Date: September 9 – 12, 2019
Location: Boston Convention and Exhibition Center (BCEC),
Speaker: Steve Hager, Senior Director, Technical Support, Catalent Biologics
Scientific Track Presentation: Speed from Gene to Market
Presentation: Beating the Clock: Case Studies in Expediting Biologic Development
Biologic drug development is complex, requiring broad capabilities and expertise to ensure the highest likelihood of regulatory approval and commercial success. The journey from cell line development to clinical trial supply can result in unforeseen issues that delay timelines or require additional resources. These added costs and delays can be detrimental to both sponsor companies and patients.
The presentation covers these challenges and tools for risk mitigation during biologic development and manufacturing, including case studies on how strategic partnerships and effective communication can result in reduced scheduling delays during drug substance development and expedited timelines between drug product filling and clinical trial supply.
Tuesday, September 10, 2019 | 2:30PM - 3:00PM
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