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Illustration: Eniola Odetunde/Axios

Pharma startups are in the media spotlight, after decades of playing second-fiddle to consumer and enterprise tech, but are facing their own pandemic-related challenges.

What's happening: Many clinical trials have been put on indefinite hold, particularly if they involved hospital sites. The upshot is that such startups are effectively in a holding pattern, with investors scrambling to decide whether or not to foot the elongated bill.

The key date was March 23, which is when Eli Lilly announced it would "delay most new study starts and pause enrollment in most ongoing studies."

  • Pharma VCs tell me that many of their companies followed suit.
  • There were exceptions, particularly for studies that already relied on remote monitoring or telehealth, but an investor in a clinical testing facilities operator estimates that around 70% of studies starting in late March got delayed.
  • It is unclear what will happen to studies that were paused in-progress. There is hope that the FDA will provide added flexibility, given the circumstances, but that's likely to be determined on a case-by-case basis (here is FDA's current guidance). For some companies, months (or even years) of work may be scrapped.

Pfizer's decision last week to restart some trials could have its own tailwinds, but expect to see some costly changes for future pharma startup investing.

  • Longer runway: Venture fundings for pharma companies often are intended to get a company through a Phase 1 or Phase 2 clinical trial. Now, investors must build in the possibility that trials will be stopped, restarted, and then stopped again for exogenous reasons. Particularly if there is a COVID-19 resurgence in the fall.
  • Site spread: There will be greater emphasis on geographic diversity for clinical trial sites. For example, don't focus most enrollment in New York and Boston — or any small set of potential viral hot spots. Plus an increase in remote monitoring, such as sending phlebotomists to patient homes.
  • Bigger pool: COVID-19 may play havoc with trials for non-coronavirus conditions, in terms of added complications and morbidity. This could require pharma companies to increase the number of enrolled patients.

The bottom line: Lots of pharma is being forced to sit on its hands, while it waits for other pharma to move us into the next normal.

Go deeper

Aug 11, 2020 - Podcasts

Russia’s vaccine gamble

Russia announced Tuesday that it approved a vaccine for COVID-19 and has plans to inoculate health care workers, teachers and others in the coming months, despite barely starting Phase 3 clinical trials.

Axios Re:Cap digs into the ramifications of this announcement for the global vaccine race with Derek Lowe, medicinal chemist, author and expert on drug development and the pharmaceutical industry.

4 hours ago - Health

FDA advisory panel recommends Pfizer boosters for those 65 and older

A healthcare worker prepares a dose of the Pfizer-BioNTech Covid-19 vaccine at the Key Biscayne Community Center on Aug. 24, 2021. Photo: Eva Marie Uzcategui/Bloomberg via Getty Images

A key Food and Drug Administration advisory panel on Friday overwhelmingly voted against recommending Pfizer vaccine booster shots for younger Americans, but unanimously recommended approving the third shots for individuals 65 and older, as well as those at high-risk of severe COVID-19.

Why it matters: While the votes are non-binding, and the FDA must still make a final decision, Friday's move pours cold water on the Biden administration's plan to begin administering boosters to most individuals who received the Pfizer vaccine later this month.

5 hours ago - World

France recalls ambassadors from U.S. and Australia over submarine deal

Secretary of State Antony Blinken (L), French Foreign Minister Jean-Yves Le Drian (C), and French ambassador to the U.S. Philippe Etienne. Photo: Nicholas Kamm/AFP via Getty Images

France has taken the extraordinary step of recalling its ambassadors to the U.S. and Australia after both countries blindsided their French allies with a new military pact and submarine contract, the French Foreign Ministry announced on Friday.

The backstory: While sealing an agreement with the U.S. and U.K. to acquire nuclear submarines, Australia ripped up an existing $90 billion submarine deal with France. That led senior French officials to accuse the U.S. of a "stab in the back."

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