 8, 10, and 12 year olds swim, play hockey, chess, etc.
Bucket List: Race a Formula One car; hold his great grandchildren
A Proven Leader and Mentor
Lorence Kim, M.D., and his team at Moderna Therapeutics want to create a new generation of transformative medicines based on the promise of mRNA science for patients and potentially treat diseases previously viewed as untreatable.
In 2015, under Dr. Kim’s leadership as chief financial officer, Moderna raised more than $500 million in one of the largest private rounds of financing in biotech history. This funding has provided the company with the flexibility to follow the science and pursue programs with the highest promise for patient treatments. This financing would not have been possible without Dr. Kim’s specific approach to understanding and communicating the underlying science of Moderna’s mRNA technology to investors and showcasing the potential impact.
He also was instrumental in teaming up with key partners, thoughtfully choosing them not only based on the financial deal terms, but also what they could bring to Moderna’s platform and, ultimately, patients themselves.
Dr. Kim joined Moderna in 2014 from Goldman Sachs where he was a managing director and co-head of the U.S. biotechnology investment banking effort. As a member of the healthcare investment-banking group for almost 14 years, his responsibilities included corporate finance and mergers and acquisitions for the pharmaceutical and biotechnology industries, with several billion dollars in equity and equity-linked financings, and more than $55 billion in M&A transactions.
Dr. Kim would like to be remembered for helping Moderna to establish messenger RNA, or mRNA, as a viable drug modality and demonstrating how powerful the platform can be. The company is pioneering the development of a new class of drugs made of mRNA. This novel approach builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce almost any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells.
Moderna’s pipeline is composed of a series of novel drug modalities, each representing a distinct application of the company’s proprietary mRNA platform to encode proteins that achieve a therapeutic benefit. Moderna’s current modalities include infectious disease vaccines, personalized cancer vaccines, rare disease-associated intracellular/transmembrane liver proteins, intratumoral cancer therapy, and secreted antibodies and proteins.
Playing a key role in how Moderna sources capital to fund its technology and portfolio, and how the company makes decisions to allocate that capital, under Dr. Kim’s leadership, Moderna is leveraging these modalities to advance drugs across a broad spectrum of therapeutic areas via its wholly owned ventures as well as with partners such as AstraZeneca, Merck, Alexion, and Vertex Pharmaceuticals. For example, one of the company’s collaborations with Merck, announced in June of this year, is to advance novel mRNA-based personalized cancer vaccines with Keytruda for the treatment of multiple types of cancer. The collaboration will leverage Moderna’s rapid cycle time, small-batch manufacturing to supply vaccines tailored to individual patients within weeks. Moderna’s collaboration with Vertex, announced in July of this year, is focused on discovering and developing mRNA Therapeutics for the treatment of cystic fibrosis.
Moderna became a clinical-stage company in less than five years, beginning its first Phase I study in Europe for mRNA 1440 in 2015. In 2016, the company began a U.S. Phase I study for a second program, mRNA 1851, and anticipates initiating several other clinical studies by the end of 2016 across both internal development programs and partnered programs.
“There is a tangible ability in a small company to have a major impact every day, and in so many facets of what we do,” he says.
He believes an organization’s ability to innovate requires a clarity of objectives, a passion that runs deep, and knowing how to get the blocking and tackling done, which enables the “sexy” science — qualities that could also be applied to Dr. Kim.
Louis Randall Breton
Title: Co-founder and CEO
Company: Calimmune Inc.
Education: BS, Molecular & Cellular Biology, University of Arizona
Family: Wife, Amber; three daughters, Kyla, Abbigail, Ellyse
Hobbies: Swimming, horsemanship, and fishing
Bucket List: Write a book
Awards/Honors: AZBio, Fast Lane Award, 2015; Lazard Capital Markets, Most Interesting and Most Disruptive, 2013; AZBio, Bioscience Company of the Year, Finalist, 2011; Arizona Daily Star 40 Under 40, 2010
Gene Therapy Pioneer
Until recently, gene therapy hasn’t had much of a marquee presence outside of the world of rare-disease targets, but Louis Breton, CEO of Calimmune, is changing all that. As an effective and inspirational business leader who is innovating unique gene therapy treatments for broad patient populations, he is expanding the promise of gene therapy into new areas of medicine with vast and unmet patient need.
