A constantly evolving landscape for clinical trials and drug development research has created challenges for the sector to not only keep up with changes but also to plan ahead for potential developments.
Recent changes in guidelines for trials issued by the US Food and Drug Administration (FDA) have necessitated contract research organisations (CROs), pharma sponsors, biotechs and clinical investigators to adapt quickly to ensure a successful program.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Rich Pelt, senior director of Global Regulatory Sciences at Pfizer, shared insights at the Outsourcing Clinical Trials (OCT) Southeast conference, on lessons learned from navigating the regulatory uncertainty of the last few years in pharma and clinical trials space.
In a conversation with Clinical Trials Arena, Pelt discusses the current landscape for clinical research, recent controversies surrounding vaccines, and how to plan effectively for new possibilities.
The OCT Southeast conference is taking place 10–11 March in Raleigh, North Carolina.
Manasi Vaidya (MV): How can sponsors and other stakeholders in the clinical trials space weather ongoing changes at the FDA, the Department of Health and Human Services (HHS) and other agencies? What have you found helpful?
Rich Pelt (RP): To some extent, the best way to be helpful is to be resilient, because there is no a clear magic pill for any of this stuff right now. Be nimble, be ready and just hang in there.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataI’ve been on the regulatory side for about 30 years now, and this is probably one of the most confusing times for our collective industry. This is not just for CROs, but the whole pharmaceutical, biopharmaceutical, vaccine business, be it either from a sponsor perspective, or any other contract organisations.
One thing I’ve seen over the last year is the need to keep up to date, and keep an eye on the news wires because it changes constantly. When I finished my presentation for this conference [OCT Southeast] a week ago, I said, there is a chance I may have to update it. Sure enough, a few days ago we saw that the FDA Center for Biologics Regulation and Evaluation (CBER) director is resigning again.
However, apart from the funding aspect, I have not seen any major blockades to getting trials started, at least on a regulatory basis. As long as you can pay for them, you can still get trials going. As we get into the later phases, there can be a little more scrutiny.
MV: Could you walk me through some of the regulatory upheaval observed in the vaccine space?
RP: The mRNA [technology] has definitely hit some headwinds. There’s no doubt about it. It’s clearly going to be a difficult space. We’re continuing to keep going, but at the same time, I think when any company sees strong headwinds in one area, they may diversify their investments in other areas. I think we’re seeing a little bit of that. The vaccines are not going to go away, but the money is going to flow more in other areas.
MV: With vaccines, we are seeing other physician bodies in the US like the American Academy of Pediatrics issue their recommendations on immunisation schedules. When it comes to clinical research, what is the impact of different bodies giving different recommendations?
RP: I think this is one of the questions that companies that are funding programs to design these trials and would need to determine; at the end of the day, what’s the potential return on the investment, and how does the uncertainty in those recommendations affect it? They’re going to have to assess the risk that the immunisation schedule may not be what they had in the past especially in childhood vaccines
I was at the World Vaccine Congress last year, and I was in several presentations that were talking about needing more combination vaccines.
Fast forward 6–9 months, it looks like combination vaccines are going to be really hard because [the conversation is] the other way around. So, it’s a confusing time. At the end of the day, the companies need to figure out what they want to do. And then check the ‘what if’ scenario – and what is the probability of each scenario.
MV: Mapping out these different scenarios may mean a lot of extra work, right?
RP: Yes, I would think that. It would involve a lot of scenario planning around, which throws a wrinkle in a company’s commercial program because it is hard enough for them to figure out what they’re going to do anyway, and with an extra layer uncertainty [that can be difficult]. Some of these things could also just be mitigated by, in some way, hanging back a little bit and not rushing the program forward as fast.
MV: Moving on to another area of uncertainty; tariffs. What lessons were learned after the sector navigated the upheaval around tariffs last year?
RP: The recent Supreme Court decision has definitely changed the whole tariff landscape, and it also means it’s not done yet. From the perspective of pharma – especially big pharma it has reached deals that exempt them from certain tariffs. It does still change the thought process and the landscape of these companies; where do you invest for your R&D and manufacturing facilities? But it seems like the whole tariff stir and the risk around it to pharma, at least big pharma kind of died away, even before that Supreme Court decision.
MV: Do you have any recommendations on how to stay nimble in this evolving regulatory environment?
RP: CROs or companies as a whole have to keep some level of diversity in where they’re putting their time and resources. Also, we all better get on the artificial intelligence (AI) train, or we’ll be left behind.
Another key point is to keep tabs on the news, on where things are moving. Be prepared for anything. On a personal basis, get up to speed on some of these tools and tricks [e.g AI].
It’s no longer good enough to just be really good at using one tool. You might want to learn how to use a full toolbox. I think the world’s going to change a lot, and a lot of people’s jobs are going to transition very quickly.
Click here to view a detailed agenda of the OCT Southeast conference taking place 10-11 March in Raleigh, North Carolina.
Interested in attending or sponsoring Outsourcing in Clinical Trials (OCT) Southeast event? Complete the form below and our team will be in touch.
