Incubate in the News This December

This month, Incubate executive director John Stanford's conversation with Senator Thom Tillis (R-NC) on the Making Medicine Podcast was featured in RealClearHealth, IAM Media, and IP Watchdog. Sen. Tillis called for aggressive measures to counter China's growing economic influence, particularly in life sciences innovation, highlighting the need to pass the Patent Eligibility Restoration Act to address what he described as the current law's chilling effect on innovation:

"The Patent Eligibility Restoration Act is critically important… there are inventions and

creations in the life sciences today that are not even eligible for consideration to be patented,

and that will have -- and already is having -- a dampening effect on innovation." 

Stanford was also recently featured in a BioSpace article by senior reporter Heather McKenzie, which examined growing concern among rare disease leaders about regulatory inconsistency at the Food and Drug Administration. 

Stanford argued that the issue is structural. Rare disease spans a broad set of conditions, and with limited FDA capacity, accelerating some programs inevitably means deprioritizing others:

"It's hard to balance, it's hard to standardize" when rare disease captures such a "broad set of maladies," he told BioSpace.

He also raised a broader ethical question that continues to divide the field: whether some rare conditions should be prioritized over others. Stanford asked whether a rare skin condition should "fall to the back of the line over a rare pediatric cancer."

"I don't think there's consensus," Stanford said. "I think a lot of it comes down to personal beliefs about what helps the most people, and almost a utilitarianism view that I think is very different depending on who you talk to in the ecosystem."

The article also explores how FDA initiatives designed to speed reviews may be creating new disparities. Stanford pointed to the Commissioner's National Priority Voucher (CNPV) program, launched in June, which can compress review timelines from 10-12 months to as little as one or two months for select drugs aligned with "U.S. national priorities."

"We seem to be in a winners and losers moment," Stanford said. "If you're a winner, if you get one of the Commissioner's sort of subjective review vouchers, great -- then you love this idea that you're going to get your stuff out of the FDA within a month."

But the uncertainty cuts both ways. "If we're trying to build a business plan on whether or not we will be in the FDA Commissioner's good graces, that is not something that a venture model is great at betting on."

Stanford cited the FDA's rejection of Replimune's oncolytic immunotherapy RP1 for advanced melanoma as an example of how sudden regulatory decisions can ripple through the ecosystem. "It definitely sent shudders through some of the ecosystem of, 'Wow, things can go sideways pretty quickly beyond just the science.'" Replimune's stock dropped 75% following the complete response letter.

Looking ahead, Stanford emphasized that speed alone cannot be the goal. "I think the folks who designed some of the accelerated approval pathways would like to hope that medicines that can do the most good for the most dire cases get through faster, all things being equal," he said. "That falls apart really fast when you actually get into CDER and CBER…where there are finite resources at the agency to undertake reviews, and expediting a promising asset likely means deprioritizing others."

Above all, Stanford stressed the importance of maintaining trust in the FDA. "What we also don't want to do is move medicines that don't work along too quickly and weaken confidence in the whole system," he said. "I do think we're going through a moment…where people are questioning the FDA more than they normally do, and that's got to be something we're really mindful of."