Mr. Breton has become a prominent voice over the past decade for improving access to gene therapies as a means to create a better quality of life for patients. He has advanced promising science while also introducing innovations that will bring down the cost of gene therapy, making it a realistic treatment option for more diseases than ever thought possible. In the process, he continues to positively impact his peers, his company, and the industry at large.
With more than 1 million Americans living with HIV, Mr. Breton believes there is an urgent need for a therapy that does more than just hold the virus at bay. Current medications are effective, but come with a big cost both in terms of dollars and side effects; Mr. Breton’s goal is to find an approach that effectively strengthens the immune systems of people with HIV/AIDS.
Since co-founding Calimmune in 2006, Mr. Breton has boldly led the advancement of a comprehensive therapeutic pipeline with the goal to treat and potentially eradicate HIV/AIDS. His goal, which is well under way with the company’s lead therapeutic candidate in Phase I/II clinical trials, is to develop a one-time or infrequent gene therapy treatment for HIV.
Mr. Breton leverages his inspirational leadership skills to advocate for the HIV/AIDS community, including joining in companywide volunteer efforts alongside his team that directly support local HIV/AIDS service organizations.
In addition to the area of HIV/AIDS, his team is moving forward with additional therapeutic candidates that similarly target a wide array of other disease indications. Mr. Breton’s fierce commitment to help patients prevail against currently incurable diseases has brought together some of the world’s most respected gene therapy developers, clinicians, scientific advisors, and commercialization experts to collaborate on efforts to make gene therapy available to the masses as opposed to simply industrializing it.
One significant element of his approach deals with efforts to bring down the cost of gene therapy, as this will help make it commercially feasible for larger patient populations. To do this, he has focused on expanding and improving Calimmune’s proprietary Cytegrity lentiviral vector bioproduction technology, which provides scalability for gene therapy and could result in as much as a 90% decrease in the cost of current methods for vector production.
Under Mr. Breton’s leadership, Calimmune also is steadily achieving new clinical and business milestones. He has garnered interest from highly respected investors, successfully completing a $15 million Series B financing round led by AbbVie in mid-2015. Mr. Breton is steadfast in his role to be a responsible financial steward of the funding entrusted to Calimmune, ensuring stability and an enduring ability to perpetuate the research that will enable his company to restore health and improve the lives of many people on a global scale.
Mr. Breton has skillfully built and actively inspires an employee base of highly motivated individuals who are encouraged to expand their personal and professional growth as well as further Calimmune’s mission. Mr. Breton is a stalwart supporter of everyone he leads, and recognizes that the team must be strong and cohesive to achieve the goals that are set. He takes a sincere interest in the well-being and potential of each member of the group.
A man of impeccable character, Mr. Breton leads by unwavering example and has earned and continues to maintain tremendous, enduring respect from his employees, who describe him in turn as someone who operates in top gear all the time, and who has time, patience, and kindness for everyone.
Company: Klick Health
Education: BBA, University of New Brunswick; French degree, L’Universite Laval; MBA, University of Saskatchewan
Family: Mom and Dad
Bucket List: A trip to China
The Relentless Pursuit of Awesome
As president of Klick Health, Lori Grant brings many operational assets to the nonconventional agency, but perhaps the talent that epitomizes who she is, is her ability to build an extraordinary culture of mentorship. While steering the agency toward continued growth, she has created a learning environment across the entire organization.
One of the biggest challenges for a successful agency is to retain the greatest talent possible for clients, and Ms. Grant manages to do this by cultivating and nurturing the talents of the ever-growing team of “Klicksters.”
“Mentoring is an absolute key to success and one that is immensely rewarding,” she says. “Generally, I start by trying to help people discover what they are most passionate about and then help them to realize their passion. This process helps people discover what makes them most happy and productive.”
According to colleagues, Ms. Grant always talks about how fortunate she is to be surrounded by awesome people, but she neglects to talk about how awesome she is and the many contributions she makes to the Klick environment.
