[Senate Hearing 111-309]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 111-309

   BIOLOGICAL THREATS: IS THE CURRENT U.S. VACCINE PRODUCTION SYSTEM 
                               PREPARED?

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

                                HEARING

                                before a

                          SUBCOMMITTEE OF THE

            COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE

                     ONE HUNDRED ELEVENTH CONGRESS

                             FIRST SESSION

                               __________

                            SPECIAL HEARING

                    AUGUST 21, 2009--PITTSBURGH, PA

                               __________

         Printed for the use of the Committee on Appropriations


  Available via the World Wide Web: http://www.gpoaccess.gov/congress/
                               index.html

                               __________


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                      COMMITTEE ON APPROPRIATIONS

                   DANIEL K. INOUYE, Hawaii, Chairman
ROBERT C. BYRD, West Virginia        THAD COCHRAN, Mississippi
PATRICK J. LEAHY, Vermont            CHRISTOPHER S. BOND, Missouri
TOM HARKIN, Iowa                     MITCH McCONNELL, Kentucky
BARBARA A. MIKULSKI, Maryland        RICHARD C. SHELBY, Alabama
HERB KOHL, Wisconsin                 JUDD GREGG, New Hampshire
PATTY MURRAY, Washington             ROBERT F. BENNETT, Utah
BYRON L. DORGAN, North Dakota        KAY BAILEY HUTCHISON, Texas
DIANNE FEINSTEIN, California         SAM BROWNBACK, Kansas
RICHARD J. DURBIN, Illinois          LAMAR ALEXANDER, Tennessee
TIM JOHNSON, South Dakota            SUSAN COLLINS, Maine
MARY L. LANDRIEU, Louisiana          GEORGE V. VOINOVICH, Ohio
JACK REED, Rhode Island              LISA MURKOWSKI, Alaska
FRANK R. LAUTENBERG, New Jersey
BEN NELSON, Nebraska
MARK PRYOR, Arkansas
JON TESTER, Montana
ARLEN SPECTER, Pennsylvania

                    Charles J. Houy, Staff Director
                  Bruce Evans, Minority Staff Director
                                 ------                                

 Subcommittee on Departments of Labor, Health and Human Services, and 
                    Education, and Related Agencies

                       TOM HARKIN, Iowa, Chairman
DANIEL K. INOUYE, Hawaii             THAD COCHRAN, Mississippi
HERB KOHL, Wisconsin                 JUDD GREGG, New Hampshire
PATTY MURRAY, Washington             KAY BAILEY HUTCHISON, Texas
MARY L. LANDRIEU, Louisiana          RICHARD C. SHELBY, Alabama
RICHARD J. DURBIN, Illinois          LAMAR ALEXANDER, Tennessee
JACK REED, Rhode Island
MARK PRYOR, Arkansas
ARLEN SPECTER, Pennsylvania
                           Professional Staff

                              Ellen Murray
                              Erik Fatemi
                              Mark Laisch
                            Adrienne Hallett
                             Lisa Bernhardt
                       Bettilou Taylor (Minority)
                        Dale Cabaniss (Minority)
                      Sara Love Swaney (Minority)

                         Administrative Support

                              Teri Curtin
                         Jeff Kratz (Minority)














                            C O N T E N T S

                              ----------                              
                                                                   Page

Opening Statement of Senator Arlen Specter.......................     1
Statement of Hon. Jason Altmire, U.S. Representative From 
  Pennsylvania...................................................     2
Statement of Bruce G. Gellin, M.D., M.P.H., Director, National 
  Vaccine Program Office, Department of Health and Human Services     4
    Prepared Statement...........................................     5
Statement of Jeffrey A. Romoff, President and Chief Operating 
  Officer, University of Pittsburgh Medical Center, Pittsburgh, 
  Pennsylvania...................................................    12
    Prepared Statement...........................................    14
Statement of Philip K. Russell, M.D., Retired Major General, Army 
  Medical Corps; Board of Trustees and Senior Scientific Advisor, 
  Sabin Vaccine Institute, Washington, DC........................    16
    Prepared Statement...........................................    18
Statement of Philip Gomez, Ph.D., Director, Biodefense and Public 
  Health Practice, PRTM Management Consultants, Washington, DC...    20
    Prepared Statement...........................................    22
Statement of Donald S. Burke, M.D., Dean, Graduate School of 
  Public Health; Associate Senior Vice Chancellor for Global 
  Health; Director, Center for Vaccine Research, University of 
  Pittsburgh, Pittsburgh, Pennsylvania...........................    24
    Prepared Statement...........................................    26
Statement of Nigel Darby, Ph.D., Vice President, Biotechnologies, 
  Life Sciences, GE Healthcare Bio-Sciences AB, Uppsala, Sweden..    27
    Prepared Statement...........................................    29

 
   BIOLOGICAL THREATS: IS THE CURRENT U.S. VACCINE PRODUCTION SYSTEM 
                               PREPARED?

                              ----------                              


                        FRIDAY, AUGUST 21, 2009

                           U.S. Senate,    
    Subcommittee on Labor, Health and Human
     Services, and Education, and Related Agencies,
                               Committee on Appropriations,
                                                    Pittsburgh, PA.
    The subcommittee met at 10:30 a.m., in Courtroom 6A, 
Pittsburgh Federal Courthouse, 700 Grant Street, Hon. Arlen 
Specter presiding.
    Present: Senator Specter.
    Also present: Representative Jason Altmire.


