TransCelerate BioPharma launched in September 2012 to advance innovation in research and development (R&D), identify and solve common R&D challenges and further improve patient safety. The goal of our members, then and now, is to deliver more high quality medicines to patients.
While TransCelerate is not the first organization or consortium that the biopharmaceutical industry has formed to solve common challenges, it is one of the most ambitious and supported collaborations to date.
We have not only set goals, but we have delivered on these goals. And in one year, we have made significant strides toward our initial aim of making selected components of clinical trials more efficient, including:
- Mobilized 10 companies to create TransCelerate; nine additional members added in 2013
- Created a lean and functional infrastructure for the not-for-profit entity
- Engaged multiple organizations – CTTI, SCRS, BIO, IOM, NIH, ACRO, iMi, etc.
- Risk-Based Monitoring – Published the framework and approach for RBM; launched pilot studies for RBM across multiple member companies and therapeutic areas
- Site Qualification & Training – Published the criteria for mutual recognition of GCP training
- Clinical Data Standards – Supported publishing of SHARE environment; initiated two pilots for CDS in partnership with CDISC
- Clinical Trial Comparator Network – Created network and completed first transaction of comparator drugs among member companies
In our second year, we will continue to work together in making progress toward key milestones and our ultimate goal of improving patient health. This year, we seek to:
- Launch the first release of the Shared Investigator Site Portal
- Initiate data standards development of additional therapeutic areas
- Expand framework for site qualification recognition beyond GCP training
- Engage the pharmaceutical industry and regulatory agencies in Japan, China and other regions
- Initiate new projects and expanding scope on selected existing projects
TransCelerate has been enthusiastically welcomed and supported by the biopharmaceutical industry at large, as well as regulators, other clinical trial collaborations and the general clinical trial ecosystem. My colleagues from the member companies of TransCelerate and I have an unwavering dedication to assessing, refining and creating processes aimed at the pre-competitive drug development environment. We appreciate the support during this first year and reaffirm our commitment to bring innovative new medicines to the public faster.
Dalvir Gill, PhD
Chief Executive Officer
TransCelerate BioPharma Inc.
Chief Executive Officer
Dalvir Gill, PhD, is the Chief Executive Officer of TransCelerate and serves on its Board of Directors.
Dr. Gill has more than 25 years of drug development experience. Prior to his appointment as CEO of TransCelerate in December 2012, Dr. Gill was the President of Phase II-IV Drug Development at PharmaNet-i3, an international contract research organization. In this role, he was responsible for a global business spanning nearly 40 countries and had P&L responsibility for all operational departments and business development.
Dr. Gill earned his BSc in Applied Biology from the University of Hertfordshire and his PhD in Pathobiology from the Royal Free Hospital School of Medicine, University of London. He also holds a diploma in the health economics of pharmaceuticals from the executive program of the Stockholm School of Economics. Dr. Gill has presented his research and spoken at numerous conferences, and has authored more than 30 scientific publications. He also is an elected fellow of the Royal Society of Medicine.
Chair of the Board
Dr. Annalisa Jenkins, MBBS, MRCP, is Executive Vice President, Head of Global Research and Development for Merck Serono. In addition, she leads Global Medical Affairs and Quality. Dr. Jenkins is a member of the Pharmaceutical Executive Committee. She joined the company in 2011, previously serving as Head of Global Development and Medical.
Prior to joining Merck Serono, Dr. Jenkins was Senior Vice President, Global Medical Affairs at Bristol-Myers Squibb (BMS). She started with BMS in 1997 in the UK. In 2000, she moved to Australia to serve as Executive Medical Director for Australia and New Zealand, subsequently leading the Medical Division across Asia Pacific and Latin America.
In 2002, Dr. Jenkins moved to BMS’s major R&D site in Princeton, New Jersey, to oversee the company’s International Medical Division. After three years in this role, she was appointed Chief Medical Officer (CMO) for Europe, Middle East and Africa, subsequently taking on the position of Senior Vice President and CMO responsible for the Americas and the Development Teams. During her tenure at BMS she made significant contributions to the globalization of Medical Affairs, the progression of a number of the key pipeline programs and the execution of a number of strategic transactions.