“I love the attention to be on my teams and on the patients who we ultimately serve,” Ms. Grant says. “I measure success through the success of those around me who I help to succeed.”
She has played a leading role in driving exponential rates of organic growth within portfolios and propelling Klick’s hyper growth trajectory.
She has empowered teams to produce data-driven, award-winning work that continues to change the landscape for clients. However, she diverts the attention to her teams when the accolades start to fly.
“I would like to be remembered for having made a difference in someone’s life, whether that is a patient, a client, or a team member,” she says.
To help Klick associates and teams continue to be successful, she has developed several programs and opportunities for mentoring and education, including monthly “Breakfast Meetings,” where staff members share their accomplishments and successes with others across the organization. During the month before each breakfast meeting, Ms. Grant meets with team members to help develop their presentations.
The Breakfast Meetings have become very popular, and have grown substantially over the past three years, Ms. Grant has overseen and emceed these meetings, with the ultimate goal being to educate everyone on the latest developments, case studies, and breakthroughs at Klick.
Ms. Grant also worked with the team on Listening Sessions to hear directly from staff members about their ideas, concerns, and questions.
She also launched several internal learning platforms to keep the teams engaged.
Colleagues say what they really like about working with Ms. Grant is that she can assess where she’s needed the most, whether that’s hands-on conflict resolution or inspiring her team. She’s always ready to roll up her sleeves, jump in, and lead by example and with humor.
Individual team members say when speaking with her, Ms. Grant makes them feel like they are her sole priority and that they are the most important person on her list of people to see. There are no interruptions, she’s poised and organized, and when she says her door is always open — she means it.
Ms. Grant has more than 27 years of experience on both the client and agency sides of the healthcare industry, including tenures at Merrell Dow, Nordic (now Sanofi), and Wyeth, LM&P, Euro RSCG, and Sudler & Hennessey.
Always on the “relentless pursuit of awesome,” Ms. Grant recently attended Harvard University for a certificate in negotiation skills and strategies for increased effectiveness.
Paul Bolno, M.D.
Title: President and CEO
Company: WAVE Life Sciences
Education: MBA, Drexel University; M.D., MCP-Hahnemann School of Medicine
Family: Anne, wife; two children, Jacob and Madeleine
With a goal to address challenging diseases by bringing forward meaningful, innovative medicines with integrity and empathy, Paul Bolno, M.D., is leading the growth of WAVE Life Sciences.
Within two years he has built the company from a startup of five people to a thriving, diverse, multinational organization of more than 70 talented employees with significant continued growth still ahead.
Dr. Bolno combines an extraordinary array of skills: he is able to succinctly distill complex scientific concepts into digestible and meaningful bytes of information that can be understood by diverse audiences; he has strong leadership and mentoring skills; and he has unending compassion for patients and their unmet medical needs.
Under his leadership, the preclinical genetic medicine company is advancing a pipeline of more than 20 discovery programs and is on a trajectory to have six clinical programs by 2018. The company has initiated innovative development programs to treat Huntington’s disease, Duchenne muscular dystrophy, and is collaborating with Pfizer to develop genetically targeted therapies for metabolic diseases.
The company plans to file two IND applications this year to begin human trials of new medicines to treat Huntington’s disease; if successful, together those two drugs have the potential to treat more than two-thirds of the 35,000 Huntington’s patients in the United States. Its lead Huntington’s disease candidate received orphan drug designation from the FDA, recognizing the significant need this medicine could address.
WAVE recently announced preclinical data on its lead Duchenne muscular dystrophy candidate, which targets exon 51, demonstrating an approximate 25-fold improvement in exon-skipping efficiency compared with other clinical candidates targeting the same exon. These data suggest the immense promise that WAVE’s proprietary platform and next-generation approach may have for patients who currently have few treatment options.
WAVE is able to generate drug candidates in multiple modalities, including RNAi, antisense and exon-skipping, giving it the potential to provide treatment options for a broad spectrum of genetically defined diseases. WAVE’s technology and chemistry platform opens the door to developing selective allele-specific therapeutics, placing the company at the threshold of addressing the root genetic cause of dozens of orphan disorders.
