▶ 0:00:00aa four years ago because we recognized the vulnerabilities, challenges, and opportunities that biotechnology presented. I appreciate the work that the commissioners and the commission's staff have done, especially our house members, ranking member Kana and Congresswoman Stephanie Bice. I also appreciate Senator Todd Young of Indiana, chair of the biotech commission, and Dr. Michelle Roso, the vice chair of the biotech commission for appearing before the subcommittee today. The United States has long been a leader in biotechnology. My home state of Nebraska being a big contributor to our leadership.
▶ 0:00:29But there is no doubt that China is catching up. China's invested heavily in biomat manufacturing, synthetic biology, and other biotechnologies. Meanwhile, prioritizing biotechnology leadership. It is important now more than ever for the DoD to cataly catalyze research, development in emerging biotech and dedicate the necessary resources to maintain the United States lead in this critical technology area.
▶ 0:00:52While biotech has traditionally thought of the medical and agriculture sectors, when applied to defense and national security, biotech has the potential to secure supply chains, enhance sensors to count to count counter boweapons and improve war fighter readiness and lethality. The Department of Defense has made strides in improving integration of biom manufacturing to fully maximize the power that biotechnology can bring to bear for national security. But it must continue to scale those capabilities.
▶ 0:01:18Congress recognizes this need and the massive potential biotech could have on national security leading to the creation of the national security commissioning commission on emerging biotechnology in the fiscal year 2022 defense national defense authorization act. The commission was tasked with carrying out a review of the emerging biotech capabilities and associated technologies related to national security. The commission released an interim report and recommendations in December 2023, several of which Congress authorized in the FY25 NDAA.
▶ 0:01:48The commission's final report will be released this week and and today's hearing provides an opportunity to discuss their findings and legislate and legislative recommendations to help secure our leadership in biotechnology. Thank you both for appearing today and for your your hard work on this important commission. I'll turn it over now to our ranking member Connor for his opening remarks. Thank you, Mr. chairman and uh thank you for convening this hearing and your leadership. I want to thank our witnesses for appearing today.
▶ 0:02:16Uh Senator Young has been a a great partner on uh many issues uh with the chips act and other industrial policy uh and he stepped in to uh take the chairmanship and didn't phone it in. he was present at every meeting, even ones that uh I missed and really uh dived into the details. And so, thank you for uh your leadership and thank you Dr. Rosa for your leadership.
▶ 0:02:43Uh very uh much looking forward to what you have to say and I want to thank Representative Bryce for her leadership as well on uh on the commission. Uh as you mentioned, Mr. chairman. Back in 2021, uh the NDAA recognized the need for experts to look at biotechnology and its intersection with national security and uh we created this national security commission of emerging biotechnology.
▶ 0:03:09I've been proud to be part of the commission and I'm hopeful that the final report and our discussion can lead to critical steps in addressing the challenges. I just want to say that China is moving ahead uh in at light speed. $2 trillion of industrial lending that they're doing, $200,000 AI companies that they're funding and they're certainly funding a lot in biotechnology.
▶ 0:03:35So, if there's one message that I have, it is that we need to stay ahead of China in this area. We need to recognize how serious they are about it. uh and we need to make sure that uh our innovation, our uh creativity ultimately uh succeeds and thrives and and and and leads. So, thank you, Mr. Chairman. Thank you. I appreciate your comments. With that, we'll yield to Senator Young for five Well, uh thank you, Chairman Bacon.
▶ 0:04:03uh uh Congressman Khan just offered uh I think the bottom line upfront which is uh that the United States needs to lead on biotechnology and our leadership is indeed in uh jeopardy as we outlined in the report and elaborate on uh through the classified annex. I thank all the members of the subcommittee for u this opportunity to testify today.
▶ 0:04:27I'd be remiss if I didn't mention all the hard work of of the many commissioners including Representative Bice who I know will make every effort uh to be here as well today. The United States is locked in a competition with China that will define the coming century. This competition is playing out not only through arms races but alo also through the quest to dominate cutting edge technology. Biotechnology is the next phase in this competition.
▶ 0:04:55Thanks to breakthroughs in artificial intelligence, we now have the tools to reprogram the building blocks of biological systems. These breakthroughs will advance every strategic sector, including defense, healthcare, agriculture, energy, and manufacturing. Biotechnology can help us maintain military superiority, ensuring our war fighters continue to be the strongest fighting force on tomorrow's battlefields.
▶ 0:05:22Biotech will reshore supply chains and revitalize our manufacturing sector, creating American jobs for American workers, creating American products right here in America. It will revolutionize egg production enabling larger harvests with less water, less fertilizer, less land. Um, this technology will transform medicine, uh, allowing doctors not just to treat disease, but to cure it or to wipe it out entirely.
▶ 0:05:54Biotech will also shape the future of data storage and computing power, keeping America at the forefront of other critical technologies like AI. DNA is the most sophisticated data storage medium there is. If we converted the zeros and ones of data into the genetic code of DNA, we could store all the data ever created in a container the size of a school bus.
▶ 0:06:21That capability would make our domestic companies unbeatable. But if dominated and controlled by our adversaries, biotech could be turned against us. We have a classified annex. I do want to emphasize that that we are happy to explore in an appropriate setting. But for today's session, here's what we're facing. An enemy power could exploit biological enhancements to outmaneuver and overwhelm the American war fighter.
