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American leadership in biotechnology is a vital national security asset in need of protection now, and its importance can be expected to grow in the future, the latest I am BIO podcast explains.
“America’s pharmaceutical industrial base is synonymous with the entire defense industrial base, and from a preparedness standpoint stands on equal footing with semiconductors, chemical production, and other critical materials needed to ensure our nation’s safety, during peacetime or crisis,” according to Vic Suarez, founder and principal partner of Blu Zone Bioscience & Supply Chain Solutions, also known as Blu Zone Bio.
Suarez is a retired U.S. Army colonel with 27 years of service in biotech and the healthcare supply chain. He was the lead vaccine program manager for the Moderna COVID-19 vaccines at Operation Warp Speed. After the pandemic, he founded Blu Zone Bio to work with bioscience, supply chain, and national security-focused organizations working to ensure global health.
He says years of reliance on far-flung supply chains is now causing short-term drug shortages and risking greater problems.
“We’re relying too heavily on other nations for some of our most essential key ingredients and the proportion of those who stem from adversarial nations is just too high,” he says. “If we work on building a more resilient supply chain, this reduces the vulnerabilities to disruptions caused by global events such as pandemics, natural disasters, or even geopolitical conflict. Developing a robust biopharmaceutical industrial base can drive innovation and technological advancements.”
Suarez expresses concern about the current risks of a supply chain that is so reliant on China.
“I’m not about decoupling 100% from China. I’m just simply saying we need to rebalance our portfolio so that we can have some level of independence and assurity for supporting the U.S. healthcare system, and with our partners and allies in Europe and other parts of the world as well.”
‘Are we willing to pay?’
Monique Mansoura expresses similar concerns about the pharmaceutical supply chain and credits the Biotechnology Innovation Organization (BIO) with bringing this issue to light.
“BIO did a service to all of us, to really survey its members, and assess what is the degree of dependency? How many medicines in the pipeline? How many medicines in the market? How many companies? The numbers were very significant,” she says. “Your President & CEO, John F. Crowley, just acknowledged that recently. I think it was over 124 companies that had a very significant dependency on China for manufacturing all or part of its medicines.”
Mansoura runs an organization called MITRE, a not-for-profit company that operates federally funded research and development centers and works closely with the U.S. government and other organizations to address complex challenges. She focuses on the sustainability of America’s biodefense industrial base. To do this, we must first define our terms.
“One of the big discussions we’re going to have is: Will it cost more to have a more resilient industrial base and supply chain?” she asks. “If so, how much, and are we willing to pay? I think having an honest conversation with the community, with our families, about why the industrial base resilience, supply chain resilience of medicines is a worthy discussion. We have an issue where there is risk to our access to medicines that we had not previously been aware of.”
Winning in biotech
When we talk about national security, there is no technology more important than biotechnology, according to Jason Kelly, CEO of Ginkgo Bioworks.
“We’re made of biology. Our food is produced by biology. Our air that we breathe is produced by biology,” he tells the podcast. “As we develop the technology that allows us to design and program biology to do new things, it is going to be far more impactful than electrical engineering, mechanical engineering, and chemical engineering before it. That means that we need to make sure we do it with care, and we need to do it with U.S. and democratic values.”
Kelly explains that his company, Ginkgo Bioworks, provides a platform that serves companies stretching across a range of biotechnology applications—pharmaceuticals, agriculture, biomanufacturing—to use data for innovative breakthroughs. And he predicts even greater breakthroughs in the near future.
“Biotechnologists will have a ChatGPT moment, where they say, ‘Oh my gosh, this thing writes DNA. It designs DNA better than we ever will.’ And that moment is coming. The difference is the data. We need the Library of Congress and the Wikipedia and the internet of DNA, and today, we have a little bit of that,” Kelly says. “We have very early, very small datasets to train these models.”
For Kelly, that means that making sure the U.S. can “win in biotechnology” involves addressing the data challenge.
“We need to scale our data generation on biology, our sequencing of DNA and our testing of how biology works, to huge scale, so that we can get to a ChatGPT moment in biotech before other countries,” he says.
