Mark Timney
Title: President and CEO
Company: Purdue Pharma LP
Education: Bachelor’s Degree in Sports, majoring in Marketing, Newcastle Polytechnic, (now Northumbria University)
Family: Wife, Michelle; son, Aidan, 12
Bucket List: Attend a European Champions League final, in which Liverpool wins
Awards/Honors: Southeast Asian Pharmaceutical Council — 2014
Associations: BIO and PhRMA
Setting the Tone to Make a Difference
Mark Timney leads by providing a strategic and visionary direction and empowering his employees to be accountable to achieve the company’s objectives and make a difference for patients. As president and CEO of Purdue, he sets the bar high and leads with passion and integrity.
He believes that innovation thrives by creating culture change, helping people to tap into external networks, and enabling them to work more closely with customers and to understand customers’ scientific needs.
Mr. Timney believes it is also important to continually look outside of the company and have the discipline to bring ideas through to a natural conclusion.
He focuses on his people’s strengths and he has a knack for offering encouragement at strategic moments — when the team needs it most.
After an impressive 15-year career with Merck, which encompassed leadership roles in both the United States and abroad, Mr. Timney joined Purdue in 2014.
Among his accomplishments during his time at Merck, he launched an important new hepatitis C treatment and led the acquisition and integration of a company that formed the basis of Merck Ophthalmics.
Another one of his roles involved serving as president of Merck Japan, where he was instrumental in turning 
Merck’s Japanese business around, and moving the unit from No. 14 in the industry to a top five position within two years.
Additionally, during that time he oversaw the launch of the type 2 diabetes medication Januvia in Japan, which is still the most successful launch ever in Japan.
He also served as president of Merck South Korea as well as chair of the pharmaceutical industry organization KRPIA, and it was during this period that he dealt with his most challenging assignment.
On behalf of the industry, he led the pharmaceutical section of the free trade agreement between Korea and the United States, one of the top three agenda items.
“I think that text was and still is the broadest text of any free trade agreement in the area of pharmaceuticals," he says.
His goal at Purdue is to write the company’s next chapter and look for the company’s next innovative product. Mr. Timney understands the importance of providing complete and up-to-date information about the company’s goals, performance, successes, and failures to all levels in the organization.
As an industry, Mr. Timney says it’s important to work closely with customers and patients to overcome challenges. For example, because of Purdue’s long history in pain management, the company knows how to work with key stakeholders to understand both the challenges and benefits of abuse deterrent formulations.
Those who work for Mr. Timney say he is honest, fair, and forthright, and doesn’t ask others to do anything he wouldn’t do himself. When tackling challenges, he isn’t afraid to be decisive and to make tough calls quickly when circumstances require it.
Serving as a member of the boards of both PhRMA and BIO, Mr. Timney demonstrates his commitment to improving the health and well-being of patients. His super power, were he to be granted one, would be to cure all ills and he is committed to health-related charities, including the Ellen Timney Foundation, which is his mother’s foundation for sick and underprivileged children in the northeast of England, and Alex’s Lemonade Stand.
“I’m really inspired by the story behind the founding of Alex’s Lemonade, by a girl who was sick with cancer but fought to make a difference," he says. (PV)
Chris Perkin
Title: CEO
Company: Altasciences (comprised of Algorithme Pharma, Vince & Associates Clinical Research, and Algorithme Pharma USA)
Education: B.Sc., University of Bradford
Family: Girlfriend
Hobbies: Motorcycling, brewing, DIY, camping
Bucket List: Motorcycle across the western
U.S., build a street hotrod, scuba dive in the Maldives
Success Built on Trust
With passion and conviction, Chris Perkin, CEO of Altasciences, is able to create opportunities out of obstacles.
Mr. Perkin took the helm at Algorithme Pharma in 2010 during difficult economic times for the drug development industry. 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. 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," he says.
Mr. Perkin instituted changes that helped turn Algorithme around. These included selective reorganization, the addition of marketing experience, and the initiation of an internal Lean Six Sigma program.
Most critical, though, was gaining the confidence of management and staff. This was accomplished 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 monthly online blog providing business and social updates to all staff.
He and his team have put in place consistent above-expected growth, and he reduced costs and reversed falls in revenue, successfully integrated Vince & Associates, and opened Algorithme USA. Together Algorithme Pharma and Vince & Associates represent one of the largest clinical research services providers in North America, with a focus on early stage development and supporting services. Today, Altasciences comprises Algorithme, Algorithme USA, and Vince & Associates.
Altasciences companies have been recipients of CRO Leadership awards; in 2014 Algorithme Pharma won in five categories, and in 2015 Algorithme Pharma won in five categories and Vince & Associates won in four categories. In November 2014, Algorithme Pharma was also a Grands Prix québécois de la qualité winner; the award acknowledges private companies and government agencies that have instituted rigorous quality-improvement initiatives for all aspects of their operations, and with exceptional results. The awards recognize world-class benchmarks, and are comparable with awards such as the Malcolm Baldrige National Quality Award (U.S.), the European Quality Awards or the Deming (Japan).
Mr. Perkin believes that no matter how bad a situation might appear, working collaboratively to devise a plan will get one back on track.
“If a leader really believes it can be done, then others will get on board and that’s how to succeed," he says.
He holds quarterly all-employee town hall meetings at various times and at different sites to ensure employees understand the company’s financial results and where the business is heading and why.
At Algorithme, one of the biggest concerns in the early clinical testing business is ensuring participant safety as trials become more complex, and new drug classes are introduced.
“It is a continual balance of growth with safety and ensuring that the welfare of the thousands of voluntary participants on our clinical trials remain at the forefront of our plans," he says.
His most rewarding accomplishment was to help build, and eventually oversee, the world’s largest, most diverse and most profitable preclinical contract research facility, CTBR Bioresearch, in Montreal. He joined as a study director in 1988, when there was less than 300 staff, and left in 2010 when there was more than 1,700 staff, multi-year agreements with several large pharmaceutical companies, and a worldwide reputation in the industry for quality, science, and customer service.
Trust is important in managing people, and if someone tells Mr. Perkin they can manage a project or task, he allows them to do so, providing a safety net but not control.
“Giving full responsibility with accountability drives individuals and teams to extraordinary performance, irrespective of age or experience," he says.
One of the greatest rewards, he believes, is to work with people at all levels, and see them grow and often exceed their own expectations.
To Mr. Perkin, inspiration is a product of culture plus management style. An environment where information is shared, teamwork and cross-department collaboration is encouraged and valued, individual responsibility and accountability is freely given, support is always available, and regular feedback is provided, is one that leads to inspired performance and the achievement of high goals, he maintains.
“To encourage innovation, management has to remove the fear of failure and create an environment that encourages and respects ideas and solutions from outside an individual’s area of responsibility," he says.
Mr. Perkin is so committed to promoting an environment that allows staff to acknowledge mistakes openly and participate in the solutions that this approach was incorporated into the company’s value statement.
He has a true open-door policy and a genuine interest in his employees.
“I am fascinated by people who perform incredible feats of physical endurance, whether it is in a survival situation or a planned exploration," he says.
Neill “Gobie" Walsdorf
Title: President
Company: Mission Pharmacal Company
Education: B.S., Advertising, University of Texas, Austin
Family: Son, Travis Max; daughter, Alexandra
Hobbies: Drumming, snow skiing, tennis
Bucket List: Move to Maui
Associations: Consumer HealthCare Products Association (CHPA); University of Texas College of Communications Advisory Board; University of Texas Development Board; Young Presidents’ Organization (YPO) and World Presidents’ Organization (WPO)
Diversification and Growth
Driven by passion and persistence, Neill “Gobie" Walsdorf leads Mission Pharmacal Company to identify and fulfill unmet healthcare needs with high-quality innovative products.
Mr. Walsdorf is the third generation of his family to lead this privately held company, and he has helped it to achieve continued success with revenue at an all-time high.
Passionate about combining the best of Mission Pharmacal’s founding principles with bold new strategies, Mr. Walsdorf has embraced a distinctive barrier-breaking partnership approach.
Proactively seeking new ways for Mission Pharmacal to succeed and bring novel innovations to customers, he had a powerful conversation a few years ago with Terry Herring (a PharmaVOICE 100 honoree in 2007 and 2008) about new directions. Following this discussion, he hired Mr. Herring as his president of commercial operations to carry out his “partnering to diversify and grow" strategic vision.
Together, Mr. Walsdorf and Mr. Herring formed subsidiaries Alamo Pharma Services, a specialized contract sales organization, and BioComp Pharma, a generic drug marketer, to forge national and international partnerships to deliver inventive patient-oriented products and specialized sales support.
Some recent product breakthroughs Mission has delivered include an effervescent oral solution for treating osteoporosis, a protective oral spray with diverse applications for relieving dry mouth, an environmentally friendly diaper rash spray with applications in long-term care as an adult barrier spray, and several kidney stone and urologic solutions — all of which are underserved areas.
In particular, Mr. Walsdorf is focused on new products that provide novel ways to improve convenience for patients, making it more likely they will comply with needed treatment regimens.
As an example, Mission had identified a pressing need among adult incontinence patients, particularly in the nursing home/long-term care market, for a barrier product that would provide a safe, effective treatment option while at the same time relieve irritation, help protect a patient’s dignity, and avoid staining clothing. To address this need in an innovative way, Mr. Walsdorf’s vision was to develop a Dr. Smith’s brand zinc oxide barrier spray that would be effective and easy to apply, providing patients with an alternative to creams and lotions.
“I believe that to be successful in any endeavor, passion keeps you focused and persistent," he says. “Creativity creates movement and defines the person."
Committed to high standards in all things, Mr. Walsdorf is leading the industry to attain higher environmental standards in product innovation, an achievement that has been noticed by the White House.
In September 2014, Mr. Walsdorf and Mr. Herring were invited, along with leaders from much larger companies, to participate in the White House Industry Leadership Roundtable discussion held in Washington, D.C., to discuss ways to curb emissions of hydrofluorocarbons (HFCs).
This invitation followed Mr. Walsdorf’s partnership work with Honeywell and Formulated Solutions to develop three environmentally friendly non-HFC barrier sprays for Mission’s Dr. Smith’s brand with applications in both the adult long-term care and infant markets. These were category-leading innovations that provided more convenience and privacy for patients, and also set new environmental standards for aerosols.
Last fall Mr. Walsdorf and his team launched a new primary care salesforce. This specially trained team brings Mission’s healthcare innovations to more patients in need through general practitioners.
His goal is to build a diverse company that profits on multiple platforms, and one that can be passed on to the fourth generation.
In addition, Mr. Walsdorf is committed to the community. He supports the March of Dimes and the goals it shares with the mission in terms of improving healthcare for moms and babies. He spearheads Mission’s ongoing six-year national sponsorship and inspires employees around the country to host creative fundraisers, participate in various March for Babies walks, and volunteer to help distribute healthcare information.
Mr. Walsdorf also backs his employees and local community in additional volunteer endeavors. An example of this happened when, in 2014, he both personally and corporately offered financial support and words of encouragement for an employee who was nominated as a 2014 Man & Woman of the Year Candidate by The Leukemia & Lymphoma Society.
Dr. Niranjan Sardesai
Title: Chief Operating Officer
Company: Inovio Pharmaceuticals
Education: MBA, Executive Program, The Wharton School, University of Pennsylvania, 2006; Ph.D., Chemistry, California Institute of Technology, 1995; M.Sc., Chemistry, Indian Institute of Technology, 1989
Family: Wife, Gargi Maheshwari; two sons, Aditya, 13, and Arnav, 10
Hobbies: Travel the world with family, hiking, tennis
Bucket List: Climb Mt. Kilimanjaro, run a marathon, travel the silk route through central Asia
Awards/Honors: Vaccine Industry Excellence Awards — Best Therapeutic Vaccine Award to VGX-3100 (therapeutic vaccine to treat cervical dysplasia), 2013, 2014, 2015; Best vaccine licensing deal, 2014; Best early stage biotechnology company, 2010, 2013, 2014; Fierce Vaccines — Top 10 Therapeutic Vaccines Award to VGX-3100
Associations: Bio VPAC Member; American Chemical Society; International Society for DNA Vaccines; International Society for Vaccinology; Alumni Associations of Caltech, Wharton, and IIT-Bombay
Harnessing the Immune System
Considered a world leader in vaccine development and immunology research, Niranjan Sardesai, Ph.D., has successfully navigated both the business side and the scientific side of the biotech world. Over the past 15 years, Dr. Sardesai has led the early-stage development and mid-tier growth of two leading biotech companies — Inovio Pharmaceuticals and Fujirebio Diagnostics.
Dr. Sardesai joined forces with Dr. J. Joseph Kim, a 2013 PharmaVOICE 100 honoree, in 2006 to help shape the start-up company, VGX Pharmaceuticals, which later became Inovio Pharmaceuticals.
Initially, VGX Pharmaceuticals was focused on small molecule therapeutics to tackle HIV and HCV. Teaming with Dr. Kim, Dr. Sardesai repositioned the company to a pure play DNA-based product development company. He has taken Inovio from a company of 15 employees to more than 130 employees across two sites — San Diego and Philadelphia — and three M&A transactions to support the company’s growth and transformation.
He also raised more than $100 million in non-dilutive capital through government and non-government grants and contracts.
Dr. Sardesai successfully brought Inovio’s lead product, VGX-3100, through preclinical development into
successful Phase I and Phase II clinical efficacy studies for the treatment of HPV-associated pre-cancers and cancers. The product, which is expected to enter Phase III clinical studies in the near future, has the potential to provide an immunotherapeutic (non-surgical) alternative to treating women with high-grade cervical dysplasia.
He has been instrumental in developing and commercializing cancer diagnostic tests for mesothelioma and ovarian cancer, and he has led the development of Inovio’s DNA-based immunotherapeutics platform to address multiple cancers and infectious diseases.
Driven by Dr. Sardesai’s passion, Inovio Pharmaceuticals has the potential to unleash the power of immunotherapy through the development of products that stimulate antigen specific T-cells with killing activity — T-cells generated by the body’s own immune system that can seek and destroy infected cells or cells transformed into cancer cells.
Indeed, it is Dr. Sardesai’s goal to harness the body’s immune system to address the underlying causes of disease, and to develop life-saving immunotherapies and vaccines for cancer and infectious diseases.
Inovio holds a broad pipeline of new DNA-based medicines treating a variety of cancers, including prostate, cervical, breast, lung, and pancreatic cancers, and infectious diseases such as HIV, hepatitis B and C, and ebola.
Dr. Sardesai says establishing collaborations early and often to drive scientific innovation and product development has been integral to Inovio’s success in being able to advance rapidly on multiple product programs even for a small company.
Adopting an inclusive leadership style, where there are no bad ideas, and building a team-focused work culture has helped Inovio to hire and retain top talent from major universities and pharma to drive product development. Dr. Sardesai has cultivated an open and relatively flat organization where there is a passion for problem solving and recognition of diverse points of view.
He is focused on doing what it takes to get things done in the pursuit of developing life-saving products, which has enabled Inovio to build an entrepreneurial and dynamic work culture across its organization.
“I am fortunate to be surrounded by an excellent team of colleagues, all working together on problems that will have a huge impact on human life," he says.
Dr. Sardesai has published more than 100 peer-reviewed publications and book chapters; he has presented more than 120 lectures and invited talks worldwide, and has nine granted patents and filed more than 70 patent applications worldwide covering novel immunotherapy and vaccine candidates as well as medical devices.
He teaches vaccine development and business courses as a visiting lecturer at Tufts University and Rutgers University and mentors business leaders and immunology students at The University of Pennsylvania.
Even with such a busy life, Dr. Sardesai and his family are dedicated to Manavya, a first-of-its-kind orphanage for HIV positive children in Pune, India, both as volunteers and with financial support. In particular they are focused on developing computer literacy among the Manavya children and enabling their connectivity to the global village.
Lisa Giles
Title: CEO
Company: Giles & Associates Consultancy Inc. and Optivara Inc.
Education: B.S., Juniata College; EMP, Stanford and University of Chicago
Family: Husband, one dog
Hobbies: Tennis, hiking, adventure travel, oil painting, and gardening
Bucket List: Travel throughout South America, Middle East, and Africa; learn to speak French fluently
Awards/Honors: 2010 Enterprising Women of the Year
Associations: Board of Directors of GenMark Dx; Board of Director Trustee, Northwestern Memorial Healthcare Foundation; Emeritus Auxiliary Board of Director, Art Institute of Chicago
Spurring Innovation through Strategy
Uncertainty does not intimidate Lisa Giles. Her confidence in being able to figure out how to convert uncertainty into positive scenarios engages people.