               opening statement of senator arlen specter


    Senator Specter. Good morning, ladies and gentlemen. It is 
10:30 a.m., time to proceed with the hearing of the 
Appropriations Subcommittee on Labor, Health and Human 
Services, and Education to take up the subject of 21 CB, 21st 
century biodefense.
    The subcommittee is pleased to welcome Congressman Jason 
Altmire to join us in this hearing. Congressman Altmire's 
district encompasses some of UPMC.
    Our hearing today will focus on a very serious problem 
facing the United States and facing the world and that is the 
problem of swine flu and the problem of biodefense against 
other items where we need vaccines, some of which implicates 
the threat of terrorist attack.
    As to swine flu, for which we are looking for a vaccine of 
H1N1, as of August 13, a week ago yesterday, in the United 
States 7,511 people have been hospitalized, 477 deaths in the 
United States from swine flu; worldwide, 1,799 deaths. And we 
have been looking for a vaccine of H1N1 where the expectation 
had been to have some 120 million doses as of October 15, and 
the Department of Health and Human Services (HHS) announced 
last Monday that instead of the 120 million doses previously 
forecast, we only have 45 million doses.
    A number of problems have been created, which we will hear 
detailed in our hearing. One company in Australia was taking 
care of Australia first, not taking care of the United States 
first. We would expect UPMC not to ignore Australia, but look 
at the United States first.
    Another company had to take care of their regular 
accommodations.
    I do not know what happened to the other three companies. 
The witness, the distinguished Dr. Bruce Gellin, Director of 
the National Vaccine Program Office, can tell us about what 
those problems were there. But it is obvious that we have a 
significant problem in meeting a problem which could be 
enormously serious--enormously serious.
    We are looking at the limitations of availability of 
vaccines which have quite a number of other potential fronts 
such as smallpox, anthrax, ebola virus, botulism, and another 
long list, some of which are susceptible to terrorist attacks, 
for example, if the smallpox virus were unleashed in the United 
States. What we want to do is to avoid having the Government 
come up short on something like what happened with Katrina 
where we are unprepared for the eventuality.
    Since 2004, when I chaired this subcommittee, with the 
joinder of Senator Harkin, who is now the chair, we 
appropriated $6.4 billion to deal with the vaccine problem, and 
in the supplemental recently we added $5.8 billion for the 
discretion of the President to call up the funding. So you can 
see that we are talking about very substantial funds to meet a 
very substantial problem.
    What we are looking for on the project, which has been 
worked on by UPMC, is an $830 million project, $580 million 
from the United States and $250 million from a public/private 
partnership, which is directed to give the United States 
control, not to have it in the hands of Australia or companies 
which may or may not be reliable.
    UPMC has come forth with a very important program where 
their CEO, Jeff Romoff, has played an active part. We have had 
a series of top level meetings, one in the office of Vice 
President Biden on March 31, an old train pal of mine. Early in 
his work as Vice President, I said to Joe we need a meeting 
with some people here to tackle an important problem, and he 
promptly opened his office and brought in key people. He is in 
charge of the funding on the stimulus package, $787 billion, 
and on May 20, asked Secretary Sebelius to be present at a 
meeting which was in my office. Again, CEO Romoff came, and on 
June 15 when Secretary of Homeland Security Janet Napolitano 
was in Philadelphia on another matter, we had a third meeting 
to acquaint the key people who are involved in this important 
matter.
    One witness today from General Electric (GE) will testify 
about GE's involvement on some matters and technology which 
they have exclusive control. They have the patents. Smaller 
companies, to change all the production of vaccines, have to go 
to different equipment and clean steel which takes a long time. 
GE has a disposable plastic apparatus.
    So you can see a lot of thought has been given to this 
issue, and the general approach is to recognize the primacy of 
competitive bidding. John Myers, my able deputy, is now 
drafting authorizing legislation to move ahead on this project 
so we do not get caught like we got caught on Katrina, do not 
get caught with a problem with swine flu or any of these other 
kinds of problems.
    Now I am pleased to yield to my distinguished colleague, 
Congressman Jason Altmire. Jason.


