NOTE: The content below contains the first few paragraphs of the printed article and the titles of the sidebars and boxes, if applicable.
Dr. Patrice Matchaba
For Advancing the Quest for Global Access
Title: Group Head of Global Health & Corporate Responsibility
Company: Novartis AG
Education: MD, University of Zimbabwe; Harvard Business School Program for Management Development
A number of years ago, Dr. Patrice Matchaba’s mother suffered a heart attack and was subsequently diagnosed with heart failure. She was immediately admitted to the intensive care unit in her home country of Zimbabwe, but the treatment she needed was not made available.
At the time, Dr. Matchaba was working in the global drug development department of Novartis, focusing on the research and development of a cardiovascular treatment. His unique position allowed him to provide his mother with a life-saving medication, a privilege not available to others facing a similar health situation.
As the current global head of corporate responsibility for Novartis, Dr. Matchaba keeps this personal experience in mind as he develops the company’s strategy to address the gap between access and need. He believes there is a need to prioritize the moral responsibility to address access head-on rather than leaving it up to circumstance. “We need to find new and sustainable business models to provide communities around the world with medications, and no longer leave it up to chance, status, or location when it comes to matters of life and death,” Dr. Matchaba says. “This should be our shared value promise with and for society.”
In his role, Dr. Matchaba manages Novartis’ corporate responsibility sector, which has three main priorities: expanding access to healthcare, conducting business responsibly, and ensuring transparency across corporate initiatives. He oversees the development and execution of the programs carried out by the company’s social business arm, including Novartis Access, Novartis Malaria Initiative, Novartis Healthy Family Programs, and SMS for Life. Each of these initiatives provides communities with medicines that treat the identified illnesses plaguing the respective regions, while also employing pioneering execution models to ensure widened access and sustainability. The programs have made lasting strides in combating public health epidemics.
“As the head global health and corporate responsibility for a major pharmaceutical company and as a physician, I combine my background of medical knowledge with a thoughtful, disciplined approach to business, ensuring that we address sustainable access of our medicines to as many people as possible around the world while ensuring that corporate compliance is seen to be just as important as groundbreaking innovation,” he says.
As an 18-year alumni of Novartis’ drug development team and a native of Africa, Dr. Matchaba offers a unique perspective on the gaps in the healthcare infrastructure and lack of available resources in the developing world. Colleagues say his naturally collaborative approach allows him to work across teams to ensure all initiatives are aligned with the corporate responsibility priorities: strengthening the company’s culture of integrity, minimizing environmental impact, and ensuring transparency, both internally and externally.
Before joining Novartis he was a doctor and scientific researcher in South Africa, giving him firsthand knowledge of the impact these corporate responsibility initiatives can have on the communities. He is aware that expanding access in developing countries is not just about providing innovative medications, but also about creating entire ecosystems to successfully deliver healthcare products and monitor their impact.
For example, last year Novartis launched a heart failure medicine for patients worldwide — the first drug of its kind in two decades. Even with a vast investment and effort, Dr. Matchaba realized that current business models would only allow the company to reach about 1 million people with heart failure, while close to 60 million people around the world are living with the condition. “This convinced me that we need to be doing more to develop innovative access models that are sustainable to reach more patients,” he says.
He knows he has an opportunity to take a more globally minded, patient-centric approach to bring together innovative medicines and digital innovations to improve and extend lives for as many people as possible. While recognizing the challenges in altering existing delivery models that have been used for many years, Dr. Matchaba notes that it is imperative that the industry continue the quest to provide access to people worldwide because universal access to innovative medicines is an ambition worth fighting for. “Our developments should be complemented by our reach,” he says.
He knows that by combining technology-driven innovation with access-expanding corporate responsibility programs, global epidemics can be eradicated by a rate of up to 10-fold.
Colleagues are deeply inspired by Dr. Matchaba’s patient-first worldview, cemented by his years as a physician, which has translated into an unparalleled community-first mindset.
From ensuring internal corporate accountability and transparency within one of the largest global healthcare companies, to developing external programs that provide innovative treatments and expand access across the world, Dr. Matchaba is leading projects that will leave a lasting effect on the global health landscape. (PV)
For Being a Champion of the People
Title: Senior Manager, US Marketing
Company: Pfizer Inc.
Education: BA, Communication, Grove City College
Family: Parents Doug and Beth Montgomery, and her brothers Kevin and Michael Montgomery, for supporting her crazy dreams and believing like her that anything is possible
Hobbies: Reading, volunteering, working out, karaoke, exploring different places around the world, trying new things
Awards/Honors: Healthcare Businesswomen’s Association (HBA) Legacy Leader Award; HBA Chapter Excellence Award; Vice-President’s Cabinet (2x) and numerous other Pfizer sales awards, Pfizer Global Women’s Council Outstanding Colleague Award, True Beauty Woman to Watch Award
Associations: HBA; Life Center Church NYC
Personal Brand: There’s no time for fear
Megan Montgomery packs a punch in everything she does and creates maximum impact whether it’s in her day job as senior manager, U.S. marketing at Pfizer or in her worldwide philanthropic endeavors to exact change in communities in need. A 12-year career veteran of Pfizer, Megan’s latest assignment has her leading the marketing strategy within the institutional space for Chantrix (varenicline). Immediately preceding this well-deserved promotion, Megan headed a team of sales professionals in the promotion of Pfizer products in Manhattan and the Bronx. During her first year as a sales manager, Megan’s team moved up 72 spots in the national rankings and won district of the year.
“Once I have my mind made up to do something, I normally keep pushing forward even in the face of opposition, which has led to accomplishing things that people didn’t initially believe could be achieved,” she says. “When I commit to something I believe in, I put my full heart and energy into it.”
Megan’s career may have started as a sales rep for Pfizer, but she earned her sales chops as a kindergartener, who was savvy enough to resell nails found discarded at a construction site near her home back to the same workers.
Her entrepreneurial spirit still burns bright. Colleagues are inspired by Megan’s determination, passion, and compassion, not to mention her savvy business acumen and innovative approaches to tackling tough challenges. In addition to coming up with creative strategies for her own functional area, she has a big picture view and shares suggestions on how innovate with other parts of the business. “To be truly innovative, it’s important to break down silos and have a wide network of diversity of thought, which helps bring forth the best ideas as we all have perspectives that can help make ideas richer,” Megan says.
Megan is not one to shy away from a challenging assignment or take on a role that stretches her beyond her comfort zone. “When people ask if you can do something, that’s not the same as asking if you have done it before, just say yes and then figure out how to do it,” she says.
“Don’t ever let fear stop you from doing something that’s in your heart to try.”
