[Senate Hearing 116-492]
[From the U.S. Government Publishing Office]


                                                     S. Hrg. 116-492

                         SHARK TANK: NEW TESTS
                              FOR COVID	19

=======================================================================

                                HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                     ONE HUNDRED SIXTEENTH CONGRESS

                             SECOND SESSION

                                   ON

                    EXAMINING NEW TESTS FOR COVID-19

                               __________

                              MAY 7, 2020

                               __________

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                                Pensions
                                
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          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

		    LAMAR ALEXANDER, Tennessee, Chairman
		    
  MICHAEL B. ENZI, Wyoming		PATTY MURRAY, Washington
  RICHARD BURR, North Carolina		BERNARD SANDERS (I), Vermont
  RAND Paul, Kentucky			ROBERT P. CASEY, JR., Pennsylvania
  SUSAN M. COLLINS, Maine		TAMMY BALDWIN, Wisconsin
  BILL CASSIDY, M.D., Louisiana		CHRISTOPHER S. MURPHY, Connecticut
  PAT ROBERTS, Kansas		        ELIZABETH WARREN, Massachusetts
  LISA MURKOWSKI, Alaska		TIM KAINE, Virginia
  TIM SCOTT, South Carolina		MARGARET WOOD HASSAN, New Hampshire
  MITT ROMNEY, Utah		        TINA SMITH, Minnesota
  MIKE BRAUN, Indiana			DOUG JONES, Alabama
  KELLY LOEFFLER, Georgia		JACKY ROSEN, Nevada


		 David P. Cleary, Republican Staff Director
	   Lindsey Ward Seidman, Republican Deputy Staff Director
		    Evan Schatz, Minority Staff Director
		John Righter, Minority Deputy Staff Director

                           
                           
                           C O N T E N T S

                              ----------                              

                               STATEMENTS

                         THURSDAY, MAY 7, 2020

                                                                   Page

                           Committee Members

Alexander, Hon. Lamar, Chairman, Committee on Health, Education, 
  Labor, and Pensions, Opening statement.........................     1
Murray, Hon. Patty, Ranking Member, a U.S. Senator from the State 
  of Washington, Opening statement...............................     5

                               Witnesses

Collins, Francis, M.D., Ph.D., Director, National Institutes of 
  Health, Bethesda, MD...........................................     8
    Prepared statement...........................................    12
Disbrow, Gary, Ph.D., Acting Director, Biomedical Advanced 
  Research and Development Authority, Office of the Assistant 
  Secretary for Preparedness and Response, United States 
  Department of Health and Human Services, Washington, DC........    14
    Prepared statement...........................................    16

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.
     COVID-19 has shuttered scientific labs. It could put a 
      generation of researchers at risk..........................    52

 
                         SHARK TANK: NEW TESTS
                              FOR COVID-19

                              ----------                              

                         Thursday, May 7, 2020

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 10 a.m., in room 
SD-106, Dirksen Senate Office Building, Hon. Lamar Alexander, 
Chairman of the Committee, presiding.
    Present: Senators Alexander [presiding], Enzi, Collins, 
Cassidy, Roberts, Murkowski, Scott, Romney, Braun, Murray, 
Casey, Baldwin, Murphy, Warren, Kaine, Hassan, Jones, and 
Rosen.

                 OPENING STATEMENT OF SENATOR ALEXANDER

    The Chairman. The hearing of the Health, Education, Labor, 
and Pensions Committee will please come to order. As we begin 
our hearing, I would like to explain a few of the changes that 
we have made to address the health and safety recommendations 
made by the Attending Physician and the Sergeant at Arms after 
they consulted with the Department of Health and Human Services 
and the Center for Disease Control and Prevention.
    First, as you can see if you are watching, seating has been 
spaced so that we are 6 feet apart. Second, we have made it 
possible for Senators and witnesses to participate via 
videoconference if they choose to do so and several have. 
Third, to maintain social distancing we have very limited 
seating so we don't have room for members of the public to 
attend.
    However, this hearing is available to watch live online and 
the recording will be available on the Committee's website, 
which is www.help.senate.gov. It is important to be clear that 
the hearing will be shown from gavel-to-gavel in its entirety, 
unedited by anyone from the moment we start until the very end 
when we stop.
    Fourth, due to the limited seating, representatives from 
the press are working as a pool to relay their observations to 
their colleagues, and Senators and staff present have been 
reminded about the safety guidelines put in place by the 
Attending Physician. We all wore our masks. I am not going to 
wear mine during the hearing since we are 6 feet apart but 
Senators may do whatever they choose to do. I would like to 
thank the Senate Rules Committee, the Sergeant at Arms, the 
press gallery, the Architect of the Capitol, the Capitol 
Police, and our non-partisan Committee staff, Chung Shek and 
Evan Griffis, for all of their hard work to help keep all of us 
safe as we conduct these important hearings.
    In April, the owners of a senior living facility gave a 
COVID-19 diagnostics test to 2,500 employees and residents, 
that is 26 communities in Tennessee and Kentucky. According to 
the owner Gary Keckley, there were ``very few who tested 
positive of the 2,500.'' Those who tested positive were all 
without symptoms and they were all put in quarantine. This is 
what Mr. Keckley told the Tennessean newspaper, ``Because of 
the fear, we decided the only way to make sure residents didn't 
have the virus was to test them. There is no substitute for 
testing everybody,'' Mr. Keckley said.
    All roads back to work and back to school lead through 
testing. Our country will soon be doing 2 million diagnostic 
tests for COVID-19 a week, an impressive number. But to contain 
the disease and give Americans confidence that it is safe to go 
back to work or go back to school, we will need tens of 
millions of tests, many more than our current technologies can 
produce. Testing is necessary first to identify the small 
number of us who have the disease or have been exposed to it so 
those Americans can be quarantined, so we don't have to 
quarantine the whole country. And testing is important secondly 
because it will help Americans who are traumatized by the daily 
reports of the virus, it will help us gain confidence that will 
be necessary to go back to work and back to school.
    This hearing is about how we will find those new 
technologies that are needed to rapidly produce tens of 
millions of tests in one of the most ambitious scientific 
enterprises in recent memory headed by one of our country's 
most distinguished scientists. Looking ahead, I want to mention 
two important oversight activities for this Committee.
    Number one, next Tuesday our hearing will examine how we 
are dealing with this pandemic, COVID-19. Our witnesses will be 
Dr. Anthony Fauci, Director of the National Institute of 
Allergy and Infectious Disease at the National Institutes of 
Health, Dr. Robert Redfield, Director of the Center for Disease 
Control and Prevention, Dr. Brett Giroir, Assistant Secretary 
for Health at the U.S. Department of Health and Human Services, 
and Dr. Stephen Hahn, Commissioner of the Food and Drug 
Administration.
    The second oversight activity I would like to mention is 
that during the next few months, our Committee will examine 
what our country needs to do to prepare for the next pandemic, 
which will surely come. I believe that Congress should put in 
place the structures and the funding to be ready for that next 
pandemic during this year while the current crisis is still on 
our mind. Over the last 20 years, the last three presidents and 
several Congresses, including after 9/11, bird flu, Katrina, 
SARS, and Ebola, have passed seven major laws that created the 
national stockpile and assistant secretary for preparedness, 
provided incentives for development and manufacturing for 
diagnostics, treatments and vaccines, strengthen the Centers 
for Disease Control, and for the last time five years, thanks 
to the leadership of Senator Blunt and Senator Murray as well 
as others, have provided record funding for the National 
Institutes of Health.
    We will talk about the importance of preparing for the next 
pandemic at our hearing next Tuesday as well. As a result of 
all of that effort by three Presidents and several Congresses 
over the last 20 years, the New York Times reported on March 
the 1st on its front page the following, ``Most experts agree, 
the United States is among the countries best prepared to 
prevent or manage such an epidemic,'' but I think we would all 
agree that we would like to have been even better prepared for 
COVID-19. And it is everybody's responsibility to make sure 
that we are even better prepared for the next infectious 
disease.
    I want to place in the record a remarkable speech by former 
Senate Majority Leader Bill Frist delivered in 2005 who saw 
very clearly then the problems we still have to deal with 
today. On April 13, the American Mind published Senator Frist's 
essay, ``A Storm for Which We Were Unprepared,'' which I would 
also include in the record. The end of this crisis will be 
determined by three things, tests, treatments, and vaccines. 
There is promising news that we are likely to hear today from 
our witnesses that treatments and therapies will be available 
this summer.
    The Administration's warp speed pursuit of a vaccine has a 
goal of 100 million doses by the fall and 300 million doses by 
January, a target that is much more ambitious than ever has 
been achieved before. And the private sector is demonstrating a 
capacity to turn out quickly tens of millions of serology 
tests. These are the tests that determine whether you have had 
the disease and have antibodies that might create some 
immunity, at least for a time, although that has not been 
proven yet.
    The FDA this week is taking aggressive steps to make sure 
serology tests are accurate. After a bumpy start caused mainly 
by a faulty test developed by CDC, the United States is now 
conducting over 1 million diagnostic tests weekly. By mid-June, 
there will be 2 to 2.5 million available weekly according to 
Dr. Deborah Birx, Coordinator of the Coronavirus Task Force. 
And as of yesterday, according to President Trump and John 
Hopkins University, the United States has conducted over 7 
million diagnostic tests. On May 1, The Wall Street Journal 
described the testing situation this way, ``The Food and Drug 
Administration has now approved 70 coronavirus tests, about 
four times more than it approved for the H1N1 flu virus in 
2009.
    More tests per capita have been performed in New York City 
than in Singapore, South Korea, and Australia. Hospitals and 
labs have performed about 1.6 million tests in the past week, 
according to the COVID Tracking Project. Governor Andrew Cuomo 
last week said tests would be available at some 5,000 
pharmacies across New York State. Abbott Lab says it has 
shipped 1 million tests for its 18,000 portable machines in the 
field that can return results in 5 minutes and is manufacturing 
50,000 kits a day. U.S. hospitals have more than 5,000 Cepheid 
fast testing machines, which require no special training.
    Some 93 percent of the U.S. population lives within 10 
miles of a test site, according to the Wall Street Journal. 
``As testing has expanded,'' the Journal said, the choke point 
now is a shortage of no swabs and chemical reagents to process 
specimens, but those shortages are easing thanks to FDA 
flexibility and the resourcefullness of private industry. The 
FDA is allowing polyester swabs so that swab manufacturers can 
prioritize coronavirus tests.'' That is the end of the Wall 
Street Journal summary. The Coronavirus Task Force reports that 
states have submitted their goals for testing for May and the 
administration is working to help supply media and swabs that 
states are not able to obtain on the commercial market so that 
states can meet those goals.
    All that is very impressive but not nearly enough to test 
every nursing home, every prison, everyone in an operating 
room, and some entire classes and campuses and factories, teams 
at sports events. And to give those tests more than once, we 
will need millions more tests than we are producing today. This 
demand will only grow as the country goes back to work and some 
100,000 public schools and more than 5,000 colleges plan to 
reopen this August. There are two ways to increase our testing 
capacity. Of course the first is to squeeze every possible test 
out of our current technologies, and the second which is to 
focus our--our focus today is on the need for new testing 
technology.
    Throughout March and April, Senator Blunt, the chairman of 
the Senate Appropriations Subcommittee on Health, and I had 
many conversations with experts across the Government and the 
private sector. We couldn't find anyone who believed that 
current technology could produce the tens of millions of test 
necessary to put this virus behind us. So we worked to include 
in the most recent coronavirus legislation $1.5 billion for 
what we called a competitive Shark Tank. This is described, the 
name was described after the reality television show that pits 
entrepreneurs in a competition to see who can succeed.
    This Shark Tank at the National Institutes of Health would 
utilize the capacities of Government itself, in coordination 
with the private sector, to pull out all the stops and fast-
track new technologies designed to produce tens of millions of 
tests by August, or at least millions more tests by August, and 
even millions more than that by the flu season. We allocated 
another $1 billion to BARDA, the Biomedical Advanced Research 
and Development Authority, to work with the National Institutes 
of Health to accelerate production of those tests.
    Talking with scientists across the country, there are many 
ideas, some utilize CRISPR, the gene editing technology. At 
least one allows you to use your cell phone to photograph your 
test swab result and send it to your doctor. Several may 
incorporate wearable technology. There is a lot of talk about 
antigen tests. The NIH, only five days after the funding was 
signed into law, announced the official start of its Shark Tank 
program to boost the most promising testing technologies. There 
were 400 requests for applications in the first 24 hours as of 
May the 5th, and I am sure Dr. Collins will update us on this, 
there were 850 expressions of interest and 50 applications have 
been submitted in review.
    Many of these early stage concepts won't work or they won't 
be able to be scaled up quickly enough, but that is okay. 
Thomas Edison said that he tried 10,000 times, made 10,000 
mistakes, before he produced the first incandescent light bulb. 
We hope we don't have that many failures, but all we need are 
two or three successes, or even one from this Shark Tank. The 
first place to find these technologies is at the National 
Institutes of Health. Dr. Francis Collins who leads the NIH, 
who once led the effort to map the human genome, is here today 
to talk about the $1.5 billion Shark Tank program.
    The second place is BARDA, a Division of the Department of 
Health. It has been working across Government and the private 
sector to invest in multiple innovative ideas to achieve 
accurate, fast, and easy testing capabilities to help build new 
capacity. Dr. Gary Disbrow, the Acting Director of BARDA is 
here to talk especially about BARDA's role in scaling up 
whatever new innovative test Dr. Collins finds. BARDA has 
another $1 billion for that purpose, bringing it to $2.5 
billion the total effort for this acceleration of diagnostic 
tests. Nearly 80 years ago, in 1942, President Franklin D. 
Roosevelt invited Senator Kenneth D. McKellar of Tennessee, the 
chairman of the Senate Appropriations Committee, down to the 
White House for a private talk.
    ``Senator McKellar', President Roosevelt said, `I would 
like for you to hide $2 billion in the Appropriations bill to 
create a project to win the war.'' Senator McKellar said, ``Mr. 
President, that should be no problem, I just have one question, 
where in Tennessee will the project be built?'' Well, that was 
Oak Ridge, Tennessee. That $2 billion funded the Manhattan 
Project that in record time produced two nuclear devices that 
won World War II. That effort assembled perhaps the greatest 
number of distinguished scientists working on one project in 
history.
    Dr. Collins' Shark Tank is at least a mini Manhattan 
Project. It doesn't have to be in Tennessee but Tennesseans at 
the Oak Ridge National Laboratory will be helping it succeed 
with their supercomputers and their other assets. $2.5 billion 
does not go as far today as $2 billion did in 1942 but it is 
still a lot of money. And it is likely that at this moment, 
more scientists are working to create solutions to COVID-19 
than on any other project in the world.
    Their success in delivering new technologies to create 
simple diagnostic tests with quick results, and then safe and 
effective treatments and vaccines, is the only way this will 
end. There is no safe path forward to combat the novel 
coronavirus without adequate testing. Let us hope that out of 
Dr. Collins' Shark Tank will emerge at least one mighty great 
white shark that will help us combat this disease.
    Senator Murray.

                  OPENING STATEMENT OF SENATOR MURRAY

    Senator Murray. Well, thank you very much, Chairman 
Alexander. Good to be here today with you. And I also want to 
thank our Committee staff who helped us set up this technology 
to make this hearing possible. And of course, thank you to our 
witnesses for being here today as well. Our Committee's last 
hearing on COVID-19 was March 3rd, and during that hearing I 
expressed my intense frustration at the administration's lack 
of preparedness, its failure to ramp up testing, the White 
House's constant contradictions of public health experts 
guidance and more. Now we are more than 60 days later.
    I wish I could say I had better things to say about the 
administration's response but I do not. The only difference is 
that now over 800 people in my home state have died, nationwide 
now more than 73,000 are dead, and tens of millions are 
unemployed. Meanwhile, the President is still denying the 
severity of this crisis, he is still insisting it is not his 
problem, and he is increasingly attempting to control and 
silence those who want the truth to be told. The President is 
afraid of the truth because here it is, he failed and continues 
to fail to protect lives and our economy and our way of life. 
And that brings me to our witnesses today.
    I appreciate you being here and I expect you to tell the 
truth today. I will want to know your honest assessment of 
where we stand on testing capacity and whether we are preparing 
appropriately to have a safe, effective vaccine as soon as 
possible. I will want to understand how you are planning to 
prioritize public health over political influence and corporate 
profits, and I will want your commitment that you will protect 
workers at HHS who will speak out when they see that public 
health is not being put first.
    Dr. Disbrow, you are here instead of Dr. Rick Bright who 
filed a complaint earlier this week detailing a shocking 
culture of corruption that prioritized cronyism over public 
health, including at an agency critical to vaccine development 
and distribution. You can expect a question from me on that and 
I expect the truth from you. And while I appreciate the 
interest in this ``Shark Tank'' initiative to develop new 
tests, we have to remember that the fight against this virus is 
reality--it is not reality television. It has to be led by 
scientists and it has to prioritize public health, not profits, 
not politics.
    While innovation plays an important role in the development 
of vaccines and treatments and tests, there is no silver 
bullet. In fact, we have already innovated faster high 
throughput tests, at home collection tests, and point-of-care 
tests, and critically there is much more in the pipeline. The 
problem is not lack of innovation, it is lack of national 
leadership and a plan from this White House. You can innovate 
the fastest car in the world. It still won't get you to where 
you are going without a good driver and good directions. And 
when it comes to testing, this administration has had no map 
and no one at the wheel.
    There is a reason they say failing to plan is planning to 
fail and it absolutely applies here because the fastest, most 
innovative test is not much use if we don't know how many tests 
we need, if we don't have a supply chain with capacity to 
manufacture all the tests and supplies that we need, and if we 
don't have the workforce and lab capacity to actually use those 
tests and supplies.
    Even if we had enough tests and supplies and labs and 
workers, they can't have the necessary impact if they aren't 
distributed widely across the country, if they don't reach 
essential workers, and underserved communities, and tribes, 
people with disabilities, homebound seniors, communities of 
color, and high risk populations if test don't become available 
to asymptomatic people or if we don't enforce current law that 
requires free testing for everyone. And even addressing these 
issues won't be enough without plans to use testing results as 
effectively as possible to fight coronavirus like rapidly 
recruiting training and sustaining the workforce we need for 
public health efforts like contact tracing, and quarantine, and 
isolation, and using data to surveil and track this disease 
within our communities while protecting privacy.
    Now, I was pleased the administration finally told 
Washington State last week it would be sending all states a 
significant number of supplies to help expand testing capacity. 
However, even if they finally deliver the supplies we have been 
asking for months, that is still not a plan, it is a piece of 
the puzzle. As long as the administration refuses to look at 
this full picture and develop a detailed, national plan to 
rapidly ramp up testing, we are not going to make the progress 
we need to get people safely back to school, back to work, and 
to some sense of normal life on a national scale because our 
experts won't have the visibility into transmission they need 
to ensure public health drives our efforts to reopen.
    That is exactly why I fought to secure language in the 
latest COVID-19 package that Congress passed that requires the 
administration to submit a strategic testing plan no later than 
May 24th. I am going to be watching closely to make sure their 
plan addresses all of the questions we desperately need 
answered. And I am going to be pushing for more resources to 
build and sustain the testing efforts that we need, support 
contact tracing and other public health efforts, and to plan 
for vaccine production and distribution so that as soon as we 
have an effective vaccine, we can scale it up quickly and make 
it available and free for everyone.
    While the $25 billion we passed for testing recently was a 
good start, it is going to take a lot more to get this job 
done. Yes, it will take innovation, but it will also take some 
semblance of leadership from the President because no matter 
how innovative our tests are, we cannot reopen our country 
safely until they are fast, free, and everywhere.
    No matter how hard frontline workers and Governors and 
families work to do their part, we still need the Federal 
Government and its President to step up and finally do its 
part. Thank you, Mr. Chairman. It is great to be with you this 
morning.
    The Chairman. Let me make sure my microphone is on. I am 
pleased to welcome our two witnesses. I want to give them a 
full introduction, and after they give us their statements, we 
will proceed back and forth from the parties in seniority. So 
technologically that is the way it is recommended that we do 
it.
    We are very fortunate to have these two witnesses today on 
the subject of how do we create new technologies for diagnostic 
testing so that we can have millions more tests to help us go 
back to work and back to school and to contain the disease. Our 
first witness is Dr. Francis Collins. I have asked him to take 
up to 10 minutes for his opening remarks. He is the director of 
the National Institutes of Health and we are fortunate to have 
him in this position at this time. He oversees the work of the 
largest public funder of biomedical research in the world. He 
is a physician geneticist by training.
    Prior to becoming the NIH Director 11 years ago in 2009, he 
served as Director of the agency's National Human Genome 
Research Institute from 1993 to 2008, during which he led the 
International Human Genome Project. He is an elected member of 
the National Academy of Medicine and the National Academy of 
Sciences, was awarded the Presidential Medal of Freedom in 
2007, and received the National Medal of Science in 2009.
    We are looking for a distinguished scientist to head this 
accelerated program. I think we are lucky to have one. He is a 
graduate of the University of Virginia, received a Ph.D. from 
Yale, his M.D. from the University of North Carolina School of 
Medicine, and he plays the guitar very well. Next we will hear 
from Dr. Gary Disbrow. He is broadly experienced as well. I 
have asked him to summarize his written testimony in 5 minutes. 
He serves as Acting Director of BARDA, the Biomedical Advanced 
Research and Development Authority. He is responsible for 
making sure BARDA is focused on the innovation, advanced 
research development, and procurement of medical 
countermeasures, such as diagnostic test subject today, 
critical to preventing and combating COVID-19 and other health 
threats we may face.
    Dr. Disbrow has been at BARDA for more than 10 years. He 
joined in 2007. He began working on the smallpox vaccine 
program. Since then, he served as Deputy Assistant for 
Preparedness and Response, and Director of Medical 
Countermeasures at the U.S. Department of Health and Human 
Services. In 2014 and 2015, he was named Ebola Incident 
Coordinator for BARDA and played a key role in efforts that led 
to the first licensed Ebola vaccine.
    Prior to joining BARDA, Dr. Disbrow was Assistant Professor 
of Oncology and Pathology at Georgetown University Medical 
Center where he focused on vaccines and therapeutics. He 
received his undergraduate from the University of Rochester and 
a Ph.D. from Georgetown. Welcome again to our witnesses. We 
will begin with you, Dr. Collins. Welcome.


