Good Day BIO: Recap of White House biotech summit

September 15, 2022

We recap yesterday’s biotechnology summit at the White House, and look at what’s ahead for COVID-19 IP protections at the WTO. Plus, today marks the start of Hispanic Heritage Month. (745 words, 3 minutes, 43 seconds)

Biden administration huddles with biotech, promises $2B in action

Top White House officials met with biotech industry leaders yesterday—including many BIO members—where we got more details on the executive order on biotechnology and biomanufacturing signed Monday.

The details: The executive order is backed “with funding of more than $2 billion,” the White House said yesterday. HHS announced related actions, including supporting research programs at the FDA, spearheading global regulatory harmonization, facilitating biotech animal products, and investing $40 million in biomanufacturing “active pharmaceutical ingredients” and antibiotics for the next pandemic.

A pledge to partner with industry: HHS Secretary Xavier Becerra said the next generation of FDA user fees will facilitate bio-innovation—adding HHS wants to partner with industry, not regulate it.

Administration officials outlined more actions and funding commitments, particularly focused on ag and biomanufacturing:

Deputy Agriculture Secretary Jewel Bronaugh outlined USDA support for business, including a $500 million grant program for innovative, sustainable American fertilizer. USDA is also building new regulatory processes to promote safe innovation in agriculture and alternative foods, allowing USDA to review more diverse products.
Deputy Defense Secretary Kathleen Hicks said her agency would spend $1.2 billion to expand U.S. bio-industrial manufacturing—to catalyze the establishment of the domestic bioindustrial manufacturing base that is accessible to U.S. innovators—as well as infrastructure, biosecurity, and cybersecurity.
Energy Secretary Jennifer Granholm announced $178 million in grants for research on renewable bioenergy, quantum-enabled bioimaging, gene function in bioenergy crops, and microbiome. Through the Sustainable Aviation Fuel Grand Challenge, the DOE will work with DOT and USDA to leverage the estimated 1 billion tons of sustainable biomass and waste resources in the United States to provide domestic supply chains for fuels, chemicals, and materials.

Why it matters: The bioeconomy will help strengthen supply chains, lower prices, expand manufacturing capacity, and create jobs, providing $30 trillion in opportunities by the end of the decade, said Brian Deese, Director of the National Economic Council.

What BIO members who participated are saying: “It’s not often that one action fuels the economy, combats climate change, and strengthens supply chains at the same time,” said Christophe Schilling, CEO of Genomatica, a BIO member company. "We're expanding the market forward," added John Melo, CEO of Amyris (BIO member). "We do it cheaper, we deliver it faster and we deliver it in a more quality way than any other source in the world. That's biomanufacturing, that's bioengineering."

The big picture: Achievements of our new “DNA Age” may dwarf those of the “electronics age,” said Jason Kelly, CEO of Gingko Bioworks, another BIO member. By 2040, consumers will have access to sustainable, affordable versions of every product they buy, predicted Jennifer Holmgren, CEO of Lanzatech (also a BIO member).

Read more from the White House.

TRIPS waiver redux? Doubling down on failed policy

The WTO is considering an expansion of the waiver of IP protections for COVID-19 technologies—shaking investor confidence in an industry that already voluntarily shares innovations, Bio.News reports in a new exclusive.

What's happening: A document reportedly circulating among WTO members, and shared with Reuters foresees a waiver on COVID therapeutics like Veklury and Paxlovid by November or December. “In Geneva, the discussion is going to be whether to expand this TRIPS waiver for vaccines to COVID-19 therapeutics, as well,” Hans Sauer, BIO’s Deputy General Counsel and VP for IP, told Bio.News.

The first waiver fell flat: The original waiver of IP protections for COVID-19 vaccines was intended to facilitate distribution of vaccines around the world, even though vaccine distribution was already taking place. By the time it was approved, global vaccine distribution was no longer a problem.

But the damage done: What the waiver did do was weaken faith in IP guarantees that drive innovation.

The industry already shares—voluntarily. Biotech companies already have efforts to share IP effectively, which allowed global distribution of COVID-19 vaccines and therapeutics. Examples include:

Novavax partnered with Serum Institute of India to increase global production of its vaccine.
Pfizer signed a voluntarily licensing agreement with the Medicines Patent Pool to share oral therapeutics.
Moderna promised to not enforce COVID-19 patents during the pandemic.
Gilead signed voluntary licensing agreements to expand access to generic versions of its Veklury in 127 low- and middle-income countries.

Even before COVID-19, efforts have been underway in Africa to provide access to IP and innovations, especially for cancer—something companies did “of their own accord,” says BIO's Sauer.

BIO’s view: “They passed the waiver and it has not really been used, which supports what we have been saying for a long time, that waiving IP is not going to be a solution,” says Sauer.

Read the whole thing.

P.S. Today is the first day of Hispanic Heritage Month—and BIO is celebrating the achievements of Hispanic Americans in science, medicine, and biotechnology, while also reflecting on the work that needs to be done to combat inequities that still exist. Read more on Bio.News.

BIO Beltway Report

President Biden’s Thursday: Hosting the United We Stand Summit at the White House to oppose hate-fueled violence.

What’s Happening on Capitol Hill: The House Ways and Means Committee will hold a hearing on preparing America’s health care infrastructure for the climate crisis. A House Foreign Affairs subcommittee will discuss Sustainable Development Goals and recovery from the COVID-19 pandemic. A subcommittee of the House Committee on Science, Space, and Technology has a hearing, “The Fountain of Youth? The Quest for Aging Therapies.”