Good Day BIO: Animal biotech is exciting – let's get it to market

October 8, 2021
The Senate voted to raise the debt ceiling and bipartisan House members are calling on the administration to improve the regulatory process for animal biotech. We also look at why the Merck-Ridgeback COVID-19 pill is an example of the importance of Bayh-Dole and…
BIO

The Senate voted to raise the debt ceiling and bipartisan House members are calling on the administration to improve the regulatory process for animal biotech. We also look at why the Merck-Ridgeback COVID-19 pill is an example of the importance of Bayh-Dole and America’s innovation ecosystem. (990 words, 4 minutes, 57 seconds)

 

Animal biotech is exciting—so let’s get it to market

 
 

Bipartisan House members are urging USDA and FDA to work together to improve the regulatory process for animal genetic and biotech innovations—here’s what’s going on. 

“Zoonotic disease, climate change, and a growing global population require us to consider new solutions to protect our food supply and sustainably meet demand,” says the letter to Agriculture Secretary Tom Vilsack and FDA Acting Commissioner Janet Woodcock, led by Reps. Stacey Plaskett (D-VI) and Jim Baird (R-IN). 

“Ongoing research and existing innovations in animal genetics show great promise in addressing these challenges,” they continue—innovations like breeding pigs resistant to deadly disease.

Animal biotech can provide many benefits for American livestock, but it’s been difficult to get it to market, Rep. Baird said during yesterday’s House Agriculture hearing on the state of the livestock industry. “The regulatory process is incredibly onerous” and “tends to stifle innovation.” (Watch starting at 01:37:00.)

Currently, animals modified or developed through genetic engineering are regulated as “new animal drugs,” overseen by the U.S. Food and Drug Administration (FDA). This deters R&D and unnecessarily stigmatizes these animals and their progeny, significantly reducing the likelihood that such animals will be grown by producers or accepted by consumers, as we’ve explained

USDA and FDA must develop an “efficient, risk- and science-based regulatory system that can create a safe, predictable path to market for these innovative technologies,” Rep. Baird continued. 

“This is a technology that is important and relevant,” agreed Secretary Vilsack, noting the agency is working to ensure they are not "impeding the market or the importance of this technology."

He also told Rep. Vicki Hartzler (R-MO) that USDA has “to work collaboratively with our friends at FDA to make sure that our regulatory system is able to respond quickly enough, and be able to keep aligned or keep pace [with change].”

BIO’s take: FDA oversight of animal biotech needs an overhaul, as we’ve said. The Biden administration needs to create a regulatory framework that’s more appropriate for overseeing animal health and creates a much clearer path to commercialization as well as greater transparency.

Download BIO's Issue Brief on Animals and Genetic Innovation. 

More Reading: What biotech can expect from the administration’s ag policy agenda


More Agriculture & Environment News:

House Agriculture Committee: Chairman David Scott Applauds Announcement of Rod Snyder as EPA Agriculture Advisor
“I am very pleased that Environmental Protection Agency Administrator Regan has named Rod Snyder as his Ag Advisor. The House Agriculture Committee and the broader agriculture community have been eagerly awaiting this announcement. I know that he will be a valuable member of the Administrator’s senior leadership team,” said Chairman David Scott.

 
 
 
Twitter
 
LinkedIn
 
Facebook
 
 

Meet Daniel: Supporting Access to Mental Health Services

I am BIO: Meet Daniel
 
 

“There is no physical health without mental health,” says Daniel Gillison, CEO of the National Alliance on Mental Illness (NAMI).

Daniel and his family were personally affected by suicide—but he says it’s his calling to do “any small thing” he can to help individuals living with mental illness and their families. 

Watch Daniel tell his story.

Learn more about NAMI and Mental Illness Awareness Week.

 
 
 
Twitter
 
LinkedIn
 
Facebook
 
 

The tale of a COVID-19 breakthrough

 
 

ICYMI: Merck and Ridgeback Biotherapeutics developed an oral COVID-19 antiviral that reduces the risk of hospitalization or death by 50%—and it’s thanks to Bayh-Dole and America’s drug development ecosystem, writes Joe Allen in IPWatchdog.