 statement of hon. jason altmire, u.s. representative from pennsylvania


    Mr. Altmire. Thank you, Senator, and thank you for allowing 
me to participate as part of this very important----
    Senator Specter. Jason, you may want to wait just a minute. 
The TV cameras are being set up.
    Mr. Altmire. I think they are probably here to see you, 
Senator.
    Senator Specter. I am not going to begin my presentation at 
the start, although I probably should, but I will rely on PCN, 
Pennsylvania Cable Network, to carry it.
    Mr. Altmire. Well, I would just say very briefly thank you, 
Dr. Gellin, for being here. There are few, if anyone, in the 
country who knows more about this and has a level of expertise 
about this subject matter than you, and we very much appreciate 
you being here today.
    This is an issue that is very important to many in the 
Congress, both in the House and the Senate. We feel that we 
need to have some advice from you on whether or not we are 
prepared as a Nation because it appears often--we saw it with 
H1N1--that we are in a reactionary mode rather than a 
preparedness mode. We are always reacting to what we see. And I 
know you cannot predict the future. You cannot predict what is 
coming down the road, but we believe that the Nation would 
benefit from having a better prepared system.
    We strongly believe here in western Pennsylvania that we 
have assets that we can bring to the table that would be of 
great national interest. We have strength of organization here 
that is unmatched anywhere else with regard to this issue. We 
believe we have the expertise and the planning to put this 
together in a way that is unmatched anywhere in the country. We 
have the strengths of infrastructure and in financing that we 
feel like are unmatched anywhere in the country. Regardless of 
what the conclusion is on that, we believe that the first step 
has to be an acknowledgement that we could do better with 
regard to preparedness with our vaccination program.
    So we greatly appreciate you being here and look forward to 
your remarks on this issue, and we look forward to hearing the 
second panel as well. Thank you.
    Senator Specter. Thank you, Congressman Altmire.
    Just one additional note. With the kind of a proposal for 
UPMC, it would create 1,000 jobs, 6,000 indirect jobs, and 
there is a major concern in Washington, DC, about stimulating 
the economy. We are not going to spend any money which is not 
really necessary as a matter of public policy and public 
welfare, but in an area which has been hard hit by an economic 
decline, this is something which the President has in mind and 
I know the Vice President does as do the Secretaries of HHS and 
Homeland Security.
    Dr. Gellin is the Director of the National Vaccine Program 
Office within HHS. He has held positions at the National 
Institutes of Health (NIH), the Centers for Disease Control and 
Prevention (CDC), the two premier Federal agencies dealing with 
health, also the Rockefeller Foundation and the Johns Hopkins 
University School of Public Health, quite a prestigious 
background.
    Under our subcommittee procedures, Dr. Gellin, you have 
testified many times. So you know it is 5 minutes. To stay 
within the limit, to the extent you can, would be appreciated. 
Please proceed.
STATEMENT OF BRUCE G. GELLIN, M.D., M.P.H., DIRECTOR, 
            NATIONAL VACCINE PROGRAM OFFICE, DEPARTMENT 
            OF HEALTH AND HUMAN SERVICES
    Dr. Gellin. Thank you very much, Senator Specter. It is a 
pleasure to be with you here today to discuss this important 
topic, particularly what you have highlighted in terms of our 
ongoing challenges related to the H1N1 influenza outbreak and 
in terms of lessons that we have learned in our preparedness 
planning for an influenza pandemic. Vaccines are an important 
part of our public health system and our medical countermeasure 
armamentarium particularly against biological weapons. But we 
also need to recognize--and my role at HHS is in vaccines at 
the National Vaccine Program Office, but what we are talking is 
the range of countermeasures of which vaccines are one. So it 
is in addition to the preventive aspects or some of the 
treatment aspects for chemical, biological, radiological, and 
nuclear threats.
    In the interest of time, I am going to focus my brief 
remarks this morning specifically on medical countermeasure 
advanced development, recognizing it is just one step in the 
larger process.
    In July 2008, Dr. Bob Kadlec, then the Special Assistant to 
the President for Biodefense and Senior Director for Biodefense 
at the Homeland Security Council, requested that HHS and the 
Department of Defense (DOD) conduct an analysis of alternatives 
to identify the optimal facilities and operating models to 
address the gaps in the production and manufacturing of medical 
countermeasures against weapons of mass destruction threats in 
a manner that provides the best long-term value to the 
Government. Again, that highlights what Congressman Altmire was 
talking about, just the relative degree to which we are looking 
at preparedness rather than just reacting to things and just 
recognizing that we need to be moving forward on this.
    To accomplish this analysis, HHS and DOD commissioned an 
independent third-party study of manufacturing facility 
alternatives that should be considered. Because the commercial 
market for these products is small and the pathways long and 
the complexities are many--I think that is evidenced with what 
you discussed, Senator Specter, about the complexities of just 
the reliability of producing the influenza vaccine by the 
manufacturers that make vaccine.
    For these reasons, the industry as a whole has not been 
particularly interested in these kind of products, and there is 
a perception that large gaps exist in the manufacturing and 
production facilities. The recent history shows that both HHS 
and DOD have successfully contracted with biotechnology 
innovators and contract manufacturers for advanced development 
and procurement of medical countermeasures. Moreover, some of 
these contractors are investing heavily in production 
facilities, and the majority in the United States, to further 
address these gaps.
    The independent third-party analysis, which I mentioned, 
suggests that the Government should increase our capabilities 
to oversee the advanced manufacturing process development and 
supply programs to ensure that the needed medical 
countermeasures achieve FDA approval, there is an ongoing 
supply of the product, and there is an ability to surge 
production should a need be there.
    Three alternative scenarios for the development, approval, 
manufacturing, and the sustained replenishment of large 
molecule medical countermeasures were examined in this analysis 
using both quantitative and qualitative criteria.
    The first of the three examined the continuation of the 
existing process of contracting the development and manufacture 
of medical countermeasures.
    The second alternative examined was continuing the existing 
process of contracting for the development but, in addition to 
that, strengthening the technical, quality/regulatory, and 
sourcing and supply capabilities in addition to contracting 
with additional manufacturers for bulk ingredients, as well as 
additional manufacturers for final formulation and filling. 
This approach also provides for enhanced access to process 
development and manufacturing capabilities.
    The third alternative is one that has been proposed in 
previous studies, and it calls for the Government to 
manufacture all needed medical countermeasures. This approach 
includes establishing a new public/private partnership that 
would include the need for a fully dedicated manufacturing 
facility for all medical countermeasures under control of the 
U.S. Government.
    HHS is committed to protecting the health and safety of 
American citizens from both CBRN biodefense threats and 
emerging infectious diseases and, as we talked about, assuring 
the Nation's preparedness. Along with our colleagues at DOD, 
HHS is committed to a full examination and discussion of all 
viable options for the manufacture of vaccines and other 
medical countermeasures against these identified threats.


