Balancing Biotechnology Innovation and Biosecurity: Securing U.S. Leadership in a Global Race

Welcome to today's hearing entitled " Balancing Biotechnology Innovation and Biosecurity, Securing US Leadership in a Global Race." I recognize myself for five minutes for an opening statement. Today's hearing examines a question that goes to the heart of our national security and economic future. is American biotechnologically enterprise adequately protected and are your taxpayer dollars that fund it being wisely spent or safely spent. For decades, the American biotechnology has led the world and become one of our nation's greatest strategic assets. Our researchers, our universities, and our companies have produced vaccines, therapeutics, and innovations that have saved countless lives and driven our economy forward. But that leadership is no longer guaranteed. The Chinese Communist Party has made biotechnology a national priority, pursuing it with the same coordinated effort and intensity that applied to semiconductors and artificial intelligence. The CCP understands that whoever leads in biotechnology will hold significant advantages in medicine, agriculture, industry and defense for decades to come. We cannot afford to be complacent. At the same time, we must ask the question closer to home. Has our oversight of high-risk biological research kept pace with the risks that we face? In two thousand fourteen, the federal government paused funding for certain gain of function research while it evaluated the risks versus benefits. In two thousand seventeen, the Department of Health and Human Services established the P three CO framework a case-by-case review process. Subsequent experience, particularly with the federally funded research involving the Wuhan Institute of Virology and E- Ecohealth Alliance, raised serious questions about how effectively that system worked in practice. I am encouraged that this administration has taken that stretch seriously. Executive Order fourteen two ninety-two directs federal agencies to restrict support for dangerous gain of function and other high-risk biological research, where adequate oversight and safeguards are lacking and cause for a stronger screening of synthetic nucleic acids. These are important and overdue steps, but an executive order is only as strong as its implementation, and this committee has an obligation to ensure these directives are carried out fully consistently without loopholes for research conducted overseas are outside the scope of federal funding. We cannot discuss biosecurity today without also addressing artificial intelligence. AI is transforming biotechnology, helping accelerate drug recovery, discovery and protein design, and bio-manufacturing in ways that strengthen American competitiveness and saves lives into the future. That's a progress that I recognize and welcome. But the same tools that accelerate beneficial research can also lower the barriers to biological misuse, making it easier to search, organize, and analyze dangerous biological information which can be weaponized. We must ensure that the federal support, open data sets, and widely accessible A I services do not become a shortcut for adversaries or bad actors. That is why I introduced the Biotechnology Workforce Alignment Act to close the gap. between the federal research dollars we invest in biotechnology and the trained workforce needed to build and scale those innovations here at home, not overseas. My home state of Georgia is a shining example of this put into action. Without schools like Georgia Tech or the University of Georgia leading the way, we are in big trouble. We need to ensure that American breakthrough translates into real American jobs. manufacturing capacity, and economic strength. I also introduced the Biotechnology Diplomacy Leadership Act to ensure the United States speaks with coordinated voice on biotechnology policy abroad and confronts the risks posed by adversaries seeking access to our data, technology, and capabilities. I welcome our witnesses today who will help us examine whether federal biosecurity policy and oversight have kept pace with the challenges, how the convergence of AI and biotechnology is reshaping both opportunities and risks, and what additional steps Congress must take to keep America's biotechnology enterprise secure, competitive, and worthy of the American people's trust. With that, I yield back the amounts of my time. I now recognize ranking member Sykes, the representative from Ohio, for opening s- statement.