STATEMENT OF FRANCIS COLLINS, M.D., PH.D., DIRECTOR, NATIONAL, 
               INSTITUTES OF HEALTH, BETHESDA, MD

    Dr. Collins. Well, thank you very much. Good morning, 
Chairman Alexander, Ranking Member Murray, and distinguished 
Members of this Committee both here in the room and joining 
virtually at this unusual time. I am glad to be here with my 
colleague Gary Disbrow from BARDA who has also just been 
introduced.
    I want to thank you Senators for your sustained commitment 
to the National Institutes of Health, which has enabled us to 
be at the forefront of action in this time of a national public 
health crisis. I am grateful to have this opportunity to 
address how we at the NIH and our scientists across the country 
are harnessing innovation to diagnose, treat, and prevent the 
novel coronavirus. Can you hear me alright?
    The Chairman. You are muffled either because of your mask 
or because of the microphone. I am not sure which it is.
    Dr. Collins. Well, we are going to do an experiment here. I 
don't know if this is randomized but it is at least a 
comparison test----
    The Chairman. You are still pretty--you are still pretty 
muffled. We did get advice from the Attending Physician of the 
Senate that it was appropriate for us not to wear our masks if 
we chose to when we were six feet apart and arranged this way.
    Dr. Collins. Well, I see I am at a safe six-foot distance 
from everybody and I do want you to be able to hear the 
testimony so I will follow that direction. NIH has taken an 
all-hands-on-deck approach to bringing the best and the most 
innovative science to diagnosis, to treatment, and to 
prevention.
    If I could have the slide up that I would like to be 
showing, that would be great, thank you. When the genetic 
sequence of SARS-COVID-2, the virus that causes COVID-19, was 
first released on January 10----
    The Chairman. Dr. Collins, let me ask you to wait just a 
minute and let technicians try to work on your microphone.
    Dr. Collins. Yes, we are having a little bit of a staticky 
thing, I think.
    The Chairman. You are our principal witness so we want to 
hear what you have to say.
    Dr. Collins. I am staticky enough without help. Maybe the 
other microphone was actually better. Now that I have the mask 
off, can we try that again?
    The Chairman. Sure. We will take just a moment for a 
technical adjustment and see if that makes a difference. Yes, 
sir. You like my mask? Well, it didn't work for other things. I 
thought it might work for this.
    [Laughter.]
    Dr. Collins. How is this one?
    The Chairman. That is a lot better----
    Dr. Collins. Sounding better? No staticky thing? Okay. 
Thank you for your patience. Well, when the genetic sequence of 
SARS-COVID-2, the virus that causes COVID-19 was first released 
just on January 10th of this year, NIH worked quickly to 
identify possible therapeutic agents and to begin developing a 
fast-track vaccine. Within a month, the National Institute of 
Allergy and Infectious Diseases, NIAID, had launched a clinical 
trial on the Gilead drug remdesivir at sites across the Nation, 
as well as internationally, and that trial reported, as you 
heard, preliminary results just last week showing that patients 
that received remdesivir had a 31 percent faster time to 
recovery than those who received a placebo.
    While this is not a home run, it does represent a landmark, 
the first rigorous demonstration of efficacy of a treatment for 
COVID-19. And on March 16th, just 63 days after receiving the 
viral genome sequence, NIAID completed all pre-clinical 
evaluation of a vaccine candidate and the first human patient 
was dosed in a phase 1 trial. That trial, I am happy to tell 
you, is going really well and I am excited to see how the 
timetable for full phase 3 testing of this vaccine and several 
other candidates has been advancing.
    As more information has poured in from scientists and 
patients all over the world, we have been sifting and sorting, 
looking for the best ideas, funding everything from basic 
biology to clinical trials, while closely watching private 
sector efforts and seeking ways to collaborate. And it has been 
apparent that the biomedical research world has fully charged 
up to tackle the COVID-19 challenge. And that expression of 
American creativity also applied to the development of new and 
more powerful and accessible approaches to diagnostic testing, 
and that is the main topic of our hearing and I will come to 
that shortly.
    But first if you will permit me, I wanted to share just a 
bit more about progress on therapeutics and vaccines for COVID-
19. On April 17th, NIH announced the start of an unprecedented 
partnership that now includes 18 pharmaceutical companies, 
multiple academic experts, the FDA, the CDC, BARDA, the 
European Medicines Agency, the Department of Veterans Affairs, 
and the Department of Defense. This partnership, which I am 
happy to co-chair with Paul Stoffels of Johnson & Johnson is 
called ACTIV, Accelerating COVID-19 Therapeutic Interventions 
and Vaccines.
    You may be able to see on the slide the incredible 
selection of organizations across all sectors that have come 
together to speed up progress. To conduct its work, ACTIV has 
developed an executive committee made up of senior leaders from 
industry, NIH, and FDA, and four working groups, each working 
group is co-chaired by a senior scientist from industry and one 
from NIH. As just one example, that clinical therapeutics 
working group has been conducting a rigorous scientific review 
of approximately 170 therapeutic candidates already proposed, 
seeking to prioritize those that are of the greatest urgency to 
get into clinical trials. We can't do 170 clinical trials.
    We want to be sure we used the resources for those that 
have the greatest promise. Another active working group is hard 
at work to make sure that the maximum clinical trials capacity 
is assembled and used for this purpose in order to test those 
highest priority candidates and standardized the evaluation 
methods to speed FDA review. We have never done it like this 
before to have this kind of coordinated approach across sectors 
to identify the highest priority candidates and figure out how 
to get them into trials efficiently and quickly.
    I have to say a word about our industry partners here. 
Within two weeks, they embraced this partnership. They made 
unprecedented commitments. They agreed to abide by a 
prioritization of candidates no matter who owns the drugs, and 
even indicated their willingness to contribute their own 
clinical trial capacity irrespective of whether the drug being 
tested was one of their own. That is a partnership in the 
truest sense of the word, but there is more. The most recent 
endeavor of our COVID-19 effort spurred in part by you the 
Congress and representing the main topic for today's hearing is 
our diagnostic innovation initiative and I want to turn to 
that.
    First, the National Cancer Institute is using their 
expertise in virology immunology and lab medicine, and 
supported by funding from this Congress, to evaluate and 
improve serology testing. Serology testing is based on the idea 
that we can look through your immune system's playbook to see 
whether your body has produced antibodies that respond to this 
virus. Such a serology test has the potential to tell generally 
how widespread a disease has been but it is critical that such 
a test be validated to make sure it is sufficiently sensitive 
and specific. You don't want a test out there that is giving 
wrong information. The tests are getting better and better.
    At the moment we still do not know for sure, however, 
whether someone with a prior infection with SARS-COVID-2 and 
who is antibody positive is completely resistant to 
reinfection, and if so, how long such immunity will last. The 
answer to those questions are being intensively studied. Once 
that information is in hand, we will be in a better position to 
advise people about the meaning of a positive antibody test. 
Second and most directly relevant for this hearing, NIH 
launched a COVID-19 initiative called Rapid Acceleration of 
Diagnostics or RADx just last week. As you heard from the 
Chairman, most current testing for the virus depends on 
detection of the viral RNA genome using the polymerase chain 
reaction or PCR.
    A PCR test takes a small code of DNA or RNA, amplifies it 
millions of times over so that it can be detected, but that 
amplification process is time-consuming, requires a thermal 
cycling machine available only in laboratory settings in 
general, and needs personnel who know how to run the test and 
how to troubleshoot problems. This program, RADx, supported by 
the funding from the Congress, seeks to expand the range of 
diagnostic technologies to include a whole bunch of novel 
approaches that can rapidly expand access to testing.
    RADx is engaging scientists across the country from the 
basement to the boardroom in an effort to improve current tests 
and advance completely new technologies. As America moves back 
into public spaces but seeks to avoid increased infections with 
COVID-19, tests have to be more accessible ideally to people at 
the point of care to make it easier for everyone to get tested. 
We need tests that don't require hours or days to determine 
results. The new types of tests need to be sensitive enough to 
flag asymptomatic individuals who may have just become infected 
and don't even know it yet. They must be reliable and have a 
user-friendly design. They must utilize various types of 
samples including saliva. And ideally, they should be able to 
integrate with mobile devices to process and show results and 
transmit data seamlessly.
    Above all, they need to be accessible to everyone. So, how 
should we inspire this outpouring of new technologies? How can 
we unleash the legendary American ingenuity at this time of 
great public urgency? How will we provide the resources to 
accelerate development, scale up, and deployment of new and 
powerful testing platforms? Our approach, which Senators 
Alexander and Blunt recently compared to a Shark Tank, is 
diagrammed on this slide. You can see a bunch of light bulbs. 
Your comment from Thomas Edison seems relevant here. Light 
bulbs that maybe have promise or maybe they need some work. 
Well, this is what is going to be happening with this RADx 
initiative. It occurs in three phases.
    First of all, there is a call for innovative technologies 
that went out last week on April 28. Phase 0, though, requires 
a review to be done of what the responses were to that call to 
be sure that they fit this model. Phase 0 is then a rapid 
evaluation of the technology over the course of only about a 
week by clinical technical business, regulatory, and 
manufacturing experts. Expert review boards covering 
scientific, clinical, regulatory, and business domains are 
going to rapidly evaluate these proposals, looking for the gems 
that provide real promise for COVID-19. Those promising early 
stage technologies will initially move into phase 1 where we 
will make a modest award of funds while simultaneously 
supporting that inventor or company with technical and clinical 
experts to address any scientific or business weaknesses 
identified in the review.
    Already well developed technologies can actually go 
directly to phase 2. We don't want to hold anybody back and it 
is possible that some of these arrivals in the Shark Tank are 
already big enough fish that they are ready to move on and we 
will support that as well, providing scale up for tests for 
validation. We have to know it works, meeting regulatory 
requirements, supporting manufacture and distribution, working 
closely with our colleagues at BARDA.
    In that regard, we are interested in reproaches that can 
substantially increase throughput and accessibility of 
laboratory based tests even though the ultimate goal of RADx is 
to develop and deploy point-of-care tests. So to tell you the 
update, as you heard, the RADx solicitation was just announced 
last week. This is day eight since that came out. We are 
allowing submissions of proposals on a rolling basis. I got to 
say I am delighted and somewhat astounded that as of noon 
yesterday, there were 1,087 applications initiated, 79 of those 
already complete. They had to provide a lot of details.
    In 27 years at NIH, I have honestly never seen anything 
move this quickly. The expert review team already in place has 
identified 20 of these completed applications that are ready to 
move into that first phase of intense scrutiny and the game is 
on and it is going to be a wild ride. Before I close though, I 
want to tell you about the third part of our initiative, a 
major focus on implementation of strategies to enable testing 
of rural, underserved, and under-resourced populations, among 
the hardest hit by the coronavirus, and often those for which 
testing has been less available.
    This effort which we are calling RADx-UP, as in 
underrepresented populations, will include the development of a 
centers program that will allow demonstration projects to be 
put in place across the country in places where COVID-19 has 
hit hardest and where testing has thus far been accessible. It 
will also include a program focused on the ethical, legal, and 
social issues associated with COVID-19 diagnostic testing and 
ways to try to avoid the inequities associated with unequal 
access.
    To conclude, the goal of RADx is to help make millions more 
accurate and easy to use tests per week available to all 
Americans by the end of summer and even more in time for the 
flu season. I must tell you Senators that this is a stretch 
goal that goes well beyond what most experts think will be 
possible. I have encountered some stunned expressions when 
describing these goals and this timetable to knowledgeable 
individuals.
    The scientific and logistical challenges are truly 
daunting, but I remain optimistic because of the track record 
of American ingenuity and the outpouring that has already 
happened of great ideas coming into this Shark Tank. So at NIH, 
we believe that putting the best minds in the world together is 
the only way to meet the challenge and to bring this virus 
under control. So I thank you for this opportunity to testify 
and to lead this initiative, and I look forward to your 
questions.
    [The prepared statement of Dr. Collins follows:]
                 prepared statement of francis collins
    Good morning, Chairman Alexander, Ranking Member Murray and 
distinguished Members of this Committee. It is an honor to appear 
before you today. I want to thank you for your sustained commitment to 
the National Institutes of Health (NIH) which has enabled us to be at 
the forefront of action in this time of a national public health 
crisis. I am grateful to have this opportunity to address how we at the 
NIH and our funded scientists across the country are harnessing 
innovation to prevent, diagnose, and treat the novel coronavirus 
currently plaguing our Nation.

    When the genetic sequence of SARS-CoV-2, the virus that causes 
COVID-19 was first released on January 10, 2020, NIH worked quickly to 
identify possible therapeutic agents and to begin developing a fast-
track vaccine. Just one month later, the National Institute of Allergy 
and Infectious Diseases (NIAID) launched a clinical trial on the Gilead 
drug remdesivir at sites across the Nation, which reported preliminary 
results just last week, showing that patients who received remdesivir 
had a 31 percent faster time to recovery than those who received 
placebo. This is a landmark--the first rigorous demonstration of 
efficacy of a treatment for COVID-19.

    On March 16th, just 63 days after receiving the viral genome 
sequence, NIAID completed all pre-clinical evaluation of a vaccine 
candidate and the first human patient was dosed in a Phase I trial.

    As more information has poured in from scientists and patients all 
over the world, we have been sifting and sorting, looking for the best 
ideas, and funding everything from basic biology to clinical trials--
while closely watching private sector efforts and seeking ways to 
collaborate. It soon became apparent that the biomedical research world 
is fully charged up to tackle the COVID-19 challenge, but what was 
needed was coordination of that vast community.

    On April 17th, NIH announced the start of an unprecedented 
partnership with 16 biopharmaceutical companies, academic experts, and 
government partners that now include the Centers for Disease Control 
and Prevention (CDC), the Biomedical Advanced Research Development 
Authority (BARDA), the Food and Drug Administration (FDA), the 
Department of Veterans Affairs (VA), and the Department of Defense 
(DoD). The partnership is called ACTIV--Accelerating COVID-19 
Therapeutic Interventions and Vaccines. That initiative has moved 
quickly to accelerate progress by conducting a scientific review of the 
approximately 170 therapeutic compounds and more than 50 vaccine 
candidates already identified. Another ACTIV Working Group is hard at 
work to ensure the maximum clinical trials capacity is assembled, in 
order to test the highest priority candidates and standardize the 
evaluation methods to help FDA review.

    I must say a word about our industry partners here. Within two 
weeks, they embraced this partnership and made an unprecedented 
commitment. They agreed to abide by a prioritization of therapeutic 
candidates, no matter who owns them, and indicated their willingness to 
contribute their clinical trial capacity irrespective of their 
potential for profit. It is a partnership in the truest sense of the 
word.

    But there's more. The most recent endeavor of our COVID-19 effort 
is an initiative called Rapid Acceleration of Diagnostics, or RADx, 
which NIH launched just last week.

    Most current testing for the virus depends on detection of the 
viral RNA, using a polymerase chain reaction or PCR. A PCR test takes a 
small code of DNA or RNA and amplifies it millions of times over so 
that it can be detected. This amplification process is time consuming, 
requires a thermal cycling machine available only in laboratory 
settings, and needs personnel who know how to run the test and 
troubleshoot problems.

    RADx seeks to expand the range of diagnostic technologies to 
include novel approaches that can rapidly expand access to testing. 
RADx is engaging every scientist from the basement to the boardroom in 
an effort to improve current tests and advance completely new 
technologies. As America moves back into public spaces but seeks to 
avoid increased infections with COVID-19, tests must be accessible, 
ideally to people at the point of care to make it easier for everyone 
to get tested. We need tests that do not require hours or days to 
determine results. The new types of tests need to be sensitive enough 
to flag asymptomatic individuals who have just become infected but may 
not know it. They must be reliable and have a user-friendly design, 
must utilize various types of samples (nasal swabs, saliva, blood, 
exhaled breath, etc.), and ideally should be able to integrate with 
mobile devices to process and show results and transmit data 
seamlessly. Above all, tests need to be accessible to everyone who 
needs them.

    Such tests sound like science fiction but are scientifically 
possible. One category we will pursue actively is called viral antigen 
testing. Antigen testing detects a part of the protein capsule of the 
virus itself and not its genetic code. This doesn't require PCR, and 
allows for immediate detection if the virus is present in the body. 
With time and effort, antigen tests can be modified to be done at home 
which would allow for easier and more frequent testing. They have 
traditionally been more difficult to develop to a sufficient level of 
accuracy, but that is where RADx comes in.

