The Gene Therapy Product Development ProcessByDavid Shoemaker, PhDJuly 1st 2019Navigating the many complexities in clinical trials, manufacturing, and regulatory interaction in moving gene therapies from development to market.
The U.S. Biosimilar Pathway: Policy Precedes ScienceByDavid Shoemaker, PhDJune 1st 2015A regulatory perspective on the current state of protein science and the implications for biosimilar approval.