Thank you, Mister Chair, and good morning everyone, and a special thank you to our witnesses for joining us today. Uh, these are very important topics and I look forward to a very robust and nuanced conversation uh in the respect that this uh topic deserves. Biotechnology is an incredibly exciting field of scientific research with immense potential to solve some of our biggest problems, from manufacturing to medical treatments to crop resilience, innovation is racing ahead and generating advances at an astounding rate. America's leadership in biotechnology has brought enormous benefits to our economy and our society in recent decades. Recent estimates estimates suggest that US biotech sector supports over six hundred thousand jobs and contributes over two hundred billion dollars, annually to our national GDP. Biotech innovation is no less vital for American competitiveness in emerging technologies. The cutting edge breakthroughs developed in the biotechnology sector position our nation at the forefront of the next generation of scientific discoveries. With the help of the Chips in Science Act, the gift that keeps on giving, and my district, Ohio's thirteenth district, the biotech sector has grown rapidly in recent years. In twenty twenty four, I announced a fifty-one million dollar investment for the Akron Sustainable Polymer Tech Hub through the federal tech hub's program. Thank you to this committee. Biotechnology now supports tens of thousands of high-paying jobs in Ohio, many of them concentrated in the Akron, uh, Cleveland region and leading at leading institutions such as the University of Akron. A recent survey found that Ohio's life sciences industry employed nearly sixty-five thousand people earning average annual wages exceeding six figures. Biotechnology is an engine of growth for our local economy and offers tremendous opportunities for working families within our region. But America's leadership in biotechnology is not a given. There is no question that China has made enormous strides in developing its own biotech in recent decades. To compete with China, we must and we need to invest in biotechnology with smart policies and a wise approach. This is a refrain we hear often in this committee and something that gets rare bipartisan support. However, the Trump administration has done the opposite. In May twenty twenty five, President Trump issued an executive order that claimed to end federal funding for dangerous gain of function research. But the executive order was so broad, so sweeping, so vague, and poorly written, written, that it had a chilling effect on biotechnology research around the country. And I want to be clear, biosecurity is a serious issue. And of course we must ensure that biotechnology research is conducted in a way that is safe, secure, and responsibly minimizes risk and potential harm to our society. Nobody disputes that we need a well-crafted safeguards to govern so-called gain of function research when it has a genuine risk of harm. Least of all, the scientific community itself, which truly understands the need for proper safety protocols, clear transparency and strong ethical guardrails. But instead of being smart, the administration has embraced a rigid black and white policy that threatens to undermine our innovation economy, while impeding our ability to address infectious disease threats and respond to future pandemics and outbreaks, further challenging this country's public health. Scientists, universities, professional societies, and even federal agencies have struggled to make sense of the ambiguous definition of dangerous gain-of-function research. As a result, whole fields of science have been gripped with fear, that long-standing research might unwittingly run afoul of the new federal restrictions, and their fear is not unfounded. In the summer of twenty twenty five, the administration terminated dozens of research grants, allegedly due to gain of function concerns, including grants in fields such as tuberculosis research, that had no plausible connection to any safety risk. In July twenty twenty six, the administration issued a new policy to carry out the executive order, But gain of function remains so ill-defined in the policy that researchers continue to be mystified about whether their own research might be classified as potential or dangerous gain of function. These definitions are broad, the penalty for violation is high, and researchers continue to fear the personal and professional consequences that could result if President Trump decides to target their work. The only thing that is clear about the Trump's administration approach is that it badly needs guidance from actual scientists, the actual experts and human beings who understand biotechnology and understand how to prudently oversee it. More than anything, that is what has been missing from this recent debate, the voices of the scientific community who can help guide us to a culture of biosecurity that allows biotech innovation to thrive rather than lockdown mentality than a lockdown mentality that impedes biotech and allows China to get the best of the United States. That is one thing that I hope to rectify today, and I know, Doctor Granville, you are a leading scientific expert. I hope I pronounced your name correctly. And I am grateful for your willingness to testify before the committee. So thank you. Look forward to hearing from all of you and I yield back.

Thank you, ranking member Sykes. I now recognize the Chairman of the full committee for a statement.

Thank you, Chairman McCormick, for holding this hearing on an issue with significant implications for our entire country. Today we are here to address a field that is increasingly consequential to our national security, to our economic competitiveness, and to our scientific leadership. Biotechnology is a term that many of us hear free- frequently, but may not fully grasp just how many industries that it touches. Biotech uses biological systems to develop products, processes, and solutions. As these technologies advance, The field is reaching into an expanding range of industries, including health care, agriculture, chemical manufacturing, fuel development, and even artificial intelligence. Uh, developments in biotechnology can provide tremendous benefits to our communities our industries and our economy. But these advances also present significant risks. Laboratory accidents, deliberate misuse, inadequate oversight, or the release of information or biological materials that could u- be used to harm the public pose serious threats to our national security and to our public health. Maintaining leadership in this field, therefore, requires not only sustained support for research and development, but also strong and effective safeguards. In May of twenty twenty five, President Trump signed executive order one four two nine two. improving the safety and security of biological research, which strengthens federal oversight of high-risk biological research, particularly dangerous gain-of-function research. And our - the order seeks to distinguish legitimate and bio- and beneficial biological research from activities that could pose unacceptable risks to public health or to our national security. Not every country or every, uh, company operating within the country shares the same concerns about biosafety and biosecurity. And that is one reason that Congress enacted the Bio-Secure Act. Last December the act establishes restrictions on federal procurement and contracting involving equipment, services or other capabilities provided by identified biotechnology companies of concern. These actions are critical steps. But more work remains to be done. We must continue developing policies, procedures and oversight mechanisms that balance American leadership in biotechnology with the responsibility to protect our country from serious risks. China is not standing still. The CCP is rapidly expanding its biotechnology capabilities. Its biomanufacturing capacity, research and development efforts, and workforce continue to grow. The United States must strengthen and expand our own capabilities, and move faster to stay ahead. Biotechnology is one of the fastest growing areas of scientific research and manufacturing. The United States must support this growth because it's critical to our economy, national security and to our communities. We will only maintain our leadership in the face of strategic competition if we adopt policies that actually strengthen our domestic capabilities while protecting our research resources and people from bad actors. I look forward to hearing from our witnesses today uh about what more we can be doing to advance American biotech research, domestic and bio-manufacturing, and supply chain security and innovation while ensuring that the United States remains competitive with China. I want to thank all of our witnesses uh, witnesses that are here today, I'm looking very much forward to hearing your testimony and, uh, you sharing your knowledge and your expertise, and I'll also wanna again thank, uh, Chairman McCormick for holding this very important, uh, hearing, and I yield back the balance of my time.