Her dynamic leadership prowess extends beyond Pfizer’s brand lines and into its very culture, where she is a leader in the company’s women’s internal network, the Global Women’s Council (GWC), a group of senior-level female and male colleagues that focuses on women’s talent and pipeline management. She has been influential in having senior Pfizer executives — men and women — present on topics ranging from gender parity to diversity and inclusion and career advancement to members of the Healthcare Businesswomen’s Association (HBA). She is Pfizer’s ambassador to the HBA and she has been instrumental in positioning the company as the association’s largest sponsor.
Megan’s history with the HBA positions her perfectly as a valued connector and convener. In 2014, Megan served as president of the HBA Metro Chapter, the association’s largest volunteer base in terms of members at the time. Coincidentally, it was also the 10th anniversary of the chapter, and Megan and her fellow chapter board leaders created a highly successful event to celebrate a legacy of leaders and loyal sponsors. HBA colleagues are inspired by her collaborative nature, strategic insights, and passion for driving change, particularly as it relates to achieving gender parity in the life sciences. She remains an active volunteer and can be seen in the HBA’s video series Voices of HBA, where she discusses the importance of diversity and inclusion.
Megan’s passion also runs deep to address underserved communities. She has traveled the globe to improve health and safety of populations, with a specific focus on improving outcomes for children. For most of us a vacation means a two-week holiday at a luxury resort, for Megan it means venturing to the Democratic Republic of Congo, for example to volunteer with Justice Rising to build schools in conflict zones. She is fearless in her desire to help those who do not have the resources or opportunities available to help themselves.
In her spare time, Megan was one of the founding members of Wit + Grace magazine. The magazine, which launched last fall, was developed by a diverse collective of women who believe that faith has the potential to impact culture, lifestyle, and health.
“I strongly believe in the work that we do each and every day to help patients and I also strongly believe that my life has purpose and meaning and I want to do all that I can to fully live out that purpose,” Megan says. (PV)
Dr. Ben Wiegand
For Innovating for a World Without Disease
Title: Global Head, World Without Disease Accelerator
Company: Janssen Research & Development LLC
Education: BS, Chemistry, University of Illinois at Urbana-Champaign; MA, Chemistry, Harvard; PhD, Chemistry, Harvard
Family: Wife, Michelle; children, Lauren, son-in-law Jamin, Emily, David, and Cami; grandchildren, Reuben, Eli, and Clara; grandparents, David and Ethel, Jim and Juanita
Hobbies: Hiking, reading history books, basketball
Awards/Honors: Johnson’s Medal
Personal Brand: No excuses
If you want to keep up with Ben Wiegand, Ph.D., you better be able to sprint. Literally. Urgency not only describes his approach to his work, but physically manifests in how fast he walks.
He has a passion — and the energy — to pursue new innovations and solutions for healthcare, with a goal “to catalyze the creation of a world without disease.” In fact, delivering on that goal is how he measures success, as well as delivering innovations that change people’s and the healthcare system’s behavior.
His experience in identifying and piloting new business and funding models, accelerating growth opportunities, and scouting new and emerging scientific areas has consistently delivered innovative solutions for Johnson & Johnson.
His experiences across different sectors, products, and businesses, have given him a unique vantage point to empathize with patients and understand the needs of different stakeholders across the healthcare ecosystem.
Dr. Wiegand started in Johnson & Johnson’s consumer division. He initiated a group in Consumer R&D called Upstream Innovation. His passion for healthcare led to a business built on a foundation of behavior science and proven outcomes. Ben led a team of scientists who created digital health technology products focused on disease management and wellness.
He drove new consumer research programs exploring opportunities in maternal health, obesity, and sleep health. Always innovating on the science and the business, he started to introduce new ideas into the Consumer R&D group — bringing in external funding and collaboration, particularly with suppliers; filtering out assets that were great ideas but not priority; and focusing on the external environment as a source of innovation.
Dr. Wiegand moved from consumer R&D in 2014 to start the Disease Interception Accelerator within Janssen. Always bringing that blend of scientific and business acumen, his team set out to incubate in a whole new area for Janssen’s “disease interception” based on the idea that the future of healthcare will be about intercepting disease vs. treating it. He is focused on leading a paradigm shift from disease care to healthcare, through novel approaches to prevention, interception, and cure.
Success in launching new ventures in this area led Dr. Wiegand to take on a bigger role leading the World Without Disease Accelerator. In this role, he heads scientific exploration in such areas as immunosciences, the microbiome, diagnostics, and behavioral science, to name a few.
He says starting a new Accelerator within Janssen has been his most challenging assignment. “It is a completely new field, new processes, new metrics surrounded by new people,” he says. “And it has been the most rewarding.”
He says a career highlight was transforming the infant sleep market with the launch of Johnson’s Bedtime Products through a combination of internal and external partnerships. He combined a behavioral science approach to a launch a bedtime routine with clinically proven efficacy around better infant sleep. This resulted in him and his team winning the prestigious Johnson’s medal, given to only one successful scientific achievement and product per year in each of the company’s three sectors.
Colleagues say Dr. Wiegand’s most inspiring quality is his passion and talent for innovation. He connects dots, sees new patterns, and drives paradigm shifts. Many times in his career he has established new areas of R&D and business models. Those who work with Dr. Wiegand say his energy is infectious, and they leave meetings with new ideas that make them feel they could change the world.
He says he tries to empower individuals with a clear vision and lots of autonomy. “I always look for the best in people, innovations, research, companies,” he says. “Making a difference in people’s lives through new innovations, made possible by all of global advances, motivates me.” (PV)
For Championing Innovation in Renal Disease
Title: Senior VP, Chief Business Officer
Company: Akebia Therapeutics
Education: MSc, MBA, HEC Paris (grande école)
Family: His wife, Audrey, who’s been supportive and understanding, particularly over the last three years of intense travel and deal-making activities; 1-year-old daughter, Emma, who always welcomes him with a smile
Associations: Alumni institutions in France, Lycée Louis-le-Grand, Paris 6 University, HEC Paris
A consummate dealmaker and relationship builder, Michel Dahan’s contributions have been instrumental in transforming Akebia. The company started out as an early-stage biopharmaceutical company and now has ongoing global Phase III studies and strategic partnerships with major healthcare companies around the world to address HIF-based therapeutics to treat anemia and other serious diseases. Akebia was founded in 2007 to discover and develop therapeutic solutions leveraging the potential of hypoxia inducible factor — or HIF — biology, with a particular focus on renal disease. The company’s technology is based on HIF-Prolyl Hydroxylase (HIF-PH) inhibition, which it believes represents an approach to treating certain conditions where there is unmet need.