Dr. Jenkins began her career as a Medical Officer with the British Royal Navy, and served with the Minesweeper Squadron during the Gulf conflict, rising to the rank of Surgeon Lieutenant Commander. She graduated in Medicine from St. Bartholomew’s Hospital London and trained in Cardiovascular Medicine in the UK National Health Service.
Dr. Jenkins is Chair of the Board of TransCelerate BioPharma Inc. In addition, she serves on the Boards of Directors for the Healthcare Businesswomen’s Association European Chapter; the Concert Artists Guild New York; and the corporate advisory board of the Center for Talent Innovation. She is also a member of the Scientific Leadership Advisory Council at PhRMA.
Dr. Jenkins was named the Healthcare Businesswomen’s Association Woman of the Year in 2014, a prestigious award that honors exceptional leaders and role models in the healthcare industry.
Lynn Marks (Secretary)
Lynn Marks, MD, currently has operational accountability for clinical trials over a broad range of disease and therapeutic areas on a global scale ranging across the Phase I to IV development landscape. Additionally, he has responsibility for business support functions such as performance metrics, clinical systems support, clinical trial contracting, outsourcing strategy & implementation and GCP, as well as, core training across R&D. Further, his remit includes key capabilities such as Project Planning & Management, Study & Data Management, clinical trial Monitoring, Programming and Statistics (non-clinical and clinical). Areas of analytical science and modeling are included through the Global Health Outcomes, Genetics, Computational Biology, PK/PD modeling and Epidemiology teams. More recently the Clinical Development teams in Japan and China are his accountability. He also leads the Simplifying Clinical Development Change Initiative which focuses on increasing productivity across R&D by bringing together a focus on behaviors, processes, standards and technology. This concept has expanded to include a collaborative effort across more than 15 Pharma companies in a newly formed TransCelerate BioPharma Inc.,not-for-profit entity.
He joined the company in 1993 working in the Infectious Diseases Clinical organization with increasing levels of accountability. He then transferred to the Consumer Healthcare R&D team to lead an Rx to OTC switch initiative and subsequently became head of Consumer Health Medical and Regulatory Worldwide. Next he returned to Pharma R&D as head of the Infectious Diseases Therapy area. Over the next 10 years, he had the opportunity to grow and learn from varying organizational changes with resultant shifts in accountability as head of the Infectious Diseases Development group. Subsequently, he transitioned to lead the Center for Project and Study Excellence in 2008 which has now expanded to become the Projects, Clinical Platforms & Sciences team.
Dr. Marks is Board Certified in Internal Medicine and Infectious Diseases. Before joining GSK, he was on faculty at the University of South Alabama Medical Center with joint appointments in Infectious Diseases, Microbiology and Pharmacology. In addition to teaching and patient care responsibilities, he led a NIH grant funded research effort focused on the molecular genetics of bacterial pathogenicity.
Andy Lee (Treasurer)
Andy Lee is the Deputy Head of Clinical Sciences and Operations at Sanofi. He is responsible for the execution of clinical trials, across diverse phases and therapeutic areas, around the world to deliver clinical trials to high-quality international GCP and regulatory standards in a timely and cost effective manner.
Andy has 20 years industry experience conducting clinical studies ranging from pre-clinical to phase IV drug development, across multiple platforms such as devices, small molecules, biologics and gene-therapies. He started his career at Pfizer, managing a clinical research department in South Africa. During this time he gained experience in conducting trials in a wide variety of therapeutic areas
Andy moved to the United States in 1996 to work as a Clinician in the Cardiovascular and Metabolic Diseases group. Since then he has chaired an Early Candidate Management Team from First in Human to phase III development, been a Local and Global Clinical Leader. His passion has been for conducting large global trials as evidenced by his experience with a 37-country breast cancer study and as the Global Protocol Leader for an 8,500-subject, 32-country protocol in postmenopausal women at risk for osteoporotic fractures, cardiovascular disease, and breast cancer. He has undergone numerous regulatory sponsor/monitor inspections as well as site and vendor inspections following MAA/NDA filings. Since 2005, Andy has focused his efforts on Clinical and Development Operations at Pfizer, where he held a variety of Leadership positions as the WW Head of Clinical Study and Data Management, the WW Head of Clinical Study Operations, the Global Head of Clinical Project Management and Clinical Quality Management. Andy moved to Genzyme in 2009 where he was the Head of Global Clinical Operations prior to the Sanofi acquisition of Genzyme
Andy is interested in Human Subject Protection, Multiregional Studies, Quality and Compliance, Operational Excellence and finding more efficient ways to run clinical trials.
