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Drug Industry Coordinates Covid-19 Response With NIH (1)

April 17, 2020, 2:45 PM; Updated: April 17, 2020, 8:42 PM

More than a dozen drug companies including Pfizer Inc., Johnson & Johnson, and Sanofi are coordinating their Covid-19 efforts with the NIH to push out new treatments and vaccines.

The public-private partnership plans to develop an international framework for prioritizing vaccine and drug candidates, streamlining clinical trials, coordinating regulatory processes across different countries, and using assets available among all collaborators to respond rapidly to both the current and future pandemics. The National Institutes of Health announced the Accelerating COVID-19 Therapeutic Interventions and Vaccines partnership Friday.

More than 300 clinical trials on Covid-19 are underway, and that number increases almost daily, a spokesperson for the Pharmaceutical Research and Manufacturers of America told Bloomberg Law earlier this week. But more than 90% of drug candidates fail in the clinical trial stage, and there are concerns about manufacturers’ ability to scale up production to treat a worldwide pandemic once a vaccine or therapeutic becomes available.

NIH Director Francis S. Collins said the partnership aims to break down traditional boundaries in the biomedical research ecosystem to identify and prioritize the most promising therapies for clinical trials.

“Because we all know this particular virus is going to be with us for some time, the best hope we have as we think to limit the number of ill people and deaths from this disease is to develop and test rigorously therapeutic interventions that may save lives,” Collins said Friday at a press briefing.

Clinical Trials

There are already about 100 ideas that have been put forward for clinical therapeutics, Collins said. He said that by June or July he expects to have some data showing which of the promising compounds to treat Covid-19 are working and should be prioritized in drug development.

There are also more than 40 vaccine candidates that are now in clinical trials, Collins said.

Esther Krofah, executive director at FasterCures, said Friday at a separate policy event hosted by the Commonwealth Fund that there are about 86 active vaccine projects and that she expects two dozen more to enter clinical trials by the end of the summer or early fall. Faster Cures, which is part of the think tank the Milken Institute, is tracking the development of potential Covid-19 medicines and vaccines.

The Food and Drug Administration has been “very open to creative ideas,” about rapidly moving forward with a vaccine once it’s proven safe and effective, Collins said.

Flexibility in how scientists set up their clinical trials and using real-world evidence can help speed up the process, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said at the Commonwealth Fund event.

“We can’t dismiss out of hand any potential useful design here—real-world evidence base, traditional base, or otherwise,” Marks said.

Marks didn’t rule out the possibility of issuing an emergency authorization for a vaccine, but he said it would depend on the evidence and if the virus is still circulating at that point.

Collaboration Needed

The NIH is leading the partnership with the nonprofit Foundation for the NIH, the Health and Human Services Office of the Assistant Secretary for Preparedness and Response, the Centers for Disease Control and Prevention, the FDA, and the European Medicines Agency.

The chief scientific officers of Pfizer and Johnson & Johnson both said in statements that ending the pandemic is beyond the ability of any single entity.

“COVID-19 is the most significant global health challenge of our lifetime, and it will take all of us working together as a global community to put an end to this pandemic,” Paul Stoffels, chief scientific officer at Johnson & Johnson, said.

Other companies involved in the effort are AbbVie Inc., Amgen Inc., AstraZeneca plc, Bristol Myers Squibb, Evotec, GlaxoSmithKline plc, KSQ Therapeutics Inc., Eli Lilly and Co., Merck & Co. Inc., Roche Holding AG, Takeda Pharmaceutical Co. Ltd., and Vir Biotechnology.

Gilead, whose antiviral product remdesivir has been described as the most advanced stage of development, wasn’t among the companies listed in the NIH announcement.

Future Implications

The work of the partnership could boost the ability of drug companies and the NIH to respond to future pandemics, Collins said.

ACTIV’s work could serve as a roadmap for public-private partnerships to identify and prioritize experimental compounds and to develop more creative approaches to creating new tools and standards for evaluating medical products.

“I don’t think anybody involved in this standing back and looking at it would say this is really just a one-shot deal, even though we’re focused on it right now for the urgency of the moment,” Collins said.

—With assistance from Jacquie Lee

(Updated with additional reporting throughout.)

To contact the reporter on this story: Jeannie Baumann in Washington at jbaumann@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloomberglaw.com; Andrew Childers at achilders@bloomberglaw.com

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