    The RADx solicitation for applications was just announced last 
week, and proposals may be submitted on a rolling basis. The RADx 
technology assessment and potential scale up process will occur in 
three phases. Phase 0 is a rapid evaluation of the technology by 
clinical, technical, business, regulatory, and manufacturing experts. 
Expert review boards covering scientific, clinical, regulatory and 
business domains will rapidly evaluate technology proposals to find 
gems with promise for COVID-19.

    Promising early stage technologies will initially move to Phase I, 
where NIH will make a modest award of funds while simultaneously 
supporting that inventor or company with technical and clinical experts 
to address any scientific or business weaknesses identified in the 
review. Already well-developed technologies may go directly to Phase 
II, where support will be provided for scale-up of tests for 
validation, meeting regulatory requirements, and support manufacture 
and distribution. We are also interested in approaches that can 
substantially increase throughput and accessibility of laboratory-based 
tests. While the ultimate goal of RADx is to develop and deploy of 
point-of-care tests, lab-based approaches can also be supported as 
intermediate solutions.

    The goal is to help make millions of accurate and easy-to-use tests 
per week available to all Americans by the end of summer 2020, and even 
more in time for the flu season. To be completely honest, this is an 
ambitious goal. The scientific and logistical challenges are truly 
daunting. But I remain optimistic because of the track record of 
American ingenuity. At NIH, we believe that putting the best minds in 
the world together is the only way to meet the challenge and bring this 
virus under control.

    Thank you again for this opportunity to testify. I look forward to 
your questions.
                                 ______
                                 
    The Chairman. Thank you, Dr. Collins.
    Dr. Disbrow, welcome.

 STATEMENT OF GARY DISBROW, PH.D., ACTING DIRECTOR, BIOMEDICAL 
  ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY, OFFICE OF THE 
   ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE, UNITED 
 STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, WASHINGTON, DC

    Dr. Disbrow. Thank you. Good morning, Chairman Alexander, 
Ranking Member Murray, and distinguished Members of the 
Committee. Thank you for the opportunity to testify today. I am 
Dr. Gary Disbrow, Deputy Assistant Secretary and Acting 
Director of the Biomedical Advanced Research and Development 
Authority, or BARDA, within the Office of the Assistant 
Secretary for Preparedness and Response at the Department of 
Health and Human Services.
    The Chairman. Could you put the slides back up for him, 
please?
    Dr. Disbrow. Today, I want to highlight how BARDA is 
supporting efforts to develop vaccines, treatments, and 
diagnostics and response to the COVID-19 pandemic. HHS 
Secretary Alex Azar declared a public health emergency on 
January 31st, 2020. At nearly the same time, as per BARDA, 
established an interagency call with industry highlighting our 
high-level strategy for the development of vaccines, 
therapeutics, and diagnostics to address COVID-19, attracting 
over 1,500 participants.
    That same day, BARDA opened a medical countermeasure or MCM 
portal to accept market research missions from stakeholders, 
receiving over 2,700 submissions to date. We are working with 
our interagency partners to quickly prioritize and review all 
submissions. Prior to receiving supplemental funds, BARDA 
modified our two solicitations to allow submissions of COVID-19 
products. We have received 210 submissions under our Broad 
Agency Announcement, or BAA, and 310 to our Easy BAA, which is 
a streamlined solicitation with a cap of $750,000 in funding.
    This is what we do, we engage innovative stakeholders, 
establish partnerships, develop medical countermeasures, and 
bring them forward to the American people to save lives. Under 
the response structure, task forces were established to bring 
together experts from across the U.S. Government to address key 
challenges and find solutions. One task force is the Medical 
Countermeasure Task Force as shown on this first slide. The MCM 
task force includes representation from across the USG and 
working groups were established to address vaccines, 
therapeutics, and diagnostics.
    BARDA is a key leader in the MCM task force working groups. 
The goals of the task force are to prioritize and align MCM 
development and share information across the USG in a 
transparent manner. BARDA has a track record of success in 
delivering effective countermeasures in response to public 
health emergencies. Past examples include H1N1, Ebola, and 
Zika. BARDA has unique authorities, allowing my organization to 
leverage and rapidly expand partnerships to push candidates 
forward to the review, testing, and approval phase. To date, 
BARDA has leveraged the $3.5 billion provided under the CARES 
Act COVID-19 supplemental and made investments in multiple 
vaccine candidates, multiple therapeutic candidates, and 
important for today's discussion, COVID-19 diagnostic programs.
    The second slide shows diagnostic candidates supported by 
BARDA, CDC, and the Department of Defense. Starting at the top 
with molecular lab-based or near patient, then molecular point 
of care, and the last two rows highlight investments in 
antibody and antigen based tests. On the next slide, it is 
showing the BARDA specific products with emergency use 
authorization. To support the need for expanded diagnostic 
capacity, BARDA has made investments in molecular tests for 
commercial labs, near patient and point of care test to 
identify individuals who are infected. The slide shows lab-
based and near patient molecular diagnostics on the left and 
point of care on the right.
    The green stars indicate diagnostics that have been granted 
emergency use authorization or EUA by the Food and Drug 
Administration, FDA. BARDA has recently only shifted our focus 
to antigen and serological tests. BARDA is supporting a total 
of 19 diagnostic products and 8 have been granted EUA by the 
FDA. BARDA's efforts have helped ensure the availability of 
diagnostic testing in the U.S., with 2.7 million diagnostic 
tests shipped in the last seven weeks, and we expect our BARDA 
funded partners to continue to increase production in the 
coming weeks.
    BARDA is proud to collaborate with NIH on two new efforts. 
First, we are integrated with the efforts established by Dr. 
Collins under the accelerated COVID-19 therapeutic 
interventions of vaccines or the ACTIV partnership. Second, we 
are collaborating with the rapid acceleration of diagnostics, 
or the RADx program, run by the National Institute of 
Biomedical Imaging and Bioengineering. BARDA will provide 
subject matter expertise as applications are reviewed, 
potential candidates are identified, and as teams are assembled 
to shepherd development.
    NIH's initiative and BARDA's efforts are complementary, and 
together, we will make the RADx program a success. BARDA has 
over 300 industry partners, 13 years of product development 
experience, and 54 FDA approvals. BARDA's long-standing 
expertise in accelerating advanced research and development of 
candidate diagnostics, therapeutics, and vaccines is a 
testament to our dedicated and experienced team.
    This Committee and Congress at large have been very 
supportive of the BARDA mission, and today more than ever we 
need your continued support and flexibility to ensure our staff 
can stay focused on the task at hand. Again, thank you for 
passing the recent supplemental appropriations that will aid in 
our overall response efforts.
    We could not do our job without your partnership and 
support. I look forward to discussing how we can continue to 
work together on this important issue. Thank you.
    [The prepared statement of Mr. Disbrow follows:]
                   prepared statement of gary disbrow
    Chairman Alexander, Ranking Member Murray, and distinguished 
Members of the Committee, thank you for the opportunity to testify 
today on our efforts to develop appropriate and effective medical 
countermeasures to prevent infection and test and treat those with or 
suspected of having COVID-19. I am Dr. Gary Disbrow, Deputy Assistant 
Secretary and Acting Director of the Biomedical Advanced Research and 
Development Authority (BARDA) within the Office of the Assistant 
Secretary for Preparedness and Response at the Department of Health and 
Human Services (HHS or Department). Today, I will provide a brief 
overview of the current response structure and then provide detail on 
BARDA's role in developing countermeasures and diagnostics to aid in 
the overall response.

    As you all know, the Federal Government has been monitoring the 
spread and threat of the severe acute respiratory syndrome coronavirus, 
SARS-CoV2, the virus that causes COVID-19--since last December when 
cases began emerging in the city of Wuhan, Hunan province in China. 
COVID-19 is a new disease, caused by a novel (or new) coronavirus that 
has not previously been seen in humans. Immediately after the virus was 
detected, various HHS agencies to include the Centers for Disease 
Control and Prevention (CDC), the Assistant Secretary for Preparedness 
and Response (ASPR), the National Institute of Allergy and Infectious 
Diseases (NIAID) along with several other components of the National 
Institutes of Health, and the Food and Drug Administration (FDA) began 
coordinating and leveraging tools and resources to respond to COVID-19. 
Specifically, these agencies began implementing efforts to prevent and 
slow the spread of the disease, assisting repatriated Americans, 
protecting the supply of food, drugs, and devices, and developing 
diagnostics, therapeutics, and vaccines.
                        ASPR's Role in Response
    ASPR's mission is to save lives and protect Americans from 21st 
century health security threats. During past response operations, ASPR 
has led, on behalf of HHS, Emergency Support Function #8: Public Health 
and Medical Services, under the National Response Framework. This means 
ASPR serves as the primary coordinator for public health information 
and deployment of assets to support the health components of a 
response.

    For the current COVID-19 pandemic response, ASPR is participating 
in 14 Task Forces comprised of subject matter experts that are 
operating under the Federal response structure. ASPR has subject matter 
experts leading and/or serving on a number of the task force groups, 
including the Supply Chain Task Force, the Medical Countermeasures Task 
Force, the Healthcare Resilience Task Force, Laboratory Diagnostics 
Task Force, and the Data and Analysis Task Force to name a few. The 
purpose and goal of the various Task Forces is to explore policy 
issues, identify gaps in capabilities, and identify solutions to aid in 
the response. The Task Force structure supports streamlined 
communication across the Federal Government and expedites 
implementation of identified solutions as and when needed.
 The Biomedical Advanced Research and Development Authority's Role in 
                   Medical Countermeasure Development
    Outside of the current FEMA response structure, ASPR's BARDA 
continues to support the innovation, advanced research, development, 
manufacturing capacity improvements, and acquisition of medical 
countermeasures (MCM) (e.g., vaccines, medicines, diagnostics, and 
other necessary medical supplies). Since late January, BARDA has been 
collaborating with counterparts across the government, under the 
Medical Countermeasure Task Force, to continue to identify potential 
candidates and accelerate their advanced development.

    Even before initial COVID supplemental funds were made available on 
March 6, 2020, BARDA initiated investments utilizing annual funding to 
quickly evaluate existing partnerships to determine those that had 
promising candidates and immediately made investments in vaccines, 
therapeutics, and diagnostics. Supporting this strategy, ASPR hosted an 
interagency call with industry on January 30, 2020, to inform external 
stakeholders of the high level strategy to pursue development of 
vaccines, therapeutics, and diagnostics. Over 1,500 attendees 
participated in the call. Shortly after the industry call, BARDA 
established the MCM Portal for Coronavirus, or Portal. This Portal 
which is accessible by NIH, CDC, FDA, the Department of Defense (DoD), 
and BARDA, ensures U.S. Government partners are able to stay current 
with the rapidly evolving landscape of promising, emerging 
technologies. Information and proposals from industry are submitted to 
the portal and then reviewed and prioritized by BARDA and interagency 
colleagues. After the initial review ``CoronaWatch'' meetings are 
scheduled. CoronaWatch is a unique tool that BARDA utilizes to ensure 
that those technologies that are ranked as highly relevant by 
interagency partners can be further evaluated and considered for 
funding across the U.S. Government. During the CoronaWatch meeting, 
BARDA and interagency experts discuss the specific proposal with the 
submitter, review data and other supporting information, and provide 
technical input for future submission for potential funding. As of May 
1, 2020, over 2,590 applications have been submitted via the Portal and 
over 250 CoronaWatch meetings have been held with companies that were 
ranked at the highest priority level for the interagency, 99 of these 
for diagnostics.

    In addition, BARDA continues to encourage applications to its two 
primary funding solicitations. To date, there has been 128 submissions 
under BARDA's Broad Agency Announcement (BAA) and 275 submissions under 
our Easy BAA (EZ BAA). The EZ BAA was established in 2018 to advance 
early stage innovative approaches to health security, with the ability 
to make awards in as few as 12 days.

    Leveraging the funds provided in the first COVID-19 supplemental, 
the Coronavirus Preparedness and Response Supplemental Appropriations 
Act, 2020 (Public Law 116-123), awards have already been made to 
promising candidates to date. Specifically, BARDA has made investments 
in three vaccine candidates, 8 therapeutic programs and 19 diagnostic 
programs. BARDA's COVID-19 portfolio is rapidly expanding, with daily 
awards and updates. For the most up-to-date information, please visit 
https://www.medicalcountermeasures.gov/app/barda/coronavirus/
COVID19.aspx.

    BARDA has a track record of success in delivering effective 
countermeasures in response to public health emergencies. Past 
successes include the 2009 H1N1 influenza pandemic, Ebola outbreaks in 
2014-2016 in West Africa and in 2018 the Democratic Republic of the 
Congo, as well as Zika in 2015. For these past response operations as 
well as the current response to COVID-19, Congress has provided 
emergency supplemental funding to support medical countermeasure 
development. For the current COVID-19 response, BARDA reviewed 
investments with Regeneron, Janssen, Sanofi Pasteur, and Genentech, all 
of which have previously shown success in the successful development of 
both prophylactic and therapeutic medical countermeasures for emerging 
infectious diseases. BARDA's leveraging of these existing partnerships 
and established platforms may help shave months off the development 
timelines for medical countermeasures and has been made possible 
because of flexible authorities and prior investment into these 
platforms.

    Beyond medical countermeasure development, BARDA is also supporting 
efforts to strengthen domestic manufacturing capacity. Several years 
ago, BARDA established the Centers for Innovation in Advanced 
Development and Manufacturing (CIADMs). While these CIADMs provided 
such benefits as training opportunities for current and future industry 
and government scientists who engage in advanced development and 
manufacturing of medical countermeasures, there is great potential that 
they will aid the response to COVID-19 by supporting manufacturing as 
products are identified. Specifically, Janssen, a Johnson & Johnson 
company, has identified a lead candidate using their AdVac system. They 
have signed a partnering agreement with the BARDA CIADM at Emergent 
BioSolutions to help manufacture their vaccine.

    The focus of today's Hearing is diagnostics. To support the 
anticipated need for expanded diagnostic capacity, BARDA initially 
invested in molecular tests to identify individuals who were infected 
with COVID-19. These tests specifically look for the virus RNA in 
respiratory samples. In March, BARDA invested in adding SARS-CoV-2 
assays to systems that are routinely used in the commercial and 
clinical diagnostic space to rapidly expand high throughput capacity 
(Hologic, Luminex, DiaSoran, Cepheid). BARDA also invested in near 
patient/hospital based molecular diagnostics (Qiagen, GeneMark, 
Cepheid, Vela, Luminex). Finally, BARDA has supported hand-held and 
point of care molecular diagnostics (Mesa BioTech, Cue, Cepheid). The 
latter, point-of-care diagnostics are ``sample-to-answer'' systems that 
do not require the separate extraction reagents required by other 
systems that have been in short supply. BARDA's efforts have helped 
ensure the availability of diagnostic testing in the Unites States. In 
the last 6 weeks, 2 million diagnostic tests have been shipped by 
BARDA-funded test developers for use domestically and we expect our 
partners to continue to increase production and scale. As the pandemic 
has progressed, the need to develop antigen or antibody/serological 
tests is now the emphasis. These types of tests will allow for 
identification of individuals who were infected and now have antibodies 
against the virus. BARDA's investments include antibody/serological 
based tests (DiaSoren, InBios, Nanomix, Hememics) and antigen tests 
(OraSure, Nanomix, Hememics). BARDA has and will continue to work 
closely with interagency partners (FDA, CDC, NIH/NIAID, DoD) and with 
the Laboratory Diagnostics Task Force to help address existing and 
emerging technical and operational challenges related to COVID-19 
diagnostics. BARDA is also currently supporting the Serology Project 
Team established by HHS to address the research, technical, and 
operational issues and gaps for utilization of antibody tests.

    BARDA is proud to partner with the new NIH effort, Rapid 
Acceleration of Diagnostics (RADx). BARDA will provide subject matter 
expertise to review applications, evaluate potential candidates, and 
support development teams as they are assembled. NIH's initiative and 
BARDA's efforts are complimentary and will ensure RADx is as successful 
as possible to expedite development of new countermeasures. As products 
are developed, BARDA stands ready to aid in the manufacturing as 
needed, through established partnerships.
                               Conclusion
    Since its inception, BARDA has entered over 300 industry 
partnerships, attained 13 years of clinical product development 
experience, and helped partners achieve 54 FDA approvals. BARDA's long 
standing expertise of accelerating the advanced research and 
development of candidate diagnostics, therapeutics, and vaccines 
through to FDA approvals, clearances, licensures and Emergency Use 
Authorizations, is unmatched across the government and underscores the 
overall capabilities that we have brought to bear on COVID-19.

    Thank you for passing the recent supplemental appropriations that 
will aid our overall response efforts. We could not do our job without 
your partnership and support.