▶ 0:06:51Adversaries could silently attack our infrastructure and disrupt transportation and trade without being detected. They could target our a sector, killing off crops and livestock and leaving grocery shelves empty. Adversaries could cut off our access to pharmaceutical supply chains. Biotech is no longer constrained to the realm of scientific achievement. It's now an imperative for national security, economic power, and global influence.
▶ 0:07:21Until recently, America's position as the biotech leader of the world was considered un unassalable. It was also undisputed. But China has caught up. China has made biotech a strategic priority for over 20 years. They've had a plan. Under President Xi, the Chinese Communist Party has led an aggressive campaign to develop the most cutting edge biotechnologies and to translate those gains into military and economic power.
▶ 0:07:51China's strategy hinges not only on its well-known theft of American technology, but also on its significant investment in its domestic industry. China spends massively, massively on research and development, supporting its handpicked champions with immense subsidies and preferential treatment. It helps these state champions acquire the US companies with the most promising technologies.
▶ 0:08:18For example, the Chinese company BGI, which is a world leader in sequencing, bought up US intellectual property and use state subsidies to undercut competition. and it is now one of the largest sequency companies in the world and it's opened its massive trove of biological data to the Chinese Communist Party. China's strategy is now paying off.
▶ 0:08:43China's making breakthrough after breakthrough, including this year creating the first fully AI generated prescription drug and it now dominates the biioarma supply chain. We know from experience how the Chinese economic playbook works. corner the supply chain, then choke it off in the hopes of America. Economic warfare isn't the only tool the CCP is eyeing.
▶ 0:09:10China's investing heavily in gene editing, bionic robots, human machine teameing, and biio manufacturing, and it's targeting these technologies for defense applications. We've every reason to believe China will weaponize biotech. The government already deploys genomic surveillance to rep repress weaguer Muslims, part of its extensive campaign of tech- enabled genocide. And it has the means to take efforts to the next level.
▶ 0:09:38Back in 2018, a Chinese scientist produced gen genetically modified babies causing an extreme backlash around the world. But after a stint in jail, that scientist is back in the lab. And others have surely followed in his footsteps. The possibility of PLA super soldiers is no longer science fiction. The biotech race is not over, but our window to act is shrinking.
▶ 0:10:04Our commission's primary recommendation is that the US government should dedicate significant resources over the next 5 years to win the biotech race. Our strategies twofold. Make America innovate faster and slow China down. To innovate faster, we need to harness America's tremendous strengths. Our private sector is the envy of the world. And our capital markets are four times larger than China's.
▶ 0:10:30But we must make it easier to get innovations out of the lab and into factories and create a regulatory and business environment that enables us to commercialize and scale the best ideas. The US government needs to prioritize biotech as a holistic field, including by mobilizing the private sector to unleash the power of American innovation. And I'm closing here. Okay. I had to g my hand. Yes. Yes. This was evidently I prepared this for a Senate audience. Okay.
▶ 0:11:00I am self-aware. Uh and I apologize for that. Uh so thank you for indulging me. Uh busy members of this committee and I feel grateful to be with all of you. We need to slow China's progress down. That's the second uh dimension of this strategy. That starts with ending our blindness to China's clear ambitions for biotech. We must strictly defend our intellectual property and data against Chinese espionage and acquisition.
▶ 0:11:28Chinese state-owned enterprises aren't ordinary competitors and should not be treated as such. We've learned the cost of inaction. We let China catch up with us on semiconductor manufacturing and allowed the Chinese to take our tech, our industry, our jobs, our leadership, the chips and science act, which many of us worked on here, has helped return America to its position as the leading global hub for chips. But it wasn't easy and it wasn't inexpensive. Let's avoid that.
▶ 0:11:57The recommendations in our report represent our best chance to ensure biotech remains a hallmark of American innovation. Thank you again all of you for indulging me and I look forward to answering any questions. Thank you, Senator Young. Dr. Roso, you're you're Thank you. recognized. Thank you so much, Chairman Bacon, and thank you to my fellow commissioner, Ranking Member Kana. Um, our chairman, Senator Young, just laid out the stakes. Emerging biotechnology is the next battlefield in the great power competition with China.
▶ 0:12:26The race for biotechnology dominance is on. China is catching up. and in some key areas they are already overtaking us. Today I would like to take a step back and talk about how we got here and what we can do to ensure America wins the biotechnology race. I come to my role as vice chair of the National Security Commission on Emerging Biotechnology as a molecular biologist by training.
▶ 0:12:48I know firsthand that molecular biology and modern biotechnology has existed as a field of study for less than a century ever since Watson and Crick began unraveling the DNA helix. But biology is complex and this has previously limited our ability to fully harness its potential. But this is changing thanks to advances in artificial intelligence and engineering biology. Today, cuttingedge AI foundation models have predicted thousands of protein structures for help with tasks like designing drugs.
▶ 0:13:18This would have previously taken hundreds of millions of researcher years using conventional methods. We are arriving at what we refer to as the chat GPT moment for biotechnology. This will both be a technological leap forward as well as its widespread public embrace. We are about to see decades of breakthroughs happen seemingly overnight. And as we hear it, biotechnology is reaching beyond medicine to touch nearly every aspect of our lives. And this includes the battlefield. Biotechnology will be a gamecher for major problems facing our military today.
▶ 0:13:48It can solve for logistics on demand, secure supply chains, enhance operational readiness, and military medicine. One example, and I brought some some props for you all. The golden hour. This is the critical period following trauma during which treatment significantly improves chance of survival. Access to blood saves lives. But access to this blood is difficult in combat zones or in remote areas in the United States.
