Join us for Cocktails & Chemistry in San Mateo

We invite you to join us for a seminar geared specifically toward scientists from pharma and biotech companies working with new chemical entities. Enjoy an evening of cocktails and chemistry in San Mateo compliments of Regis Technologies.

Regis is excited to host guest speaker, Dr. Gregory A. Stephenson, for a special presentation on the the critical importance of understanding solid form selection and the influence of it on early development programs.

Limited seating is available. RSVP by October 13^th to save your seat.

Happy hour starts at 4:30 pm; presentation begins at 5:00 pm; Q&A and networking at 6:00 pm. We hope you can join us.

RSVP 

Abstract

Rarely does a pharmaceutical compound exist in a single solid-state form. As a result, early in a compound’s life one seeks to identify the physical forms that are viable for development into a pharmaceutical product. This process typically involves screening different crystalline salt forms, if the compound is ionizable, followed by screening for different polymorphic forms of the salt or unionized form of the compound. Form selection is a critical step in a compound’s development life as it influences the rapidity and ease with which a compound is developed.

Polymorphic form impacts product yield, purity, and its ability to be processed into a product. One often must balance different physical properties, such as lower solubility for enhanced physical or chemical stability. Hence, the selection process requires sound judgement, involving a comparison of high quality characterization data of the different forms and evaluation of their impact on the overall process and its critical process parameters. Thorough and efficient solid-form screening, characterization, and selection are critical to the successful development and approval of a new drug substance, as they impact many elements of the product’s chemistry and its manufacturing processes.

Meet Our Speaker

Greg Stephenson earned his Ph.D. in Medicinal Chemistry from Purdue University for research of the solid-state properties of pharmaceuticals under the advisement of Professor Stephen Byrn. He subsequently joined Eli Lilly and Company in its Material Science and Physical Characterizations group as a senior scientist. Greg was responsible for the small-molecule X-ray crystallography and powder diffraction laboratories, where he worked with process chemists and product teams to produce, identify, and select the physical forms of the pharmaceutical as the active pharmaceutical ingredient and the commercial product. Later, his responsibilities broadened to include the early-phase physical form selection team within the company’s Biopharmaceutics department, working closely with drug discovery scientists and preclinical formulation scientists, optimizing the bioavailability and chemical stability of drug candidates through formation of salts, amorphous solid dispersions, and cocrystals.  

Greg has a knack for solving problems that involve dissolution, physical form, and manufacturing problems, resulting in his being awarded Eli Lilly and Company’s Presidential Award in 1995, 1997, 2004 and 2012. He has authored approximately 70 peer-reviewed journal articles, is named as co-inventor on 14 patents, and has authored multiple book chapters. He was elected as a Fellow of the International Centre for Diffraction Data’s (ICDD) awards committee.  He serves on the Editorial Advisor Board for The Journal of Pharmaceutical Sciences and Pharmaceutical Development and Technology and continues to publish and review articles for multiple journals.

Greg recently retired from Eli Lilly and Company as a Research Advisor, after nearly 30 years of service and has become an independent consultant and founder of Pharmaformfinders, LLC. Greg enjoys working with new clients and contract research organizations who move rapidly, conduct well-designed experiments, and produce high-quality data that result in fast product approvals.

© Regis Technologies, Inc. 2019