Board of Directors
Alfred W. Sandrock Jr., MD, PhD, is Chief Medical Officer and Group Senior Vice President of Development Sciences at Biogen Idec, overseeing clinical development in all therapeutic areas, regulatory affairs, safety and benefit risk management, global clinical operations, and biometrics. He received an MD from Harvard Medical School, and a PhD in Neurobiology from Harvard University. He completed an internship in Medicine, a residency and chief residency in Neurology, and a Clinical Fellowship in Neuromuscular Disease and Clinical Neurophysiology (electromyography) at Massachusetts General Hospital.
Board of Directors
Briggs W. Morrison, MD is the Head of Global Medicines Development (GMD) and Chief Medical Officer at AstraZeneca Pharmaceuticals, LP. Briggs joined AstraZeneca in January 2012 from Pfizer where he held a number of roles including Head of Clinical Development for all therapeutic area, Head of the Medicines Development Group for Pfizer’s Primary Care Business Unit, and Head of Medical Excellence overseeing Development, Regulatory, Safety and Medical Affairs. Briggs joined Pfizer in 2007 after spending 12 years at Merck & Co., Inc. in various R+D roles.
Briggs has a BS degree in Biology from Georgetown University and an MD degree from the University of Connecticut. He completed his internship and residency in Internal Medicine at the Massachusetts General Hospital, completed his fellowship in Medical Oncology at the Dana Farber Cancer Institute, and completed postdoctoral basic cancer research in the laboratory of Dr. Philip Leder in the Department of Genetics at Harvard Medical School. Briggs has been married for 27 years to Angela, and they have 3 children. Briggs lives in New Jersey.
Board of Directors
Corsee is the Senior Vice President and Global Head of Product Development Innovation and Clinical Operations. In her Innovation role, she is accountable for partnering with all of the global functions to nurture an innovative PD culture and to identify and implement innovative ways to change the way we do drug development. As head of Clinical Operations, the largest function in PD, she leads a function spanning all of Product Development’s global locations with approximately 1,700 full-time employees.
Corsee joined Genentech in 1994 as Associate Director, Biostatistics, and was named Director in 1998. She held positions of increasing responsibility in Biostatistics, Statistics, Biometrics and Business Operations before being named Vice President of Biometrics and Development Services in 2003. She was named Vice President of the DATA (Design, Analysis, and Technology and Administration) Group in 2005. In 2009 she was named as Vice President and Global Head, Global Biometrics and was promoted to Senior Vice President in early 2011. Prior to joining Genentech, Corsee was the Biostatistics Associate Director for allergy, asthma and cytokines at the Schering-Plough Research Institute in Kenilworth, New Jersey. Corsee graduated from the Philippine Science High School and holds a Bachelor of Science, Magna Cum Laude, in statistics and a Master of Science in statistics from the University of the Philippines. She also received a master's degree and a doctorate in statistics from the University of Pennsylvania Wharton Doctoral Program.
Board of Directors
Elias Zerhouni, MD, is the President, Global Research & Development, and a member of the Executive Committee for Sanofi.
Dr. Zerhouni’s academic career was spent at the renowned Johns Hopkins University and Hospital where he was professor of Radiology and Biomedical engineering and senior adviser for Johns Hopkins Medicine. He served as Chair of the Russell H. Morgan Department of Radiology and Radiological Sciences, Vice Dean for Research and Executive Vice Dean of the School of Medicine from 1996 to 2002 before his
appointment as Director of the National Institutes of Health from 2002 to 2008. In that position he oversaw the NIH’s 27 Institutes and Centers with more than 18,000
employees and a budget of $29.5 billion (2008).
In November 2009, President Obama appointed Dr. Zerhouni as one of the first residential U.S. science envoys.
Dr. Zerhouni has founded or co-founded five start-up companies, authored more than 200 publications and holds eight patents and a number of prominent positions on several Boards, including most recently, the board of the Lasker Foundation and of the Transcelerate BioPharma Inc. He is also a member of the Institute of Medicine of the U.S. National Academy of Sciences, received the prestigious Legion of Honor medal from the French National Order in 2008, and was elected in 2010 as a member of the French Academy of Medicine and appointed as Chair of Innovation at the College de
France in 2011.