Ms. Giles established her own boutique strategy firm Giles & Associates Consultancy 15 years ago to help clients optimize the commercial potential of their R&D pipelines.
Ms. Giles and her team have tackled many challenging client assignments since then, from prioritizing growth opportunities across 80 unique technologies in 190 countries, to optimizing the sequence of diverse indications for product development of a novel mechanism of action that has applicability across many disease areas. Her breadth of knowledge across therapeutic areas is enormous and her to identify analogues, current trends, and likely future states, to flag opportunities and challenges her clients may encounter.
“I am constantly evaluating how to evolve our services and products to better address our clients’ needs," she says. “Often, clients are looking only from one vantage point. We have the opportunity to use our broader perspective and understanding of the intersection between the provider and supplier sides, be it — therapeutics, medical devices, diagnostics, or alternative medicine — but we have to be creative and assemble meaningful information to reveal the full picture and why it matters to their success."
Throughout her career as a strategist, Ms. Giles has a track record of spurring innovation, translating research from the lab to the patient, and creating shareholder value. She frequently operates at the intersection of research and commercialization, helping to set executive level strategy, to align organizational priorities and investments, and to design and deploy innovation processes. Her firms serve clients ranging from large and small biopharma, diagnostics, and devices to academic research centers.
She realizes that looking forward sometimes requires the ability to examine past practices and benchmarks to 
draw lessons for the future. Her strategic thinking, knowledge, and relationships with the global life-sciences industry bring enormous value to the business and to healthcare providers. As an example, while tackling the launch planning of a new drug perceived as quite similar to other marketed products, Ms. Giles led a team that helped maximize clinical and commercial potential by crystalizing key points of differentiation. The product was then effectively marketed to broader patent segments for use in defined areas of competitive advantage, and clearly demonstrated improved patient outcomes.
As an outgrowth of her consulting work, Ms. Giles launched a sister company, Optivara, in 2013, focused on providing technology-based platforms to clients to accelerate the efficiency and effectiveness of building portfolio strategies, and planning for and optimizing launches. Optivara develops, implements, and supports a suite of proprietary products and services designed to address strategic growth questions where knowledge management, information synthesis, and advanced analytics are required.
“I enjoy finding ways to effectively address our clients’ challenges and optimize their opportunities through new approaches and ideas," she says. “I am blessed to do interesting work with a terrific team of people."
Before establishing her own company, Ms. Giles enjoyed a very successful career on the client side of pharma, including as VP of strategy at Searle, where she was intimately involved in the merger with Pharmacia.
Described as a master networker, Ms. Giles has created an agile consulting delivery model that effectively leverages consulting staff with networks of experts from across the life sciences. Her ability to quickly assemble the right senior level team for major strategy projects is another competitive advantage for the firm.
She inspires those around her by constructing a framework to explore concepts, encouraging brainstorming and out-of-the-box thinking, and encouraging people to use their innate gifts.
“I enjoy helping people see options, envision, and articulate views of the future, and create ideas about how to positively participate in the future state," she says. “I am not intimidated by uncertainty. I have confidence in our ability to see through cloudiness to define viable options to help our clients be the most successful."
She approaches each project with optimism and greets new ideas openly. Leading a company requires a fine balance of responsibility and letting go, Ms. Giles says.
Dr. Jules Mitchel
Title: President
Company: Target Health Inc.
Education: Ph.D., New York University; M.S., University of Oregon; MBA, Pace University; B.S., Queens College
Family: Wife, Joyce; and four children, Alex, Daniel, Rachel, and Vanessa
Hobbies: Going to the theater and opera and walking with the wildlife in New York’s Central Park
Bucket List: Learn to sing
Awards/Honors: Certificate of Appreciation In Recognition of Outstanding Service and Contributions on Behalf of CTTI (Clinical Trials Transformation Initiative), Sponsor of the Year from the Center for Dermal Research, Leaders Society from Dermatology Foundation
Associations: ASCPT, ASCO, AUA, CTTI, ACRP, DIA
Tweet: @julesmitchel
Paperless Clinical Trials
When Target Health was established in 1993, when Jules Mitchel, Ph.D., was tasked to do address trials in the eWorld. He did that and more.
Today, Target Health has a full software suite supporting the paperless clinical trial, and has supported multiple FDA submissions with more to follow. The company has also gained deep interest from both sponsors and technology solution providers.
Under his leadership, the company recently submitted the industry’s first Web-based eSource FDA submission for an important medical device — direct entry of patient data at the time of office visit into the company’s proprietary EDC system, Target*CRF. This will pave the way for broader industry adoption of the company’s eSource methodology.
But it hasn’t been easy sailing, with the most difficult aspect getting the pharmaceutical industry to embrace the transition from a paper-based, record-keeping system to the paperless clinical trial. It remains his goal to have the industry embrace Target Health’s software solution to the paperless clinical trial.
The company continues to deliver metrics to show that its eSource solution tied in with its novel approach to risk-based and central monitoring can revolutionize clinical research operations.
Through vision and perseverance, Dr. Mitchel, a PharmaVOICE 100 honoree in 2014, has introduced a simple, pragmatic innovation that has the potential to transform clinical development operations.
When sites and sponsors are spending less time entering and checking data multiple times, the focus can be shifted to patients so that resources can deployed to ensure faster completion of clinical trials and faster submission, and subsequent approvals of new drugs that cost less money to develop.
Dr. Mitchel’s knowledge of clinical research and understanding the needs of all of the stakeholders make his innovations and transformational approaches pragmatic to the pharmaceutical industry.
Dr. Mitchel shares his passion for science and the pharmaceutical industry and how Target Health can make a difference, and he inspires by being himself and being honest.
One of his main concerns is making sure that the right leaders are in place so that long-term planning becomes the norm rather than the quarterly report.
Humble in his approach to leading, Dr. Mitchel says there is no hierarchy when it comes to innovation.
“We empower our staff to come up with novel ideas to solve problems and to optimize outcomes by working on teams," Dr. Mitchel. “And we let everyone know that it is ok to fail as long as you learn from failures."
Taking a progressive approach to life, Dr. Mitchel says he would change nothing about his career choices, noting that life is a process that always builds on the past. But he might tell his younger self that while it’s okay to have your head in the clouds, it’s important to make sure your feet are on the ground and never quit.
A pragmatist, Dr. Mitchel says if he could he would control population growth so there would be no shortages of food, water, and energy.
His talent extends into many other areas in life, and in high school Dr. Mitchel was an All-City Honorable Mention basketball player in New York City.
Michelle Keefe
Title: President and CEO
Company: Publicis Touchpoint Solutions Inc.
Education: B.A., Marketing, Seton Hall University
Family: Husband, Ralph; daughter, Taylor; and three dogs
Hobbies: Golf, travel, New York Yankee’s baseball
Bucket List: Skydive, race in an Indie 500 car, and attend The Masters Tournament, go
on an African safari, and traveling to
Australia, including sailing on the Great Barrier Reef
Awards/Honors: PharmaVOICE 100 — 2014, 2015; Visiting Nurse Service of New York’s CEO Innovation Award; Pfizer Hall of Fame
Associations: Healthcare Businesswomen’s Association (HBA)
Tweet: @pTouchpoint
Leading with Purpose and Sincerity
Since her promotion to president and CEO, Michelle Keefe has been taking Publicis Touchpoint Solutions to a new level thanks to her innovative, strategic, decisive, and yet, engaging and thoughtful leadership style. The promotion has been her biggest career highlight to date, and she is deeply grateful to her mentor and predecessor Rick Keefer for his guidance.
“When Rick recruited me to Touchpoint, he had a focused succession plan that really set me up for success in this position," she says.
Her goal is to continue Mr. Keefer’s legacy by driving double-digit business growth and continuing to innovate Touchpoint’s offerings while exceeding clients’ expectations.
Colleagues describe her knowledge of the industry and ability to predict trends as inspiring and motivating.
She sets the bar high in terms of how the organization respects and treats its customers, how Touchpoint strives for executional excellence with both its relations and its results, and how it values its people.
She focuses attention on the difference the agency makes in healthcare communications by the simple fact that
it ensures effective delivery of life-changing messages. It’s a message that resonates well within the organization and carries through in employee engagement and commitment. And she seeks and leverages differences in thought, perspective, and experience when developing approaches to issues and solving problems.
Her approach to problem-solving and needs assessment results in changes to the benefit of all those involved, whether it’s a creative solution to a client need, identifying an area of opportunity, or implementing a new approach toward an ongoing challenge.
Before joining Touchpoint, Ms. Keefe was VP of market development for Visiting Nurse Service of New York (VNSNY), a nonprofit organization that provides health services for people who often fall through the cracks in the healthcare system.
“This was a completely different industry, sector, and business model than my experience with big pharma," she says. “My role was to help the organization build its business development function and put processes in place to ensure appropriate utilization of services and payer verification so that the organization was able to use the revenue to focus on delivering charitable care and programs to New York City residents in need."
She sees the enormous value the industry has created over the past few decades, with improved life expectancy and improved outcomes for those with cancer. The future for pharma is to continue to invest in critical life-saving and life-extending medicines while focusing on the cost and quality of care.
The ability to fail fast is a gift, Ms. Keefe says, and every experience — negative and positive — contributes to career development.
“By embracing change and looking forward to the next challenge you become a stronger leader," she says.
Ms. Keefe is passionate about contributing to the development of future business leaders.
“This year I have volunteered as an executive mentor for the Healthcare Businesswomen’s Association’s Metro Chapter Mentoring Program and this experience has made me realize how much I love to advise and guide emerging talent," she says.
At Touchpoint, she fosters a positive culture and seeks to create an environment that enables others to do their best work and provide stretch assignments while supporting employees in their development.
“We hold enterprisewide monthly town hall meetings where we challenge our people to ideate about ways we can innovate our business model," she says. “This is a small competition that produces exceptional ideas."
She believes that the best way to inspire others is to help them recognize their own strengths and desires and then support them in achieving their goals.
Encouraging work/life balance, Ms. Keefe evaluates deliverables/results rather than focusing on traditional work hours and face time. This goes a long way to create a culture of retention and loyalty.
Ms. Keefe draws inspiration from her mother, who put herself through nursing school, earned a master’s degree and became a professor at the College of Staten Island, and is an author of a number of textbooks in nursing that are still in use today.
In addition to her own philanthropic commitments, Ms. Keefe encourages a culture of giving back at Touchpoint.
“We also hold several Touchpoint Volunteer Days per year where our employees can participate in a group volunteer activity in the community, while still getting paid for the day," she says.
Dr. Bruce Feinberg
Title: Chief Medical Officer and VP, Clinical Affairs
Company: Cardinal Health Specialty Solutions
Education: D.O., Philadelphia College of Osteopathic Medicine; Certifications: Internal Medicine, Medical Oncology; M.A., Molecular Biology, Temple University; B.S., Biochemistry, Dickinson College
Family: Wife, Iris: four children: Jon, Michael, Rachel, Daniel
Hobbies: Pilates, swimming, running, going to the gym, hiking, biking, radio host, writing, playing the piano, reading, crosswords
Bucket List: Write a book, trek the Inca trail to Machu Picchu, hike the Three Towers in Patagonia and the Milford Track in New Zealand, visit Galapagos Islands — all completed
Awards/Honors: Advancement Patient Services Award, Community Health Charities of Georgia, 2003; Excellence in Leadership Award, 2003; Chief fellow at M.D. Anderson Cancer Center in Houston, 1986-1987; Chief resident at Delaware Valley Medical Center, 1984-1985; Doctor of Laws, honorasis causa, Philadelphia College of Osteopathic Medicine, 2015.
Associations: President, Georgia Cancer Foundation, 1998 – 2004; board member, American Cancer Society, Georgia Division, 1995 –2002; board member, American Cancer Society, 1994 – 1997; president, Rockdale County Chapter; DeKalb Medical Society; ASCO; AMA; Southern Association of Oncology; American Osteopathic Association; Georgia Society of Clinical Oncology
Tweet: @WeeklyCheckup
Driving a Healthcare Vision
Few people have contributed more to the fields of oncology and outcomes research over the past 25 years than Bruce Feinberg, D.O.
His role at Cardinal Health as chief medical officer and VP, clinical affairs, is his first in industry, having spent 25 years as a practicing physician, teacher, practice managing partner, and concurrent serial entrepreneur and author. But he says he can’t imagine another corporate role that would be more rewarding.
A board-certified oncologist, Dr. Feinberg is widely recognized for his visionary leadership in improving the quality and consistency of care — and reducing costs — for patients with cancer and other complex diseases. For more than 20 years, Dr. Feinberg served as founder and CEO of Georgia Cancer Specialists (GCS), one of the first and largest integrated oncology specialty practices in the United States. While at GCS, he led dozens of clinical research trials that resulted in the institution of new treatment protocols for oncology care. He also pioneered outcome measurement tools for medical oncology and clinical practices to promote the delivery of high-quality, cost-efficient patient care. In addition, Dr. Feinberg has been instrumental in the advancement of clinical pathways and the development of cloud-based clinical decision support tools to support those pathways.
Dr. Feinberg believes inspiring others comes through creating actionable ideas, having a future vision, and being able to communicate a compelling narrative, which he tries to do in all aspects of his life.
An example is his work with clinical pathways. For Cardinal Health’s healthcare delivery system to undergo meaningful change, Dr. Feinberg says there has to be consensus around the problems, recognition that change is needed and possible, belief in proffered solutions, and a willingness to invest in the process to make solutions actionable.
“Over the past five years, I have been fortunate to have the trust and support of colleagues and clients to implement clinical pathways in oncology and rheumatology and publish those results to contribute to the ongoing discussion about healthcare reform and value-based care," he says.
Dr. Feinberg believes much needs to change in healthcare.
“I believe innovation is the only way to create a new reality for healthcare — it’s the only way to improve the quality of care all patients receive, in a sustainable way," he says.
Dr. Feinberg says through Cardinal Health’s involvement across the industry, there is a real opportunity to make meaningful contributions to healthcare reform. He recognized that high-level, peer-reviewed, and reputable journal published data would be needed to achieve broad consensus among stakeholders. The senior leaders at Cardinal Health supported this vision and, since 2012, he and his colleagues have contributed more than 75 citations to the literature of healthcare reform and value-based care.
As a passionate advocate for bringing real-world evidence into the clinical setting, Dr. Feinberg is helping to shape a new dialogue among healthcare providers, pharmaceutical manufacturers, and payers about the role of real-world data in guiding more effective and affordable patient care.
The journey to reform is a marathon, not a sprint, Dr. Feinberg maintains, and he remains focused on tackling future opportunities such as practice transformation networks; oncology-care model medical homes; a national rheumatology medical home; and real-time, point-of-care decision support software, among others.
He is excited about medical breakthroughs in recent years in areas such as imuno-oncology, virology and vaccines, which he says have introduced unprecedented value not seen since the golden era after World War II.
His professional goal is to embrace the Mishnah (Jewish oral law) expression Tikkun Olam, which roughly translated means healing the world. The basic concept is to see illness not just on an individual level, but on a societal and universal level and live life in a way that contributes to its repair. He is focused on research and development of healthcare delivery models that improve health through better treatment at lower cost.
Dr. Guillaume Leroy
Title: VP, Dengue Vaccine, Sanofi Pasteur
Company: Sanofi Pasteur, Sanofi group
Education: Ph.D., Pharmacy, Rouen, France; MBA, Marketing & Health Organizations, ESCP, Paris; Executive Development Program, Wharton School, Philadelphia
Family: Married; two children, 15 and 10
Hobbies: Oenology, cooking, golfing
Bucket List: Cross the Atlantic on a sailing boat with friends, bike across the Atacama Desert in South America, teach or mentor about public health, own a vineyard somewhere in the world
Associations: Bristol Who’s Who List, International Trade Advisor to French Government in Mexico
Champion for Life-Saving Public Health Programs
Public health has a dedicated ambassador with Guillaume Leroy, Ph.D., whose commitment to developing alliances between public institutions and private companies is delivering huge health benefits.
Since embarking on his career at Sanofi Pasteur — then Pasteur Mérieux Serums and Vaccines — in 1993, Dr. Leroy has played a key role in establishing the company’s public health partnership role both from leadership positions within four different countries in Latin America, as well as from the company’s headquarters in Lyon, France, where he is currently driving the global launch of the world’s leading dengue vaccine candidate.
During his time in Mexico, he was able to quickly build the type of partnerships needed to drive change and advance the public health agenda locally as well as throughout the rest of Latin America. Being fluent in Spanish and Portuguese, he was able to foster collaborations between key Mexican public institutions, the national vaccine manufacturer, and universities, such as Instituto Politécnico Nacional. These types of agreements allowed for the development of Phase I, II, and III vaccine studies, production facilities, and HR capabilities to address public health needs in Mexico.
