Baertschi Consulting, LLC
Carmel, Indiana, USA
Dr. Steven Baertschi is President of Baertschi Consulting, 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 PhD 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).
Hertfordshire, United Kingdom
Dave Elder, Ph.D.
David P. Elder Consultancy
Hertfordshire, United Kingdom
Dr. Elder has 41 years of service within the pharmaceutical industry, with Sterling, Syntex and 23 years with GSK. He is now an independent CMC consultant and has broad based experience in formulation and analytical method development.
Dr. Elder obtained his PhD in crystallography from the University of Edinburgh. Dr. Elder is a visiting professor at King’s College, London. He is a Fellow of the RSC and chartered chemist and scientist. He is a member of the British Pharmacopoeia. He is the chairman of JPAG (Joint Pharmaceutical Analysis Group). He is a member of the Editorial Advisory Board for the Journal of Pharmaceutical Sciences. He has published 18 book chapters, 147 papers in international journals and has given 19 webinars and over 167 presentations at national/international symposia. He has 9 patents to his name.
He has co-edited a book on the Analytical Characterisation and Separation of Oligonucleotides and their Impurities (with George Okafo and Mike Webb) and a second on the ICH Quality Guidelines (with Andy Teasdale and Ray Nims).
Senior Principal Chemist
Sandwich, United Kingdom
Garry Scrivens is a Senior Principal Chemist at Pfizer in Sandwich, UK. 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 20 years’ experience in analytical chemistry in the pharmaceutical industry, working in a wide diversity of areas ranging from inhalation and dissolution and has authored numerous regulatory submissions. Garry has recently focused 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 has 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.
In 2005, Sabine Thielges obtained her Ph.D. from Mulhouse University Ph.D. in Organic and Medicinal Chemistry. Sabine then spent 3 years as a postdoctoral fellow, at McGill University, Quebec followed by 2 years as a Research Associate at the NRC (National Council of Canada).
In 2012, Sabine Thielges worked at Janssen, Pharmaceutical Companies of Johnson and Johnson in Belgium where She built and supervised a Stability Science Group focused on early development, stability investigation and the use of ASAP (Accelerated Stability Assessment Program) in the company.
Since 2016, Sabine Thielges works for Novartis has analytical project leader and stability expert and is implementing ASAP (Accelerated Stability Assessment Program).
Ellen Verheyen obtained a PhD in Pharmaceutical Sciences at Utrecht university in 2011. After working as formulation scientist in the animal feed industry, she joined the drug product development organization at Janssen Pharmaceutics in 2013. As material scientists, Ellen was responsible for excipient characterization, and the implementation of a strategy to study potential API-excipient interactions. Currently she is working as stability expert with a strong focus on accelerated stability studies to understand and predict the chemical as well as physical (in)stability of drug substances and drug product formulations. In addition, she is a key member of Janssens’ Center of Excellence for predictive analytics and stability sciences, that provides end-to-end project support for the small molecule pharmaceutical development portfolio.
FreeThink Technologies, Inc.
President & Founder
Branford, Connecticut, USA
Dr. Ken Waterman received his B.S. degree with honors in Chemistry from UCLA, his Ph.D. in Physical Organic Chemistry from UC Berkeley and conducted post-doctoral studies in physical and photo-chemistry as an NIH research fellow at Columbia University. Dr. Waterman worked 12 years at Polaroid (as a distinguished scientist) developing imaging products, then 13 years at Pfizer (as a Research Fellow) working on drug stability, drug delivery, biopharmaceutics and prodrugs. He is the author of over 70 publications and was made an AAPS Fellow in 2011. In 2011, he started FreeThink Technologies which both produces and licenses the accelerated stability software package ASAPprime® and is a CRO that has Connecticut-based laboratories specializing in stability for pharmaceuticals, generics, OTCs, nutraceuticals and consumer products.
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