We recently welcomed Jan Hewett as our senior vice president, FDA regulatory advisor. With a decade of experience as regulatory counsel in the FDA’s Center for Drug Evaluation and Research – Office of Scientific Investigations, her experience will help Advarra’s clients and internal teams navigate the ever-shifting regulatory landscape for human subjects research. Jan will continue to advance Advarra’s review services for clients and industry stakeholders on pertinent FDA regulatory and policy programs while steering Advarra’s compliance roadmap and scaling its consulting and training offerings.
We sat down with Jan to explore her background in healthcare, research, and regulatory policy, and to hear how she plans to put that expertise to work at Advarra.
From operating room nurse to IRB director to a decade as regulatory counsel at the FDA, how has each stage shaped your perspectives on regulatory policy?
Every role has given me a stronger perspective on human subject protection. I began at the bedside, coordinating haematology and oncology trials and seeing what research protocol participation and decisions mean for patients and their families. Running a Human Research Protection Program and several IRBs at major research universities, including Yale University and the University of Michigan, the experience has given me deep insight into the safeguards these institutions use to protect clinical research participants and the rigorous regulatory rules and procedures that sustain those protections. Then, the FDA gave me the regulator’s view: why the regulations and published guidance read the way they do, and the considerations that shape new regulatory actions and policy.
What inspired you to join Advarra, and how will your perspective help our customers?
I always want to continue to learn and build upon the knowledge I have gained. Joining Advarra lets me round out the “three-dimensional” viewpoint of human‑subject protection: academia, government, and industry. I’ve long seen the company as the gold standard, and now I can add an FDA perspective that sponsors rarely find outside the agency. My goal isn’t just to provide an interpretation of the FDA-regulated research regulations and rules, but rather an understanding of why they were established and the rationale for compliance and enforcement.
Sponsors often ask, “How will the FDA view this?” — how will you turn your experience into clear, tangible guidance?
At the FDA, I learned that published guidance doesn’t always provide sponsors and stakeholders with everything they need to know, such as the rationale for a particular rule or a revision to an existing rule. I hope to provide context on how and why a regulation was drafted, why specific phrases appear in a rule or guidance, where helpful resources can be found, and what inspection teams focus on in practice. When new rules are proposed or guidance is drafted, I also want to increase the opportunity for Advarra as a respected stakeholder to comment on these emerging rules and guidance before they become final. These actions help inform the agency and result in a clearer understanding of the issues on both sides.
Part of your role will be expanding Advarra’s consulting and training services for sponsors, sites, and institutions. What is your vision?
First, I think it is fair to say that we are entering uncharted waters here, especially with the uncertainty around indirect research dollars and the future of federal funding. Many institutions either lack the administrative support needed for clinical investigators conducting clinical research or are shrinking their current research support infrastructure, which affects the entire clinical research continuum. Second, the sheer pace of regulatory change (not just with the FDA) frequently leaves investigators and clinical research teams scrambling, trying to understand what they need to do and then actually getting it done. We can close these gaps by offering more targeted support and training to sites and partnering with sponsors and institutions to explore alternative ways to fund their research portfolios. Education and training have always been central to Advarra’s mission, and there are many ways to leverage our expertise and scale to deliver them where and when clients need them most.
Looking further down the road in your role, what does success look like?
Success is measured when our clients can point to Advarra’s expertise as a catalyst for their successful outcomes, whether in the review of clinical research and regulatory filings or compliance evaluation outcomes. And this is not just with the FDA but across all federal agencies that oversee the clinical trials submitted by our clients.
I’m also very excited to work with our internal teams on innovation in the compliance training space. We have a real opportunity here to bring advanced compliance training tracks for institutions hit by federal funding cuts, all of which can identify and improve preventative and corrective measures, inspection readiness, and long-term compliance. When Advarra is the first call for a complex FDA-regulated research question, and our customers are able to better address regulatory submissions, I’ll know we’ve moved the needle.