Michel oversees Akebia’s business development, alliance management, strategic and commercial planning functions and was essential in formulating the business plan to support the company’s 2014 IPO. In just 18 months, he has spearheaded the company’s completion of five major partnership and licensing agreements to bring the lead investigational compound — vadadustat — to major territories across North America, Europe, and Asia, subject to regulatory approval, and to bolster the pipeline with additional promising compounds. In addition, Michel played an instrumental role in Akebia’s merger with fellow renal company, Keryx Biopharmaceuticals, announced June 28, 2018, and expected to close by the end of this year.
A role model for business development professionals, Michel excels at defining a vision for Akebia and its programs through long-term strategic planning and translating that vision into a common goal with partner companies. He works tirelessly to ensure that Akebia’s priorities are well-represented, and that the company maintains the stature of a true partner, despite working with companies many times its size, including Johnson & Johnson, Mitsubishi Tanabe Pharmaceutical, Otsuka Pharmaceutical Company, and Vifor Pharma. Michel is dedicated to forging quality and durable relationships that have the potential to bring important medicines to patients who need them.
“In collaboration with my team and colleagues at Akebia, particularly business development and legal, we secured the funding needed for our global Phase III program, through these licensing collaborations: more than $2.2 billion in total funding commitments, of which more than $550 million is committed capital,” he says. Michel counts this as a career highlight.
His goal is to keep growing as a person and a leader, and to inspire the best work from others and ultimately good outcomes for communities.
He began his career in the industry as an M&A analyst across industries including pharmaceuticals. “This is the role that first inspired me to pursue a career in biotech,” he says.
Michel says the ability he and his team have to improve patients’ lives inspires him. He is motivated by his team and in turn inspiring them to be at their best.
“I see myself as a person who brings together people and ideas and inspires them toward a vision,” he says. “I also lead others to challenge their presumptions and not necessarily accept, as truth, success recipes of the past. Innovation starts with a belief that progress is possible, and a drive to reach it unconventionally if necessary.”
At the same time, he is constantly mindful that his team has the tools and resources they need to balance their workload given the intense pace that the company keeps. “That pace can become difficult to sustain over time,” he says.
Over the years, Michel benefited from mentors who played crucial roles for him, particularly current Akebia CEO John Butler. “I am also deeply inspired by St. Vincent de Paul, who established charitable hospitals and changed society’s view of the poor and needy,” he says.
“My favorite charitable causes are helping refugees and the homeless, as well as supporting charities that provide urgent healthcare to people in developing countries.”
To him, being a mentor means being available to his team to support their professional development and success, which is what he strives to do every day. He also enjoys providing support and advice to alumni from his academic institutions in France, particularly about career advice in science.
Michel says his achievements have come as a result of the very talented teams and mentors he has had the pleasure of working with over the years.
“I’d like for people to look back and say that I was a compassionate person who inspired them to reach their fullest goals,” he says. (PV)
For Advancing the Goals of Inclusion and Diversity
Title: Director, Global Leadership
Company: Sanofi US
Education: BS, Biology, Greensboro College
Family: Her husband of 28 years, Eddie Sr., is also her high school sweetheart; three successful millennial children, Eddie II, Malcolm, and Jasmine, who are constantly expanding their ways of thinking
Hobbies: Writing, including children’s books featuring her grandson, Jaden Israel, as the main character; train enthusiast
Awards/Honors: Women in Leadership, National MBA Association; Stroke Hero, American Heart Association; Leadership Excellence and Development Award, Sanofi Women Inspiring Change; Talent Champion, Sanofi US Process Excellence Award; Likins Award
Associations: Healthcare Businesswomen’s Association; Society for Human Resource Management; International Coach Federation; Association for Talent Development; National Association of African-Americans in HR
Personal Brand: Live your life as a distribution center, not a storage facility
With a passion for developing her fellow employees, La’Wana Harris is committed to making a difference, helping the next generation of leaders, and creating a better way of doing things.
In her role as director, global leadership development at Sanofi, La’Wana seeks to create a culture of innovation by constantly asking tough questions about strategic direction and tactical execution. For La’Wana, it’s about always exploring new ideas and staying abreast of trends, working with industry partners to drive innovation through best practice sharing and collaborative initiatives, and listening to customer feedback to stay one step ahead.
Colleagues say there is no better example of an individual who leads, coaches, develops talent, and inspires than La’Wana.
La’Wana started her pharma career as a sales rep for Johnson & Johnson, and 18 years later still holds the tenets outlined in the company credo as guiding principles for her career.
Even before then, she was involved in helping to save lives by working as a radiologic technologist and mammographer from a Winnebago in West Virginia. “We would often see ladies who had never had a mammogram or physical exam. As you can imagine, I was the center of many jokes back then, but I couldn’t have been happier driving that big pink Winnebago — knowing that early detection of breast cancer saves lives.”
La’Wana still measures success by the positive impact she has on patients’ lives and how her role supports the corporate commitment to patients. “My professional goals have shifted over time and are no longer linked to a position or title,” she says. “I’m in constant pursuit of a series of experiences. To take on roles that allow me to succeed with authenticity and make a difference, to invest in the next generation of leaders, and to do things that have never been done before.”
For La’Wana, leadership is an opportunity to serve as opposed to the traditional command-and-control model. “The next generation of leaders demand that we abandon outdated leadership practices,” she says. “Companies are realizing that hierarchical leadership structures will not yield the levels of engagement and productivity needed for a competitive advantage in the global marketplace.”
One of her greatest concerns is workplace diversity and inclusion. She says the latest data suggest that at the current rate, the global gender gap will take more than 200 years to close, and the number of black CEOs heading up Fortune 500 companies has fallen to three from six in 2012.
With the retirement of Ursula Burns from Xerox, there are currently no African-American women leading Fortune 500 companies. Her appointment as CEO in 2009 was an inspiration and significant milestone for all women of color, La’Wana says. “I view her departure as both an inspiration and a call to action,” she says. “On one hand, I’m inspired to see that a black woman shattered the glass ceiling. Conversely, I am concerned about the absence of a robust pipeline of women of color to enter the pool of applicants for future C-suite opportunities. For these reasons, I’m even more compelled to action to help develop and support women of color. I believe one of the major constraints stopping organizations from being innovative is the lack of value and importance placed on harnessing the innovative power created by a diverse and inclusive workforce.”
She optimistically notes that a global network of like-minded people, communities, and organizations are working to reverse these alarming trends.