Board of Directors
Garry Neil, MD, is the global heat of R&D at Medgenics.
Garry has broad experience in science, medicine and pharmaceutical development. He has held a number of senior positions at Johnson & Johnson, EMD Pharmaceuticals and Astra Zeneca. He has also held a number of academic posts at various academic institutes including the Ludwig Institute for Cancer Research, the University of Toronto, the University of Iowa College of Medicine and the University of Pennsylvania (adjunct). Most recently he was Corporate Vice President of Science & Technology at J&J, and before that he was Group President, Johnson & Johnson Pharmaceutical Research and Development. Under his leadership a number of important new medicines for the treatment of cancer, anemia, infections, central nervous system and psychiatric disorders, pain, and genitourinary and gastrointestinal diseases, gained initial or new and/or expanded indication approvals. Garry is also an industry thought leader. He is on the Board of Directors for TransCelerate Biopharma Incorporated (TBI), a precompetitive cross-industry partnership established to enhance the effectiveness and efficiency of biopharmaceutical R&D.
Garry has written more than 50 articles and book chapters. He holds a Bachelor of Science degree from the University of Saskatchewan and a medical degree from the University of Saskatchewan College of Medicine and completed his postdoctoral clinical training in internal medicine and gastroenterology at the University of Toronto. He also completed a postdoctoral research fellowship at the Research Institute of Scripps Clinic. He is a Fellow of the American College of Physicians, a Fellow of the American College of Gastroenterology, a member of the American Association of Immunologists, and the Society for Clinical Trials, the Clinical Trials Transformation Initiative. He is a member of the Boards of the Reagan Udall Foundation, the Foundation for the NIH and is a member of the Science Management Review Board of the NIH. He was former Chairman of the Pharmaceutical Research and Manufacturers Association (PhRMA) Science and Regulatory Executive Committee, former Chairman of the PhRMA Foundation Board, and former Chairman of the Scientific Advisory Board of the Center for Advanced Biotechnology and Medicine (Rutgers). He is also the 2007 discovery awardee of the American Geriatrics Society.
Board of Directors
Prof. Dr. med. Iris Loew-Friedrich is Executive Vice-President Biopharma Development Solutions and Chief Medical Officer, UCB S.A.. She provides strategic global leadership for project leadership, world-wide clinical development, medical affairs and global regulatory affairs for UCB’s portfolio of pipeline projects and products.
The mission of Biopharma Development Solutions is to develop patient solutions with proven superior and sustainable value for patients suffering from severe diseases. Dr. Loew-Friedrich also oversees UCB’s Patient Affairs function, which places a strategic focus on better understanding and improving the patient experience in currently underserved medical areas in immunological and neurological diseases.
Prior to taking on her current role in March 2008, Dr. Loew-Friedrich was
UCB’s Global Head of Development, during which time she oversaw clinical development of key neurology and immunology products. From 2001 to 2009, Dr. Loew-Friedrich also served as the head of Global Research and
Development for Schwarz Pharma, which UCB moved to acquire in 2006. She was also on the Schwarz Pharma Executive Board.
Dr. Loew-Friedrich held several medical and R&D roles, including Vice-
President and Head of Global Projects at BASF Pharma, Ludwigshafen, Germany; Vice-President, Head of Global Clinical Management, HMR/Aventis,
and Therapeutic Area Head Rheumatology and Bone Diseases, Hoechst/HMR,
Bridgewater, New Jersey.
Dr. Loew-Friedrich received her medical license and her PhD from Frankfurt
University, Frankfurt, Germany, in 1985. From 1985 to 1992, Dr. Loew- Friedrich was the staff physician at the Department for Internal Medicine at
the Frankfurt University Medical School, with sub-specialties in immunology, nephrology, and transplantation medicine. She is board-certified in internal
medicine and holds a professorship at Frankfurt University Medical School.
Board of Directors
Jan M. Lundberg, PhD, is Executive Vice President for Science and Technology and President of Lilly Research Laboratories (LRL). He is also a member of the company’s executive committee.
