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Politics, Policy & Law

Warp Speed reflections, master protocols & Biden’s COVID plan: a BioCentury podcast

Jan 26, 2021 | 2:33 AM GMT

On the latest edition of the BioCentury this Week podcast, BioCentury editors discuss the successes and limitations of Operation Warp Speed, proposals for streamlining master protocol trials and highlights for industry from the Biden administration’s COVID-19 plan.

Washington Editor Steve Usdin recaps his exit interview with Moncef Slaoui, who touted Warp Speed’s success in facilitating vaccine development, and acknowledged flaws in the initiative’s approach to vaccine administration and therapeutics development. Slaoui, who served as Warp Speed’s chief scientific adviser and co-leader, has stayed on as a consultant to the Biden administration. 

Usdin also highlighted Slaoui’s comments on therapeutics development, namely, that the IV mAbs drug developers first products created too many logistical hurdles for widespread use, and that a mass of poorly designed trials diverted resources from more efficient master protocol studies, which were ultimately slow to implement. 

“For future pandemics, and I would argue that this one isn’t over, it’s not too late for this one, a priority should be set for ensuring the monoclonal antibodies can be administered through sub-Q or IM injections,” says Usdin. 

Senior Editor Lauren Martz homed in on the barriers to implementing COVID master protocols in the U.S. and outlined proposed solutions that could make them easier to run. 

Major academic medical centers, where most clinical trials are run, are spreading patients and staff between too many different trials, many of which are underpowered. In the short-term, Martz says companies are beginning to standardize contracts, endpoints and training protocols, making it easier to set up new trial sites. 

Editor in Chief Simone Fishburn says the bottleneck at academic centers emphasizes “the need to bring more community health practices into the clinical trial enterprise.” 

In the long-term, Martz says institutions would need to implement systems that help triage poorly designed trials in order to boost enrollment in higher quality studies, including master protocols. 

“These trials aren’t being prioritized at the institutions where they’re being run,” says Martz. “There needs to be a way to encourage physicians and patients to participate in trials. That means making the endpoints simple and just making these as small of a burden as possible.” 

Lastly, Fishburn and Usdin touched on the latest moves from the Biden administration as it relates to COVID-19 and health agencies in general. 

Fishburn highlighted four components of the new COVID-19 plan important for drug developers: testing, with the establishment of a National Pandemic Testing Board, plans to develop therapeutics and specifically antivirals, the role of data collection in guiding the pandemic response and the establishment of a health equity task force. 

Sponsorship opportunities: Sponsorship and Underwriting packages are available for webinars, podcasts and surveys. For more information, please contact Eric Pierce and Josh Berlin at conferences@biocentury.com.

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