    Thank you for your time and I look forward to discussing how we can 
continue to work together on this important issue.
                                 ______
                                 
    The Chairman. Thank you, Dr. Disbrow. We will now go to 5 
minute round of questions. We will go and seniority order 
including those Senators who are participating by video. And I 
will begin. Dr. Collins, you said that you would define the 
millions, tens of millions of tests that we need, diagnostic 
tests--first thing you are going to do is squeeze every test 
out of existing technology, but am I correct that existing 
technology won't produce that number of tests so we need a new 
technology?
    Dr. Collins. I think it is both and, not either, or. I do 
think existing technologies have the potential for further 
scaling up and we are very interested in seeing that happen. 
And BARDA is also very much in that space and we will work 
closely together on that, but most of the existing technologies 
are done in central laboratories.
    They are not what you would call point of care and we want 
to see that feature very heavily emphasized in what we do with 
the new technologies so that they could be more accessible, 
give a more rapid turnaround as far as a result of the tests, 
and be generally distributed to places that currently don't 
have much access.
    It is definitely the case--anything we can do that is going 
to increase the number of tests available by a factor of 5 or 
maybe even 10 is very worth what we would want to put into it. 
But we also believe that it is not just a matter of taking what 
we have and making it higher throughput, we need new 
technologies that have these more appropriate features.
    The Chairman. I want to have a question for Dr. Disbrow, 
but let me ask you one first. Just before I came in here, I got 
off the phone with the chancellor of the University of 
Tennessee at Knoxville. They have invited their students to 
come back in August. Talked to the President of University of 
Middle Tennessee State University, South of Nashville.
    They have done the same. What can you tell university 
presidents and principles? We have 5,000 colleges. We have 
100,000 public schools. They would like to go back to school in 
August. What can you tell them about the availability of 
testing in August, including the possibility there may be some 
of these new tests that would expand the supply dramatically?
    Dr. Collins. Well that would very much be our goal and you 
have made the point, I think repeatedly, how critical that is 
going to be in terms of getting us back into school and not 
having what would be another second or third wave of 
coronavirus at that very vulnerable moment when the flu season 
is starting up as well. What you want to have at that point is 
the ability in a community to know whether the virus is 
circulating. So that means being able to do surveillance, 
finding out whether the virus is around.
    If so, then immediately identifying those who are infected 
and getting them quarantined. And obviously schools and 
colleges are a critical place to watch over. So having a great 
expansion in the number of point-of-care tests at that point so 
that university presidents or chancellors have a chance of 
knowing what are the risks of bringing people back. That is 
what we want to contribute to. That is what this project is all 
about.
    The Chairman. Let me ask you and then Dr. Disbrow, if you 
will save him some time. Let's talk about scaling up. I am not 
a scientist and I am not going to pretend to be one but I have 
so much respect for our scientific community in the United 
States. I cannot imagine that out of the thousand applications 
that you have, or expressions of interest that you have 
received, that there won't come a few new ideas that will 
permit us the kind of quick, simple, inexpensive, easy to 
administer tests that will be widely available, and we are 
talking about tens of millions of tests.
    But the question is, how do you manufacture all those? And 
when you select the survivors of your Shark Tank or your RADx 
experiment, are you taking into account whether you can scale 
them up? And then let me ask Dr. Disbrow within my minute and 
20 seconds, what will BARDA do working with you to scale up 
what you discover is a new technology for producing tens of 
millions of tests?
    Dr. Collins. Great question. Very quickly, the review group 
that is going to be looking at these more than a thousand 
applications is well populated with people who are experts in 
business and commercialization and scale up. We are not going 
to invest in something that looks like it doesn't have that 
potential.
    But then once you have decided it is going to have that 
potential, you got to get the resources together. These may 
come from small businesses. Most of the applications are. How 
do you find a large business partner? How do you provide the 
resources? BARDA is in a great spot there to assist with that 
scale up.
    The Chairman. Dr. Disbrow.
    Dr. Disbrow. Right. Thank you. So, as Dr. Collins 
mentioned, we envision this as a seamless transition. So BARDA 
does have experience, our 300 industry partners that we have, 
partnering with industry, bringing together engineers. So that 
as those products are moving through the funnel that you saw, 
it is a seamless transition and we assist with funding that we 
would have available to help scale up the manufacturing.
    The Chairman. You will be involved in helping to identify 
promising technologies based upon their scalability----
    Dr. Disbrow. Correct.
    The Chairman. Then you will be coordinating with outside 
groups to see that the scaling is done so that we can----
    Dr. Disbrow. To help partner them, correct.
    The Chairman. That is right.
    Senator Murray.
    Senator Murray. Well, thank you very much, Mr. Chairman, 
and thank you again to our witnesses. You know, two months 
after the President claimed everyone who wants a test, gets a 
tests, we now have well over a million COVID-19 cases. As I 
said, there is more than 73,000 deaths and no plan to bridge 
the huge gaps in testing across the country. Instead take 
states are left to respond with limited Federal support and 
blind spots on how the disease has spread and fighting with 
each other for critical supplies.
    To address those failures, Congress required the 
administration to submit a national strategic plan to increase 
testing by May 24th. On Tuesday, approximately 260,000 tests 
were performed in the United States. Experts have said we need 
anywhere from 500,000 tests per day right now to 5 million a 
day or even more going forward.
    To reach those targets, states need more than vague musings 
from the White House. They actually need numbers and timelines 
and clear expectations of how the Federal Government intends to 
get us there.
    Dr. Collins, I want to ask you just yes or no, in order for 
that plan to ensure America's Governors and public health 
leaders have enough testing to begin safely reopening, should 
that National strategic plan on testing include specific 
numeric targets testing capacity, supply chain capacity, and 
projections of shortages?
    Dr. Collins. Senator, I am sorry. It is not my sweet spot 
because of course this is the job of the Coronavirus Task Force 
and the CDC. Certainly, I know states are looking for those 
kinds of specific guidelines, and I totally understand that.
    Senator Murray. Well, should a plan detail how to best 
allocate different tests for use in different settings? For 
example, at a hospital versus a workplace?
    Dr. Collins. There is certainly scientific reasons why 
those kinds of decisions ought to be nuanced based on the 
circumstances. They can be quite different from one environment 
to the next. So I would hope yes, any plan would have that kind 
of specific recommendation about particular environments where 
testing is going to be offered.
    Senator Murray. Okay. Thank you, doctor. Dr. Disbrow, thank 
you for testifying here so soon in your tenure in this role. 
This week, your predecessor, Dr. Bright, filed a complaint with 
the Office of the Special Counsel, detailing actually an 
alarming degree of corruption and incompetence among political 
leadership across HHS and the Trump administration. We learned 
from Dr. Bright yet again that the White House has largely 
ignored warnings about COVID-19, failed to take steps to 
adequately secure supplies of PPE, and otherwise prepare a 
response.
    The White House failed to secure supplies for testing, they 
pushed untested and unproven drugs against the advice of 
experts, and political leaders put career public health 
officials in terrible positions where they had to decide 
between doing what they have been told versus doing what is 
right with people's lives on the line. Dr. Collins and Dr. 
Disbrow, I expect you to cooperate fully with any investigation 
into Dr. Bright's complaint and I am going to continue to look 
into these allegations.
    There are so many workers across the Federal Government 
that are trying to do the right thing to help us get increased 
testing and generate a plan to develop and distribute a 
vaccine, putting science ahead of politics and refusing to put 
the public health at risk.
    To those of you who are doing that who are watching, thank 
you. Dr. Disbrow and Dr. Collins, can you commit to me today, 
without reservation, that you will always prioritize the public 
health and never give in to pressure to do political favors and 
that you will speak out against corruption and incompetence and 
misconduct when you see it?
    Dr. Collins. Yes.
    Dr. Disbrow. Yes.
    Senator Murray. Thank you. And I appreciate that. And do 
you both commit to doing everything in your power to protect 
HHS employees from political interference and doing their jobs, 
and especially to protect those who speak out to make sure 
public health efforts are guided by science and not personal 
profit or politics?
    Dr. Collins. Yes.
    Dr. Disbrow. Yes.
    Senator Murray. Do either of you have any reason to doubt 
that Dr. Bright faced the political pressure that he described 
in this complaint?
    Dr. Collins. It is Dr. Collins. I have to say I just don't 
have any personal primary information so I am only going by the 
things that I have read. It is not a circumstance that I can 
form my own opinion because I don't have the facts as a sort of 
personal experience.
    Dr. Disbrow. Right. This is Gary Disbrow. So, now that this 
is a personnel matter being handled by the Office of Special 
Counsel, I can't really comment.
    Senator Murray. Okay. Well, do you both commit to being 
transparent with Congress and the public regarding any 
partnerships your agencies engage in throughout this COVID-19 
response, including regarding what guardrails are in place to 
make sure Government resources are devoted to the products most 
promising to public health and not those that will drive 
profits for politically connected companies?
    Dr. Collins. Yes.
    Dr. Disbrow. Yes.
    Senator Murray. Did I hear yes from both of you?
    Dr. Disbrow. Yes, you did.
    Senator Murray. Alright. Thank you. I just have a few 
seconds left and I hope to ask a few more questions in the next 
round if that is possible, Mr. Chairman.
    The Chairman. Sure. Thanks, Senator Murray. Good to see you 
even if at a distance.
    Senator Enzi.
    Senator Enzi. Thank you, Mr. Chairman, and thank you, 
Senator Murray, for this hearing. I want to thank the witnesses 
for all of the information that they provided. It is very 
helpful.
    This is a critical thing for our Nation and I hope this 
doesn't turn into a hearing about Trump. I noticed that the 
vaping one that was surprisingly turned into that but getting 
to my questions, the administration has announced a number of 
public, private partnerships are geared to bring the Federal 
agencies and private industry together to develop medical 
countermeasures.
    The NIH is at the helm of most of these efforts. How is the 
agency's role different in the RADx and ACTIV partnership and 
Operation Warp Speed? Dr. Collins.
    Dr. Collins. Yes, we are very much a fan of partnerships to 
get science to happen. When I had the privilege of leading the 
Human Genome Project, I learned how much can be gained by 
bringing groups together that have different skills and talents 
and not worrying too much about who is going to get the credit, 
just get the job done. More recently, I have had the privilege 
of leading several of these public-private partnerships focused 
on trying to develop the next generation of therapeutics for 
diabetes, for Alzheimer's disease, for rheumatoid arthritis and 
lupus, for Parkinson's disease, for cancer, and those have 
turned out to be enormously productive by bringing the best and 
brightest scientists around the same table to design the work, 
hold themselves accountable, and make sure all the data is 
accessible to everybody.
    When the COVID-19 crisis came along. It was clear that we 
might benefit from that same kind of model. And by talking to 
my colleagues in all sectors, we did decide that this was worth 
a try. On April the 3d, which is just 34 days ago, convened 
senior leadership of pharmaceutical companies, of FDA, CDC, 
BARDA, and the NIH, and the European Medical Medicines Agency, 
came up with a series of things that we thought could be done 
better as a partnership than either of the sectors or either 
the companies or institutions could do on their own. And that 
is what ACTIV has become.
    I must say, it has been astounding to see the way in which 
people have rolled up their sleeves and plunged in to this 
effort to advance therapeutics and vaccines for COVID-19. Some 
of those previous partnerships I mentioned took a couple years 
to sort of work out the details and finally get everybody 
sitting down at the same table. This took two weeks. And on 
April 17th, we announced the launch of this enterprise, and it 
has been 24/7 for these working groups that are trying to knock 
down the barriers that might otherwise get in the way.
    The RADx effort is not the same kind of partnership. I 
might call it more of a bottom-up kind of partnership in the 
sense that the talent and the innovation and the creative ideas 
about new testing platforms is largely coming from small 
businesses. And so they become our partners because they are 
feeding these ideas into the Shark Tank.
    Of those 1,087 that I told you that we have already 
received as far as responses to the solicitation, two-thirds of 
those are from small businesses. There is also a wonderful 
input from academics and a few middle sized businesses as well. 
That is just the kind of thing you would like to see for this 
kind of a partnership which is going to be intensely 
competitive.
    Yes, I guess in my time at NIH, 27 years now, I learned 
over and over again, if you want to get something done, find 
all of the potential contributors who have skills, talents, 
energy, motivation, and resources, and let's do it together, 
and that is certainly what we have to do at a time like this 
with this global pandemic all around us.
    Senator Enzi. Thank you. I now have a question of--it is 
kind of a who is in charge question. We are having to scramble 
to catch up and that means conducting the early stage of 
research at the same time that we are trying to move products 
through the advanced development stages.
    Public health emergency MC mission statement identifies the 
National Institute of Health taking the lead role in the early 
research and BARDA as taking the lead role in advanced 
development and manufacturing. Do NIH or BARDA have primary 
authority for advanced manufacturing support or scale up?
    Dr. Collins. I think this is what we are talking about at 
this hearing, the handoff that we are making sure happens in 
this space. We are really good at getting those early ideas 
started, figuring out how technologically they can be advanced. 
But when they get to the point of being ready for a real 
commercialization scale up, BARDA steps in with all their 
skills. Gary, you may want to say more about how that works.
    Dr. Disbrow. Yes. I appreciate that, Francis. So this is 
not the first partnership between NIH and BARDA. We have 
partnered over the past decade or more with the National 
Institutes of Allergy and Infectious Diseases transitioning 
vaccines and therapeutics for some of the greatest threats that 
our Nation faces such as chemical, biological, radiological, 
and nuclear threats, and pandemic influenza.
    I think this is, just a building of that natural 
partnership that occurs. We work hand in hand. You saw on Dr. 
Collins's slide that BARDA is integrated into the ACTIV 
partnership. You saw on the slide that I presented that it is 
in a whole of Government where everybody is integrated and 
working across Government, sharing information, and helping to 
develop those medical countermeasures.
    Senator Enzi. Thank you. The clock on my screen is behind 
my picture so I suspect that I have used my time and I thank 
you.
    The Chairman. Thank you, Senator Enzi. your timing is very 
good. Senator Casey, who has done a lot of work in this area 
over the years with Senator Burr especially.
    Senator Casey.
    Senator Casey. Can you hear me?
    The Chairman. We can hear you.
    Senator Casey. Mr. Chairman, thanks very much. And I want 
to thank our witnesses, both the Dr. Collins and Dr. Disbrow. I 
want to start with the reality that so many communities are 
facing now that the case numbers and the deaths are 
overwhelming. As we all know the national numbers, those 
numbers translate in Pennsylvania to something on the order of 
more than 51,000 cases.
    The death number in our state went up recently. We are now 
over 3,100 deaths. So we are thinking of those families that 
are suffering in so many ways. I want to start by commending 
the frontline workers in this crisis. The frontline healthcare 
workers as well as so many others, and I won't try to list all 
of the occupations, all of the work that is being done on those 
front lines.
    Second, I want to commend those who are, throughout our 
country, the tens and tens of millions, who are doing their 
part by staying home and by social distancing and wearing masks 
and doing all the things that the experts tell us we should do 
to stop the spread of the virus. We are grateful for that. I 
think the administration's response so far has been inadequate 
and that might be an understatement. It is nowhere near the 
dedication of those frontline workers nor is it compliant or 
adhering to standards like people are at home.
    I wanted to start with that in terms of just the what I 
think our failures that we have to recognize and try to 
mitigate in the short term, but make a pledge never to have 
such failures in the future. I think there are at least three, 
the testing failure, the failure to deliver adequate supplies 
of personal protective equipment, and then third the failure to 
effectively communicate over time. Sometimes the administration 
has been guided by science and expertise, and then that 
expertise is undermined by way the administration has 
communicated.
    Finally, let me just say before I get to my questions, the 
Senate, as it has in the first four pieces of legislation, four 
being the Response Act, the Families CARES Act, the CARES Act, 
and then the--we have been focused on both stopping the spread 
of the virus, dealing with the public health challenge, but 
then second also helping those who are adversely impacted by 
the terrible economic consequences that flows in the wake of 
the virus.
    I would say that is also concern or should focus our work 
on oversight. And I know the Chairman will be getting to that 
but we have to do a lot more oversight of the response so far. 
Dr. Disbrow, I want to pose a question to you about the next 
generation of PPE. You know BARDA's mission and part of BARDA's 
mission is to make sure that when we have a pandemic, the 
agency, or BARDA itself, limits the harm of such a pandemic and 
PPE is obviously part of that.
    You have heard, and you have read, and I am sure you are 
well aware of the limitations that the PPE has meant for so 
many workers. Sometimes out-of-date PPE, sometimes personal 
protective equipment that is causing harm to those workers. We 
have to get to the next generation of personal protective 
equipment and I would hope that you would work with us on 
preparing not just for the next couple of months but preparing 
for the next 50 years. And I hope we can have your commitment 
on that, both you personally as well as BARDA. Do we have that 
commitment from you?
    Dr. Disbrow. Yes, you do.
    Senator Casey. Thank you very much. And Dr. Collins, in my 
remaining minute, let me just get to a question about evidence-
informed policymaking. We have heard so much from public health 
experts and from scientists about how to stop the spread of the 
virus and how to deal with this pandemic. I would ask you, Dr. 
Collins, do you agree that science and peer-reviewed evidence 
should be what we implement by way of policy in our response to 
the pandemic?
    Dr. Collins. Well, I have built my whole career on science 
and evidence and rigorous ways to derive that. In the hopes 
that, that would in fact be the way in which we as a society 
make decisions. So I certainly agree that ought to be the way 
in which we move ourselves forward in a fashion that we can be 
confident is based on real facts.
    Senator Casey. I hope you will continue to advocate for 
decisions that we make in the Senate based upon science and 
based upon the best possible expertise, not based upon 
arbitrary deadlines of politics or philosophy. So I thank you 
for that. We are grateful. Mr. Chairman, I might have some 
follow-up questions in the next round. Thank you.
    The Chairman. Well, we will see Senator Casey, whether 
there will be a next round. We are going to try to end by 12:45 
p.m. because the witnesses have to go on and we have votes at 
noon, I think.
    Well, we have a vote at 1:30 p.m. So we will see if there 
is time for next round. Thank you. We will--Senator Roberts has 
an important engagement and has asked to go next and others 
have been kind enough to allow him to do that.
    Senator Roberts.
    Senator Roberts. Mr. Chairman, thank you very much. I 
apologize to my colleagues for going out of order. At 12 p.m., 
I am to speak on the floor of the Senate and it is in regard to 
the fact that the Eisenhower Memorial dedication has been 
delayed obviously because of circumstances. And this is on 
behalf of the Eisenhower Commission of which I am very 
privileged to be in the chair.
    For that reason, I am going to proceed and I will try to 
make my remarks very succinct. Thank you to the witnesses for 
being here this morning and your tireless work. I want to talk 
about--I am sorry. I want to talk about--well, Okay. I hope you 
heard my--the reason that I am stepping forward here out of the 
recognition of the situation. I want to talk about a situation 
that is unique, that we are going through right now, and that 
is the packing plant situation, the meatpacking plant 
situation.
    Testing rates in Kansas have largely logged or lagged 
behind other states during this crisis, but that really changed 
here in the past couple of weeks. We have 23 percent of the 
cattle market. We have five packing plants in Kansas, Liberal 
Kansas, Garden City, Dodge City where I am from, and then also 
Emporia.
    We have had quite a break out among the workers of the 
meatpacking plants. We are working with Governor Kelly of 
Kansas. We made an early decision and the Governor concurred 
that we would try to keep these plants open. We don't need not 
only a problem with our meat supply, but it was backing up the 
entire food chain. Others on the Committee can speak to that.
    The same situation is happening at the pork industry and in 
the poultry industry. At any rate, the CEOs of the packing 
companies were very eager, and we are very pleased when the 
President initiated the Defense Production Act over three of 
them. I could have just gone up there and whispered in your 
ear----
    [Laughter.]
    Senator Roberts. It might have worked out. But at any rate, 
the CEOs at the packing houses have really stepped forward. The 
President initiated the Defense Production Act. He declared the 
meatpacking plants a national asset. Not only the guards to 
meat or pork, which is in a more serious situation, and 
poultry, but the backing up of our entire food chain.
    Our consumers are discovering, finally, that their food 
doesn't come from grocery stores, it comes from farmers and 
ranchers and growers. So the CEOs have really stepped up. They 
wanted to invest in this kind of a situation before but now 
they are absolutely forced to but it is a willing kind of 
situation.
    The problem is our workers. And just this morning they 
showed up at the plant, not numbers that we had hoped for, but 
we at least kept the meatpacking plant open. And what is 
happening is that they are not catching the virus at the 
meatpacking plant. It is afterwards. And so we have CDC, we 
have OSHA, and we have NIOSH. That is a fancy acronym for a 
team of people going out to inform the workers that the plant 
is safe and that they should practice social distancing, lack 
of congregation, etcetera, etcetera when they leave the plant 
and then at home. That has not been the case, at least up to 
date. So I think we are in a situation where if there is any 
need, that I can see, for an immediate test, right now they are 
having their temperature taken and when they go in and then 
when they come out.
    My question to you is on a rapid test, this is the kind of 
situation that demands an answer now if in fact we had any kind 
of a situation where you could have an immediate test. By the 
way, that they are--in most making most meatpacking plants 
there are at least 15, 16 different languages that are spoken, 
and so to educate the workers and to alleviate their fears is a 
tall job as well. So you can see the need for the test.
    Now I have gone on over time and I haven't left you any 
time to respond. But can we at least get something done on the 
rapid testing on something like this that is happening right 
today?
    Dr. Collins. If I could take 10 seconds I would say, this 
is a very good example of why we need exactly, what this RADx 
program is trying to put forward which are rapid point-of-care 
tests that are readily accessible in any kind of place where 
there has been an outbreak because that is the only way you are 
going to identify who the people are who are infected and 
quickly get them quarantined so they don't spread it to others.
    We know that people who have no symptoms sometimes and no 
fever can be carrying the virus. We need to have a test to 
identify that. That is what we are trying to do with RADx.
    The Chairman. Thank you, Senator Roberts.
    Senator Roberts. Appreciate it. Thank you, Mr. Chairman.
    The Chairman. Senator Baldwin.
    Senator Baldwin. Thank you, Mr. Chairman, and Ranking 
Member, and to our witnesses. Dr. Collins, I think you are 
quite aware of how supportive I am of Federal investments in 
medical research and it is encouraging to hear about the work 
of the NIH during this really difficult time. You noticed--you 
noted in your testimony that above all, tests need to be 
