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Ms. Finkle leads the Regulatory Consulting Services in North America for Catalent, which provides comprehensive consulting services, developing and implementing solutions to enhance clients' performance in pharmaceutical and biotechnology research and development. Catalent has a team of experienced regulatory affairs professionals who can provide regulatory support at early and late stage product development, from Pre-IND FDA meeting support and IND filing to Pre-NDA/BLA support and managing NDA/BLA/MAA submissions. Catalent's unique approach is a combination of strategic and tactical consulting and practical, hands-on implementation to improve the speed, efficiency and quality of the entire product development process, for example the development of high yielding cell lines utilizing GPEx® mammalian cell line development technology.
Ms. Finkle has more than 25 years of scientific and industry experience including 15 years in management of drug and biologic development, quality and regulatory affairs for companies in the U.S. and Canada. Before joining Catalent, Ms. Finkle worked with MedImmune/AZ, PAREXEL International, Celsion Corporation, TherImmune Research Corporation, GeminX Biotechnologies, ConjuChem and BioChem Pharma. She has received numerous awards and scholarships throughout her career and currently serves as a faculty member of the PERI and adhoc faculty for the University of California San Francisco (UCSF) American Course of Drug Development and Regulatory Sciences (ACDRS). Ms. Finkle has also co-authored one book chapter, more than 18 abstracts and 12 papers for industry associations and scientific publications.