Pharmaceutical Cocrystals: the Implications of the Latest FDA Guidance

SSCI, a division of Albany Molecular Research, Inc. is pleased to see the United States Food and Drug Administration’s (FDA) recently take the important step to revise the draft guidance to the industry on the regulatory classification of pharmaceutical cocrystals.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, 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 two Lunch and Learn events (see below).  An additional webinar featuring SSCI, which will include this topic, will also be hosted by Strafford Publications, Inc.

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Science at SSCI will introduce the participants to the concept of solid forms, with specific focus on the revised FDA Draft Guidance on Cocrystals, which likens cocrystals in the same group as solvates.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.

Since registration at each Lunch and Learn session is limited to forty participants, please register early by visiting and entering your contact information and the event date you will attend.  Lunch service will start at 11:30 AM (local time), with the presentation starting at approximately 12:00 PM (local time).


Lunch ‘n Learns
Pharmaceutical Cocrystals as Drug Substance and the Implications of the Latest FDA Guidance San Francisco Airport Marriott
1800 Old Bayshore Hwy
Burlingame, CA
15 Nov 2016
Pharmaceutical Cocrystals as Drug Substance and the Implications of the Latest FDA Guidance Boston Marriott Cambridge
50 Broadway
Cambridge, MA
8 Dec 2016
Drug Substance Patents: Leveraging New FDA Guidance, Protecting Composition of Matter Patents, Drafting Solid Form Claims Live Webinar – 1 Nov 2016 1:00pm-2:30pm EDT


About the Presenters

Dr. Steef Boerrigter is currently a group leader in Materials Science at SSCI. 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.

Eyal Barash, JD is a patent attorney who specializes in pharmaceuticals and chemical products. He currently practices in Lafayette, Indiana. His practice includes drafting and prosecuting patent applications, client counseling, and negotiating licenses and other contracts. A native of West Lafayette, Mr. Barash obtained undergraduate degrees in chemistry and history from Indiana University, a Masters in physical chemistry from UC-Berkeley and his law degree from Northwestern. After practicing in Washington, DC for eight years, he returned to Indiana to work with emerging technology companies. Mr. Barash is a frequent speaker both nationally and internationally on intellectual property topics related to pharmaceuticals. In addition to his private practice of law, Mr. Barash is the Chief Patent Counsel to SSCI and has an adjunct appointment in Chemical Engineering at Purdue University.