From IRA to AI

The 2023 BIO Investor Forum wraps with a look at the impact of the Inflation Reduction Act on investment—and the powerful potential of AI in developing new cures. Plus, we recap a Senate HELP hearing on the nomination of Monica Bertagnolli, M.D., for NIH director. (597 words, 2 minutes, 59 seconds)

Is the Inflation Reduction Act affecting drug development?

Indeed—but companies and investors can strategize their next steps, said experts at the 2023 BIO Investor Forum.

What investors are thinking: “Now, more than ever, I’m seeing investors fold in the regulatory considerations that come from the IRA and thinking very strategically about things like the orphan drug exemption, the plasma exemption—really factoring that into their playbook of diligence when they’re looking at potential investments,” said Meenakshi Datta, partner at Sidley Austin LLP.

Don’t plan on the IRA being taken down—but with several lawsuits filed and the potential for the IRA to go to the Supreme Court, something could happen, said Datta.

Meanwhile, there’s momentum “to make some changes that could be beneficial in the short term,” said BIO’s Chief Policy Officer John Murphy—such as the bipartisan Optimizing Research Progress Hope and New Cures (ORPHAN Cures Act), which would change the IRA’s incentive structure to encourage follow-on investment into orphan drug development.

Good Day BIO Live at BIF: Investors factoring IRA ‘into their playbook of diligence’

Meenakshi Datta, Partner at Sidley Austin LLP, discusses how investors are thinking about the Inflation Reduction Act – read more.

Senate HELP discusses reasonable pricing, march in, AMR, and more at NIH nominee’s hearing

Meanwhile on Capitol Hill, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing yesterday on the nomination of Monica Bertagnolli, M.D., for NIH director—and a few priority issues came up.

On reasonable pricing: Sen. Bernie Sanders (I-VT) asked her to commit to reinstating and expanding the reasonable pricing clause in NIH contracts to ensure the U.S. is not charged more than other countries, specifically highlighting prostate cancer drug Xtandi. Sen. Bill Cassidy, M.D. (R-LA), on the other hand, expressed deep concerns about the impact reinstating reasonable pricing would have on translational research.

The response: She committed to work with both, to follow the law, and to prioritize research that benefits—and is both affordable and available to—the public.

On march in: Sen. Cassidy asked if she supports using march in rights to lower drug prices, while Sen. Roger Marshall, M.D. (R-KS) asked if she will follow and uphold the integrity of the Bayh-Dole Act.  

The response: She will follow and uphold the Bayh-Dole Act (or “the law,” in response to Sen. Cassidy) and said her goal will be to ensure people get the treatments they need.

On antimicrobial resistance: Sen. Maggie Hassan raised AMR as a serious threat to global public health, asking how she envisions NIH engaging in public-private partnerships to combat AMR and leverage clinical trials should be confirmed – watch a clip.

The response: “Full support” for any research, as well as citing social and educational components such as prescribing practices and antibiotic use in agriculture. Also, she wants to make faster, more inclusive, and responsive clinical trials a priority.

On the COVID IP waiver: At the end of the hearing, Sen. Sanders asked whether Bertagnolli would support expanding the use of IP waivers, like those President Biden invoked to increase access to COVID treatments, so that more "NIH-funded technology" could be shared with developing countries.

The response: Dr. Bertagnolli said she shares a concern and passion for bringing care to developing nations, and is committed to “working with” Sen. Sanders on the issue.

Good Day BIO Live at BIF: AI can bring ‘better drugs faster, more scalably, for some of the most challenging diseases’

Mark DePristo, CEO and Co-Founder of BigHat Biosciences, and Ruchita Sinha, General Partner at AV8 Ventures, discuss the potential of AI in drug development –watch and read more at Bio.News.

President Biden’s Thursday: He's scheduled to address the nation at 8:00pm ET about his trip to Israel.

What’s Happening on Capitol Hill: Yes, still trying to choose a new speaker...