For Technical Inquiries:
Andrew P. Byrnes, PhD
US FDA/CBER, Division of Cellular and Gene Therapies
HFM-725, NIH 29B, Room 2NN04
8800 Rockville Pike, Bethesda, MD 20892
Phone: (301) 827-1786, Email: andrew.byrnes@fda.hhs.gov
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Beth Hutchins, PhD
Merck Sharp & Dohme Corp
901 S. California Avenue, Palo Alto, CA 94304
Phone: (650) 496-6560, Email: beth.hutchins@merck.com
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For Data & Reference Submissions, Plus Comments:
Keith Carson, BS ChE, MBA
International Society for BioProcess Technology (ISBioTechTM)
110 Willow Grove Court, Norfolk, VA 23505
Phone: (757) 467-8903, Fax: (757) 257-3800
Email: kc@isbiotech.org
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REV 8/22/2017