Some of his other major accomplishments included the introduction an acP-IPV combination vaccine on the Mexican Immunization Program in 2007, the first such program in Latin America; supporting the national recommendation and introduction of the influenza vaccine; and the introduction of the Pneumococcal 23 valent vaccine.
In 2007, when several Mexican towns were hard hit by a major storm, Dr. Leroy galvanized the company to 
supply the townspeople with thousands of doses of hep A vaccine, free of charge. Later, when he had been promoted to VP of Latin America, but was still based in Mexico, he again rose to the occasion in the face of disaster, by contributing to an unprecedented response to the H1N1 pandemic in the region and securing millions of doses of vaccine, which led to mass vaccination programs in countries such as Brazil and Mexico.
Dr. Leroy is proud of what he and his team achieved in the Latin American business unit, including developing key talent, ensuring sustainable growth for the region, and setting up successful public private partnerships in different countries.
Following this legacy in Latin America, Dr. Leroy returned to France with his family in 2012 to lead the launch of Sanofi Pasteur’s leading dengue vaccine candidate. As head of the newly formed Dengue Company, he had his work cut out for him. For starters, the dengue vaccine project would soon find itself at a precarious crossroad, due to less-than-stellar Phase IIb results from a study in Thailand. Dr. Leroy would have to decide whether or not to continue with development or cut the company losses and scratch the project altogether, despite an upfront investment of 300 million euro in a dedicated production facility for the vaccine.
True to his public-health spirit, Dr. Leroy rallied his organization to move forward given the critical unmet need and the growing public health threat that dengue represents.
“We continued to hire new people and grow the organization, and kept our focus on our ultimate goal to make dengue the next vaccine-preventable disease," he says.
Last year, the company received successful results for its Phase III efficacy trials, opening the road for licensure and first access to the innovation in endemic countries. The experience taught Dr. Leroy that focus and taking informed risks are keys to success.
“As we approach first licensure for the dengue vaccine and are one step closer to realizing our commitment to bring innovation to address unmet needs in emerging and middle-income countries, I am proud of the team’s resilience in the face of uncertainty," he says.
The Dengue Company continues to face a major yet exciting challenge. The company’s mission with the dengue vaccine is to “flip" the innovation model and ensure that the vaccine is available first to those populations in endemic regions at greatest risk. Typically, new vaccines are launched first in developed or mature countries that have advanced healthcare systems and then products are made available some five to 10 years later to low- and middle-income countries even if this is where the bulk of the unmet need exists.
This is uncharted ground and it will require strong partnerships, local relationships built on trust, and a long-standing commitment to public health to make this a success.
“Innovation happens when people have a common goal, when they bring diverse experience and thinking to achieve that common goal," he says. “I see my role as enabling organizations to work together based on mutual respect, trust, and sharing of ideas."
Matt McNally
Title: President
Company: Publicis Health Media
Education: B.S., University of Delaware
Family: Partner, Ralph Bassett
Hobbies: Running, house renovation
Bucket List: Take a trip to the Maldives
Awards/Honors: PharmaVOICE 100 — 2014; MM&M Agency Marketer of the Year, Silver award 2014; Clio Healthcare Awards 2014 Best Integrated Campaign, Crossroads Community, in partnership with Saatchi & Saatchi Wellness
Associations: Philadelphia Interactive Marketing Association; Google Health Advisory Board, Big Brothers Big Sisters Southeastern Pennsylvania Board of Directors
Tweet: @MattMcNally4
Media + Creative = Reinvention
By rewriting what pharma could do in the world of advertising, Matt McNally is creating a new generation of incredible thinkers at Publicis Health Media (PHM).
As president of the company, Mr. McNally has focused on re-inventing what media is in the health and wellness space. He transformed media from being a commoditized business focused on buying space, to a strategic function that brings media into the spotlight of the planning process and includes developing and brokering content. Under his leadership, the company has secured media agency of record status with a number of pharmaceutical companies and has introduced some of the most innovative programs in the space today.
His vision for a consolidated media strategy and buying within the Publicis Healthcare network has transformed the way the company partners with publishers within the industry and the solutions it brings to clients.
His grasp of the fast-moving media landscape, coupled with his vision for the future and ability to lead through change has made PHM a standout success and tremendous engine for future innovation at Publics Healthcare today. Launching PHM, expanding the team to more than 200 people, and achieving double-digit revenue growth over the past three years have been true career highlights for Mr. McNally.
“We have dedicated subject matter expert groups across 18 different areas such as social, point of care and connected TV, which were developed to fuel innovation," he says. “We also recognize and celebrate innovative work and team members."
This year, he worked with sister agency Vivaki to introduce programmatic advertising to the pharmaceutical, health and wellness sector, while encouraging adoption of the practice among health publishers and client companies.
He is steadfast in his commitment to deliver against client priorities, team development, and industry progress. Indeed, countless brands have benefited from Mr. McNally’s ability to navigate the delicate balance of analytics and creativity. He challenges conventional wisdom to create a great product that pushes his clients further into the future.
That’s where the challenge can sometimes lie — encouraging brand teams to take risks.
“Change is never easy; often people are more comfortable doing what is tried and true, versus trying something new," he says. “I love partnering with clients, encouraging them to step outside of their comfort zone and be leaders in their field."
Completely in touch with the consumer, Mr. McNally is able to think through how media placement can inspire consumers to take their healthcare decisions into their own hands and, in so doing, he helps to create a more educated and empowered consumer.
“It’s about providing customers with what they need, not what a company wants to tell them," he says. “We are too focused on marketing messages and selling product versus delivering true value beyond our products."
People are the most important asset to Mr. McNally, who has built an organization and culture of mentoring and teamwork. He says he once changed jobs for money, which was the biggest mistake he ever made.
“I quickly realized it is more about the people you work with rather than the paycheck you bring home," he says.
Mr. McNally has a natural way of energizing and inspiring his teams to not only put forward their best effort but to go above and beyond, and without having to directly ask anyone to do so. He always challenges his teams to think past the way they have always done things, empowers the team to innovate and come up with new solutions, and gives the team credit where it is due.
“I often say, it takes a village, and my team, clients, and publisher partners know that I am in it 100% with them," he says.
Mr. McNally has also made it his mission to positively impact at-risk children in the Greater Philadelphia area by joining the governing board of directors of Big Brothers Big Sisters Southeastern Pennsylvania. As one of the newest members of the board, joining in 2015, he has made an immediate and significant impact by providing guidance, offering resources, and securing new relationships to help the nonprofit serve the more than 200,000 children in need in the community.
He was 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. Mr. McNally has also lent his professional expertise to the organization’s cause by securing more than $1 million of pro-bono media placement and advertising to be used for a 100-year anniversary marketing campaign. The crux of this campaign is to raise awareness and recruit volunteers to help mentor youth. In addition, he has made financial contributions to help remove kids from the waiting list to join the program, serves on one of the largest fundraising committees, and provides facilities for the organization to host meetings with community members and supporters.
Dr. Stuart Peltz
Title: CEO
Company: PTC Therapeutics Inc.
Education: Ph.D., McArdle Laboratory for Cancer Research, University of Wisconsin; B.S., University of Illinois, Champaign-Urbana; Chemistry
Hobbies: Reading, movies, wine, architecture, art, travel, and sports
Bucket List: Design and help build his next house; spend winters in a warm place; get back in shape; play a lot of basketball; own a nice RV to drive around the country trying different diners, drive-ins, and dives
Awards/Honors: 2014 Dr. Sol J. Barer Award for Vision Innovation and Leadership; 2014 Legend of Technology Award — New Jersey Technology Council; 2014 Outstanding Innovation Award — Rare & Orphan Advocacy and Research (ROAR)
Associations: Chairman, BioNJ; Fellow of the American Academy for the Advancement of Science; Board of directors for the Biotechnology Industry Organization (BIO); BIO’s Emerging Companies Section Governing Board
Concept to Commercialization
Through innovation and limitless passion, Stuart Peltz, Ph.D., has led PTC Therapeutics in the development of a rich pipeline of therapeutic molecules targeting rare and neglected diseases.
Dr. Peltz is the co-founder and driving force behind the company’s mission to leverage its knowledge of RNA biology to bring novel therapeutics to patients affected by rare and neglected disorders.
He challenges the organization to move faster, think bigger, and not accept no in its quest to bring important treatment options to patients.
PTC Therapeutics was born from cutting-edge science that Dr. Peltz researched during his years as a professor in the Department of Molecular Genetics and Microbiology at Robert Wood Johnson Medical School, Rutgers University.
Dr. Peltz recognized the potential of post-transcriptional mechanisms to advance medical science and help patients in need. His work was instrumental in identifying and characterizing components of multiple mRNA decay and translation pathways.
“Learning and embracing all disciplines involved in building an organization with a strong pipeline of products to treat rare diseases has been the most challenging aspect of my career," he says.
Very few biopharma CEOs have the opportunity to take their own scientific idea from a concept to a commercialized treatment therapy sold around the world.
In 2014, PTC Therapeutics saw the first fruits of its labor when its lead product Translarna was approved in the EU as the first treatment for Duchenne Muscular Dystrophy (DMD). Dr. Peltz describes receiving approval for the treatment as a great thrill.
PTC Therapeutics continues to advance its research pipeline with programs in other genetic disorders, oncology, and infectious diseases. PTC became a publically traded company in 2013, and in 2014 completed two successful follow-on offerings, raising net proceeds of about $236 million.
The funds allow the company to independently commercialize Translarna, investigate new indications for Translarna, and continue to advance the exciting programs in the pipeline.
Dr. Peltz’s goals are to make Translarna available to patients across the globe and to work to bring multiple innovative products to patients. He wants to continue building PTC Therapeutics to benefit the patients, allow employees to grow and develop, and bring value to investors.
Dr. Peltz embeds a culture of creativity, collaboration, and caring for employees and patients alike. He has established an environment that encourages risk taking, making sure employees know their ideas matter and letting their ideas be shared with the team. This leadership approach has a tremendous positive impact on the organization, in that every employee feels valued and motivated to do their best.
“I try to be both realistic and optimistic," he says. “I try to see the best in people and situations, while being critical, but not cynical. I try to get the team to dare to do great things, to take risks."
He cares deeply about the communities that PTC’ Therapeutics’ medicines are aimed toward. Dr. Peltz actively works as an ally with the Duchenne patient and caregiver community.
Dr. Jean Pierre Wery
Title: President
Company: Crown Bioscience Inc.
Education: Ph.D., Universite of Liege, Belgium; PostDoc, Purdue University
Family: Married; two children
Hobbies: Reading, traveling
Bucket List: Visit as many countries as possible
Designing a Platform for Discovery
Jean Pierre Wery, Ph.D., is striving to provide a solution to one of the biggest challenges faced by drug developers — high attrition rates during clinical trials.
He has been instrumental in inaugurating Crown Bioscience’s leadership in the field of preclinical translational services and in assisting clients to identify and accelerate their most promising drug candidates into the clinic.
Despite the emergence of numerous novel drug treatment candidates with significant potential in the fight against cancer, the rates of attrition during clinical trials have risen to between 90% and 95%.
Dr. Wery has a unique perspective on the situation and understands all too well that the rising costs of developing new treatments is accompanied by a decreasing return on investment for shrinking patient populations with relevant tumor types.
With a commitment to establishing Crown Bioscience as a worldwide provider of preclinical services for the advancement of effective therapeutic development in oncology, he has led the development of the company’s innovative platforms, enabling the identification of drug targets for novel candidates while allowing previously abandoned compounds to undergo parallel screening under multiple conditions, to ensure that the potential of effective therapeutics is not lost or ignored.
In 2008, he oversaw the creation of Crown’s oncology platform and then the subsequent launch of the company’s metabolic diseases platform in 2010. Since then, Crown has offered its services to more than 300 companies and research institutions worldwide.
Possibly the greatest of Dr. Wery’s achievements has been the adoption of Crown’s surrogate testing platform using patient-derived xenografts (PDX) and genetically engineered mouse models.
First-generation PDX models are generated by grafting human tumor tissues into immunodeficient mice. As the human tumor develops, drug candidates can be administered to the surrogate to test the efficacy and safety of the active compound without interference from the animal’s immune response.
Dr. Wery has further assisted in the evolution of the platform through to Phase II of the HuPrime collection.
HuPrime Mark II models include rare tumor types and models with acquired-resistance to drug treatment for experimentation with previously failed candidates and combination therapies. In April 2014, Crown’s HuPrime collection passed the 1,000 model mark, providing clients with access to a larger collection of tumor types and allowing them to make better informed preclinical decisions on prospective drug candidates.
His drive to establish Crown’s global offering represents both his personal and Crown Bioscience’s corporate commitment to assisting academic institutions and pharmaceutical companies in relegating cancer to the status of chronic disease.
Furthermore, in 2015 Dr. Wery negotiated the acquisition of the assets of Molecular Response and overnight Crown’s collection became the largest and most clinically diverse collection of preclinical models in the world.
With the emergence of immunotherapy as a treatment paradigm in oncology, Crown needed to further develop its line of PDX models, as the effective screening of immunotherapeutics requires functional immunity in the test subjects. Dr. Wery is leading the development of HuPrime Mark III models, which incorporate both mouse and human immunity to more accurately simulate the mechanisms of response to immunotherapeutic treatments.
Having established a partnership with the NCRMM in 2014 to provide Crown with immunocompromised mice for the creation of PDX models, Dr. Wery led negotiations in expanding the original agreement to include the generation of immunocompetent mice for use in immunotherapy studies.
The new agreement, signed in 2015, will ensure that Crown can provide immunotherapeutic developers with patient relevant models that can evaluate targets for their new and novel candidates.
Despite these achievements, Dr. Wery says the transition from science to business and management has been a challenge.
Dr. Wery joined Crown Bioscience from Vitae Pharmaceuticals, where he was VP of computational drug discovery. Before that he had worked for Eli Lilly and Company for more than six years as head of the information science and computational chemistry departments.
As an industry leader, he has regularly offered his invaluable insights into both the pharmaceutical market and the complex process of drug development in oncology and metabolic disease.
Additionally, through participation in high-profile clinical discussions he has actively promoted the sharing of knowledge and expertise between key figures in the industry.
His passion for assisting clients and the wider life-sciences community can only be matched by his commitment to fighting cancer and improving outcomes for patients throughout the world.
Dr. Wery inspires his teams by believing in their capabilities and by listening and respecting others.
Keith Stenlund
Title: Chief Financial Officer
Company: AbelsonTaylor Inc.
Education: B.S., Accountancy, University of Illinois; CPA, Urbana-Champaign, School of Business
Family: Wife, Amanda; son, Henry
Hobbies: Cooking and brewing beer, including growing his own hop vines
Bucket List: Space travel; see the Aurora Borealis; travel to see Mt. Everest and the other major mountain peaks
Awards/Honors: PharmaVOICE 100
Tweet: @theKRS1
Taking the Agency to New Heights
Ethics and transparency are front and center for Keith Stenlund. As chief financial officer for AbelsonTaylor, he believes these principles — embedded in a purpose-driven culture — not only benefit clients, but also lead to the long-term success of the agency.
In 2006, when Mr. Stenlund joined Abelson Taylor, the agency was located in an outdated building, growing quickly but without a plan to accommodate the fast-moving changes. He recruited individuals from various departments, solicited their input, and built a team to create a plan for growth. In the process Mr. Stenlund saw how everyone collaborated and discovered the agency’s purpose-driven culture. He used that knowledge to get consensus on a plan and find offices that would accommodate the agency’s growth now and into the future, transforming AbelsonTaylor into the agency it is today. Within a short period of time, AbelsonTaylor moved into its new space, built on efficiency and adjacency.
Mr. Stenlund continues to be one of the main drivers of change for the agency. Whether the change is a simple project or an initiative that will impact the whole company, he tackles it first by listening, thinking, and communicating. He listens to what is said and not said. He thinks through and analyzes issues to formulate and achieve all goals. He’ll review, vet suggestions, and seek advice from his own team. Only then will Mr. Stenlund make the decision. And when he does, he communicates so all parties understand his point of view to achieve consensus or change. Mr. Stenlund knows that change is not an easy topic, which is why he firmly believes in transparency.
Currently, AbelsonTaylor is going through a series of initiatives to refresh many of its internal processes, while also installing a new software package. Because of the alignment structures and communication tools the agency has instituted, there are high hopes for the best outcomes when these changes are completed.
