In the final episode of the second series of “Small Biotechs, Big Decisions,” Citeline’s VP of Clinical Solutions Claire Riches and a panel of biotech experts reviewed the industry environment. Here are some highlights from their discussion.
Times have been challenging for the biotech sector, especially in terms of funding. But experts say there are signs the mood is turning. Biotech deals are beginning to regain steam, and funding appears to be on the upswing.
In our recap of the most recent episode of Citeline’s “Small Biotechs, Big Decisions” podcast, Citeline VP of Clinical Solutions Claire Riches and a panel of expert biotech executives discuss the biotech environment and what they think is in store for the sector in the coming year.
Key topics covered in this blog include:
- Upturn in funding and deals
- Improved efficiency
- Smart adoption of AI
- China’s continued rise
Funding mood is cautiously turning
Ross Pettit, Chief Development Officer at Kestrel Therapeutics, called 2025 “frustrating.” Despite the quality of Kestrel’s asset, he said, “getting access to capital was a challenge. And probably we all felt it was more of a challenge than it needed to be or should have been. So, it was a little frustrating, but you get there in the end.”
However, Pettit indicated his belief that biotech is coming out of its funding funk. “I think JPM [the J.P. Morgan Healthcare Conference] kicked it off this year, and people coming out of the JPM conference suggested that things were a little bit more positive and optimistic,” he said. “And I think if you look at the press over the first month of the year, there have been a few IPOs that have gone out. There have been a number of deals executed. So, it would seem that the purse strings are opening up a little bit.”
Pettit’s fellow panelists agreed. “That’s what I’ve heard as well,” said Carrie Melvin, Head of Global Clinical Development Operations at Lantheus. “Time will tell as we march along this year, but I’ve heard that there’s more excitement, there’s more funding being put back into the life sciences. So, I’m hopeful.”
“Again, time will tell, but I think January overall was good,” said Jennifer Burg, Senior VP of Development Operations for Atlas Venture. “And it feels a little bit better.”
“It feels a little bit like we’re getting a little more stability back,” said Marissa Volpe, Senior VP of Clinical Development Operations at NervGen Pharma.
Critical thinking over box-ticking
When Riches asked each panelist to name one word to describe how 2026 will impact their industry role, Pettit chose “competition,” while Volpe singled out “milestones.”
“If I have to think of one word, I think it would be ‘efficiency,’” Melvin said.
“I'm going to hyphenate mine. ‘Cautious-optimism,’” Burg said, to the approval of the other panelists.
When asked to elaborate, Melvin said she is looking for efficiency both externally and within her team and their thinking. “How can we be efficient with our spend, with our resources, with our requests?”
Pettit said he would like to see “speedy decisions” across the board. “I think some of us are fearful that regulators are slowing down rather than speeding up. And it might be a resource issue and things along those lines. But I think for us to be efficient, we’ve all got to make speedy decisions.”
Volpe emphasized the importance of critical thinking. “That’s what I was educating my partners and my team, my department last year. You’re not just checking a box. … You have to think about it, to build in that efficiency.”
Burg referenced ICH E6(R3), the latest revision of the International Council for Harmonisation’s Good Clinical Practice (GCP) guideline for conducting clinical trials. ICH E6(R3) takes a modern, flexible, risk-based approach to trial design.
“I think it’s interesting because I think … ICH E6(R3), it’s all about risk-based approach, finally,” Burg said. “Now everyone has a framework to fall back on. But I think, to that efficiency and speed, it’s got to be a risk-based approach.”
Overall, the panelists welcomed the implementation of ICH E6(R3). “We don’t want people to see it as a set of rules, though,” Pettit said. “It’s a philosophy, and to be honest, it’s common sense, and it’s what we’ve been waiting for, for 10 years.”
Embrace AI, but with a human touch
Critical thinking also was mentioned as an important element in the artificial intelligence (AI) loop. When asked about AI, NervGen’s Volpe said she was open to it, “but it doesn’t take away the human piece of thinking. That critical thinking. Because it doesn’t always get it right, and you’re like, ‘Oh, I didn’t write that. That’s not what I meant to say.’”
Burg said she loves AI. “But I think let’s start with having it do the easy stuff that it’s going to get right. And then allow us, giving us more time, to do the critical thinking pieces.”
Lantheus’s Melvin said AI is great for things like standard operating procedures (SOPs). “But I think Marissa raised a good point. It doesn’t mean that you just have them write it and you don’t review them, and then you just submit them. … You have to feed it what you’re looking for. So, it has to learn. And then once you get there, then it can be extremely efficient. Protocols as well. We’re starting to utilize it.”
“I think it’s going to facilitate decisions with less,” Kestrel’s Pettit said, “so you can make quicker decisions with less data. … I’m a great fan to see where it can enable things.”
Mandated diversity may be wrong approach
Pettit expressed strong views on the topic of diverse clinical trials. “I don’t like the fact that diversity is being thrust upon us,” he said. “Patients are patients. I want to be able to give access to all patients, all socioeconomic classes. But the fact that I’m being held to a number or that I’ve got to have a plan for it, I think, is too much.”
“My last company that I worked at, we were doing a breast cancer study,” Melvin said. “And we went back to the agency, not once, not twice, three times because they kept trying to force higher numbers in. And we were like, ‘The only thing else we can do is try to go to very diverse locations that don’t have the facilities, and we’re going to have to train them ….’ I mean, it was going to be an extremely costly thing for us to do. And again, I want every patient that could possibly receive benefit, but the numbers being forced, I think, is not the right approach.”
“I think as sponsors, the one thing that we can do is do our best to ensure access to the trial for a diverse group of people,” Burg said. “As an industry, if we all came together to do more education around clinical trials, I think that would be tremendously helpful.”
“The one thing that has not changed in our industry is the percentage of participants that joins clinical trials because us as an industry, we have done nothing to educate the world on what it means to be a participant, why we do it, why we need them,” Melvin said.
China as partner, not threat
Pettit said he sees China as an opportunity that has been positioned as a threat. “China’s setting the bar for fast, effective, low-cost clinical trials, and they’re doing it very, very well,” he said. “And everybody will counteract with, ‘Well, the data’s a bit dodgy.’ It’s not. It’s not dodgy at all. I've worked in Chinese sites. The physicians and nursing staff and coordinators are just as qualified and just as invested in running a good clinical trial. They just do it quicker and cheaper.”
Melvin agrees there is “a huge opportunity” to be found in China. “I think the costs are significantly less. I do think over time you’ll see that creep up,” she said. “But for now, I think it is a really untapped opportunity for a lot of companies. And I’m not saying it’s simple, but I think it’s a huge opportunity.”
The panel agreed that assets are beginning to move from China to the US for further development.