La’Wana is also a respected humanitarian and philanthropist. Understanding how important it is for children to read books with characters they can relate to she created two book series featuring children of color. These books promote cultural diversity and are translated in the native languages of underserved nations. La’Wana has traveled to Haiti annually since 2009 and has donated 10,000 books in Haitian Creole to schools and orphanages in partnership with Grace International. Through her efforts, U.S. sales from these books help support young females entering careers in STEM.(PV)
For Creating Digital Disruption
Title: Senior VP and Global Markets Leader, Life Sciences
Education: MS, Computer Science, Indian Institute of Science
Family: Parents and wife, who have always supported and encouraged him unconditionally; kids, who bring childhood back to his life
Hobbies: Playing squash, chess, reading
Awards/Honors: PharmaVOICE 100 — 2017; Cognizant CEO leadership award
Associations: Executive Sponsor for TransCelerate consortium
personal Brand: Go get it
Bhaskar Sambasivan is always pushing the boundaries and looking for ways to transform the industry — not just deliver me-too services for life-sciences companies. As senior VP and global markets leader, life sciences, at Cognizant, he has helped to lead the company’s transition to digital products and platforms.
He is leading the convergence of life sciences and healthcare. He has made investments in digital health and value-based contracting, taking advantage of relationships and products within Cognizant’s healthcare business unit and with outside partners to build relevant solutions and offerings for the life sciences.
In fact, Bhaskar says a career highlight has been helping Cognizant Life Sciences become recognized as an industry leader not only in terms of size and scale, but as a leading force in digital first transformation. He is particularly proud that Cognizant’s Life Sciences business has grown more than 30-fold in the past 13 years. Cognizant maintains an entrepreneurial culture by giving each industry business unit the autonomy to develop and market industry-specific solutions while taking advantage of corporatewide initiatives as they apply.
One of the company’s corporate initiatives is known as Cognizant Accelerator LaunchPad, a Shark Tank type of program to find, nurture, fund, and launch new Cognizant products. In the last round of LaunchPad financing, hundreds of applications across 15 business units were submitted; five ideas were selected for internal funding. Two of the five came from the life-sciences business unit, which is a direct result of Bhaskar’s leadership and his team.
He initiated a products and solutions group within life sciences to focus filling big gaps or unmet needs. He refers to these as “BHAGs — Big, Hairy Audacious Goals.” By bringing together client advisors, industry experts, and Cognizant consulting and technology groups to brainstorm, the life-sciences business unit is prepared to take advantage of the corporate Accelerator LaunchPad program to drive innovation and transformation in the industry.
He is admired as a leader in the life sciences who has been able to make a meaningful impact in the industry’s transformation through digital.
“Success is measured by the value that has been created and business outcomes that have been met, and not just by personal goal achievements,” Bhaskar says.
He says his biggest challenge is to run the business at an industry-leading growth rate, while changing it at the same time to be relevant, staying ahead of the competition, and being impactful to clients and industry.
If he had unlimited resources, he says he would focus on two areas: R&D transformation through meaningful use of new emerging technologies like automation and AI and setting up collaborative cross-industry consortiums to identify synergies and best practices that can maximize innovation and transformation.
Bhaskar demonstrates a personal commitment to social outreach, diversity, and academic enrichment. He is an active sponsor of the Cognizant Outreach program, which helps provide education and facilities to underprivileged children around the world. Cognizant is now ramping up and rolling out its STEM education volunteer opportunities, and he is already encouraging co-workers to use their strong science and technology backgrounds to mentor students.
“A good mentor can identify and unlock the unique skill or potential that every individual has but has not realized,” he says.
He has developed collaborations with Carnegie Mellon University in areas such as supply chain serialization and AI in drug discovery, and the company’s technology leaders frequently provide topics and guidance for Carnegie Mellon’s Capstone projects.
Within Cognizant, Bhaskar is committed to increasing the number of women in the organization. This year he is sponsoring one of Cognizant’s Women Empowered luncheons.
Women Empowered is a Cognizant movement that formed from the desire to increase recruitment of women at all levels of the organization, provide opportunities for career growth and leadership, and develop a network to build business relationships and celebrate successes. (PV)
Dr. Mark Wildgust
For Transforming Medical Affairs
Title: VP, Global Medical Affairs Oncology, Janssen
Company: Johnson & Johnson
Education: PhD, University of Manchester, UK; BSc (Honors) University of Plymouth, UK
Family: Wife, Heather, without her unwavering support he would not have been able to accomplish what he has done working in the pharmaceutical industry; children, Andrew and Emma, who inspire him and are truly everything to him
Hobbies: Running, especially half marathons; scuba diving — for more than 25 years
Associations: American Society of Clinical Oncology; American Society of Hematology
Personal Brand: Live Life
Mark Wildgust, Ph.D., VP, global medical affairs oncology at Janssen, is an esteemed medical affairs professional with expertise that spans all phases of clinical development. He has significant experience building and implementing medical strategies for both pre- and post-launch initiatives. Colleagues say he is a strong leader with a proven track record in managing and leading teams, developing talent, and understanding how to work within matrix organizations and build alignment on initiatives. Through his efforts, he has positioned Janssen as a premiere, evolving, oncology company. He has changed the way the organization thinks about the compound value story and integrated evidence generation planning.
Lauded by many as the most talented and brilliant individual in any medical affairs role, Mark combines his talent for developing transformational strategies that optimally support market access and utilization of oncology brands with leading-edge creativity in knowledge transfer and talent development. He led Janssen’s oncology global medical affairs organization in developing a unique, proactive approach to global integrated evidence generation plans, which provides the evidence to support the company’s oncology-based scientific communication platforms and strong value propositions for each of its leading brands.
The process works this way: Early in a drug’s lifecycle — at least two years prior to launch — Mark engages with all regional teams to start asking what evidence is needed to communicate the value story, when is it needed by, and where will it come from. Once the framework is in place, his team of global medical affairs leaders work closely with the local and regional MA teams using a bottom-up approach to ensure they have the best evidence generation plans in place to address key clinical evidence gaps that are essential for supporting oncologists’ treatment decision making and market access soon after launch. His disciplined evidence generation assessments and pre-approval access plans often provide such a clear set of solutions to ensuring comprehensive development and market access for the oncology portfolio that management often approves incremental funding requests to execute these business-critical strategies.
Another objective measure of the success of Mark’s leadership is the number of publications that are generated from his initiatives. Mark’s group supported more than 150 publications in 2017, including several which appeared in top-tier journals and were the basis of several oral and plenary presentations at the major hematology/oncology conferences. In addition, Mark works directly with his team to enhance the effectiveness of evidence communications ensuring that the key clinical messages and barriers to use are mastered and consistently transmitted by the regional medical affairs teams to support access and reimbursement decisions across the regions.
A familiar figure at national conferences, Mark commands a room with his ability to deliver complex information with passion, fluency, and clarity. With his 20 years of experience in oncology, he combines his understanding of the science and medical practice and thought leader relationships to drive evidence generation plans to support Janssen’s oncology strategy and portfolio development.
