The Synergy Partners Team
James S. MacDonald, Ph.D.
Jim MacDonald has led the preclinical development of dozens of new molecular entities during more than 30 years in the pharmaceutical industry. Many of the compounds that came forward under his leadership in Toxicology at Merck, including Primaxin®, Vasotec®, Mevacor®, and Zocor®, are now important human medicines with global registration. As executive VP of preclinical development at Schering-Plough, he directed the activities surrounding the movement of new potential therapeutic entities from discovery research into and through the development process and brought forward several important new medicines through registration for global marketing including Asmanex®, Nasonex®, PEG-Intron®, Noxafil®, and Victrelis®. Jim currently consults for clients to facilitate the development of new molecular entities for unmet medical needs.
Catherine D. Strader, Ph.D.
Catherine Strader has more than 30 years of pharmaceutical R&D experience, with expertise ranging from the selection of molecular targets through clinical proof of concept. She has held executive leadership positions at both Merck and Schering-Plough with responsibility for drug discovery and early development. Catherine has successfully guided more than 50 compounds through the early pipeline at both companies, including Emend®, Victrelis®, Zontivity®, and Zepatier®, as well as several earlier stage compounds. She currently consults with biopharmaceutical and venture-backed companies on both the strategic and technical aspects of building and maintaining a pipeline, including translation of compounds through discovery and early development, realization of an appropriate risk profile for the portfolio, and design of productive multi-partner collaborations.
Marvin L. Bayne, Ph.D.
Marvin Bayne is a drug discovery specialist with over 25 years experience in the biotech and pharmaceutical industries. Marvin began his career at Unigene, working in the early stages of the biotech industry. He then led multiple projects in diabetes and endocrine research at Merck, before moving to Schering-Plough as head of genomics and discovery biotechnology. Most recently Marvin was Vice President of Discovery Technologies at the Schering-Plough Research Institute where he coordinated a department of enabling technologies including genomics, transgenic animal models of disease, high throughput screening and biomarker research. He currently consults with clients on strategies for building connections between early stage research in academia and development activities in the biotech industry.
Leanne L. Bedard, Ph.D., RAC, DABT
Leanne Bedard provides expertise in drug metabolism, pharmacokinetics and mechanistic toxicology. She has more than 10 years of experience as a strategic leader in drug design and solving ADME issues with lead compounds and series in drug discovery. Leanne holds board certifications granted by the American Board of Toxicology and the Regulatory Affairs Professionals Society. Leanne assists client companies in problem-solving of ADME-Tox issues and in the design and data interpretation of nonclinical ADME-PK, TK and IND-enabling toxicology studies. Based on nonclinical data, Leanne provides predictions of human PK parameters by applying empirical and physiologically-based PK (PBPK) modeling approaches, efficacious dose-to-man (PK/PD), drug-drug interaction potential and safety margin estimations. Leanne is experienced in reviewing nonclinical PK and toxicology study reports for regulatory submissions as well as preparing CTD nonclinical summaries.
W. Robert Bishop, Ph.D.
Bob Bishop has more than 20 years of experience in oncology drug discovery and early development, with expertise ranging from target validation through clinical proof of concept. Bob received his PhD in Biochemistry & Molecular Biology from the University of Connecticut Health Center, followed by post-doctoral research at Duke University Medical Center. During more than 20 years at Schering-Plough Research Institute, Bob led a team of 75 scientists conducting drug discovery research in both oncology and virology. He has authored over 70 peer-reviewed publications and several comprehensive reviews, primarily in the area of signal transduction in cancer cells. Bob retired from his position as Executive Director, Oncology at Merck in March 2011 and has been serving as an independent consultant in oncology since that time.
Joy Cavagnaro, PhD, DABT, Fellow ATS
Joy Cavagnaro’s career spans academia, government and the biotechnology industry. She served as FDA’s safety lead and rapporteur for ICH S6 and has held multiple leadership positions, including chair of the Regulatory Affairs Professional Society, National Capital Area Chapter of SOT, multiple areas within the American Society of Gene and Cell Therapy and the Drug Information Association. Joy is Founder, Past Chair and current ex officio member of the leadership committee of BioSafe, an expert preclinical science committee within BIO. She is a member of the Scientific Advisory Committee on Alternative Toxicological Methods, a reviewer and advisor to the California Institute of Regenerative Medicine and chairs CRRI, an independent IRB. In 2011 Joy received the Society of Toxicology’s Biotechnology Specialty Section first Career Achievement Award. She currently serves on multiple scientific advisory boards and consults and lectures internationally on translation and risk assessment of novel therapies.