Dr. Lundberg joined Eli Lilly and Company January, 2010, with responsibility for Research and the Development Center of Excellence. Prior to assuming his position at Lilly, Dr. Lundberg served as Global Head of Discovery Research at AstraZeneca for ten years and was a member of the senior executive team. He was involved with numerous candidate drug nominations, development projects and support for marketed products.
After his medical education and receiving his PhD, Dr. Lundberg served as Professor at the Department of Pharmacology, Karolinska Institute, Stockholm, Sweden. Dr. Lundberg has authored over 500 publications of original articles in international peer-reviewed journals and is listed as one of the highly cited authors by the Institute for Scientific Information (ISI). His work has focused on cell signaling in integrated systems using multiple mediators (peptides, purines, and nitric oxide) with translational applications to nervous system, endocrine, inflammation and cardiovascular areas. This research has been highly recognized and has received several awards. He has also been appointed as Honorary Doctor at the Pharmaceutical Faculty, Uppsala University (2006).
Dr. Lundberg is the co-founder of a biotech diagnostic company (Aerocrine AB).
Dr. Lundberg has served on several committees which include Chairman, PhD and post doc programs at the Karolinska Institute, Evaluation Committee for the Swedish Medical Research Council, Executive Advisory Board, the Swedish Medical Products Agency Registration of New Drugs (part of EMEA), and EFPIA Research head group generating the Innovative Medicines Initiative (IMI), a major public private partnership with the European Union. He served on the board of Biotechnology Industry Organization (BIO) and PhRMA’s Science and Regulatory Committee from 2010-2013. He is currently a board member of the PhRMA Foundation, TransCelerate Biopharma, Inc. and BioCrossroads.
Board of Directors
Dr. Hubbard is Senior Vice President and Worldwide Head of Development Operations for Pfizer Inc. In this position, he is responsible for clinical trial operations and management of more than 450 clinical projects from Phase I to IV. Dr. Hubbard serves as Co-Chair of Pfizer’s early Development Committee and Clinical and Medical Excellence Innovation Board and is a member of the Portfolio Strategy and Investment Committee and Worldwide Research & Development Leadership Team.
He has been leading pharmaceutical research and development activity for more than 28 years and has held positions of increasing responsibility in the Biopharmaceutical and Clinical Research & Development Services industries. Prior to joining Pfizer, he was Group President, Clinical Research Services at ICON Clinical Research, a top 5 global clinical research organization.
Dr. Hubbard received a Bachelor of Science degree in Biopsychology from the University of Santa Clara and a Doctorate from the University of Tennessee, with a research focus on the genetic basis of hypertension and autonomic dysfunction. He was a National Institute of Health Postdoctoral Fellow in Cardiovascular and Clinical Pharmacology at the University of Texas Health Sciences Center. He is a member of the Society of Clinical Pharmacology and Therapeutics, Drug Information Association and has served on the Special Interest Advisory Committee on Project Management. He is a Board Certified Diplomate in Applied Pharmacology and was elected to Fellow of the American College of Clinical Pharmacology (ACCP) in 1994. Dr. Hubbard was Chairman of the ACCP Public Policy Committee from 1999 to 2007. He has authored or co-authored three book chapters and 76 published articles and abstracts in the areas of biopsychology, cardiovascular and autonomic pharmacology, clinical pharmacology, and global drug development.
He is a Board Member of TransCelerate Biopharma, a Business Advisory Board Member of SAFE Biopharma, a Scientific Advisory Board Member of MedAvante Corporation, Advisory Board Member and Fundraising Vice-chair for the Children’s Brain Tumor Foundation.
Board of Directors
Prof. Klaus Dugi, MD, is Senior Vice President Medicine and Chief Medical Officer at Boehringer Ingelheim. His responsibilities include Translational Medicine and Clinical Pharmacology, Clinical Development from First in Man to Registration, Medical Affairs, Clinical Operations, and Biometry and Data Management for Boehringer Ingelheim. During his more than 10 years at BI, Prof. Dugi has previously served as Corporate Vice President Medical Affairs and Vice President Therapeutic Area Metabolic Diseases.
Prior to joining Boehringer Ingelheim, Prof. Dugi was head of the Metabolic Outpatient Clinic at Heidelberg University Hospital.
