Get started. I called this meeting of the Senate Homeland security and Government Affairs subcommittee on emerging threats and spending oversight to order. I want to thank senator hassan for allowing this bipartisan hearing to occur. Welcome to each of our panelists. Thank you for joining us. The purpose of this hearing by the subcommittee on emerging threats and spending oversight is to discuss, as our name implies, the emerging threat posed by gain of function research. We will hear from a panel of three witnesses, all of whom are extraordinarily accomplished experts in the Scientific Community. We are grateful for that work, and we are grateful to each of you for taking the time to appear here with us this afternoon. Gain of function research is a controversial Scientific Research method involving the manipulation of pathogens to give them a new aspect or ability, such as making viruses more transmissible or dangerous to humans. Despite all we have learnedre about the potential risks of this particular method of research, this is the first congressional hearing on the subject. Today we will discuss what gain of function research entails, how gain of function research is defined, and whether the definition of gain of function research is applied consistently by the department of health and Human Services p3co review committee, which is responsible for evaluating the risks benefits of such research. Well also discuss how this p3cf committee operates. The p3co approves or denieswe projects from receiving federal funding based on whether the pathogen is considered to be a credible source of a potential future human pandemic, and if the potential risks as compared to the potential benefits to society are justified. In other words, a project is noo gain of function if the review committee is unsure if a recombinant virus will create a future pandemic. Theres a question of whether or not there is a reasonable expectation that it might be a weather not it has been in the past or what viruses should be and should not be experimented upon. Broad criteria gives one Soul Committee which is comprised of an unknown group of bureaucrats, i believe the names are not released that was on the committee so theres not necessarily in oversight over oversight. The power to spend millions of taxpayer dollars on a single preemptive guest with potentially devastating consequences. Today we will also considerns whether gain of functionwe research was being performed atw the Wuhan Institute of virology. First, no one, not myself or anyone im aware of, argues that a recombinant supervirus that has been published in scientific journals is covid19 or a close relative. If covid19 leaked from the wuhan lab, it would be a laboratorycreated virus that the wuhan scientists have not yet, and are unlikely ever, to reveal. I maintain that the techniques that the nih funded in wuhan to create enhanced pathogens may also have been used to create covid19. The American People deserve to know how this pandemic started, and to know if the nih funded research that may have caused this pandemic. Gain of function research has the potential to unleash at Global Pandemic that threatens the lives of millions, yet this is only the first time the issue has been discussed in a congressional committee. I am sure each member of this committee as well as the full senate can agree that we need stronger government oversight of how our tax dollars are being used to finance experimenting possibly fatal diseases. Again, i thank each of our distinguished witnesses for being here today and i think chairwoman hassan for working with me towi convene this meeti. Before we begin i would like to note that i invited senators were not on the subcommittee to also takek today, therefore i k unanimous consent to allow senator marshall and senator johnson to fully participate in the hearing, provided any members of the subcommittee being given deference in order of the recognition without objection. Next i would like to remind witnesses in written testimony they have done anything that submitted, will be included in the record and to please keep her your opening remarks to around seven minutes. With that im going to introduce the witnesses and we will hear their remarks after the introduction which is highly different than we do sometimes and then i will introduce the witness. The first witness will t be with us by zero or skype is dr. Richard e bright. Dr. Ebright is the board of governors professor of chemistry and chemical biology at the director of the Waksman Institute of microbiology at rutgers university. Dr. Ebright completed his undergraduate degree from Harvard University in biology where he earned some a cum laude honors. He later received a phd in microbiology and molecular genetics also from harvard. Dr. Ebright research has led to over 175 publications as well as over 40 issuedpa and pending patents. He has received numerous awards for research at his curly member of the American Academy of arts and sciences as well as the Institutional Biosafety Committee at rutgers. He is a fellow of the Infectious Disease society of america, the American Academy of microbiology, American Association for advancement of science. He was editor of molecular biology for 16 years. Dr. Ebright currently serves as a project leader of three current nih Research Grants provided, has provided testimony to the House Committee on energy and commerce on the 2014 anthrax incident, was a Founding Member of the Cambridge Working Group whose Cautionary Statement on gain of function Research Involving Potential Pandemic