Gregory C. Davis, Ph.D.
Greg Davis began his professional career in 1980 with Monsanto Agricultural Products studying the effects of endogenous plant growth hormones on reproductive processes and yield. In 1985, Greg joined the Biotechnology Product Development Group in the Control Division of the Upjohn Company and was named Director of that group in 1987. In 1992, Greg moved to joined Eli Lilly, where he held various leadership positions over a 20 year career in Product Development, Global Regulatory Affairs, Global Brand Teams, and Quality. Greg retired from Eli Lilly in 2012 as Executive Director and Senior Principle Fellow in Global Regulatory Affairs. Greg has expertise in both the scientific and regulatory aspects of monoclonal antibody and biosimilars development. He has held various leadership positions on PhRMA committees, USP, BIO, and was the PhRMA liaison to the International Conference on Harmonization for Q5 (Biotechnology) topics for five years. Greg currently consults with biopharmaceutical companies on CMC development issues and regulatory affairs.
Keith A. Bostian, Ph.D.
Keith Bostian is an entrepreneur scientist with a distinguished career in industry and academia. He is currently the Dean of NJ Center for Science, Technology & Mathematics at Kean University, and a founder and CEO of the Institute for Life Science Entrepreneurship. He has held senior executive positions in numerous life science companies including CEO of European pharma for Kemin Industries and Vanta Bioscience, founder of Mpex, founder and CEO of Iconix, and founder and COO of Microcide. Prior to his biotech career, Keith was Head of Microbiology at Merck, with global responsibility for antimicrobial drug discovery.
Keith has contributed to the development of several marketed drugs, including the anti-fungal antibiotic CANCIDAS®, the fluoroquinolone, Aeroquin®, and the probiotic, Anaban™. A fellow of the American Academy for Microbiology, Keith earned his doctorate from the University of London and served on the faculty at Brown University.
Shelley V. Ching, DVM, Ph.D., DACVP
Shelley Ching has over 25 years of experience in regulatory toxicology/risk assessment, nonclinical development of pharmaceuticals, and toxicologic pathology. She has been a consultant to pharmaceutical research organizations for 17 years, providing nonclinical toxicology and pathology drug development strategies and management for compounds intended for many different therapeutic indications. Prior to consulting, Shelley had international responsibility for safety assessment of compounds in full development for Glaxo Wellcome, following experience at both Merck and Burroughs Wellcome. Shelley also served as Principal Investigator for a NTP Pathology Support Program at Integrated Laboratory Systems where she managed pathology research studies and served as chairperson for NTP Pathology Working Groups. She is board certified by the American College of Veterinary Pathologists, and has published on the toxicology and pathology of bone disease, ophthalmology, antiviral and pulmonary drug products.
Harry R. Davis Jr., Ph.D., FAHA
Chip Davis received his PhD from the University of Chicago, where he was also an Assistant Professor of Pathology before beginning his drug discovery career at Schering-Plough (now Merck). During his >25 year pharmaceutical career, he led successful projects in cardiovascular, diabetes, and metabolic diseases and played a key role in the discovery of Zetia® , Vytorin® and Zontivity®. His research interests include experimental models of atherosclerosis, dyslipidemia and thrombosis as well as mechanistic research on cholesterol absorption and metabolism. Chip is a fellow of the American Heart Association Council on Arteriosclerosis and was honored with the 2006 PhRMA Discoverer’s Award and the 2015 Akira Endo Award from the National Lipid Association for his work in atherosclerosis research. Chip is the author of more than 100 publications and patents and is a frequent invited speaker at international meetings. He currently advises client companies on cardiovascular drug development.
Ashit K. Ganguly, Ph.D.
