“cGMP ASAP”
May 19th, 2020
Moderator: Dr. Maria Krisch
Introduction: Dr. Ken Waterman
Speakers: Dr. Dorothy Kopchik and Tom Morison
Moderator: Dr. Maria Krisch
Introduction: Dr. Ken Waterman
Speakers: Dr. Dorothy Kopchik and Tom Morison
Richard Waterman owns the accounting firm Waterman and Associates. He received his B.S.E. (UCLA) and MBA in accounting (San Jose State). He advises FreeThink on financial and taxation issues.
Patrick Kelleher received his B.S. (Stonehill College) and Ph.D. (Yale University) in physical chemistry before completing post-doctoral studies at the University of Virginia. His graduate and post-doctoral work focused on the development of spectroscopic and mass-spectrometric techniques for structural elucidation of small molecules. Patrick joined FreeThink in 2020 where he leads the physical sciences department.
Dave received his B.S. from Springfield College and has over 20 years of pharmaceutical industry experience, including supply chain management, clinical development operations, and global clinical trial management. He founded and led the drug product development consulting firm Verdure Bay before joining FreeThink in 2018 where he leads global business development.
Alisa received her B.A. (Wesleyan University) and Ph.D. (Albert Einstein College of Medicine) in cell biology. She completed post-doctoral studies (Yale University) before spending 24 years at Boehringer Ingelheim (as a Senior Research Fellow), championing discovery and development of biological and small molecule drug candidates. In 2015, she joined FreeThink Technologies where she manages the customer portfolio of projects.
Mark received his B.A. (Washington University) and MBA (University of Rochester). After working on Wall Street for 17 years (Credit Suisse First Boston, Merrill Lynch) as an equity analyst, he helped found FreeThink Technologies in 2011 and currently heads the software division and manages company finances.
After receiving his B.S. (UCLA) and Ph.D. (UC Berkeley) in physical-organic chemistry, Ken completed post-doctoral studies (Columbia University) before spending 12 years at Polaroid (as a distinguished scientist), then 13 years at Pfizer (as a Research Fellow), and has successfully invented and commercialized many imaging and pharmaceutical products. He is an AAPS Fellow, the author of over 75 publications and patents, and a speaker at numerous international conferences. He helped found FreeThink Technologies in 2011 and serves as a technical expert and provides overall company leadership.
Pharmacist and toxicologist, member of the board of directors of the Brazilian Society of Toxicology (SBTox) and CEO of Spektra Consultancy. She worked in the pharmaceutical industry in Brazil actively participating in the scientific and regulatory development of the areas of analytical development and toxicological evaluations focused on impurities assessments. More than 15 years of experience in developing stability-indicating methods and toxicological assessment of impurities in drug substances and drug products (degradation products, mutagenic impurities/nitrosamines, elemental impurities, extractable and leachable) using in silico tools and integrated risk assessment. She currently works as a consultant at Spektra Consultancy in the area of impurity assessment in compliance with ANVISA and ICH regulations. Spektra is also the representative of FreeThink Technologies in Latin America.
After receiving his B.S. (UCLA) and Ph.D. (UC Berkeley) in physical-organic chemistry, Kenneth Waterman completed post-doctoral studies (Columbia University) before spending 12 years at Polaroid (as a distinguished scientist), then 13 years at Pfizer (as a Research Fellow). He has successfully invented and commercialized a number of products and is the author of over 75 publications. He was made an AAPS Fellow in 2011 the same year he started FreeThink Technologies.
A firm specializing in solutions to the most difficult stability, impurity, analytical, solid-state, and formulation issues. Retiring from Lilly in 2015, he brings 30 years of experience in the pharmaceutical industry to his consulting firm, with a demonstrated track record of innovation and problem-solving. He obtained his Ph.D. in Organic Chemistry in 1989 from Vanderbilt University, joining Lilly that same year.
Dr. Baertschi has organized/chaired numerous scientific conferences / symposia on stress testing, stability, photostability, and impurities, and has published extensively in these areas, including two editions of a book on pharmaceutical stress testing / drug degradation. Dr. Baertschi is a member of the American Chemical Society, the American Association of Pharmaceutical Scientists (AAPS), is a Fellow of the AAPS (since 2007).
He has a B.Sc. in Chemistry and a D.Phil in the application of magnetic resonance spectroscopy (ESR and NMR) to determine the mechanisms and kinetics of organic oxidation reactions. He has over 25 years of experience in analytical chemistry in the pharmaceutical industry, working in areas ranging from inhalation to dissolution, and has authored numerous regulatory submissions. In recent years, Garry focuses on pharmaceutical stability and has helped to develop, refine, and apply accelerated studies for the prediction of long-term stability performance. Garry has authored numerous scientific papers and recently co-authored a book on “Accelerated Predictive Stability.” Garry’s role at Pfizer also includes troubleshooting pharmaceutical product problems, understanding causes of poor stability, and improving product design.
Dr. Hemingway graduated from the University of Hull in 2012 with a Ph.D. in Chemistry under the supervision of Steve Archibald, developing tumor-targeted therapeutics. The multidisciplinary project allowed her to develop skills in organic, analytical, coordination chemistry, and cell culture. After two and a half years working as a research scientist for a chemical manufacturer, Rachel joined Lhasa Limited. She has been part of the science team at Lhasa for over 8 years, working almost exclusively on the software program Zeneth. As a principal scientist, Rachel leads a team of scientists who develop the Zeneth knowledge base while influencing the software’s strategy and direction. Her interests lie in developing software tools to address knowledge gaps and support decision-making in the degradation community. She has co-authored five journal articles (one in preparation) and four book chapters.