Since Watson and Crick discovered DNA's double helix structure in 1953, the US has been a leader in biotechnology innovation. American excellence in this field has greatly benefited people around the world. In this episode, we talk about why this leadership position may be threatened and why that matters to our national security.
Since Watson and Crick discovered DNA's double helix structure in 1953, the US has been a leader in biotechnology innovation. American excellence in this field has greatly benefited people around the world. In this episode, we talk about why this leadership position may be threatened and why that matters to our national security.
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Theresa Brady (00:44):
Since Watson and Crick discovered DNA's double helix structure in 1953, the US has been a leader in biotechnology innovation. American excellence in this field has greatly benefited people around the world. For example, America mass-produced the first polio vaccines, which played a crucial role in saving over 1.5 million lives and preventing an estimated 20 million cases of paralysis worldwide. Other examples include the development of antibiotics that prevent infections. And, the US developed treatments that have turned HIV from a fatal diagnosis into a manageable chronic illness. The US has been at the forefront of therapies that have revolutionized cancer care, and it leads in gene therapy breakthroughs. In today's episode, we talk about why this leadership position may be threatened, and why that matters to our national security. I'm Theresa Brady, and you're listening to I am BIO.
(02:02):
The COVID-19 pandemic laid bare the vulnerabilities of global supply chains, especially in the biopharmaceutical sector, but it also forced a broader discussion about how significant the biotechnology industry is to our national security. Today, we talk with three guests who discuss exactly why biotechnology plays such a crucial role in protecting our nation and our allies. Our first guest brings a wealth of experience from his military background, having served in the US Army with a focus on biodefense.
Vic Suarez (02:35):
My name is Vic Suarez. I served in the US Army for over 27 years on active duty as a biotechnology advanced developer and healthcare supply chain senior leader. When COVID-19 struck our country back in 2020, I had the great honor of serving in a role among many fine men and women at Operation Warp Speed, as the lead vaccine program manager for the Moderna COVID-19 vaccines. COVID-19 exposed our reliance on foreign, fragile supply chains for essential pharmaceuticals and personal protective equipment.
Theresa Brady (03:05):
Vic explains that his expertise in biodefense, developed while serving in the Army, led to the next chapter in his life.
Vic Suarez (03:12):
I am the founder and principal growth partner at Blu Zone Bioscience & Supply Chain Solutions, also known as Blu Zone Bio. I retired in the Army in the fall of 2023, and decided to dedicate the next chapter of my career to helping US and allied nation life science companies grow and be more competitive and meet their objectives of advancing human health and protection against disease and other threats.
Theresa Brady (03:35):
In Vic's estimation, a self-reliant biopharmaceutical industrial base and supply chain are critical to America's national security.
Vic Suarez (03:44):
We're relying too heavily on nations for some of our most essential key ingredients and the proportion of those who stem from adversarial nations is just too high. Having a strong domestic industrial base ensures the country can meet its own healthcare needs during emergencies in times of crisis. 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.
(04:20):
Put simply, the biopharmaceutical industry represents a critical commodity which has too much overreliance on these overseas manufacturing and supply chains. Its essential for US healthcare, and our independence is really important to having a long-term economic growth and stability that also supports our national security capability in this area. We see right now ongoing chronic drug shortages, and overseas manufacturing in adversarial nations represents a existential public health threat to our citizens and our entire healthcare system. 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.
Theresa Brady (05:08):
As we've discussed, the COVID crisis highlighted our heavy reliance on foreign sources for critical supplies, and underscored the need for robust domestic biomanufacturing capabilities. But how did we get here? A combination of factors has contributed to our current situation. We talk with Vic about a few of them.
Vic Suarez (05:29):
During the '80s and '90s, as companies were exploring ways to reduce the cost of goods and services, overseas locations, often in Asia, became an attractive option due to their unlimited supply of cheap labor, their more relaxed environmental laws, and really, the ability to produce cheap raw materials. I do believe the proverbial knife in the back of US manufacturing came in December of 2001, and this is when the US actually voted for including China as the most favored nation in global trade. Most of the nation was busy reeling from the 9/11 terrorist attacks during this time, and our focus for nearly 20 years after that was in the Middle East and not in Asia, at least not as a near-peer economic competitor. I believe it's ingrained in our national culture to buying cheap and disposable things versus spending a bit more up front for quality and durability.
Theresa Brady (06:25):
By redirecting our focus and setting clear priorities, we can still reverse this trend and build a resilient bio-industrial base, while also maintaining the integrity of the current supply chain.