Ashit Ganguly received his Ph.D. from Imperial College, London under Sir Derek Barton and then continued working with him at the Research Institute of Medicine and Chemistry, Cambridge, MA before joining the Schering-Plough Research Institute as a Senior Scientist in 1968. During his 30 year tenure, he progressed to the position of Senior Vice President of Chemical Research, directing all aspects of chemical research at the Institute. His contributions to drug discovery include the cholesterol absorption inhibitor Zetia®, the potent antifungal Noxafil® and the HCV antiviral Victrelis®. Ashit is widely recognized for his contributions to medicinal chemistry and structural biology. He is the recipient of multiple awards, including the ACS Herschberg Award, a lifetime achievement award from the Indian Chemical Society and was inducted into the ACS Hall of Fame, Medicinal Chemistry. Ashit has consulted internationally for pharmaceutical and biopharma companies on drug discovery and design.
William J. Greenlee, Ph.D.
Bill Greenlee received his B.S. degree in chemistry at The Ohio State University and his Ph.D. degree from Harvard University. He was an NIH Posdoctoral Fellow at Columbia University before joining Merck Research Laboratories in Rahway, New Jersey. At Merck, Bill was a member of the team that discovered Merck’s antihypertensive drugs Vasotec® and Prinivil®. He was promoted to Director in 1989 and to Senior Director in 1992. In 1995, Bill joined Schering-Plough as Senior Director, Cardiovascular and CNS Chemical Research, and was promoted to Vice President in 2002. During 15 years at Schering-Plough, he and his group advanced eleven drug candidates into clinical trials, including Zontivity® for prevention of thrombosis and the beta-secretase inhibitor verubecestat for treatment of Alzheimer’s disease (Phase 3). Following the acquisition of Schering-Plough by Merck in 2009, he served as Chemistry Site Head in Kenilworth, New Jersey until August, 2010.
Russell R. Hensel, Ph.D.
Russ Hensel has over 34 years of experience in bioanalytical chemistry. His scientific expertise includes Clinical Chemistry, Clinical and Forensic Toxicology, and Bioanalytical Chemistry, including mass spectrometry and immunoanalytical techniques. He holds a BS in Chemistry and Clinical Chemistry from West Chester University, an MS in Medical Technology and Clinical Chemistry from the Medical College of Pennsylvania and a Ph.D. in Analytical Chemistry from Drexel University. Dr. Hensel has held positions of increasing responsibility in the Drug Metabolism and Pharmacokinetics Department at Rhone-Poulenc Rorer, has been the Acting Director of Labs North America for Covance Laboratories, responsible for business and project management at the WI, IN and VA bioanalytical facilities, the Director of Immunoanalytical Chemistry for Johnson and Johnson, and the Director of the Biomarker and Immunoanalytical Division of Tandem Labs.
William G. Kramer, Ph.D.
As a drug development consultant, Bill Kramer draws on his over 30 years of experience in the pharmaceutical industry and academic research to work with client companies in the development of research strategies to minimize the time for completion of clinical trials and FDA approval. An expert in clinical pharmacology, pharmacokinetics and pharmacodynamics, Dr. Kramer assists client companies in program design, protocol preparation, study implementation, and the analysis and interpretation of results. Dr. Kramer has prepared pharmacokinetic sections of INDs, NDAs, ANDAs, BLAs, and submissions to European regulatory agencies. He has presented at all levels of FDA meetings, including Advisory Committee Meetings, and has published extensively on the pharmacokinetics/dynamics of drugs in adult and pediatric populations.
Sander G. Mills, Ph.D.
Sandy Mills has more than 25 years of experience in the design and synthesis of small molecule drugs. He earned his BS in chemistry from Drew University and his Ph.D in physical organic chemistry from the University of Illinois followed by post-doctoral work on the total synthesis of natural products at UC Berkeley. Sandy first joined Merck in process research before moving to medicinal chemistry, where he was part of the team that discovered aprepitant (Emend®) and fosaprepitant (Ivemend®). For this work, he was awarded the Thomas Edison Patent Award in 2004. Sandy held a number of key leadership positions during his career at Merck, including Head of Global Chemistry, Head of Process Chemistry and Rahway Site Head. He has co-authored more than 90 papers on drug design, synthetic organic chemistry and the biology of medicinally active substances, and is an inventor on 88 U.S. patents. Sandy's scientific contributions earned him election to the New Jersey Inventors Hall of Fame in 2013.
