86% of voters want more support for women’s health R&D

There’s a lot to know today—but we’re still under five minutes. Today, we look at what voters say about women’s health research and what the industry is saying about Colorado’s PDAB. Plus, a few more things we learned at BIF 2024 and op-eds from BIO member leaders. (809 words, 4 minutes, 2 seconds)

86% of voters want more support for women’s health research, says BIO-backed poll

More than 8 in 10 voters believe the National Institutes of Health (NIH) should devote additional resources to understanding health conditions that primarily impact women, finds a new poll conducted by Morning Consult for BIO.

Why it matters: “Voters are surprised to learn that just 4% of biopharmaceutical research and development investment goes toward women's health issues,” says Phyllis Arthur, EVP and Head of Healthcare Policy and Programs at BIO.

Additional key findings:

• 54% were unaware that women's health issues receive just 4% of biopharmaceutical R&D investment.
• 66% are more likely to support a Member of Congress who voted for legislation that increased government incentives for women's health R&D.
• 81% support requiring agencies like NIH to create detailed plans for increasing funding for women's health research. 

Read the full results of the poll.

BIF 2024: The ROI of AI

AI can make biotech development dramatically more efficient, and also more profitable, experts agreed at last week’s BIO Investor Forum in San Francisco.

AI pioneer NVIDIA started early, launching a drug development platform called BioNeMo. “Essentially, it’s a large language model for biology and chemistry,” said Renee Yao of Healthcare Life Sciences at NVIDIA.

AI can model biomanufacturing using NVIDIA’s Omniverse platform, a “digital twin” of the actual process. “We can help companies simulate the future vaccine plant or design the next lab in the loop through virtual factory planning,” Yao explained.

AI also assists with clinical trials, helping drug developers find patients and locations, said Michelle Longmire, M.D., Medable CEO.

ICYM BIF 2024: Experts discussed biotech financing, the “pill penalty,” and neurodegenerative therapies. Read our full coverage here.

Colorado price-setting board conflicts with federal law, BIO tells court

Colorado’s efforts to impose price controls on prescription drugs are preempted by federal law and threaten innovation and patient access to drugs, says BIO’s amicus brief.

What it is: The Sept. 13 brief, filed in support of Amgen, questions the legal basis for Colorado’s Prescription Drug Affordability Board (PDAB), a new body created to set the price of prescription drugs in the state.

Why it matters: “Colorado’s approach disregards the careful balance between innovation and access struck by Congress in the Orphan Drug Act, the Hatch-Waxman Act, and a multitude of other federal health laws,” says BIO Deputy General Counsel John Delacourt.

The big picture: A number of states have established, or are considering establishing, PDABs, and some are preparing to start setting prices. This case will show that a patchwork of state PDAB laws would inevitably lead to conflicts and is simply unworkable, argues BIO.

As Amgen’s lawsuit points out, by imposing price caps on drug products that are still within the patent term, Colorado’s PDAB law robs those patents of much of their value.

BIO’s amicus brief agrees with Amgen’s contentions, noting that, in addition to the conflict with federal patent law, the Colorado PDAB law:

• conflicts with federal health laws encouraging innovation in new drugs through exclusivity rights;
• interferes with drug prices outside of Colorado, including with federal program pricing mechanisms that affirmatively rely on market forces.

Read more on Bio.News.

What Else to Read This Week

The Inflation Reduction Act (IRA) undermines the search for safer, effective replacements for opioids,explains BIO. “Effective pain medicines generally must be small molecules, a key attribute that helps the therapies cross the blood-brain barrier to access the nervous system.” However, the IRA’s “pill penalty” discourages small molecule drugs by making them vulnerable to price controls earlier. Read at Bio.News.

“Beware elected leaders who would weaken patents,” warns Daniel M. Skovronsky, CSO of BIO member Eli Lilly, writing in STAT News. “Likely more than in any other industry, patents are essential to incentivize R&D in biopharmaceuticals due to the extremely lengthy, costly, and risky nature of drug development.”

Candidates push soundbites on medical costs, but many of these ideas won’t work, explains BIO Board member Fritz Bittenbender, SVP at Genentech, in STAT News. “Some of the soundbite policy proposals that candidates bring up for short-term political impact could in practice have consequences that lead to less innovative medicines, significant job loss, and diminishment of America’s global leadership in the development of medicines. Perhaps most importantly, in the end they won’t make medicines more affordable for patients.”

“Good intentions without good policy are only good intentions,” cautions Sebastian Guth, COO of Bayer Pharmaceuticals in a STAT News opinion piece. “Meaningful progress must ensure fair market practices, fix the PBM and 340B broken programs, protect innovation and safeguard intellectual property. It’s the only way to turn good intention into good policy that makes the next cure possible.”

“We are anticipating an opinion coming out of the [U.S.-Mexico-Canada Agreement] panel in the very near future,”said USDA’s Chief Agriculture Negotiator, Doug McKalip, of the dispute against Mexico’s biotech corn ban. “We’ve got to ensure that countries don’t backslide on science and that we continue to export into all of those markets.”

Beltway Report: What's Ahead in Washington

Congress remains in recess until after the election.

The BIO Patient & Health Advocacy Summit is taking place this week in Washington, D.C., and BIO is launching the latest episode of the I am BIO Podcast, which explores how one family is working to fight pediatric rare disease and supporting the reauthorization of the Pediatric Priority Review Voucher Program. The episode launches tomorrow, 10/22, at www.bio.org/podcast – and we’ll have more next week.