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.
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.
Chair of the Board
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
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
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
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
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
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
Dr. Bernhardt G. Zeiher has an extensive background in the biopharma industry and is currently Executive Vice President Global Development and Therapeutic Area Head of Immunology, Infectious Disease, Transplant, Central Nervous System and Pain at Astellas. In this role, he has responsibility for Global Development Operations and Global Clinical Pharmacology and Exploratory Development (GCPED), in addition to development portfolio therapeutic area leadership. Dr. Zeiher has more than 15 years of experience in the pharmaceutical industry. Prior to joining Astellas, he was the Vice President of the inflammation/immunology therapeutic area at Pfizer. He earned his medical degree at the Case Western Reserve University School of Medicine. After medical school, he completed an internal medicine residency at University Hospitals of Cleveland and a fellowship in Pulmonary and Critical Care Medicine at University of Iowa Hospitals and Clinics.
Board of Directors
Dr. David Nicholson serves as Senior Vice President at Actavis Global Brands R&D, which has combined Acatvis’ and Forest’s R&D operations. In this role, he leads the global teams focused on developing Actavis’ significantly expanded branded R&D portfolio, as well as defining long-term product development strategies and collaborations. David reports to Robert Stewart, the new Chief Operating Officer of Actavis.
David is a seasoned R&D leader who has transformed organizations into drug development powerhouses. He has developed an exceptional track record spanning more than 30 years in the industry, including expertise in the development of a diverse portfolio of products including treatments in women's health, psychiatry, cardiovascular, anesthesiology and immunology. He also has significant expertise in the development of biological products. David's experience working in the U.S., UK, Germany and the Netherlands, as well as leading a team of 2,400 colleagues in sites around the world also gives him a unique understanding of the global clinical and regulatory environment, which will be invaluable to TransCelerate’s work around the world.
Prior to his position with Actavis, David most recently served as Chief Technology Officer, Executive Vice President R&D of Bayer Crop Sciences, and before that, as head of R&D at Organon before its acquisition by Schering-Plough. At Bayer Crop Sciences, David led a team of approximately 4,000 scientists globally in the development of next-generation agrochemicals and seeds. While at Organon, his teams developed an impressive array of specialty pharmaceutical products including Saphris and Remeron in CNS; NuvaRing, Implanon, Elonva and NOMAC/E2 in Women's Health; Bridion and Zemuron in anesthesia; and Arixtra in cardiovascular. Dr. Nicholson’s teams also had a pioneering role in the discovery of MK-3475, an immuno-oncology PD1 inhibitor project that is now in phase 3 trials at Merck.
Board of Directors
Dr. Mike Severino is Executive Vice President, Chief Scientific Officer, where he leads the discovery, research and development of AbbVie therapies, and is responsible for managing scientific partnerships and establishing research and development strategies for the company.
Prior to joining AbbVie, Dr. Severino was Senior Vice President and Chief Medical Officer at Amgen, Inc. During his time at Amgen, he served in several leadership positions, including Vice President, Global Development; Vice President, Therapeutic Area Head, General Medicine and Inflammation Global Clinical Development; and Therapeutic Area Head, Inflammation Global Clinical Development. Dr. Severino has supervised broad therapeutic areas including oncology, inflammation, neuroscience and metabolic disorders. Prior to joining Amgen, he was Associate Director of Biologics Clinical Research at Merck & Co., Inc.
Dr. Severino has published and presented extensively in a wide-range of areas including genomics, virology, immunology and biologic chemistry. He serves on the board of directors of the Biotechnology Industry Organization (BIO) and is a member of its Regulatory Environment and Health Section Governing Board Committees.
He earned a bachelor’s degree in biochemistry from the University of Maryland, College Park and a doctorate in medicine from The Johns Hopkins University in Baltimore. Dr. Severino completed research and post-doctoral training at Massachusetts General Hospital and Harvard Medical School in Boston, serving as Research Fellow for the Infectious Disease Unit/AIDS Research Center, Clinical Fellow for the Infectious Disease Unit and completing his residency in Internal Medicine. He is certified by the American Board of Internal Medicine.
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.
Board of Directors
Dr. Cavazzoni is the Senior Vice President for Worldwide Development Operations at Pfizer. Prior to this role, she was the Senior Vice President for Safety and Established Products Regulatory, with responsibility for the company’s global product safety organization and the regulatory affairs functions supporting Pfizer’s largest business unit. Previous to her joining Pfizer, she held leadership positions within the R&D organizations at Eli Lilly and Sanofi.
Dr. Cavazzoni serves as the Pharmaceutical Industry’s representative to the Food and Drug Administration’s Drug Safety and Risk Management Advisory Committee and is a member of the Steering Committee for the Reagan-Udall Foundation’s Innovation in Medical Evidence Development and Surveillance Program.
Prior to joining the pharmaceutical industry, she was an Assistant Professor of Medicine at the University of Ottawa, where she was engaged in clinical work, teaching and research of genetic predictors of mood disorders, authoring numerous peer-reviewed scientific publications.
After obtaining her medical degree at McGill University, Dr. Cavazzoni served as a Medical Officer in the Canadian Armed Forces and subsequently completed a residency in psychiatry and a fellowship in mood disorders at the University of Ottawa, becoming a recipient of the American College of Psychiatrists’ Laughlin Fellowship.
Dr. Cavazzoni is certified by the American Board of Neurology and Psychiatry, a Fellow of the Canadian Royal College of Physician and Surgeons and a member of the Canadian College of Neuropsychopharmacology.
Board of Directors
Roy Baynes is Senior Vice President Global Clinical Development at Merck Research Laboratories in Rahway, New Jersey. He was previously Senior Vice President of Oncology, Inflammation and Respiratory Therapeutics at Gilead Sciences and prior to that was Vice President Global Clinical Development, and Therapeutic Area (TA) Head for Hematology / Oncology, at Amgen Inc. He graduated as a Medical Doctor and obtained a Master of Medicine and Doctor of Philosophy from the University of the Witwatersrand, Johannesburg, South Africa. He has had a long and distinguished career in the haematology-oncology-and stem cell transplantation fields, including drug development, basic research, clinical practice, clinical research, teaching and administration. He is a member of many international societies, including the American Society of Hematology (ASH) and the American Society of Clinical Oncology (ASCO), and has authored some 150 publications. He has been recurrently named among America’s top physicians. Before joining Amgen in 2002, he was the Charles Martin Professor of Cancer Research at the Barbara Ann Karmanos Cancer Institute, an NCI designated Comprehensive Cancer Center, at Wayne State University, Detroit, Michigan, USA.
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.