Dr. Bolno has prioritized the company’s pipeline to best capitalize on that value proposition, opening up significant commercial opportunities while maximizing the potential to offer new or improved therapeutic options to patients impacted by a wide range of diseases.
His business skills are apparent. In late 2015, during truly unfavorable market conditions, Dr. Bolno masterfully led one of the most successful IPOs of 2015, raising $112 million in investment.
During the IPO roadshow, Dr. Bolno tailored multiple presentations to fit the needs of each meeting, never repeating the same presentation. His view throughout this experience was that even if people to whom he was presenting did not plan to invest in the company, he wanted them to understand the technology and development plan. He was able to clearly demonstrate the team’s passion and commitment to the patient communities the company is working to serve.
Having gone through three doublings of employee headcount in the past two years, he is focused on ensuring that the culture and commitment to patients is not only preserved, but continues to evolve.
Innovation, he maintains, thrives in an open-minded environment and accepting diversity of opinions. He works to create an environment that enables people to “fail forward” rather than focus on fear of failure, and lets people try and challenge new ideas.
Dr. Bolno’s training as a physician gives him uncommon insight into the challenges that patients impacted by serious rare diseases must face each day. The desire to serve patients is what called him to become a medical doctor and it’s also what drives him in business roles while at GlaxoSmithKline — where he was VP, worldwide business development — head of Asia and neuroscience BD and investments, as well as head of global oncology BD — and now at WAVE, where he is seeking to impact an even greater number of lives by delivering new and more effective tools for physicians to wield against severe genetic diseases.
Title: President and CEO
Company: TrialCard Inc.
Education: BS, Business, University of Mary Washington
Family: Wife of 21 years, Jennifer; three children, Mackenzie, 17; Kaitlyn, 15; Joey, 13
Hobbies: Coaching his children’s baseball and basketball games; attending soccer and lacrosse games, going to the lake
Bucket List: Travel to Italy with his wife; attend a baseball game in every major league baseball stadium with his son Joey
Pioneering a Patient-Focused Evolution
Since assuming the role of CEO and president of TrialCard, Mark Bouck has masterfully led the company’s evolution from a niche service provider in the copay savings space to a full-scale pharmaceutical services organization.
Mr. Bouck’s goal from the outset was to offer manufacturers a diversified and integrated menu of patient access solutions that increase adherence and engagement and drive positive health outcomes. This vision not only reinforced TrialCard’s cornerstone position as a provider of copay offset solutions but more importantly set the stage for providing patients a better avenue to access the medications they need to live a better life.
Mr. Bouck’s leadership has been essential to this evolution. By establishing what TrialCard could be — and subsequently has become — and placing priority on building the technical and personnel infrastructure to support this transformation, he has ensured that everyone in the organization is committed to working on behalf of patients who are in need of life-transforming therapies.
His impact is most prominently displayed in his commitment to delivering best-in-class, patient-centric healthcare solutions to pharma companies, providers, pharmacies, and patients.
Mr. Bouck has been a visionary in recognizing the drivers that cause patients to miss out on the care they need, and understanding the support services that can reduce or eliminate such access barriers.
TrialCard was already helping manufacturers combat the roadblock of high patient out-of-pocket costs upon his arrival in 2012, but since then Mr. Bouck has driven the company to dive deeper in exploring cursory factors. Increased payer challenges brought about by the shift to more high deductible health plans, the underuse of the pharmacist as a brand advocate, and the lack of outcome-based approaches to care that provide patients with support beyond financial savings are all areas that Mr. Bouck has placed organizational priority on addressing through a diversified suite of patient-centric solutions.
Under his charge TrialCard has unveiled a host of offerings that enable pharmaceutical manufacturers to directly combat the challenges that are inhibiting the delivery of care to patients at every stage of their journey.
Mr. Bouck has pioneered TrialCard’s expansion into multiple new sectors, all in direct response to the needs of today’s pharmaceutical marketer. From day one as CEO, one of Mr. Bouck’s top priorities at TrialCard has been his focus on building and maintaining a company culture of excellence and creating an environment that makes TrialCard a choice employer for top talent.