▶ 0:14:13With technology under development at DARPA, you can mix red dried red blood cells, platelets, and plasma, crack this like a glow stick, and make shelf stable blood. This can turn the golden hour into a day. Imagine if soldiers in combat could quickly brew chemicals, medicines, and supplies on the front line, not unlike how we brew beer from yeast. This is not science fiction. Biotechnology holds so much promise for national security.
▶ 0:14:40But we need to get these innovations into the hands of the war fighter and in the consumer. America should dominate this technology. Modern biotechnology is an American invention after all. But just because you invent the future doesn't mean you get to control it. Our commission found that America's biotechnology strengths are atrophying and dangerously so. We lack a federal strategy to direct biotechnology development and federal funding for R&D has stagnated. We do not treat biological data as the precious strategic resource it is.
▶ 0:15:10Our biotech infrastructure and ability to attract and retain talent is second rate. And while American innovations are extraordinary, we fail to sufficiently commercialize them. Above all, the US market is not currently supporting all the diverse applications of biotechnology. There is a wellestablished group of biotech investors that fund therapeutic product development.
▶ 0:15:30But companies exploring biotech products or platforms for health security, agriculture, industrial manufacturing, energy, and defense, all things critical to US national security, are being largely ignored. America is struggling to take advantage of this chat GPT moment that's coming for biotechnology just as China is having a deep-seek moment showing that they can out innovate us in this key technology. They're making pharmaceuticals more cheaply and quickly not just fast following. These are FDA approved drugs.
▶ 0:15:59Multinational pharmaceutical companies are seeking out Chinese biotech for innovative IP and licensing deals. And this deep-seek moment in pharma could soon be coming in agriculture. China is outspending the US and the EU in agriculture R&D. In 2019, for the first time, China applied for more international patents than the United States and many of these applications were for patents that use crisper, which is this cutting edge biotechnology tech technique and agriculture.
▶ 0:16:26From there, China could outpace us in industrial applications and even in defense. They have more widely cited papers in synthetic biology than we do after all. They stand to lead at every aspect of the value chain from research and innovation to manufacturing and the underlying supply chain. We need to get our house in order unless we want to forfeit our global leadership. Our report set out an action plan for how the US government can avoid that future. Critically, we need to mobilize the private sector.
▶ 0:16:52That means simplifying pathways to market, exempting certain products from unnecessary regulation, investing in technology startups, and making the government a better customer for biotech products. all while pushing back against Chinese brute force economics. If put into actions, these recommendations will give America a fighting chance in the biotech race. But we must act now while we still have time to compete. Thank you. I'm going to ask my questions at the end and I'll yield to the ranking member Okano.
▶ 0:17:23Thank you, Mr. Chair. And I'm only going to ask one question because I don't I want my colleagues to have time. I'm I've been on the commission. Uh I guess Dr. Rosa, thank you also for your leadership. And my question to both of you is if there were one or two big uh legislative priorities that you would recommend that we could work on on a bipartisan basis, what would they be?
▶ 0:17:44Senator, well, I'll begin uh with uh one that uh I I I think is essential to our work, and that it's to uh optimize our regulatory system. uh we we propose uh creating a new entity to uh help innovators and entrepreneurs navigate uh our regulatory morass when it comes to biotech.
▶ 0:18:07Uh unfortunately so many of our innovators have to deal with multiple government agencies uh at the same time in order to get products through the process. bioindustrial products in particular. And uh so many of these steps are duplicative, unnecessary and uh significantly increase the time from innovation to market.
▶ 0:18:32thus changing your the hurdle rate for any investment and and um reducing the extent to which we see a lot of people even attempting to innovate in the bioindustrial space which is the one that most comes to mind when we think about what could benefit our war fighters. So we need to improve our regulatory process.
▶ 0:18:52Um fortunately uh we've laid out uh a viable means to do that uh in the report uh by helping uh people navigate through the process standing up a a small entity uh to serve that purpose and and work across different agencies and um uh that is not a significant investment of resources.
▶ 0:19:13I actually think in the end it could lead to more uh profitable companies and and and be resource positive for the Thank you for that question. I think one of the benefits of the work that we've done is that as as you well know um because it's all bipartisan and has all been agreed upon by a partis bipartisan group of commissioners ideally this entire leg legislative suite is open um for action which you know was one of the benefits of the work that we did over the last two years.
▶ 0:19:39Uh it's kind of like picking between your children to pick which ones are um you know the the nearest and dearest. But I think one of the elements that's critically important as we talk about the intersection with AI and biology is really treating biological data like a strategic resource. And we laid out a series of recommendations for the US to do that. That includes authorizing a web of biological data.
▶ 0:20:02Basically creating um an entry point for researchers to access the high quality biological data and the large biological data sets that already exist but are now uncoordinated and fragmented which slows innovation. Um it also includes working with NIS to create standards so that researchers um ensure that US biological data is ready to meet these models and drive forward new products and capabilities for the US Thank you Mr. McCormack. You're recognized.
▶ 0:20:32Thank you Mr. Chair. Uh thank you for both being here. I know you have incredibly busy schedules as well. Uh, one of the things I I've noticed is since the advent of uh, biomade during World War II and just trying to figure out what we're going to do with rubber at the time, we've come a long way since then, but we still have a lot of challenges. Uh, what do you think the most significant um, things they're bringing to the table right now and innovation and things that we can use something that the common person might think, oh, I didn't know that came from biomade or what's the most leading edge technology?
