SOURCE: Xtalks

Xtalks Webinars

August 29, 2017 07:30 ET

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

The Latest FDA Guidance and Regulatory Implication

TORONTO, ON--(Marketwired - August 29, 2017) - In an Xtalks webinar scheduled for Wednesday, September 13, 2017 at 11am EDT / 4pm BST (UK) / 5pm CEST (EU-Central) industry experts Eyal H. Barash, JD of Barash Law, LLC and Chief Patent Counsel to SSCI and Dr. Steef Boerrigter, Group Leader in Materials Science at AMRI will introduce the participants to the concept of solid forms, with specific focus on the revised FDA Draft Guidance on Cocrystals, which likens cocrystals in the same group as solvates.

The United States Food and Drug Administration (FDA) recently took the important step to revise the draft guidance to the industry on the regulatory classification of pharmaceutical cocrystals.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.

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.

For more information about this complimentary event visit: Striking While the Iron is Hot: Pharmaceutical Cocrystals as Drug Substance

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

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