Drug discovery can be an uphill battle, especially lately given recent upheaval at the FDA and muted investment activity. BioSpace spoke to four industry executives about key issues facing those working in this space, starting with planning around uncertainty.
It can take 10 to 15 years for a drug to get to market, during which time multiple challenges can impede or derail drug discovery professionals’ work. To explore four of those challenges, which include not only industry uncertainty and funding issues but also the innovation process itself, BioSpace interviewed four biopharma executives.
Planning Around Uncertainty
The uncertainty within biopharma makes long-term planning difficult, noted Brian Culley, CEO of Lineage Cell Therapeutics, a biotech developing novel allogeneic cell therapies for serious medical conditions. Culley told BioSpace that the speed at which capital markets vacillate between promising and concerned, influential people come and go at the FDA and the FDA introduces new policies vastly outpaces any therapeutic’s normal development cycle.
“So, how as a company can you sit here and think about the next three, five, eight years on a program when three, five, eight days later, the geopolitical environment could be totally different, people’s views on interest rates could be totally different, the person who’s in charge of your program at the regulator could be totally different?” he said.
When dealing with such uncertainty, mindset matters, according to Culley. He said what brings him solace is thinking about the mission behind his job.
“No matter what’s going on out there in the world, the work that we are doing is grounded in improving the human condition, i.e., making new medicine,” Culley said.
From a tactical perspective, he recommended that drug discovery executives be aware of what’s happening in the industry.
“People say all the time to CEOs, ‘Oh, just put your head down. Focus on the business. Share price will take care of itself,’” Culley said. “And that’s a lovely saying, but it is incredibly impractical.”
Instead, he advised, CEOs must keep their heads up.
“You’ve got to be seeing what’s going on, because you need to know what the long-term view of interest rates is going to be,” Culley said. “You need to know what’s going on at FDA and their leadership, and whether it’s going to affect your timelines that you’re going to communicate or you’re going to budget for.”
Navigating Funding Scarcity
Drug discovery professionals working to better understand human diseases benefit from genetic studies in large populations, noted Martin Brenner, CEO and chief scientific officer of iBio. However, he told BioSpace, those studies are expensive, and with that expense comes the biggest threat to biotech: funding issues in academia.
“Basically, if funding for academia goes down, we will not be able to have these targets coming at the rate we saw them before,” said Brenner, whose biotech uses artificial intelligence (AI) and advanced computational biology to develop therapies for several diseases.
Cuts at the National Institutes of Health, which backs biomedical research at universities, has been a hot topic in the past year, with some grants axed and later ordered to be restored, although not all are back in place.
Another issue Brenner noted is venture capital favors some companies over others. For example, he said, because there’s a lot of interest in using AI tools and treating obesity and cardiometabolic diseases, that’s where investors are spending their money. Brenner likened it to herd behavior.
“If some funds go in one area, everybody runs to this area, which sometimes leads to quite silly investments, because do you really want to invest in the 103rd GLP-1 that gets to the clinic instead of really kind of diversifying your risk?” he said.
As to how companies can deal with challenges in today’s funding environment, Brenner noted a complication: The industry has become less cash efficient. For example, he said, businesses that raise money may turn around and hire 10 to 15 people without considering whether that makes sense long term.
“Being cash efficient, being nimble, being fast in decision-making, that’s the strength of biotech, and you tend to lose this if you start with $400 million to a billion dollars as a Series A,” Brenner said.
Doing Things for the First Time
Doing something in discovery for the first time, whether it involves a modality or mechanism of action, is difficult, noted Dan Tardiff, chief scientific officer at CAMP4 Therapeutics, a biotech developing RNA-targeting therapeutics for a broad range of genetic diseases.
“There’s not an exact blueprint that you’re following based on what someone else has done,” he told BioSpace. He explained that while other companies might be developing something similar to what a drug discovery professional is working on, there’s still a lot of trailblazing happening.
Because people who are working on something new don’t always know exactly what to do, Tardiff said, they need to inform themselves and tap into all possible resources to ensure they’re making well-informed decisions for their programs and the patients they serve. To make that possible, he recommended building a network of academics, clinicians, regulators, opinion leaders, patient advocacy groups and peer companies.
Academics can be especially helpful to drug discovery professionals because there’s a lot of exciting science happening in the academic space, Tardiff noted.
“These are the scientists that are really focusing on sort of basic underlying biology and really tapping into that,” he said.
Tackling Innovation Silos
While biology is multidimensional, pipelines and development frameworks are siloed by indications, therapeutic areas and mechanisms of actions, according to Vic Clavelli, CEO and president of Oxia Therapeutics. As a result, he told BioSpace by email, most therapies aim to interrupt disease processes, manage decline and stabilize symptoms but rarely restore function.
“The sad result is that we accept patients must live with scarring and loss of function and this drives enormous personal, economic, and societal burden,” said Clavelli, whose biotech is addressing that issue by developing endogenous repair modulators meant to activate the body’s mechanisms for protection, repair and restoration.
While siloing is a challenge, the Oxia executive shared that there’s cause for optimism based on his meetings last week with biotech operators, investors and policymakers in China, Hong Kong and Japan. He said there’s a fierce determination there to contribute to translating biological insights into biotech innovation.
“The biotech opportunity is to weave together the capital, scientific, and commercial resources of the East and West to move from insight to product to solution faster and more efficiently,” Clavelli said. “The visionaries and leaders who do this are poised to surpass the gains in longevity and healthspan delivered by the 20th century.”