▶ 0:21:02Obviously AI for example is going to be instrumental in the in the way it transforms the future battlefields and weaponry and stuff like that. But what are we getting from biomade that we can actually apply right now that maybe would be exciting to hear Please go ahead doctor. You you you actually brought show and tell more examples and we have a a reception after this more examples will be shown of the really exciting research happening at the Department of Defense and other aspects of the federal government.
▶ 0:21:29But one of the things that we talk a lot about a lot these days is our supply chain dependency, right? And and our issues um with dependency on foreign suppliers for critical inputs to our supply chain. I think when we talk about biotech, we think a lot about active pharmaceutical ingredients and the dependencies we have there which are real and and are serious and biotech can provide a solution there. But let me talk about one that we might not immediately associate with the biotech solution and that's rare earth elements.
▶ 0:21:55So again, something we've been talking about a lot here in Washington, dependencies on China for production and processing of critical elements that go in our semiconductors, phones, automobiles, um weaponry, really um significant vulnerability. There are rare earth elements that exist in the United States that are sitting in mining deposits unused because it's too difficult to extract them out of these complex measures.
▶ 0:22:18There's also rare earth elements in our electronics, the watch I'm wearing, my phone and my bag that could be recycled out if we had the means to do so. But again, too complex, too difficult to extract these rare earth elements. So I have an example here that's actually by one of our fellow commissioners, Dr. Angela Belchure. I should say National Science Medal Foundation winner, Dr. She's present today. And this is a super high surface area carbon made by biology that was engineered to mine critical minerals.
▶ 0:22:47um and be magnetic in order to efficiently separate them to solve this problem that I've been describing about how do we get these rare earth elements out of these complex mixtures which I'll just show you might be hard to see from the dis but with this magnet you can see this material is moving and is able to be you know separated therefore out and so biotech can provide a solution to some of the dependencies we face like in rare earth elements I would like to volunteer to be the first uh uh recipient of a venom suit based on that material Um, I
▶ 0:23:18noticed that the FDA has kind of double application of standards when it comes to China versus US. Like they don't get investigated the same way. They have to have an announcement. They know when they're coming and they don't have the same quality. I know for a fact their drugs they produce don't have the same quality as American produced antibiotics and and other medicinal effects. Um, that worries me that we don't have the same standards. Uh, I also think that they're warping the market obviously by the way they subsidize their their their producers and they put us out of business.
▶ 0:23:45They've been taken to court, I think, by the World Trade Organization on our behalf, I think, 27 times, lost every single time. They just get better at cheating since they joined. What are we doing to combat that so we can be in a competitive market and actually hold them accountable for the future of America, not only just in biomay, but also in just anything that we need as a strategic uh strategically important substance that that we can get a hold of.
▶ 0:24:09So, so Congressman, you hit on a a key weakness of uh how we've been working uh or competing with China in recent years as it relates to biotech. We cannot wait for the Chinese Communist Party to run their playbook again. We know what it is.
▶ 0:24:26uh they aim to subsidize and distort the biotech market the same way they have other markets to corner the market in various uh strategic areas and then to choke access to the market if if we don't behave the way the Chinese Communist Party wants us to. That's called economic coercion and um it's uh it's it's something that uh we we have come to understand.
▶ 0:24:52So we need to reshore not all of our biio manufacturing but enough of it. We need to take risk out of our supply chains and and and come up with commercial pathways for the innovations that we make in this country and then to ensure that we have a a uh robust a sufficiently robust biommanufacturing sector so that we can manufacture what we innovate in here uh turn those things into products.
▶ 0:25:19And so we've we we've come up with a an approach to regulatory optimization that I mentioned. Uh we have identified uh how we can get more biio manufacturing in this country by uh strategic targeted uh investments and crowding in private sector investments so that we can create highv value ad jobs across the country and and produce these products here.
▶ 0:25:46uh consistent with President Trump's vision and the vision of Republicans and Democrats alike. And then way upstream, we need to continue to invest in the amazing innovation ecosystem we have. Uh personally, I'll speak uh just as as as a member here.
▶ 0:26:03I think some of the efficiencies that we may find in the research enterprise can be uh rededicated towards this critical area of bio biotech so that we're making sure we have as uh enough uh attention to biological innovation turning those things into products here. Do you have anything to add Dr. Roso? Yes, just I'm actually at time. It'll be great. I keep forgetting that you actually respect time in this chamber. So, but thank you for all your hard work.
▶ 0:26:33I look forward to the show and tell. I hope my staff takes lots of pictures that have been tonight. And thank you for the super soldier sent them to it. Really benefited me. Thank you. We're all having a cultural uh moment here. Senate Mr. Keing, you're recognized. Well, thank you, Mr. Chairman. Uh it's great to see Senator Young. Uh Dr. Roso, thank you so much for being part of this.
▶ 0:26:54We're talking about uh you know biotech and innovation and in the silo of the defense industry but really I can't conceive of the fact that uh in the bigger picture the cuts that were made the cuts that are forecast in our budget the decisions that are being made by Doge the tariffs that are being uh you know by the administration now the effect that has on the people uh that will be
▶ 0:27:24entrepreneurs, uh the cuts in our universities for research, uh the effects of immigration, all these things are going to have an effect as well. So, Senator, I mean, how much of these outside I don't call them outside factors. I think they're really integrated. Uh our brand in this country is research.
▶ 0:27:42we're the best and and both of you are saying we're losing ground, but these other decisions can't but have a a very negative effect uh on the kind of research that we're talking about that's so important uh not just for our defense but for our economy. Well, thank you, Congressman. It's good to see you again.
