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Hello! Hope you had a restful and reflective long weekend. Today, we talk a lot about regulatory policy — for flu vaccines and for physicians. We also speak with the new NIH director about how she’s finding a balance between government and industry priorities, and explore the feared brain drain from the new, $500 million research initiative that just launched in Kendall Square.
The new NIH director’s balancing act
Monica Bertagnolli, the new director of the NIH, is torn between President Biden’s drug pricing agenda and the priorities of the broader biopharmaceutical industry. Biden’s stance is simple: “You shouldn’t pay the highest price in the world for drugs that your tax dollars have already helped create,” he said last month.
However, Bertagnolli told STAT that broadly implementing change is “very difficult,” since the NIH’s relationship with industry is “really, really critical.” Beyond industry, Congress is now assembling a 2024 budget that may imperil several NIH programs — changing the makeup of the agency Bertagnolli has only just taken over. For instance, a $1.2 billion effort aimed at developing treatments for long Covid has been largely fruitless thus far, and may be axed. But Bertagnolli understands this (“What did we get for our billion dollars?” she says) and wants to focus in on prioritizing the root causes of disease, starting with inflammation, metabolic syndrome, and immune dysfunction.
A $500M innovation engine raises fears of brain drain
A cadre of billionaires and top-tier scientists is launching a new biomedical institute in Kendall Square. Arena BioWorks, backed with $500 million in private funding, aims to speed up the medical innovation engine. Investors include Michael Dell, former Bain Capital co-chair Steve Pagliuca, and the initiative is being led by Harvard scientist Stuart Schreiber, who was a founder at the Broad Institute of MIT and Harvard.
Arena Bioworks is luring scientists away from academic labs with tantalizing compensation. Though Arena hasn’t publicly named many of these scientists, there is concern that this will trigger a brain drain at universities — creating a dearth of mentors for younger scientists.
“Somebody has to educate the next generation, and that’s happening at universities,” said Ruth Lehmann, head of the MIT-affiliated Whitehead Institute for Biomedical Research, a nonprofit. Arena, which is profit-driven, “was creating haves and have-nots, and it’s a shame that universities have to say now that we’re the have-nots.”
WHO and regulators want to change the flu vaccine
The WHO and some drug regulators want flu vaccine makers to quickly remove a component from the shots called B/Yamagata. They say that this targets a lineage of flu B viruses that went extinct during the Covid-19 pandemic: “There’s no [B/Yamagata] virus circulating, so why include the antigen?” one influenza expert told STAT. It’s actually a matter of safety — many flu vaccines contain live but weakened forms of the virus. There’s the potential that the attenuated B/Yamagata virus could reseed the strain in the world.
But that’s easier said than done, and some say it’ll take until the 2025-2026 vaccine cycle to accomplish the reconfiguration. In some countries, the regulatory pathway to make such changes is complex and time-consuming. About 170 regulatory agencies will have to sign off on a cumulative 1,500 vaccine variations that need to be made to existing licenses.
Docs in dark about FDA approval processes
Many physicians have little understanding of how drugs and devices are regulated in the U.S. In a recent survey published in Health Affairs, only 17% of physicians felt they understood the FDA’s device approval process, and 41% understood the drug approval process. Researchers at UCSF are trying to close this gap.
“We really want to make sure docs understand FDA regulation because they’re the ones with the pen to write prescriptions to recommend devices, and they need to be able to adequately advise patients about the benefits and harms of these therapies,” one of the study’s authors told STAT.
This could be as simple as dedicating a few hours of medical school to teaching the outlines of the U.S. regulatory pathway. Then, as physicians progress to residency and fellowships, they could be taught the intricacies of regulating the devices they would use in their practice.
More reads
- New congressional bill would thwart patent thickets in order to speed generic drugs to market, STAT
- Neurosurgeon works to slow Alzheimer’s progression, treat addiction with cutting-edge technology, CBS News
- Record budget for Gates Foundation as wider global health funding stalls, Reuters
- CAR-T hype faces infrastructure reality check, FiercePharma