Adele M. Gulfo
Title: Chief Strategy Officer
Education: BS, Biology, Seton Hall University
Family: Father, mother, husband, siblings
Hobbies: Fitness and health, skiing, fashion
Bucket List: Appear as an extra on The Good Wife or Madam Secretary
Awards/Honors: Pinnacle of Leadership Award: The Girl Scouts’ Top 100 Diverse Corporate Leaders in STEM, 2015; Executive Women of NJ Professional Distinction Award, 2014; The Pinnacle Award — Fairleigh Dickinson University, 2014; Luminary Award Winner for Corporate Innovation, 2014; The Committee of 200, 2012; Oracle Award, 2013; Highest Leaf Award Women’s Venture Fund, 2007; PR Association of America — Silver Anvil Award, 2000; Warner Lambert Global President’s Award for Innovation, 2000; Advertising Age Top 100 Marketers, 1999; Financial Times Pharmaceutical Awards Best Product Launch, 1999; Healthcare Businesswomen’s Association Rising Star, 1998
Associations: Bemis Company Inc. ; Volunteers of America; Partners Healthcare Innovation; Healthcare Businesswomen’s Association; Cleveland Clinic Global Cardiovascular Innovation Center; Healthcare Leadership Council; The Committee of 200 (C200)
The Business Side of Science
Measuring success for Adele Gulfo is not about individual glory but about the number of lives that she has positively influenced, and the magnitude of those positive effects, whether or not the individuals know who she is or that she was the person behind the scenes.
Apparent or not, her influence is immense on a global healthcare basis through her work with the best-selling drug of all time, Lipitor, as well as on an individual basis through the number of organizations to which she lends her time, expertise, and mentorship.
“I want to be remembered as someone whose work mattered, that it helped a great many patients while advancing the reputation of the industry,” she says.
Launching and commercializing Pfizer’s cholesterol-reducing agent Lipitor was both a career highlight and one of the biggest challenges of Ms. Gulfo’s career.
“Growing revenue and earnings when Lipitor went generic, while running Pfizer’s U.S. primary care business meant I had to make very hard choices about prioritizing certain brands and take bold and unpopular actions, which worked,” she says.
To make it work, Ms. Gulfo relied on pragmatism and creativity, two traits she learned from her parents.
“My father taught me to take nothing at face value and my mother taught me to live in the moment,” she says. “Creativity comes from my strong scientific background where I learned how nature adapts and devises unexpected solutions to challenges to thrive.”
During that same time, not only were Ms. Gulfo and her team breaking sales records, but she was personally breaking the proverbial glass ceiling. There were very few women at the time who had the business influence that she did, and she took her husband’s advice to break every ceiling and to follow her gut. Her efforts earned her numerous leadership accolades and business awards. Additionally, she is considered a role model by dozens of women leaders throughout the industry who say Ms. Gulfo provides sage career advice, strategic business direction, and leadership guidance.
“As a mentor I have the unique opportunity to affect the personal and professional life of someone,” she says. “Being a mentor is not only gratifying, but mutually beneficial.”
Ms. Gulfo is a change agent, and while under her leadership as president and general manager of Pfizer’s U.S. primary care business unit, the business generated more than $12 billion in revenue. While also at Pfizer, she served as president of Latin America in the company’s emerging markets business unit. Once again, she and her team — more than 4,000 colleagues in about 24 countries — generated company-leading results.
There are very few people who can claim to have launched one, nonetheless two, blockbuster products.
While at AstraZeneca, she led the launch of the cholesterol-lowering medication Crestor and grew the brand into the $2 billion-plus cornerstone of the company’s primary care franchise.
Colleagues say Ms. Gulfo is a superstar and a team player and they want to be part of her winning ways. They are drawn in by her brilliance and dynamic personality.
Today, Ms. Gulfo serves as Mylan’s chief strategy officer. Reporting directly to the CEO, she focuses on areas of future growth for the company, including the company’s expansion of its key franchises around the globe, and the development of innovative commercial strategies to maximize Mylan’s diverse portfolio of products and services across customer and distribution channels.
“My goal is to advance the health of 7 billion people worldwide while adding value to all stakeholders — patients, shareholders, employees, etc.,” she says. “I also am driven to deliver on our vision at Mylan; to conquer challenges; and to inspire others to realize their full potential. I am blessed to work for a purpose-oriented company, which provides a great deal of motivation for me.”
