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Key Presentations Announced for Landmark Future of Biosimilars Event Co-Sponsored by DIA and FDLI, Co-Chaired by Merck and PAREXEL
Date:4/28/2011

, will present "FDA: The Agency's Approach to Biosimilars" at 10:00 a.m.
  • Sandra J.P. Dennis, J.D., Deputy General Counsel of the Biotechnology Industry Organization (BIO), and John Coster, Ph.D., RPh, Senior Vice President for Government Affairs, Generic Pharmaceutical Association, will present "Industry Challenges in Developing Biosimilar Medicinal Products" at 11:15 a.m.

  • Susan C. Winckler, President and CEO of FDLI, and Paul Pomerantz, Worldwide Executive Director of DIA, will provide the welcome and opening remarks for the event.  Program Co-Chair Philip L. Huang, MBA, M.D., Vice President, Vaccine Strategy & Innovation, Merck & Co., Inc., will present the first session of the conference entitled "Overview of Biosimilars:  Patient Access, Challenges, Statutory Framework Enacted as Part of Affordable Care Act."

    According to Alberto Grignolo, Ph.D., Corporate Vice President, Global Strategy and Services, PAREXEL Consulting, and a member of the Program Committee, "Participants will learn about all the significant issues, opportunities and challenges associated with biosimilars development and commercialization in the U.S., including the perspective of the FDA. These learnings will provide the foundation for strategic decisions that companies will need to make, and will no doubt lead to further debates, initiatives, and events as this field continues to evolve."

    To access a podcast with a preview of the key issues that will be discussed at the event, including the viewpoints of Program Co-Chair Cecil J. Nick, B.Sc. (Hons), FTOPRA, Vice President, Technical, PAREXEL Consulting, visit:  http://www.fdli.org/podcast/FDLI_Biosimilars_Podcast.mp3.  More in-depth information about the conference can be found in the article

    SOURCE PAREXEL International Corporation
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