▶ 0:28:02Uh it won't surprise you that uh I anticipated uh this uh naturally this this line of questioning uh especially about tariffs since you and I worked together on working on the other we did we did and and one of the points of emphasis uh that that both you and I had was uh we wanted to create more good jobs here in America. Uh we wanted to make our economy more resilient.
▶ 0:28:26We we saw uh some of those efforts is as is consistent with that and and uh both of those things we think are are laid out and this is a summary version of the report about how we can do those things. And then let me just hone in on on your emphasis on on research spending. I know it's very important in your part of the country as it is mine. It's important to our national security historically. Um we've laid out uh the areas in which we feel like uh continued investment in research is essential.
▶ 0:28:54I mean uh we we have seen through the space race and up into the computer age and now into this age of biology uh that handsome dividends associated with making targeted and smart federal research investments. Um I think the ad administration believes uh I think we should all be open to the notion that uh not every single investment we're making in in our research enterprise is a first order of importance.
▶ 0:29:24This is this is national security relevant. This is a national security investment. So we think so much of of uh research investment can be channeled uh into these missionritical areas uh like this one. So uh we've come up with ways that we think uh are smart and costeffective to do that.
▶ 0:29:45I should also emphasize we have a lot of uh in inherent talent uh that uh we in we recommend uh we we leverage in our department of energy labs biological talent. Now perhaps a generation or two ago we would have just created a a standalone DOE lab but that would have been costly and this isn't what our our taxpayers are looking for. They want us to take our assets and figure out the most coste effective way we can meet the mission.
▶ 0:30:13So what we recommended is borrowing from the model of DARPA grand challenges, identifiing really hard scientific problems that need to be solved for the US to continue to lead the way in biotech and charging these groups with administering uh grand challenges for our amazing researchers, innovators and entrepreneurs out there that would love the opportunity to be welcomed into solving a hard problem.
▶ 0:30:41So that's how we address the research uh dimension of it. Dr. Rosa, do you have anything to add? Yeah, I was just going to expand a little bit on those research challenges, Senator, that you lay out. Um we again, this is an area to to reference Dr. Angela Belchure, that that she led um with our staff. What were the questions that if we could solve here in the United States that would make the US be the perennial leader in biotechnology, be able to rapidly engineer biotech products, um and then scale them up?
▶ 0:31:09And so that is how we laid out these grand challenges. The first is around making biotechnology predictably engineerable. Um one of the luminaries in the field describes how biotech is still this field of tinker and test and we need to get to design and build this true engineering discipline. So we lay out a series of efforts to do that.
▶ 0:31:28Um and then uh the second grand research challenge is around making biio manufacturing scale up and predictable uh predictable and cost competitive so we can move these products from lab to market into the hands of war fighters. I understand for instance trying to avoid the valley of death and some of the problems with small businesses but I also think our universities remain a tremendous uh you know resource in our country and they're being damaged with these cuts uh as are uh people that are thinking about being entrepreneurs who could locate in another country
▶ 0:31:59and talking about China I know in my own district there are uh scientific uh facilities there where they're offering their own private labs their own housing uh just competitors and I'm worried of these young PhDs, these young scientists. Uh we're going to lose them and we could lose them for a generation. I know my time is up. I'm not on Senate time and I'll yield back. I've been trying to be generous. I think Mr. Vinman, you're you're recognized next.
▶ 0:32:29Thank you, Mr. Chairman. Um, so we're obviously entering a phase of growth regarding our ability to engineer biology enhanced by AI and other digital technologies. What areas is the US leading in and where are we trailing?
▶ 0:32:48So we have laid out in the report a series of our uh perennial strengths which has been in that innovation ecosystem in the ability to create the cutting edge tools around engineering biology um having the best market in the world as we lay out and so that area that intersection you know we have historically led in um when it comes to manufacturing and sort of the next stage of scaleup this is an area where we're seeing trends replicate as we did in other industries where US companies particularly
▶ 0:33:18that are doing bioindustrial manufacturing are leaving the US to do their scaleup and we've heard from the commission we spoke with over 1,800 stakeholders um across the biotech ecosystem domestically and abroad and we're able to understand some of the challenges facing those researchers and inventors here in the United States who want to perform manu biommanufacturing here domestically um the facilities are not available um and they're not those that are are not accessible
▶ 0:33:48to those individuals. And so while they would like to be here, they are going abroad to do that work. Um we have a series of recommendations around this that would create pre-ompetitive u pre-commercial I should say uh facilities here in the United States for products of uh industrial agriculture and medicine to be able to innovate around biio manufacturing techniques and bring back some of these manufacturing capabilities to the United States.
▶ 0:34:17So I'm concerned like my colleague Mr. heating that um we're taking a hatchet to something that um Senator Young you described may require a scalpel and so uh cutting funding to NIH, CDC, NSF um and um when we're in this period of of global competition um the Chinese are they're throwing money at at this issue.
▶ 0:34:44Uh we are looking at actually being thrifty and I think that's the wrong approach. um it's not going to serve it's uh pennywise and pound foolish in that regard. So I think we need to u have the administration or make the case that this is an area of geopolitical competition, national security imperative. I'm convinced in that issue, but let's not be pennywise and pound foolish on an issue like this.