Magali Haas, M.D., Ph.D.
Title: CEO and President
Company: Cohen Veterans Bioscience
Education: BSE, University of Pennsylvania; MSE, Rutgers University; M.D., Ph.D., Albert Einstein College of Medicine
Family: Parents, Dharma and Guirualdo Reyes; husband, Franz Haas
Hobbies: Biathlon — cross-country skiing and target shooting; beekeeping
Bucket List: Hike the Appalachian Trail; cross-country ski across Norway; kayak the Galapagos
Associations: Institute of Medicine, Neuroscience Forum
For someone with the ability to make a profound difference in the lives of others, Magali Haas, M.D., Ph.D., CEO and president of Cohen Veterans Bioscience, has just one straight-forward goal: find cures for brain diseases. She has an even more direct mantra: Let’s do this.
And that is her leadership plan at Cohen Veterans Bioscience, where the mission is to speed the discovery of first-generation diagnostics, treatments, and cures for post-traumatic stress disorder (PTSD) and traumatic brain injury (TBI) by improving the scientific understanding of the basic biological mechanisms that set the stage for these conditions, especially for veterans who are returning home with these conditions.
“I engage people, seize opportunities in technology, and take action to cure brain disease,” Dr. Haas says. “I am constantly trying to make tomorrow a better future.”
Philanthropist Steve Cohen is a major sponsor of Cohen Veterans Bioscience, and he believes that with Dr. Haas’ leadership, the company will advance the science and availability of new medical treatments. He says Dr. Haas is truly changing lives through her passion and dedication.
In July 2012, Dr. Haas founded her own nonprofit organization, Orion Bionetworks, focused on developing computational bionetwork models of brain disease before big data was even a buzzword. The initial focus was on multiple sclerosis, and resulted in the first predictive disease models for MS prognosis and identification of biomarker pathways that could be used for diagnostic testing and/or therapeutic targets.
As Dr. Haas became more familiar with the increasing burden being placed on returning veterans and their families, she became a warrior on their behalf. She migrated Orion Bionetworks into Cohen Veterans Bioscience in 2015. Dr. Haas’ focus is now dedicated to using all of her knowledge to accelerate the development of next-generation diagnostics and treatments.
And her dedication is already paying off: Cohen Veterans Bioscience has entered into multiple collaborative partnership efforts, including ones with the Stanley Center for Psychiatric Research at the Broad Institute of MIT and Harvard, McLean Hospital’s Harvard Brain Bank, NYU Langone Medical Center, and Stanford University.
Leaving big pharma and launching her nonprofit organization was one of her most challenging assignments to date.
“Every day is a learning opportunity — whether it is defining our mission, inspiring and directing a team, fundraising, learning to use social media tools, managing finance, or making sure we don’t lose sight of the impact we want to make for patients,” she says.
Before Orion, Dr. Haas worked predominantly at Johnson & Johnson, where she assumed broad end-to-end development leadership roles in medical marketing, full clinical development, early development, and translational and biomarker sciences in psychiatry and neurology. She successfully filed new drug applications in the United States and Europe for risperidone indications in autism, adolescent schizophrenia, juvenile bipolar disorder, and conduct disorders. She also led development teams evaluating compounds for depression, neuropathic pain, epilepsy, and migraine disorder. She established the first neuroscience translational medicine and integrative solutions department and co-founded the first healthcare innovation team.
The highlight of her career occurred earlier on, when she conducted the first therapeutic studies of childhood psychiatric disorders. Before these studies, physicians were prescribing psychotropics off-label for early onset schizophrenia, juvenile bipolar, conduct disorders, and autism without the benefit of well-controlled studies to evaluate efficacy and safety.
“Conducting this type of research was highly controversial at the time because of the special population and prevailing concerns about placebo studies,” she says. “Our research ensured that future generations would benefit from an evidence-based treatment regimen.”
Dr. Haas is motivated to work so hard by her concern of those close to her who are suffering from MS, PTSD, or TBI, and the scientific challenge to provide them with a cure.