Colleagues say Mark has a wonderful collaborative style and interpersonal skills, which transcend organizational hierarchy. Ultimately, his approach translates into delivering data generation strategies that are comprehensive and differentiated, enabling hematologists/oncologists worldwide to make the best treatment decisions for the benefit of their patients. A key example of this was a safety management initiative. A regional team identified education of community physicians in managing adverse events as an area of focus and attention. Working in partnership with the region team, he supported the delivery of this project that has been very successful in enabling the professional education of 3,000 healthcare professionals across 300 countries. In addition, the concept is now being globally adopted. Colleagues say it is through Mark’s foresight that this educational program was so successful, underpinned by evidence communications and development of clear and effective clinical messages.
“Helping to launch ibrutinib, the first BTKi in B-cell malignancies, and in particular supporting the launch of the worldwide early access program providing more than 4,000 patients to this new life-saving medicine has been a career highlight,” Mark says.
Mark’s focus on the professional development of those on his team has created a legacy of enhanced talent and growth, with many team members moving into positions of increased responsibility and influence throughout the industry. As a scientist, mentor, and leader, Mark is a major voice for Janssen, medical affairs, and for those whose lives are or may be enhanced by novel treatments. (PV)
Jennifer De Camara
For Enhancing Social Engagement
Title: VP Law, US Pharmaceutical Strategic Customer Group
Company: Johnson & Johnson
Education: JD, University of Virginia School of Law
Family: Her parents, who made her the person that she is, and her wise daughter, who pushes her to keep growing
Hobbies: Gardening, cooking, and knitting
Awards/Honors: Janssen BRAVE, 2017; Janssen RAVE, 2013; numerous Standard of Leadership and Encore awards
Associations: Bar associations in Washington, DC, NY, and PA; Healthcare Businesswomen’s Association; Johnson & Johnson Women’s Leadership & Inclusion
Personal Brand: Own it
With a collaborative, flexible and solutions-oriented leadership style, Jennifer De Camara has been at the forefront of changing how Janssen approaches its interaction with one of its most important constituencies: patients.
As VP law, U.S. pharmaceutical strategic customer group, Jennifer sits on the management board of the strategic customer group and advises its senior management on legal matters supporting all levels of engagement with payers, institutional customers, and patient access programs as well as the rapidly evolving healthcare environment in which they operate.
She has been at the forefront of helping others to address guidance on how to appropriately navigate social media and she draws on a collaborative style of advising business partners and influencing team direction. As a result, she has been able to impact business strategy and establish a pragmatic course that allows the company to advance its social media communications to help patients and healthcare professionals with information about her company and its products.
She has worked closely with her cross-functional colleagues to provide clarity of thought and direction on processes to appropriately balance key regulatory concerns. Through this approach, the company developed internal standards and channels to move beyond asking whether to execute social/digital media to providing insight into how to successfully engage online.
Her efforts paid off. In 2015, Janssen was recognized as the most connected company in the pharmaceutical industry. When the FDA guidance was published, no changes were required to any platforms in which Janssen was engaged. In January 2014, J&J was recognized by the IMS Institute for Healthcare Informatics as No. 1 in social media engagement.
Colleagues say these achievements can be attributed in part to Jennifer’s resilience as a leader.
“Keep calm and carry on’ is one of my favorite quotes, because simply the act of learning to breathe and keep moving despite adversity shows both courage and increases the potential for mission success,” she says.
A resourceful leader, Jennifer likes solving problems and helping the people around her achieve their goals, which takes patience, attention to detail, creativity, and sometimes fearlessness. Jennifer is committed to being a valuable contributor and leader for her company and identifying spaces important to the industry in the future.
Beyond her role as a legal expert, Jennifer is passionate about enabling innovation by removing barriers and looking for creative solutions. She understands that figuring out what really motivates people and addressing that underlying issue can make the difference between project success and projects that don’t advance the ball.
She motivates others by reminding her teams why the goal was important in the first place, and how it fits into the bigger picture of helping patients.
Jennifer measures success in terms of if she has helped someone achieve his or her goal, and she continually looks for opportunities to help talented and committed people to enhance their skills and find new development opportunities.
“I would like to be remembered as a trusted advisor who cared about the right goals and the people advancing them, and someone who brought thoughtful and innovative solutions to the market,” she says.
To help other people maximize their potential, Jennifer focuses on building diverse and talented teams, treating others with respect and dignity, and never compromising integrity.
She believes mentorship is important to help others achieve their potential and work through situations when they just don’t know what to do or how to get there.
“My biggest career highlight has been the several opportunities I have had to make a difference in other people’s careers through advice and mentoring,” she says. “Seeing them succeed and get to their dreams reminds me how important it is to help one another.”
Jennifer credits many mentors in her life who helped her achieve her own goals, including Wendy Krasner, VP of regulatory affairs at PCMA, who took her in as a fledgling first year associate and taught her what it means to be an excellent lawyer and counselor to a business; Ilyssa Levins (2012 PharmaVOICE 100 honoree), from the Center for Communication Compliance for their partnership on numerous DIA and HBA activities, who has shown the importance of supporting each other and sharing hard-earned learnings, even on challenging subjects; and Deidre Meehan, assistant general counsel, J&J.
“There are many skills I have learned by example from Deidre Meehan, including the motivational power of trust and communication calibrated to the recipient,” she says.(PV)
For Driving Change in Healthcare
Title: Director, Healthcare and Pharmaceutical Management Program
Company: Columbia Business School
Education: MBA, Harvard Business School; BA, political science from Columbia University
Family: Dad, who passed away in 2014, was her biggest fan and supporter; she got her authenticity from him, and his legacy lives on in her and her son; Mom, a highly accomplished professional woman, taught her the importance of hard work and passion for work
Hobbies: Running; NY Times Sunday crossword; Manolo Blahnik shoe shopping
Awards/Honors: Ellerin Harvard Business School Healthcare Alumni Achievement Award
Associations: Founder and president, NYC Health Business Leaders; board member, The Fund for Public Health NYC, an independent, nonprofit organization that connects the NYC Health Department with public and private sector partners to build public health programs that make New York city healthier and safer
Beatrice Ellerin, who is known as Bunny throughout the industry, is also known for her strength, energy, and passion. Colleagues say she is a force to be reckoned with — she started her first business at age 15 — and is so passionate about disruptive innovation that she is constantly looking for an opportunity to drive change in the current healthcare ecosystem.
Over the 20 years of her career, she has amassed a track record of building and leading extraordinary healthcare organizations, many from the ground up, including her own agency and several associations. The diversity of her experiences, which has included healthcare delivery, life sciences, and digital health, has given her a broad-based knowledge of the entire ecosystem.
In 2016, Bunny was named director of Healthcare and Pharmaceutical Marketing (HPM) at Columbia Business School. In this role, she handles a variety of strategic, curricular, and industry outreach initiatives, working closely with students, faculty, and staff members, and alumni. The HPM program is one of the largest and most innovative healthcare programs among top-tier global business schools.
