What the FDA Commissioner said about trials and collaboration

June 11, 2020
It’s the last day of the BIO Digital education sessions, but the fun continues all day long at www.bio.org. Right now, we’re recapping what FDA Commissioner Dr. Stephen M. Hahn said during yesterday’s fireside chat and unpacking the latest news on when you might fly a…

It’s the last day of the BIO Digital education sessions, but the fun continues all day long at www.bio.org. Right now, we’re recapping what FDA Commissioner Dr. Stephen M. Hahn said during yesterday’s fireside chat and unpacking the latest news on when you might fly a biofuel-powered plane, in around 740 words, or 3 minutes, 40 seconds.

We’ve expanded our list this week to include the BIO Digital and convention community, and we’ll be sending a morning and special evening edition each day through today. Like what you see? Opt in here to keep receiving this email after the event.

How to follow BIO Digital:

What we’re watching today: Today’s headliner is an important panel on diversity and race featuring Dr. Michelle McMurry-Heath, Drs. Tony Coles, Ted Love, and Jeremy Levin (3 PM ET/12 PM PT). Genentech will lead discussions about how to make trials more patient-centric (1 PM ET/10 AM PT) and how to drive access to personalized medicine (7:30 PM ET/4:30 PM PT). Dr. Jeff Settleman, Pfizer’s Chief Scientific Officer for Oncology R&D, will also chat about where the industry’s headed (6:30 PM ET/3:30 PM PT).

Stay tuned to the BIO Digital Live Blog for our round-the-clock coverage of news and highlights, and if you’re registered, head to the BIO Digital Hubb to watch them live.

What the FDA Commissioner said about trials and collaboration

Yesterday, U.S. Food & Drug Administration (FDA) Commissioner Dr. Stephen M. Hahn joined BIO Digital for a fireside chat to discuss collaboration and COVID-19 response efforts.

FDA is seeking to review COVID-19 products “as fast as we can,” said Dr. Hahn. They are prioritizing science-based solutions with a “rolling” approach, focusing on those with the greatest chance of approval, and there's a lot of engagement with developers and manufacturers. (Reuters has more on what to expect.) 

Public-private partnership has been important. “What’s been remarkable about this is the speed with which this pandemic came upon us and the significant number of unknowns, but how remarkable the response has been from the biopharma community in collaboration with regulators and the FDA,” he said. 

Collaboration between companies is important, too. “There has been incredible alignment, collaboration, and cooperation among...the private sector. This is usually a very competitive environment but what I’ve seen is a really significant lean-in of industry to work together in sharing information,” he continued.

Post-COVID clinical development will be “very different.” Dr. Hahn said we should consider domestic manufacturing of medical products, and flexibility around existing clinical trials. (Bloomberg Law has more on what he said about the outlook for trials.) 

Did you miss it? Catch up on the BIO Digital Live Blog or watch the session recording (if you’re registered) here

The conversation with FDA continues today, with a town hall featuring Dr. Peter Marks, Director of FDA’s Center for Biologics Evaluation and Research (CBER), and Dr. Peter Stein, Director of CDER’s Office of New Drugs (OND). 


More Health Care News: 

CNBC: Johnson & Johnson to begin human trials for coronavirus vaccine in late July, earlier than expected
“It is using the same technologies it used to make its experimental Ebola vaccine, which was provided to people in the Democratic Republic of Congo in late 2019.” 

Regulatory Focus: Marks dishes on COVID-19 vaccine development at BIO
“[FDA’s] Peter Marks…thinks global regulators will be aligned on the clinical endpoints and design features of Phase 2 and 3 clinical trials for vaccines to prevent coronavirus disease.” 

STAT News: New report underscores the recent roller coaster of the biotech market
“A new report from BIO shows just how chaotic the last few years have been for ‘emerging therapeutic companies’—basically, biotech companies that bring in less than $1 billion in sales.” 


LanzaTech’s SAF is ready for takeoff

We’re not taking too many flights these days—but when it’s safe to travel again, your flight could very well be powered by sustainable aviation fuel (SAF), thanks to a new plan from BIO member LanzaTech.

LanzaTech announced the launch of LanzaJet, a new company in partnership with Japanese investment company Mitsui & Co. and Canadian oil and gas producer Suncor, to make sustainable aviation fuel available to Japan’s All Nippon Airways, reports TechCrunch

The companies will build a plant that will produce 10 million gallons of SAF per year, from any source of sustainable ethanol, including recycled pollution, says the press release.

This is another example of how biotech can solve our biggest problems, from cleaning up air pollution (and in turn improving human health) to boosting rural economies by creating new clean jobs in biofuel manufacturing and R&D.

What they’re saying: “The launch of LanzaJet marks an historic milestone in the clean energy transition that is underway globally. I’ve been part of many renewable energy and sustainability firsts over the last decade, and this one is the most exciting,” said Jimmy Samartzis, CEO of LanzaJet. This “gives our world, and aviation in particular, an important solution in shaping a cleaner future.”

BIO Beltway Report

President Trump’s Thursday: He’s heading to Dallas, Texas, for a “listening session” with faith leaders, law enforcement, and small business owners, then a private fundraising dinner.

What’s Happening on Capitol Hill: Lots of hearings today on the impact of the pandemic on nursing homes, the VA, elections, and more. Meanwhile, House Democrats are working on police reform legislation.

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