“The brain is one of the most difficult organs of study,” she says. “Every day is an opportunity to understand something new that might help so many.”
Dr. Haas is described as a change-maker and a role model for others who are looking to move beyond their current careers to lead in a more meaningful way.
Title: President and CEO
Company: BioNJ Inc.
Education: M.S., Public Relations, Newhouse School, Syracuse University; B.A., Communications, Trenton State College
Family: Husband, mom, three younger sisters and seven beloved nieces and nephews
Hobbies: Running, bird watching, interior decorating, laughing, and having fun
Bucket List: A safari in Africa
Awards/Honors: One of the world’s 100 Most Influential People in Biotechnology in 2015 by Scientific American Worldview; HudsonMod Magazine’s 2015 list of Women in Power; one of New Jersey’s top CEOs by Commerce Magazine; one of New Jersey’s 2015 Top 25 Leading Women Entrepreneurs by Leading Women Entrepreneurs; and for the fourth time named in 2016 to the NJBIZ Power 100, a listing of the 100 most influential people in New Jersey business; Women’s Fund of New Jersey as a Woman Advancing Science; recognized by NJIT with a New Jersey Inventors Hall of Fame Award; in commemoration of Women’s History Month, honored by the New Jersey General Assembly as a Woman Advancing Science; one of 50 people to PolitickerNJ’s Health Care Power List in 2014
Associations: The American Society of Association Executives, the Public Relations Society of America, the Mid-Atlantic Society of Association Executives, New Jersey Chapter of the Public Relations Society of America; Healthcare Businesswomen’s Association
Tweet at: @BioNJDebbieHart
The Heart of NJ Bio
Debbie Hart is BioNJ. She is the founding president and CEO of the life-sciences trade association. She worked alongside New Jersey’s biotechnology industry leaders to establish BioNJ in 1994 and has been dedicated to the organization ever since. She has also garnered the respect and admiration of the more than 400 member companies that represent research-based life-sciences companies and stakeholders dedicated to supporting science and creating and developing new drugs for patients in need.
“As the industry’s voice in New Jersey, we fulfill our mission to help companies help patients by driving capital formation and fostering entrepreneurship, advocating for public policies that advance medical innovation, providing access to talent and education and offering a cost-saving array of critical commercial resources,” Ms. Hart says.
Ms. Hart and her dedicated team are embarking on a new venture — the BioNJ venture fund — which she says is her most challenging assignment to date.
“We are in the midst of this initiative, and it has been immeasurably exciting and challenging getting to this point, and it will be landscape altering when we arrive,” she says.
Ms. Hart adamantly believes that by focusing on the significant funding needs of early-stage companies and making sure they are well funded, important new therapies and cures will make their way through the system to the patients who need them.
Along with her team, Ms. Hart has also been instrumental in the development of several BioNJ firsts, including the association’s Inspiring Women in STEM Conference. The conference brought together 200 professionals of all levels from the STEM community for a day of empowering professional development.
“Supporting the growth of women in STEM is an important part of BioNJ’s mission,” Ms. Hart says. “Women in scientific and technology roles need more than technical skills for career growth; we need strong leadership skills, the ability to communicate effectively and develop collaborative teams and be innovative in our solution resolution. The program was designed to do just that.”
Ms. Hart’s teams are inspired and motivated by her drive, determination, and stalwart commitment to patients and are in awe of her seemingly never-ending reserve of energy. And they say Ms. Hart has an infectious sense of humor and she is always willing to inject fun into every project.
Ms. Hart is quick to credit her teams and measures success one milestone at a time, whether it is hers, her team’s, or BioNJ’s members, success she says is an evolving and cumulative process.
“I am so lucky to have so many special moments in my career, including witnessing milestones reached by our team, our members, and meeting precious patients like 8-year-old Max Schill, a RASopathy’s patient who lobbied Congress for the 21st Century Cures Act; it doesn’t get any cooler than that,” she says.
Ms. Hart is passionate about fulfilling BioNJ’s mission, which is centered around patients; in fact the association’s tag line sums it up best: Because Patients Can’t Wait.
