Good Day BIO: World Food Prize and non-opioid analgesics

We meet the 2022 World Food Prize Laureate, and take a deep dive into the FDA’s new draft guidance on non-opioid analgesics and BIO’s response. (642 words, 3 minutes, 12 seconds)

World Food Prize recognizes links between climate and food systems

Dr. Cynthia Rosenzweig was awarded the 2022 World Food Prize for her work exploring how climate change impacts our food systems. BIO’s VP of Agriculture and Environment Sarah Gallo attended the ceremony and shared with us why this research is more important than ever.

What:The World Food Prize is awarded annually to an individual whose work advances “human development with a demonstrable increase in the quantity, quality, availability of, or access to food through creative interventions at any point within the full scope of the food system.” 

Who: Dr. Cynthia Rosenzweig is honored for four decades of work linking climate and food systems. Founder of the Agricultural Model Intercomparison and Improvement Project (AgMIP)—and a farmer herself—she’s currently head of the Climate Impacts Group at NASA’s Goddard Space Flight Center.

How: “Through designing and leading rigorous, collaborative observational and modeling research, she provided the evidence used by thousands of decision-makers in more than 90 countries to both mitigate and adapt to climate change in local, national and global food systems,” says the World Food Prize Foundation. 

Learn more about Dr. Rosenzweig and her work. 

The context: We’ll need to feed 10 billion people by 2050—so we must ensure our food supply is both nutritious and resilient in the face of climate change. Expect to hear a lot more about the links between climate and food systems as the White House prepares to host the first White House Conference on Hunger, Nutrition, and Health in 50 years. 

More Reading: How biotech is improving food systems

FDA’s draft guidance on non-opioid analgesics: too little, too late?

The Food and Drug Administration (FDA) issued new draft guidance in February for companies developing non-opioid analgesics—but the industry has concerns, BIO’s Camelia Thompson told Bio.News in a new exclusive. Here’s the industry’s response to the guidance and where we go from here.

The context: The opioid epidemic killed more than 70,000 in the U.S. in 2019 alone—with the crisis intensifying during the pandemic. New non-opioid analgesics are needed to help alleviate patient suffering, particularly those with chronic pain, while mitigating the risks of using opioids.

“Preventing new addiction through fostering the development of novel non-opioid analgesics is an important priority for the FDA,” said Dr. Patrizia Cavazzoni, Director of FDA's Center for Drug Evaluation and Research as she announced the draft guidance on pain medicine without opioids.

But it feels like too little, too late: “The FDA withdrew the first guidance on non-opioid analgesics in 2017 and it has been five years where there’s been no guidance to the industry on development of these types of medicines,” Camelia Thompson, Senior Director of Science & Regulatory Affairs at BIO, exclusively told us.

BIO has several concerns—including the fact that the five-year delay has put development of non-opioid alternatives on hold, and that the guidance does not address chronic pain, said BIO’s comments to FDA.

Furthermore: “[E]stablishing an unnecessarily high threshold for supporting a general acute pain indication could discourage the development of novel analgesic drugs for such uses,” continued BIO.

Despite obstacles, biotech has continued work to develop alternatives—with BIO member Vertex announcing positive results in a phase 2 trial in March, among other companies' efforts.

But: “The lack of guidance creates hurdles in the sense that sponsors don’t know what to do,” said Thompson. “You can’t develop a drug in a vacuum.” 

Read the whole thing, including BIO's recommendations to FDA.

More Health Care News:

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“The number—equivalent to the population of San Jose, California, the 10th largest city in the U.S.—was reached at stunning speed: 27 months after the country confirmed its first case of the virus.”

President Biden’s Monday: Delivering remarks on the Bipartisan Infrastructure Law and high-speed internet at 1:30 PM ET, then participating in a DNC fundraiser this evening. 

What’s Happening on Capitol Hill: Quiet day, but it’s only Monday.