Paul D. O'Shea, Ph.D.
Paul O’Shea has more than 25 years of multidisciplinary experience in process chemistry R&D. He earned his Ph.D. in Chemistry from University College Galway, Ireland and has served in leadership positions in Pharmaceutical Sciences at Merck in Europe, Canada and the US during his career. Paul has developed synthetic routes for more than 40 NCE’s from gram and kilogram to ton scale production and has experience working with CRO’s and CMO’s based in US, Europe and Asia and in API technology transfer from lab to pilot to manufacturing scale. Paul also has considerable expertise in the transition of programs from late stage lead optimization through to FIH clinical studies, including the development of efficient synthetic strategies for analog synthesis in support of SAR, assessment of physiochemical properties, phase and form selection and the development of formulations to support preclinical in-vivo and toxicology studies.
Eric M. Parker, Ph.D.
Eric Parker has over 25 years of drug discovery and early development experience at BMS, Schering-Plough and Merck. During his career, Eric has led programs in the areas of neurodegenerative and psychiatric disease, metabolic disease and supportive cancer care. He was a major contributor to the discovery and development of the BACE inhibitor verubecestat for the treatment of Alzheimer’s disease (Phase 3) and the NK1 antagonist Varubi® for the treatment of chemotherapy-induced nausea and vomiting. Eric is the author of more than 95 scientific articles, lectures extensively and has served on several external advisory boards. He was chosen to be a Merck Presidential Fellow in 2010 and was awarded the PhRMA Research and Hope Award in 2012 for his work on Alzheimer’s disease. Eric holds a B.S. in pharmacy and a Ph.D. in pharmacology from the University of North Carolina at Chapel Hill.
Scott A. Reines, M.D., Ph. D.
Scott Reines has led the clinical development of important new drugs in five different therapeutic areas. As SVP for CNS, Pain, and Translational Medicine at J&J, he oversaw the development and approval of Invega® for schizophrenia, Nucynta® for severe pain, Reminyl-ER® for Alzheimer’s, Risperidal Consta® for schizophrenia and bipolar disorder, Risperidal® for autism, and Topamax® for prevention of migraine and seizures. Previously, Scott was VP, Clinical Research at Merck, where he led the development of Emend® for prevention of chemotherapy-induced nausea and vomiting, Maxalt® for treatment of migraine headache, Sinemet-CR® for Parkinson’s disease, and Trusopt®, Cosopt®, and Timoptic-XE® for prevention of glaucoma. Scott currently consults for biotech, pharmaceutical, and venture firms. He was recently co-chair of the Neuroscience Steering Committee, Foundation for NIH Biomarkers Consortium, and previously served for five years on the National Drug Abuse Advisory Council.
William C. Schinzer, Ph.D.
Bill Schinzer has worked for more than 30 years within the pharmaceutical industry and has been an independent consultant since 2010. Bill earned a BS in Chemistry from Eastern Illinois University and a Ph.D. in Physical Chemistry from Indiana University Bloomington, followed by 23 years at Upjohn/Pharmacia/Pfizer and 4 years at an analytical CRO. During his career Bill has developed and validated analytical and physical methods, served as an analytical team leader, managed drug development projects, and directed the work of a method development group. Bill’s expertise includes solid oral dosage and semisolid dosage forms as well as sterile injectable formulations diagnostics and combination medical devices, including pumps and drug coated stents. He has significant experience with all aspects of API and drug product development, including method development, validation and transfer and regulatory CMC filings for INDs and NDAs.
Eve E. Slater, M.D., FACC
Eve Slater supervised worldwide regulatory activities for all Merck medicines during the 1990s, with responsibility for registration of major medicines to treat HIV, hypercholesterolemia, hypertension, osteoporosis, asthma, arthritis, prostate disease, and vaccines for chicken pox and h. influenza. In 2001, she was named U.S. Assistant Secretary for Health, serving as chief health policy advisor for HHS under George W. Bush. In 2007, she was named Senior VP for Worldwide Policy at Pfizer. Eve has served on the Boards of many biotech companies and medical agencies, providing strategic, clinical and regulatory guidance to move medicines forward in both the developed and developing world. Eve earned her BA from Vassar and MD from Columbia, followed by residency at MGH and Harvard, and was the first woman chief resident in medicine at MGH. She is a Fellow of the America College of Cardiology and is currently Professor of Clinical Medicine at Columbia, practicing cardiology and internal medicine.
