Joel Welch, Ph.D.

Primary office:


Summary

Joel Welch is the Associate Director for Biosimilar & Regulatory Policy (Acting) in the Office of Biotechnology Products in the Office of Pharmaceutical Quality at the US Food and Drug Administration.   He is responsible for assessing emerging,  complex, or precedent-setting issues impacting science policies of the office with particular emphasis on the biosimilar program.  He also serves as the Rapporteur for The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) revision to Q5A(R1).  Prior to his current role, he served as a Review Chief where he oversaw as many as 20 assessors who evaluate CMC information for monoclonal antibodies and therapeutic proteins. In his time at FDA, he has worked as a regulatory project manager, a product quality reviewer, and a product quality/CMC team leader.  He received a B.S. in Chemistry from the University of Kansas in 1999, and a Ph.D. in bioinorganic chemistry in 2004 from the University of Iowa. Prior to joining FDA in 2010, he spent six years in industry supporting late state analytical development of small molecules.    


LaunchKU


The SEARCH Symposium was partially funded by donations made to KU Student Endowment Board’s crowd-funding campaign, LaunchKU. If you would like to support our graduate student organizations and the 2020 SEARCH Symposium, please consider making a donation. Even the smallest donations make a difference. 

LaunchKU

Thank you for supporting graduate students' efforts to promote science education and outreach, professional development events, and travel to professional meetings.

Twitter Feed
One of 34 U.S. public institutions in the prestigious Association of American Universities
44 nationally ranked graduate programs.
—U.S. News & World Report
Top 50 nationwide for size of library collection.
—ALA
5th nationwide for service to veterans —"Best for Vets: Colleges," Military Times
KU Today