Catalent Expert to Teach Drug Development at Pharmaceutical Education and Research Institute (PERI) Course
Somerset, NJ, March, 8, 2011 - Carolyn Finkle, Vice President of Regulatory Consulting for North America at Catalent Pharma Solutions will have a leading role in this year’s Pharmaceutical Education and Research Institute (PERI) by teaching a spring and fall course on drug development. The spring course is entitled, “Basic Drug Development: From Molecule to Market” and will be held at the PERI training facility located in Arlington, VA on March 14 to March 15, 2011 from 8 a.m. to 5 p.m. on each day.
In both an online and live classroom setting, the “Basic Drug Development” course will provide an overview of the process and issues common to all new chemical entity (NCE) development projects. The course will focus on the decisions that need to be made throughout the drug development process and the criteria influencing these decisions. Additionally, the course will cover key topics such as drug discovery, decision points in drug development, regulatory review process (FDA, EMA), pharmaceutical dosage form development, nonclinical drug safety, clinical development, marketing input in the drug development team and striving for quality as well as access. The course will also feature a panel discussion with FDA representatives entitled “Putting It All Together.”
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.
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 Pharma Solutions, Ms. Finkle worked with MedImmune, 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 with an optimal regulatory strategy and Right-First-Time regulatory submissions, enhance product performance, and provide superior, reliable manufacturing and packaging solutions. Catalent employs approximately 9,000 people at 28 facilities worldwide and in fiscal year 2010 generated more than $1.7 billion in annual revenue. Catalent is headquartered in Somerset, NJ.