Prof. Dugi qualified in Medicine at Philipps University Marburg and between 1991 and 1996 spent more than four years doing basic and applied biomedical research at the National Institutes of Health in Bethesda, MD, USA. Prior to joining Boehringer Ingelheim, Prof. Dugi practiced Internal Medicine and Endocrinology for six years at Heidelberg University Hospital and also conducted clinical and pre-clinical research in the fields of atherosclerosis, diabetes, and lipid metabolism. Prof. Dugi holds a Professor in Medicine at Heidelberg University and continues to teach general Internal Medicine as well as Endocrinology.
Board of Directors
Dr. Marco Taglietti is a physician, board certified in Infectious Disease and Dermatology with over 20 years of experience in drug development.
In 2007, Dr. Taglietti joined Forest Laboratories Inc. where he holds the position of President, Forest Research Institute, Inc. and Corporate Senior Vice President, R&D, Forest Laboratories, Inc. Prior to joining Forest Labs, Dr. Taglietti held the position of Senior Vice President, Head of Global R&D at Stiefel Laboratories for three years. Before joining Stiefel Labs, Dr. Taglietti spent 12 years at Schering-Plough where he held the position of Vice President, Worldwide Clinical Research in the therapeutic areas of Anti-Infectives, Oncology, Neuroscience, Endocrinology and Dermatology.
In his career, Dr. Taglietti has brought to market more than 30 different products in the U.S. and Internationally through various regulatory strategies including NDA 505(b)1 and 505 (b)2, 510k Medical Device, ANDA for generics, and EMA MAA.
Dr. Taglietti has published and presented extensively on a broad range of therapeutic areas and he has a keen interest to advance the drug development of new and innovative compounds. Dr. Marco Taglietti received his medical degree and board certifications from the University of Pavia in Italy.
Board of Directors
Patrick is President, Pharma R&D and a member of the company’s Corporate Executive Team. He is responsible for the pharmaceutical pipeline: leading delivery of current late stage portfolio, and ensuring sustainability of R&D productivity through innovation.
Patrick joined GSK in May 2006 as Head of Drug Discovery. He transformed GSK’s discovery engine by driving a more entrepreneurial culture. Patrick established the Discovery Investment Board, and by focused small, empowered teams, Discovery Performance Units, on therapy areas with the most promising science. Between June 2010 and December 2011, Patrick integrated discovery and development into Therapy Area Units to sharpen the focus on pipeline delivery and execution.
Prior to joining GSK, Patrick was a clinical academic and led the Division of Medicine at UCL. He has over 20 years of experience in clinical medicine, general internal medicine, cardiovascular medicine and clinical pharmacology. He was elected to the Academy of Medical Sciences in 1999 and subsequently became its Registrar before leaving to join GSK.
Board of Directors
Paul Stoffels is the Chief Scientific Officer, Johnson & Johnson, and Worldwide Chairman, Pharmaceuticals. As Chief Scientific Officer, he works with the R&D leaders across Johnson & Johnson to set the enterprise-wide innovation agenda. Dr. Stoffels serves as a member of the Executive Committee and the Management Committee.
Dr. Stoffels has more than 20 years of global experience in both pharmaceutical and HIV/AIDS research and development and has held many leadership positions within Johnson & Johnson.
Dr. Stoffels joined Johnson & Johnson in 2002 with the acquisition of Virco and Tibotec, where he was Chief Executive Officer of Virco and Chairman of Tibotec. In 2005, he was appointed Company Group Chairman, Global Virology where he led the development of PREZISTA® and INTELENCE®, leading products for the treatment of HIV.
In 2006, he assumed the role of Company Group Chairman, Pharmaceuticals, with responsibility for worldwide research and development for the CNS and Internal Medicine Franchises. Dr. Stoffels was appointed Global Head, Research & Development, Pharmaceuticals, in 2009 and in 2011 became Worldwide Chairman, Pharmaceuticals Group, with responsibility for research and development, business development and global strategy and innovation. In this role, he leads global teams across Janssen to discover and develop innovative medicines and vaccines for unmet medical needs worldwide and to leverage the power of science for global health.
In October 2012, Dr. Stoffels was appointed Chief Scientific Officer, Johnson & Johnson. He chairs the company’s R&D Management Committee, and provides oversight to Johnson & Johnson Development Corporation, the Johnson & Johnson innovations centers, and for product safety for all products of the Johnson & Johnson Family of Companies worldwide.