                           prepared statement


    There have been numerous conversations at the technical 
level about the needs that have been identified and this gap 
that is being discussed, as well as the range of possible 
solutions. Given the importance of this topic, all options are 
on the table right now. And HHS and DOD leadership will be 
meeting soon to discuss the findings of this report and 
determine the path forward.
    We appreciate your support on this very important topic and 
your continuing interest in this area. I am happy to answer any 
questions you have.
    [The statement follows:]
                   Prepared Statement of Bruce Gellin
                              introduction
    Good morning, Senator Specter and Representative Altmire. I am Dr. 
Bruce Gellin, Director of the National Vaccine Program Office within 
the Department of Health and Human Services (HHS). I am honored to be 
here today to discuss this important topic, particularly in light of 
our ongoing challenges related to the 2009-H1N1 influenza outbreak. 
Vaccines are an important piece of our public health system and our 
medical countermeasure armamentarium, particularly against biological 
weapons. This morning I will provide a brief overview of HHS 
responsibilities for medical countermeasures development for chemical, 
biological, radiological, and nuclear threats and then will focus more 
specifically on the topic of medical countermeasure manufacturing.
          medical countermeasures--development and acquisition
    Our progress in securing medical countermeasures begins with and 
depends on effective planning. The central framework for medical 
countermeasures planning and implementation in the Federal Government 
is the HHS Public Health Emergency Medical Countermeasures Enterprise 
(PHEMCE), established in July 2006. This coordinated interagency group 
is led by the Assistant Secretary for Preparedness and Response (ASPR), 
and includes my office, the Centers for Disease Control and Prevention 
(CDC), the Food and Drug Administration (FDA), and the National 
Institutes of Health (NIH) as well as our partners from the Department 
of Defense (DOD), Department of Homeland Security (DHS), and Department 
of Veterans Affairs (VA). Through this Enterprise-wide effort, we are 
able to ensure that Federal activities with respect to needed medical 
countermeasures are effectively coordinated from research and 
development to acquisition and, ultimately, deployment. This supports a 
range of programs that I will briefly summarize for developing and 
acquiring medical countermeasures for man-made and naturally occurring 
public health threats while building domestic manufacturing 
infrastructure.
    The Biomedical Advanced Research and Development Authority (BARDA) 
within HHS's ASPR directs and coordinates the Department's 
countermeasure and product advanced research and development 
activities. BARDA establishes systems that encourage and facilitate the 
development and acquisition of medical countermeasures such as 
vaccines, therapeutics, and diagnostics, as well as innovative 
approaches to meet the threat of chemical, biological, radiological and 
nuclear (CBRN) agents and emerging infectious diseases, including 2009-
H1N1 influenza. BARDA provides an integrated, systematic approach to 
the development and purchase of the necessary vaccines, drugs, 
therapies and diagnostic tools for public health emergencies. It 
directs and coordinates the Department's countermeasure and product 
advanced development activities and medical countermeasure domestic 
manufacturing infrastructure building, including strategic planning for 
medical countermeasure research, development, and procurement. This 
coordinated approach is critical to achieving success in the area of 
bioterrorism preparedness and has been proven through the recent H1N1 
effort.
    Specifically with respect to vaccines, HHS has a number of efforts 
underway. These efforts supported the first U.S. licensure of an avian 
influenza-based H5N1 vaccine in April 2007, which was highlighted by 
Time Magazine as the number one medical breakthrough of 2007. By the 
end of 2007, HHS had stockpiled 12 million courses of pre-pandemic H5N1 
vaccine. However, maintaining a domestic production capability for 
these priority countermeasures is also an essential component of the 
pandemic influenza preparedness strategy. In May 2006, HHS awarded five 
contracts for more than $1 billion to GlaxoSmithKline, MedImmune, 
Novartis (formerly Chiron), Solvay, and Dynport (with Baxter) for 
support of advanced development of cell-based influenza vaccines toward 
U.S. licensure and expanded domestic vaccine manufacturing surge 
capacity. In June 2007, we awarded two contracts for the retrofitting 
of existing domestic biological manufacturing facilities to produce 
egg-based influenza vaccines and included warm base operations for up 
to 5 years. Additionally, contract awards were made in 2008 for the 
construction of new domestic facilities for manufacturing cell-based 
influenza vaccines that is expected to quadruple the domestic pandemic 
vaccine manufacturing surge capacity by 2012.
    A robust and groundbreaking advanced development program has led to 
the rapid maturation of modernized cell-based influenza vaccine 
production and antigen-sparing technologies. New combinations of 
adjuvants and products provided by multiple manufacturers are currently 
supported by performance-driven milestone contracts. More rapid vaccine 
production may be afforded by the development of next generation 
recombinant influenza vaccines, which HHS will support.
    These investments enhanced our current capabilities to respond to 
the urgent needs for development and manufacturing of vaccine for use 
against 2009 H1N1 influenza. Currently, HHS has contracted with five 
companies that are now producing and conducting clinical trials or 2009 
H1N1 vaccine for U.S. supply (GSK, Sanofi, Novartis, CSL, and 
MedImmune).
            medical countermeasure analysis of alternatives
    In July 2008, Dr. Robert Kadlec, the then-Special Assistant to the 
President for Biodefense and Senior Director for Biodefense at the 
Homeland Security Council, requested that HHS and DOD conduct an 
Analysis of Alternatives:

        ``to identify the optimal facilities and operating model for 
        addressing the gap in production and manufacturing of medical 
        countermeasures against WMD [Weapons of Mass Destruction] 
        threats in a manner that provides the best long-term value to 
        the U.S. Government.''