accessible to everyone who needs them.
    I agree and it is why I introduced the Medical Supply 
Transparency and Delivery Act with my colleague Senator Murphy, 
who you will likely hear from shortly, which requires the 
administration to develop a national testing plan and it 
unlocks the full authority of the Defense Production Act to 
increase the production of supplies needed for testing.
    Dr. Collins, the goal of RADx is to develop and deploy 
tests for COVID-19. Each of the tests is likely to have 
supplies that will be needed in order to actually utilize and 
get specimens for these tests. We also need to know whether we 
will need personal protective equipment or swabs or reagents to 
actually conduct these tests. Can you describe sort of with 
your crystal ball looking forward to what might be produced by 
RADx, what sort of associated supplies will be needed to use 
these tests?
    Dr. Collins. Senator, that is a great question. Every one 
of these various nominated platforms for technological advances 
is going to have a different set of requirements as far as 
those kinds of supply questions. And here again, we will be 
looking at that closely as we try to evaluate which of these 
ought to get the strong support in the Shark Tank to move 
forward quickly.
    Many of them will require swabs in order to acquire the 
sample. We do, by the way, think that swabs that sample the 
front of the nose are maybe just about as good as the ones that 
have to go all the way in the back and most people would be 
glad to hear that. We also think that saliva may very well turn 
out to be an attractive alternative which might then not 
require a swab at all if you had a way of collecting just a 
saliva sample. But all those things have to be thought about 
and certainly we would not want to make a major investment in a 
particular diagnostic technology without having a very clear 
sense of what that supply chain need was going to be if this 
was going to be distributed and implemented all over the 
country.
    Here again, as we are working closely with BARDA, is going 
to be critical because this is a sweet spot for them in terms 
of keeping track of all of the details of how you make sure you 
don't end up with a success story that you can't actually 
implement because you forgot about some part of the supply 
chain.
    Senator Baldwin. Right. I thank you for that answer because 
what I am seeing with the available already testing platforms 
is that each has a different swab, a different reagent. They 
are sort of closed loop in many instances. And if that is going 
to be the case in the future, we need to anticipate that as we 
try to ramp up and make sure that we are supplying the reagents 
and the swabs and the specimen collection for each of the 
various tests that will be out there.
    The second complication I see frequently is the--if I look 
at Wisconsin, for example, there is so many different entities 
that are trying to seek these tests for enhancing their testing 
capacity. Certainly the state. Some hospitals and systems, 
employers who want to test employees before they reopen for 
business when that time comes, K through 12 private and public 
schools, higher education, etcetera. There is no streamlined 
logistics right now.
    Again, I return to this idea of having the full authority 
of the Defense Production Act involved with you at NIH and 
BARDA in order to make--to create a streamline system for 
testing. Would it help you to know at your stage at NIH what 
sort of facilities and institutions will need testing and when 
so that you can identify the gaps and actually be looking at 
tests that are likely to be able to fill those gaps?
    Dr. Collins. Yes, of course we want to have a full sense of 
the needs that are out there from multiple institutions and 
particularly in places that are vulnerable. And we are aware 
that this is not evenly distributed. I mentioned these 
demonstration projects that we are going to try to put in place 
for places that don't have ready access to testing for 
underrepresented groups. And that is just one example of what 
you are referring to. So we do need to have our finger on that 
pulse.
    The Chairman. Okay. Thank you very much, Senator Baldwin.
    Senator Collins.
    Senator Collins. Thank you, Mr. Chairman. Mr. Chairman, let 
me start by saluting you for your extraordinary leadership in 
putting together this initiative that is going to make such a 
difference for the health of our country. Dr. Disbrow, last 
year I introduced a bill called the MEDS Act after I reviewed 
alarming data that indicated how dependent our country's 
pharmaceutical market was on overseas suppliers of active 
pharmaceutical ingredients APIs.
    I discovered that 72 percent of the facilities producing 
APIs were located overseas, 13 percent of the facilities where 
located in China. And sure enough in the midst of this 
pandemic, India took steps to restrict the export of 26 APIs to 
our American market.
    Clearly we should not be so dependent on foreign nations 
for essential ingredients for our medications and that is going 
to be really important as we develop treatments for the 
coronavirus. As RADx leads to the development of promising new 
diagnostics, how will you ensure that we have the capacity to 
manufacture and scale up these innovations right here in the 
United States?
    Dr. Disbrow. Thank you. So the global pandemic has 
highlighted the vulnerabilities in the supply chains for many 
products. PPEs were one of the first things that we saw and now 
it is also raw materials for manufacturing active 
pharmaceutical ingredients. So for the active pharmaceutical 
ingredients and raw materials for drugs, we are currently 
looking at advanced manufacturing technologies.
    We are evaluating multiple programs. Those are ongoing 
right now so I can't discuss that but it is to bring that into 
the U.S., use a much smaller footprint than you would for a 
typical or traditional manufacturing facility to try and bring 
that back. But again for these raw materials for the 
diagnostics is to partner them with U.S. companies that have 
the experience and know how to scale up diagnostics.
    They have the engineers and work with them to acquire all 
those raw materials that they would need now so that we can 
scale that up. That is what we are doing for vaccines. Vaccine 
manufacturing is a very long process so we need to acquire 
those raw materials now so that our vaccine manufacturers can 
manufacture on scale.
    Senator Collins. Well, part of the MEDS Act, which I 
authored, was included in the Cures Act, but I really think we 
do need to do more work in this area and I appreciate the fact 
that you are very aware of the problem and are working on it.
    Dr. Collins, let me turn to you next. So you were just 
talking about swabs and how they are an essential part of 
diagnostic tests. I am proud of the fact that one of the two 
leading manufacturers of swabs is Puritan Medical Products, 
which is located in rural Guilford, Maine. And just last week, 
with support from the Defense Production Act and private 
investments, Puritan has teamed up with Cianbro, a large 
construction company, and Bath Iron Works, better known for 
building Naval destroyers, to open a new facility in record 
time that will double the production of swabs. So that 
obviously is very good news.
    In addition, we have a laboratory, that is Abbott Labs, in 
Southern Maine that has helped produce the point of care rapid 
test. My question to you is what more could we be doing to tap 
in to the authority under the Defense Production Act so that 
when you do get a winner, we can be assured of a rapid scale up 
in manufacturing of the new test?
    Dr. Collins. Would any of us imagined four or five months 
ago we would have talked about swabs at a Senate hearing? It is 
like this is coming in such an interesting and unexpected way 
and yet it has absolutely been critical to the availability of 
testing. But certainly, again, this comes back to needing to 
think ahead.
    With any one of these new kinds of technologies that we are 
trying to encourage through the Shark Tank, what are all of the 
things that you are going to be short of and you should have 
plan for, and how can you take advantage of what BARDA has in 
terms of experience and resources to make sure that happens, 
deal with the supply chain and make sure that is not going to 
get cutoff by something international, and if necessary, come 
up with ways as you have done in Maine to double or triple the 
production.
    Just what you need to do. We have to be thinking of 
everything in advance and not get caught by surprise. We 
won't--we will not make that mistake again.
    Senator Collins. Thank you.
    The Chairman. Thank you, Senator Collins.
    Senator Murphy.
    Senator Murphy. I thank you very much, Mr. Chairman. Thank 
you for being here today. A comment and then a couple of 
questions. We are just so grateful for all the work that you 
are doing and your efforts to inform us as to some of these 
innovative partnerships. But of course, you are only as good as 
the direction that you are given by the President of the United 
States and what you have effectively told us today is that this 
new effort to try to find widely available point-of-care test 
was launched eight days ago, largely at the urging of members 
of the Senate.
    If we had a President who truly prioritized testing, this 
effort would have been launched the minute that we heard about 
the prospect for coronavirus coming to the United States. And 
instead literally in the middle of the epidemic, when some of 
our states have actually gotten through the worst of it, we are 
now launching this initiative. It shouldn't be lost on us how 
far behind we are on testing.
    Frankly, it is not an accident. It is not an accident. The 
President told us early on that de didn't want to bring folks 
to the United States from a cruise ship because it would drive 
up our numbers not because of any public health risk. And then 
just yesterday he said this, by doing all this testing we make 
ourselves look bad.
    That is the President's belief that the testing makes us 
look bad. And if you don't think that perception is important 
to this President, you haven't been paying attention for the 
last three years. And so we are playing catch-up and so the 
question is how we do that most effectively. And so Dr. 
Collins, let me ask you a question not so much about the new 
diagnostic project but ACTIV, which is the project to try to 
develop a vaccine and treatment.
    I appreciate the fact that you have reached out to our 
European partners to be a part of this effort, but there are 
ready is an international effort designed to try to develop a 
vaccine, CEPI. In fact, it has been working on pandemic 
vaccines for three years and on Monday of this week, or maybe 
it was last week, the partners, our European partners all got 
together to try to rally the world to put more money not into 
ACTIV but into CEPI. And so my question is this, we should be 
running our own efforts to try to develop a vaccine, but why 
not also join CEPI?
    Why not also make sure that we have a seat at the table 
when it comes to the biggest international effort to develop a 
vaccine? And maybe just my question is this because it is not 
necessarily your policy decision as to whether to join. We 
could do both, right. We could be developing our--leading our 
own efforts to develop a vaccine and also be a member of this 
international group, which by the way, all of our allies are 
part of, the Europeans are part of it, the Saudis are a part 
of, the Japanese, the Indians, the Australians, the Canadians, 
everybody is working on a vaccine together.
    We are not part of that effort, which is just really hard 
to understand. We could do both, right?
    Dr. Collins. I actually was present at the founding of CEPI 
at the World Economic Forum in Davos and that has been a 
wonderful contribution to try and prepare for pandemics, which 
we are now in the middle of. And while we were not present in a 
direct way at this recent fundraising effort to try to put 
together additional support for vaccine development in Europe, 
we are certainly connected in multiple other indirect ways.
    For instance, the companies that are part of ACTIV, many of 
them have strong European connection, some of them are in fact 
European companies, and CEPI is in a position also to 
contribute to the development of some of the vaccines that we 
are actually talking about getting into this master protocol 
this summer.
    It is, I think--you are exactly right. This is a global 
crisis. We should approach it globally wherever the resources 
are and not get too wound up about what obstacles are in the 
way. I am a scientist. I want to see this project succeed.
    Senator Murphy. Mr. Disbrow one quick question. You 
referred to the allegations that Dr. Bright made as a personnel 
matter, but it is not a personnel matter. He didn't get fired 
for showing up late. He alleges he got fired because he was 
trying to talk to his superiors about a culture of corruption 
in which industry players and non-scientific input had 
influence over the decisions that BARDA was making.
    That is not a personnel matter. That is a public policy 
matter. And so would you agree that getting to the bottom of 
the allegations that he makes is important for you as the 
temporary or acting head of this agency? And do you have any 
opinion as to whether outside industry groups have too much 
sway inside this operation?
    Dr. Disbrow. I do think it is important and I am sure there 
will be an investigation. I stand by--I have been at BARDA for 
13 years. All proposals that come in have to go through a 
scientific review. The review is based on science, technical 
merit, the feasibility of the actual program, and the ability 
of the company to potentially do the work.
    We review those. They are done by interagency partners 
through the technical evaluation process. They are then 
reviewed and then we make awards. And so I am still confident 
in the way that we make our investment decisions that they are 
based on science and based on the best technology that we can 
bring forward.
    Senator Murphy. Thank you. Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Murphy.
    Senator Cassidy.
    Senator Cassidy. Dr. Collins. All three questions will be 
for you. Thank you both for your good work. I appreciate it. I 
was intrigued it wasn't in your testimony, but I would like to 
hear your kind of further thoughts about the RADx underserved 
population program. In Louisiana we have been hard hit. We have 
many populations underserved, and we--I am actually kind of 
working with my group, with people back home as to how we 
address this. So how do we apply for it? How do we get it? What 
resources, and you can reply to that as a QFR too.
    [Laughter.]
    Dr. Collins. Well very quickly, this is a program, again, 
because the funding for RADx just came along fairly recently, 
that is still in the formative spaces, but we will be in 
soliciting applications for centers that could be placed in 
locations where underrepresented groups have been particularly 
hard hit and have not had access to testing in the way that you 
would ideally want to see. And that will be coordinated 
together along with an ethical, legal, and social implications 
program, and a coordinating center. So watch this space, it 
will be coming.
    Senator Cassidy. Who do I call, you can call me?
    Dr. Collins. You can call me.
    Senator Cassidy. Sounds great. Second, next question. You 
spoke about having to look at the ability of antibodies to 
provide protection and the duration, etcetera. But if it is 
like flu, quite likely those antibodies will be completely 
protected in some, and mitigate the symptoms in others, and in 
a few it may just not have any effect whatsoever. And indeed, 
we may not know the duration of the benefit until three years 
from now.
    I guess my question was all that. There is going to be 
uncertainty as we roll out this information. Are you suggesting 
that we wait for absolute certainty before we begin to make 
policy decisions based upon how useful anybody testing is both 
in terms of looking at the spread of disease, but more 
importantly I think as to its protection against reinfection?
    Dr. Collins. It is a fundamentally important question and 
you as a physician have thought deeply about this as I have. We 
do know that coronavirus, the COVID-19, is one the immune 
system recognizes and eradicates the virus. We do know that 
people recover from it, and after a while, you can't recover 
the virus anymore. That is good. That tells you the immune 
system knows what to do with this. It is not like HIV.
    At the same time, we do know that this virus can mutate. We 
have already been able to observe that. It is an RNA virus. 
Fortunately, it doesn't mutate the way influenza does so we 
don't think it will have this sort of very rapid seasonal 
change that we have to deal with influenza, which means last 
year's vaccine is maybe not the one you want this year.
    We really don't know the answer though to a lot of your 
questions and they are fundamentally important. Can you get re-
infected with this? There have been a few cases of that. They 
are not incredibly convincing. If you do develop immunity, how 
long does it last? We do not have a good reason to----
    Senator Cassidy. Can I ask you though, there is evidence 
both from rhesus monkeys that this antibody is protective and 
there is also from SARS-1, if you will--somebody writes about 
immunity being for 18 years. So it does seem as if the 
scientific evidence is pointing in that direction.
    Dr. Collins. It is pointing in that direction. You are 
absolutely right and we are counting on that to be the answer 
here, but until we know--we will need to know.
    Senator Cassidy. Now, let me ask you though, what is 
defined as knowing? Because knowing may not be for one or two 
years and yet we have to make policy decisions hopefully before 
then.
    Dr. Collins. Indeed and I think at the present time to be 
able to evaluate the meaning of a positive antibody test one 
should be quite cautious. I think it is going to help a lot to 
see if there is anybody who has such an antibody test that 
turns out to get infected again in the next six months or so 
because the virus is going to be around. We will start to get 
an early warning sign there, but we won't know whether it is 
three years or five years or ten years for quite a long time.
    Senator Cassidy. You are suggesting that not only should we 
test but we should be tracking who is positive so that we can 
follow them longitudinally to see whether or not they develop 
once more.
    Dr. Collins. With their appropriate consent, of course, and 
this is where the All of Us program that you and I have talked 
about which has enrolled now 300,000 Americans who are pre-
consented for exactly this kind of follow-up is going to be 
very useful to track and see what happens.
    Senator Cassidy. Let me ask you as well, and to the 
Chairman, I would like to enter an article for the record, 
``COVID-19 has Shuttered Scientific Labs, Putting a Generation 
of Researchers At Risk.''
    The Chairman. So ordered.
    [The information referred to can be found on page 52]
    Senator Cassidy. This is an issue that my universities back 
home have told me that they just had research projects shut 
down. The article, which I speak about specially raised 
genetically modified rats we have had to be euthanized because 
of the inability to access the lab, for example. And the 
expense of extending programs in want in just one of my 
university is $20 million for all the grad students who need to 
complete now.
    I understand that NIH is a relaxed budgetary and spending 
guidelines and allowed no-cost extensions to grants and 
contracts but I'm also told that probably won't be enough. So 
I'm just asking you what is NIH's planning for all these 
scientists.
    Dr. Collins. Well, I am deeply concerned about that. This 
is a heartache seeing the rest of the scientific enterprise 
pretty much put on hold. My own research laboratory has 
researchers who are at home trying to write papers and read 
literature, but they are not at the bench doing experiments 
they would be doing on diabetes or aging right now if we had 
the chance.
    If you add up what this is going to cost just in terms of 
the lost productivity, the need to keep people employed, the 
estimates are something like $10 billions of NIH-funded 
research is going to disappear because of the way in which this 
virus has affected everybody, requiring this kind of distancing 
and sending people home. And universities, of course, are very 
much hoping that this is something that could somehow be 
ultimately compensated. I worry particularly about trainees who 
have lost time who are really quite concerned about what this 
does to their professional career.
    We have to do everything we can to reassure them that we 
are going to get through this and that they will look back on 
this someday and say, well, that was a pretty bad time but we 
all managed to figure out a way to cope with it. But you put 
your finger on something that wakes me up at night a lot, what 
have we done to the rest of the research enterprise because of 
COVID-19.
    Senator Cassidy. I am not sure you though you gave me a 
plan. You sympathize with the issue, but didn't give a plan, 
but I am over my time. I yield back.
    The Chairman. Thank you, Senator Cassidy.
    Senator Warren.
    Senator Warren. Thank you, Mr. Chairman. Three months ago, 
America saw its first case of coronavirus, and President 
Trump's response has been a complete disgrace. Instead of using 
this time to drastically ramp up our testing supplier, make an 
actual plan to test as many people as possible, he has dawdled, 
he has peddled conspiracy theories, and he has bragged on 
television that U.S. cases would soon be close to zero. Today, 
over 70,000 people are dead, 1.2 million people are infected, 
and 30 million people have lost their jobs.
    Meanwhile America is still racing to get its testing 
numbers up. I showed a detailed plan for how to do it. I am 
pleased that some pieces like funding to boost testing capacity 
and better reporting of demographic information are already 
logged, but there is more we need to do to correct for the 
President's failures, including using the power of the Federal 
Government to publicly manufacture testing supplies.
    Dr. Disbrow, you are the Acting Director of BARDA which was 
set up 14 years ago to make sure that the Government has life-
saving drugs on hand in a crisis even if it isn't profitable 
for drug companies to make those drugs on their own. Does that 
mean that the Federal Government is running drug factories all 
over the country with Federal employees inside and on the 
production line?
    Dr. Disbrow. Thank you for the question. What we do at 
BARDA is we partner with companies and we form these public-
private partnerships to help develop life-saving medical 
countermeasures vaccines, therapeutics, and diagnostics. We 
provide funding. The companies also in most cases provide 
funding.
    There is a cost shared in some instances for the 
development of that, but we are providing the funds, and in 
particular for COVID-19, the Government will take the risk for 
developing those vaccines, therapeutics, and diagnostics 
because we need to expedite the development of those. No, 
Federal employees are not inside the factories, but we do work 
as a true partnership with our industry partners to bring those 
medical countermeasures forward.
    Senator Warren. Thank you, Dr. Disbrow. In other words, 
BARDA identify a public health threat, helps take a drug or 
other countermeasures from concept to reality, and then 
contracts with private companies to make it happen. So in other 
words, it uses the power of the Federal Government to ensure 
that the market uses what we need and when we need.
    BARDA has already invested, I should point out, in dozens 
of companies including Moderna and Hello Check, both based in 
Massachusetts making therapeutics and vaccines and diagnostic 
tests to fight COVID-19. Our scientists are racing around the 
clock and they are going to get it done. But coming up with 
these life-saving innovations isn't the only challenge we face 
in this area.
    Dr. Collins, let's say that science delivers all the tests 
we need and eventually a vaccine, what other basic medical 
supplies do we need to be able to actually produce and 
administer these tests and treatments?
    Dr. Collins. Well again, I think we have to think about 
exactly what those supplies would need to be and whether that 
involves some kind of swab to collect the sample to do the test 
or some sort of material, some sort of solution that you have 
to transmit to the laboratory.
    All of those parts of the supply chain have to be thought 
about if we are going to make this as successful as it needs to 
be. Likewise with vaccines, people are worried about, do we 
have enough medical glass to be able to put all of these doses 
of the vaccines in vials so that they can be administered and 
that is a serious issue to think about. Right now, even as we 
are anticipating if all goes well, that such vaccines may be 
available in millions of doses as soon as this fall, again all 
of that requires thinking forward.
    Senator Warren. Alright, so thanks very much. I appreciate 
that, Dr. Collins. In other words to put it bluntly, even if we 
come up with vaccines or better tests, if we don't have the 
right supplies, if we don't have enough cotton swabs, if we 
don't have enough reagents, if we don't have enough glass, then 
it is not going to do us any good because we won't be able to 
get the job done. So let me ask this, Dr. Disbrow, is BARDA's 
job to supply the Nation with cotton swabs and reagents?
    Dr. Disbrow. BARDA will do whatever is necessary to get the 
job done to protect our Nation. So, your question about 
vaccine. So BARDA is focusing on ancillary supplies. So making 
the bulk vaccine, which is the liquid, is only one staep . You 
need a vial to put the vaccine in, you need a stopper to, close 
the vile, and you also need needles and syringes. So we are 
responsible for making sure that all of those ancillary 
supplies to develop and administer that vaccine are taken care 
of.
    Senator Warren. Well, so in other words, we can't just wait 
for the cotton swabs and the--to roll off the assembly line 
from the cotton swab factory. We have really got to be planning 
this out as Dr. Collins was saying.
    Dr. Disbrow. Correct.
    Senator Warren. I think that means that Congress should 
pass Senator Murphy and Senator Baldwin's bill to force the 
President to use every bit of his authority under the Defense 
Production Act and get private companies making what we need. 
And we can do more.
    Last week, I announced the COVID-19 Emergency Manufacturing 
Act. My bill establishes an Office of Manufacturing for Public 
Health. It is modeled after BARDA. This office would publicly 
manufacture or enter into contracts for manufacturing 
everything the country needs to fight COVID-19, swabs, 
reagents, masks, face shields, intubation drugs, other COVID-19 
products, and manufacture them at scale.
    Congress should include it in the next coronavirus relief 
package so that we can save lives that are still being put at 