Dr. Stoffels began his career as a physician in Africa, as part of the Janssen Research Foundation (JRF) under the mentorship of Dr. Paul Janssen, focusing on HIV and tropical diseases research. He studied Medicine at the University of Diepenbeek and the University of Antwerp in Belgium and Infectious Diseases and Tropical Medicine at the Institute of Tropical Medicine in Antwerp, Belgium.
Throughout his career, Dr. Stoffels has had a passion saving lives and improving quality of life and for using the power of science to solve health care challenges in the developing world. He was instrumental in building the relationship between UNAIDS/WHO and the pharmaceutical industry on provision of HIV drugs in Africa, and has a continued interest in exploring new and collaborative solutions to address serious unmet healthcare needs in the developing world. Dr. Stoffels also represents Johnson & Johnson in discussions on global health topics at international forums such as the annual World Economic Forum in Davos, Switzerland.
Board of Directors
Dr. Carberry is responsible for enhancing the effectiveness and efficiency of Astellas Pharma Global Development’s integrated global operational platform through leadership of the global Data Science, Clinical Science and Medical Writing organizations.
Prior to joining Astellas, Dr. Carberry was the vice president of Clinical Operations, Development Planning and Performance Analysis, and the office of International Development at Genentech. In that role, Dr. Carberry developed a global platform for the execution of non-clinical and clinical activities and established many key relationships with company stakeholders.
Previously, Dr. Carberry was the senior vice president of Global Clinical Operations at Johnson & Johnson Pharmaceutical Research and Development. Dr. Carberry began his industry career with Upjohn/Pharmacia in 1992 where he held positions of increasing responsibility across the development organization including clinical development, clinical pharmacology, corporate Pharmacovigilance and clinical operations.
Dr. Carberry earned his MD at the University of Nairobi, College of Health Sciences in Kenya and completed his Post Doctoral Fellowship in Clinical Pharmacology at the University of Texas. He earned his MBA at Western Michigan University.
Board of Directors
Steven C. Gilman, PhD, has served as Executive Vice President, Research & Development and Chief Scientific Officer since September 2010. From February 2008 until September 2010, Dr. Gilman served as Senior Vice President, Discovery & Non-Clinical Development and Chief Scientific Officer. Prior to joining Cubist, Dr. Gilman served as Chairman of the board of directors and CEO of ActivBiotics, a privately held biopharmaceutical company. Previously, Dr. Gilman worked at Millennium Pharmaceuticals, Inc., where he held a number of senior leadership roles including Vice President and General Manager, Inflammation, responsible for all aspects of the Inflammation business from early gene discovery to product commercialization. Prior to Millennium, he was Group Director at Pfizer Global Research and Development, where he was responsible for drug discovery of novel antibacterial agents as well as several other therapeutic areas. Dr. Gilman has also held scientific, business, and academic appointments at Wyeth, Cytogen Corporation, Temple Medical School, and Connecticut College. He currently serves on the board of directors of the Massachusetts Biotechnology Association, Inhibikase, Inc., a privately held biotechnology company, and TransCelerate Biopharma, Inc., a nonprofit organization emphasizing increased quality in clinical studies and improved patient safety. In addition, Dr. Gilman serves on the Scientific Leadership Advisory Council of PhRMA and the Penn State University Biotechnology Advisory Board. Dr. Gilman received his PhD and MS degrees in microbiology from Pennsylvania State University, his post-doctoral training at Scripps Clinic and Research Foundation, and received a BA in microbiology from Miami University of Ohio.
Board of Directors
Takuko Sawada is Senior Executive Officer, Executive General Manager, Global Development for Shionogi & Co., Ltd.
Takuko Sawada graduated from the Faculty of Agriculture, Kyoto University, and joined Shionogi & Co., Ltd. After engagement in the new drug development for several years, she was appointed as Project Manager for IL-2 in April 1995, Head of Oncology and Pain in April 1999, Strategic Development Dept. in April 2002. She assumed the position of Corporate Officer, Executive General Manager of Pharmaceutical Development Division in April 2007.
Board of Directors
Paul Biondi is currently SVP, R&D Operations at Bristol-Myers Squibb. As leader of R&D Operations, Paul oversees Global Development Operations and Business Operations, BioPharma Project Management, R&D Resource Management, R&D Strategy and Analytics, R&D Strategic Operations Management, R&D Productivity and Continuous Improvement, and Portfolio & Asset Strategy. He is a member of the R&D Sr. Leadership Team as well as numerous other governance bodies within Research & Development.
