November 30, 2012

Biosimilars: Creating Workable Solutions to Global Regulatory and Analytical Challenges

Biosimilars: Creating Workable Solutions to Global Regulatory and Analytical Challenges 

Global manufacturers are exploring the possibility of producing biosimilars or follow-on biologics to extend product pipelines and increase availability of lower cost products. As biopharmaceuticals are large, complex molecules manufacturing changes may alter clinical efficacy and safety of the biologic product, complicating their development.

This webinar will explore the current regulatory and scientific challenges facing industry engaged in developing biosimilars with emphasis on EU and US regulatory framework.

This seminar will provide beneficial guidance and expert commentary geared towards scientific, analytical and regulatory managerial and professional staff in the biopharmaceutical and biotech industry responsible for the development of biologic products.

In addition to these target audience members, the seminar will also be particularly helpful to those engaging in or responsible for broader biologic development that are interested in understanding industry trends, strategies for overcoming challenges in the biosimilar space, or understand the current regulatory environment within the US and EU.

Ms. Finkle has over 27 years 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, including VP, Regulatory Consulting for North America, Catalent Pharma Solutions, Senior Director, International Regulatory Affairs, MedImmune, Vice President, Global Product Development Strategy and VP North America Consulting, PAREXEL International, VP Regulatory Affairs at Celsion Corporation, VP PreClinical Development at TherImmune Research Corporation (now Gene Logic Inc.), VP Drug Development at GeminX Biotechnologies, Director of PreClinical Development at ConjuChem and Manager of PreClinical Development at BioChem Pharma.

Ms. Finkle holds a M.Sc. Chemistry from the University of Toronto, Canada and has a B.Sc. Chemistry from the University of Ottawa, Canada. She has worked in research at Stanford University, the Toronto General Hospital and spent a year as a Foreign Researcher in Chiba University, Japan, prior to her industry managerial appointments.

Ms. Finkle has co-authored 1 book chapter, over 18 abstracts and 12 papers for industry associations and scientific publications and chaired DIA sessions at the annual meetings. She has received numerous awards and scholarships throughout her career and currently serves as a faculty member of the Pharmaceutical Education and Research Institute (PERI) and the UCSF American Course of Drug Development and Regulatory Sciences (ACDRS).

Vincy Abraham has about 20 years of scientific experience in mass spectrometry including both GC/MS and LC/MS. She has hands on knowledge in identification and characterization of both small and large molecules in the environmental and pharmaceutical industry. She has multiple years of experience managing GMP laboratories and projects.

Ms. Abraham received her MS in Chemistry from University of Madras, India, and her Ph.D. in Analytical Chemistry (Mass Spectrometry) from Mississippi State University. As a post doctoral associate at Mississippi State Chemical Laboratory, she supported environmental monitoring and analysis using mass spectrometry for the State of Mississippi. She then joined Midwest Research Institute (MRI), Kansas City as Manager of the Mass Spectrometry Facility. She was responsible for the day to day operations as well as Project Manager/Technical Lead for various projects.

Ms. Abraham then joined Quintiles, Kansas City in 2001 as a Senior Scientist. Currently, she is a Senior Manager of the Structural Characterization Group, Catalent Pharma Solutions that offers various instrumentations including LC/MS, ICP/MS and ICP/OES, Gel/Capillary Electrophoresis, Malvern particle sizer, FTIR, polarimeter and e-tongue. Her group specializes in characterization of both large and small molecules using mass spectrometry and supports method development and validation of various techniques within the group.

Catalyst + Talent. Our name combines these ideas. From drug and biologic development services to delivery technologies to supply solutions, we are the catalyst for your success. With over 75 years of experience, we have the deepest expertise, the broadest offerings, and the most unique technologies to help you get more molecules to market faster, enhance product performance and provide superior, reliable manufacturing and packaging results.

Catalent develops. With our broad range of expert services we drive faster, more efficient development timelines to help you take more molecules to market and create more effective products.

Catalent delivers. As the world leader in drug delivery innovations, we have a proven record of enhancing bioavailability, solubility and permeability, improving ease and route of administration, and strengthening patient compliance for better treatments.

Catalent supplies. Globally positioned to serve all your manufacturing and commercial packaging needs, we are the largest, most reliable supplier in pharmaceutical outsourcing.

Catalent. More products. Better treatments. Reliably supplied.™