Even in the face of change, Mr. Stenlund never loses sight of what is important to AbelsonTaylor employees. He believes that having a sense of purpose and following a set of values are greater motivators than numbers. So Mr. Stenlund and his tightly knit team work to ensure that whatever change the agency executes, it does not alter the purpose-driven culture. Purpose, according to Mr. Stenlund, can lead to a general sense of betterment for everyone.
As the person in charge of several key departments at AbelsonTaylor, Mr. Stenlund has built a tightly knit, efficient team whose members are empowered to manage and make decisions without significant need for layers of approvals or oversight. He values everyone’s opinions, believes everyone’s voice should be heard, and encourages ownership of roles and responsibilities.
While Mr. Stenlund may not have the day-to-day contact with clients, he is one of the reasons why companies continue to turn to AbelsonTaylor. He has a keen understanding of the agency’s role in helping its customers traverse a constantly changing and challenging regulatory and business environment. He has helped AbelsonTaylor and its clients find common ground so they can move toward building long-term relationships.
Unassuming and fair, Mr. Stenlund treats everyone as an equal and is always open and willing to discuss any issue, topic, or concern. And while he is meticulous and detail-oriented, he also knows when to pull back and not obsess about little things if they don’t relate to the bigger picture.
He welcomes collaboration and ideas, which facilitates respect and admiration among the entire agency
“The agency has some of the most amazing and talented group of individuals in the industry," he says. “I walk in every day knowing that I’m helping to build an organization that encourages these individuals to do great work."
The future is exciting to Mr. Stenlund who would, if he could, like to see how the world changes beyond what he will see in his lifetime.
One piece of advice he would give to his younger self is to maintain a better work-life balance, saying early in his career he spent more time working and pursing his career goals when he could have been spending more time with family.
“I do a much better job of it now because the stakes are much higher — I now have a 5-year-old son at home," he says. “Today, I work just as hard at making time for my family as I do at work. It’s worth all the effort."
Jim Robinson
Title: President
Company: Astellas Pharma US Inc.
Education: B.S., Marketing, DePaul University
Associations: BioScience Council for ChicagoNEXT; MATTER, a group of
industry leaders passionate about
creating products and services that advance the healthcare industry; PhRMA trade association; Healthcare Businesswomen’s Association
Status Quo Disrupter
With more than 20 years of experience in the industry, Jim Robinson has many commercial successes to his credit. Yet, it is his leadership skills that have inspired improvements in the organizations where he has worked at all levels that landed him on the PharmaVOICE 100 list.
Mr. Robinson firmly believes that innovation stems from talented people who are focused on doing what’s right for the patient, and since he has taken the helm at Astellas US, he has driven numerous changes and process improvements by involving all employees from every corner of the company.
A skilled and thoughtful leader who constantly challenges the status quo, he spearheaded the development of the first 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.
Under Mr. Robinson’s leadership, the company’s Americas sales have nearly doubled to more than $2.95 billion in fiscal year 2014 (ending March 2015). This accounts for about 25% of global sales, second only to Japan where the company’s global headquarters is located.
In the United States, Astellas Pharma US has been recognized as one of the top places to work in the Chicago area.
Additionally, Mr. Robinson has been instrumental in the launch of seven new products in the U.S. market since he joined the company in 2005.
As Astellas commemorates its 10th anniversary in 2015, it is reinforcing its commitment to the community by launching a variety of volunteer activities in the United States, Canada, and Brazil as part of its global Changing Tomorrow Day initiative.
In his current role, Mr. Robinson is responsible for health systems, sales and marketing, and commercial operations for a diverse and growing portfolio of products in the therapeutic areas of cardiovascular, oncology, transplant, urology, and anti-infectives.
Before this position, Mr. Robinson served as senior VP for sales and marketing at Astellas. In that capacity, he led the company’s expansion into the oncology market, taking a strategic role on the project team for the 2010 acquisition of OSI Pharmaceuticals, which established the company in the oncology space.
He joined Astellas in 2005 as the VP of health systems and established the managed markets, reimbursement strategy, state government affairs, and government accounts teams.
Before joining Astellas, he held senior marketing and sales positions with Schering-Plough in New Jersey, where started his career in 1992 as a sale representative and moved through positions of increasing responsibility until he was promoted to VP of hepatitis sales and managed care in 2003. In this position, he led the largest specialty pharmaceutical sales division within Schering-Plough.
Mr. Robinson, who was a keynote speaker at the Healthcare Businesswomen’s Association’s Annual Conference in 2014, noted that there are two very important leadership traits needed in today’s ever-changing healthcare environment. The first characteristic is strategic agility. Mr. Robinson says with the pace of change occurring faster than it has in 20 years, strong leaders need to not only know where they are headed, but be nimble enough to react to changes along the way as necessary.
The second-most important trait he says is the ability to motivate team members through challenges.
“A leader needs to be an enthusiastic motivator who can keep team members on track and keep them feeling excited about achieving the goals despite the challenges they face," he says.
Rachael Wyllie
Title: CEO
Company: CRF Health
Education: M.A., Pharmacology, University of Cambridge
Family: Husband; three sons, 28, 26, and 23; grandson
Hobbies: Bridge, gardening
Associations: Royal Society of Medicine, DIA
Driving eCOA Innovation
CRF Health, a provider of electronic clinical outcome assessment (eCOA) solutions for global clinical trials, has hit a recent milestone: a record-breaking 1 million patient interactions taking place every month using its TrialMax eCOA platform. Patients from across more than 15 therapeutic areas interact with the technologies to capture clean data with high compliance during clinical development programs.
As eCOA adoption steadily increases, CRF Health is at the forefront, being led by seven-year-CEO Rachael Wyllie.
Colleagues say in a field notorious for the slow adoption of technology, Ms. Wyllie is a true leader with a global vision for improving the clinical trial experience for patients and sponsors.
It is her vision that is driving CRF Health’s business to continuously look for more effective ways of conducting clinical trials and developing innovative methods for collecting patient data that make a real difference to the success of clinical trials and drug development programs.
Ms. Wyllie has an unwavering commitment to make things work better for all parties involved, according to her co-workers and colleagues.
In many cases, this means challenging the norm and looking at different ways of doings things. Her dedication to process improvement has helped drive what can be a largely reluctant industry toward change and the incorporation of new technologies into the clinical trial lifecycle.
This focus on the development of quality, patient-focused and intuitive eCOA solutions has helped create some of the most exciting data collection technologies in the field today. Ms. Wyllie has been credited with being the driving force behind the development of a broad range of solutions that are helping to improve the lives of patients and caregivers globally.
As a true advocate of the patient voice, she possesses a deep understanding of the importance of the patient experience in clinical trials. This is just one of her leadership traits that underpins her commitment to driving the introduction of solutions to overcome industry challenges. She is also committed to ensuring clinical trials remain compliant with industry standards and are straightforward in terms of keeping patients engaged, thereby ensuring retention. In addition, she recognizes the importance of investigative sites to the process and the need to keep processes simple and efficient for them.
CRF Health’s solutions have been used in over 550 trials across 75 countries and 100 different languages. The solutions span multiple therapeutic areas, including respiratory, oncology, immunology, musculoskeletal, cardiovascular, and endocrinology.
Creating and implementing the vision for CRF Health is one of her career highlights.
“Working to build CRF Health’s team and creating a culture where we learn, grow, and are recognized for our individual achievements and contribution to the success of the organization has been a great accomplishment as well as a challenge," Ms. Wyllie says. “Taking over as CEO at CRF Health and managing the expectations of all the different stakeholders and effectively communicating and listening was, and still is, immensely important."
Under Ms. Wyllie’s leadership, employee engagement is at the top of the agenda and a prime factor in the company’s achievements. Her unique management style has created an innovative culture that is without a doubt at the core of the company’s success in the eCOA market today.
She has a dedicated interest in inspiring others and is providing a platform for team members to succeed and make their mark on the industry for which she is so passionate.
Ms. Wyllie views being a mentor as a very important part of her role as CEO, and she enjoys helping develop the senior management and middle-management teams within the company.
She encourages positive one-on-one relationships within the teams at CRF Health, while fostering an open mindset, advocating autonomy among team members to help them prosper.
“Everybody wants to do well and make his or her mark, but what often gets in the way are corporate processes," she says.
A pioneer in the development of patient-focused technology, she has supported and nurtured customer-focused solutions to meet the needs of the pharmaceutical industry for more than 20 years.
Before joining CRF Health she worked for etrials (formerly MiniDoc and Araccel) as operations lead, managing director and company secretary of the U.K. division.
Before etrials, Ms. Wyllie worked for Pfizer, UK, as a discovery scientist as well as in biology computing where she specialized in laboratory information, automation systems, and real-time data acquisition of physiological signals.
Dr. Melissa Manice
Title: CEO and Co-founder
Company: Cohero Health
Education: Ph.D., Mount Sinai School of Medicine; B.A., Vanderbilt University; M.PH., Hunter College
Family: Husband Charles, sons James,4, and Oliver, 1
Hobbies: Hot Yoga, tennis, travel with family
Bucket List:
Visit Patagonia, Southeast Asia, Galapagos, Alaska; meet Michelle Obama, Sheryl Sandberg, and Warren Buffett
Awards/Honors: National Research Science Award NIH fellow, MM&M Top 40 Healthcare Transformer
Associations: Springboard Enterprises, StartUp Health, Grand Central Tech
Tweet: @melissamanice
A Breath of Fresh Air
Envisioning a truly radical platform for digital healthcare management of chronic disease, Melissa Manice, Ph.D., co-founded Cohero Health to build connected devices for respiratory patients.
Cohero Health’s mission is to improve care for patients with pulmonary disease by equipping them with tools to better manage their care and improve connectivity with their providers, while also equipping clinicians with data to improve clinical decision-making and outcomes for patients and their stakeholders.
Dr. Manice’s doctorate focused on the problem of medication adherence and delivery, particularly in chronic diseases such as asthma. Rather than continuing to study the status quo, Dr. Manice came up with an idea for new, innovative mobile health delivery tools for improving medication adherence of asthma patients.
Dr. Manice is taking a unique approach in that rather than addressing just one aspect of respiratory care she is creating a better system for improving medication adherence, patient engagement, and physician decision-making at point of care by providing patients with reminders and incentives to take medication and measure their lung function while providing physicians and caregivers with information about patient medication usage to make more informed decisions for how to best manage asthma and/or COPD.
Dr. Manice embraces and synthesizes wide-ranging interdisciplinary research on topics such as gain-framed messages, habit building, and the impact of technology on patient adherence. Her investigations and management toolkit guide and drive forward Cohero Health’s progress on developing state-of-the-art medical wearables.
She has an unrivaled ability to assess the rapid pace of change in smart device technology and pick the innovations that have staying power and are amenable to deployment in a healthcare setting.
The development of new smartphone apps, new FDA-approved devices, and new
HIPAA-compliant backend technology under her watch provide a holistic case study and model for how innovation can spread in the healthcare setting.
Her vision for the future of care for respiratory illnesses has garnered interest from major industry forces, including big pharma companies, the insurance industry, clinicians, and the technology sector.
And her career highlight to date was speaking at the White House round table on healthcare technology.
She draws on a decade of experience studying chronic diseases and using new digital technology to optimize chronic care. Her previous work at the National Cancer Institute and in pharmaceutical risk management established lasting relationships with government and pharmaceutical organizations.
In building Cohero Health, Dr. Manice says the greatest challenge was finding a well-rounded and incredibly passionate founding team. A relentless thought leader, Dr. Manice approaches problems with a unique sense of compassion and teamwork. She motivates her employees to be better versions of themselves and inspires through passion and positive energy.
She encourages her team members to take ownership and ensures that they interact with the community they serve — patients and providers — to foster the best end result possible.
“I try to constantly be a bridge between clinical need and development of a meaningful product," she says.
“Close proximity between these two elements is essential."
As a female CEO, she strives to lead diverse teams that produce bright, innovative ideas.
“Rather than studying problems, I seek to create solutions," she says.
And she seeks a constant re-assessment of form and function, while keeping an open cross-team dialogue to troubleshoot.
“I spent a long time cultivating my idea, but I encourage those with the innovative ‘itch’ to run with their idea and to not let fear inhibit them from making that first jump," she says.
Dr. Michael Hayden
Title: President of Global R&D and Chief Scientific Officer
Company: Teva Pharmaceutical Industries Ltd.
Education: FRCPC Internal Medicine, University of British Columbia; American Board Medical Genetics, Harvard Medical School; American Board Internal Medicine, Harvard Medical School; DCH Diploma in Child Health, University of Cape Town; Ph.D. Genetics, University of Cape Town; M.B., Ch.B., Medicine, University of Cape Town
Family: Married; four children
Hobbies: Avid art and book collector, hiking
Bucket List: Dance at his children’s weddings
Awards/Honors: Honorary Doctor of Science, University of Gottingen, 2014; Luminary Award, Personalized Medicine World Conference, 2014; The Diamond Jubilee Medal, on behalf of HRH Queen Elizabeth II, 2012; Aubrey J. Tingle Prize, Michael Smith Foundation for Health Research, 2011; Killam Prize, Canada Council of the Arts, 2011; Canada Gairdner Wightman, Gairdner Foundation, 2011; Order of Canada, 2010; Canada’s Health Researcher of the Year, CIHR Michael Smith Prize in Health Research, 2008; Prix Galien, Research Category, 2007; Distinguished Scientist Award, Canadian Society of Clinical Investigation, 1998
Associations: Society for Neuroscience; American Society of Clinical Investigation; American Society of Gene Therapy; Royal College of Physicians and Surgeons of Canada; American Federation for Clinical Research; American Association for Advancement of Science; American Society of Human Genetics
Leading the Fight for Cures
Internationally renowned geneticist Michael Hayden, M.B., Ch.B., Ph.D., is committed to solving some of the world’s most pressing medical problems through scientific discovery.
As the president of global R&D and chief scientific officer of Teva Pharmaceuticals, Dr. Hayden is at the forefront of the fight against neurodegenerative disorders. He is motivated by the knowledge that there are millions of people waiting for news that a cure or relief is in sight for the medical challenges affecting them or their loved ones.
Discovering the role that genes play in coronary artery disease and adverse drug reactions, as well as developing the first predictive genetic test for Huntington’s disease are among two career highlights. Dr. Hayden has also identified the genes responsible for a number of disorders, including amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease), type 2 diabetes, and pain. He continues to lead research efforts into diseases that have unmet needs, identifying one of the biggest challenges as defining novel ways to prevent and treat neurodegenerative disorders, such as Huntington’s disease.
Dr. Hayden leads research and development at Teva where three late-stage clinical trials with novel agents are being conducted to improve symptoms and modify the course of Huntington disease.
Under Dr. Hayden’s leadership, Teva continues to find new ways to translate its combined strengths in generic and specialty R&D into innovation, significantly increasing its productivity and expanding the number of life-changing treatments offered to patients. Thanks to these efforts, Teva now ranks among the top seven out of 30 companies with the largest increase in productivity. In 2014, the company also ranked second in a reputation study of neurological patient groups worldwide — the first time Teva was included on The Corporate Reputation of Pharma list.Teva is also unique in that it is the only fully integrated R&D organization in the world encompassing a generic and a specialty portfolio.
“I am committed to capturing these synergies to create novel solutions that address unmet patient needs," Dr. Hayden says.
He inspires his team at Teva by helping them to understand that failure is intrinsic to the work they do; it’s important to learn from these failures.
“The challenge is not avoiding failure, but picking ourselves up and having the confidence to keep moving forward," he says.
Dr. Hayden is also committed to fostering the next generation of industrial and academic researchers to continue to perform the legacy of improving care for currently incurable diseases globally. As a professor, he has trained more than 100 researchers from 30 countries, and he continues to mentor scientists in South Africa, Canada, and Singapore.
“My goal is to help them grow and stay optimistic in the face of seemingly insurmountable challenges," he says. “Together, they have the ability to make the impossible possible."
Outside of Teva, Dr. Hayden leads an international effort to benefit people impacted by HIV/AIDS in the township of Masiphumelele, outside Cape Town. In collaboration with colleagues around the world, he spearheaded and built a youth recreation center there, which provides confidential support and health-education for at-risk children and youth.
Steven Michaelson
Title: CEO
Company: Calcium USA
Education: B.S., Pratt Institute
Family: Wife, Judy; children: Sophia, Robert, and Daniel
Hobbies: Tennis and real estate
Bucket List:
Marry his business acumen with his love for tennis
Awards/Honors: Numerous awards from the Rx club, MM&M, Doctor’s Choice, and Med Ad News Agency of the year award
From Strength to Strength
The dyslexic kid from New Jersey has gone from strength to strength as an entrepreneur and creative innovator.
