Join us for Coffee & Chemistry in Morton Grove

We invite you to join us for a seminar geared specifically toward process chemists and analytical scientists. Enjoy a morning of coffee and chemistry with us at Regis Technologies's Morton Grove facility. Regis is excited to host guest speaker, Dr. Steven Baertschi, for a special presentation on controlling impurities. Limited seating is available. RSVP by October 15th to save your seat.

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Abstract

Development and implementation of impurity control strategies is a complicated, yet critical process necessary to ensure overall pharmaceutical product quality and patient safety.  Existing guidelines for control of new impurities in drug substances and new drug products (ICH Q3A/Q3B, USP Chapters <476> & <1086>) apply to commercial products or products in late-stage clinical development (Phase 3). In addition, guidance for mutagenic impurities (ICH M7), which covers early clinical development through commercialization, is a relatively new guideline and questions regarding its implementation remain. The lack of regulatory guidance regarding impurity controls at early stages of clinical development (prior to Phase 3) provides both questions and opportunities for the development of effective control strategies. This talk will focus on risk-based, chemistry-driven approaches to speeding the development of organic impurity control strategies throughout clinical development. Relevant examples and references will be provided.

Meet Our Speaker

Dr. Steven Baertschi is President of Baertschi Consulting, LLC, an Indianapolis, IN based firm specializing in providing solutions to the most difficult stability, impurity, analytical, solid-state, and formulation issues.  Retiring from Eli Lilly and Company in early 2015, he brings more than 29 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 (Nashville, TN) joining Eli Lilly and Co. (Indianapolis, IN) that same year. While at Lilly he was responsible for developing the areas of degradation chemistry, including stress testing, photostability testing, degradation product prediction and identification, mutagenic impurity and analytical control strategies for small molecule drug candidates. Dr. Baertschi has helped organized / Chair numerous scientific conferences and symposia on stress testing, stability, photostability, and impurities; he has published 60 scientific articles in refereed journals and 30 book chapters.  He has edited two editions of a book focused on the topic of pharmaceutical stress testing, and has made critical contributions to more than 15 NDA/CTD and dozens of IND/CTA submissions. Dr. Baertschi has been a member of the American Chemical Society since 1980, the American Association of Pharmaceutical Scientists (AAPS) since 1993, and was named a Fellow of the AAPS in 2007.