risk by the President. Thank you very much.
    The Chairman. Thank you, Senator Warren.
    Senator Murkowski.
    Senator Murkowski. Mr. Chairman, thank you. Gentlemen, 
thank you for your leadership. Greatly appreciate it. So this 
hearing is Shark Tank, a reality TV show. Alaska knows a little 
bit about reality TV shows and I have got a stress test for you 
today. And that stress test is Cordova, Alaska, a small fishing 
community, population about 2,000. In the winter, it doubles 
during the summer when the fisheries come on. It is a strong 
fishing community, 7th in volume of landings in Alaska, 16th 
nationwide, overall about $50 million in revenue plus so it is 
significant for us.
    I mentioned that it is a small community. So that means it 
has a small hospital facility. We have got a license for 23 
beds, 12 of those are long-term and are occupied. So we 
basically have 6 available beds for the community there. The 
fisheries begin, the big salmon season, the copper rivers are 
coming on, and that season begins May 14th. So we are moving 
onto it very, very quickly. We have got five processors that 
work in town. They bring in on average about 450 seasonal 
workers. Total workforce there is about 550. Yesterday, we had 
the first positive COVID test that we have seen in Cordova and 
it was a worker who had flown in to begin the fisheries season.
    I want to share with you what the community of Cordova in 
collaboration with the processors has done to make sure that we 
keep this virus out. All out of state workers are gathered in 
Seattle. They are put up in a hotel room. There are security 
guards at the doors. They are tested and then they wait until 
the tests come back. If they are cleared, then they are put on 
an airplane, either a charter or Alaska Airlines, flown direct 
into Cordova, they are met at the airport, they are put in a 
special bus, they go directly to the processing facility where 
they are again administered a second test.
    It was on that second test that this individual tested 
positive and they got the results just yesterday. The 
individual was asymptomatic. So we have got a situation here 
where you have got a community that is completely cutoff from 
the rest of the world. You only get in by airplane. There have 
been no ferries since the entire winter and you have got a 
situation where we now have three Abbott ID analyzers. We are 
waiting on a Cepheid test. All the other tests are completed by 
swab and those swabs are then flown to Anchorage, an hour's 
flight away and we have about 1,300 tests that are available in 
the community now.
    I talked to the Mayor. I am texting back and forth with the 
Mayor last night speaking with our chief medical officer, Dr. 
Zinc last evening. What do you need? We have got this, we have 
got the Shark Tank going on. What does Alaska need? We need to 
have at point testing. We have to recognize that when you have 
these rural distances. It just doesn't work otherwise. It has 
to be easy to run.
    Dr. Collins, you have mentioned the RADx-UP demonstration, 
and that sounds very intriguing and I will probably be calling 
you along with Senator Cassidy here, but you have indicated 
that it is intended for those areas that are hard hit. We don't 
want Cordova to be hard hit because if Cordova is hard hit, 
that fishery doesn't move forward. And it is not just Cordova's 
fishery that doesn't move forward, it is the Bristol Bay 
fishery that will be coming up in another month that is going 
through these same protocols here to try to determine if it's 
even possible to open up the fisheries. This is our economy.
    I appreciate what you are saying about testing for those 
that are hard hit. This is your stress test in the Shark Tank. 
What are you going to give me?
    Dr. Collins. That is a great story and a wonderful way to 
point out just how critical this is.
    Senator Murkowski. It is for real though and it is in real 
time.
    Dr. Collins. Shark Tank aims to give you, by the end of the 
summer, it is not going to help you this month, a kind of point 
of care testing that you really would love to have where you 
have an immediate answer within an hour. And you can actually 
not just test people when they come in but maybe test 
everybody, every week to be sure that there is not something 
brewing there because you always worry about a negative test 
from somebody who actually has the virus but not enough of it 
yet to pop up on the tests. Maybe that is what happened with 
the individual you talked about a negative test and then it 
went positive.
    You would want to be able to do this continually. And of 
course, as you say, you want to be able to do this in a way 
that doesn't require shipping the sample off to a central 
laboratory and waiting for the results to come back, if it 
does. You want something that is going to work right there. 
That is affordable. That is highly accurate.
    It is a little bit of a knock on the Abbott test because it 
does have false negatives where you have somebody who probably 
is already infected but the test doesn't quite pick it up yet. 
We want to drive that number up to 100 percent. So that is what 
Shark Tank aims to do for you. Meantime, this whole business of 
RADx-UP, the idea of providing a special attention to places 
where testing has not been available, I think you make a very 
good point.
    It doesn't mean they have to already be hard hit. It means 
they are vulnerable to becoming hard hit if the testing isn't 
accessible to them in a very special circumstance and you have 
just taught me about one of them. Thank you.
    Senator Murkowski. I look forward to speaking with you more 
about it. Thank you.
    The Chairman. Thank you, Senator Murkowski.
    Senator Kaine.
    Senator Kaine. Thank you, Mr. Chairman for the hearing and 
to our witnesses. The last time that we were here as a 
Committee was March 3 and 9 deaths had occurred in the United 
States of coronavirus when we were last together. And today the 
number is 74,665 in the days we have been apart. It has been an 
average of about 1,126 deaths a day. Personally, I am a well-
off U.S. Senator.
    I know four people who have died of coronavirus since we 
were last together. Jeanette Galliano, my brother Steve's 
mother-in-law, Dolson Anderson, a friend of 25 years in 
Richmond who was married to one of my agency heads when I was 
state Governor, Gerald Glenn a bishop and an Act of Faith 
leader in the Richmond community who was active and appointed 
by both Democratic and Republican Governors to juvenile justice 
positions, Louis Shaver who is my wife's best friend's mother 
who died in a nursing home here in Fairfax County couple weeks 
ago. My next-door neighbor Dean DeForest died, next door 
neighbor of 28 years in the last two weeks, not of coronavirus 
but of a long battle with lung cancer, but because of 
coronavirus, couldn't have visitors like he normally would, 
couldn't grieve with the family together like a family normally 
would.
    Then Lorna Brie and I didn't know Lorna, but I have gotten 
to know her family. Lorna is from Charlottesville and was 
working in emergency medicine at Columbia Presbyterian Hospital 
and was trying to save as many people as she could. And she got 
coronavirus and went home, and then when she was well, she came 
back to the hospital and found it overwhelming, went back to be 
with her family in Charlottesville, and died 10 days ago by 
suicide.
    I don't know who it was that said this brutal thing about a 
million deaths are a statistic and one death is a tragedy. The 
numbers are large, but we can't forget that each one is a 
tragedy. March 3d, we had nine deaths in this country. On March 
3d, South Korea had 28 deaths on March 3d. The total death toll 
in South Korea today from coronavirus is 256. 19--I am sorry, 
28 on March 3d and 256 today.
    My question to you is why? South Korea is a messy, 
vigorous, robust democracy like us. It is not an authoritarian 
nation. South Korea is filled with super packed metropolitan 
areas, but also rural areas. So in that sense, it is like us. I 
am assuming, and this is a hearing about testing, I am assuming 
it has something to do with testing, but that is the only 
question I have, why on March 3 to today has the South Korean 
death toll gone from 28 to 256 and the U.S. death toll has gone 
from 9 to 74,665.
    Dr. Collins. Senator, it is very sobering. I am glad you 
started talking about specific individuals because sometimes we 
get into these conversations about coronavirus as if it was an 
academic question or it is about statistics or it is about some 
fancy technology, which I confess I spend a lot of my time on 
that too, but this is really about people, real people who have 
lost their lives, have been terribly sick, whose families now 
have found the chance to grieve but not be able to grieve in 
the usual way.
    My wife said to me a couple days ago, she said, you seem so 
burdened about this particular set of intense priorities and 
projects, you have done this before and you seem to just sort 
of sail along, what is going on? Said, when I was in charge of 
trying to lead the Human Genome Project it was incredibly 
competitive. It was comparably exciting. It had this historic 
nature to it.
    But this time it is about people living or dying. It is 
different, and we have to think about that at every step in a 
conversation like this. South Korea did some amazing things. It 
is certainly helpful for them that they are a smaller country 
than we are with a whole lot less population to try to manage. 
They did figure out how to do the distancing thing and the 
testing thing and with great speed and rapidity.
    South Korea, which I have visited, is an amazing 
technologically advanced country. If you haven't been there, it 
is like pretty breathtaking when you see what they have been 
able to do. And so they jumped in on this in a very effective 
way. A big, sprawling country is a whole other kind of 
challenge and obviously a challenge that we now grieve to see 
what has happened with those more than 75,000 deaths and we are 
not through this.
    We are nowhere near through this and everything we have to 
do right now is to try to look at that experience and say we 
have got to put everything we have got into keeping this 
terrible tragedy from getting any worse. And that means testing 
and that means therapeutics and that means vaccines. And I will 
tell you, for me personally, that is what I am doing 24/7 and I 
will continue as long as there is anybody still at risk.
    Senator Kaine. Thank you, Dr. Collins. Thank you, Mr. 
Chairman.
    The Chairman. Thank you, Senator Kaine.
    Senator Scott.
    Senator Scott. Thank you, Mr. Chairman. Thank you to the 
panel for being here with us today. And I know that we have 
made significant progress over the last several weeks. And I am 
excited to see that I am also excited about the future 
prospects of your Shark Tank activities and efforts. So thank 
you for your willingness to spend 24/7, 7 days a week on trying 
to find ways to insulate America's health. Coming from the 
State like South Carolina we have around 6, 936 confirmed 
cases.
    We assume that there is probably over 50,000 infected in 
South Carolina, but we haven't had the availability of testing, 
because as you already know, South Carolina is a state that is 
considered to be on the low side of the number of cases and 
therefore the testing resources are going in other directions. 
As you think about our future, we really want to make sure that 
as we serve America's needs, that those rural communities, and 
South Carolina is a fairly rural state, that we do indeed have 
more access to testing.
    That is why I am encouraged by your, I think it is your 
RADx prospects. I would love to hear you talk a little bit more 
about the RADx prospects because in McCormick County, or 
Calhoun County, or in Newberry, or Greenville County, a larger 
county, the testing needs are very important in rural America 
and rural South Carolina. So would love to have you illuminate 
that a little bit more for us. The second question that I have 
is about the vulnerable populations in certainly rural America, 
and rural South Carolina is a part of that.
    Are some minority groups like African Americans and 
Hispanics, in Alaska Native Americans as well, Native Alaskans, 
are all a part of the same type of grouping as it relates to 
the underlying health conditions that may make you more 
predisposed, having a significantly harder road through the 
coronavirus. Love to have you talk about the importance of 
having folks in control groups of minorities in our country 
participate there as well.
    Dr. Collins. Great questions, Senator. And yes, it sounds 
like South Carolina and Alaska are both in the same situation 
here of not being able to have access to tests that you need 
right now to try to keep people in your state healthy. That is 
one of the main reasons that we are proposing this so-called 
RADx-UP program to try to put in places like that where there 
are vulnerable populations, some of which are getting sick at 
an alarming rate. The access to testing particularly needs to 
be focused on there.
    I am particularly concerned when I look in across the 
country at the statistics about what is happening with African 
Americans where clearly the burden of COVID-19 in terms of the 
most serious illness and the deaths are falling 
disproportionately on the shoulders of black individuals.
    Look at Georgia where something like 80 percent of the 
individuals with serious illness and hospitals are African 
American and Georgia is only 30 percent African American. So 
that tells you right there, there is something going on. And a 
lot of that is the disproportion in terms of access to testing, 
making it much more difficult for many of those societies to be 
able to practice physical distancing just because of social 
circumstances and maybe can't really afford to stay at home and 
stay out of the public circulation because you have an hourly 
job and if you don't show up, you are not going to get paid.
    We recognize that this is one of those moments where health 
disparities, which in this country have been a problem for 
decades, a bright light is being shown upon them and we should 
not miss the chance to react to that and come forward with 
solutions. And that is what in this area of trying to be sure 
that testing is accessible, maybe we can do something that 
hasn't quite been done this way before.
    We imagine something like 10 or 20 of these demonstration 
projects located in places that are in particular need of 
access to these resources now populated by scientists who are 
dedicated to that goal with a very strong community outreach to 
try to be sure the community embraces what it is, that this can 
represent, and recognizes this may also be a way in which when 
vaccines come along, we make sure the vaccines are also 
distributed in a fashion that is not otherwise affected by 
going to the obvious places where there happened to be more 
resources.
    We want to work through the federally qualified health 
centers for testing and for vaccine delivery, so I am right 
there with you. And I think South Carolina is a great example 
of a place that we could really benefit from working with.
    Senator Scott. One comment, and I am sure I will be out of 
time but I will ask the question as the time ticks away and 
maybe the Chairman will allow you to answer that question.
    One of the things that I found to be quite interesting is 
when you take a look at the prevalence of the coronavirus in 
nursing homes, look at the fact that the death rates are 
significantly higher there, you couple that with the fact that 
as I talked to the nursing home community, about 60 to 70 
percent of their certified nursing assistants are African 
Americans, about 80 percent are female. You have a very 
vulnerable population serving another vulnerable population. If 
there is ever a case for more testing in nursing homes, not 
only for the residents but for the workers, this is a classic 
example.
    Final question, perhaps to both the panelists, would be 
around the CRISPR and gene editing technologies to advance more 
testing and new types of testing. Any closing comments with my 
last 38 seconds?
    The Chairman. The--if you can make your answers succinct, 
that would be appreciated. We have other Senators waiting.
    Senator Scott. I apologize.
    Dr. Collins. Well that is a question I loved but I will try 
to be quick. Yes, CRISPR which is this amazing new technology 
that allows you to find a very specific DNA or RNA sequence of 
letters in a complicated mixture is a really powerful way to 
find the presence of a little bit of a virus somewhere in a 
biological sample.
    A number of the new protocols that are coming into the 
Shark Tank are based upon that and those are some of the ones I 
am most excited about because it is a totally different 
approach. It looks like it could be very point-of-care and very 
readily done but without requiring special technology.
    Dr. Disbrow. I agree with that completely. I mean, it is a 
new technology that could look at a very low level of the virus 
in a sample and I think that is the true advantage of that and 
we look forward to pushing those forward.
    Senator Scott. Thank you, Mr. Chairman, for your 
indulgence.
    The Chairman. Thank you, Senator Scott.
    Senator Hassan.
    Senator Hassan. Here we go. Thank you, Mr. Chairman, and 
thank you Ranking Member Murray for holding this hearing and 
allowing for remote participation. Thank you as well to the 
witnesses for being here today and for your ongoing work and 
that of your entire teams in responding to this pandemic. We do 
know how hard people are working.
    I will just start by saying that yesterday in the small 
State of New Hampshire, a little under 1.4 million people, we 
lost 19 people all of whom were in long-term care facilities. 
Death rate is now about 8 per 100,000 from the coronavirus.
    The need for testing has never been more clear and I think 
what is hanging over this entire hearing is that question, the 
question Senator Kaine so eloquently asked, but it is the 
question that we have all been really referencing is what would 
our trajectory look like right now if we had more testing where 
and when we needed it, accurate testing that could be done 
rapidly and why have some countries been able to do that 
testing and we haven't? So we need to discuss the near-term 
testing issues today to be sure and the other issues that the 
Chairman has talked about are also important too.
    But I would like to just formally request that we also hold 
a hearing on COVID-19 vaccines as well because as it has 
already been discussed, we need to plan for the entire 
production and distribution of vaccines if we are fortunate 
enough to meet these intense and rapid goals or getting a 
vaccine up and operating. In my state, there is a manufacturer 
of hypodermic needles who says they have not been receiving the 
kind of purchase orders from the Federal Government that will 
allow them to have the kind of volume of hypodermic needles on 
hand when we are hoping this vaccine might be ready.
    I hope very much that we will have a hearing just on 
vaccines and the manufacturing supply chain that we need to 
have up and ready because this administration has been slow to 
respond to the needs for testing and for personal protective 
equipment, and we need to learn from those mistakes and avoid 
this situation in the future.
    Dr. Collins, a couple of questions for you because 
relatively few people can access testing and I would like it if 
we would start talking about the rate of testing we are doing 
per population in this country not just the wrong numbers. On 
advising those with potential COVID-19 symptoms who cannot 
access a test as to behave as though they have the virus has 
been an important part of our containment efforts. However, as 
states reopen and people are asked to return to work, it will 
become harder to comply with this advice. Meanwhile reports 
suggest some COVID-19 diagnostic tests are returning inaccurate 
results 15 to 30 percent of the time.
    These quality issues may hinder containment of COVID-19 as 
individuals either correctly believe they aren't infected or 
incorrectly believe that they were infected and therefore they 
have developed immunity.
    Dr. Collins, the goal of the Shark Tank initiative is to 
accelerate development and increase testing capacity. However, 
a reliable testing infrastructure depends as much on quality as 
it does on quantity. What steps will NIH take to ensure that 
any companies receiving funding or support through the Shark 
Tank initiative are producing high-quality products?
    Dr. Collins. That is a critical question, Senator, and it 
is a critical step in the Shark Tank phase 1 too. The approach 
that we are taking, which is that along that, fairly early in 
that pathway, the technology has to be validated. That is, it 
has to be tested against a variety of gold standard samples of 
varying degrees of the presence of the virus to see whether it 
is sensitive enough to be able to detect the virus when it is 
there and specific enough so that it doesn't give a false 
positive on a sample that has no virus in it.
    That is absolutely essential. Anything that fails at that 
point will basically fall out of the Tank and will not be taken 
forward unless there can be a technical solution to dealing 
with that performance issue. Once of course this does pass that 
gate and gets successfully moved forward into commercialization 
and scale up, the FDA will be in the strongest position then 
and they will look at this carefully to see whether it passes 
their muster. You may know in this current crisis, FDA has been 
authorizing tests with what is called EUA, emergency use 
authorization.
    But in the longer term, they are going to be very 
determined to make sure that these tests pass all of the 
appropriate validation steps so you can count on that coming in 
there as well. So it is really critical question. We will make 
sure not to have this missed as an opportunity. It has got to 
not just be out there, but it has got to be accurate.
    Senator Hassan. Very quickly, and I know I am over time Mr. 
Chairman, what--how will you ensure, Dr. Collins, that in order 
to receive Federal funding these new diagnostic tests will 
represent a significant enough improvement over existing 
products that justify Federal investment?
    Dr. Collins. That again will be something that BARDA will 
also be engaged in. We will not want to put taxpayers money 
into something that doesn't represent a significant advance 
over what is already there. I don't think we will have to worry 
though that there is going to already be enough testing that 
you don't want to think about bringing on board one of these 
new point-of-care platforms. If it is highly accurate and if it 
is quick and giving a response, it seems highly likely we will 
want to invest in it.
    Senator Hassan. Thank you very much. Thank you, Mr. 
Chairman.
    The Chairman. Thank you, Senator Hassan.
    Senator Romney.
    Senator Romney. Thank you, Mr. Chairman. I appreciate very 
much you holding this hearing. The first question is for Dr. 
Disbrow. It is a pretty quick question, which relates to 
probabilities. Those of us who have been in the business world 
have dealt with probabilities. People at NASA, I am sure do. 
Doctors certainly have to. What is the probability that we will 
have a generally available vaccine for the American public by 
the end of the year? What is your personal sense of what the 
probability is? 50/50, 90 percent, 20 percent? What is the 
likelihood?
    Dr. Disbrow. I am not a betting person but if we don't set 
lofty goals, we will never achieve those goals. And so we are 
working very hard across the Federal Government to make sure 
that we were doing everything we can to expedite the 
development----
    Senator Romney. I know that. I know we all have lofty 
goals. I am not asking for goals. I am asking for the 
probability. What is the probability, 50/50, 90/10, 60/40? What 
is your sense of what the likelihood is that we will actually 
have a vaccine available for the general public let's say by 
the begining of the year for the population of our country. I 
know what our goal is, of course. Our goal is a 100 percent. 
But what is your sense of the probability. You have been in 
this vaccine world for a long time?
    Dr. Disbrow. Yes.
    Senator Romney. What should we be thinking about?
    Dr. Disbrow. That is why I don't like to set either 
timelines----
    Senator Romney. Never mind. Never mind. You won't answer 
the question, we will move on. Second question, Dr. Collins, 
which is the Abbott machine. It is already providing 
information I guess almost on a real-time basis. What is wrong 
with sort of making a lot more of those and using that as a 
machine that could be available at most businesses retailers 
and so forth? Is it just an inadequate? Is it the false 
negatives that gives? But it strikes me that we already have a 
technology that works. Am I wrong on that?
    Dr. Collins. No, it is a great machine, Senator. This is 
the Abbott ID now approach. It does provide you point of care 
and it does it very quickly in the space of 15 minutes. It does 
require having this special machine. And of course, there is a 
limited number of those machines out there. I think it is 
18,000 or something like that. And to be able to really meet 
the need, that would have to go up substantially, and the 
machines are not exactly inexpensive--I think the other concern 
has been that it does have about a 15 percent false negative 
rate.
    If you are in a circumstance where you really, really don't 
want to miss a diagnosis of somebody who is already carrying 
the virus, you would like to have something that has a higher 
sensitivity than that, and I know they are working on how to 
make that happen. But, so it is great. It is certainly one of 
the most exciting things we have got right now, but we think we 
could even do better.
    Senator Romney. Yes, I am--your judgment is a lot better 
and more experienced than mine in this regard, but it does seem 
to me that given the fact we have a test that works, it can 
perhaps be made more sensitive. If we were to devote a lot of 
resources to making a lot of these machines, perhaps having 
some other people around the world or around the country at 
least making these machines on accelerated basis, while we 
could fulfill the need that we are talking about with 
technology that already exists because the probability of 
finding a new technology--I hope we can find that but it 
strikes me that this kind of machine has some potential.
    Finally, the last question for you, Dr. Collins. You know, 
I have been sort of puzzled by the conflicting data that I see 
and I am sure you see the same thing. The reports that came out 
of Massachusetts as to the number of people there that were 
asymptomatic, the people that the course of the testing, and 
New York that suggested over 20 percent of the people there had 
already had COVID-19, the prisoners tests as well in five 
states in the South which is our recall 93 percent of the 
people who had tested positive never had any symptoms, and then 
the experience of Sweden, which said we are really not going to 
test everybody and we are going to let the economy keep going.