Steven Michaelson has proven his business acumen time and again. He founded and built Wishbone to become a thriving and successful business, and he is now building Calcium to achieve similar strength.
Mr. Michaelson started Wishbone in 1998 with just one project from NovoNordisk: a sticker that read “Sample — Not for Resale." Six months later, he was doing $100,000 projects with this client. Later that year, he began working with BMS, initially for one product but by the end of the year, Wishbone was working on 11 products.
This was the direct result of Mr. Michaelson’s ability to understand the market dynamics, identify the needs of his clients, and respond accordingly. Wishbone became the lead agency for all of BMS’s mature brands.
Over the next few years, Wishbone grew rapidly, winning large amounts of business and multiple creative awards. The agency hit a difficult patch in 2006 when it lost business due to one drug being pulled from the market, another being sold to another company, and a third losing its patent before its time. Losing that much business could have been devastating, but Mr. Michaelson made the decision to retain every one of the Wishbone employees, and personally carried the expense and, in six months, replaced all the business that had been lost.
A savvy businessman, Mr. Michaelson sold Wishbone in 2010 to Rosetta. Mr. Michaelson knew what was going on in the market and what his clients needed to have from their agency in order to thrive.
Rosetta was the most comprehensive digital player in the marketplace at the time. His clients and the industry saw the benefits. A year later, in an unprecedented deal, Rosetta itself was sold to Publicis.
His latest venture, Calcium, which merged with Star Life Sciences last year and Vox Medica, has Mr. Michaelson again at the helm. As one agency, Calcium is now better equipped to service clients and attract new ones.
Mr. Michaelson is committed to building Calcium to have the same or greater industry recognition as Wishbone … “same high standard of strategy, creative, and service with stronger and broader tactical capabilities," he says.
He says the biggest challenge is not being able to fix something that is not working right when clients or corporate management don’t see it.
Mr. Michaelson attributes his success to having the good fortune of being around great people, specifically his partner and wife Judy Capano.
He believes in being vigilant in the pursuit of excellence, no matter what you do, and above all he believes it is imperative to be appreciative and kind to the people you are doing it with.
He seeks to provide people with the tools they need to do their job and then get out of their way.
“I spend a lot of time walking the halls — that is where you hear what is really going on and helps motivate people when they need it," he says.
Although Mr. Michaelson is extremely thankful for his own success, he is much more proud of all the careers his company has helped launched — even more so than the brands the agency helped build.
“What has real meaning to me is that I started and grew an agency, where people have met, fell in love, got married, and had babies; how cool is that?," he asks.
Artistic, successful, and always ethical — not bad for a man who was thrown out of Boy Scouts.
How has he achieved this?
“Never give up," he says, “Be determined and relentless in business and you achieve your goals. Plus love what you do."
Peter Goldschmidt
Title: President
Company: Sandoz
Education: M.A., Sociology; B.A., Politics and Economic Geography, University of Muenster, Germany
Family: Wife; four children
Hobbies: Cooking
Awards/Honors: Novartis Chairman’s Leadership Development Award, 2011
Associations: US Generic Pharma Association
Experiencing Greatness
When Peter Goldschmidt took up the role of President of Sandoz Inc., Head of North America, in July 2013, the company was in fourth position by volume share with 5.9% of the U.S. generics market. Just 18 months later, Sandoz is the fastest-growing growing generics company among the top four in the United States, with double-digit growth over the past year propelling it to the No. 3 position. And Mr. Goldschmidt has plans to take Sandoz all the way to first place.
“My professional goal is to lead the best team in the generics industry in the United States," he says.
From his first day, Mr. Goldschmidt challenged every U.S. associate to “be the best," with the goal of making Sandoz the No. 1 generics company in the United States. According to colleagues, be the best is more than a management mantra. At its heart is a belief that Mr. Goldschmidt instills in every associate, that their work is transforming patient outcomes; increasing innovation, focusing on quality; and demonstrating courage and integrity.
The transformation of Sandoz began with Mr. Goldschmidt handpicking his senior management team to ensure his passion for excellence was shared throughout the business. He partnered with his HR team and agencies to find talent inside and outside the industry, and then he personally spent time with each team member to ensure he or she brought superior technical excellence and the extra passion to win. According to one peer, every executive on Mr. Goldschmidt’s team has a unique story about his or her interview with him, but all will say he or she felt the same after the interview — his passion and vision were irresistible. After potential candidates met with Mr. Goldschmidt they were compelled to join the company.
“If you have great talent, these team members will do everything to accomplish the vision," he says. “For me, it’s not about inspiring in terms of motivating and showing the carrot. It’s about creating an environment where people can make great things happen and be the best they can be. They will work hard and with enthusiasm."
Mr. Goldschmidt’s involvement continues throughout the business. He is personally involved in recruitment at all levels to ensure Sandoz finds people who are committed to improving quality, processes, reliability, and efficiency, and focused on excellence in every interaction with investors, partners, journalists, customers, regulators, and patients. Associates are empowered to lead at every level, to be accountable, and to never settle for second-best.
Through Mr. Goldschmidt’s leadership Sandoz continues to grow, with significant investment in areas such as dermatology and biosimilars. The company recently earned the Walmart Supplier Award for Made in the US.
Despite his short tenure, Mr. Goldschmidt has led Sandoz US through an unprecedented series of product firsts.
In the past 12 months, Sandoz US doubled its launches year on year with 42 new products, five of which were first to file. One of these first-to-files was filgrastim, the first biosimilar application lodged with the FDA and the first to be approved under the Biologics Price Competition and Innovation Act. Sandoz also received the first approval on the generic version of Copaxone, a once-daily, 20 mg, product for multiple sclerosis, by the FDA in April 2015 and launched in June. Finally, Sandoz forged a series of unique strategic product collaborations. And, he was personally involved in every deal for the U.S. business.
A John Wayne fan, the German-born leader says he can relate to the characters Mr. Wayne played in his numerous movies.
“In those old Westerns, someone is always going for it," he says. “Someone is standing up for what he or she believes in and fighting for something with clear-cut values; it’s fantastic."
Mr. Goldschmidt demands a great deal from himself, his colleagues, and his family. He often brings stories of his family into town halls, telling how he expects them to be the best, with anecdotes about his children’s feats in swimming, soccer, and even the prom dance floor.
Mr. Goldschmidt has been recognized for his dedication to excellence, receiving the Chairman’s Leadership Development award (Novartis) in 2011.
Mike Menta
Title: Chief Operating Officer
Company: Campbell Alliance
Education: MBA, University of Southern California USC; B.A., Chemistry, Vanderbilt University
Family: Wife; three daughters
Hobbies: Skiing, mountain biking, traveling with family
Bucket List: Hike the Inca Trail; visit
Iceland
Looking Forward to Success
Mike Menta is an innovator who is dedicated to finding creative ways to develop solutions. This forward-thinking leader has set Campbell Alliance, a consulting arm of inVentiv Health, on a path for long-term growth and success. As chief operating officer and the lead of the company’s medical practice area, Mr. Menta continually challenges the status quo by questioning traditional thinking and moving the dialogue forward in critical key areas such as the role of medical affairs throughout the product lifecyle, risk management, and clinical development planning and optimization.
Colleagues say he can “see around corners," describing his ability to envision key industry trends five to 10 years out. He breaks down complex problems into their individual components to craft creative, compelling solutions that are consistently well-received by clients and consulting team members alike.
For example, eight years ago, when medical affairs was not as top of mind in the industry, Mr. Menta knew that this role would evolve to become increasingly important. Thus, under his leadership, Campbell Alliance established a practice dedicated to medical affairs.
Mr. Menta also established the company’s Medical Affairs Leadership Summit. His brainchild, the annual summit provides an open forum for a group of a dozen medical affairs leaders to share challenges, ideas, and solutions. Industry leaders drive the discussion, while Campbell facilitates and provides survey data to enhance the conversation. This work has developed a community of leaders who drive thought leadership within the industry. Campbell Alliance is currently planning its seventh summit and has held these meetings in the United States, Europe, and Asia.
Under his leadership, the overall consulting organization has returned to significant positive growth, driven in large part by the explosive growth that he has been able to generate within the medical and market access practice areas.
Mr. Menta’s depth and breadth of industry knowledge, from clinical and commercial to medical affairs, puts him in a unique position to think out-of-the-box and fully understand clients’ challenges from all angles.
Colleagues say he is an amazing consultant, exceptional team player, true partner to the leaders of biopharma, and most importantly, the role model for professionalism for everyone he interacts with.
A dynamic, trusted, respected leader, Mr. Menta shows others what good looks like every day, demands the highest level of excellence from his team, and is always, without hesitation, ready to roll up his sleeves and work beside his team if needed.
“There is nothing that makes me more inspired than to have the ability to work with a talented group of people, be challenged daily in an industry I love, and have ongoing opportunities to learn and grow personally and professionally," Mr. Menta says.
Kim Johnson
Title: President
Company: Palio
Education: B.S., Babson College
Family: Married, with two children.
Hobbies: Running, travel, wine, music
Bucket List:
Sail around the world
Awards/Honors: MM&M Rising Star; DTC Top 25 Marketer of the Year
Associations: Healthcare Businesswomen’s Association; Women 2.0; Babson Alumni; Kappa Kappa Gamma Alumni
Go Big or Go Home
As the first woman president of Palio, Kim Johnson goes big.
“She goes big; she always lobbies for the big idea," colleagues report. As president, she hit the ground running, immediately charting an invigorated vision for the agency that firmly placed the cornerstone in building Palio for the future. This vision is focused on four imperatives: brilliant ideas, strategic excellence, transformative technology, and community cultivation.
Ms. Johnson took the agency’s 2013 merger of Palio and Ignite Health to a new level. She took two legacy companies that were joined together and created one company with a new vision. She rebranded the agency Palio and ignited a new era in healthcare communications.
Creating beautiful disruption with an intense focus on ideas, is the agency’s theme for 2015 and beyond. The revitalized brand identity represents the edgy and passionate team of creative thinkers who are shaping the agency, and the industry. Her leadership and vision are the reasons key talent has joined Palio.
Ms. Johnson has made transparent financial health a powerful motivator by focusing on the agency’s bi-coastal offices. She realizes that the multi-geography model is a key catalyst for the agency’s growth and has strengthened the agency around its books of business. She possesses impeccable strategic and financial prowess, with a business mind of someone twice her age, her co-workers say. She consumes information at such a speed it’s hard to comprehend.
“Growing up in account management, I have an appreciation for the difficulty involved in leading cross-functional agency teams and service clients effectively to grow business, always in lock step with creative partners," she says. “It requires a brilliant balance."
She is steadfastly focused on short-term successes while envisioning long-term growth. Ms. Johnson understands the meaning of partnership. In building the agency of the future, she is grounded by the fundamental power of what makes an agency great, which is listening to and understanding the needs of clients.
She recognizes great talent is Palio’s greatest asset and works to understand what drives someone, what they’re passionate about, and then looks to see how she can create more of those opportunities for them.
“Our core value at Palio is do the great thing; this inherently calls everyone at the agency to challenge convention, bring brilliant, disruptive ideas forward, and push boundaries," Ms. Johnson says. “We set aside time to dream in possibility and accept that failure is okay when learning is garnered."
Cynthia LaConte
Title: CEO
Company: Dohmen Life Science Services
Education: B.S., Mount Mary College
Family: Married; son, 25
Hobbies: Reading
Bucket List:
Take a month off to explore local wine and food in Tuscany
Awards/Honors: E&Y Entrepreneur of the Year National Finalist; Biz Times Woman Executive of the Year
Associations: BIOforward, TEMPO, the Greater Milwaukee Committee
Recreating a Heritage
In 1858, a German pharmacist, Friedrich Dohmen, set sail for America, with the goal of opening an apothecary in Wisconsin. That venture became The F. Dohmen Co., which grew to be a national drug wholesaler by the end of the 20th century.
In 1990, fifth-generation Cynthia LaConte joined the family business, and in 1996, founded DDN Pharmaceutical Logistics as a service extension of the wholesaling business. A decade later, she was named chief operating officer, and initiated a complete transformation of the company. The $2 billion wholesaling business was sold to Cardinal Health, and by 2009, after being appointed CEO, she had set a new vision for the company: to create a more efficient, effective, and accessible healthcare supply system for healthcare producers and payers. The company now has 750 employees in seven states, almost 1 million square feet of space, and processes billions of dollars in client transactions annually. Anticipating changes in the industry that would lead to an increasing number of targeted therapies with smaller markets, she redefined her family’s legacy business, and as Ms. LaConte likes to say now she leads a 157-year-old start-up.
Through her strategic vision, focus, and collaborative leadership style, Ms. LaConte has formed an integrated company that delivers the highest level of care for the most vulnerable patients. Since 2009, Dohmen has acquired nine life-science service companies, achieved a CAGR of 49%, and has become a trusted partner to hundreds of drug and device companies by providing services that more closely connect life-science innovators with the patients they serve. She has built a company that touches the lives of millions of patients every year.
Ms. LaConte is commitred to helping people lead healthier lives. In 2008, she founded the Dohmen Company Foundation as another way to walk the talk of Dohmen’s values system. Each year a percentage of Dohmen’s profits fund the foundation, and since inception, Dohmen has given more than $10 million and connected 123 million people to life-saving healthcare products and services. The foundation has most recently focused on maternal and children’s health issues. Since 2012, for example, significant gifts have been made to the Nurse-Family Partnership in Denver, which bring together low-income, first-time mothers with nurse-led maternal health and home visitation programs; to Meta House, a special center in Milwaukee to help women and their children reclaim their lives from the effects of substance abuse; the Maternal Child Family Health Coalition in St. Louis to improve birth outcomes and promote healthy families; Brighter Beginnings in San Francisco to strengthen families by helping parents become self-sufficient; and Le Bonheur Children’s Hospital in Memphis.
Ms. LaConte says the thrill of building and creating a better health experience for clients, their customers, and, ultimately, for patients inspires her every day, and she motivates others by reminding them that everyone has a responsibility to make life better for others.
“Words I live by: be the change you wish to see," she says.
Leo Sheridan
Title: CEO
Company: Advanced Clinical LLC
Education: B.A., St. Michael’s College; Kellogg School of Management
Family: Wife, Martha; three sons; one daughter
Hobbies: Fishing, golfing, skiing, and adventure travel
Bucket List: After skiing to the North Pole in 2009, he feels compelled to achieve balance and go to the South Pole
Awards/Honors: Chicago Tribune’s 100 Top Workplaces — five consecutive years
Associations: DIA, ACRP, YPO/WPO, ASA
Making a Difference Daily
Leo Sheridan lives and works with one singular purpose: to make a difference. He aligns his personal goals and values with the work that is done every day at Advanced Clinical. The focus at Advanced Clinical is to impact people’s lives in a substantial way by working with candidates to find employment and enhance their careers, while working with clients to ensure they exceed their business goals.
Advanced Clinical, which started as a talent solutions agency, has evolved into a leading provider of strategic resourcing solutions as well as a full-service CRO. Mr. Sheridan’s vision and his ability to attract the best and brightest minds to Advanced Clinical are instrumental in this success.
His exceptional leadership skills include a systemic approach to business. He has been a student of systems thinking throughout his career and it permeates everything he does. He understands that the only thing that matters is relationships, whether internal or external. Mr. Sheridan handles difficult situations with such grace that even in the most sensitive of situations, the other party still walks away respecting him.
It is evident that Mr. Sheridan truly values every employee as well as every client relationship by the fact that his company has earned a Chicago Tribune’s 100 Top Workplaces award five years in a row. The staff at Advanced Clinical remains loyal and turnover is low. Some employees have been there from the start of the company —20 years ago — and many others have been employed for more than 10 years. By providing constant learning and training for both personal and professional development, his teams remain knowledgeable, engaged, and fresh.
“People make the greatest impact on an organization," he says. “Hiring well and putting people in the right seats is critical to success. Over the past 30 years I would say identifying the right person for a leadership role has been make or break for achieving the results we want to see."
Mr. Sheridan dedicates himself and his company to giving back to the community. Staying true to his “make a difference everyday" attitude, he implemented the Advanced Charity Contest to celebrate his company’s 25th anniversary. Each of the Advanced Group businesses selected a charity that was meaningful to them and they worked toward specific company goals to earn money for their respective charities. The event resulted in a distribution of more than $100,000 to the selected charities. In June of 2013, he committed all Advanced Group offices to the Cristo Rey St. Martin’s corporate work study program, which helps high school students pay their tuition. Every Cristo Rey student carries a full course load of college preparatory coursework while working five 8-hour days each month at one of Advanced Clinical’s business partners.