Vic Suarez (06:37):
So I think some of the ways we can reverse this trend without jeopardizing the current supply chain is, it will require us to be a lot more dynamic and transformative in our policymaking, our investments. First, we need to better map the supply chain so we know where our vulnerabilities are. Secondly, we need to measure the quality of products and rate the quality of their manufacturing processes, plants, and technology. And third, we need to shift investments, long-term contracts, towards suppliers who are not exposed to geopolitical and geographic risk, and reside in locations where there is access to an independent judiciary, and provide patent protections and intellectual property are always safeguarded.
(07:20):
This scenario, where I believe both industry and government can have a sober conversation about striking a sound balance of not spilling over the apple cart by knee-jerk policies, and we can co-develop well-thought-out conversion strategies where the US and its allied nation partners can take on risk in areas not appropriate for industry. 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 US healthcare system, and with our partners and allies in Europe and other parts of the world as well.
Theresa Brady (07:58):
We talk more about sustaining a robust biotech sector with our next guest, a scientist turned national security specialist.
Monique Mansoura (08:06):
My name is Monique Mansoura. I'm the executive director of global health security and biotechnology for The MITRE Corporation.
Theresa Brady (08:14):
Monique's career path was heavily influenced by the events of 9/11.
Monique Mansoura (08:18):
My background started as graduate student in bioengineering and human genetics. This was around the time of the Human Genome Project as well, and following grad school, Dr. Francis Collins was one of my graduate advisors, followed him to NIH, to the National Human Genome Research Institute, was very privileged to do my postdoc there, and then work in the front office during an extraordinarily exciting time in biotechnology.
(08:44):
On 9/11 and the subsequent anthrax attacks in 2001, those events became a career calling for me, a career pivot. I wanted to use my passion for making medicines to do good. Into this new domain, post-9/11 and the anthrax attacks, we were seeing, in the civilian sector, the intersection of national security and biotechnology in a very powerful way. It became a much broader mission space, and government program was the recognition number one that the threats were real, that we were vulnerable, clearly, and that we were not ready. So that really was a powerful intersection of national security and biotechnology.
Theresa Brady (09:25):
Monique tells us that she left government to pursue a business degree, because she thought she was missing one part of the puzzle.
Monique Mansoura (09:33):
What I realized as a scientist, needing industry to make the medicines, whether it was an anthrax vaccine, or a small pox antiviral, or an Ebola medical countermeasure, that I didn't have the skills to really understand the drivers of industry, why we weren't having the best of the best companies necessarily really swarming to (laughs) to answer these national security needs.
(09:54):
So, I left the government and went to get a business degree at MIT Sloan. I was a MIT Sloan fellow, uh, learned a new language of business, and finance, and economics, and transitioned that learning, and this new language that (laughs) I had acquired, to work for Novartis, the vaccines division. Following that sorta tenure, five or six years working on the private sector side, I joined MITRE. I've been there seven years now, and leading this. I think the broader lens in bringing now is that it's not just these high-consequence events, a pandemic or an anthrax attack, but it, it is really recognition that medicines and our access to safe and effective medicines in and of itself is a national and economic security issue.
Theresa Brady (10:40):
Those of us who work in biotechnology recognize its importance in our everyday lives. Monique thinks it's important that those outside our industry understand this as well.
Monique Mansoura (10:50):
I believe everyone has a vested interest in this conversation that we're having about the intersection of biotechnology, and biomanufacturing, and national security, as virtually all of us, personally, our families, or certainly somebody we know needs a medicine to keep them healthy or to treat an illness. Better understanding where those medicines come from, and the risks posed if we don't have more control of our supply chains or resilience built into our supply chains and industrial base. It's on us again, the narrative, when I tell my family what I do and why I do it, and why they should care.
(11:28):
One of the big discussions we're gonna have is will it cost more to have a more resilient industrial base and supply chain? If so, how much, and are we willing to pay? I think and 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.
Theresa Brady (12:02):
How much of a risk is not necessarily clear, as Monique explains.
Monique Mansoura (12:06):
I wish I could give you a precise number with three decimal point accuracy. First, let me state that the geopolitical risk is not a static, right? It's a dynamic, and I think we're all raising awareness of the strategic vulnerabilities in supply chains, whether it's critical minerals, or semiconductors, or medicines. I think an awareness that geopolitical risk and the experience of COVID, when it's everything, everywhere, all at once, and you can't count on a supply chain that you don't control, or is controlled outside of your borders. So I think within that context, you know, how dependent is the industry? I credit BIO, earlier this year, after the introduction of the proposed BIOSECURE Act.
(12:53):
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. Your CEO, John 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. And so the number's not small. You know, again, what we have to realize is there is a dependency there. There are things that we don't control, and with that lack of control, arguably, comes risk.