Under Ms. Hart’s deft leadership, enthusiasm, and support of innovation, BioNJ is fulfilling its mission by ensuring that science is supported, companies are created, drugs are developed, and patients are paramount.
“My team and our members have the ability to make a difference in our ecosystem and for patients each and every day and this is what keeps me motivated,” she says.
Having been named to numerous state and national top lists of the most influential and inspirational leaders, Ms. Hart is considered the go-to person in New Jersey when it comes to the life sciences and healthcare and she is willing to go toe-to-toe for patients, and she inevitably always comes out on top.
Company: Altasciences Clinical Research, comprised of Algorithme Pharma, Vince & Associates Clinical Research, and Algorithme Pharma USA
Education: BSc, University of Bradford
Family: Long-term girlfriend
Hobbies: Motorcycling, brewing, DIY, camping
Bucket List: Motorcycle across the Western United States; build a street hot-rod; scuba dive in the Maldives
Awards/Honors: Algorithme Pharma (Montreal) named Best Full Service Early Stage Clinical Research Provider in Canada by Global Health & Pharma’s Biotechnology Awards, 2016; Algorithme Pharma one of 19 organizations recognized at the 31st Annual Canada Awards for Excellence, 2015; Algorithme Pharma, honorable mention at the Grands Prix québécois de la qualité, 2014
A Real Team Leader
To his colleagues, Chris Perkin, CEO of Altasciences Clincial Research, is the ideal leader. He 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 leadership style. He never talks about problems, only solutions. He is able to transform a mass of information into concrete projects. He is open to all ideas and is always looking to innovate. Mr. Perkin listens, makes time, and always follows through on his commitments. It is for these reasons that he has been named a PharmaVOICE 100 for a second time.
Mr. Perkin was appointed CEO at Altasciences in mid-2010. He led the company through a reorganization, and employed an internal Lean Six Sigma program, which reduced costs significantly, improved quality, and reversed a fall in revenue and profitability.
His greatest challenge to implementing this turnaround was to gain the confidence of management and staff. This was accomplished through communication and transparency, by sharing and discussing all aspects of the business, both positive and negative, with senior management, presenting summarized information, including financial performance, to all staff every quarter, and issuing a regular online blog providing business and social updates to all staff.
Mr. Perkin has always strived to create a single, cohesive management team that contributed to the plans and actively implemented them, irrespective of their individual management responsibility. This has resulted in new ideas and approaches and has created an environment that encourages individual contribution.
The integration of Vince & Associates Clinical Research in 2013 and Algorithme Pharma USA in 2014 to the Altasciences family was accomplished quickly and effectively by employing the same principles of information sharing and openness and encouraging the exchange of ideas, technology, and processes rather than mandating them.
The result has been a rapid change in the culture to one that promotes teamwork and allows staff at all levels to admit to mistakes openly and participate in the solutions. Mr. Perkin has been able to establish a culture of trust and growth without changing the core values of quality service, flexibility, and responsiveness.
“The challenge was to learn a new business, recruit additional management expertise, and align and motivate the whole management team in the preparation of a five-year growth plan and its subsequent execution,” he says. “After 35 years in a different sector of the drug development industry, this was an exciting but challenging undertaking. I was particularly impressed that a number of managers from my previous company wanted to join me, and that the existing management actively contributed to and embraced our plans for re-engineering the business. Six years later, we have above plan-growth, including successfully integrated acquisitions, and solid plans for the future.”
Colleagues say Mr. Perkin is very approachable, generous, and transparent in his dealings with both internal and external clients. He sets very high standards and expectations for those around him, and more often than not his expectations are met by a team eager to surpass set standards.
Mr. Perkin wants to be remembered as someone who never compromised on honesty and integrity and was able to encourage and motivate others to achieve more than they expected. He says inspiration is a product of culture plus management style.
“An environment where information is shared, teamwork and collaboration are encouraged and valued, individual responsibility and accountability are freely given, support is always available, and regular feedback is provided, is one that inspires performance and the achievement of high goals,” he says.
He believes good managers provide guidance, time, understanding, and advice to their staff.
“These managers are sought out by others and can be considered a mentor, a title that I think that can only be bestowed by others,” he says. (PV)