R. John Stubbs, Ph.D.
John Stubbs has over 35 years of experience in Pharmaceutical R&D, primarily in bioanalytical chemistry, analytical chemistry, drug metabolism, and all phases of drug development. He holds a BS in Chemistry from the University of Salford, and a Ph.D. in Bioanalytical Chemistry and Drug Metabolism from the School of Pharmacy, University of London. He worked for Beecham and Merck Research Labs in the UK, and transferred to the USA with Merck Research Labs working in drug metabolism. Dr. Stubbs worked in R&D for Johnson & Johnson holding various positions of increasing responsibility, and his last role was global head of bioanalytical supporting preclinical, clinical pharmacokinetics and toxicology Departments, using HPLC, LC-MS/MS, CE, and immunochemistry technology. He also spent almost 4 years in the Quality and Compliance group, heading up stability testing, lab investigations, new methods, and lab IT groups.
Margaret van Heek, Ph.D.
Margaret van Heek earned her PhD in Nutritional Biochemistry at Cornell followed by postdoctoral work at the Cleveland Clinic Foundation. She has spent more than 24 years conducting research and targeted drug discovery in dyslipidemia, diabetes, atherosclerosis, obesity and metabolic syndrome at Schering Plough and Merck. Margaret has served on multiple early development teams, collaborating with colleagues from drug safety and metabolism, pharmaceutical sciences, clinical development, medical and regulatory affairs, and commercial development to progress lead candidates into the clinic. More recently, she was a member of Merck's External Basic Research and In Vivo Pharmacology-Diabetes teams, leading scientific collaborations and drug discovery both internally at Merck and externally in collaborations with biotechnology companies and CROs around the globe. Margaret is a recipient of the 2006 PHARMA Discoverer’s Award for ZETIA™/VYTORIN™, a novel sterol absorption inhibitor for the treatment of dyslipidemia.
Jackson B. Gibbs, Ph.D.
Jay Gibbs specializes in Oncology and Pharmacology R&D. During his 30 year pharmaceutical career, Jay held senior management positions at both AstraZeneca and Merck and led programs ranging from target validation through IND filing, particularly in the area of signal transduction. Jay served as Adjunct Professor of Pharmacology at the University of Pennsylvania School of Medicine for 15 years and is currently Adjunct Professor of Biochemistry and Molecular Medicine at the George Washington University. He publishes and speaks extensively about oncology drug discovery and has served on external advisory boards for several disease-focused foundations. Jay currently uses his broad knowledge of cancer biology, his large network of collaborators, and his understanding of the interfaces between industry, academia, and non-profit foundations to support clients in the biopharmaceutical industry. Jay holds a B.A. in Biology and Chemistry from Bucknell and a Ph.D. in Pharmacology from the University of Virginia.
Stacy Hammonds, RAC
Stacy Hammonds provides project management, regulatory, operational and business development expertise to clients with projects in the late discovery through registration phases of development. She began her career at Cato Research, Ltd, where she held positions of increasing responsibility, ranging from Project Manager to Director, Drug Development. She has been an independent consultant for the past 10 years, managing projects ranging from due diligence to FDA interactions for multiple biotechnology and pharmaceutical companies. She has experience in the initiation and management of multicenter clinical trials in the areas of cardiovascular, neurology, oncology and metabolic diseases. Stacy also has experience in post-marketing pharmacovigilance and CMC regulatory compliance and has managed the preparation and submission of multiple successful IND and NDAs. She is certified by the Regulatory Affairs Professional Society and currently serves as Secretary for the NC Regulatory Affairs Forum.