Thank you, Mister Chairman, I now recognize the ranking member of the full committee for a statement.

Uh, thank you Mister Chairman, uh, McCormick and ranking member Sykes, uh, for this hearing and I wanna thank the witnesses for being here and for your testimony. Um, I wanna start, Mister Chairman, by asking unanimous consent to enter into the record a letter from the American Society for Microbiology.

Without objection.

Uh, it's one of the, uh, country's oldest and most respected scientific societies, and I agree very much with the ranking member that the voices of the scientific community need to be heard in this discussion. Uh, ASM has a valuable perspective

Mm-hmm.

on these issues and I'll return to that during our questions. One of the things that they point out in their letter is that uh the McKinsey Global Institute has estimated that as much as sixty percent of the physical inputs to the global economy could in principle be produced biologically that is a stunning possibility and I see that one of our witnesses is connected with the uh Doctor Endy uh visiting Doctor Endy's lab at Stanford uh is mind-blowing to see what the possibilities are. Um now th- this committee has a long and really impressive legacy uh of bipartisanship uh and oversight for technology and biosecurity. Uh the Bipartisanship in Science Act had several provisions uh taking our agencies uh tasking our agencies to support research on the safety and implications of engineering biology. And in this Congress, we approved H R thirty twenty nine, a bill to support nucleic acid uh screening research at NIST. Uh, that bill has since passed the full House and I wish the Senate would take it up. Um, we're also looking closely at the legislative ideas catalyzed by our colleagues from the National Security uh Commission on emerging biotechnology important stuff. Uh for this year, uh for years, this committee has maintained a deep understanding of and respect for the spirit of openness that animates life science uh research. Republicans and Democrats have taken biosecurity and safety uh seriously, but also understand that to be world leaders in biotechnology we must be strategic uh in how we legislate and perform, uh oversight on biosecurity and unfortunately, the term " strategic" does not really uh adequately define the actions of the Trump administration in this area and how they've approached the issue uh Ranking Member Sikes has talked uh length about these concerns so I'll focus instead on what is at stake for us to lose one of the things I I um wanna talk about uh Mr. Hodges in your work with Doctor Endi at Hoover um Doctor Endi was part of the research community that contributed to the development of the very first synthetic cells created entirely from scratch, a remarkable achievement uh for American life science. And when I texted him congratulations, uh he did uh text back saying that he we beat China. So that was uh a a good step forward, but he, Doctor Andy recognizes that the US can't, uh he says, ride the brakes on biotechnology innovation and expect to remain a world leader. Uh, I, I remember touring the lab. Um, the, there's a little sign that one of the scientists made that says the Wright uh, brothers didn't need a license. Um, and it's, it's, we have to keep that in mind if we are going to be successful. And that doesn't mean that we don't take security seriously. We do. But, uh, we have to make sure that we also don't stifle innovation in a way that is not strategic. I just wanna say a final thing on a concern that I have, it's not really the purview entirely of this committee, and that's the fact that for years we in the United States have benefited from the fact that eighty percent of foreign-born STEM PHD graduates wanted to stay in the United States and become Americans with us, uh, for a variety of reasons, hostility towards immigrants, lack of, uh, uh, visas avail- availability, uh, h- hostility, uh, the number of people coming from other countries to get their PHDs and stem has dropped and the number uh who want to stay afterwards has also dropped precipitously. That is bad news uh for our country. You know, a little under fifty percent of the Nobel American Nobel Prize winners were Americans who are here by choice, Americans born in another country who decided to become one of us. And losing that, uh, will, uh, harm us and it will not only harm the research done here, but also our international, uh, partner- uh, partnerships and our dialogue and transparency. So with that, um, Mister Chairman, I'll yield back with thanks also, uh, for this hearing, which I think is an important one.