▶ 0:35:13Well, uh thank you for the opportunity to respond, Congressman. Um, you know, one of the responsibilities we have uh in the Senate is advise and consent. So I've had the opportunity to visit with uh the president's team uh which is now mostly in place and and uh everyone from uh uh Michael Katzios OSTP to uh secretary Lutnig at at commerce uh to uh various DoD officials uh including
▶ 0:35:44uh but not exclusively uh limited to uh our now secretary of defense u have emphasized the importance of this because I've asked about it. Uh they recognize that that our competition with China, but also with other strategic rivals and adversaries is a technoeconomic competition and that we're going to have to make the requisite investments in those areas uh and uh prior prioritize it strategically uh in order
▶ 0:36:14to defeat China. So I I think you know the notes they have hit are entirely consistent with what we are recommending uh here and and uh I do believe that uh much of of uh what is needed is is just more focus and bringing to bear existing funding lines uh or institutions uh and and repurposing that towards uh our highest priority uh uh uh uh areas uh like biotech
▶ 0:36:45And I don't want to uh you know understate the importance of uh the regulatory piece of this as well. We go out into field hearings and consistently hear uh that innovators either had to stop innovating uh or uh go overseas with their amazing innovations on account of our our tedious regulatory atmosphere. It just drove up costs unnecessarily. Yeah. Do you have any um legislation that's on the shelf? I mean we do. Sure. Okay. Yes.
▶ 0:37:15Yes. And um our commission will will remain impanled for a number of months to see these recommendations through to provide technical assistance uh to members of Congress and and committees uh so that uh we can we can uh move these recommendations through the process. Yeah. Thank you. Thank you. Miss Hulahan, you're recognized. Thank you everybody. I'm really excited for this conversation.
▶ 0:37:45Um, biology is, I think, something that scares the hell out of me and I'm really, really excited that we've spent so much time, your commission has spent so much time, uh, thinking about it. I want to sort of foot stomp on what Mr. Vinman uh mentioned and my colleague also uh mentioned that we we can't possibly have this conversation without seeing the hypocrisy of cutting all of this science research dollars and all of the workforce uh issues that we're uh busy uh worrying about.
▶ 0:38:15We have to be able to recognize that in order to stay competitive on something like biology, we have to make sure that we're maintaining our competitive advantage with basic research and that we're maintaining, if we have it, an advantage with workforce. Um, but I would actually like to ask questions, a couple questions of Senator Young. Could you tell me a little bit more about uh the commission's recommendation in terms of how uh we as a nation, the United States should be uh leading the way on the ethical use of biotechnology.
▶ 0:38:44So the ethics and the US military, why is that important that we lead by example and how do we uh set those examples? You mentioned the Chinese are not necessarily known for their uh uh example. Um well I'm grateful for the question uh uh Congresswoman because uh that that is essential and this is one of the reasons why we need to have a robust uh bio uh tech enterprise here from from uh the upstream innovation
▶ 0:39:14all the way down to biio manufacturing and and make making sure that our our war fighters are procure procuring u biotech products uh as well. the the commission recommends for those who who aren't familiar with this recommendation creating an advisory body an advisory body to think through um uh the various you know ethical issues that might come up as new innovation occurs uh because as you rightly pointed out this
▶ 0:39:44becomes very complicated and uh can be ethically fraught and and so having some assistance to think through those issues there's there's precedent to uh a lot of precedent to advising outside bodies to consult members of Congress. This would be nonpartisan advice. Uh we recommend standing up this Congressional Commission on Responsibility and Ethics in Innovation.
▶ 0:40:10And we're just we're at a point right now uh in which uh we we see the People's Republic of China in particular and most notably um experimenting with designer babies and um they seem less inclined to be concerned about these sorts of issues and they can use certain um please go ahead. No, no, I I I think that that's a fantastic suggestion. I believe that's one of the recommendations that uh that Mr.
▶ 0:40:39Vinman was asking about legislative ideas and I think this is one of them and and I hope that we're able to move forward on that and in the interest of of time I was uh wondering if you might also speak a little bit more about uh along the same line what the DoD needs to do to be a better customer uh for the biotech industry. I know that we struggle as a defense industry just in general on any technology.
▶ 0:41:03um how can we focus on uh the the industry on um the DoD uh sector on um biotech? I can take um the the start of this question. So having come from the Department of Defense, I see firsthand um and I've seen firsthand in my work the really exciting research that's going on in the department of defense and I've brought some of those examples to share with you all today.
▶ 0:41:25Um I also shared a little bit in my opening statement about some of the market challenges and uh you know where there is a wellestablished group of investors that invest in therapeutics. There is not the same uh group of investors investing in biotech for national security applications. Um the risk is too high and the reward is uncertain.
▶ 0:41:46And so we lay out a series of recommendations that would make the DoD a better customer with um efforts like offtake agreements or advanced market commitments for specific biotech products that meet defense needs to be able to say should a company be able to develop this product that meets DoD specifications. The department will purchase it. This demonstrates that there is a market available and take some of the risk away from those investors who can then step in and support some of these companies through development.
▶ 0:42:16And with my last half a minute, I it strikes me that we've seen this play before in a lot of ways. And you're saying um China has kind of a strategy that they've developed already for other industries to dominate other industries. I think it was something like copy and then uh conquer and then strangle I think was the language that you guys used in your report. How do we make sure that we don't end up having to do the Chips and Science Act 30 years from now?
