Fit-for-Purpose Strategies for Solid-form Discovery and Development

The tension between cost, speed, and quality (risk) has been an ever-present consideration during the early phases of development. The pressure to progress compounds quickly to a go/no-go decision point has driven an evolution in the early development process whereby development strategies are now being crafted to be fit-for-purpose. This has led to an evolution in the timing and scope of activities surrounding salt, form, and co-crystal screening.

Fit-for-purpose strategies have led to crystal-form screening studies that focus on the discovery of a suitable (unoptimized) crystalline form of a compound so that two or more compounds can be fairly compared in a solid-dose pharmacokinetic study. In a similar frame, salt screening has targeted identification of a salt that provides a boost (unmaximized) in solubility and correspondingly an increase in bioavailability relative to that of the free-base. Also, fit-for-purpose strategies have targeted formation of a stable co-crystal of a compound that could only previously be isolated as an unstable amorphous solid.

This webinar will explore the utilization of fit-for-purpose strategies in the discovery and development of solid-state forms of drug substances and highlight how these strategies impact cost, speed, and risk.

Speakers

Joanna Bis, Principal Scientist, Optiform™ Technologies, Catalent Pharma Solutions

Joanna Bis received her M. Sc. degree in Analytical Chemistry from Jagiellonian University, Kraków, Poland, in 2002. Next, she joined the research group of Dr. Michael Zaworotko, at the University of South Florida to study crystal engineering of organic compounds. While in the Ph.D. program, Joanna worked as research assistant for TransForm Pharmaceuticals Inc. (J&J) and applied the fundamental crystal engineering strategies in design and preparation of novel pharmaceutical compounds. After she obtained her Ph. D. degree, in 2006, Joanna assumed a Principal Scientist position at GlaxoSmithKline in the Solid Form Sciences department, where she was responsible for supporting solid-state form screening and selection activities for early-, middle-, and late-stage drug development projects, as well as addressing solid-state issues encountered during the development of crystallization and formulation processes. Currently, Joanna continues to support solid-state form development activities at Optiform™ Technologies at Catalent Pharma Solutions.

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Pingyun (PY) Chen, Manager, Optiform™ Technologies,Catalent Pharma Solutions

Pingyun (PY) Chen is currently Manager of Optiform™ Technologies at Catalent Pharma Solutions. He received a Ph. D. degree from the University of North Carolina at Chapel Hill in 1989, joined Nicolet Instrument Corporation as FT-IR/Raman Product Specialist in 1998, and began his pharmaceutical career at GlaxoWellcome in 1999. After spending one year as Principal Research Scientist in the Crystallization Process Laboratory at Eli Lilly in 2004, he returned to Chemical Development at GlaxoSmithKline to provide global salt and polymorph screening and selection support of drug candidates from discovery through commercialization. PY has given multiple presentations at national meetings, coauthored a book chapter on the application of vibrational spectroscopy in pharmaceutical development, and named a co-inventor on multiple patents. PY’s research interests include solid form screening strategy and technologies, material characterization, crystallization process development, drug absorption and delivery.

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David Igo, Director, Optiform™ Technologies, Catalent Pharma Solutions

David Igo received his doctorate from the University of Cincinnati where he studied the structural behavior of inorganic/polymeric electrochemical sensors using extended X-ray absorption fine-structure (EXAF) spectroelectrochemistry under the direction of William R. Heineman and Richard C. Elder. David began his industrial career with Glaxo Inc. in 1991 (now GlaxoSmithKline, “GSK”) where he supported various aspects of drug development including preformulation, product development, chemical development, materials characterization, and technology development. In his nearly 2 decade tenure at “GSK”, he co-invented a variety of high-throughput technologies utilized in solid-state screening along with a range of unique crystalline salts and solid-state forms of “GSK” compounds. David is currently Director of Optiform™ Technologies at Catalent Pharma Solutions. Optiform™ Technologies combines novel automation tools and solid-state workflows to support the discovery and evaluation of crystalline forms, salts, and co-crystals.

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