Thank you. Ranking Member LaFleur. Now let me introduce our witnesses. Our first witness today is Doctor Anamona Franz, a visiting research fellow at the American Enterprise Institute. Thank you for being here. Our other witness is Mister Joshua Hodges, visiting fellow at the Hoover Institute. And our final witness is Doctor Gigi Grombol, Professor for Bloomberg School of Public Health at Johns Hopkins. I now recognize Doctor Friends for five minutes to present her testimony.

Thank you. Chairman Babin, met- ranking member Lofgren, Chairman McCormick, ranking member Sykes. Members of the subcommittee, thank you for the opportunity to testify today. I'm a visiting research fellow at the American Enterprise Institute and a post-doctoral research associate at the University of Notre Dame. My work focuses on dual-use research, biosecurity, and emerging technology governance. The central point I want to make today is that the US does not have to choose between leading in biotechnology and governing it responsibly. However, both require active investment in the research that sustains American leadership, and in safeguards that keep pace with technological progress. Biotechnology has already transformed sectors ranging from medicine to agriculture and its impact will grow as the underlying technologies mature. But the same research and tools that produce those benefits also create risk. This so-called dual-use dilemma makes biotechnology so difficult to safeguard without slowing beneficial research. Biological threats themselves are not new. Natural outbreaks, laboratory accidents, and deliberate misuse are all well documented. What has changed is the pace of progress. Together with falling costs, the barriers that once made engineering biology difficult, I wrote in. AI in particular is changing what is possible, and introducing risk with little precedent. Advanced models could reduce the expertise required to manipulate and potentially weaponize biological agents, a concern that has been raised even by the companies building these models. In a recent paper published in the journal Science, researchers used such models to generate viral genomes from scratch. Sixteen of those designs produce viable infectious viruses. The capability to design novel pathogens creates new risks for two reasons. These pathogens may not resemble anything found in nature, so existing safeguards may not recognize them. And a pathogen that is optimized for the sole purpose of causing harm, could be more dangerous than anything natural selection has produced. These risks are substantial, but tractable safeguards have been identified. Here, I want to focus on three. First, Congress should require screening of synthetic DNA and RNA orders. DNA and RNA are key ingredients for life sciences research. Researchers order custom sequences from commercial providers. To date, no binding fegr- federal requirement obliges those providers to screen synthesis orders or to verify their customers. Safeguards rest on voluntary industry screening. But an actor turned away by one provider can simply order from another that does not screen. Congress should establish the requirement for every provider to screen orders and verify customers. The bipartisan biosecurity modernization and innovation act introduced in the Senate earlier this year would be a major step towards that goal. Second, Congress should fund pathogen-agnostic biased surveillance. Most surveillance today targets specific known diseases and would likely miss a novel threat. And funding has followed a pattern. It surges during each crisis and contracts afterwards, letting capacity erode before the next crisis arrives. Congress should provide stable, multi-year funding for pathogen-agnostic detection systems. The capacity has to be in place before a crisis and cannot be assembled during one. Third, Congress should close two gaps in federal research oversight. Recent federal dual-use research governance policies, the July twenty twenty-six US government policy for stopping high-risk life sciences research could significantly strengthen oversight. Realizing that potential will depend on implementation and on clear guidance for the scientists and biosafety officers who apply these policies in practice. Two remaining gaps require legislation. The policy does not reach purely computational design of biological agents, and it binds only institutions

Thank you, Doctor Frams. Now I recognize Mister Hodges for five minutes to present his testimony.