▶ 0:42:41Well, with the chairman's uh permission, I'll respond in about 20 seconds here because yeah, I mean, you've basically tooken taken my my line from me. Uh, Congresswoman, we don't want to have to resort to another Chips and Science Act. If we act smartly, that is to say, preventatively, we can avoid that right now. we can continue to lead in biotech, our war fighters, the American people will benefit uh in in so many different ways. But if we wait, uh this could be very costly.
▶ 0:43:11Uh yes, in terms of the federal budget, but also uh conceivably in in terms of uh uh the lives of of our men and women in uniform. So that's what we're trying to avoid. Thanks. I yield back. Mr. Ryan, uh thank you, Mr. Chair, and I'm sorry that uh I'm tardy. I'll do I'll do push-ups after this. Um uh thank you all for thank you both for being here and if I do ask something that you've already answered please um feel free to let me know. Um uh this is far from my area of expertise.
▶ 0:43:40So kind of an elementary question within our broader um within the broader space here in the US like where would you say the the true intellectual property and and knowledge exists visav academia and research and the sort of um early early stage or is is more of the real subject matter expertise in the commercial space. H how would you kind of weight and ratio that both of you just to understand the landscape?
▶ 0:44:11So this is actually one of my favorite things about biotech is that it is kind of all across the country. It is really for everyone. There are pockets of expertise at certain universities at um certain cities in the country but that really is spread across you know the entire ecosystem because biio manufacturing takes uh raw inputs like that's grown in fields in the heartland of America and can use that as the starting input and starting material to grow products.
▶ 0:44:41This is really a technology that is accessible across the United States. Um and you know we have companies we've talked to many of them who are taking IP and technology in one part of the country and commercializing and trying to build manufacturing facilities in another part um and putting those facilities next to large agricultural fields and being able to port over the surplus agriculture and using that as a starting material. Uh one more point if you'll allow me this is actually gets back to the grand challenges.
▶ 0:45:12Um right now that starting input is limited somewhat to raw sugar things like coming from corn. But with what's called flexible feed stocks and we have a grand challenge around that you can innovate around the starting material for biio manufacturing. You really just need a source of carbon. So what today is corn from the Midwest could tomorrow be mushrooms in Pennsylvania or apples in Washington. It's really an accessible technology. It can be in the backyards across all of America um and grow jobs across the country.
▶ 0:45:40It is again Mike just want to know we have a lot of apples in New York's upstate New York just just for the record Senator Yeah please and if I could congress and I just emphasize these aren't these aren't PhD jobs most of them these aren't jobs that require uh a fancy MBA or or graduate degree these these are jobs that if you have a high school education you may may require a little follow-on training at the lo local community college but uh good paying biommanufacturing jobs uh across America America, we
▶ 0:46:11could we could imagine a reordering of supply chains and I think we'll we'll actually realize that in in uh the next several years uh where there's more distributed manufacturing uh occurring near customers uh drawing on corn stovers and and switchgrass and other inputs uh that uh go into as feed stocks to uh biio manufacturing and and so uh really exciting economic opportunities.
▶ 0:46:37At the same time, we're staying in front of the Chinese, which has national security implications. And just one quick followup on on both of the national security, but also the economic development side. Are there places or groups, excuse me, that have kind of started to get this right that are really leading the nation right now in terms of bringing that all together or are we still have work to do to like is there a place you could point to as a case study of success where this is already happening where my my mind goes to places outside of the United States
▶ 0:47:07unfortunately but there there have been uh a few green shoots so to speak uh here in the United States uh one was through the Chips and Science Act at TechHub uh in Illinois uh that that uh could could definitely uh become much more important to that area's economy. But uh Dr. Rosa, sure.
▶ 0:47:26Um there's also Biomade, which is a manufacturing innovation institute that was funded by the Department of Defense uh that works on scale up challenges for biommanufacturing, but is putting facilities across the country to be able to drive forward biommanufacturing. And again, we you may have missed my um my telling everyone about the reception that is happening after this event where we'll have some of those products to show people, but it's things like a shirt from Lululemon or shoes from Nike. And so there are great examples of this happening and and coming to fruition.
▶ 0:47:56We just need to make that flywheel turn faster. Yeah. No, appreciate that. And um again, appreciate not only both of your work, but everybody involved in the uh the commission. I know it's a lot of time um and uh I think it's a great service to the nation. So thank you and yield back, Mr. Chair. Thank you. We have a guest with us, Miss Stephanie B. So I ask unanimous consent that non-committee members be allowed to participate in today's briefing after all the committee members have had an opportunity to ask questions. Is there an objection? No, Mr.
▶ 0:48:24Chair, I just like to say I really enjoyed working with Representative Vice uh on the commission and she uh added a lot of valuable contributions. Fantastic. Without objection, non committee members will be recognized at appropriate time for five minutes. Miss Spice, you're recognized. Well, thank you very much, uh, chairman, and it's really great to be back in the city subcommittee hearing room, uh, with all of you. I want to first say thank you to Senator Young and Dr. Razio for their tireless work um, the last two years on this report.
▶ 0:48:52And I see many of our fellow commissioners that are also uh, participating in the audience this afternoon. So uh it's been a privilege to be part of the commission the last two years for me I did not have a lot of knowledge of biotech or biio manufacturing in the last two years I have learned a tremendous amount and it I think is uh really incumbent upon us to take what's in this report and move forward with it.
▶ 0:49:19Um there's been a growing interest in the biotech space and as everyone here knows the CCP is investing heavily into biotech and biio manufacturing. In 2023 the R&D spend in biioharmaceuticals reached 15 billion dollars a 42,000% increase from 2015. China currently controls 80% of global pharmaceutical supply and possesses a monopoly of key elements of the global pharmaceutical chain.
