Catalent Expert to Present Development, Regulatory, and Market Access Considerations for Elsevier Webinar on Biosimiliars and Biobetters
Somerset, NJ, August 15, 2011 – Carolyn Finkle, Vice President of Regulatory Consulting for North America at Catalent Pharma Solutions, along with other industry experts, will present a webinar on “Biosimilars and Biobetters: Development, Regulatory and Market Access” for Elsevier on August 17, 2011 from 12:00 to 1:00 pm EDT.
This webinar will explore the current regulatory, scientific and market access challenges facing industry engaged in developing biosimilars or biobetters with special emphasis on recent US legislation emphasizing an abbreviated regulatory pathway yet to be defined by FDA, existing EU regulatory framework and new policies implemented by global public and private payers. Case studies will focus on lessons learned from approval, pricing and uptake of biosimilar products.
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.
From drug and biologic development services to delivery technologies to supply solutions, Catalent Pharma Solutions has the deepest expertise, the broadest offerings and the most unique technologies in the industry. With over 75 years of experience, Catalent helps customers get more molecules to market faster, enhance product performance, and provide superior, reliable manufacturing and packaging solutions. Catalent employs approximately 8,000 people at 24 facilities worldwide and in fiscal year 2010 generated more than $1.7 billion in annual revenue. Catalent is headquartered in Somerset, NJ.