Thank you, Chairman McCormick, Ranking Member Sykes, members of the subcommittee. I also wanna thank the Chair and Ranking Member of the full committee for being here today. This is a topic that could not be more timely. In addition to serving as a visiting fellow to Hoover's biostrategies and leadership initiative, I also serve as Commissioner to the US China Commission. That commission has taken ample time to look at this issue as well, um, but I do want, my views today are my own and, uh, not necessarily reflective of the entire commissions, but we have taken several, uh, recommendations in the past on this issue. biotechnology is currently squarely inside the Chinese Communist Party's cam- active campaign to destabilize the United States and overtake us when it comes to strategic priorities that we need in order to maintain that our leadership role in the United States and internationally. And their - their - their campaign stems from research to data, to manufacturing, to talent and finance. And they're working to dominate a field with enormous potential for America, and to make us reliant on their companies. for the future. As I was listening to the opening testimony, I couldn't help but notice that there's a there's a quote on the wall wall by Tennyson, "For I dipped into the future far as human eyes could see, saw the vision of the world and all the wonder that it would be." And it struck me that this is an co- incredibly apt quote to be on the wall for this hearing today as several of you have alluded to this field is very exciting, it's got enormous potential, and it's mind-blowing. I have been absolutely amazed over the past year through my work with Doctor Indian at Hoover. as we've traveled internationally and looking at the capabilities and some of the things that American high school students and international students are working on. So again, the the potential here is enormous from an economic opportunity, but the Chinese are actively working to make sure that they control it instead of the United States. This is an uncomfortable topic, but one we cannot ignore. The threats are real and the clock is real. In the last eight months there have been over a half a dozen Department of Justice and federal actions working to prevent incidents inside the United States where they've uncovered up to labs, uh, buried under - under houses and other - other types of efforts here in the United States. Again, most of these were not uncovered because we have a really robust intelligence system. One of them was uncovered by a maid who got sick. That should be a - a massive warning sign to every member of Congress that we clearly don't have the tools in place to detect these types of pathogens that are dangerous for Americans and have a clear direct line to threats. Multiple commissions, academia and the private sector have independently landed on the same deadline. The next nineteen months is vital. China's built into that time frame. Its fifteenth five-year plan makes biomanufacturing and advanced materials a national priority with explicit goal to lead the world in biotechnology by twenty thirty-five. And this is the honest picture. They're running an all of society effort on biotechnology. They're pulling ahead on clinical trials, manufacturing, supply chains. The United States is still leading on talent, finance and innovation. So the question that we're, that we need to answer today is simple. How do we use our strengths to our advantage? Our lead in the United States is our laboratory and our innovation. We fall short where it matters most, on the factory floor, because that's what's driving future business. China passed uh, has surpassed us in clinical trials in twenty twenty and medicines in twenty twenty three. Again, these should all be wake-up calls for, for this committee, and I, again, I applaud you for the letter that you sent earlier this uh month. to uh several departments and agencies urging them for leadership, and frankly that is what we need most. And as w- it was previously alluded to, I'm just gonna kind of brush over this part by Doctor Franz. There, with the advent of AI is increasing and raising the stakes on this beyond state actors and lowering the threshold for some of those dangerous pathogens, it's expanding that, so this is a- absolutely an area where safeguards should be considered, again not to stop the technology from advancing, but to work alongside of it. Biotechnology can be dangerous. It's yielded ma- but it has also m- yielded modern innovations in countless medicines and tech advancements. We're seeing it cut lead times and actually provide benefits to Americans on a daily basis. The natural instinct with the technology is, um, emerging is to wall it off. As we all know, history is not kind to that instinct. There's countless examples in my written testimony which I submitted that demonstrate this. The stakes cut both ways. And so what can Congress do? In my, in my written testimony I've provided a number of recommendations, but just to give you sort of the top-line ones that we absolutely must advance that the committee is actively working on is biological intelligence and measurements. We cannot secure what we cannot see and we cannot win what we cannot measure. On biological intelligence, the United States still lacks a coordinated real-time capability to see biological threats whether naturally occurring accidental or deliberate, as they emerge. This is something that Congress should absolutely take I appreciate the the uh Chairman raising the Biosecure Act in addition to that, last year Congress passed the outbound legislation. I would I would urge you to take a look at expanding that to include biotechnology into that as well.

Thank you, Mr. Rogers. I now recognize Doctor Granvall for five minutes to present her testimony.

