Joanna Gerry-Paul

About

Currently I lead the R&D Global Regulatory Compliance department at a biotech start-up (Allogene – https://www.allogene.com). I lead a team that is responsible for making sure we adhere to the federal and global rules for clinical trials and drug safety surveillance. These sorts of rules include making sure research subject have appropriate consent, treatment, that the pursuant data/science is not corrupted and regulatory expectations are followed. We also make sure that the company has processes in place to make sure market information (good AND bad) on our products are captured and analyzed. We are working on CAR-T treatments for a variety of cancers.

I have also been involved with developing compliance programs around sales and marketing of pharmaceutical products. Compliance programs for sales and marketing are less of a regulatory nature and more of an ethical/legal nature. Whenever Pharmaceutical companies interact with health care professionals, there is a risk (perceived or actual) that should be minded. Mylan….. need I say more? It can be very tricky.

Personal Interests

I am an avid runner/hiker and I love to travel (a hobby that has been shelved amidst COVID-19). I studied Spanish while at UC Irvine and love to visit Spanish speaking countries. I am also involved in my local church and recently climbed San Gorgonio Mtn. My husband is a biostatistician so we talk a lot about “big data”.

I was once in a TV commercial for a Bayer medical device too :).