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Jack A. Reynolds
Jack A. Reynolds, DVM, DACVP, DACLAM & FIATP
Chairman of the Advisory Board 
Drug Safety Executive Council
 

Dr. Jack A. Reynolds has recently retired from Pfizer after a total of almost 18 years with the Pfizer Global Research and Development division and over 30 years in the pharmaceutical industry.  Over this time period, he has held numerous positions of increasing responsibility and until his planned retirement earlier this year, he was Senior Vice President of Research and Development and Worldwide Head of Safety Sciences and Comparative Medicine.  He received a D.V.M. (Summa Cum Laude) from Washington State University and completed a residency in Comparative and Experimental Pathology at the Bowman Gray School of Medicine in Winston-Salem, NC.  He received graduate training in pathology and pathologic biochemistry.  He is board certified in both Veterinary Pathology and Laboratory Animal Medicine and is a Fellow of the International Academy of Toxicologic Pathologists.  

Dr. Reynolds is viewed by many of his peers and associates, as one of the most influential and visionary leaders in the safety sciences and risk management practices.  Dr. Reynolds has been employed by several major pharmaceutical companies, including Bristol-Myers Squibb and Bayer before rejoining Pfizer in 1997 to head the Drug Safety Evaluation Group.  His professional experience has focused primarily on drug safety evaluation, safety sciences and pharmaceutical development.  In recent years he has participated in national and international activities focused on the optimization, improved effectiveness and enhancement of the drug discovery and development processes.  Dr. Reynolds is active in numerous professional societies, including the Society of Toxicologic Pathologists and the Society of Toxicology.  He was very active in the ICH process and served as a member of all Quality Expert Working Groups developing the ICH Impurities Guidelines and the Residual Solvent Guideline.  In addition, he served as an ad hoc member of several Safety Expert Working Groups.  Jack frequently speaks and lectures on the important and emerging role of the safety sciences in significantly improving the lack luster performance of the pharmaceutical business model.  He is continuing to be very active in scholarly activities and has held an adjunct appointment at Yale University Medical School. 

His most recent roles at Pfizer have been marked by his industry leadership in the area of safety science and risk management, his close and collaborative work with regulatory agencies across the globe and the evolution of the industry leading and cutting edge Safety Sciences organization.  He was very instrumental in describing and leveraging the emerging trends in science and technology as they could be applied to the drug discovery and development enterprise.  Jack was the primary architect for the globally connected and expansive safety organization that has driven Pfizer’s important advances in reducing safety attrition, enabled the implementation of cutting edge science and technology and markedly impacted the evolution of regulatory decision making processes and public policy improvements.  His group at Pfizer is noted for blazing a path towards defining and implementing new paradigms to elucidate, characterize, measure and monitor the biological aspects of adverse events.  This activity has markedly influenced the recent advances in safety risk management and underpinned the evolution of the regulatory decision making framework related to safety and benefit: risk. 

Dr. Reynolds career has been characterized by his extensive work and leadership in building partnerships with regulatory agencies and through his leadership role in professional societies, industry executive groups and scientific organizations.  During his decade of service on the Preclinical Steering Committee for PhRMA, he has organized numerous workshops with the FDA and the pharmaceutical industry exploring ways to improve the drug development and regulatory processes.  Most recently, this activity has culminated in the implementation of the Exploratory IND Guidelines, the result of proactive PhRMA and FDA collaboration to improve the early clinical trial process.  Dr. Reynolds was the first chairperson of FDA’s Nonclinical Studies Subcommittee, a Pharmaceutical Sciences Advisory Committee.  He is the co-founder and past president of the Regulatory and Safety Evaluation Subsection of the Society of Toxicology, a member of the Board of Trustees and Vice President for the Toxicology Education Foundation and the former Chair of PhRMA’s Preclinical Steering Committee.  He is also a member of the Health and Environmental Sciences Institute Board of Trustees and a member of the Board of Directors of the Toxicology Forum.  He has recently been elected to the Executive Board of CIIT Centers for Health Research in Research Triangle Park, NC.  In 2004, Dr Reynolds received the Washington State University Distinguished Alumnus Award for Research and Teaching. 

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