    Do we really need to have a kind of testing we are talking 
about or does this information suggests that given so many 
people that are asymptomatic--this was in a hearing yesterday 
with the Homeland Security Committee, the suggestion was 
between 50 and 90 percent of the people that get COVID-19 have 
no symptoms. If that is the case, should we let this run its 
course through the population and not try and test every 
person? I am saying that a bit as a strong man, but I am 
interested in your perspective.
    Dr. Collins. I appreciate your putting it forward as a 
strong man because while it is true that lots of people seem to 
get this virus without any symptoms at all and the estimates 
are that maybe 60 percent of new cases are transmitted by such 
people, it is still the case that 74,000 people have died from 
this disease. And so the people who are out there infected who 
may not themselves be suffering are passing this on and 
becoming a vector to others who were vulnerable with chronic 
illnesses or in the older age group. And sometimes young people 
too.
    Let's not say that they are immune. There are certainly 
plenty of sad circumstances of young people who really you 
would not have thought would be hard hit by this, who have 
gotten very sick or even died. So I think it is extremely 
unusual to have a virus like this that is so capable of 
infecting people without symptoms, but having them then spread 
it on.
    We just haven't encountered something like that before but 
it doesn't mean that it is not a terribly dangerous virus for 
those people who aren't so lucky and who get very sick and end 
up in the ICU and perhaps lose their lives. The only way we are 
really going to put a stop to that is to know who the people 
are who are infected even if they have no symptoms, get them 
quarantined, follow their contacts. It is just good, solid shoe 
leather public health and we have learned it over the decades 
and it applies here too.
    Senator Romney. Thank you, Dr. Collins, Mr. Chairman.
    The Chairman. Thank you, Senator Romney.
    Senator Jones.
    Senator Jones. Thank you, Mr. Chairman, and thank you for 
having this hearing, you and Ranking Member Murray. It is very, 
very important. I have been monitoring this and decided to come 
down. But I have been listening to a number of things and I 
want to first follow-up a minute on what Senator Collins said 
and alluded to with regard to foreign dependence on vendors for 
healthcare equipment. She was talking more in terms of 
prescription drugs, but obviously we have seen a lot of 
problems with regard to PPE, other healthcare manufacturing.
    I have been working on a bill that we hope to file next 
week that will give tax incentives and other things to try to 
get those manufacturing, healthcare manufacturing into this 
country so that in any future endeavors and as we replenish the 
national stockpile we can do so with American-made goods. And I 
would encourage my colleagues on the Committee to take a look 
at that and perhaps join me on that. I also listened carefully 
to Senator Murkowski and Senator Scott's questions regarding 
the rural areas of the country and how important that is in 
their particular states.
    Senator Scott in particular stole my questions, Dr. 
Collins, but I appreciated your answers very, very much. And so 
I would like to follow-up just a little bit on that because 
with all candor, we talked about rural areas, but we also 
talked about vulnerable populations yet we--and I think your 
word is that this pandemic has shown a spotlight on the health 
disparities in this country.
    It is a phrase I have been using as well in my home state 
and I don't think--it is not lost on me that ironically we are 
having this discussion this week when just within the last 24, 
48 hours, the administration has issued briefs in the U.S. 
Supreme Court attempting to dismantle a health care program 
that has given good health care and insurance to millions of 
Americans in this country not only through the exchanges but 
also through Medicaid expansion in any number of states.
    Unfortunately, my State Alabama is one of 14 states that 
did not expand Medicaid, and so as part of those vulnerable 
populations in Alabama and those rural areas, I have got some 
326,000 Alabamians that are without healthcare and without 
healthcare insurance and access to good healthcare and I find 
that just appalling when we have the opportunities. And so as 
we go forward, number one, I am hoping that we, the Congress, 
in its next package will consider ways to incentivize states to 
expand Medicaid the way we did under the ACA.
    I am obviously hoping that the ACA remains viable and 
intact, but I would like for you to comment just a little bit. 
We have spoken a lot on the your RADx and I really appreciate 
that, but I would also like to figure out what we can do now 
that we have shown this spotlight to make these vulnerable 
populations less vulnerable not just to this pandemic, but to 
all of the pre-existing conditions that we see in these 
populations, and I would appreciate you may be commenting on 
that and how specifically we are going to get some of these 
testing and the distributions into those areas. Thank you, Dr. 
Collins. Thank you all so very much.
    Dr. Collins. I appreciate the question. This is a matter of 
great passion I think for virtually all of the institute 
directors at NIH and we have an entire institute, the National 
Institute of Minority Health and Health Disparities, which is 
focused on this issue. And increasingly, the research that we 
are doing is going beyond trying to identify what the factors 
are that are responsible for health disparities. We learned 
pretty much about those into what we could actually do about it 
in terms of interventions and demonstration projects.
    That is what we are thinking of in this space by having 
these demonstration projects where you introduce the access to 
testing, introduce therefore connection to vaccines, you can 
actually change the dynamic instead of just studying it. We 
have studied health disparities a lot. It is time to take some 
actions.
    We think as the largest supporter biomedical research in 
the world, we have a chance to do those things and really learn 
what works and then try to see if that can be extrapolated to 
the whole country.
    Senator Jones. Would you agree that if something like this 
happens in the future, that one of the things we also focus on 
and use a spotlight to try to make sure that people with pre-
existing conditions, we reduce the number of the vulnerable 
population, we reduce the number of folks with the pre-existing 
conditions by doing all we can to get good, affordable access 
to healthcare throughout this country?
    Dr. Collins. That is what we need as long, with all the 
other things you need to do to reduce the incidence of obesity 
and diabetes and cardiovascular disease, all of these things 
which at the present time take a heavy toll on people from 
certain subgroups and we ought to be doing everything we can to 
prevent that.
    Senator Jones. Great. Well, thank you, Dr. Collins. Thank 
you, Mr. Chairman. I appreciate it.
    The Chairman. Thank you, Senator Jones.
    Senator Braun.
    Senator Braun. Thank you, Mr. Chairman. Patience pays off. 
I may be the last one. I am not sure. Testing, you hear it so 
often, to me it repeats what we all agree with. I would like to 
find out as you said South Korea kind of was the standard to 
maybe try to aspire to. If there is a test that they used that 
was part of their protocol, is that--was that a significant 
part of it or was it their hygiene, their sheltering, and all 
the other things that all of us are doing anyway? Because if 
there is a test that anybody else used wouldn't we want to have 
access to it?
    Dr. Collins. I don't recall the details of their particular 
technology, but I don't think it was anything out of the 
ordinary. It was based upon using this PCR reaction to be able 
to identify the presence of the viral RNA genome and certainly 
the kind of test that we are doing lots of those in this 
country as well. I think it was more the speed with which they 
were able to set this up their access to be able to test people 
very quickly who had any symptoms and their very strong 
enforcement of such things as physical distancing, doing this 
in a country where people were also quite amenable to those 
recommendations. Maybe not quite as much in the sort of 
American zone of not necessarily where Government has to tell 
you----
    Senator Braun. Which tests and which company would be 
closest to what they use there that we have here?
    Dr. Collins. I think the kinds of ones you see now in 
companies like LabCorp and Quest would be the sort of thing 
that you have where it's a fairly high throughput but it is 
done in a central laboratory.
    Senator Braun. What is the timeframe, and talking to a 
pharmaceutical company one of the few headquartered in Indiana, 
the CEO said that about 40 companies across the country, that 
it has been at a breakneck pace to get there, especially for 
the one that is quick for a country our size that is going to 
have reliable results. We hear so often and we heard it today, 
that we dawdled and that we didn't get there.
    I would really like your opinion, and from what I heard 
from the people that are actually doing it, they have been 
working at this in an entrepreneurial at a feverish pace and 
they didn't even have the genome to work with until what maybe 
four months ago or so. What is your comment on that?
    Dr. Collins. I think there has been an incredible amount of 
energy put into trying to do this testing. I just gave you a 
small example. At NIH up here in Bethesda, I have 25,000 
employees. I want to be sure that they are safe. We didn't have 
access to easy testing for our own employees and we wanted to 
be sure if they were coming to work, that they weren't going to 
be infecting other people.
    I asked our laboratory in the clinical center, which is a 
research hospital, to set up a lab test. And they were able to 
do that but the most tests we can do in a given day is in the 
hundreds, it is not in the tens of thousands. It is not simple 
to do this.
    Senator Braun. It is not that we dawdled. It is the fact 
that we have got a country that is scaled much larger than say 
South Korea and then it is going to take a point to get the 
equipment in place to do it. Is that fair?
    Dr. Collins. I think that is part of it and part of it is 
bringing on board with some of these new technologies, which is 
what RADx is all about to try to do this at a scale----
    Senator Braun. That is going to take time in and of itself.
    Dr. Collins. But we haven't had the need to do this kind of 
scale of testing. I mean the kind of testing we do now even for 
something like HIV or for hepatitis C, which is a lot of tests, 
it pales by comparison to what we need now for this. So we 
didn't have in the laboratory community the kind of capacity to 
take on this number of tests and all of a sudden there it was.
    Senator Braun. Very good. And answers one question for me. 
Last question would be, and we have touched on it a little bit 
here, Senator Romney, Senator Jones talked about it, that idea 
of the broad methodology where we took an approach say similar 
to Sweden where you let herd immunity be the approach. Yes, I 
know.
    Could we have built an iron dome around the most vulnerable 
in some fashion with better protocol to where it would have 
been different from a one size fits all blanket approach that 
might have had difficulties to unfurl in this country just due 
to the nature of who we are as well? Could we have protected 
the most vulnerable if we had focused the available resources 
to where we could have contemplated a different approach since 
it seems to pass over so many people in a way where, they are 
asymptomatic. I am just throwing that out there as a question.
    Dr. Collins. Yes, it would have to have been an iron dome 
that was pretty impenetrable because imagine that if just one 
case got in there and then again with the easy spread from 
people who don't have symptoms pretty soon you have a nursing 
home situation in your iron dome. And in a certain way in this 
country we have been doing a version of the iron dome which is 
particularly with vulnerable people having them stay at home, 
keeping physical distance, making sure that other people around 
them are doing the same. It has been I would say a fairly 
successful enterprise when you see the flattening of the 
curves.
    That has happened in many places. That didn't just happen 
because we got lucky. That happened because people went to 
considerable difficulties, and it did terrible damage to our 
economy, to try to save lives by this kind of sequestering of 
people so that they couldn't get fatal illnesses. But obviously 
what we really need to get back to where we all want to be is a 
circumstance where you don't have to do that anymore. That is 
why the vaccine is so prominent in our minds, and until we had 
the vaccine, the idea for the testing to identify people and 
get them quarantined if they are actually already incubating 
this virus.
    It has got to be that mix, the diagnostics, the 
therapeutics, and vaccines. Don't let anybody tell you, what if 
we just did one of those it will be alright. We have to do all 
three.
    Senator Braun. Thank you.
    The Chairman. Thank you, Senator Braun.
    Senator Rosen.
    Senator Rosen. Can everyone hear me Okay?
    The Chairman. Yes, we can hear you.
    Senator Rosen. Thank you. I guess I think I get the luxury 
of being the last question. I hope it is a good one. I really 
appreciate Chairman that you set up this hearing and I 
appreciate the scientific research that the doctors are doing 
in their teams. I know how important it is. I know you have 
been working around the clock in Nevada. Of course, the 
seriousness of the pandemic is very real. We have had strict 
lockdown order, social distancing. We are beginning to flatten 
our curve. Our hospitals aren't overwhelmed and we seem to be 
doing alright there.
    But of course everyone has talked about how we reopen our 
economy in a way that is thoughtful, that is science-based, how 
we need diagnostic testing capacity, antibody all of that. I 
spoke about this yesterday, but Senator Rubio and I have 
introduced legislation to start a longitudinal study for COVID 
with NIH and CDC. It is going to be reporting to us every three 
months and six months and further as we go down so we can point 
to scientists and us as policymakers with data into some better 
directions as we collect that.
    Dr. Collins, have you seen any studies yet on your end or 
are you doing any that will track those individuals, so we 
talked about the have the positive antibody test, see how long 
they stay in their system, and what that means? That is my 
first question there and then I have I will just give them all 
so you can answer them.
    The Shark Tank program doesn't include the antibody test, 
only acute testing. Are we going to add the antibody test to 
that? And then, I am very concerned about unintended 
consequences when you talk about the Shark Tank. In this 
instance, we need researchers to collaborate all around the 
world.
    The competitive nature of Shark Tank is going to spur 
people on. What are their unintended consequences of putting 
people in silos where collaboration that we so desperately need 
right now are not happening to get the best results? So those 
are my three questions for you.
    Dr. Collins. Those are great questions. In terms of the 
need to track people and to see what happens, and particularly 
as was brought up earlier, is the presence of antibody actually 
something you can say makes you immune? I think maybe our best 
chance at this is this program that Congress has funded and it 
is part of 21st Century Cures Act.
    I have to specifically give a shout out to this Committee 
about that and the Chairman. And that is this program called 
All of Us, which is tracking, when we get there, a million 
people over time. We are already up to over 300,000 that have 
signed up and those individuals answer lots of questions, their 
electronic health records are available for researchers to look 
at after they have been anonymized, they give blood samples 
over the course of time so you can track and see, oh, it didn't 
have the antibody, then, oh, now it does have the antibody, 
what happened there? We should be able to utilize that for this 
and many other purposes to try to get some of those answers and 
I totally agree we need those.
    Your second question about antibody testing, our sense was 
that the commercial community has done a pretty good job of 
getting anybody tests out there. Our scientists at the National 
Cancer Institute were asked by FDA to do the validation and 
they have been able to do so and a bunch of those, which was 
just published a couple of days ago, actually are really good 
in terms of their sensitivity and specificity, so there seemed 
to be less of a need to make a big investment in the antibody 
testing area.
    But I would say if we have a new technology that would give 
a twofer where you could get both a virus test and the antibody 
test at the same time for a really good price, that might be 
something we would be pretty interested in. And finally, in 
terms of the unintended consequences of Shark Tank resulting in 
silos, we are going to do our darnest not to let that happen.
    Our kind of a Shark Tank actually kind of discourages that 
kind of siloing because the advisers who are going to be 
helping each of these platform developers that have new 
technology to succeed, they are very well connected. They come 
from the business community. They are going to be constantly 
looking for ways that the technology developer ought to meet 
this particular company that has the ability to do the scale up 
and we will not let those sort of opportunities go by. We will 
watch for that closely.
    Obviously there will be competition and the successful 
companies are going to want to be on top and that is what 
American capitalism success, which is what we need in this 
space too, but not in the point where it becomes destructive 
and people don't share information that we could all learn 
from.
    Senator Rosen. Thank you very much for your time and your 
work. And I will yield my last few seconds back.
    The Chairman. Thank you, Senator Rosen. I am going to call 
on Senator Murray just a moment for her closing remarks and 
then I am going to wrap up the hearing. We told our witnesses 
they could leave by 12:45 p.m. So if Senators could ask any 
other questions they have for the record and we will have an 
opportunity on Tuesday because we have a hearing Tuesday on 
back to school and back to work which includes Dr. Fauci from 
NIH, Dr. Redfield, the head of CDC, the head of FDA, Dr. Hahn, 
and Admiral Giroir, who is in charge of testing.
    The questions will be relevant to them. For those who might 
be watching, I want to assure you we are following the rules 
that the Attending Physician told us. We are socially distant. 
We have worn our masks and he said we could take them off while 
we were asking questions and we will put them back on as we 
leave.
    I thank the Senators who have joined by video and I hope we 
have had an audience because this has been a very interesting 
time. Now, let me call on Senator Murray and after that we will 
conclude the hearing.
    Senator Murray. Mr. Chairman, thank you so much for doing 
the hearing. I do have a number of other questions. I 
especially wanted to ask Dr. Collins about the racial and 
ethnic disparities and how he is going to ensure testing and 
diagnostics and the agency's partnerships are going to be 
deployed to communities in need and several others. I will 
submit those for the record, but Dr. Collins, I hope that you 
and I can talk about that in the future. And thank you to both 
of our witnesses today.
    Mr. Chairman, I want to thank you. I do really want to 
thank our witnesses for coming in today circumstances, but I 
also really want to thank all the Senate employees, especially 
those who were required to come to the campus today. We really 
owe it to all of you and your families and your communities to 
take adequate safety precautions and I am pushing hard to make 
sure that happens. I also want to really thank everybody who 
helped set up the technology to make this hearing possible.
    You know, our country has really grappled with a world of 
change since our last hearing on coronavirus and my gratitude 
goes out to our healthcare and public healthcare heroes to our 
essential workers, to our families across the country who have 
made sacrifices, both big and small to help slow the spread of 
this. And my heart goes out to everyone who is struggling with 
this awful disease themselves, the illness or loss of a loved 
one, or they are very real mental health effects of isolation 
and loneliness and stress and trauma.
    But one thing has not changed since our last hearing, even 
though it has been over two months since President Trump said 
anyone who wants a test can get one, it still is not true. And 
that is not going to change if the President continues to deny 
the severity of this crisis to insist it is not his problem and 
to silence those who wanted the truth to be told.
    While President Trump has yet to show the leadership or 
type of detailed national plan I think he should, I am not 
going to stop pushing on this because our families and our 
communities and our country cannot afford to keep waiting to 
finally get our response to this crisis on the right track. So 
thank you very much for having this hearing, Mr. Chairman, and 
I look forward to our next one as well.
    The Chairman. Thank you, Senator Murray, and thanks for 
your cooperation and that of your staff and all the employees 
always in arranging for this hearing and the one on Tuesday. 
Just a few comments as we wrap up. According to Johns Hopkins, 
as well as President Trump, the United States has conducted 7 
million diagnostic tests. That is more per capita than South 
Korea, for example, and that is a very impressive total.
    This hearing is about needing millions of more tests, but 
that is because of the uniqueness of the situation not because 
we don't conduct a lot of tests today. For example, my State of 
Tennessee, the Governor has been pretty aggressive on testing.
    For example, he is testing everybody in the state prisons. 
He has drive-through testing on the weekends in many parts of 
our state. I began my testimony or my statement today with the 
nursing home in Franklin, Tennessee that has tested all 2,500 
of its residents and staff. So we have been able to find that 
number of tests for those kinds of activities yet it is not 
enough for me to assure the president of the University of 
Tennessee, with whom I talked, that she will be able to have 
enough tests to assure students and faculty it is safe to come 
back.
    On the other hand, I talked to a professor at University of 
California at Berkeley and he has converted his own laboratory 
into a laboratory that he believes can test everybody on the 
Berkeley campus within a week if they wish to be so tested. So 
while this is a hearing about needing tens of millions more 
tests, already having 7 million test, no country in the world 
has tested that many people for coronavirus.
    I want to emphasize also the effort. I know that Senator 
Blunt, I, many others, we understand that in your RADx Shark 
Tank program there will be failures. In fact, if there are not 
failures, you are probably not doing your job because failure 
can mean it doesn't work or it doesn't work well enough to be 
scaled up fast enough to help the schools and to be ready for 
this education season and the flu season as it comes on.
    We understand that and we support the idea that there may 
be failures. On the other hand, going to Senator Rosen's 
comment, the closest thing to this I remember is when I was the 
Education Secretary and David Kearns was the Deputy under H.W. 
Bush, we sent out a solicitation for ideas for new American 
schools.
    There was a lot of money available. We were deluged with 
good ideas, only a few could win, but we gave a citation to so 
many others and we may have gotten more bang for our buck out 
of the ones that didn't win than the ones who did because it 
unleashed so much enterprise and opportunity. And as you said, 
maybe that will produce the test or the platform that can be 
used for the next virus or maybe it will introduce a really 
bright scientist to a manufacturing company that is looking for 
such a person.
    I can see all sorts of dividends coming from this 
enterprise other than the one or two or three or four new 
technologies that will allow us to produce tens of millions of 
diagnostic tests so we can number one, identify all those with 
the disease--and they are not many of us. I don't know number. 
Maybe it is 3. Maybe it is 5. Maybe it is 7 percent. We really 
don't know. But those of us who are sick, those of us who are 
exposed, that will permit us to track and quarantine that 
percentage of us and then the rest of us can go back to work 
and back to school.
    Right now, we have been quarantining the whole country 
because we are unable to identify just those who are sick or 
those who were exposed. We--that works, but it causes a 
terrible price to pay on our economy. I would like to also 
mention that tests are free. I mean Congress and the 
administration have made sure that if you take a COVID-19 test, 
it is free. You are--either your insurance company or the 
Government is going to pay for it. And that is also true with 
the antibody test.
    First test is whether you have it and the antibody test is 
whether you have had it. And on those tests, at least in the 
conversations Senator Blunt and I had with a large number 
people, sounds like the private sector is well on their way 
with the serology are antibodies tests that we are not likely 
to have any problem with shortages of those over the next six 
months. Although the FDA has a job to do in making sure that we 
know which ones are accurate and which ones are not. So let me 
complete conclude the hearing with the appropriate words or I 
will be in trouble.
    The hearing record will remain open for 10 days. I want to 
especially thank Dr. Collins and Dr. Disbrow for being here 
today. We are counting on you to do something that doesn't 
always happen in Government, which is unleashing the private 
sector, taking advantage of the best of it, and then letting 
our agencies collaborate and work together and not be sunk into 
their individual silos.
    We need for Dr. Collins to find the new technology with the 
help of Dr. Disbrow who will say, well that may be a great 
idea, but I can't scale it up, and then we need for Dr. Disbrow 
to work with all the manufacturing people that he knows to make 
sure we can produce tens of millions of them so that we can go 
back to work and back to schools. Members may submit additional 
information for the record within the next 10 days if they 
would like.
    The Chairman. As I have mentioned, we will meet again at 10 
a.m. on Tuesday, May 12 for our hearing on COVID-19, safely 
getting back to work and back to school. Thank you for joining 
us today. The Committee will stand adjourned.

