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Dr. Geigert has over 25 years experience in Chemistry, Manufacturing & Control (CMC) strategies for the development of biopharmaceutical and biological medical products. He has demonstrated successful CMC leadership for moving six drug products (Recombinant IFN-beta, IL-2, GM-CSF and TNFR; Monoclonal Antibodies Rituxan and Zevalin) from clinic into market approval with both the FDA and EMEA. He served for 10 years as Vice President of Quality (Immunex - now Amgen, IDEC - now Biogen IDEC). He has consulted since 2001 with emphasis on CMC regulatory strategy and assessment of quality systems. He is Regulatory Affairs Certified (RAC) by the Regulatory Affairs Certification Board; a past Member of USP Expert Committee on Biotechnology, Natural Products & Diagnostics, 2000-2005; and past co-chair of the PDA Biotechnology Advisory Board, 2004-2007. He is the author of The Challenge of CMC Regulatory Compliance for Biopharmaceuticals, Plenum Press, New York (2004). Dr. Geigert specializes in the following areas: 1. Developing cost-effective CMC strategies for managing limited resources from clinical development through market approval 2. CMC due diligence audits for product/company acquisitions/mergers 3. Review of technical CMC summary reports for EOP2 FDA meetings and product comparability studies 4. Preparation and review of CMC sections for BLAs/NDAs, CTD format 5. Expert testimony and OOS dispute resolutions 6. Effectiveness and gap assessments of Quality Systems 7. Negotiation and development of intercompany quality agreements

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