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Supply of raw materials has been a risk to the biomanufacturing industry for many years, however, the pandemic has worsened and accelerated what is now no longer a risk but a reality.
The session will explore how industry and the regulators are mitigating risks for the current and future state of the raw material supply chain; three perspectives will be shared, that of suppliers, end users and regulators.
Session Speakers: 10:45 - 11:10 Managing Raw Material Supply Chain Challenges during the COVID-19 Pandemic and Resulting Future Opportunities - A Roche Perspective V Stefan Paschen, Roche Diagnostics GmbH
11:10 - 11:35 Supplying an mRNA COVID 19 Vaccine at Unprecedented Pace and Scale V David Sullivan, Pfizer, Inc.
11:35 - 12:00 Regulatory Approaches to Manage Supply Chain Challenges V Patricia Hughes, CDER, FDA
“Alone we can do so little, together we can do so much” is a Helen Keller quote which captures the spirit of CASSS-organized conferences like WCBP, the regional CMC strategy forums, and technology specific meetings…
Use of animals and/or animal derived products to demonstrate safety or efficacy supports drug development and, in some cases, is required by law to release drug product…
Industry and regulatory authorities speed of response to the COVID-19 pandemic crisis demonstrated the capability to develop new therapeutics in the face of a dire situation…