In 2012 and 2013, in conjunction with the Young President’s Organization and Free the Children, Mr. Sheridan led 10 families to Nairobi and into the Maasai Mara in Kenya. Working with Free the Children, he and the group assisted the building of several schools. He has also been a volunteer coach for New Trier High School Boys Rugby Club and spends countless hours cultivating and growing the program.
He also is currently on the Board of Directors for the American Staffing Association and a benefactor for the Chicago Public Library Foundation. He has recently been elected to the Board of Directors at Robert Morris University.
Dr. Edmundo Muniz
Title: CEO
Company: Certara
Education: M.D., Autonomous University, Santo Domingo; Ph.D. and M.Sc., University of Michigan; Center for Disease Control and Prevention (CDC)Family: Wife, two sons, one daughter
Hobbies: Nature and exercise
Bucket List: To travel to outer space and back
Awards/Honors: Team of the Year, Coach of the Year
Associations: American Society of
Clinical Oncology (ASCO), International Society for Infectious Diseases (ISID), Council of
State and Territorial Epidemiologists (CSTE), International Society for Disease Surveillance (ISDS)
A Quintessential CEO
Combining the skills of an expert clinician, a medical researcher, and experienced businessman, Edmundo Muniz, M.D., Ph.D., is ideally suited to appreciate the perspectives of the different life-sciences industry stakeholders — R&D, regulatory, payer, and commercial. He is focused on living a life with purpose, and for him that means ameliorating the suffering of those experiencing diseases.
Dr. Muniz heads up Certara, a biosimulation technology-enabled drug development company. His customers include hundreds of biopharmaceutical companies around the globe as well as regulatory agencies and academic institutions. Certara’s solutions, which span the discovery, preclinical, and clinical stages of drug development, enable data-driven decisions, increasing the probability of and shortening the timelines for bringing safer, new drugs to market.
As a senior R&D executive and CEO, he has managed the problems that Certara’s solutions address. As a physician, drug developer, and scientist he has great affinity and respect for Certara’s internal scientific community. He also appreciates the fact that the company’s scientific members have become trusted, essential partners to biopharma companies of all sizes, and are able to tackle the toughest therapeutic challenges, including complex populations such as pediatric and elderly patients.
Since joining Certara as CEO in June 2014, Dr. Muniz has helped to redefine Certara’s strategic direction, transforming the company from a portfolio of independent, siloed companies into an integrated team organized around four business units.
He oversaw Synchrogenix’s January 2015 purchase of ClinGenuity, the only artificial intelligence-assisted (AI) medical writing service in the pharmaceutical industry. Synchrogenix is Certara’s regulatory writing consultancy.
In March 2015, Dr. Muniz opened larger corporate headquarters, which include a world-class education center in which the company can conduct scientific and product training. In fact, Certara held its first client workshop there in late April for 40 scientists from major N.J.- and Pa.-based biopharma companies.
One of his great achievements has been to make Certara’s work with pharmacokinetic and pharmacodynamic modeling and simulation accessible and relatable for multiple audiences. Certara recently used its biosimulation technology, together with Phase II and early Phase III data, to get a central nervous system drug onto market three years early, saving $60 million to $80 million in expenses. He believes that biosimulation is one of the most cost-effective and ethical ways to conduct certain types of studies, including drug-drug interaction trials.
Dr. Muniz joined Certara from Kirax, where he served as president and CEO for nine years, overseeing and growing a strong oncology portfolio.
While at Lilly, Dr. Muniz achieved nine major oncology submissions in one year; was instrumental in obtaining nine oncology approvals on four continents in 15 months; and led the global development and approval of Alimta for mesothelioma and non-small cell lung cancer.
“I am enormously proud of Lilly’s Oncology on Canvas program, which we launched in 2004 in partnership with the National Coalition for Cancer Sponsorship," he says. “Under this program, individuals with cancer — along with their families and support systems —were encouraged to express, through art and narrative, the life-affirming changes that give their cancer journeys meaning."
The quintessential CEO, Dr. Muniz is passionate and charismatic with a razor-sharp mind, and at the same time funny, thoughtful, and approachable.
Dr. Muniz identifies, coaches, and grows talented individuals and encourages them to challenge each other. Through the power of stories, he demonstrates how each person’s efforts can collectively result in helping to develop a novel drug that impacts patients’ lives.
“There is nothing more inspiring to human beings than a sense of purpose and a transcendent meaning to what they do," he says. “Further, I encourage my team to make their journey, and not their destination, the focus and most joyful part of what they do."
The best you can offer the world is being yourself, Dr. Muniz believes.
“Be you, be calm, be serene, and be confident," he says.
Just as important though is having a trusted advisor.
“The role of a leader, and particularly the role of a CEO, is a very lonely job," he says. “Like the emperor, you sometimes walk naked through the hallways of the palace thinking you are beautifully and appropriately dressed, yet people are naturally reluctant to tell you ‘you are naked, go get dressed!’ As a leader you have to avoid being isolated from both the most critical issues facing the organization and from the most critical issues facing yourself as a leader. Otherwise you will fail."
Jim Curtis
Title: Chief Strategy Officer and Chief Revenue Officer
Company: Remedy Health Media
Education: B.S., Whittemore School of Business and Economics, University of New Hampshire
Family: Parents; son, Aidan, 7; two sisters; two brother-in-laws; four nieces and nephews
Bucket List: Give a Ted Talk
Awards/Honors: PharmaVOICE 100 — 2013, 2014; Crain’s NY Business Best Places to Work 2014; MM&M All-Star — 2014; Crain’s NY Business Best Places to Work 2014; Crain’s NY Business Fastest Growing Company 2013
Associations: Neuehouse, Young Entrepreneur Council (YEC), The Guru Collective, Digital NYC, Stimulati
Tweet: @jacurtis35
A Bold Vision for Consumer Health
With a vision and passion to make great ideas come to life, Jim Curtis has led the creation and execution of several innovative and ground-breaking digital consumer health information initiatives.
In his role as chief strategy officer of Remedy Health Media, Mr. Curtis keeps the company agile by developing products and services infused with catalysts to help people become healthier. He was the driver in creating Live Bold, Live Now, which is a fully immersive multi-media experience for patients to experience real patient stories, inspiring and empowering them to live better lives.
Another initiative in which he had a lead role was BerkeleyWellness.com, the first consumer wellness information site launched in partnership with a top-tier university. Designed to inform consumers with accurate analyses of health studies and tips on the best ways to integrate healthy lifestyle practices, the site was made possible through a long-standing relationship with the University of California Berkeley School of Public Health.
The Remedy platform is different from others in the space in that viewers are invited to find people with similar conditions who represent inspiration in living with and often overcoming a challenge. The fresh, honest approach to making meaningful connections is one that elicits authenticity and engagement.
Such programs have established Remedy Health Media as one of the fastest-growing consumer health information and technology companies in the world.
In building consumer health initiatives, Mr. Curtis challenges his team to develop condition-specific patient education in a more thoughtful way — going beyond providing flat encyclopedic content. He tasks his teams with analyzing the different ways people today consume non-health information, and in so doing the team has discovered that users show deeper engagement with multimedia content using words, images, video, and sounds.
Through the creative way he looks at business strategies, marketing materials, and presentations, he inspires his team to forget about the typical “marketing speak" and PowerPoint slides and motivates them to infuse relatable inspirational stories into them. By adopting these tactics, the Remedy team discovered that when relevant stories are included in a strategic inspirational way, people listen, are engaged, take action, and come back for more.
Remedy has gone on to launch a Live Bold, Live Now story on TheBody.com, to support HIV/AIDS patients and the company will be working with Breastcancer.org to present a version to people suffering from breast cancer.
Mr. Curtis prompts clients to think about their approach to patients differently, simultaneously inspiring and reigniting passion throughout the business. His inherent communication skills and charisma, positive outlook on life, and ability to relate to others provide him with a unique perspective on patient communications and have earned him a place on the PharmaVOICE list in 2014 and 2013.
Collaborative in his approach, Mr. Curtis surfaces the best solutions to the opportunity at hand. As important, he leads a team of apostles that emulate his consultative style within the marketing and advertising community.
He lives by the ethos that if you’re going to give your time and energy to a project you might as well give it your very best and enjoy the process.
Before Remedy, Mr. Curtis was director of strategic partnerships with OnHealth.com, which was eventually acquired by WebMD. As a result of the acquisition, Mr. Curtis became director of strategic partnerships at WebMD and played a role in driving the company’s growth and eventual IPO. He then joined Waterfront Media, where he was instrumental in the development of Everydayhealth.com and the company’s expansion, which led to an IPO in 2014.
Mr. Curtis’ personal story is very close to those who he now helps. About 20 years ago, Mr. Curtis was diagnosed with a nearly debilitating disease that eventually led to chronic pain and paralysis of his right leg.
Rather than let that event stop him, he helped create platforms that have inspired millions of patients living with chronic diseases to live better lives. He is committed to creating a product to allow members of the health universe to publish and promote their own personal health stories.
He displays exceptional leadership skills and has a proven ability to motivate a growing staff. He constantly encourages his team and often asks what changes can be instituted to make working at Remedy a more positive and innovative experience.
“Innovation is fostered by passion, open-mindedness, and collaboration," he says. “But it starts with a curiosity and a desire to create, build, and change."
Beyond Remedy, Mr. Curtis is influential in a number of important causes. Working with self-defense expert Avital Zeisler, he launched The Soteria Method Transformation, an online course that arms women with the tools to help them overcome abuse and domestic violence. He is also an advisor/coach for many entrepreneurs including STATE bags, Seamless Medical and Vivonne-NYC.
He is also an active member of Project Sunshine, an organization that supports children living with health conditions in and out of the hospital and is creating a documentary focused on finding “Purpose in Life."
Dr. Michelle Berrey
Title: President and CEO
Company: Chimerix
Education: M.D., Medical College of Georgia; Master of Public Health, Emory University
Infectious Diseases Fellow at the University of Washington; Internal Medicine Residency at UNC Chapel Hill
Family: Husband, Richard ET Smith, Ph.D.; two children, Elena, 18, Benjamin, 16 ; Womble
Hobbies: Gardening, golf, photography
Bucket List: Travel for fun instead of for work; take a cruise of the European waterways on a long boat
Awards/Honors: Triangle Business Journal’s Life Sciences Award CEO of the Year; Triangle Global Health Consortium’s Corporate Impact Award
Bringing Hope to Many
The potential to give families more time with the ones they love is what drives Michelle Berrey, M.D., MPH, to continue her inspirational work in infectious diseases.
“Whether that’s protecting a father from the potentially devastating effects of CMV —cytomegalovirus — after a transplant, or saving a child’s life from adenovirus after a bone marrow transplant I want to help patients and their families," Dr. Berrey says. “Improving the health of some of the most fragile among us inspires me to work harder and do better."
From her early days in college studying chemistry to her residency at Chapel Hill, and later as a clinical researcher, Dr. Berrey has remained singularly focused on improving human health. At the center of every decision she has made during her career are the patients she seeks to help by developing novel medicines to treat deadly infections.
Board-certified in infectious diseases, Dr. Berrey has led scientific research and development teams working on new treatments for HIV and hepatitis C.
When Dr. Berrey joined Chimerix as the chief medical officer in 2012, she saw promise in the company’s primary compound, brincidofovir, to treat multiple DNA viruses, with the potential to decrease mortality from adenovirus in patients with weakened immune systems, and the opportunity to prevent — not just treat — CMV infection in pediatric and adult stem cell transplant recipients.
When she took the position as CEO for the company in 2014, she charted a vision built on the scientific platform of brincidofovir, to change the way life-threatening viral infections are approached, to prevent disease in individuals with weakened immune systems, and to treat viral diseases never before able to be treated.
Advancing a clinical program of this breadth was not without risks, and Dr. Berrey says her greatest challenge to date has been establishing a regulatory path with the FDA for the first potential therapy for life-threatening adenovirus infection.
“We have been working to define the patients who are at highest risk and the predictors of rapid progression, particularly in children who have undergone a bone marrow transplant or a liver transplant and who face up to 80% mortality from disseminated adenovirus infection," she says.
There were so many unknowns that Dr. Berrey and her team had to address along the way, but they recognized the difference a safe and effective therapy could make for patients with this life-threatening viral infection and this knowledge kept them pushing forward.
Chimerix worked closely with U.S. regulators to design an appropriate adenovirus trial to gather the efficacy and safety data needed to inform a regulatory decision of its investigational drug brincidofovir. To date, brincidofovir has been studied in more than 150 patients with adenovirus through the Phase III AdVise trial.
Preliminary results from the first 85 patients show a mortality rate of fewer than 40%, compared with historic mortality rates of up to 80% for disseminated disease.
Brincidofovir is also in Phase III clinical testing for the prevention of CMV in allogeneic stem cell transplant recipients. In spite of advances in bone marrow transplants over the last 30 years, CMV remains one of the leading causes of death in the first year following a transplant.
Dr. Berrey played an integral role in progressing the development program for brincidofovir and furthering enrollment; in fact, as of June 2015, the company completed targeted enrollment of the 450 subjects in the Phase III SUPPRESS trial for CMV prevention.
“I’m most proud of bringing forward new medicines for HIV, hepatitis C, and now completing Phase III trials in cytomegalovirus and adenovirus," Dr. Berrey says. “Medicines are not always able to save every life, but they can provide hope and transformation."
With patient need driving the company’s strategic investments, Dr. Berrey has been exploring other potential applications for brincidofovir, including prevention of CMV in kidney transplant recipients. While there have been improvements in kidney transplant survival in recent years, fewer than half of transplanted kidneys are still functioning 10 years after the transplant. Reducing injury to the kidney from viral infections could make a dramatic impact. She has been driving discussions with U.S. and E.U. regulators regarding the scientific design of clinical trials, which could deliver clinically meaningful endpoints for patients who are receiving a kidney transplant.
“I’ve always been driven to try to improve human health," Dr. Berrey says. “If I can continue to lead our great Chimerix team in developing life-saving and life-changing medicines, then I’ll be achieving my goal."
She leads by asking questions about every aspect of the company, with the hope that her curiosity is contagious.
“I believe that great ideas can come from anyone in the organization," she says.
Family is equally important and Dr. Berrey strives to ensure that every member of the Chimerix team knows they are a critical part of the company, but they also deserve balance with their family and friends, and time to contribute to their local and global community.
Christi Shaw
Title: U.S. Country Head, President of Novartis Corp. and President of Novartis Pharmaceuticals Corp.
Company: Novartis AG
Education: MBA, University of Wisconsin — Madison; B.A., Iowa State University
Family: Husband, Mark; son, Christian
Hobbies: Cooking and creating an intimate environment for friends and family in her home, reading, sports, and playing games
Bucket List: Creating precious moments with loved ones, regardless of where it is, to have more lasting memories
Awards/Honors: DiversityInc’s Top Company for Diversity — 2014 and 2015; Novartis Chairman’s Award for Business Excellence — 2012; multiple J&J Standards of Leadership Awards; Eli Lilly & Co. President’s Award
Associations: Board memberships: Biotechnology Industry Organization; Healthcare Leadership Council; Young Women’s Leadership Network ; advisory board members — Healthcare Businesswomen’s Association
Building a Powerful Mission
Creating more moments for more memories is a phrase that defines Christi Shaw’s passion for improving the lives of patients across a wide spectrum of disease conditions. Her unwavering commitment to enabling patients to live longer, healthier lives and to building a diverse and inclusive culture make her a truly inspiring leader.
Since being appointed the U.S. country head and president of Novartis last year, Ms. Shaw and her team have reorganized the structure and transformed the organization to put the patient at the center of every stage of the business, from research and development through commercialization.
“This focus on patients has enabled us to better meet their needs and reach more people with our innovative medicines," she says. “From a purely business performance standpoint, as of May we’ve grown our promoted brands by 33% in just over a year."
Ms. Shaw’s dedication to helping patients stems from personal experience — she lost her mother to breast cancer and her father to a rare disease, and her sister is living with multiple myeloma.
When she initially joined Novartis Oncology as North America region head, she had no previous experience in oncology or in managing the clinical development and medical affairs side of a pharmaceutical organization.
“I stepped into a new company with an entirely different culture than I was used to, at a time when the organization faced significant business and reputation issues," she says. “I had to learn about the disease area, our portfolio, and the environment as quickly as possible while successfully inspiring the team and leading through a tumultuous period."
During her tenure in oncology, Ms. Shaw led the unit to unprecedented growth despite significant patent losses.
Under her leadership, Novartis Oncology successfully launched two new chemical entities and six new indications for strategic brands as well as building a new franchise focused on rare diseases. She also championed the implementation of Novartis Oncology’s groundbreaking “Signature" trial program, pioneered by U.S. oncology’s clinical development and medical affairs team.
