Striking While the Iron is Hot: Pharmaceutical Cocrystals as Drug Substance

The Latest FDA Guidance and Regulatory Implication

The United States Food and Drug Administration (FDA) recently took the important step to revise the draft guidance to the industry on the regulatory classification of pharmaceutical cocrystals. As the established leader in small-molecule cocrystal technology and development with a full-suite of proprietary and patented methods for preparing and characterizing cocrystals, AMRI, featuring SSCI, is uniquely positioned to create valuable cocrystal intellectual property for its clients.

Exploring the opportunities available when cocrystals are used to modify the supramolecular properties of crystalline pharmaceutical compounds and the regulatory implications of the latest FDA guidance, is the aim of this webinar.

Eyal H. Barash, JD of Barash Law, LLC and Chief Patent Counsel to SSCI and Dr. Steef Boerrigter, Group Leader in Materials Science at SSCI will introduce the participants to the concept of solid forms, with specific focus on the revised FDA Draft Guidance on Cocrystals, which likens cocrystals in the same group as solvates.

Attendees will learn:

• Innovative patent strategies for cocrystals
• How solid form claims are drafted
• Examples of recent case law

This session will also provide specific examples of products in the Orange Book using patents for such forms to provide drug substance protection beyond composition of matter and will discuss both patentability and infringement issues related to such patents.

Speakers

Dr. Steef Boerrigter, Sr. Research Scientist, AMRI

Dr. Steef Boerrigter is currently a group leader in Materials Science at AMRI. Beyond performing experimental screening for polymorphs, salts, and cocrystals, his group specializes in crystal growth for single-crystal structure elucidation and is investigating computational methods for virtual coformer screening.  Dr. Boerrigter obtained his PhD in Materials Science from Nijmegen University (Netherlands) on the subject of crystal morphology prediction. In 2002 he moved to Antwerp, Belgium where he worked on a Marie-Curie postdoctoral fellowship at the imaging company Agfa-Gevaert.  He has been associated with the Industrial and Physical Pharmacy Department in the College of Pharmacy at Purdue University since 2003 and currently serves as an adjunct assistant professor.

Message Presenter

Eyal Barash, JD

Eyal H. Barash, JD of Barash Law, LLC and Chief Patent Counsel to SSCI and Dr. Steef Boerrigter, Group Leader in Materials Science at SSCI will introduce the participants to the concept of solid forms, with specific focus on the revised FDA Draft Guidance on Cocrystals, which likens cocrystals in the same group as solvates. Attendees will take away innovative patent strategies for cocrystals, how solid form claims are drafted, and examples of recent case law. These sessions will also provide specific examples of products in the Orange Book using patents for such forms to provide drug substance protection beyond composition of matter, and will discuss both patentability and infringement issues related to such patents.

Message Presenter