In a recent video interview with Applied Clinical Trials, Kate Gallin Heffernan, life sciences attorney, Epstein Becker Green, discussed the challenges clinical research teams face with compliance due to evolving executive orders and federal funding policies. She highlighted the confusion and increased scrutiny on research projects, particularly those involving diverse populations. Practical risks include potential legal scrutiny and funding agency actions. Heffernan also emphasized the importance of accurate reporting and careful documentation to avoid false claims. Future-proofing compliance involves thorough portfolio assessments, diversifying funding sources, and strengthening partnerships between academia and industry to support early-stage research and innovation.
ACT: What is your top piece of advice for clinical research organizations that want to future-proof their compliance programs in an increasingly politicized funding environment?
Heffernan: I think the main advice that I would give people is, is a pretty obvious one, which is what people, I think, have been doing since January: do a thorough assessment of your research portfolio, look at the areas that your organization really wants to focus on. What are the areas that align most with your mission, your patient population, the potential for IP development and commercialization for your organization, the ultimate financial impact ways in which your organization can supplement funding for certain efforts and maybe not others. I think ultimately, diversification of funding sources is going to really be key for all parties involved going forward, and a point that I think is sometimes overlooked, but really important to note is that these cuts to federal funds are not only impacting the academic sector, so the pharmaceutical industry and a lot of the other industry players have been and continue to be in strong partnership with academic hospitals, medical centers, universities, with respect to that early-stage investment time, so the cuts to this early-stage funding that we’re seeing are also going to have downstream impact on the ability of pharmaceutical companies to have access to important early-stage ideas that they can then evaluate and decide whether to license and how to possibly partner with respect to the commercialization. I think we’re going to have to see a new commitment by both industry and academia to a renewed partnership around how we go from bench to bedside with these new early-stage concepts and innovations because that missing bridge funding that we get, normally, from the federal government to help determine what’s worth bringing to market is something we’re going to see, obviously, severely reduced. I think for our academic and institutional and other research clients, using your innovation offices, your clinical trial offices, for increased outreach to the private sector for these types of early-stage collaboration agreements and collaboration arrangements to try and supplement that bench science research funding, I think, is something that we’re going to have to see our clients focusing on in the near future.