Paul joined BMS in 2002 as Executive Director, Global Development Planning & Resource Management and was appointed Vice President of the then newly formed R&D Operations Department in May 2005. This new team was formed to join project management, resource management, performance measurement and strategic operations functions into one cohesive unit focused on managing the growing complexities of running a global R&D organization. Under his leadership, the responsibilities of R&D Operations have increased to include leadership of R&D's productivity transformation efforts, oversight of R&D's portfolio management, and coordination of complex integrations for new acquisitions. Most recently, his responsibilities expanded to include late stage clinical operations.
Paul holds a Bachelors degree in Government and Economics from Dartmouth College and an M.B.A. from J.L. Kellogg School of Management at Northwestern University.
Operations Committee Chair
Jonathan Zung, PhD, is Vice President and Head of Global Clinical Sciences and Operations at UCB.
Prior to joining UCB, he served as Vice President and head of Global Development Operations (GDO) at Bristol-Myers Squibb in Princeton, NJ. Global Development Operations integrates all key functions involved in setting up and managing the conduct of clinical studies, site monitoring, data management and review across all therapeutic areas from phase II through registration. The organization consists of over 1300 staff at 19 centers and operates in over 45 countries. Jonathan is responsible for an annual operating budget in excess of $570MM. Jonathan is also chair of the TransCelerate BioPharma, Inc. Operations Committee, which is responsible for the oversight and management of all TransCelerate workstreams.
Jonathan joined Bristol-Myers Squibb in December 2001 as Executive Director, Project Management. Since joining BMS, he has held different positions of increasing responsibility, including head of Global Project Management. Jonathan led the integration of the $2.1 Billion Medarex acquisition in 2009. Prior to Bristol-Myers Squibb, he was with Pfizer Global Research and Development in Groton, CT from 1991 through 2001. At Pfizer, Jonathan held various positions, with increasing responsibility in the Analytical Research and Development (AR&D) department and in the Global Project Management organization.
Jonathan received his PhD in Analytical Chemistry from Emory University, Atlanta, Georgia and his BS degree in Chemistry from the Florida Institute of Technology, Melbourne, Florida. He was named a member of the Florida Institute of Technology Board of Trustees in 2010.
Head of Delivery Excellence & Corp Affairs
Janice Chang is the Head of Delivery Excellence and Corporate Affairs at TransCelerate Biopharma Inc. In her position, Janice works closely with the CEO and the Board of Directors to shape the long-term strategic vision and objectives for the organization. Janice also works closely with the CEO to define TransCelerate’s overall external engagement strategy and identify synergistic opportunities with other industry groups and regulatory bodies. Since 2013, she has played an instrumental role in launching and delivery the five initial initiatives, as well as shaping the newly launched initiatives in 2014. Janice has the overall accountability of overseeing TransCelerate’s corporate operations and the ongoing delivery of the Board-approved initiatives.
Janice has 15 years of industry experience working across large pharma, biotechnology, and medical devices environments. She has extensive experience in delivering transformational programs to help pharmaceutical companies define business strategies, implement global, complex technology solutions, as well as process and organizational redesign and implementations. Janice also has a deep background in regulatory compliance, having worked closely with various Quality organizations across the industry. Prior to joining TransCelerate, Janice was part of Accenture Management Consulting’s Global Life Sciences R&D leadership team.
Communications Committee Chair
Seema Kumar is Vice President, Enterprise Innovation and Global Health Communication, Johnson & Johnson. In this role, Seema works to position Johnson & Johnson as a leader in innovation and global health. She played a leadership role in enhancing worldwide public awareness and understanding of the Human Genome Project, the effort to map and sequence the blueprint for a human being. Seema serves on several external advisory boards and has published more than 200 news and feature articles on science and medicine, for which she has won several awards, including an Award of Excellence in writing from the American Medical Writers Association and three Gold Medals for Media Relations, Science Education, and Web Development. She holds a Master’s degree in science journalism from the University of Maryland, which included a fellowship at the National Cancer Institute, a Bachelor of Science and Communication from the University of Maryland, and a Bachelor of Science in Physics from Stella Maris College, in Madras, India.