Pathogens remains as relevant as the day it was released in july 2014. Dr. Ebright. Thank you. Thank you for inviting me to discuss dana function research and its oversight to discuss gain of function research and its oversight. In my oral statement, i will discuss the definition of dana of function Research Talk dana function research and steps to strengthen oversight of the research. What is gain of function research of concern . It is defined as Research Activities reasonably dissipated to increase transmissibility, ability to overcome immune response or ability to overcome a vaccine or drug. Gain of function involves the create thing creation of new Health Threats that did not exist previously and that might not come to exist by natural means for tens, hundreds or thousands of years to a small part of Biomedical Research. It constitutes less than 1 10 of 1 of Biomedical Research and less than 1 of virology. Because gain of function research of concern can cause a pandemic, this mopar is highly consequential. Gain of function research of concern poses five potential he existential risks. Gain of function research of concern poses material risk by creating new potential pandemic pathogens. If released into humans, this can cause a pandemic. Gain of function research of concern poses information risk by providing formation on Construction Properties of pathogens. Provides instructions, stepbystep recipes that can enable a rogue nation, individual to construct a new pathogen and cause a pandemic. What are the benefits . Gain of function research of concern provides limited benefits. Gain of function research of concern can advance Scientific Understanding but gain of function research of concern has no civilian practical applications. In particular, gain of function research of concern is not needed for and does not contribute to the development of vaccines and drugs. Companies develop vaccines and drugs against pathogens that exist and circulate in humans. What should oversight until . Because gain of function research of concern poses potentially existential risks and provides limited benefits, the riskbenefit ratio is almost always unfavorable and in many cases is extremely unfavorable. It is imperative gain of function research of concern be subject to national or International Level oversight to ensure before the research is started that risk benefit ratios are except blue and risks are mitigated. Effective oversight includes three components. First, Research Proposals that include gain of function research of concern must be identified and flagged. Second, a riskbenefit assessment must be performed. This entails enumerating risks and benefits, weighing risks and benefits and reaching a decision whether to proceed as proposed or to proceed with additional risk negation or not to proceed. Third, compliance with a decision from the riskbenefit assessment must be monitored and enforced. I turn now to u. S. Oversight of gain of function research of concern. Before 2014, there was no u. S. Oversight of gain of function research of concern. 2014 to 2017, the government put in place a moratorium on federal funding for court for quote selective gain of function research. The policy was referred to as the pause. Under the pause, 18 projects were paused. At least seven of the 18 projects were allowed to resume almost immediately. More important, other projects that met the definition for coverage including a project on sars related coronaviruses were not paused due to the failure of the nih to identify and flagged projects. By the end of 2017, the pause was lifted and replaced by a policy that requires riskbenefit assessment before awarding hhs funding for quote research involving enhanced pandemic pathogens. Defined as Research Activities anticipated to increase the transmissibility of a potential pandemic pathogen. Under the framework, projects must be identified and flagged the ending agency and projects must be reviewed by a secretary level committee. The framework assesses the reasonably anticipated results of the proposed research. The reasonably anticipated standard employed in the policy is equivalent in all respects to the breeze person standard employed in u. S. Administrative law and civil law. The framework ensures riskbenefit assessment of gain of function research of concern. In practice, the framework has existed primarily on paper. In the form to have years since the policy was announced, only three projects have been reviewed. Most projects including the project by Eagle Health Alliance and wuhan partners were not reviewed due to a failure by the nih to identify and flagged projects. In addition, the committee has been nontransparent and unaccountable. The affiliations of members have not been disclosed. Proceedings have not been disclosed. Decisions have not been disclosed. Current u. S. Oversight has serious shortcomings. Any effective system of u. S. Oversight of gain of function research of concern must address the shortcomings. My recommendations are as follows. First, responsibility for u. S. Oversight of gain of function research of concern should be assigned to a single dependent federal agency that does not perform research and does not fund research. Second, u. S. Oversight of gain of function research of concern should cover all u. S. And u. S. Funded Research Perspective of funding, source, classification status and research location. U. S. Oversight of gain of function research of concern should be codified in regulations and enforced. U. S. Oversight of gain of function research of concern should be