News of fresh pharma deals at this year’s J.P. Morgan Healthcare Conference in San Francisco triggered optimism among leaders that the industry is on the upswing.
“The mood is definitely more optimistic than it was last year at JPM,” Trevor Martin, CEO and co-founder of Mammoth Biosciences, a CRISPR-focused company, told PharmaVoice.
As funding picks up, biotech innovation is steaming ahead and Big Pharma partnerships are back. Still, Martin pointed out that many of his peers were “reading the tea leaves” with regard to incoming macroeconomic headwinds.
At this year’s conference, PharmaVoice met with a range of leaders — from preclinical biotechs to large pharmas — to find out which policies they’re tracking in 2024 and how it could impact their approach to business and leadership strategies.
Here are some of the key trends they identified.
It's not all ire at the IRA
The industry has pushed hard against the Biden administration’s Inflation Reduction Act, which includes numerous provisions aimed at lowering drug prices. With several lawsuits pending against the regulation and speculation the issue could be decided in the Supreme Court, large pharmas have generally expressed concerns the IRA could hamper R&D.
“We are continuing to watch the dynamics in the health and policy areas like the IRA,” Lynelle Hoch, president of Bristol Myers Squibb’s cell therapy organization, said. “In the healthcare ecosystem, we’re watching the velocity of the science and want to make sure it’s an enriched ecosystem.”
But other leaders are preparing to adjust to the new law and the controversial provisions that could disincentivize small molecule development.
“We have a different molecule for every market and a different IP for each one,” said Mark Litton, CEO of Athira Pharma, which is developing small molecule drugs for neurodegenerative conditions like Parkinson’s and Alzheimer’s that work by repairing HGF/MET signaling. “We are a poster child for the IRA because we’re playing by the rules … and can maximize our returns using the same biology on separate molecules.”
And although Dr. Marcelo Bigal, CEO of Ventus Therapeutics, a company in the autoimmune and neurodisease space, expressed worries over the IRA penalizing small molecules and orphan indications, he said that on a base level, he agrees with the regulation.
“[The industry and government] want the same thing,” he said. “Medications should be affordable.”
Other impactful policies to watch
The IRA isn’t the only new law that could change the game in pharma this year.
Dr. Sean Tucker, chief scientific officer of Vaxart, which is developing oral vaccines for COVID-19, norovirus and more, said that after the pandemic-era boom in government funding for infectious diseases, the company is tracking the Biden administration’s next moves.
“The government could still play a big role in infectious disease because it’s a risky space and the government can invest with less risk. We’re interested in where the Biden administration is going to go in terms of investing in new technologies,” he said.
Jessica Ballinger, CEO of Lyndra Therapeutics, said calls by the director of the National Institute on Drug Abuse to combat opioid use disorder by improving accessibility to methadone could align with the company’s development of a clinical-stage weekly methadone pill, which received fast track designation by the FDA.
And after the Biden administration announced it could use march-in rights to allow third-party manufacturers to make certain drugs, Jon Hu, CEO of Pepper Bio, a transomics drug development company, said he’s watching developments around the proposal closely.
“It’s not the first time we’ve heard of march-in rights, but it’s the first time they’ve become more mainstream, which creates uncertainty about what the guidelines will be and how they’ll be interpreted,” he said. “You can imagine a world in which everyone stays within the confines of [the policy to] bring down costs but you could also see people abusing march-in rights … [and] it could be chaos in the market.”
With the various policies up for debate among lawmakers, Dr. John “Chip” Scarlett, CEO of Geron, which is gearing up for an FDA decision over its lead candidate this year, said pharma leaders could be called to Washington to speak for industry lobbying groups.
“It’s an endless task to educate people on the Hill,” he said. “It’s going to be interesting to see how it plays out in the trenches … [and if] the pharma industry will be asked to advocate for certain points of view.”
Creative pipeline development
Although many signs point to an improved financial environment, companies aren’t ready to loosen their purse strings quite yet.
“One of the things we’re talking about is how we allocate our cash across our portfolio,” Gene Kinney, CEO of Prothena Biosciences, which boasts a pipeline of clinical-stage therapeutics aimed at dysregulated proteins. “We're making good decisions that create value. That sometimes means spending less in one area of the portfolio and more in others while being fluid in that decision making.”
Caroline Loew, CEO of Mural Oncology, which spun out from Alkermes last year, echoed a similar sentiment and shared a story that illustrates how leaders can foster a culture of collaborative, creative problem-solving.
Loew said the last company she worked for aimed to create an environment where all “voices were heard.” And leadership stayed true to that goal, even when one of the company’s most junior scientists came to her and the chief scientific officer and shared an observation that “turned out to be groundbreaking” — but meant that everything the company had been doing was wrong.
“We looked at it, and we validated it and … it was earth shattering. We ended up fully changing the strategy of the company,” she recalled. “But [as a leader] you have to walk the walk.”
2024 will be a year of execution
Both positive milestones and company setbacks motivate leaders to keep their teams solidly on track this year.
“I’ve got a bunch of thoroughbreds on my team and I’ve got to let them run,” Dr. Bobak Azamian, CEO of Tarsus Pharmaceuticals, said. The company recently scored its first-ever approval — the drug was developed for a commonly overlooked eyelid condition that has no other treatments — and is transitioning into commercial mode. “I’ve got leaders I trust highly that are experts in the field and I’m excited to bring myself to them in an even more collaborative way.”
Mike Quirk, chief scientific officer of neurodisease-focused Sage Therapeutics, said that after an FDA win in postpartum depression that accompanied a rejection in major depressive disorder, he’s keeping his team focused on near-term goals and long-term vision.
“You have to be resilient in the brain space,” he said. “It starts by being in an area you’re passionate about … and fostering an environment of innovation.”
Despite the market’s recent ups and downs, Litton of Athira said he’s training his team’s gaze on internal goals.
“I try to focus everyone on what we need to do and be less focused on external factors,” he said. “And as a leader who has gone through missing a clinical endpoint and so many other factors beyond our control, I have our team focus on what’s important and remind folks the biggest driver is helping patients.”