▶ 0:49:48And while China may pose a doineering may pose do as doineering in biotech, the US still has an edge. But action is needed for us to grow in this uh in this realm. The commission's report hopes to give a series of recommendations to develop and maintain our lead in the field of biotechnology. It highlights the need for the US to develop the necessary infrastructure to scale the burgeoning bioeconomy at home.
▶ 0:50:13and it explores ways to grow our biotech workforce ensur ensuring that we continue to be a hub for the best and the brightest in the world. Uh it also makes re recommendations to help simplify the regulatory process and make it more appealing for businesses who want to develop their products right here in America. Uh again, it's been fun to be a part of this.
▶ 0:50:34It's been incredibly eyeopening um to to realize the work that needs to be done and I very much look forward to working with um Row and and Senator Young and Senator Padilla uh to move this many of the recommendations that have been put forward legislatively uh to make those happen become a reality. So with that, Mr. Chairman, thank you for indulging me for a few minutes uh in this uh subcommittee's work. And with that, Mr.
▶ 0:51:04Cherry, thank you. I want to thank you both for your expertise and sharing with us today. So, our, you know, our uh subcommittee, we look at cyber, electronic warfare, AI, uh, information or technology enhancements and, you know, I feel like I sort of understand this is hard and so this is something new for me. So, I really appreciate learning from you and I look forward to digging into the report and learning from it.
▶ 0:51:29And what we find in these other areas whether it's cyber, AI, EW, you know, the private sector is ahead of us ahead of the military and it's hard for the military figure out how to work with the with our private sector and fund things that year, get the technology sooner. Are you seeing the same issues with biotechnology? Yes. Yes. The same paradigm repeats itself. Um and we have a series of recommendations to try to address that.
▶ 0:51:59Um one to highlight is on military specifications. So sometimes uh a product designed by biotechnology may meet the same standards as a product with conventional or legacy manufacturing. Sometimes it may even exceed those standards. But because it biommanufactured in many instances the milspec is not written in such a way to accommodate that product.
▶ 0:52:20uh and so with adjustments you know that as you as you well know creates a chilling effect in terms of being able to actually procure that product and the acquisition cycle. So with adjustments to that we aim to to fix one of those perennial problems that we've heard about from stakeholders. Yeah. The culture of the military is have a five seven eight year plan pay down the road and it doesn't work in this in this model.
▶ 0:52:43Uh do do these companies have the same challenges that we see with others with a valley of death where they get a start but they can't get traction really. Yes. How can we help with that? Yeah. Well I I I think one of the key things we can do is is uh implement some of these demand signals uh that Dr. Roso mentioned.
▶ 0:53:06uh if if an innovator has assurance that uh once they develop a product and develop it to DoD specs, it will be procured then uh they'll continue to stay in business and they'll attract investors and and they'll remain a viable enterprise but without that demand signal uh becomes very challenging for them to sustain the regulatory process and all the rest. Thank you.
▶ 0:53:32And we also lay out a recommendation around an independence investment fund that would be run um by a non-governmental manager operate somewhat like a venture capital firm um but with government priorities in mind. We recommend that a portion of this fund be um directed towards biotechnology but not the entirety of it owing to as you describe the challenges for biotech repeat itself and other critical and emerging technologies.
▶ 0:53:55Um this aims to have the government um be a source of again buying down risk for the private sector, signaling that this is something that's important to the government and and get private sector, you know, off the the sidelines and and on the field to play for all of these emerging technologies that are necessary for national security. Thank you. How can DoD implement the use of AI with biodata to drive biotechnology innovation while protecting against malicious malicious well uses.
▶ 0:54:26Yeah. In in the biotech space, uh one of the key things uh that we consistently heard was there wasn't enough AI ready uh biotech data uh for our innovators to get access to. So we propose creation of this uh web of biodata that will allow researchers uh to share one another's uh findings and and and then we also uh allow that biodata to be accessed and then utilized by by innovators.
▶ 0:54:54So that would take some of the cost and some of the challenges uh out of assoc associated with solving problems uh for our innovators and and as sen points out critically it would be cyber secure. So you would, you know, have that added protection around access to those data Okay. Thank you. Does anybody have a follow-up question? I want to take a moment to thank Representative Con, Representative Bice, thanks for serving on this commission and your leadership.
▶ 0:55:23Thank you to you both and and I could just tell for me I'm on the tip of the iceberg. I got a lot more to learn in this area. So I appreciate your leadership and your hard work. Thank you, Chairman. Thank you. Thanks. We'll close. Go ahead. I'm I was just going to say thank you to you for putting this together and allowing us the opportunity to be able to talk about the report.
▶ 0:55:45It's important and it needs to be highlighted and I think the um you know discussion here is really a first step, a beginning to letting people understand how important this truly is and how uh critical it is for Congress to to to take action. And I would also just add that um you may not be aware but in the president's executive order he actually talked about investment in biio manufacturing.
▶ 0:56:09So I think this goes along um with the president's uh sort of vision for transformation of uh the space and I don't know senator if you wanted to add anything to that. I think we've come to a close and and I overstayed my uh welcome in the opening comments, but uh the golden age of innovation, right, uh is something we're all trying to usher in. So, uh I certainly think that's consistent with the president's agenda. Thank you. Well, I have a 10-hour flight on Friday.
▶ 0:56:37I know what I'm reading. All right, with that, we'll close. Thank you.