Theresa Brady (13:39):
After the break, we'll talk with Monique about the specific steps needed to strengthen our national security infrastructure for biotechnology. Unlock the future of biotechnology a the BIO Investor Forum, October 15th and 16th, in San Francisco. Join and network with industry leaders, innovators, and investors who are shaping the future of biotech. Don't miss out. Secure your spot today. Register at bio.org/events.
(14:30):
Monique's organization, MITRE, is a not-for-profit company that operates federally funded research and development centers and works closely with the US government and other organizations to address complex challenges. In her role at MITRE, Monique focuses on the sustainability of America's biodefense industrial base. She says to do this, we must first define our terms.
Monique Mansoura (14:55):
The steps that need to be taken to build a more resilient and self-sufficient domestic supply chain and industrial base involves really defining what is resilient. And again, here's where the details matter. If I'm talking about a vaccine that's gonna be needed for a virus that is causing a pandemic that has high mortality, then we're really talking about ensuring that we have every component of that vaccine on shore and can manufacture it at speed and scale. That's an extreme situation, but that is critical. We can't assume we're gonna get parts, whether it's pipette tips, or tubing, or bioreactors, from other entities. Ideal preparedness and resilience in that scenario is a vaccine or a two-dose vaccine for everyone in this population in 100 days and six months. Those details matter.
(15:46):
If I'm talking about a medicine that has a very different scenario, it's high value, but the timeline is more forgiving. Perhaps, maybe it's a chronic disease, it's got a more or less fixed market of those in need. It's a different calculus. My sense is industry leaders now are doing those assessments, are looking with heightened awareness of geopolitical risk, that they were always managing and mitigating risk. I think cyber risk is another, right? What are the things that are gonna risk continuity of operations to manufacture these life-saving medicines? That's the key question, and if you can't meet the market demand, whether it's a weight loss drug or a pandemic vaccine, individuals depend on those medicines, and any interruption to it, again, could be a cyberattack, could be a severe weather event, could be geopolitical risk. Resilience, arguably, is not a no-cost venture, and you have to assess those investments that you make with the value that it would bring to have continuity of operations against this array of threats, including these heightening geopolitical risks.
Theresa Brady (16:58):
The investment required to build our bioindustrial is undoubtedly a significant factor to consider. Monique emphasizes that both the private and public sectors have essential roles to play in this effort.
Monique Mansoura (17:11):
What does resilience look like? Who has what roles and responsibilities? Companies clearly are willing to do their part to reduce risk. They exist to provide the medicines to support patient needs and population needs. They are continually reducing risk in many kinds of ways, through supply chain resilience. The role of government... Again, this is interesting. Government has particular requirements that unless they are managing and responsible for those supply chains and that industrial base, who's gonna make an anthrax vaccine or an Ebola vaccine? Those traditionally have been the US government. That's a particular subset of medicines, where the government has a very significant role.
Theresa Brady (17:56):
The issue of biotechnology as a national security priority has piqued interest on Capitol Hill, which Monique finds reassuring.
Monique Mansoura (18:04):
It's really encouraging that Congressional leaders are very focused on this issue right now, in a very bipartisan and bicameral way. It's forcing an assessment and a de-risking of some of the geopolitical risks, that again, this awareness-raising. The BIO CEO referred to it even as a Sputnik moment with the industry this year. It's of that sort of consequence, that we've identified a problem. It's not a small problem, and how are we collectively going to mitigate this risk?
Theresa Brady (18:37):
Our next guest is Jason Kelly, the CEO of Ginkgo Bioworks, a unique biotech company that we have featured on our podcast before. Jason's experience across a wide range of biotechnology applications gives him a remarkable perspective on the intersection of biotechnology and national security. Jason explains what makes his company different.
Jason Kelly (19:00):
I did my PhD at MIT in bioengineering, and then I founded Ginkgo Bioworks with some of my fellow grad students and an MIT professor back in 2008. Today, Ginkgo's public company, a bit over 800 people, sites in Boston as well as in California. So, if you're, you know, not a biotech insider, you can think of us a little bit like Amazon Web Services, right? That's Amazon's big platform that many other tech companies build their product on top of.
(19:29):
Ginkgo does a similar thing in biotech. We run big automated labs, and then companies like Merck and Novo Nordisk are our customers developing drugs on top of our platform, but so aren't, um, companies like Beyer and Corteva, that are developing ag biotech products, and companies like Givaudan are developing biotech products in the fragrance industry, and, and other chemical companies. So I think one thing that makes Ginkgo special is we sorta cut across all the applications of biotech, and I think BIO, as an organization, I, I think is, is really excellent in this way as well. It's not just the biopharma companies that participate in BIO. It's also ag, and food, and industrial chemicals, and new materials, and all these amazing things that you can do with biotech outside of therapeutics.
