Policy Champion – Regulatory Affairs Committee Co-Chairs

First of all, tell us a little bit about yourself: Where you work and how long you’ve been a committee co-chair.

Scott Cunningham:I am a partner in Covington & Burling’s food & drug law practice group, where I’ve been helping drug and biologics companies navigate the FDA regulatory system for about 25 years. I really enjoy my job. I have an amateur’s interest in the science, the legal and ethical issues are fascinating, and I get to work with a broad range of people, including lawyers, sales/marketing, medical affairs, and executives. I’ve been a co-chair of the Regulatory Affairs Committee (RAC) since 2017.

Jennifer Shen: I work at ORIC Pharmaceuticals (5+ years), and I have been a committee chair for only 1 year, started in 2024.

What led you to becoming a co-chair for the Regulatory Affairs Committee? What is your role at your company that led to your involvement in this committee?

SC: I developed a friendship with Joe Panetta in 2010. At that time, Joe was very interested in making the FDA more of a focus for Biocom California. Given my focus on FDA regulatory law, Joe encouraged me to become more active by getting involved in the RAC, which at that time was called the FDA Committee. I very much enjoyed the experience. Eventually, an opportunity arose to become a co-chair. I think it was Laure Clark who offered me the opportunity, and I jumped at it.

JS: Zoe offered me the opportunity to be the co-chair, and I said yes – that’s what happened! At ORIC, I lead the Regulatory Affairs team, and I had been a member of the RAC before becoming the co-chair with Scott.

What keeps you coming back each year?

SC: I really enjoy my job. And that’s mostly because I very much believe in this industry. My father was General Counsel for Genentech in the 1980s, when Genentech was launching the world’s first biotechnology products. So, FDA was “in my kitchen,” so to speak, when I was growing up. Starting from those early days, I’ve always thought that this industry is a fascinating one, focused on a hugely important goal – improving health outcomes. I’ve dedicated my career to helping this industry succeed. I suppose I see my involvement with Biocom California and my service as a RAC co-chair as an extension of that.

JS: This is only my 2nd year as co-chair, and I enjoy working with Scott and Zoe! As a co-chair, I hope to be impactful in fostering the next generation of regulatory affairs professionals.

What do you take away from the committee that you can take back to your company?

SC: Relationships and knowledge. I’ve met a lot of people over the years working with Biocom California, and those relationships are very valuable to me. As for knowledge, working on the RAC gives me an additional avenue to hear and see what is important to life science companies, what challenges they face, and what they think is working well. That helps me advise my own clients in private practice. I also find that the fact that I work with a huge swath of industry in my private practice helps me contribute more to Biocom California and the RAC, so it works both ways.

JS: The RAC keeps abreast with FDA latest policy and changes, which are informative for me to take back to ORIC.

How does the committee help with aspects of regulatory affairs for you or for other members of the committee?

SC: I think the RAC does a great job of keeping its members up to date on current regulatory developments and provides an excellent forum for discussion of the issues.

JS: I think the RAC also serves as a platform to network and share regulatory experiences.

What aspects of regulatory policy interest you the most right now and why?

SC: Traditionally, I’ve been most interested in the issues that are most important to early-stage pharmaceutical, biotechnology, and regenerative medicine companies – namely clinical development and FDA approval. At this exact moment in time, it’s hard to ignore the impact that the Trump Administration’s emphasis on de-regulation and reduction in the size of the federal government is going to have on our industry.

JS: Regulatory policy changes that impact drug development and patient care interest me the most, as these are the topics most relevant to my day-to-day work life.

What is one piece of advice that you would give to early career regulatory professionals?

SC: Ask questions. And when someone asks you to participate in something, say yes. Sorry… I recognize that’s two pieces of advice!

JS: Be proactive to self-learn and build up your network!

Learn more about our Regulatory Affairs Committee here.

View all Policy Champions.