SOURCE: IBC Life Sciences

IBC Life Sciences

October 04, 2010 13:37 ET

Ninth FDA Presenter Announced for October's Well Characterized Biologicals Conference

WESTBOROUGH, MA--(Marketwire - October 4, 2010) -  IBC Life Sciences Conference Producer, Michael Keenan, today confirmed that an additional FDA speaker has been added to the Well Characterized Biologicals conference, October 20-22 at the Hyatt Regency Bethesda in Maryland. This brings the number of regulatory presenters to nine.

  Characterization of Biotechnology Products: An FDA Perspective
  Laurie Graham, CDER, US FDA
  Analytical Characterization for Gene Therapy Products
  Michael Havert, Ph.D., CBER, US FDA
  A Regulatory Perspective on the Development and Validation of Biopharmaceutical Potency Assays
  Carla S.R. Lankford, M.D., Ph.D., CDER, US FDA
  Strategies in the Design of Potency Assays for Therapeutic Enzymes
  Richard Ledwidge, Ph.D., CDER, US FDA
  Combination Products: An Overview
  Kathy Lee, CDER, US FDA
  Aric Kaiser, CDRH, US FDA
  Comparability of Biotechnology Products: Regulatory Considerations and Case Studies
  Rashmi Rawat, Ph.D., CDER, US FDA
  Joint Presentation: Pet Peeves and Roadblocks in CMC: Improving your Quality Submissions through the Product Lifecycle
  Chana Fuchs, Ph.D., CDER, US FDA
  Marjorie Shapiro, Ph.D., CDER, US FDA

Attendees will interact directly with these FDA reviewers and hear first-hand advice for improving characterization efforts and overcoming common pitfalls. Additional conference highlights include multiple case studies involving a broader range of classes of molecules, like enzymes, oligonucleotides and more. Unpublished new data covering characterization of conjugate proteins, antibodies, and other biotechnology products will also be presented.

Well Characterized Biologicals has a 13 year history of being one of the bioprocess industry's most respected, must-attend events. It brings together analytical, research and development, quality and CMC scientists to share insights and new approaches being used in the field while presenting the big picture of issues presented directly by FDA scientists.

Well Characterized Biologicals is being held concurrently with Process2Product: Translating Process Knowledge into Quality Biological Products, where presenters will share strategies, technologies and practical examples of enabling process automation and multivariate data analysis to improve manufacturing operations and achieve quality biological products with less manual manipulation.

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