The FDA commissioner also puts out formal reports each year and, in recent years, these reports have highlighted the FDA’s commitment to reducing animal testing. In 2020, the FDA launched its Innovative Science and Technology Approaches for New Drugs, or ISTAND program. This provided a pathway for drug development tools, including non-animal methods, to be evaluated and integrated into FDA decision-making. It launched a pilot and, as far as I know, one approach has been accepted into this program. And so we’re very excited to see more approaches accepted, and eventually qualified, through that program.
It seems that [the FDA’s] vision is advancing scientifically sound methods that can improve outcomes, while also reducing animal use
FDA also has a lot of publications and presentations, indicating that it does want to provide flexibility and wants to see more non-animal methods in submissions. And last year, I think this really all came to a head when the FDA asked Congress for $5 million to establish a new alternative methods program at the FDA, which it received.
And so the culture change, and the programs needed to do things differently are being established, but there’s still a lot of work to do.
Q3. What was the journey to get here? And what was your key involvement in it?
For about the past decade, the Physicians Committee for Responsible Medicine has really been laying the foundation for these changes. We have been lobbying Congress, we’ve been engaging with the FDA, we’ve been doing outreach to the scientific community, through hosting stakeholder workshops, and publishing and presenting to really try to build the momentum and the desire to shift toward more predictive methods.
Q4. From what you’ve seen, how has the Biotech/Biopharma industry responded to this?
I think the industry is increasingly ready for change; we’re finding ourselves working with companies that want to use non-animal approaches, and companies have joined us in talking with Congress about the importance of funding and the importance of policy change. They’ve also joined us in training targeted towards industry and agency scientists.
I also thought it was great to see that very recently, Roche launched its Institute of Human Biology to focus on reliable predictive models that can better emulate human biology. And this is just one example of many.
Q5. With such a long-standing status quo, how do we ease the transition from animal models to NAMs/in vitro models?
I think that’s a great question! There is a lot of momentum and interest, but I think a lot needs to be done and can be done to help to ease that transition.
Largely, I think it’s about building confidence in new approaches, because fear of change is real, and it can be very strong. Funding is crucial to ensure that programs are developed and that the work actually happens. Modern approaches to validation that incorporate human information are going to be critical to understanding the capabilities of new methods. We also need policies that clearly allow for the use of new approaches. And then we need training to be available both to agency and industry scientists, that can help them understand the capabilities of new methods and how they can use them in their work and in their submissions to the agency.
Q6. With the future of drug development and regulations, what are you most excited about?
I’m excited to do better by patients and to do better by animals. I think this issue really is about supporting good science and better decision-making that benefits patients, animals and even business.
There is so much great work happening across the political spectrum and in Congress; it’s at the FDA, it’s from NGOs, it’s from academics, it’s from the industry. And for those reasons, I really feel optimistic that NAMs and the non-animal approaches will soon be an important part of decision-making, testing, and drug development.
Modern approaches to validation that incorporate human information are going to be critical to understanding the capabilities of new methods
Q7. Looking to the future, what work is there still to do?
Great question! I think that the policies at FDA and industry practice still need to change. In 2020, there was a publication by FDA authors that described the agency’s current regulations as flexible to accept either animal or in vitro data. I thought this was great, because it shows the agency’s intended flexibility- but it is the case that some of the regulations and guidance are not consistent with that intention.
Not too long ago, a pharmaceutical company sought to bypass some testing in dogs that it thought was just not scientific, and they saw no value in doing the test. But the agency would not budge on requiring this testing. And so while there is a lot of work that the FDA is doing, change is still needed.
I believe that the FDA, with everything it’s putting into this initiative, will decide that policy updates that clearly allow for non-animal methods are going to be complementary to all the other work that it’s doing.
We’d like to thank Elizabeth for her time and insightful commentary on the evolving world of regulatory policy in drug discovery.
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