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Published:
Forum to Help Emerging Biotechs Plan Development TimelineIBC Life Sciences Presents the 5th Annual Early to Late Stage Bioprocess Development Summit
The meeting begins with a pre-conference workshop, "Comparability Strategies for CMC Development." Companies will share how they have approached the critical steps involved in planning for the succession of comparability studies required in preclinical and clinical development. Three keynote presentations present examples of companies that have benefited from successful process and analytical development strategies: Mark Cunningham, Ph.D. of Centocor, will outline processes used to manage the interface between discovery research and pharmaceutical development in his case study presentation "PDAC: A Cross-Functional Team Driving the Successful Transition of Biologics from Discovery Research to Pharmaceutical Development and Beyond." Sharon Ma, Ph.D. of Genentech, will show how new Quality by Design approaches are being applied in the field in a talk entitled "Product Quality Ownership throughout Clinical Product Development." Richard Crowley of ImClone will share details of a new platform-based approach to process development the company has recently adopted, as well as the limitations they encountered during implementation. Delegates may also choose from four small group problem-solving discussions:
-- Timing and Strategies for Analytical Characterization (Moderated by
Wyeth Biopharma)
-- Process Development Strategies (Moderated by ImmunoGen Inc.)
-- Program and Project Management for Bench Scientists (Moderated by
Centocor, Inc.)
-- Optimizing Inter-function, Inter-site and Company-CMO Transfers
(Moderated by BioProcess Technology Consultants, Inc.)
For further information and to register for this event, please visit www.IBCLifeSciences.com/ETL To apply for a press pass, please contact gbroughton@ibcusa.com. About IBC Life Sciences IBC Life Sciences is the worldwide leader in scientific, technological and business conferences and courses for the life science industry. To develop its programs, IBC actively researches the advancements, technologies and trends impacting and driving the race for new drugs and therapies. For more information, visit: http://www.IBCLifeSciences.com. Tags: ,Pharmaceuticals and Biotech:Drugs, PharmaceuticalsandBiotech:Biotech, PharmaceuticalsandBiotech:Trials, ,MA,WESTBOROUGH, MA _ _Is your favorite bookmark site missing? Ask for it. |
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