19 - 20 January, 2010, Grand Connaught Rooms, London, UK
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A Review of Process Analytical Technology (PAT) in the U.S. Pharmaceutical Industry by: James Munson, C. Freeman Stanfield and Bir Gujral
Monte Carlo Simulations For Risk Analysis In Pharmaceutical Product Design By: Bir Gujral
7th Annual PAT and Quality by Design - Article
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With PAT and QbD having a more established hold within the small molecules arena the focus is now turning towards the more complex Biopharmaceutical sector. This interactive workshop will discuss the different stages and important considerations focusing on the practical application of PAT and QbD principles for drug design and manufacture. Attendees will have the chance to discuss case study examples as well as work within smaller groups for more targeted discussions.
Workshop Leader:
Dr Victor A. Vinci Director, Bioprocess Operations Eli Lilly and Company
Meet your workshop leader
Dr. Vinci is currently Director of Bioprocess Operations at Eli Lilly and Company in Indianapolis, Indiana. As such, he is responsible for process operations focused on bringing new protein therapeutics to market by producing active pharmaceutical ingredients intended for clinical trials. For the last 4 years, his responsibilities have included coordination of teams involved in the design, commissioning and qualification of a new 200,000 sq ft cGMP bulk process facility, developing staffing models, and implementing effective and compliant operational practices. His team is currently engaged in tech transfer for new campaigns, bioprocess operations to produce bulk biologic API, and improving platform operations for bioproducts. He serves as the lead for the Lilly team involved with the CMC Biotech Working Group (industry consortium) which has finished a QbD case study for a monoclonal antibody (Mab). Prior to his current role, he was a scientist and group leader in process development at Eli Lilly for five years. He began his career at Merck where he was a scientist and later section head in an Manufacturing Science and Technology (MS&T) role. Dr. Vinci received his doctorate in Microbiology from The Ohio State University in 1988.
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This interactive workshop will allow you to assess successful and unsuccessful FDA and EMEA submissions as well as giving attendees the opportunity to discuss openly their own experiences and gather fresh ideas on how they can change their approach for the better.
Gerald DiDonato Associate Director Global Regulatory Sciences CMC, Bristol Myers Squibb
Gerald DiDonato, Associate Director, Global Regulatory Sciences-CMC, received his PhD in Analytical Chemistry with a specialty in mass spectrometery from Indiana University in 1987. Gerald joined Bristol-Myers Squibb as a Research Investigator solving structure elucidation problems for Discovery, Development and Manufacturing colleagues. He was one of the first to use electrospray mass spectrometry as a routine structure elucidation tool in the Pharmaceutical Industry. Subsequently he managed multidisciplinary analytical groups, and led Development and Manufacturing Teams for new products. Gerald recently chaired the Company's Specification Committee. He saw the light and switched to Regulatory Affairs in 2005, where he currently is the CMC lead for saxagliptin as well as several products in development.
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