2011 PDA/FDA Joint Regulatory – P2- Latest News and Inspection Findings in Biotech

Web Code: PDAFDAP211
Member/Nonmember Price: $75

Seminar Summary

This seminar will cover recent biotechnology business and regulatory trends and business.  FDA representatives will discuss pre-approval inspection trends and case studies.  The latest trends in the biotech business will also be covered by a leading pharmaceutical executive.

Who Should Attend

Departments
Research & Development | Regulatory Affairs | Manufacturing | Quality Assurance/Control | Marketing | Sales

Job Functions
Supply Chain | Clinical Supply Material Preparation | Executive Management

Presenters Bio

Patricia Hughes, PhD, Lead, Consumer Safety Officer, DMPQ, CDER, FDA

Patricia F. Hughes received a Ph.D. in Microbiology from Georgetown University and is currently the Branch Chief (acting) of the Biotech Manufacturing Assessment Branch in the Office of Compliance in CDER.  This branch is responsible for the microbiology product quality oversight of all CDER BLA submissions and for the pre-license and pre-approval inspections of biological manufacturing facilities, both domestic and foreign. Dr. Hughes has over twenty years of industry experience in process development and manufacturing and has held various positions in the biotech industry ranging from Senior Scientist to Associate Director of Pharmaceutical Operations.  She has been with the FDA for over 12 years and has held various positions in both CDER and CBER as a primary reviewer, lead inspector, team leader and branch chief. 

Azita Saleki-Gerhardt, PhD, President, Global Pharmaceutical Operations, Abbott Laboratories

Azita Saleki-Gerhardt, PhD is President, Global Pharmaceutical Operations, with responsibility for the supply chain, quality, manufacturing and distribution of Abbott’s proprietary pharmaceutical products, including biologics and small molecules. Dr. Saleki-Gerhardt joined Abbott in 1993 as a Research Scientist. In her 18-year career with Abbott, she has worked in key positions in science and technology, manufacturing, and quality assurance. Her roles have included Director of Technical Operations for international pharmaceutical and hospital products and Divisional Vice President, Manufacturing Science and Technology, where she led technical support for commercially marketed pharmaceutical products. Most recently she was Divisional Vice President, Quality, Global Pharmaceutical Operations, responsible for the quality of Abbott’s portfolio of global biological, chemical and pharmaceutical products. She has been published in numerous scientific publications and has been awarded several patents related to pharmaceutical sciences.

Dr. Saleki-Gerhardt is a member of the Women’s Leadership Council of the United Way of Lake County. She is Abbott’s executive sponsor for the University of Wisconsin at Madison and a member of the advisory board for the School of International studies at UW-Madison. She is also the executive sponsor for the Women in Science and Puerto Rico chapters of Abbott’s Women’s Leadership Council.

She earned her bachelor’s, master’s and doctorate degrees in pharmaceutics from the University of Wisconsin at Madison.

Laurie Graham, Biologist, OBP, CDER, FDA

Ms. Graham is a full time product quality/CMC reviewer in the Division of Monoclonal Antibodies (DMA) in the Office of Biotechnology Products, CDER/FDA.  The division is responsible for reviewing the chemistry, manufacturing, and control (quality) information in regulatory submissions for monoclonal antibodies and Fc-fusion proteins intended for in vivo use. 

Ms. Graham joined the FDA in 1993 as a full time research biologist investigating the response of immune cells to perturbation by physiological ligands or pharmaceutical agents, such as monoclonal antibodies. In 2003, Ms. Graham became a staff scientist in DMA assuming both research and regulatory review responsibilities. In 2007, Ms. Graham assumed full time CMC/product quality review responsibilities.  Ms. Graham’s review responsibilities are focused on immunomodulatory antibody products.  In addition to her review duties, Ms. Graham provides DMA with expertise in, among other things, mycoplasma testing, immunogenicity assay validation, and inspectional activities.

Registration contact

Jason E. Brown
Senior Programs Manager
Tel: +1 (301) 656-5900 ext. 131
Fax: +1 (301) 986-1093
Email: brown@pda.org

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