Thank you. Chairman McCormick, Ranking Member Sikes, and members of the subcommittee, thank you for inviting me. I am Gigi Granvall, a professor at the Johns Hopkins Bloomberg's Globe Public Health. The views I express today are my own and do not necessarily represent those of Johns Hopkins University or the Johns Hopkins health system. The National Security Commission on emerging biotechnology warned in April twenty twenty five that the US risks falling behind its global competitors, and especially China. China has produced world-class scientists and breathtaking innovation. But as the commission's report makes clear, not all its successes have come from fair competition. Much of the U. S. policy response is therefore focused on protecting American research from theft, exploitation, and misuse. That is important. But U. S. science must also continue producing something worth protecting. Since the commission released its report, U. S. policy decisions have significantly weakened our biotechnology research enterprise. Research grants have been terminated or delayed, clinical trials have been disrupted, job offers have been rescinded, American scientists have been recruited by other countries. Students and early career researchers increasingly increasingly question whether the biological sciences can offer a stable career. Talented researchers from abroad are choosing to train and work elsewhere instead of contributing to American science. This is a national security crisis. The US also confronted a conflict between competitiveness and security during the Cold War. The Courson committee concluded that despite the risks of openness, the United States would be more secure if it preserved its capacity for scientific innovation, an approach known as security by accomplishment. That principle became the basis for NSDD one eighty-nine, signed by President Reagan in nineteen eighty-five, and reaffirmed several times since. Openness and achievement are especially important in the biological sciences. Biology is studied everywhere, infectious diseases cross borders, and countries other than China are also moving forward rapidly. If the US does not pursue security by accomplishment, other countries will make discoveries discoveries and establish scientific norms without us. That will leave the United States more vulnerable, not more secure. The new federal policy for stopping high-risk life sciences research is another symptom of this problem. Its broad definitions prohibit or create disabling uncertainty around public health surveillance animal model development and medical countermeasure research. The policy acknowledges that vaccine development could overlap with prohibited activities but it provides no exception process. Even before this policy, scientists and universities avoided work that could conceivably be labeled gain of function. That chilling effect has already prevented important research. I witnessed this myself at a vaccine conference in Kyoto in twenty twenty five. Chinese researchers presented work that helped how H five N one influenza was spreading among American dairy cattle. Qualified American researchers should have been able to investigate promptly how the virus was spreading through American herds and how to stop it. Yet at that same conference, one American scientist after another described important H five N one experiments that could not proceed in the existing regulatory and funding environment. I respectfully urge Congress to take three actions. First, require agencies to account for congressionally appropriated research funds and the reasons those funds have not reached researchers. Second, call for suspension of the new high-risk research policy and use the more workable twenty twenty-four framework, while a clearer and more effective policy is developed through a transparent process involving practicing scientists, biosafety officials, and independent biosecurity experts. Third, implement the Commission's recommendations to sustain technology research, expand domestic biomanufacturing and workforce development, strengthen biological data resources, and improve regulatory coordination. We need effective biosecurity protections against theft and misuse, like gene synthesis screening and AI biosecurity safeguards. But as we cannot rely entirely on preventing all threats, we need to make sure that we also have the facilities, manufacturing capacity, international relationships, and most importantly, the scientific talent, the people who allow us to recognize biological threats and defeat them. Thank you and I look forward to your questions.

Thank you. To all our witnesses for their opening statements, I now recognize, I thank you members for five minutes of questions.

Thank you all. Uh, quite fascinating uh testimony. So I'm sure we'll have a great discussion here. Doctor Granville, you testified that President Trump's gain of function, EO, and the administration's policies would quote, prohibit or create disabling legal uncertainty around activities that are required for medical countermeasure development, public health surveillance, animal model development, and ordinary research posing minimal biosafety risk, unquote. You testified that the administration's actions had created a chilling impact on biotechnology research and this is a precisely what the scientific community has been warning about for over a year so forty universities, research societies, and security stakeholders warned in a joint letter to NIH all the way back in July, twenty twenty five, that the administration policies risk paralyzing critical areas of biomedical research. So, Mister Chairman, I request the name is consent to enter this letter into the record.

Without objection.

Absolutely. Thank you. And I want to take this opportunity to better understand the real world impacts that have already happened. Uh, Doctor Granville, the example that you gave about the H five N one was quite incredible. especially considering the challenges that we have had with dairy cows and uh beef here in the United States and wanting to protect what we have here rather than outsource it. Uh and it often seems like there's a a Trump policy attempting to do something while also undermining our economy at the same time and that is a perfect example of it um but what the current definition of gain of function was developed, uh as you say or many have said, developed without meaningful input from a community expected to comply with it. And that doesn't sound like evidence-based policymaking and ignores your expertise. Um, if the Trump administration were to actually engage, what would you tell them in how to best oversee and regulate this area?

Thank you. Um, thank you very much for the question, Congresswoman. Um, I would, uh, I think the most important thing is to make sure everybody wants to have important work get done. and they want uh it done safely. And so that is the the priority and whether you what you call it, what kind of category you put that in is that's the most important thing. And so how uh you do that is you make sure that you talk to the people who are uh part of the regulated community because you want to make sure that uh the important work that has clinical implications with regard to H five inf influenza or whatever, you know, and you might s- s- might be worried about, You wanna make sure that that work can go forward. The problem with the policy is is is that some very important public health stuff is already prohibited. It's there's and it doesn't seem like there's an exception process. So there just seems to be like no duty of care to make sure that we can do this work, um that will have clear benefits uh for the clinic or for public health.

