Ten months into 2025, and it’s clear the year hasn’t unfolded as many had expected—or hoped.
Marked by a persistent bear market and compounded by geopolitical tensions and regulatory uncertainty, the long-anticipated return to normalcy remains elusive.
Still, it’s not all doom and gloom—there are reasons for optimism.
Industry stakeholders convened in Boston for Fierce Biotech Week to exchange strategies and insights. In an Oct. 9 panel on innovation, resilience and the road ahead, speakers examined how federal uncertainty is shaping the biotech sector—particularly from an investor perspective—while also pointing to potential silver linings in the current landscape.
“I do see an openness to work and think about things,” Craig Granowitz, M.D., Ph.D., SVP and chief medical officer of Lexicon Pharmaceuticals, said about the FDA.
“I've not just heard this from my perspective but from patient organizations and other groups engaging with the FDA, that there is a different willingness to reconsider things that were previously untouchable,” he explained. “I don't know where that will all end up, but I have to say they've been responsive [and] competent.”
The inherent creative nature of biotech also gives PanTher Therapeutics co-founder and CEO Laura Indolfi, Ph.D., energy.
“There is a way to move forward,” Indolfi said. “It is not a straight line, but [it] has never been a straight line.”
She underscored how the industry has always faced challenges, whether it’s obtaining funding or lows following the COVID-19 pandemic.
“It’s the business we are in, and we should enjoy that,” the CEO said. “The next five years are going to be an incredible revolution for patients and for the industry.”
Cullinan Therapeutics Chief Scientific Officer Jennifer Michaelson, Ph.D., built on Indolfi’s framework for understanding the industry's shifting dynamics.
“I like to see this as part of a wave,” she explained. “We’re sort of in a dip part of the wave right now.”
“But if you look at the biotech markets of the last couple of decades, there’s been around three very large dips,” Michaelson continued. “After that dip, the wave is always kind of even greater heights than going into the dip.”
While she noted the importance of carefully maintaining a cash runway to weather the industry’s lows, she highlighted the overall importance of the work biotech is doing—innovating science to create new technologies and opportunities for patients.
That speed of innovation is picking up, according to ProFound Therapeutics CEO John Lepore, M.D.
“The scientific opportunity is just incredible,” Lepore said, pointing to his biotech’s work on “a whole new set of proteins that define how disease occurs and how biological processes happen.”
“There [are] these waves and waves of new things we never knew—that pace is getting faster, and the ability to pick projects from that and make medicines is just exciting,” he said.
Offstage, attendees discussed another reason for optimism: Big Pharma’s patent cliff. As expirations loom, many pharma companies are reorganizing and turning to biotech for potential drug candidates to offset the anticipated financial losses.
“The positive side is pharma still has gigantic patent cliffs that they're looking to address,” Omar Khalil, managing director at early-stage investor Santé Ventures, told Fierce Biotech in August. “Pharma still needs to fill their pipeline. The assets are still attractive. They're still important.”