Navigating the many complexities in clinical trials, manufacturing, and regulatory interaction in moving gene therapies from development to market.
David Shoemaker, PhD
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Articles by David Shoemaker, PhD
A regulatory perspective on the current state of protein science and the implications for biosimilar approval.
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Latest Updated Articles
The U.S. Biosimilar Pathway: Policy Precedes SciencePublished: June 1st 2015 | Updated:
The Gene Therapy Product Development ProcessPublished: July 1st 2019 | Updated:
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