    It is important to highlight that the inspiration behind the 
development of such a biofacility is consistent with many of the broad 
goals articulated in the draft National Vaccine Plan (November 2008), 
especially regarding the objectives of
  --Fostering advanced research and development toward new and/or 
        improved vaccines that prevent diseases, including those that 
        protect against emerging, re-emerging, and important 
        Biodefense-related pathogens, and
  --Improving access to appropriately designed pilot lot manufacturing 
        facilities that produce clinical grade material for promising 
        vaccine candidates.
    As Dr. Kadlec noted, the timely availability of sufficient 
quantities of medical countermeasures ``is essential for saving the 
lives of civilians and warfighters following a WMD attack.''
    A principal mission of HHS and DOD is to provide medical 
countermeasures--drugs, vaccines, and therapeutics--to protect civilian 
and military populations, respectively, from attack with CBRN agents. 
Developing sustainable medical countermeasures that are effective and 
readily available is an enormously complex task from a technical and 
organizational perspective.
    Such medical countermeasures require:
  --Discovery and early research;
  --Development and testing in surrogate animal models;
  --Advanced development through clinical trials;
  --FDA regulatory approval;
  --Production and manufacturing;
  --Stockpile supply management;
  --Distribution and dispensing strategies; and
  --Stockpile replenishment.
    To accomplish the requested analysis, HHS and DOD commissioned an 
independent, third-party study of vaccine manufacturing facility 
alternatives that should be considered. We will soon meet with our 
colleagues at DOD to discuss the findings and determine any 
recommendations that will be made in response to the request. But 
permit me to briefly share some general findings with you.
    The focus of the analysis was on the advanced development, FDA 
approval and sustainment phases of the medical countermeasure 
lifecycle. Within the advanced development phase, the focus was only on 
advanced manufacturing process development. Sustainment refers to the 
storage, maintenance and replenishment of the active pharmaceutical 
ingredients and the dosage forms of medical countermeasures, as well as 
procurement, storage, and maintenance of required ancillary supplies 
needed to administer the countermeasure.
    To date, the United States Government (USG) has successfully 
procured small molecule medical countermeasures (e.g., drugs) from 
established contractors, and the analysis determined that there is 
excess industry capacity available for manufacturing these types of 
products. Thus, the current process of contracting with industry to 
produce `small molecule' medical countermeasures appears to be viable 
now and in the future.
    Together, HHS and DOD have stated requirements for a collective 
portfolio of 23 large molecule CBRN medical countermeasures that are 
biologically based products. Past analyses have recommended that the 
USG own and manage a production facility for the manufacture of large 
molecule products (e.g., vaccines, monoclonal antibodies) to increase 
control of the approval and supply processes in order to minimize risk 
of supply disruption.
    Since the biopharmaceutical industry, as a whole, has not 
traditionally developed medical countermeasures for the USG, there is a 
perception that large gaps exist in manufacturing and production 
facilities. However, recent history shows that both HHS and DOD have 
successfully contracted with emerging biotechnology innovators and 
contract manufacturers for advanced development and procurement of 
medical countermeasures. Moreover, some USG contractors are investing 
heavily in production facilities, the majority in the United States, 
further addressing the facilities gap.
    The analysis suggests that the USG should increase its capabilities 
to oversee the advanced manufacturing process development and supply 
programs to ensure that,
  --Needed medical countermeasures achieve FDA approval, and
  --There is an ongoing supply of the product.
                     alternative scenarios examined
    Three alternative scenarios for the development, approval, 
manufacturing, and sustained replenishment of large molecule medical 
countermeasures were examined using both quantitative and qualitative 
criteria.
  --The first alternative examined was continuing the existing process 
        of contracting the development and manufacture of medical 
        countermeasures.
  --The second alternative examined was continuing the existing process 
        while strengthening technical, quality/regulatory, and 
        sourcing/supply capabilities; and contracting with additional 
        manufacturers of bulk active product ingredients and 
        formulation, filling, and finishing. This alternative also 
        provides for enhanced access to process development and 
        manufacturing capabilities.
  --The third alternative is one that has been proposed in previous 
        studies. It calls for the Government to manufacture all needed 
        medical countermeasures. This approach, which includes 
        establishing a new public-private partnership, anticipates a 
        fully dedicated manufacturing facility for all medical 
        countermeasures under control of the USG.
    The first alternative only satisfies the need of the USG to a 
limited degree because, although the USG has been successful in 
developing and manufacturing some medical countermeasures, it does not 
provide the USG with the most effective and efficient processes for 
managing the potential growing number of highly complex medical 
countermeasures. While this alternative is the least costly of the 
three alternatives, it provides the fewest capabilities and carries the 
risk of less than optimal oversight to ensure the manufacturing 
capability for the growing medical countermeasure supply chain.
    The second alternative builds on the successful current USG medical 
countermeasure contractual approach and enables flexible decision 
making for advanced manufacturing process development, stockpiling, 
backup, and surge. It expands current capabilities to meet the 
complexity and urgency of medical countermeasures yet to be developed 
and scaled to manufacturing requirements. This alternative offers the 
lowest operational risk to achieve current requirements of all the 
alternatives by creating a collaboration of USG and a network of 
incentivized, highly specialized, and knowledgeable industry suppliers. 
It enables future operations to be enhanced most efficiently by 
incorporating dedicated technology, quality and regulatory compliance, 
and sourcing and supply functions. In addition, contract manufacturing 
is less costly and timelier than constructing and operating a dedicated 
facility.
    Of all alternatives examined, the third alternative potentially has 
the highest risk of supply chain failure and, compared to the two other 
alternatives, carries the highest cost. In addition, the time required 
to develop reliable systems for long-term, full-scale manufacture of 
biologics (large molecules) could impede progress toward needed FDA 
approval. This alternative also does not provide sufficient surge or 
backup capabilities. Finally, only a few, if any, biopharmaceutical 
companies have clustered the production of so many products in a single 
facility. An adverse regulatory decision or a catastrophic event could 
shut down the single facility. A single facility with many products is 
more complex to manage, and is more likely to trigger an adverse 
regulatory decision than a network of specialized manufacturers.
                               conclusion
    HHS is committed to protecting the health and safety of American 
citizens from CBRN threats. Along with our colleagues at DOD, HHS is 
committed to a full examination and discussion of all viable options 
for the manufacture of vaccines and other medical countermeasures 
against identified threats.
    We appreciate your support and continuing interests in this 
important area. I am happy to answer any questions.

