SC16: New USP Initiatives for Characterization and Release of Biologics
THURSDAY, MAY 4
5:45 - 8:15 PM | DINNER INCLUDED


Maura C. Kibbey, Ph.D., Director Science & Standards, Global Biologics, US Pharmacopeia

Steven L. Walfish, Ph.D., Principal Science & Standards Liaison, US Pharmacopeia

Introduction:

United States Pharmacopeial Convention (USP) continues to build and improve its portfolio of general chapters with validated test methods, monographs, and Reference Standards that support the biopharmaceutical industry. A related goal is the reduction of in vivo testing yet replacing animal assays with suitable in vitro assays may be challenging. This presentation will include:

  • USP’s current monograph development program and new monographs and chapters
  • Case studies illustrating considerations for replacement of an in vivo assay with an in vitro assay and bridging expectations
  • Updates on revisions to USP’s bioassay general chapters
  • Illustration of practical implementation of these chapters and tips for use

Instructors:

Maura C. Kibbey, Ph.D., Director Science & Standards, Global Biologics, US Pharmacopeia

Dr. Maura Kibbey is a Director of Science & Standards in USP’s Global Biologics Department. Maura and her team work with the four USP Expert Committees and multiple Expert Panels for biologics to develop documentary standards (chapters and monographs) and Reference Standards that support biopharmaceutical quality assessment. Before joining USP, Dr. Kibbey worked for several biotechnology and diagnostic companies in the Washington DC area as well as at the National Institutes of Health. Her scientific expertise includes development and validation of many different assay types for measurement of individual molecules, their activities, or binding interactions. She has published over 40 peer-reviewed articles and has been an invited speaker or workshop organizer for numerous scientific conferences.

Steven L. Walfish, Ph.D., Principal Science & Standards Liaison, US Pharmacopeia

Mr. Walfish is Principal Science & Standards Liaison in the Global Science and Standards Division at United States Pharmacopeia (USP). Prior to this role Mr. Walfish was Principal Statistician at BD in Franklin Lakes, NJ. He is responsible for supporting continuous improvement efforts and process development for worldwide operations. Prior to BD he was a statistician at GE Healthcare in Waukesha, WI. Previously, Steven was President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to the FDA regulated industries. Prior to starting Statistical Outsourcing Services, Mr. Walfish was the Senior Manager Biostatistics, Non-clinical at Human Genome Sciences in Rockville MD.


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