Gina Maria Johns, PMP, CPM
Gina Johns has 20+ years of experience in the pharmaceutical industry, working across all segments of drug discovery and development. Over the past decade at Merck, she provided project management and operations support from programs from target validation to early and late development, through approval. In her role as the Site Operations lead, Gina managed the Discovery Cardiovascular and Endocrinology portfolios for Merck, as well as the Lead Strategy Team for all of Discovery and Preclinical Sciences. Most recently, Gina was the project manager for several high profile projects in late and early clinical development, including management of the compound registration approval and Advisory Committee preparation for the Grastek™ and Ragwitek™ allergy immunotherapy products. Gina currently provides project management expertise to clients in all areas of drug discovery and development, focusing on collaborative execution, communication and scientific/operational management.
Joseph F. Lamendola, Ph.D.
Joe Lamendola specializes in global and US Regulatory Affairs with 25+ years of experience in the area, having served as VP of Worldwide Regulatory Affairs at Schering Plough and most recently as VP of US Regulatory Affairs at BMS, with responsibility for regulatory strategy across therapeutic areas. During his career, Joe has led US and global pharmaceutical organizations in numerous therapeutic areas including oncology, CV/metabolics, anti-infectives, immunology, allergy and biologics. He has directed the strategy and operations of regulatory efforts leading to global approvals of at least 14 marketed drugs, including Intron, Nasonex, Temodar, Vytorin, Onglyza and Eliquis. Joe has established strong and longstanding relationships with FDA leadership in many therapeutic areas and has led organizations to successful advisory committee preparation and outcomes based on the integration of good science with appropriate regulatory strategies. He currently consults with clients on strategies for optimizing the path to regulatory approval.
Richard A. Morrison, Ph.D.
Rick Morrison has more than 30 years of experience in preclinical DMPK. He received his B.S and Ph.D. in Pharmaceutics from the State University of New York at Buffalo before joining the Squibb Institute for Medical Research. In increasing positions of responsibility at Squibb and BMS, Rick had direct and supervisory responsibility for conducting clinical, nonclinical, and investigative DMPK studies for several important cardiovascular products including Capoten® and Monopril®. At BMS, Rick focused his research on drug absorption and transporters and drove the design and implementation of the first automated caco-2 intestinal permeability screening system in the industry. He then moved to Schering-Plough where he was responsible for the DMPK aspects of all discovery programs; he continued this role for Merck's large NJ research sites after the merger of the two companies. Rick now consults with biopharmaceutical companies to optimize their pipelines in the areas of pharmacokinetics and drug metabolism.
Stéphane Ouellet, Ph.D.
Stephane Ouellet has deep expertise in all aspects of process chemistry, with a focus on the interface between drug discovery and development. After earning his Ph.D. in organic chemistry from the University of Toronto, followed by a postdoctoral fellowship at the California Institute of Technology, Stéphane began his professional career at Merck Frosst, Canada, where he held positions of increasing responsibility in Process Research. As Discovery Process Chemistry Lead at Merck’s Boston site, he built highly integrated and collaborative new approaches to discovery research and played a key role in the integration of the medicinal and process chemistry functions. Stéphane has been involved in the development and scale up of over 30 pre-clinical compounds and has developed relationships with an extensive network of CRO / CMO in both Europe/North America and Asia. Stéphane currently consults with clients to support the transition of small molecules from late discovery through development.
John J. Piwinski, Ph.D.
John Piwinski has more than 30 years of experience in medicinal chemistry and structure-based drug design. He received his B.S. degree in Chemistry and Biochemistry from the State University of New York at Stony Brook and his Ph.D. in Organic Chemistry from Yale. As head of Chemical Research for Schering-Plough from 1999 to 2008, John had responsibility for chemistry drug discovery across all therapeutic areas. In 2008 he was appointed head of Schering-Plough’s Cambridge, MA discovery research site, where he directed the site's efforts in medicinal chemistry, affinity-based screening and optimization, bioNMR, protein science and biologics. John is the author of 150 published research papers, abstracts and approved U.S. patents. He received the North Jersey American Chemical Society (NJACS) Lifetime Achievement Award in 2013, and currently consults in the areas of medicinal chemistry and drug discovery, including small molecule lead discovery and optimization.
Scott D. Reynolds, Ph.D.