    Senator Specter. Well, thank you, Dr. Gellin, for that 
opening statement.
    Dr. Gellin, in looking at the statistics as of 1 week ago 
yesterday with 7,511 hospitalized cases of swine flu in the 
United States and 477 deaths in the United States and 1,799 
deaths worldwide and the prospect of having serious problems of 
additional cases of swine flu, I was very concerned to see the 
report on Monday of this week that the companies were only able 
to produce 45 million doses of vaccine for swine flu when the 
expectation had been for 120 million vaccine doses.
    Now, is there not really a very substantial public risk 
when there has been that shortfall on the number of vaccines 
available for this very serious problem?
    Dr. Gellin. You are right. We were dismayed to learn that 
as well. We have been working with the manufacturers to try to 
determine what the expected number of doses would be. This to 
me, as I said, highlights how complicated this kind of 
manufacturing is.
    Senator Specter. And are there not major problems in 
looking for manufacturers because the big companies do not want 
to undertake manufacturing these kinds of vaccines because 
compared to their other business where they have enormous sales 
and very substantial sums of money, that these are relatively 
small and not attractive for other big companies?
    Dr. Gellin. Exactly. I think we should put separately the 
influenza discussion because those vaccines are being made by 
the same manufacturers that make influenza vaccine around the 
world. What we are focusing on here is exactly as you say, 
Senator, looking at the manufacturing for products that do not 
have a large commercial market.
    Senator Specter. So what are we talking about is smallpox, 
anthrax, ebola virus, botulism, and others where there could be 
a very serious public health problem if terrorists, for 
example, were to unleash smallpox germs on the community.
    Dr. Gellin. It is exactly the same. There is a list of 
those threats and there is a need to make sure that we can have 
the products that we need should we have to face a threat like 
that.
    Senator Specter. Dr. Gellin, when you testify, as you did, 
about Federal Government oversight, is that sufficient? If you 
do not have a controlling voice in what the company is going to 
do and you deal with somebody in Australia, it is 
understandable that the Australian company wants to look after 
Australia first. I do not like it, but you have to expect that. 
Or if you find a company that you have contracted with is going 
to take care of their regular business first and their 
interests, not in the public interest, I do not like that 
either, but that is to be expected.
    But does there not have to be something more than 
governmental oversight? Does there not really have to be 
something like a public/private partnership where the 
Government is able to control what the producers are going to 
do, looking out after U.S. health interests?
    Dr. Gellin. I think you are exactly right. And the 
situation you describe really underscores at least our approach 
with influenza, as you have mentioned, and the generous support 
the Congress has provided to develop domestic-based facilities. 
I think that is clearly a part of this. I think there is a 
range of possible solutions to this problem, of which the 
public/private partnership is clearly one.
    Senator Specter. And when you have a need to change 
equipment on vaccines and the standard equipment on stainless 
steel requires a good bit of cleaning and down time and delay, 
isn't GE in a unique position having the patent on the plastic 
so that they are in a position to move from one production of 
vaccine to another?
    Dr. Gellin. I cannot speak to GE specifically, but----
    Senator Specter. Well, we will hear from them this morning.
    Dr. Gellin. But GE--like many--I think--we are encouraged 
that a number of companies are taking this seriously and are 
trying to move us into the 21st century with some of these 
production techniques.
    Senator Specter. Has any entity as prominent as UPMC with 
its very prestigious, very effective operation been as 
innovative and thoughtful in coming up with a proposal to deal 
with this very serious national problem?
    Dr. Gellin. I am certainly impressed by the UPMC group 
proposal, and again, coming into Pittsburgh, it is hard to not 
see the footprint that UPMC has here. What they have put 
together, as the Congressman has highlighted, really represents 
the range of the strengths that they bring to it.
    Senator Specter. Well, my red light is on the red line, but 
I will ask you in addition to being impressed, which you 
testified to, my question was, has anybody like UPMC come 
forward to tackle this problem in this imaginative, innovative 
comprehensive way. I want to hear more than whether you are 
impressed with them. I want to know if anybody else is doing 
what they are doing.
    Dr. Gellin. There are a lot of discussions about this from 
a procurement standpoint. So I am not aware of other offers 
like this. There may be----
    Senator Specter. Okay. The answer is none that you are 
aware of.
    Dr. Gellin. Correct.
    Senator Specter. Well, you are the witness.
    Dr. Gellin. I am the witness and----
    Senator Specter. Congressman Altmire.
    Mr. Altmire. Thank you, Senator, and thank you, Dr. Gellin.
    I read your written remarks which, of course, in 5 minutes 
you cannot go into everything, and you were very thorough. And 
I wanted to ask you a couple questions that you address in 
there.
    You outlined the options in your oral statement right now 
that people are talking about, but without picking a favorite 
option, what is your opinion about the need to restructure the 
process in a way that maybe better adapts to modern technology 
and modern threats so that we are not constantly being in that 
responsiveness frame of mind that we have talked about?
    But when you do have to respond quickly, is it fair to 
say--I am not going to put words in your mouth. I am asking for 
your opinion--that we need to do a comprehensive restructuring 
of the process or that we just need to keep doing what we are 
doing and maybe just refine it a little bit?
    Dr. Gellin. To pick up where you left off, I think we need 
to take a fresh look at the way we are approaching this. What 
is comprehensive is, I think, in some ways in the eye of the 
beholder, but I think that we have identified that there are 
some substantial gaps. We need more flexibility in our 
approach, and we need to be more fluid. In my assessment of the 
assessment of the variety of alternatives, that is what they 
are looking at as a way to be able to close some of these gaps.
    Mr. Altmire. With regard to the American role, public/
private partnerships in this process, I think the Senator has 
accurately said some things that are of concern to the Congress 
generally, that when you have foreign entities involved, even 
though they are allies, they are going to look out for 
themselves first. So when we talk about the idea of putting 
forward large sums of money, $600 million or more, toward this 
effort, would it be your opinion that that would be money well 
spent if we were to look at the idea of having one leading 
center in the country that would have the expertise and all the 
assets that we talked about, regardless of where in the country 
that is located, versus having--I think you referred to this as 
an option--a bunch of co-equal centers around the country that 
do the same thing, but maybe the coordination, in my opinion, 
may not be what we would like if we had to respond very 
quickly?
    Dr. Gellin. Yes. I cannot speak to that directly. I think 
that people make an argument on both sides of that. And my 
experience with the NIH on the research side is they have a 
number of Centers of Excellence and they are able to tap into 
