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Politics, Policy & Law

Whither Woodcock; plus refresh for German biotech & modalities to market: a BioCentury podcast

Mar 2, 2021 | 3:00 AM GMT

Opposition by a handful of Democratic senators could scuttle Janet Woodcock’s chances to be nominated as permanent FDA commissioner, even as she has broad support among patient groups, clinicians and biopharma companies. On the latest BioCentury This Week podcast, BioCentury editors discuss whether Woodcock can clear the hurdles in her path to the post, as well as an FDA advisory committee’s recommendation to back EUA of J&J’s COVID-19 vaccine, the brightening environment for Germany’s biotech ecosystem and the march of new modalities to market. 

Washington Editor Steve Usdin and Editor in Chief Simone Fishburn discuss the latest considerations for the Biden administration as it moves to select a permanent FDA commissioner. Acting Commissioner Janet Woodcock’s chances to gain the nomination for the post are slipping, but, importantly not gone, says Usdin, with a trio of Senate Democrats opposing her nomination because of how FDA handled the opioid crisis during her tenure as director of CDER. In addition to the lawmakers and more than 25 public interest groups that oppose Woodcock because of the agency’s handling opioids, the acting commissioner has also attracted the enmity of other groups influential in the Biden White House and on Capitol Hill, including liberal groups that believe she has not been sufficiently adversarial to drug developers, and that she impeded approval of emergency contraceptives.

While Woodcock has the support of many patient advocates, cancer researchers and clinicians, and biopharmaceutical companies, the Democratic opposition presents the Biden administration with a difficult choice because it needs the support of all Democrats to get its broader policy agenda through Congress.

Usdin also recaps Friday’s advisory panel meeting for the COVID-19 vaccine from Johnson & Johnson (NYSE:JNJ). He notes that many important issues were not discussed by the Vaccines and Related Biologic Products Advisory Committee (VRBPAC) — for example, efficacy compared with mRNA vaccines and which populations were best suited for the vaccine — because of a sense of urgency among FDA and the panelists to push another vaccine out swiftly to the public as deaths from the virus continue to mount. FDA granted emergency use authorization to Janssen COVID-19 Vaccine (Ad26.COV2.S) on Saturday.

Associate Editor Stephen Hansen says that COVID-19 has raised the profile of German biotechs as homegrown BioNTech SE (NASDAQ:BNTX) has risen to global prominence through its Cominarty vaccine partnered with Pfizer Inc. (NYSE:PFE), and, with that, optimism that the translational and financing environment for German biotechs is improving. 

“The country has a very strong tradition of high-quality science,” Fishburn notes, but converting that to sustainable companies has been a long-standing issue.

Structural issues still need to be addressed, Hansen says, primarily around the allocation of new capital to venture to support Germany’s start-ups.

Last week’s FDA approval of Duchenne muscular dystrophy therapy Amondys 45 from Sarepta Therapeutics Inc. (NASDAQ:SRPT) marked the sixth antisense drug to reach the milestone and the eighth new modality drug to be approved in the past year, which Fishburn calls a sign that the pace of new therapeutic formats making it to market is picking up.

“It takes a very long time for the first one,” Fishburn says. “Then the question is: How much does approval of the first one become a gateway, or usher in easier times for the next molecules?”

BioCentury will publish Fishburn’s analysis of new modalities making it to market this week.

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