Theresa Brady (20:14):
In Jason's view, biotechnology stands as the most foundational and essential field of our time.
Jason Kelly (20:20):
If I was gonna give one message to folks about kind of the future of biotech and national security, it's that the most important technologies in the world are the ones that are general. Sometimes, we don't even think of them as technologies, they're so general, right? Like mechanical engineering. The industrial revolution was a product of us figuring out some of these basic things in physics and mechanical engineering, and they changed our world so much it, it, it's, it's like it's in the air, okay? And that's because you could just use it for so many di- How many different things can you use a motor for? Right? You know?
(20:55):
Like, how many different things can you use electricity for? How many different things can you use semiconductor chips and computers for? Okay? It, the more general the technology is, the bigger impact it can have on our lives. In my opinion, biotechnology is the most general, the most potentially impactful technology of anything that humans have encountered, because we're made of biotechnology. We're made of biology. Our food is, is produced by biology. Our air, that, that we breathe, is produced by biology, right? You know, biology is fundamental to everything that makes humans humans. So 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 US and democratic values, and I hope that's why all the listeners here will get smarter and learn more about biotech. It's gonna be a bigger piece of their lives in the future.
Theresa Brady (21:59):
Biotechnology's immense influence on our lives makes it something we all need to pay attention to, especially in the context of national security.
Jason Kelly (22:07):
I think for folks that are industry insiders in biotechnology, it's a little s- surprising to hear biotech put next to the words national security. And I want people to understand that national security has a much bigger umbrella than just things like defense against infectious disease or defense against biological weapons, some of these more, like, really pure defense concerns. National security is also making sure that advanced tech is led and developed in the United States, so that we can input our values into how it's regulated, we can put our values into how it's used and so on. That's really critical for us, particularly in an era where we have greater strategic competition with folks like the CCP in China and, and so forth.
Theresa Brady (22:50):
Like our other guests, Jason agrees we need to scale up our biotechnology manufacturing capabilities.
Jason Kelly (22:56):
So, domestic manufacturing is a key strategic topic in the United States, so i- if I step back, how does the US make sure we lead in an area of strategic technology? So one of the first things is, in areas where we're already ahead, we wanna protect that lead. And this relates to manufacturing, so I'm just gonna touch on it for a minute. I'll give you an example where we didn't do that, semiconductors, all right? So semiconductors was born in the United States, that technology, at places like Fairchild, and then ultimately Intel really birthed planar semiconductor manufacturing and early work on transistors and so on, Texas Instruments. And that ultimately grew all the way through the sorta '80s and '90s. You know, Intel was really king of this technology.
(23:37):
And, but what happened since then, in the last 30 years or so, was the rise of Taiwan Semiconductor Manufacturing Corp, TSMC, and really the outsourcing of the semiconductor manufacturing, largely to Asia, along with other types of electronics manufacturing. And, that's now becoming a big strategic concern, right? You know, semiconductors chips, with the rise of artificial intelligence and how important these types of advanced chip technologies have become, now suddenly, the US is wishing we hadn't outsourced all of that manufacturing, and that we had maintained it back here at home. And so you've seen, you know, the CHIPS And Science bill, which I think is a great bill in the United States, funding billions and billions of dollars to bring some of that manufacturing back. You know, let me tell you, it is a lot more difficult to bring something back versus just not lose it in the first place.
Theresa Brady (24:25):
Jason believes that one area where we have an opportunity to take the lead is with the application of AI in biotechnology.
Jason Kelly (24:33):
There will be some time in the coming years a ChatGPT moment (laughs) you know? A, a, a moment where the, the experts in the field, like in that case, it was the field of human language processing. In our case, it'll be in the field of DNA design, so the 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. We have NCBI. If you're a biotech person, you would know about this. We have the Protein Data Bank, the PDB. We have very early, very small datasets to train these models.
(25:20):
So when you ask, "Hey, what do we need to scale in the United States to make sure we win in biotechnology?" I think we do need to scale our tanks and our manufacturing, but much more importantly, 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.
Theresa Brady (25:44):
As we wrap up today's discussion, it's clear that biotechnology is not just a tool for innovation, but a critical component of our national security strategy and for the advancement of global health and our values. I wanna thank our guests, Vic, Monique, and Jason, for sharing their insights on how to navigate the complexities of creating a resilient biotech ecosystem that supports both our immediate needs and our long-term national security.
(26:19):
If you liked what you heard today, be sure to let us know with a review. And remember to follow us on X, Facebook, and Instagram @IAmBiotech. I'm Theresa Brady, and I produced this episode with help from Kourtney Gastinell. It was engineered and mixed by Jay Goodman, with theme music created by Luke Smith and Sam Brady.