the expertise of different places on common problems. So again, 
I think there are a number of approaches to this, and I think 
that that is where the discussions between the leadership of 
HHS and DOD I think will be quite helpful in trying to figure 
out what is the right balance and what is the right structure.
    Mr. Altmire. Thank you. I have no further questions, 
Senator. I have a couple of minutes left. I would be happy to 
yield to you if you had one more, or just yield back.
    Senator Specter. Well, we are not going to let any time go 
unused. So thank you.
    Dr. Gellin, how do you see the matter progressing? I 
believe that there will be considerable support in the Congress 
for the authorization and then ultimately for the 
appropriation. What next steps do you see in the consideration 
of this issue? And I ask that in the context that I want to see 
us move ahead promptly. I do not want to see the bureaucracy 
slow it down. To what extent will the Office of Management and 
Budget be a block to getting the necessary funding?
    Dr. Gellin. So I think it is clear, as I mentioned, that 
this now--the analysis has been done. The discussions have 
occurred at the technical level and it has got to be briefed up 
the chain of the respective Secretaries. That then because of 
the importance of this contract is going to obviously include 
White House conversation in which, at least in my experience, 
OMB is always a part of those conversations.
    Senator Specter. Can you give us some insights as to what 
the report has shown? I realize it has not been made public, 
but I know there is tremendous interest in knowing. Describe at 
least the parameters of the report and what it has been 
designed to seek.
    Dr. Gellin. Well, you have actually highlighted the broad 
strokes of what that report has shown. I tried to emphasize 
some of that in my testimony. Do we continue similarly to what 
we are doing now? Do we have a little bit more of a hybrid 
approach of doing what we are doing now but having additional 
ability to add more control? And then the third possibility is 
the possibility of having a place where this goes on. So I 
think that is what is out there for discussion. The analysis 
has been done. The analysis has to go up to the leadership to 
try and figure out the best route forward.
    Senator Specter. Does the executive share the sense of 
urgency, which the subcommittee feels on this subject? A sense 
of urgency to move ahead and get something done?
    Dr. Gellin. Merely because we are in the middle of the H1N1 
problem does not mean that everything else is not a problem 
right now. We recognize that a range of problems exist. The 
gaps that have been identified exist, and we need to try to 
close those gaps.
    Senator Specter. Thank you very much, Dr. Gellin. The red 
light is on and we will move now to panel two. We would 
appreciate it if you would stand by because there may be some 
questions which will arise from the testimony of our 
distinguished panel which you could shed some additional light 
on.
    We now call CEO and President of UPMC, Mr. Jeffrey A. 
Romoff, retired Major General Philip K. Russell, Dr. Philip 
Gomez, Dr. Donald Burke, and Dr. Nigel Darby.
    Thank you very much for coming, gentlemen. As noted a 
moment or two ago, in accordance with our general practice, the 
subcommittee allocates 5 minutes for opening statements to give 
a maximum amount of time for questioning and answers.
    We turn now to our first witness, Mr. Jeffrey A. Romoff, 
President and CEO of UPMC, one of the leading nonprofit health 
systems in the United States. He began his distinguished career 
at the University of Pittsburgh in 1973 as Director of the 
Office of Education and Regional Programming at Western 
Psychiatric Institute and Clinic. In 1992, he was elevated to 
the presidency of UPMC, and in 2006 became UPMC's President and 
CEO. A master degree in philosophy with a specialty in 
political science at Yale University, recipient of the honorary 
Doctorate of Public Service from Chatham College, and an 
honorary Doctorate of Science and Technology from Carnegie 
Mellon University. Welcome, Mr. Romoff, and we look forward to 
your testimony.
STATEMENT OF JEFFREY A. ROMOFF, PRESIDENT AND CHIEF 
            OPERATING OFFICER, UNIVERSITY OF PITTSBURGH 
            MEDICAL CENTER, PITTSBURGH, PENNSYLVANIA
    Mr. Romoff. Thank you very, very much, Senator Specter. 
Thank you, Congressman Altmire, for being here.
    I have submitted testimony that provides an overview of 
UPMC's perspective on this problem, and we have also submitted 
a summary of the 21st century biodefense project.
    Senator Specter. All of that will be made part of the 
record, as will all of the formal statements.
    Mr. Romoff. Also, I am privileged here to be a member of a 
panel with far more distinguished and knowledgeable scientists 
and chem specialists. So I will seek to address issues as you 
would address issues rather than get into many of the details.
    The first issue that is so absolutely essential here is the 
issue of preparedness, which you, Senator, highlighted in the 
previous testimony. It is our view and I think it is the view 
of most commentators and most observers that when it comes to 
the protection of the national security from a bioterrorist 
attack, all of the protection of the national security and the 
national well-being from various naturally occurring infectious 
diseases, this country and virtually all countries in the world 
are relatively defenseless. We can talk about why and how, but 
this is a very, very grave problem and one that we do not often 
realize regrettably until after the fact.
    It is not just a problem of finding the right medical 
countermeasures or vaccines to address the problem, should 
there be a natural accident, as we already saw, or should there 
be SARS, as we already saw. It is even a more serious problem 
because the public psyche is highly vulnerable. It is always 
vulnerable. It was vulnerable after 9/11. It was certainly 
vulnerable after Katrina, and now coming out of, hopefully, the 
recession, we see that something that happens unexpectedly, 
something that shocks like a bioterrorist attack or a lot of 
what happened with the subprime causes ripple effects that are 
even more profound than the initial occurrence.
    The most serious harm for this country that will come from 
even a small bioterrorist attack would likely not be the 
casualties that occurred initially, but the harm will come in 
the school systems, in the workplace, in the economy, in all 
the aspects of our daily living because when we do not have the 
confidence that our Government or that our corporations or that 
our society is well-prepared to deal with something that is 
unknown and frightening, we lose confidence completely.
    I find it fascinating that yesterday there were statistics 
that only, if you will forgive the expression, 15 percent of 
the subprime mortgages actually went into foreclosure. Now, 
this country reacted extraordinarily to the fact that subprime 
mortgages were very, very vulnerable. Now, the facts now come 
out that it was a limited damage in itself, but the damage to 
the economy, the fact that the credit system came to a 
screeching halt is profound.
    We are now watching the H1N1 situation, and that is a 
situation where I believe, despite this last finding that they 
were not making enough vaccine as anticipated, the Government 
deserves kudos because as soon as the H1N1 emerged, Secretary 
Sebelius, Secretary Napolitano, the CDC got in front of the 
public and said we are on top of this or we are learning about 
it. This is what we are doing, and it calmed the public and it 
raised the expectations. Now, of course, if the expectations 
are not completely met, then we have a secondary set of 
problems.