This innovative initiative is revolutionizing clinical trial recruitment by bringing the protocol to any patient with a certain genetic mutation — no matter their diagnosis — and speeding the rate of drug-to-patient in clinical trials from an average of six months to as fast as three weeks. In recognition of her outstanding accomplishments, in 2012 Ms. Shaw was awarded the coveted Novartis’ Chairman’s Award for Business Excellence. What continues to define Ms. Shaw’s work is not merely the bottom line, it’s her ability to inspire and mobilize individual associates and teams.
“It’s easy to get caught up chasing the bottom line, but I’ve found that you can only motivate your associates so far with financial incentives," she says. “What really resonates is purpose tied to a deep sense of mission."
Ms. Shaw nurtures an empowering culture of “leading at all levels." She is known for her willingness to continually challenge the status quo. For example, recognizing that diversity and inclusion are critical to innovation, she insists on reviewing a diverse slate of candidates for open positions at Novartis. This has resulted in an increase in diverse talent; about 60% of Ms. Shaw’s direct reports are women. She’s also a firm advocate for inclusiveness in the workplace. Ms. Shaw empowers her associates to speak up and encourages employee engagement, as she understands that an engaged workforce is critical to helping patients and ensuring business success.
This philosophy has led to an increase in the company’s ability to understand and meet the needs of different customers, which in turn has translated to strong growth year-over-year. Under her leadership Novartis Pharmaceutical Corp. was named the Top Company by DiversityInc for diversity and inclusion in 2014 and 2015, making it the only company to receive this honor in two consecutive years.
“It’s critical that our associates feel comfortable speaking up and challenging the status quo as this ensures we are continuously raising the bar in how we serve our customers," she says. “Collaboration is also key: to have the biggest impact on patients, we need to work together as one team. It sounds logical and simple, but it’s a big challenge at large and complex organizations."
Ms. Shaw’s dual passions for serving patients and developing talent extend far beyond Novartis. Ms. Shaw and her sisters continue their family heritage dedicated to sustainable farming and supporting local farmers in Iowa.
She volunteers time and resources to the Young Women’s Leadership Initiative, which helps underprivileged women gain leadership skills through education, and the Healthcare Businesswomen’s Association’s advisory board, which aims to empower women as leaders.
“I believe that it is important to pay it forward and support other women who have the potential to contribute so much to our society, and that education is one of the strongest tools for this," she says.
Timothy Walbert
Title: Chairman, President, and CEO
Company: Horizon Pharma plc
Education: B.A., Business, Muhlenberg College
Family: Married, three children
Hobbies: Coaching his kids’ sports
Bucket List: Taking family on safari
Awards/Honors: Ernst & Young Entrepreneur of the Year Winner (Midwest) — 2015; Greater Chicago Arthritis Foundation’s Freedom of Movement Award — 2014; Chicago Innovation Award – DUEXIS – 2014; PharmaVOICE 100 — 2013; Chicago Innovation Award — HUMIRA – 2003
Associations: Co-chairman of MATTER (Chicago’s Health/Bio incubator); board member, XOMA Corp.; chairman of the board, EGALET Corp; board member – emerging companies governing board for the national Biotechnology Industry Organization (BIO); vice chairman, human health for the Illinois Biotechnology Industry Organization (iBIO); PhRMA board of directors; previously served on the Illinois Governor’s Innovation Council; chairman of the Business Advisory Council of Cures Within Reach; active participant in ChicagoNEXT
Tweet: @horizonpharmceo and @HZNPplc
Beyond the Horizon to Improve Lives
Tim Walbert is driven by a straightforward goal: there is always more that can be done to help people with diseases. And while it’s impossible to help everyone, he and his colleagues at Horizon are certainly trying.
Mr. Walbert was diagnosed with an autoimmune disease similar to rheumatoid arthritis when he was a junior in college. As he learned about his condition and began to understand how it would affect his future, he committed himself to participating in the biopharmaceutical field.
He and colleagues at Abbott, now AbbVie, built the immunology franchise, which led to the FDA approval, launch, and subsequent growth of Humira into one of the biggest brands in the industry.
“It was amazing what we achieved with a third-to-market launch and how many people we helped," he says.
During his time at IDM Pharma — since sold to Takeda — Mr. Walbert was involved in helping children with bone cancer.
He became CEO of Horizon in 2008 and since then the company has grown from fewer than 10 employees to more than 700 global employees; from a $150 million market cap to more than a $5 billion market cap; and from one to seven marketed medicines.
“The experience has been surreal in a sense because in 2008, while the goal of growing into a big company was always the plan, I never imagined it would happen this quickly," he says.
And the growth certainly wasn’t without its challenges. Mr. Walbert moved Horizon from Palo Alto, Calif., to “Chicagoland" and had to build the company with very little capital, no infrastructure, or commercial-stage products. The next three years were equally challenging: raising money in the worst financial climate since the Depression, completing a Phase III clinical trial for the company’s lead product, and preparing for an IPO.
“But we got through it and are now one of the fastest-growing companies in the industry," he says.
Mr. Walbert attributes his own health issues as the driving force behind his “patients first" management style and his unrelenting commitment to doing whatever it takes to drive results around the further development of innovative therapies. He understands first-hand what it means to have access to therapies that can significantly improve the daily life of a patient, including himself.
Additionally, Mr. Walbert ensures his personal experience as a patient influences product development, acquisition targeting, and his focus on disease areas where there are currently unmet treatment needs. He has identified opportunities in revitalizing older products that a larger company may have cycled out, as well as identifying innovative therapies ripe for commercialization or optimization. This approach is differentiating Horizon in the biopharmaceutical industry.
“Through my career, I’ve seen the impact that innovative medicines can have on someone’s life and that drives me to continue to grow Horizon Pharma," he says.
At his core, Mr. Walbert is an entrepreneur and he strongly believes in fostering innovation.
“We hire smart, talented people and they are rewarded for their ideas," he says. “If those ideas prove viable, employees are encouraged to pilot them, setting the stage for potential companywide implementation.
Although some ideas fail in the pilot phase, others are widely successful and grow into foundational programs that are integrated across all of Horizon Pharma’s business units."
Mr. Walbert has also created a culture that promotes a healthy work-life balance. One recent example of this commitment was the opening of an interactive, co-working space in downtown Chicago. He realized that more than 25% of the company’s employees live in downtown Chicago and opening an office would significantly improve the quality of life for those employees by reducing their daily commutes — in some cases up to two hours.
Describing himself as an over-achiever, Mr. Walbert says there is no substitute for hard work, and stands side-by-side with his colleagues, sleeves rolled up to ensure that Horizon’s goals are achieved.
Mr. Walbert also believes strongly in being a responsible corporate citizen. He has created a full-time position on Horizon’s management team dedicated to building out a corporate social responsibility program. Through Mr. Walbert’s direction, Horizon is an active supporter of civic programs, including youth education, STEM, anti-violence, children’s literacy, and affordable adoption.
Maryellen Royle
Title: President, North America
Company: Tonic Life Communications
Education: B.A., Journalism, Temple University
Family: Husband, Art; daughters, Alexa, Olivia, and Sophia
Hobbies: Gardening
Bucket List: A summer in Italy
Associations: Healthcare Businesswomen’s Association and Pennsylvania BIO
Energetic, Creative, and Loyal
From unique patient documentaries to award-winning disease awareness campaigns to groundbreaking social media-based advocacy programs, Maryellen Royle harnesses the power of communications to meet her clients’ needs by reaching their audiences at their sweet spot, online.
As president, North America, for Tonic Life Communications Ms. Royle has built an agency that is nimble and creative, tackling issues across OTC, medical devices, pharmaceuticals, and biotechnology with her always-present can-do attitude and a smile.
She has overseen more than four years of profitable, consecutive revenue growth despite the challenges of corporate change.
Recently, Ms. Royle lent strategic guidance and hands-on support in planning and hosting HealtheVoices, a first-ever two-day conference for 60-plus influential and up-and-coming online patient advocates across 12 disease states. This made a valuable impact on her clients’ ability to forge relationships with groundbreaking influencers.
Titles are unimportant to Ms. Royle, who once said, “I don’t care if they call me chief cook or bottle washer, I am here to get the job done."
Over the course of her two-decade plus career at Tonic, which was formerly Dorland Global Health Communications, and DSJ before that, Ms. Royle has more than “gotten the job done."
She infuses her dynamic energy and creative flexibility into everything, keeping her team satisfied and thriving, all the while delivering award-winning client work.
In every role she has held, Ms. Royle’s sunny disposition and trademark megawatt smile inspire others to do their best work.
The terms open-door policy and roll up your sleeves epitomize Ms. Royle’s approach to leadership, creating a culture of teamwork, commitment, and bringing the best work to clients.
To drive innovation, Ms. Royle and her colleagues in senior management encourage cross-team sharing of successes and failures and, they look outside — both the agency and healthcare in general — to see how innovation can be translated within the business.
She says many factors foster innovation and among those she deems important include building a work environment that helps foster employee confidence by giving staff permission to try new things without fear of failure.
“Promoting innovation, whether in the form of a small, incremental improvement or a revolutionary new approach, should be encouraged and recognized," she says.
In addition, Ms. Royle is a champion of women in a male-dominated marketplace. She heads up a management team of 10, and nine of those executives are women.
Under her leadership, the agency continues to grow and earn industry and client accolades for award-winning strategies, forward-thinking creative, flawless execution, and unmatched service.
When it comes to motivating her teams, she says this is personal and self-driven.
“The best we can do as team leaders is provide and maintain a supportive work culture that allows talent to grow and thrive," she says.
While she recognizes that she can never please all of the people all of the time, Ms. Royle remains committed to pleasing most people, most of the time.
Mike Rea
Title: CEO
Company: IDEA Pharma
Education: B.Sc., University of Newcastle upon Tyne
Family: Wife, Clare; children Michael, 19; Imogen, 17
Hobbies: Cycle, play guitar, own an independent record label, listen to far too much music, bake sourdough bread
Bucket List: Take a trip to Vietnam and another visit to the Nurburgring
Turning Ideas Into Possibilities
Motivation can come from many different sources. For Mike Rea it’s what he calls the Monday-morning purpose. Because he says what gets him out of bed on Monday morning is not money or duty, but purpose.
“Because we’re about work that matters, we tend to find clients who care deeply about what they’re doing," he says. “So, we tend to have work that is at the game-changing, innovative end of pharma. We’re working on cures for cancer, on stem cell therapies, on disease modifiers — the types of programs that make work meaningful and provide their own motivation."
As CEO of IDEA Pharma, Mr. Rea is impacting change by asking medical innovators and marketers to rethink how their products should impact patient lives.
Mr. Rea says IDEA works in that wonderful space of possibility — when a molecule is in early phase development, and could take many different paths.
“Helping a drug take a non-obvious path to market involves persuading some people that ‘easy’ doesn’t mean ‘best,’ " he says.
He challenges the pharmaceutical industry into adapting to better, more logical ways of conducting drug development, based around early positioning of new drugs to ensure they deliver value to the market, rather than simply get onto the market.
“Instead of thinking commercially in the later phases of development, companies need to be thinking commercially all of the way through development," he says. “Although it sounds obvious to everyone, turning the tanker around from it’s current position requires enormous patience."
In 2015 alone, IDEA has been involved in positioning three of the top 10 blockbusters, and more than half of the fastest-growing drugs in the past five years.
The biggest challenge he says usually comes from aligning different perspectives, opinions, experience levels, knowledge, and objectives on any project.
He maintains that the biggest barriers to innovation are processes that get in the way of experts working with other experts.
As someone who reinvents his career almost weekly, he says there’s no time for regrets, just embrace what’s possible. He would tell his younger self to be comfortable that life’s mostly about how you respond.
“So much of what we’ve done in the past 10 years wasn’t even imaginable when I was at university," he says.
As a leader, he has built a nurturing environment where thought leadership is actively encouraged and where everyone can have input — this is particularly important when it comes to IDEAting around creating powerful marketing strategies for clients’ molecules.
“Innovation demands a framework grounded in great questions, and then agility so decisions can be made quickly," he says. “With those two things, innovation is like a sourdough culture — always there, always ready."
He gives his employees the freedom to hone their collective creativity and intelligence to unearth something new and innovative for the company and its clients.
Inspiring others isn’t a conscious exercise for Mr. Rea; rather he believes that people are looking to see whether you believe what you say.
“It’s easy when you’re doing something that has real purpose to find people aligned with that purpose," he says.
“If we were just consulting for money, that would be hard. We’re not — we’re genuinely making a difference to the types of medicines the world will be seeing in five, 10, and 15 years time. If that isn’t enough to motivate someone, they’re in the wrong company. If they’re in the right company, then they want to see someone who is wholly invested in making change happen."
Ceci Zak
Title: Chief Operating Officer, Healthcare
Company: DAS-Omnicom
Education: B.S., Business, Skidmore College
Family: Mother, sister, niece, nephews, three stepchildren
Hobbies: Skiing, hiking, biking, yoga, being outdoors
Bucket List: Hike Kilimanjaro, skydive, drive a racecar, and travel the world
Awards/Honors: Gerson Lehrman Group, Top 15 Brand Leader, 2014; PharmaVOICE 100; PE, Emerging Leader in Healthcare
Associations: Healthcare Businesswomen’s Assocation — past president, executive committee member, and chapter mentor; Women’s Business Leaders Advisory Board Member; Julia’s Butterfly Foundation board member; Pachamama Alliance, corporate development committee
Tweet: @cecizak
Paying it Forward
Ceci Zak does not shy away from a challenge. Whether it’s spelunking 250 feet below the earth, cave diving in New Zealand, or eliminating an unprofitable business unit, incurring layoffs and consolidations, she faces each task with authenticity and compassion. Through it all, she hopes to have a meaningful impact on improving consumer navigation of health, the healthcare ecosystem, and communications among all healthcare stakeholders.
As chief operating officer at Diversified Agency Services, Omnicom, she oversees more than 40 companies worldwide. Her role is focused on servicing healthcare clients throughout the globe by developing new strategic and operational opportunities that provide meaningful solutions for clients, as well as managing healthcare agencies, dedicated to the bio/pharma market. Omnicom colleagues say her leadership skills and enthusiasm have fostered a rejuvenated culture of collaboration within the agency. For example, she implemented regularly scheduled meetings with CEOs to discuss ideas on how to better serve clients. She quickly identified the need for strategic emphasis in three areas including, China, big data, and global operational efficiencies, all toward developing the path forward to generate the value creation that clients demand. Ms. Zak has defined the strategic imperatives for each of these initiatives, gained executive alignment, and has been executing against these imperatives since late 2014.
Ms. Zak’s passion for growth and results are at the core of who she is, and she strives to serve as a role model for her team and associates. She identifies and seeks out prospective colleagues to mentor. As past president of the Healthcare Businesswomen’s Association (HBA), Ms. Zak is passionately committed to developing women leaders in the industry and has been volunteering as an executive leader for the HBA for more than 10 years. She has also taken an active role in supporting the Center for Talent Innovation in developing its most recent round of research focusing on engaging women decision makers for health outcomes called Power of the Purse.
She mentors at her alma mater, Skidmore College, and serves on the board of several charities, including Pachamama Alliance, a nonprofit organization focused on empowering indigenous people of the Amazon rainforest to preserve their lands and culture and, using insights gained from that work, to educate and inspire individuals everywhere to bring forth a thriving, just and sustainable world.
This passion of giving back also led her to become actively involved with a local tri-state-focused (NY, NJ, CT) 501(c) 3 nonprofit organization called Julia’s Butterfly Foundation, whose mission is to provide assistance to families of terminally and chronically ill children. Ms. Zak identified the need for a strategic plan and led the executive committee on a six-month task of building a five-year plan. Under her direction, a revised mission statement evolved and the team identified core values and beliefs for the board to adapt. This strategic plan, developed in 2013, enabled the board to clearly define goals and deliverables, resulting in double-digit growth in fundraising and sponsorship activities and 20% growth in revenue. In addition, the target focus of increased donations has provided a double-digit increase of applications, and the organization is on track to reaching its goal of donating $1 million by the 10th anniversary in first-quarter 2016.
One of Ms. Zak’s key strengths is recognizing and developing the talent of her team and colleagues. She believes people are the No. 1 asset when it comes to getting a job done and she strives to develop an environment where individuals are engaged and satisfied through development, rewards, and recognition.
Ms. Zak has demonstrated this through her many roles within Roche, Sanofi, and now Omnicom. She has mentored numerous individuals who have gone on to become industry leaders.
