Webinar: KENx “Use of Modern Accelerated Stability Methods in Regulatory Filings”

Mariah Ultramari, PhD

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.

Moderated by Ken Waterman, PhD, President, FreeThink Technologies, Inc.

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.

Steven Baertschi, 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 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).

Garry Scrivens, Associate Research Fellow 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 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. 

Rachel Hemingway, Ph.D.

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.

Webinar: “Use of Modern Accelerated Stability Methods in Regulatory Filings”

“Use of Modern Accelerated Stability Methods in Regulatory Filings”

October 7th, 2020