                          ADDITIONAL MATERIAL

 Covid-19 has shuttered scientific labs. It could put a generation of 
                          researchers at risk
    By Justin Chen May 4, 2020
    Reprints https://www.parsintl.com/publication/stat/.

    Scientists are skilled at tackling unexpected problems that 
threaten the integrity of their experiments--it comes with the 
territory. But the coronavirus pandemic poses a new--and entirely 
unprecedented--challenge.

    The global health emergency has shut down scientific research labs 
across the country in a crisis that has left some scientists scrambling 
to save their work--and has left others grieving the loss of 
experiments they had dedicated months or even years to carrying out. 
Many are grappling with an overwhelming sense of uncertainty about how 
they'll continue their work.

    The situation has hit early career researchers particularly hard. 
Their funding--and their futures--depend on quickly gathering data to 
publish in prestigious journals. Without additional financial support 
and an extension of tenure clocks, some scientists who have just 
started their own labs fear the delays to their studies may be too 
disruptive to overcome.

        ``Early career scientists will be very vulnerable,'' said 
        Cullen Taniguchi, assistant professor at University of Texas MD 
        Anderson Cancer Center. Taniguchi said it will be crucial to 
        properly support researchers when labs reopen--or, he warned, 
        ``we may lose a whole generation of researchers because of 
        this.''

    Related: Patients, drug makers grapple with how to continue cancer 
trials during the coronavirus https://www.statnews.com/2020/04/29/
patients-drug-companies-grapple-cancer-trials-coronavirus/.

    Despite these struggles, many researchers say that shutting down 
the labs was necessary to stem the spread of the virus. And some labs 
are still up and running, though not all are doing so at full capacity. 
But for scientists whose work has been deferred, the closures have 
fueled a devastating ripple effect of consequences, both big and small.

    Even when laboratories are reopened, it may take months to a year 
for research to resume as normal.

        ``I have [new hires] in the lab that haven't even met each 
        other physically,'' said Alice Soragni, a cancer researcher and 
        assistant professor who runs a lab at the University of 
        California, Los Angeles. ``There is a lot of training that 
        needs to have happened that hasn't happened,'' she added.

    STAT spoke to scientists across the country to better understand 
the wide-ranging impacts of lab shutdowns.
  In Portland, Ore., a scientist races to save her research--and then 
                            grieves its loss
    Scientists have transitioned from long hours in the laboratory to 
working from home--but the abrupt halt to their research projects has 
left a lingering sense of disorientation for researchers like Kathleen 
Beeson, a sixth-year graduate student at Oregon Health and Science 
University.

    Like many of her colleagues, Beeson was caught off guard by her 
lab's closure.

        ``We were given a week's notice,'' she said. ``Immediately, I 
        and others were in a race to finish experiments, collect any 
        data that we could, and get the lab prepared for a minimum of 
        six weeks of shutdown.''

    Beeson had been completing a final experiment for a publication she 
needs to earn her Ph.D. and move onto a postdoc research position at 
Harvard Medical School.

    The shutdown has upended Beeson's research, which involves 
measuring electrical activity in the brains of genetically engineered 
mice. Her work aims to describe how proteins at the junction of nerve 
cells help transmit chemical signals--an important step in 
understanding neurological dysfunctions such as epilepsy.

    While other scientists were able to freeze cells or preserve tissue 
samples in formaldehyde, Beeson's research relied on analyzing freshly 
dissected brain tissue. Because she could no longer come into the lab, 
she had to sacrifice most of her mouse colony, which she had 
painstakingly raised from one male and one female to approximately 200 
animals.

        ``In the end, I found myself euthanizing mice by the masses in 
        the university basement,'' she said. ``It was the punctuation 
        on a sad and disorienting week.''

    Beeson said it will likely take her months to raise enough animals 
for experiments again. In the meantime, she has been working on her 
Ph.D. dissertation and a second publication from home--although not at 
the pace that she had hoped for.

        ``I applaud anyone making any progress, on anything, during 
        this time,'' she said. ``Sometimes my progress is processing my 
        grief.''
    In Los Angeles, an early career researcher confronts `exquisite 
                              challenges'
    Disruptions to research and long startup times pose an especially 
daunting challenge to early career scientists who have just a few years 
to establish themselves as experts in their fields and obtain critical 
funding for their laboratories.

    With experiments on hold, some early career scientists can't 
collect the kind of preliminary data that is crucial for them to 
compete with more established researchers who have a decade or more of 
experimental findings to build on.

        ``[All researchers] are impacted but I think there are 
        exquisite challenges for early career investigators like 
        myself,'' said UCLA's Soragni.

    To protect early career scientists, the NIH has extended the 
timeframe for which researchers can be considered ``early stage 
investigators''--a status that helps government institutes and centers 
prioritize funding for scientists running new laboratories. The agency 
has also relaxed some of the eligibility requirements for maintaining 
grants and added additional flexibility for spending funds.

    Despite these welcome efforts, early-career researchers--especially 
those lacking data needed to apply for new grants--remain in a 
precarious position. Soragni and others said they hoped the NIH would 
take the impact of Covid-19 into account and temporarily adjust its 
criteria for reviewing applications. However, the agency has 
recommended that scientists without enough preliminary data submit 
their applications at a later date.

    For Soragni, the most difficult challenge has been the uncertainty.
``You are kind of left not knowing what you should do. . . . Should you 
  be ramping up completely? But what if you are switched down again?''
    ALICE SORAGNI, UCLA CANCER RESEARCHER

        ``We really don't know if we are going to have a second wave of 
        infections and what will be the consequences,'' she said. ``You 
        are kind of left not knowing what you should do. . . . Should 
        you be ramping up completely? But what if you are switched down 
        again? Should you be hiring? Will the economy bounce back? What 
        is going to happen to your grants?''

        ``We are just at a more vulnerable stage of our career,'' 
        Soragni said. ``I believe we may lose some laboratories to 
        this, so that will be very painful to witness.''
     In Atlanta, a postdoc grapples with saying goodbye to a mentor
    The shutdowns have taken a toll not only research, but also on the 
close professional relationships at the heart of scientific 
collaboration.

    COURTESY STEPHANIE CAMPOS

    For Stephanie Campos, Covid-19 meant that she would not complete 
her research or be able to say goodbye to her mentor, Walter 
Wilczynski, in person. Campos had come to Georgia State University for 
a postdoctoral fellowship with Wilczynski, a pioneer in the field of 
behavioral neuroscience and the first director of the university's 
Neuroscience Institute. But after 37 years of research, the lab was 
scheduled to close this summer after Wilczynski's cancer, once in 
remission, returned.

    Campos and her colleagues were wrapping up their research--a study 
of the brain activity in lizards aimed at unraveling the neural 
underpinnings of social behaviors--when the pandemic hit. The lab 
shuttered earlier than expected.

    Related: Covid-19 Drugs and Vaccines Tracker https://
w.w.w.statnews.com/2020/04/27/drugs-vaccines-tracker/.

    With the laboratory closed, Campos has been limited to writing 
manuscripts from home and analyzing old videos of lizard behavior. She 
can't see Wilczynski--who is immunocompromised--again in person before 
she moves to a new role as a visiting assistant professor at Swarthmore 
College.

        ``[This experience] has really affected me emotionally in the 
        way that I knew I was going to be his last student,'' Campos 
        said. ``And so I had really wanted to get as much as I could.''

    With Georgia easing restrictions on social distancing, there is a 
possibility that Campos could return to the lab late in the summer, but 
she is still unsure if returning to work would be socially responsible. 
Instead, she is planning on mailing the bulk of her delayed research 
project--which involves 68 lizard brains preserved in vials of 
paraformaldehyde--to Pennsylvania, where she will begin work in August.

    Campos credits Wilczynski, who was at times too fatigued to read 
papers, for guiding her through the gauntlet of an academic job search 
and giving her the confidence to continue in academia.

        ``His kindness during this time is what I'll remember the 
        most,'' Campos said. ``For me it is all about the personal 
        connection, how well your mentors make you feel. Those are the 
        things that I will take away.''
       In Boston and Baltimore, lab leaders plan for a new rhythm
    Waiting for their labs to reopen, principal investigators are 
steeling themselves for the months of effort that will be needed to 
reestablish the rhythms of a productive laboratory.

    There's a mountain of work to muddle through before experiments can 
get off the ground again.

        ``We will have to first retest [our equipment] to make sure it 
        is working, regrow our [bacterial] cultures, which takes a 
        while, before we can even consider doing an experiment,'' said 
        Eric Rubin, an immunology and infectious diseases researcher 
        and professor at the Harvard T.H. Chan School of Public Health. 
        Rubin also the editor-in-chief the New England Journal of 
        Medicine.

    Regrowing bacteria in Rubin's laboratory is not a job for the 
impatient. The focus of his studies, Mycobacterium tuberculosis, causes 
tuberculosis and kills more people worldwide than any other infectious 
pathogen. M. tuberculosis also grows approximately 50 times more slowly 
than other microorganisms. Experiments that would take a day with other 
commonly studied bacteria typically take weeks in the Rubin lab.

    Related: Infect volunteers with Covid-19 in the name of research? A 
proposal lays bare a minefield of issues https://w.w.w.statnews.com/
2020/05/01/infect-volunteers-with-COVID-19-in-the-name-of-research-a-
proposal-lays-bare-a-minefield-of-issues/.

    When laboratories closed, Rubin's team was in the midst of testing 
a batch of promising drug compounds for the ability to kill the 
bacteria. To resume the study, researchers will have to thaw out stocks 
of frozen bacteria and coax them to replicate in liquid broth.

        ``We normally always have things growing so that we can grab 
        them and do our next experiment,'' said Rubin. ``[But now] it 
        will likely take four months before we will have enough cells 
        to do experiments at full tilt again.''

    Restarting research may take even longer--up to a year--for those 
working with laboratory animals, such as Subhash Kulkarni, a scientist 
and assistant professor at Johns Hopkins University School of Medicine.

    In 2017, Kulkarni showed that, contrary to established dogma, nerve 
cells lining the intestines continue to grow and divide in adult 
animals. To understand how this discovery could lead to new treatments 
for digestive disorders, Kulkarni had begun analyzing how neurons 
behaved over the lifespan of a mouse. This project required raising 
genetically engineered mice at staggered times to have enough of each 
age group at the start of the study.

    With his lab closed, the entire effort will have to be repeated 
once Kulkarni is allowed to work again. That timeline is daunting.

        ``Think of this as the time when the planets are in perfect 
        alignment,'' Kulkarni said. ``Once that time is lost, making 
        the next time requires [new] breedings, which can take anywhere 
        from six to 12 months.''
                                 ______
                                 
    [Whereupon, at 12:54 p.m., the hearing was adjourned.]

                                   [all]