Bunny received her MBA from Harvard. Shortly after graduating in 1995, she started the Harvard Business School (HBS) Healthcare Alumni Association from scratch; it is now one of the largest alumni groups at HBS, providing students and alumni with enhanced networking opportunities. The cross-matrixed group focuses on generating points of view and initiatives to help repair the broken ecosystems throughout the nation. The group, which has more than 650 members throughout the world, produces events, conferences, and symposia on leading-edge topics featuring top academic, business, and healthcare leaders.
To commemorate Bunny’s role in forming and leading the organization, the group created the Ellerin Alumni Achievement Award. The award is given annually to a high-profile graduate of Harvard Business School who is doing important work in the field.
Another venture with far-reaching implications that she launched is the New York City Health Business Leaders organization, which in just eight years has evolved into one of the largest, most prestigious health-related networks today. Back in 1999, Bunny and co-founder Dr. Yin Ho were frustrated that New York City’s healthcare economy was often overlooked as a center of innovation and excellence by outsiders and from within the city itself. The two believed that New York provides an ideal environment for the healthcare industry, offering expertise across all sectors plus access to capital. So they established the organization dedicated to building a healthcare ecosystem in New York that spans all sectors to fill that need. The mission is to bring together the best minds in the business to discuss important issues and spur innovation. The group released the first-ever New York City Healthcare Venture Capital Report this year to provide entrepreneurs, investors, executives, policy makers, and all industry stakeholders with an objective, data-driven look at the importance of the New York market to the healthcare industry.
Colleagues from throughout her career are inspired by her passion and willingness to mentor and promote individual growth and people development.
She gathers both positive and negative feedback every step of the way and rewards employees for their contribution. She maintains an open-door policy and strives to provide guidance to all who enter.
She also is a big supporter of women’s causes, primarily those that provide services to women who are marginalized and don’t have many options such as the victims of domestic violence.
A born entrepreneur and executive leader — remember that company at 15 — Bunny has held roles as president of her own Ellerin Health Media, an agency focused on product strategy, market entry, business development, strategic communications, and digital marketing.
Before that, she was senior VP at Intouch Solutions, managing director at InterbrandHealth, and an executive at a number of venture-backed healthcare companies.
In her personal life, she is a devoted, hands-on mom to her son Michael, who just graduated from middle school and will enter Brooklyn Tech in the fall. (PV)
For Bridging the Payer-Pharma Divide
Title: VP, National Accounts Team Lead
Education: MBA, University of Delaware
Family: Husband Brian and her 16-year-old children Lauren and Christopher, who have taught her to set her mind to accomplish her goals, to celebrate the successes, to embrace her creativity, to slow down and listen, to not take life always so seriously, and that the little things matter
Hobbies: Traveling, hiking, being on the water
Awards/Honors: PharmaVOICE 100, 2013
Associations: WBL (Women Business Leaders of the U.S. Health Care Industry Foundation), Women in Bio, HBA, Hearing Loss of America
Laura Randa is a respected thought leader within the pharmaceutical industry, addressing the payer sector and leaving an indelible mark on many different organizations. This is Laura’s second time as a PharmaVOICE 100, having been previously recognized in 2013.
Laura recently joined Novartis as VP, national accounts team lead, a strategic role in which she works collaboratively with the finance, brand, and legal teams to support the goals of Novartis’ U.S. pharma business unit by securing favorable formulary access in all relevant segments across the entire portfolio.
In her previous role as head of payer engagement at Regeneron, Laura transformed how the company launches and markets products in the managed markets space. She focused on creating transparent, mutually beneficial manufacturer/payer relationships.
Also while at Regeneron, Laura initiated a campaign to educate Regeneron’s C-suite executives on how managed care entities operate and created an enterprise-wide strategy that allowed the company to engage with payers to develop fair pricing, rapid formulary access, and appropriate reimbursement for its products. Ultimately, she was responsible for leading the executive dialogue between her company, its alliance partners, and corporate executives of payers, which led to a successful launch of Regeneron’s new injectable product to treat atopic dermatitis, Dupixent.
Laura’s experience in leading teams and creating a positive, productive environment was also fundamental in creating a productive alliance with Sanofi, Regeneron’s corporate partner in several recent launches. She continually inspires her teammates by effectively working cross-functionally and making an impact at all levels.
Beginning early in the R&D cycle of an investigational product, Laura focuses on ways effectively improve competitive positioning — by building innovative, strategic collaborations with internal and external stakeholders that deliver access to new markets or customers and inserting payer feedback on appropriate patient selection and indication into study design.
Described as an industry connector, Laura has been instrumental in helping to build bridges with other companies to help all parties increase knowledge and gain external focus. Most recently, she was Regeneron’s executive sponsor for a cross-functional initiative to develop alliance guidance for the FDA Draft Guidance on Health Care Economic Information (HCEI) communication. She worked tirelessly to align internally and with the company’s two alliance partners to develop an approach for presenting proactive economic data.
Now, at Novartis, Laura will develop contracting, value proposition, and outcomes-based strategies, leading the negotiation and implementation of customer contract/pricing programs with top national accounts. Admired for her creative thinking and constant innovation, she helps team members stand out for their contributions to driving solutions aimed to enhancing healthcare connections.
As a leader, Laura has learned that she must earn trust, be very clear about the standards she sets, and inspire and motivate those to achieve those standards. “Trust is key,” she says. “You can push people as long as they trust you.”
Laura generously contributes her insights to the professional community on topics such as leadership, technology, and innovation. Described as intelligent, funny, positive, kind, and thoughtful, Laura gives her time and resources to others.
She is committed to mentoring other young women regardless of their business interests. She is a long-standing member of the Healthcare Businesswomen’s Association (HBA) and has served as a board member for two HBA chapters.
“Mentorship is very important to me,” she says. “Every single opportunity we’re presented with gives us an opportunity to learn, grow, be inspired, and share those experiences with others.” (PV)
For Championing Progressive Solutions
Title: VP, Operations
Company: Cardinal Health
Education: Utah State University
Family: His wife Catherine, his children Justin, Aubrey, and Dallin, his parents Jerry and Kathleen Wayment, and his wife’s parents Tom and Janet Waddell
Hobbies: Serving in his church and golf
Awards/Honors: Customer Focus Award, 2011; Award for Exceptional Service and Outstanding Commitment, 2011; Award for Exceptional Client Support, 2006; Convergys emerging leaders program, 2004; Convergys Corporation Award, 2004; Convergys Corporation Manager of the Year, 2000; Eagle Scout and two Palm Awards, 1992
Associations: HDA-Healthcare Distribution Alliance, PDMA Alliance, Boy Scouts of America
Personal Brand: It is better to light a candle than to curse at the darkness
Leadership is not a title; it’s not a position you are given — it is earned by putting the needs of others and the organization ahead of one’s own interests. This is how Joel Wayment, VP of operations for Cardinal Health 3PL, inspires those around him to deliver outstanding performance in the pursuit of helping patients.