Scott Reynolds has deep experience in pharmaceutical development, with expertise in drug formulation, chemical process development and vaccines. During his 31 years in leadership roles in Merck’s Research Laboratories and Manufacturing Divisions, Scott led groups that were responsible for a broad segment of the product development life cycle, from early process development and clinical supply through manufacturing plant start-up and commercial product support. He has directed both laboratory-based teams and pilot plant operations staff in the US, Europe, and Puerto Rico with responsibility for early and late stage API programs, solid oral dosage formulations, and parenteral product development. Scott received a BS in Chemical Engineering from Columbia University, and MS and PhD degrees, also in Chemical Engineering, from the University of Virginia. He currently consults with clients in the pharmaceutical and biotechnology industry on topics related to CMC development and manufacturing support.
Peter K. S. Siegl, Ph.D.
Peter Siegl has extensive experience in drug discovery and development from his 27-year tenure at Merck, 10 years consulting (biotech, pharma and venture capital organizations) as well as contributions to external scientific and regulatory landscape. He is the author of more than 125 scientific publications in peer reviewed journals. Pete is a founder and was first president of the Safety Pharmacology Society, chaired the ILSI/Health and Environmental Science Institute Cardiovascular Safety Subcommittee (2002-2006), was Deputy Topic Leader representing PhRMA on the International Conference on Harmonization: guideline for assessing risk for QT interval prolongation, and was Safety Pharmacology Technical Group Co-Leader in the PhRMA DruSafe Committee. Recently, he served on the External Scientific Advisory Board for Medicines for Malaria Venture. Pete currently consults with companies on drug discovery and development, focusing on strategic risk assessments to increase probability of success.
Sharon C. Spence
Sharon Spence has more than 20 years of experience in drug development, with expertise in clinical operations, project planning and project management. After managing the overall clinical operations of a multinational biologic program at Johnson& Johnson, Sharon served as Director of Clinical Operations for ImmuLogic and then for LeukoSite, with responsibility for all clinical operations activities for six development programs, including for the filing and approval of Campath®. She continued as Senior Director of Clinical Operations with Millennium after its merger with LeukoSite, and was a member of the senior leadership team that transitioned Millennium from a research organization to a development company with significant in-house drug development capabilities. Sharon has planned and overseen successful pre-IND meetings, IND filings and NDA-related planning and execution and currently provides strategic and operational expertise to support program and clinical development plans for companies at all stages of development.
Mark VanArendonk, Ph.D.
Mark VanArendonk has more than 25 years of experience in pharmaceutical development, with expertise in all areas of CMC drug development. Through 2013, he was Merck Vice President for Analytical Chemistry in Development and Supply. In this role he was responsible for late stage development programs from IIB through registration, launch and commercialization. Prior to this he led the Schering-Plough R&D CMC team and R&D GMP testing laboratories. Over his career, Mark has developed numerous drug products. Through various mergers and acquisitions he has also worked at Upjohn, Pharmacia and Upjohn, Pharmacia, and Pfizer holding positions of increasing functional and geographical responsibility in Analytical R&D, Quality Assurance, and CMC. From 2010 until 2013 he served on the Board of Directors for the Innovation and Quality Consortium. Mark received his Ph.D. in Analytical Chemistry in 1982 from Colorado State University. He is presently managing partner for Garden State Pharmatech.
Ronald E. White, Ph.D.
Ron White has over 35 years of multidisciplinary experience in drug discovery and development, with special expertise in drug metabolism and pharmacokinetics. He has held positions as Vice-President of Drug Metabolism and Pharmacokinetics at Schering-Plough and Distinguished Research Fellow at Bristol-Myers Squibb. Ron received a Ph.D. in Organic Chemistry from the University of Wisconsin and completed post-doctoral training in biochemistry of the CYP enzymes at the University of Michigan. He is a past member of the Drug Metabolism Technical Group of Pharmaceutical Research Manufacturers of America and was Chair of the Gordon Research Conference on Drug Metabolism. Ron is presently a consultant to the National Institutes of Health, a member of the Editorial Board of the journal Drug Metabolism and Disposition, and Adjunct Professor of Chemical Biology in the Rutgers University School of Pharmacy.