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      The Pharma Lab Show: Addressing the Biggest Challenges in Polymorphism

      Simon Bates, Ph. D.

      In this episode, a roundtable of distinguished guests discusses the impact and challenges of polymorphism. You’ll hear from these life science and pharmaceutical experts:

      • Eyal Barash, Life Sciences Patent Attorney and Founder at Barash Law
      • Steve Byrn, Professor and Dept. Head at Purdue University
      • Mansoor Khan, Professor and Vice Dean, Presidential Impact Fellow, Rangel College of Pharmacy, Texas A&M University
      • Ken Morris, University Professor, Director Lachman Institute for Pharmaceutical Analysis, Long Island University
      • Ann Newman, Solid-State and Pharmaceutical Consultant at Seventh Street Development Group
      • Raj Suryanarayanan, Professor and William and Mildred Peters Endowed Chair at University of Minnesota

      We talked about:

      • The guests’ backgrounds and origin stories in life science
      • The biggest challenges with respect to polymorphism
      • Thinking in terms of practical benefit vs. the clinical benefit
      • Distinguishing the formulation effect from the form effect

      Key takeaways from this episode

      • “What purpose is served by controlling the polymorphic form? That's a question that we as a community need to ask.” — Raj Suryanarayanan

      • "It's a collaboration with the scientist and the patent attorney... and the patent attorney often needs a steep learning curve to get into this space.” — Eyal Barash
      • "Clients want to check off a box, and they don't really understand the impact of polymorphic forms. And that's where we all come in is in order to educate them on this.” — Ann Newman

      •  "There's one aspect of polymorphism that that gets overlooked almost universally, particularly as you get into later early development and early mid development. And that is what are potential patient based failure modes”— Ken Morris

      This episode is Part 1 of 2 on our polymorph roundtable discussion. Don’t miss the conclusion!

      Check out more information on Rigaku's work with polymorphs and why understanding polymorphs are important. 
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      Check out the Rigaku Pharmaceutical Technologies Showcase for more information on Rigaku's commitment to the pharmaceutical industry
      Simon Bates, Ph. D.
      Simon Bates serves customers as the VP of Science and Technology with Rigaku Americas. Simon Bates received his PhD in Applied Physics from the University of Hull, utilizing Neutron diffraction to study the magnetic properties of rare earth materials. The neutron diffraction work was performed at the Institute Laue Langevin in Grenoble. For his postdoctoral work in the Dept. of Physics at the University of Edinburgh, Simon helped design and build high-resolution triple axis X-ray diffraction systems for the study of solid-state phase transformations. Simon continued his work on high resolution X-ray diffraction systems at both Philips NV and Bede Scientific where he was focused on the development of X-ray diffraction and X-ray reflectivity methods for the measurement and modeling of advanced materials. Before moving to Rigaku, Simon spent the last 15 years working in contract research organizations (SSCI and Triclinic Labs) studying solid state pharmaceutical materials. In particular, he was directly involved in the development of advanced characterization methods for formulated pharmaceutical products based on the analysis of structure (crystalline, non-crystalline, meso-phase, polymorph, salt, co-crystal..), microstructure (texture, strain, crystal size, habit..) and their functional relationships in the solid state. Simon also holds an appointment as an Adjunct Professor at LIU in the Division of Pharmaceutical Sciences where he helps teach a graduate course on solid state materials analysis.