Under his leadership, Cardinal Health 3PL (Third Party Logistics) has grown from being a mid-sized player a decade ago to an industry leader in third-party logistics, providing warehousing, distribution, and order-to-cash services to more than 125 biopharma companies with products across a wide range of therapeutic categories.
“Over the past three years we have doubled our portfolio of customers and achieved double-digit revenue growth,” Joel says.
His collaborative approach to management and his passion for providing exceptional service to customers has helped the 3PL business to consistently exceed its performance goals and the unit’s momentum continues to grow.
Colleagues admire Joel’s ability to anticipate the needs of the market and how to direct where the business needs to go next. His vision has led the 3PL business to launch a proprietary transportation network, create a 3PL title model program, and establish a direct-to-physician sampling program. He has also collaborated with his Cardinal Health colleagues to significantly expand the 3PL warehouse space over the past two years in anticipation of growing demand for services.
The regulatory landscape continues to evolve, and these changes are significantly impacting how the supply chain works. “I spend a great deal of time thinking about how our business can help our customers tackle issues ranging from state licensing requirements to driving efficiencies in the supply chain to mitigating drug diversion to improving order-to-cash,” he says.
He takes a customer-centric approach to service, expecting every function of the 3PL business to focus on personalizing the client’s experience, creating positive interactions, and delivering flawless execution. To build a service-focused culture within the 3PL business, Joel took a unique approach by hiring Traub Hospitality to train his team using the same protocols used by luxury hotels and high-end department stores.
Joel has created a positive employee culture based on teamwork and recognition. Colleagues note that he and his team regularly go the extra mile for them, including serving breakfast to everyone in the building, washing employees’ cars, and publicly recognizing the contributions of his team members. As a result, employees feel deeply valued and in turn are motivated to go the extra mile, perform at a very high level, and clearly understand how to interact with their customers. He has created a collaborative environment that fosters teamwork and strives for excellence.
“I try to stay positive,” he says. “Leadership sets the pace for the organization. I keep focused on why we are doing what we are doing, not just what needs to be done. When we see and understand the why, we become committed to the work that needs to be done and it strengthens our resolve to overcome the challenges we are facing. I also focus on helping others to see what success will look like once we overcome our obstacles and reach our goals.” (PV)
For Transforming Evidence Generation
Title: President, Real-World and Analytics Solutions
Education: BA, Political Science, Union College; MBA, Kellogg School of Management, Northwestern University
Family: His wife, Shari; parents Barb and Tom
For more than a decade, Jon Resnick has shown a passion for evolving the real world evidence space (RWE) space, focusing on advancements in data collection, technology, and analytics to drive transformation in approaches to evidence generation. Having launched the first RWE group at IQVIA, Jon is now president, real-world and analytics solutions (RWAS).
His teams bring healthcare systems and life-science companies new ways to use machine learning, novel scientific methodologies and big data. He is at the forefront of the effort to drive adoption of data collected as part of routine clinical care to improve decision-making and outcomes. He is championing innovative new models and approaches from collaborations with the FDA to expand safety/efficacy monitoring, to new contracting models by creating the Collaboration for Oncology Data in Europe (CODE) initiative, and new scientific methodologies, such as pragmatic and synthetic control trials. His RWAS team has global and local capabilities to run real-world studies requiring large, complex, multi-country operations or focused market-specific local expertise.
Jon says a large part of his role involves thinking about new and better ways to generate the data needed to answer some of the biggest problems in healthcare today. “This involves innovating in many ways: collecting and curating data from new and richer sources, creating collaborations across multiple healthcare stakeholders, and leveraging newer and better technology,” he says.
In the R&D and RWE space, there has been an explosion of data availability and technology, coupled with advances in machine learning, data linkages, and privacy protections. This enables much more granularity and accuracy in the information we have about our healthcare system.
“We work in one of the most exciting sectors where advances in health information technology have the potential to transform the healthcare system, but we aren’t there yet,” he says. “I have spent my career challenging the status quo, identifying new opportunities, and focusing on how can we bring these new approaches to market.”
He says success in this space means getting the balance right between understanding the future and its potential and ensuring there is an achievable path to get there. “Advances in healthcare data, technology, and automated analytics mean that processes that previously took months to complete can now be done in minutes, helping us find patients with rare diseases, enable providers to access real-time treatment outcomes information, and allow payers and regulators to make decisions based on new insights. We have to have faith that we can protect the essential elements of our system while disrupting how we do things.”
Those who know Jon say one of his most impressive qualities is his ability to align diverse stakeholders together around a transformative vision. He has done so for virtually every major biopharma company, having led the original IMS Health RWE partnership with AstraZeneca, through championing a formal collaboration with multiple life-sciences and healthcare stakeholders in oncology, and securing other collaborative arrangements with leading providers around the world.
“I enjoy building teams, collaborating with my clients, and bringing together other experts to create something new that will change the ways things are being done,” he says. “My success is getting my teams to act based on a clear vision and engaging them to share my passion for where we are going. The balance is being open enough to allow others to help shape the vision as well.”
Jon’s collaborative approach, professional integrity, and commitment to identifying and developing talent at every level inspire loyalty. His experience and knowledge are valuable assets for showcasing the value that real-world evidence will have for the future of healthcare.
“My team continues to work toward bringing new scientific methodologies to market; embed technology to collect, link, and analyze data to become more meaningful; and create networks to provide ongoing evidence generation,” he says. “But it is the multiple stakeholders — our clients, providers, payers, and regulators — that make change possible.” (PV)
Dr. Lori Shafner
For Accelerating the Rare Drug Pipeline
Title: Global Development Team Leader
Company: Alexion Pharmaceuticals
Education: BA, Biology, Wheaton College; PhD, Pharmacology & Experimental Therapeutics, Boston University
Family: Her children, Sarena & Justin, who inspire her every day
Hobbies: Running, cycling, cooking, gardening, traveling
Awards/Honors: Alexion Guiding Star Award, 2017; Alexion CEO Award, 2016; Hartford CT Business Journal Diversity & Inclusion Award, 2014
Associations: Board of Directors, Vista Life Innovations Member, Business Development Committee, Vista Life Innovations, Women in Bio Member, Southeast CT Entrepreneurs Network
Personal Brand: Mission Possible
With a passion and commitment to delivering transformative therapies to patients with rare diseases, Lori Shafner, Ph.D., is committed to turning what seems to be impossible into something possible.
