Dr. Scott Reynolds has more than 30 years of experience in formulation, vaccine and chemical development in the pharmaceutical industry. Scott led groups responsible for a broad swath of the product development life cycle in support of programs ranging from early toxicology support, to all phases of clinical supplies, and through manufacturing plant start-up and inline product support. In his roles as Executive Director of Pharmaceutical R&D, VP Chemical Process Development and Commercialization, VP Pharmaceutical Commercialization Technology, and AVP Formulation Sciences at Merck, Scott directed multi-disciplinary groups of laboratory-based teams, and pilot plant operations staff, located at multiple sites in the US, Europe, and Puerto Rico. Under his direction these teams were responsible for early and late stage API programs, oral dosage formulations, and parenteral products for small molecules, peptides and vaccines.
Scott has extensive experience in API process development, design and development of solid oral and sterile/liquid products, and scale-up and technology transfer.
Scott received his BS in Chemical Engineering from Columbia University, and MS and PhD degrees, also in Chemical Engineering, from the University of Virginia. He is currently the founder and owner of SDR Pharma Consulting LLC providing consulting services to clients in the pharmaceutical and biotechnology industry.
Dr. Yao Yao obtained her PhD in biochemistry from the University of Tsukuba in Japan. In 1996 she was invited to the National Institutes of Health in the US for postdoctoral research. From 1997 onward, Dr. Yao worked as a research scientist at the Uniformed Services University of the Health Sciences, the US Department of Defense and several research institutes.
In 2002 Dr. Yao entered the pharmaceutical industry, where she gained broad experience across R&D, manufacturing process, quality management, clinical study, regulatory submission and compliance. In 2006 Dr. Yao obtained a Regulatory Affairs Certificate from the global Regulatory Affairs Professional Association (RAPS), and in 2007 became a Certified Quality Auditor in The American Society for Quality.
In 2010, Dr. Yao was invited to CFDA IED for providing training courses of CTD and international drug regulations. In 2012 and 2013, her two books “CTD, the Concept, Rules and Application” and “International Drug Regulations - from Inside Out” were published. In 2014, Dr. Yao returned to China and continues to contribute to development of pharmaceutical industry in China.
Dr. Nelu Grinberg has had an eminent career in research chemistry in the pharmaceutical industry. An internationally known expert in analytical chemistry, with an emphasis on chromatography, spectroscopy, and chiral separations, he was a Distinguished Research Fellow in the Chemical Development Department at Boehringer Ingelheim Pharmaceuticals in Ridgefield, CT until January, 2017.
Prior to this, he worked for sixteen years in the Analytical Department at Merck Research Laboratories in Rahway, NJ, where he was a Senior Research Fellow. Dr. Grinberg has authored and co-authored over 140 publications, including articles and book chapters, and has lectured and conducted courses worldwide. He is currently Editor-in-Chief of the Journal of Liquid Chromatography and Related Techniques, Editor of the Chromatographic Science book series, and Co-editor of the Advances in Chromatography series. He is also a member of the Board of the Connecticut Separation Science Council and was a recipient of a Koltoff Fellowship of the Hebrew University of Jerusalem.
Dr. Grinberg obtained his Ph.D. in Chemistry from the Technical University of lasi in Romania. He conducted postdoctoral research with Professor Barry Karger at Northeastern University in Boston, Massachusetts, and with Professor Emanuel Gil-Av at The Weizmann Institute of Science in Rehovot, Israel.
Dr. Ken Sigvardson has more than 30 years’ experience in pharmaceutical development in the pharmaceutical industry. Ken has led CMC development projects and teams in all phases of development from preclinical to registration. He has had a variety of management and scientific roles in support of API and formulation development at DuPont Pharmaceuticals/DuPont-Merck, Schering-Plough and Merck pharmaceutical companies. He also has a strong compliance background with direct experience with audits, CMC filings and consent decrees.
Ken has extensive experience with the establishment and optimization of development workstreams at all phases of development for internally and externally supported development projects. His passion has been the development of optimized “fit-for-purpose” workflows to rapidly move new development candidates through the early phases of development.
Ken received his BS degree in Biology and an MS degree in Chemistry from the University of Lowell (now UMass Lowell). He received his Ph.D. decree in Analytical Chemistry from the University of Colorado, Boulder. Ken is also the founder and Principal of Ocean View Consulting, LLC providing consulting services to clients in the pharmaceutical industry.