GrahamB wrote: Hi Rich,
I agree that having a skill set that involves getting a drug through the FDA is valuable.
Perhaps you can help me here.
I must have this wrong, because as I understand it Rupert Haynes was involved in the marketing end which is distinctly different, and clearly defined separate branch than that is involved in bringing a drug to market.
Can you lead me to your source that indicates he helped navigate the approval?
Marketing and promotion are quite different skill sets from drug approval.
The lead for GWPH on getting episodes approved was Catherine Maher, Ph.D., RAC Head of Regulatory Affairs
My understanding is that the team at the CDER /FDA hearing was :
James Crawforth, Ph.D.
Tilden Etges, MSc, QPPV
Catherine Maher, Ph.D.
Alice Mead, JD, VP
Gilmour Morrison, HNC
Mark Paternoster, Ph.D.
Claire Roberts, Ph.D.
David Solomon, BPharm
Ken Sommerville, MD
Colin Stott
Kevan VanLandingham, M.D., Ph.D. Xiaoting Wang, Ph.D.
Stephen Wright, M.D.
Reference:https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000AdminCorres.pdf