The Merck/Ridgeback pill owes a lot to the Bayh-Dole Act, which encourages the private-sector investment needed to turn basic government-funded research into tested and approved products—here’s more background.

The story in a nutshell: The antiviral was initially discovered by a biotechnology company owned by Emory University. Ridgeback licensed the discovery, then partnered with Merck in May 2020 to quickly develop it and begin clinical trials.

“The partnership between Emory University, Ridgeback Biotherapeutics and Merck could turn out to be one of the most significant Bayh-Dole alliances ever,” says Joe Allen in IPWatchdog—but all three players are getting unwarranted criticism.

“What Ridgeback did is what drives our drug development system,” he says. “About half of our new drugs come from entrepreneurial companies like Ridgeback. They are laser focused on development, taking early-stage inventions through the initial trials to see if they are effective.” 

If initial trials are effective, these smaller biotechs “partner with larger pharmaceutical companies like Merck, with the resources and expertise for conducting the expensive, high-risk, later stage human trials,” he continues. “These established companies also have expertise on developing large scale manufacturing to meet global needs.” 

The bottom line: Drug development is extraordinarily difficult and expensive—and most new discoveries never make it out of the lab. We need the Bayh-Dole Act, and innovative companies like Merck and Ridgeback, to bring us the cures we need.

Read the whole thing.

 

More Health Care News: 

AbbVie: The story behind our $50 billion R&D investment
“New medicines aren’t discovered quickly or easily. Despite our best intentions, most new molecules never make it out of the lab, and it takes hard work and dedication to translate foundational science into a viable new medicine. And yet that journey—pushing an idea to a breakthrough—drives this company.” 

CNN: Pfizer seeks FDA authorization of COVID-19 vaccine for children ages 5 to 11
“Pfizer released details of a Phase 2/3 trial that showed its COVID-19 vaccine was safe and generated a ‘robust’ antibody response in children ages 5 to 11.” 

Moderna: Moderna to build state-of-the-art mRNA facility in Africa to manufacture up to 500 million doses per year
“The company anticipates investing up to $500 million in this new facility which is expected to include drug substance manufacturing with the opportunity for fill/finish and packaging capabilities at the site. The company expects to begin a process for country and site selection soon.”

 
 
 
Twitter
 
LinkedIn
 
Facebook
 
 
Dr. Pamela Padilla.jpg
 
 

Dr. Pamela Padilla is President of the Society for Advancement of Chicanos/Hispanics and Native Americans in Science (SACNAS). Her involvement with SACNAS dates back to her time as a first-generation student from New Mexico, with Chicana and Indigenous roots. She's also Associate Vice President of Research and Innovation and a Full Professor at the Department of Biological Sciences at the University of North Texas.

Meet more Hispanic and Latinx scientists and innovators you should know.

 
 
 
Twitter
 
LinkedIn
 
Facebook
 
 
BIO Beltway Report
BIO Beltway Report
 
Paragraph (sm) - Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Quis ipsum suspendisse ultrices gravida. Risus commodo viverra maecenas accumsan lacus vel facilisis sample link.
 

President Biden’s Friday: Signing The HAVANA Act of 2021 (S. 1828), providing aid for victims of “Havana Syndrome,” and The K-12 Cybersecurity Act of 2021 (S. 1917), strengthening cybersecurity in schools. He’ll give remarks on the jobs report at 11:30 AM ET, and again on restoring protections for national monuments and land and water conservation at 1:45 PM ET. 

What’s Happening on Capitol Hill: Yesterday, the Senate voted to increase the debt ceiling by $480 billion, with 11 Republicans joining Democrats in support. The new debt ceiling will hit on December 3.

 
 
Paragraph (normal) - Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Quis ipsum suspendisse ultrices gravida. Risus commodo viverra maecenas accumsan lacus sample link.
 
Twitter
 
LinkedIn
 
Facebook