“Mentoring is very important to me, because there is no greater gratification in anything I do than to help others dream dreams and realize them," Ms. Zak says.
Rob Cosinuke
Title: Chief Marketing Officer, athenahealth; former President, Epocrates (2013-2015)
Company: athenahealth and Epocrates, an athenahealth service
Education: MBA, Harvard Business School; B.A., Haverford College
Family: Wife, Jennifer; daughters Abby, 21, and Willa, 17; son Gus, 14
Hobbies: Fly fishing, building things
Bucket List: To build an off-the-grid fly-fishing cabin in a particular spot in Colorado
Leading Teams in Transition
Rob Cosinuke had several career plans before he became a successful marketer at athenahealth. He had a passion for astronomy, minoring in it in college; he dreamed of being an architect; and he studied political science, thinking he might take on law or run for office. However, he found his true niche right out of college working in the account management training program for a Mad Men-esque agency.
In later years, Mr. Cosinuke cofounded the interactive advertising agency Digitas with two of his mentors, Ruben Pinchanski and Kathy Biro. Seven years ago, he brought his considerable marketing and strategic skills to athenahealth, a provider of cloud-based services for medical groups and health systems.
In 2013, when athenahealth acquired the mobile health company Epocrates, Mr. Cosinuke was handpicked to run the newly formed athenahealth division. He was charged with driving an increased number of physicians onto the Epocrates network, generating subsequent leads for athenahealth services, and increasing the number of Epocrates pharma offerings, all while maintaining the vitality, growth, and integrity of the elite Epocrates brand.
Drawing on more than 20 years of sales, marketing, and change management experience, he redefined Epocrates’ vision and mission and set about rebuilding and re-energizing nearly every aspect of the business.
Colleagues say Mr. Cosinuke is especially skilled in revitalizing brands, building marketing engines, and driving measurable results, which he has demonstrated at Epocrates. He has managed to transform the Epocrates identity into an innovative, highly adaptable, client-centered marketing channel that is responsive to the rapidly changing needs of clients in the life-sciences industry.
Putting his strategic marketing and implementation skills to task, he successfully merged two different divisions and geographies within Epocrates and transformed a well-known drug reference app into a thriving platform for point-of-care EMR integration, clinical intelligence support and pharmaceutical/provider engagement.
He has faced some large challenges in his career, but managing the integration of Epocrates was one of his biggest feats to date.
“It was a challenging, exciting, and very hard assignment in terms of cultural and product strategy dissonance; I needed to bring the two companies together and do it in a way that kept people focused and motivated and aligned," he says.
Under his guidance, Epocrates has increasingly focused its outreach and effort on understanding the burdens and mounting pressures of the pharmaceutical industry.
With the help of his team, he has taken the campaign “on the road." Meeting one-on-one with pharma marketers, hosting roundtable discussions with pharma CEOs, and speaking at leadership institutes — Mr. Cosinuke has eagerly shared his knowledge about the changing healthcare landscape with those in the pharma industry and brainstormed solutions which he has brought to life inside the moment of care workflow.
This year he continued to grow the Epocrates brand as a highly integrated service of athenahealth with a business model focused on clients’ needs and measureable results. To this end, Mr. Cosinuke instituted a new performance-based, client-centric, pharma-relevant approach to reporting and analysis. The result is higher sales, satisfied clients, and a more stable, high-performing company.
A true team player with an open mind, he welcomes collaboration and expects participation from those at every level. Mr. Cosinuke’s ability to successfully manage at many levels keeps him committed to and focused on the greater goals.
He likes to engage with his employees, and sometimes surprises them by showing up to assist on sales calls and participate in walk-arounds within the office.
A hard-driving strategist, Mr. Cosinuke also likes to have fun.
“At heart, I’m in it for the adventure so I like to drive hard, have a clear vision, know the hill we’re trying to take, engage people personally, but make sure that we have some fun along the way," he says.
Thomas Wicks
Title: Chief Strategy Officer
Company: TrialScope Inc.
Education: MBA, Baruch College; B.S., Communications, Ithaca College
Family: Wife, Stephanie; two daughters, Kathryn and Sarah
Hobbies: Ancestry research, cooking
Bucket List:
Walk the Camino De Santiago; experience the Northern Lights
Associations: Drug Information Association; DIA Clinical Data Disclosure team
Paperless Clinical Trials
Whether you are a prospective client or an industry colleague, Thomas Wicks is happy to take the time to exchange information and opinions on ways to improve the clinical trial process.
Colleagues credit him as being a valued contributor and leader in developing both the strategy and tactics of how pharmaceutical companies can meet the challenges of ever-increasing clinical data disclosure.
His knowledge and expertise go far beyond the normal perception of a businessman marketing a software solution to solve a problem. With almost 20 years of experience in performance and content management solutions, Mr. Wicks approaches each task as an opportunity to improve the process and each client as an opportunity to create a trusted and long-term partnership.
He challenges the status quo continually, and his progressive thought leadership in the clinical trials transparency arena has positioned him and his team at the forefront of innovation in the marketplace.
Mr. Wicks also plays an important internal leadership role, mentoring colleagues on emerging regulatory and business requirements. He is passionate about delivering value and leads the team to develop and deliver first-to-market solutions.
Almost 10 years ago, Mr. Wicks originated the initial concept for a clinical trial solution that would approach disclosure requirements using content and process management themes.
He collaborated with business, technical, and process strategists to evolve the concept into a commercial solution. Today, this solution, PharmaCM, is TrialScope’s flagship transparency platform that is being used by six of the top 10 clinical trial sponsors. Mr. Wicks cites this as one of his career highlights.
“It has been satisfying to see the system develop from concept to a successful solution that not only helps sponsors comply with trial transparency regulations efficiently, but also contributes to the public good by harmonizing the publicly disclosed data and providing free tools to trial sponsors to facilitate disclosure," he says.
Mr. Wicks has played a key role in curating information about industry trends, channeling his vision through the organization and ensuring a common understanding across the team. These efforts have enabled the team to interpret data and respond quickly to market dynamics.
“In the spirit of continuous improvement, we are constantly evaluating our approach and questioning assumptions," Mr. Wicks says. “I am constantly sharing tools and content that I think will foster innovation among our team members. I am an avid reader and regularly curate articles on leadership and innovation for our team."
In recent years, Mr. Wicks has delivered more than a dozen novel presentations at industry conferences. The topics he chooses are spot-on in terms of the challenges facing clinical trial sponsors, such as the 2016 European Clinical Trial Regulation.
He is adept at breaking down complex concepts, and educating his audience while also learning from their shared experiences.
Mr. Wicks is currently developing a maturity model for clinical trial transparency that will help sponsors assess their own internal capabilities and determine where compliance risks may arise. In this effort, he has worked with team members and industry peers to ensure that the model truly represents practical, real-world scenarios.
“I have the good fortune to work with truly talented and engaged colleagues," he says. “True motivation comes from personal engagement, solving challenging and important problems, and being able to make significant contributions to the solution. I see my role as providing the perspective of the broader market and the evolving requirements and helping to establish the strategic priorities for our team."
Dr. Glynn Wilson
Title: Chairman, CEO
Company: TapImmune Inc.
Education: BSc., Ph.D., Royal Holloway College, University of London, Heriot-Watt University, Edinburgh
Family: Daughter, Danielle, 28; son,
Alexander, 26
Hobbies: Tennis, hiking, wine
Associations: Society for the Immunotherapy for Cancer, American Association of Pharmaceutical Scientists, Union of Concerned Scientists
Pioneering Cancer Vaccines
TapImmune CEO Glynn Wilson, Ph.D., lost his wife of 30 years to metastatic breast cancer in 2003. When Dr. Wilson became one of more than 200,000 families per year in the United States whose loved ones die from breast cancer, he vowed to find a way to prevent it from happening to others.
At the time of his wife’s death, there were no treatments that could have saved her life. Dr. Wilson experienced first-hand the overwhelming clinical need for new treatments. Consequently, he is committed to spearheading promising new approaches to the treatment of breast and ovarian cancers. TapImmune is using an approach called immunotherapy that stimulates the body’s own cellular immune system to recognize and kill breast cancer cells.
“Immunotherapy has the potential to treat cancer as a chronic disease," he says.
The comprehensive approach stimulates T-killer and T-helper cells and augments antigen presentation to develop T-cell vaccines. The company is preparing vaccines for Phase II clinical trials for HER2 breast, triple-negative breast, and ovarian cancers, and to improve antigen presentation through its PolyStart and TAP technologies, which have significant potential for widespread use. While TapImmune is focused on cancer, the company nonetheless strongly reaffirms that this core technology has widespread applicability in the development of vaccines for viral disease. The PolyStart technology increases the production of proprietary antigenic peptides of the vaccine by as much as four-fold, thereby increasing vaccine potency — presenting more antigen — and potentially making manufacturing and commercialization of large volume vaccines more cost effective.
Successful proof-of-concept studies conducted in collaboration with Mayo Clinic clearly demonstrated that human cells containing a PolyStart construct containing vaccinia virus — smallpox — and antigenic peptides could naturally express, process, and present these antigens on the cell surface and that cell surface presentation occurred in a manner recognizable by immune system cells, such as CD8+ killer T-cells. Importantly, CD8+ T-cells recognizing a PolyStart-encoded antigenic peptide on the cell surface will destroy that cell. In addition, T-cells recognizing the antigenic peptide are stimulated to expand in number, thereby providing a strong longer-lived capacity to destroy many more cells infected with the virus.
Dr. Wilson and his team are greatly encouraged that the clinical programs in HER2/neu breast, triple-negative breast, and ovarian cancer vaccines have already shown positive immune responses in Phase I studies and are now progressing to Phase II clinical studies starting later this year.
Dr. Wilson loves what he does and motivates his teams by example and sharing his vision. He is optimistic that a viable breast cancer vaccine will be developed in his lifetime, as a tribute to his wife, and the mother of his children. (PV)
o; needs and measureable results. To this end, Mr. Cosinuke instituted a new performance-based, client-centric, pharma-relevant approach to reporting and analysis. The result is higher sales, satisfied clients, and a more stable, high-performing company.
A true team player with an open mind, he welcomes collaboration and expects participation from those at every level. Mr. Cosinuke’s ability to successfully manage at many levels keeps him committed to and focused on the greater goals.
He likes to engage with his employees, and sometimes surprises them by showing up to assist on sales calls and participate in walk-arounds within the office.
A hard-driving strategist, Mr. Cosinuke also likes to have fun.
“At heart, I’m in it for the adventure so I like to drive hard, have a clear vision, know the hill we’re trying to take, engage people personally, but make sure that we have some fun along the way," he says.
Thomas Wicks
Title: Chief Strategy Officer
Company: TrialScope Inc.
Education: MBA, Baruch College; B.S., Communications, Ithaca College
Family: Wife, Stephanie; two daughters, Kathryn and Sarah
Hobbies: Ancestry research, cooking
Bucket List:
Walk the Camino De Santiago; experience the Northern Lights
Associations: Drug Information Association; DIA Clinical Data Disclosure team
Paperless Clinical Trials
Whether you are a prospective client or an industry colleague, Thomas Wicks is happy to take the time to exchange information and opinions on ways to improve the clinical trial process.
Colleagues credit him as being a valued contributor and leader in developing both the strategy and tactics of how pharmaceutical companies can meet the challenges of ever-increasing clinical data disclosure.
His knowledge and expertise go far beyond the normal perception of a businessman marketing a software solution to solve a problem. With almost 20 years of experience in performance and content management solutions, Mr. Wicks approaches each task as an opportunity to improve the process and each client as an opportunity to create a trusted and long-term partnership.
He challenges the status quo continually, and his progressive thought leadership in the clinical trials transparency arena has positioned him and his team at the forefront of innovation in the marketplace.
Mr. Wicks also plays an important internal leadership role, mentoring colleagues on emerging regulatory and business requirements. He is passionate about delivering value and leads the team to develop and deliver first-to-market solutions.
Almost 10 years ago, Mr. Wicks originated the initial concept for a clinical trial solution that would approach disclosure requirements using content and process management themes.
He collaborated with business, technical, and process strategists to evolve the concept into a commercial solution. Today, this solution, PharmaCM, is TrialScope’s flagship transparency platform that is being used by six of the top 10 clinical trial sponsors. Mr. Wicks cites this as one of his career highlights.
“It has been satisfying to see the system develop from concept to a successful solution that not only helps sponsors comply with trial transparency regulations efficiently, but also contributes to the public good by harmonizing the publicly disclosed data and providing free tools to trial sponsors to facilitate disclosure," he says.
Mr. Wicks has played a key role in curating information about industry trends, channeling his vision through the organization and ensuring a common understanding across the team. These efforts have enabled the team to interpret data and respond quickly to market dynamics.
“In the spirit of continuous improvement, we are constantly evaluating our approach and questioning assumptions," Mr. Wicks says. “I am constantly sharing tools and content that I think will foster innovation among our team members. I am an avid reader and regularly curate articles on leadership and innovation for our team."
In recent years, Mr. Wicks has delivered more than a dozen novel presentations at industry conferences. The topics he chooses are spot-on in terms of the challenges facing clinical trial sponsors, such as the 2016 European Clinical Trial Regulation.
He is adept at breaking down complex concepts, and educating his audience while also learning from their shared experiences.
Mr. Wicks is currently developing a maturity model for clinical trial transparency that will help sponsors assess their own internal capabilities and determine where compliance risks may arise. In this effort, he has worked with team members and industry peers to ensure that the model truly represents practical, real-world scenarios.
“I have the good fortune to work with truly talented and engaged colleagues," he says. “True motivation comes from personal engagement, solving challenging and important problems, and being able to make significant contributions to the solution. I see my role as providing the perspective of the broader market and the evolving requirements and helping to establish the strategic priorities for our team."
Dr. Glynn Wilson
Title: Chairman, CEO
Company: TapImmune Inc.
Education: BSc., Ph.D., Royal Holloway College, University of London, Heriot-Watt University, Edinburgh
Family: Daughter, Danielle, 28; son,
Alexander, 26
Hobbies: Tennis, hiking, wine
Associations: Society for the Immunotherapy for Cancer, American Association of Pharmaceutical Scientists, Union of Concerned Scientists
Pioneering Cancer Vaccines
TapImmune CEO Glynn Wilson, Ph.D., lost his wife of 30 years to metastatic breast cancer in 2003. When Dr. Wilson became one of more than 200,000 families per year in the United States whose loved ones die from breast cancer, he vowed to find a way to prevent it from happening to others.
At the time of his wife’s death, there were no treatments that could have saved her life. Dr. Wilson experienced first-hand the overwhelming clinical need for new treatments. Consequently, he is committed to spearheading promising new approaches to the treatment of breast and ovarian cancers. TapImmune is using an approach called immunotherapy that stimulates the body’s own cellular immune system to recognize and kill breast cancer cells.
“Immunotherapy has the potential to treat cancer as a chronic disease," he says.
The comprehensive approach stimulates T-killer and T-helper cells and augments antigen presentation to develop T-cell vaccines. The company is preparing vaccines for Phase II clinical trials for HER2 breast, triple-negative breast, and ovarian cancers, and to improve antigen presentation through its PolyStart and TAP technologies, which have significant potential for widespread use. While TapImmune is focused on cancer, the company nonetheless strongly reaffirms that this core technology has widespread applicability in the development of vaccines for viral disease. The PolyStart technology increases the production of proprietary antigenic peptides of the vaccine by as much as four-fold, thereby increasing vaccine potency — presenting more antigen — and potentially making manufacturing and commercialization of large volume vaccines more cost effective.
Successful proof-of-concept studies conducted in collaboration with Mayo Clinic clearly demonstrated that human cells containing a PolyStart construct containing vaccinia virus — smallpox — and antigenic peptides could naturally express, process, and present these antigens on the cell surface and that cell surface presentation occurred in a manner recognizable by immune system cells, such as CD8+ killer T-cells. Importantly, CD8+ T-cells recognizing a PolyStart-encoded antigenic peptide on the cell surface will destroy that cell. In addition, T-cells recognizing the antigenic peptide are stimulated to expand in number, thereby providing a strong longer-lived capacity to destroy many more cells infected with the virus.
Dr. Wilson and his team are greatly encouraged that the clinical programs in HER2/neu breast, triple-negative breast, and ovarian cancer vaccines have already shown positive immune responses in Phase I studies and are now progressing to Phase II clinical studies starting later this year.
Dr. Wilson loves what he does and motivates his teams by example and sharing his vision. He is optimistic that a viable breast cancer vaccine will be developed in his lifetime, as a tribute to his wife, and the mother of his children. (PV)
