William J. DeLorbe, PhD
The DeLorbe Group, LLC
Dr. William DeLorbe is the owner of the The DeLorbe Group, LLC and serves as Chairman of the Board of Directors. Before leaving the industry, Dr. DeLorbe served as the Senior Vice President of Human Resources and a member of the Operating Group of The DuPont Merck Pharmaceutical Company for more than a decade. Dr. DeLorbe obtained his PhD degree in Molecular Biology from the University of Iowa. In 1981 he joined Molecular Genetics, Inc. (MGI), Minneapolis, Minnesota, as a senior scientist working on the production of recombinant subunit viral vaccines. In 1987 he left MGI to become Vice President and Chief Scientific Officer of Cistron Biotechnology, where he had primary responsibility for all research and development activities of a company focused on therapeutic proteins and on development of immunodiagnostic assays for the research, clinical laboratory and home use markets.
Jonca Bull, MD
Director, Office of Minority Health
Office of the Commissioner
US Food and Drug Administration
Dr. Jonca Bull took position as the Director of the Office of Minority Health at the US Food and Drug Administration in 2012. Dr. Bull first worked for the FDA in 1994 in the Office of New Drugs within the Center for Drug Evaluation and Research, and departed as Office Director in 2006. Before returning to the FDA, Dr. Bull served in leadership positions in Regulatory Affairs at Genentech and Novartis.
C. Robert Eaton
President and CEO
Your Bio Team
Bob Eaton, currently serving as President & CEO of Your Bio Team, has spent many years supporting the growth and success of bioscience companies, having held a variety of senior positions in associations and companies at the forefront of bioscience innovation. Prior to launching Your Bio Team, Bob served as President & CEO of the Arizona BioIndustry Association, following 10 years as President of MdBio, Inc., a bioscience industry support organization seeking to unify, empower and advance the bioscience industry in Maryland. Mr. Eaton also held a variety of positions in the Science & Technology Division of the Pharmaceutical Manufacturers Association (now PhRMA) in Washington, DC, and was Director of Programs for the Suburban Maryland High Technology Council. Mr. Eaton holds a Master’s degree in Science, Technology & Public Policy from George Washington University and a B.S. in Applied & Engineering Physics from Cornell University.
David I. Goldsmith, MD
President & Senior Consultant
Goldsmith Pharmacovigilance and Systems
Dr. Goldsmith has an M.D. degree from New York Medical College and is board certified in Pediatric Nephrology. He conducted bench and clinical research at Albert Einstein College of Medicine where he served as an Associate Professor of Pediatrics. He has authored and co-authored more than 50 publications, and served on the Einstein Institutional Review Board. Since joining the pharmaceutical industry in 1983 he has been a participant in Pharmacoepidemiology. He served as a board member, and Vice President of Finance for International Society of Pharmacoepidemiology and was the Scientific Program Chair for 3 International Conferences and received the ISPE Distinguished Service Award in 1999.
Judith K. Jones, MD, PhD
Dr. Judith K. Jones is a clinical pharmacologist, pharmacoepidemiologist, and geriatrician/internist with a long-standing interest in the study of adverse drug reactions, drug utilization, and drug development and regulation. She received her medical training at Baylor College of Medicine, followed by clinical training, a fellowship in clinical pharmacology and a PhD in developmental pharmacology at University of California at San Francisco. In 1978, she came to Washington, DC as Director of the FDA’s Division of Drug Experience (now Epidemiology) until 1984, and was then Special Asst. to the Director, Biometrics and Epidemiology through mid-1985. In 1988, she founded The Degge Group, Ltd., a consulting business that provides services relating to drug safety information, regulation, research and education. Dr. Jones also serves as President of the Pharmaceutical Education and Research Institute, Inc. (PERI) that was founded in 1989 by PhRMA.
Anthony J. Piraino, MD, PhD, FACP
Senior Medical Director
Medical Affairs & Strategic Development
Dr. Piraino currently serves as Senior Medical Director, Medical Affairs & Strategic Development, at AstraZeneca Pharmaceuticals, where he has held this position for nearly 15 years. In addition to serving as an industry leader, Dr. Piraino is a faculty member at Drexel University, where he teaches as the Clinical Professor of Medicine and Pharmacology. Dr. Piraino first entered the industry CibaGeigy Pharmaceuticals upon completion of medical school, where he served as the Executive Director, Clinical Pharmacology. Dr. Piraino has authored or co-authored 29 research papers and 7 book chapters in areas of clinical pharmacology and clinical nutrition, 40 scientific abstracts and 12 invited review/opinion articles.
Jean-Louis Saillot, MD
JLS Pharma Consulting
Dr. Saillot is currently President of JLS Pharma Consulting. He has over 25 years of international pharmaceutical industry experience across multiple functions, including Clinical Research, Clinical Operations, Regulatory Affairs, Quality & Compliance, Pharmacovigilance, and Project and Portfolio Management and Leadership. His most recent responsibility prior to independent expert consulting was VP, Project & Pipeline Management, Bone, Respiratory, Immunology & Dermatology at the Merck Research Laboratories. In addition, Dr. Saillot is a former co-chair of PhRMA’s Clinical Leadership Committee. His industry-wide experience includes participation in multiple PhRMA activities in areas such as clinical development, research ethics, regulatory affairs, and pharmacovigilance. He also participated as industry expert to ICH working groups.
Claudio P. Spiguel, PhD
Retired Higher Education Professional, Industry Executive
Dr. Claudio Spiguel holds a PhD in Computer and Communication Sciences from the University of Michigan, Ann Arbor, 1982 and served as a leader in the pharmaceutical industry for more than 15 years. As Vice President and Head of the Development Systems and Information Management Group at Zeneca Pharmaceuticals, he established the integration and integrity of the international information management systems which support the US and UK development function. Prior positions include senior information management roles with The R. W. Johnson Pharmaceutical Research Institute and The UPJOHN Company. In addition, he was a PhRMA (Pharmaceutical Research and Manufacturers of America) Information Management Liaison to the FDA, with particular focus on the Information Management aspects of the FDA Modernization Act of 1997.
Gillian R. Woollett, MA, D.Phil
Senior Vice President
Gillian Woollett is Vice President, FDA Regulatory Policy at Avalere Health, a leading advisory company focused on healthcare business strategy and public policy. She was most recently Chief Scientist at Engel & Novitt, LLP, a boutique law firm with a global client base, which develops and implements science-based solutions to resolve legal/regulatory and public policy issues affecting the biopharmaceuticals industry, involving specific and general matters relating to drugs, biologicals, medical devices, and genomics. Prior to joining Engel & Novitt, LLP, Dr. Woollett was Associate VP at PhRMA with responsibilities for all activities concerning biologics and biotechnology. Dr. Woollett earned her M.A. in Biochemistry from the University of Cambridge, and her D.Phil in Immunology from the University of Oxford in the United Kingdom.