In her role as product development team leader at Alexion Pharmaceuticals, a global biopharmaceutical company focused on serving patients and families affected by rare diseases, Dr. Shafner is responsible for leading the global development program for the “crown jewel” in Alexion’s pipeline, ALXN1210. ALXN1210 is a long-acting C5 inhibitor, being investigated for the treatment of patients with two devastating, ultra-rare disorders, paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). The ambition behind ALXN1210 is to raise the standard of care for patients with PNH and aHUS around the world.
Under Dr. Shafner’s leadership, Alexion’s cross-functional team rapidly progressed ALXN1210 research into patients with PNH through pivotal Phase III clinical trial completion in record time. In fact, the trials constitute the largest, most robust, development program ever in PNH.
Dr. Shafner says this was one of the toughest challenges she has faced, as it required studies to be conducted in patients switched from the current standard of care, which also happens to be Alexion’s flagship medicine, Soliris (eculizumab).
Fortunately, Dr. Shafner and her team’s hard work and dedication has been paying off.
Recently, comprehensive data from two Phase III clinical trials were used in submissions of biologics license application to the Food and Drug Administration and a marketing authorization application to the European Medicines Agency for ALXN1210 for the treatment of patients with PNH.
Dr. Shafner believes the mark of a true leader is one who challenges the status quo and helps teams achieve more than they imagined they could. It is with this shared mission possible mantra that Dr. Shafner has cultivated an innovative, dynamic, and driven team across research, development, manufacturing, commercial, medical affairs, and regulatory operations to raise the bar for patients. Her team says she comes to work every day with an unmatched drive to make a difference for patients.
“I have experienced the helpless feeling of an unexpected medical condition that almost took my life,” Dr. Shafner says. “I want to give back in a meaningful way.”
She encourages her team members to listen to each other, to patients, and to the medical community. Dr. Shafner measures her own success by the growth and accomplishments of her team, collectively and as individuals.
“It’s all about the ‘we’ that allows us to go beyond and shape the future,” she says. “Good riddance to the ‘me’ culture. People grow multi-dimensionally when they work together.”
Dr. Shafner’s vision for the future is to further harmonize product registration, approval, and labeling globally to streamline and expedite clinical development and registration of important new therapies.
“This would, in turn, free up resources to invest in and advance additional new medicines for diseases with no current treatment,” she says.
As important as hard work is, Dr. Shafner also maintains it’s important to have balance.
“I worry that we are always on and that is what gets rewarded too often,” she says. “Down time is required to think, to push your own bounds, and to truly innovate.”
Dr. Shafner is passionate about helping people with disabilities function in the workplace by building their confidence through mentorship and community involvement. At Alexion, she focuses on mentoring women who are looking to make the move from scientific to leadership roles and helping them chart a path forward for growth and success. She also mentors Ph.D. students, new professionals, and peers. “I have learned many lessons through mentoring and believe it is a wonderfully informal way to help others see beyond their own desk,” she says.
A truly dedicated and innovative leader, Dr. Shafner gives it all she has — to her family, to the teams she leads and to the patient communities Alexion serves. (PV)
For Creating Opportunities Out of Obstacles
Title: Global VP Life Sciences Product Strategy
Company: Oracle Corp.
Education: BS, Computer Science, Eastern Connecticut State University
Family: Wife, Lori, who has sacrificed so much to allow him to grow as a leader in this industry
Hobbies: Fishing, hunting, hiking, skeet, cooking, meat smoking
Awards/Honors: Pfizer Global Research and Development Achievement Award; Oracle Product Champion Award
Associations: Drug Information Association; Society for Data Management
Personal Brand: Make It Happen
Jim Streeter, Oracle’s global VP of life sciences product strategy, brings together a combination of knowledge, compassion, and experience that is having an instrumental impact on Oracle and the life-sciences industry at large. He has an undying passion for clinical trials and he is in this business for very human reasons — to help patients with disease have hope while trying to eliminate or alleviate their suffering and improve their quality of life.
Colleagues admire that his conviction creates opportunities out of obstacles. Since he joined Oracle in 2014, he has pioneered new paths and lifted Oracle Health Sciences and the life-sciences industry at large to new heights by developing breakthrough strategies, products, and services to improve clinical trials.
He is bringing his vision to hundreds of people globally. Oracle’s Health Sciences Global Business unit delivers technology solutions that power everything from clinical trials and pharmacovigilance to precision medicine. Jim has played an instrumental role designing products that appeal to the broader life-sciences market, including pharmaceutical companies, CROs, innovators in biotech and healthcare organizations. Under Jim’s watch, more than 200 new customers have come to rely on Oracle’s health sciences solutions to bring life-saving and life-changing drugs to market.
Jim was a key visionary behind the Oracle Health Sciences Clinical One platform, which was launched in June 2017. “This platform reimagines the way clinical trials are run and promises to cut trial times and costs by as much as 50%,” he says. “The first capability on the new platform — Randomization and Trial Supply Management — has, for the first time, made trial set up self-service, allowing clients to quickly define studies and efficiently implement any mid-study changes without programming.”
Traditional clinical research and development has consisted of many disjointed processes and technology silos that don’t share data, thereby slowing the progress of developing a potentially life-saving drug from a promising molecule to an FDA-approved therapy. Jim’s combined experience on the pharma, CRO, and technology side have helped him deliver a cloud-based solution that delivers universal access to all clinical data that is captured once, secured in the cloud and shared across all clinical research teams involved in the clinical development lifecycle — from trial set up to clinical data collection and management to regulatory compliance and post marketing.
Jim began his career as software, hardware and systems engineer for the Naval Underwater Research Center for the U.S. Navy. He brought his technology chops to the world of life sciences when he joined Pfizer two decades ago. There, he learned what it took to bring a drug from a molecule to a patient. He learned how to run a clinical trial inside an organization that brought significant treatments to market from life-saving vaccines to medicine for chronic conditions. He recognizes the vital role CROs play and spent almost a decade at PPD pioneering global clinical technical operations to support more effective clinical trials.
Jim is grounded in the notion that clinical trials should be a treatment option for all patients and to effect that change in thinking technology must be married to a clinical trial process that is effective, safe, efficient, and most importantly, centered on the patient. Doing this not only helps the individual patients enrolling in clinical trials, but also overcomes one of the biggest challenges for drug developers — meeting patient enrollment targets. Without sufficient patient enrollment, clinical researchers don’t have enough of the statistical data required to get a drug approved.
“My goal is to make sure that technology and innovation in clinical trials make a major difference in the cost, time, and quality of clinical trials for today and for the future,” he says. “I would like to change the industry to take on new and innovative technology easier and faster.
“The saying ‘the patient is waiting’ motivates me every day when I wake up, we have to improve clinical trials so we can get drugs to market faster and we need to find better ways to do this.” (PV)