Orphan Drug Model To Be Debated By Catalent Expert At FDA/CMS Summit




Orphan Drug Model to be Debated by Catalent Expert at FDA/CMS Summit

Somerset, NJ – December 10, 2013 — Carolyn Finkle, Catalent Pharma Solutions’ Vice President of Global Regulatory Affairs, is to participate in a panel discussion, “A Rare Opportunity: Orphan Drugs,” at the forthcoming FDA/CMS Summit for biopharma executives, which takes place on the 11th and 12th of December at the Ritz Carlton Hotel, Washington DC. The session will explore how well the Orphan Drug model is operating in a world of evolving science and business, including an update from the FDA’s Orphan Products Office, and perspectives from industry and patients on the interplay of regulation, reimbursement and unmet need for patients with rare diseases. Joining Ms. Finkle in the discussion, which takes place on Thursday 12th December at 10.30 am, will be senior experts from the biopharmaceutical industry and the FDA.

The global leader in development solutions and advanced delivery technologies for drug, biologic and consumer health products, Catalent recently announced several new clinical and commercial supply contracts focused around its Kansas City, MO, facility, including for Pharmacyclics’ oncology drug IMBRUVICA™, Aegerion’s lipid-lowering treatment JUXTAPID™, and Exelixis’ COMETRIQ® for the treatment of progressive, metastatic medullary thyroid cancer. Members of the Catalent management team will be available to talk about these projects and Catalent’s range of products and services designed to reliably supply innovative and orphan drugs to market.

Carolyn Finkle has over 27 years of scientific and industry experience including 19 years in management of drug and biologic development, quality and regulatory affairs for companies in the U.S. and Canada. Ms. Finkle holds a M.Sc. in Chemistry from the University of Toronto, Canada and has a B.Sc. in Chemistry from the University of Ottawa, Canada. She has worked in academic research at Stanford University and at the Toronto General Hospital, and spent a year as a Foreign Researcher in Chiba University, Japan, prior to her industry managerial appointments.

She has co-authored 1 book chapter on First-in-Man global regulatory requirements, over 18 abstracts and 12 papers for industry associations and scientific publications, chaired DIA sessions (global regulatory), AAPS workshops at the annual meetings, and currently serves as a faculty member of the Pharmaceutical Education and Research Institute (PERI). Ms. Finkle is also a contributor to the UCSF American Course of Drug Development and Regulatory Sciences (ACDRS), and co-Director of the Georgetown University Master’s Program in Clinical and Translational Research.

For further information visit www.elsevierbi.com/mkt/Conf/FDA-CMS/2013 or to arrange a meeting with a member of the Catalent team contact Richard Kerns at NEPR: richard@nepr.eu .

About Catalent

Catalent Pharma Solutions is the global leader in development solutions and advanced drug delivery technologies, providing world-wide clinical and commercial supply capabilities for drugs, biologics and consumer health products.  With over 75 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable product supply. Catalent employs approximately 8,500 people, including over 1,000 scientists, at nearly 30 facilities across 5 continents and generates more than $1.7 billion in annual revenue. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com .

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