transparent and accountable. Thank you for your attention. I would be pleased to address questions. Thank you. Next we will have dr. Steven kwei. The founder and chairman of the seattle based therapeutics. Clinical stage Pharmaceutical Company that develops delivery methods for Breast Cancer and other conditions with the goal of preventing the 2 million rest cancer cases worldwide. Earlier in his career he received his nd and phd from gain, trained as a postdoctoral fellow at m. I. T. And served on the faculty of Stanford University school of medicine. He published contributions to the world of medicine. As a medical entrepreneur. He has founded six startups come invented seven fda pharmaceuticals and is the holder of 87 patents and over 130 pending u. S. And foreign patent applications. He is an author. During the pandemic he published his number one amazon bestseller stay safe, a physicians guide to survive coronavirus. He recently testified the lawmakers as part of an export forum convened by the House Select Committee on coronavirus titled the covid19 origin story. [indiscernible] i offer six statements. One, there is no dispositive evidence the pandemic began as a spillover in market. All evidence is consistent with a laboratory infection. I understand this conclusion is not widely held. I could spend an entire hearing going through the Scientific Evidence for this conclusion but that is not the purpose of this meeting. Im happy to discuss the evidence contained in my written remarks contained in questioning. Im willing to debate any virologist at any time or place. Only one doctor was willing to debate this with me in a formal format and he lost. Im willing to testify under oath if requested. All evidence is consistent with an accidental and not deliberate release. Sars two has features consistent with gain of function research. Two features involve acceptable research. These two features have never been found in nature and related viruses that could have reasonably started the pandemic because of the closeness of these viruses to wuhan. These features are routinely engineered into viruses. In 2018, u. S. And scientists proposed inserting human specific sites in bat virus backbone. Two years later, sars appeared. Sars two is a that derived a bat derived fires. A sentiment transmission and immune system evasion. The wa was engineering a protein related to or fate to have these two properties before 2019 as shown in two masters degrees thesis available only in chinese. Covid exhibits 40 asymptomatic transmission unheard of for a new respiratory virus. Patient infected with have a motor infection. Could the reduced efficacy of vaccines and natural unity be in engineered feature . It appears likely. In december of 2019, the Han Institute of viral gene was conducting Synthetic Research on a virus that is 60 lethal. The virus was an infectious clone format. It is a level four pathogen and cdc designated bioterrorism agent. This is the most Dangerous Research i have encountered. We should assume this continues to this day. Whether the pin where did the pandemic begin . Completing the computing policies are a spillover in wuhan and a lab infection. There are at least six Serious Problems with these papers. The most important are that in the early months no animal has ever been found to be infected with covid19 anywhere including the market and the molecular clock sars to places the infection in the fall of 2019. All infections in the market in humans or what is called lineage be and not the most ancestral. I like many scientists believe the market cases where a superspreader event. This first chart here. The earliest cluster of hospitalized patients was at the Peoples LiberationArmy Hospital in wuhan. This hospital is six kilometers from the lab and line two of the subway system. All early cases are in hospitals adjacent to line two and the problem will do this is a chance occurrence is one in 68,000. The conduit includes the pla hospital, the wav, the market and the international airport. You can literally walk down into the subway system from the wav and exit outside into london, paris, dubai or new york without having symptoms. Modeling by others suggested the pandemic could not have occurred without the international spreading impact of line two. I have found no evidence gain of function helped in either the covid pandemic or other smaller epidemics. We know and m. R. I. Vaccine can be designed within days of a new outbreak once the pathogen is sequenced and largescale manufacturing can begin soon thereafter. This capability has been fully road tested and provides the best defensive capability against future microbes. It is also important to point out gain of function research is a tiny sliver of all Research Funded in rh by nih. There were over 36,000 grants funded in 2020. Of these, the selfdescribed gain of function on potential pathogens Research Grants numbered only 21 in the latest funding year. Even expanding this by tenfold with a less stringent definition would mean we are talking about less than 1 of all research funding. I cannot imagine a scenario where for this Research Effort a new pandemic occurs. What reform should be considered to assure such research is conducted in a safe and manner . A proposal i believe is achievable is placement of all select Research Within existing Institutional Review Board structure used for human clinical trials. I believe this effort would put guardrails around the most dangerous aspects of the research and has the added benefit of International Acceptance including in china. My second ref