Thank you for sharing that and it it seems to I'm thinking of the parallel of the conversations we're having right now, AI regulation and the administration says, let the industry figure it out. But when it comes to biomedical and biotech research, uh, it is through executive orders. It says, doesn't quite make a lot of sense, but, uh, we hear that quite often. So you discussed, uh, the workforce and ensuring that people are confident and capable of doing the work without fear of retribution or, uh, punishment. Uh, can you talk a little bit more about, um, the chilling effect of the workforce and also of the scientific gains of uh these EOs and and strange conversations from the administration.

Yeah, thank you for that question. Um I think that the, when it comes to gain of function, potential gain of function research, I think people are very pers- uh concerned about the potential optics. And it's just another layer of um there should be an ongoing conversation of what work needs to get done what questions we need to answer, how can we do it the most safe and the most safe manner. And that is a conversation that should be with the scientific community, biosafety experts, biosecurity experts. But instead it is been this overlay of, you know, how how much trouble could I potentially get in, how much harassment might I be bringing onto myself or my institution. And institutions can be quite wary of that attention as well. So I think there is a lot of sen- self-censorship um in what projects are proposed.

Mm.

And I think that is perceived in the international community as well. And I think if you talk to the uh the scientists in your in your s in your uh districts, you will you'll see that that's the case. Um when it comes to workforce generally, I think there are bigger problems because we we don't have the workforce that we want to have. You know, we at Hopkins, um I'm just speaking from my personal observations, we we have been able to only accept a few graduate students where we'd normally accept several dozen. We, and that's the case in universities across the country, um and so it's a it's a problem.

Thank you so much. I go back.

Thank you, Ranking Member Sykes. I now recognize full committee Ranking Member Lofgren for five minutes of questions.

Well, thank you, Mister Chairman, and and thanks again um for this hearing. Um, Doctor Granville, you made a point in your testimony that I think is is correct. Uh protection alone uh can't preserve American scientific leadership because we have to produce something worth protecting. Uh and our scientific accomplishments are vital to our national security, and if we erode that capacity, it's gonna open the door for other nations to achieve what we can't. So let me just return to the ASM letter which I entered into the record during my opening statement. Uh, they informed us that, and this is a quote, a competitive shift has already occurred between the United States and China, in the biotechnology uh area. Uh, biotechnology is a broad term, there's many sub-fields with many different applications, but the overall evidence uh seems that the relative R and D spending, the number of clinical drug trials, the flow of licensing technology from China to the US instead of the other way around, is um something noteworthy, uh something is happening, it maybe it already has, uh how would you assess the near-term consequences of this competitive shift in biotechnology innovation?

Thank you for the opportunity to to reflect on that, congresswoman. Um I think that the the issues involved here are um very complex and um certainly uh the US has not been able to, US researchers have not been able to collaborate in the way that we um used to, with uh our international counterparts. And I I think that um there once was a time when the US was the only game in town, the US uh n- uh biotechnology was born in the US, but now it's not just US and China, um there are many countries that have um fantastic scientific uh collaborators uh that we would like to work with. And so when we're not part of that biotech ecosystem, when we pull back, that that area gets filled with with others and um in that and mostly China. And so I think that that is that is what you're seeing now is that we're not being able to to be fully present in um in the scientific community.

Uh let me just mention, I I mentioned earlier visiting a couple of times the uh bioengineering uh lab at Stanford. and I came away with their um report, the Hoover Institute report, biosecurity really, a strategy for victory, which you mentioned, Mister Hodges, in your testimony. Matter of fact, I was so impressed with it I shared it with the chairman of the full committee, and, and I'm mindful and I, if you have a comment on this, it doesn't look to me that what the administration has done in biosecurity really matches the recommendations in the Hoover report. Do you think that's unfair?

The way I wou- I would respond to this, ma'am, is the - the system, I think we can all agree, again, China's been rapidly catching up to us. There,

Right.

uh, as I said in my opening testimony, as others have alluded to, there've been a number of commissions that have said that China's rapidly catching up to us. In response to the last question, it was just asserted that, you know, the United States is having a hard time engaging with some of our allies and partners. Again, that's - that's not a new phenomenon. This has been a problem in the works for decades. So I I don't think we can put the problem squarely on the administration's shoulders with their recent f- own sort of funding decisions and sort of memos that have come out. I think they've prioritized biosecurity and biotechnology generally. They are still looking at this problem and I think there's still ample room for engagement to make sure they get it right. Again, if we look in the rearview mirror, then I think we're gonna have a really hard time. I think what we need to do is pri- and again, the the big part here is money alone isn't gonna solve this problem.

No, I understand that. The One of the things that I I'm interested in, and this committee doesn't have jurisdiction over FDA, but we've had clinical trials move away from the United States. And that's not just a funding issue, that's a bureaucracy issue at the FDA. I don't know, Doctor Granville, over at from your perch,

Hmm.

whether we could do something in terms of the structure of the clinical trials so that we don't send everything to China. as we used to, I mean you've at at Johns Hopkins, yeah I'm sure you've seen this.

This is a big priority for patients, I mean we want uh patients to have the latest cancer advances, et cetera, um in the US and it's really a burden to travel to other countries to get that, and it's and of course it's only for people who can afford to do that.

Correct, yeah. Uh uh let me just

If I may ma'am, there's there's one piece on this I also wanna just add it on. Uh the other part of

yeah. Yeah.

this is is something I alluded to in my opening testimony which is Again, I recognize it's outside of the community's jurisdiction, but from an oversight perspective it's something you absolutely should be aware of. Another reason a lot of that licensing is happening is because American firms are investing in Chinese corporations that are doing this work. And so again, we're, the United States is funding the the rise of the Chinese. And so that's something that Congress could definitely take an action on right now and work with the administration.

The final comment I want, and I know my time has expired, but I can't tell you the number of university presidents who have come to me to say that the kind of mindless grant um cut-offs in bio uh tech and health uh have caused them uh not to admit otherwise admissible doc- uh doctoral students and post-docs cuz they don't know how they're gonna pay for the research. And so we've had a dramatic reduction that's kind of hidden from view of the of scientists we've lost them they're either gonna go to another country or they're gonna go to biskel uh they're not gonna be scientists here and that's something that uh we could uh it's really a self-inflicted wound and we need to stop it if if we can uh mister chairman i know i've i've used more than my time so i will yield back

thank you renke member loftrin i now recognize uh member bonamici bonamici from Oregon. Actually no, this is, I'm from Oregon too.

Thank you, Mr. Chairman.

Thank you.

Yes, I know. Uh, thank you, Mr. Chairman, um, and thank you, ranking members, and thank you to the witnesses for this, uh, uh, really important conversation. Uh, yes, I represent a district in Northwest Oregon and certainly innovation in the biotech sector is generating lifesaving medical discoveries, safer and more sustainable food products and cleaner energy solutions. Uh, it's also an economic driver. There is close to thousand different firms of all sizes in Oregon, bioscience firms of all sizes in Oregon, about twenty-one billion annually, uh, supporting a lot of family wage jobs across the state. In fact, in the district I am honored to represent, Junette Tech just announced a seven hundred fifty million dollar investment that's gonna double their size there. And Oregon Health Sciences University and Oregon State University are investing in the workforce and the research but we can only maintain our lead and do it safely if our bio security oversight systems keep pace with the development and the executive order we're talking about today is is not the answer. I wanna thank you, Doctor Granvall, for um also highlighting all of the issues affecting science uh and the concerns about us falling behind. I I share those concerns as a long time senior member of this committee, also the Committee on Education and Workforce. Uh research funding cuts, um we've heard many times that it's difficult, if not impossible, for international students to come here. uh, to study but also even to attend conferences with these draconian, inhumane immigration policies. All of these things are affecting, uh, the growth and - and potential i- in - in biosciences and sciences in general. So - so, Doctor Granville, you described in your testimony, you gave an example of how sort of prohibitive restrictions on dangerous gain-of-function research and international coordination. Your example was a chilling effect on research to combat avian flu transmission. We were all of of course concerned about safety, but this administration's recent executive order, it's seeking global leadership in biotechnology, but it looks like it's doing this by tying scientists' hands behind their backs. And I just wanted to get a sense from you, um, what are some of the specific examples of discoveries that US researchers w- might likely seed, uh, because of this vague and somewhat myopic policy, and how does research isolationism undermine the economic growth and as you mentioned the US leadership and as as uh ranking member Lofgren mentioned, we have to have something where where we are leading. So so could you answer those questions like what are some examples and then how does this research isolationism undermine the the growth in the industry?