                           PREPARED STATEMENT

    If this Government, if there is a bioterrorist attack or 
there is a new infectious disease, cannot stand before the 
public and say straightforwardly we anticipated this--and it is 
anticipated. It was anticipated in the Weapons of Mass 
Destruction Commission report which says there is a reasonable 
chance that in 5 years--that is, 5 years from a year or 2 ago--
that there will be a bioterrorist attack. If the Government 
cannot stand before the people and simply state we anticipated 
this, we knew about it, and this is what we did, we caused 
these things to happen, not that we caused these studies and 
analysis to happen, but that we caused these concrete 
approaches, just like we caused new--about H1N1 for now, then I 
believe beyond whatever attack occurs, there will be a 
significant, significant diminution in the confidence of the 
Government and a diminution in the competence of the 
Government. This, of course, is what we saw after Katrina.
    So in conclusion, I thank you once again for caring about 
these very, very important issues, and UPMC stands absolutely 
ready to do everything we can if we have the opportunity.
    [The statement follows:]
                Prepared Statement of Jeffrey A. Romoff
    Thank you, Senator Specter, for the opportunity to provide 
testimony on the vital issue of improving the Nation's capacity to 
develop and manufacture countermeasures critical to national and 
homeland security. I'd also like to recognize and thank Congressman 
Jason Altmire (and Congressman Mike Doyle).
    I am here today in my capacity as president and CEO of the 
University of Pittsburgh Medical Center (UPMC), the University of 
Pittsburgh Medical Center. UPMC is a unique organization that has, over 
the past two decades, evolved from an outstanding academic medical 
center into an $8 billion integrated global health enterprise. We have 
50,000 employees and are the largest employer in western Pennsylvania. 
We act as a major health resource for residents of the western 
Pennsylvania, and contribute more than $500 million annually in 
community benefits. UPMC is closely affiliated with the University of 
Pittsburgh, which ranks fifth in National Institutes of Health (NIH) 
research funding.
    One of the key roles that UPMC plays is revitalizing the economy of 
western Pennsylvania by nurturing new capabilities derived from our 
intellectual capital and based on medicine, science, and technology.
    UPMC's core expertise in this regard is vividly demonstrated by the 
new $622 million, state-of-the-art Children's Hospital of Pittsburgh of 
UPMC, where we have deployed a fully integrated electronic health 
record, developed in collaboration with and for the doctors, nurses, 
pharmacists, and infection control practitioners at the hospital. 
Children's is among the only 1.5 percent of the Nation's hospitals that 
use a comprehensive electronic record, and the care provided is among 
the finest, safest, and most cost-effective available today.
    Our expertise and capacity for innovation are also evident in the 
Hillman Cancer Center, which acts as the hub of a network of cancer 
centers throughout western Pennsylvania. These centers are connected 
through sophisticated linkages that enable the most advanced forms of 
radiation therapy to be delivered to patients here and abroad.
    In a similar vein, one of the telemedicine programs that we have 
implemented now provides the expertise of stroke specialty consultants 
to physicians and patients in distant community hospital emergency 
departments without the risks attendant in spending valuable time in 
transit to larger hospitals.
    In Italy, a decade ago, in collaboration with two hospitals and the 
Region of Sicily, we brought transplantation and other specialty 
surgical care to Palermo at a level never before available in the 
region. The hospital we built, which is known as ISMETT, has become a 
leader in transplantation in Italy. Building on the success of ISMETT, 
UPMC is now working with the Italian Government on plans to create a 
new biomedical and biotechnology center in Sicily, in collaboration 
with the University of Pittsburgh, the Italian Council of Ministers, 
the Region of Sicily, and the Italian National Research Council.
    Obviously, we are proud of each of these accomplishments, but what 
do they have to do today's topic, ``Advanced Development and 
Manufacturing for U.S. Biodefense?'' I would submit that these 
seemingly unrelated initiatives share a number of common threads.
    First, each of these examples demonstrates that extraordinary 
achievements can be brought about through out-of the-box creativity and 
innovation. This creativity should be applied to the challenge of 
protecting this Nation from bioterrorism. My colleagues on this panel 
will speak to this issue in greater detail.
    Let me just say that UPMC has had a long-standing commitment to 
serving the Nation and advancing our readiness in the area of 
biosecurity. In 2003, we founded the Center for Biosecurity of UPMC, an 
independent, academic think tank dedicated to providing research, 
analysis, and policy solutions to address national and international 
biosecurity challenges. We have been at the table in a wide array of 
regional readiness efforts, and most recently have been conducting 
comprehensive analysis, in collaboration with DARPA, to assess the U.S. 
Government's biodefense countermeasure requirements and the Nation's 
infrastructure in place to meet those requirements.
    The second theme that our experience illustrates is that by 
departing from traditional paradigms, one can develop new and effective 
solutions. This is as true in biodefense as in electronic health 
records or telemedicine.
    We are already seeing growing recognition that biological weapons 
and naturally occurring pandemics represent a grave risk to the health 
of the populace and to the continued economic recovery of this Nation.
    Over the past decade, we have all seen official Government report 
after report cite biological weapons as being among the top national 
security threats to the Nation. A recent Weapons of Mass Destruction 
Commission report concluded that a biologic or nuclear attack somewhere 
in the world is more likely than not in the next 5 years. President 
Obama recognized biological threats as a major national security issue 
during his campaign and has committed to improving U.S. biosecurity 
since taking office. Congress also has worked to improve the state of 
U.S. biosecurity.
    In particular, the central importance of countermeasures--medicines 
and vaccines--to U.S. biosecurity has been recognized. The Obama 
administration has expressly committed to ``accelerate the development 
of new medicines, vaccines, and production capabilities.''
    It is also recognized that the traditional platforms for developing 
solutions have not yielded the biologics, vaccines, and countermeasures 
that are required.
    It is not because the Nation lacks great scientific knowledge or 
new ideas--our universities are brimming with new leads and new 
directions, but they lack the ability to bring these great ideas to 
market.
    It is not for lack of superb pharmaceutical companies that have the 
top-level industry knowledge and experience to develop, license, and 
manufacture biodefense countermeasures. There is no commercial market 
for these products outside the Government, there are substantial 
opportunity costs for these companies, and they have largely not seen 
the Government as a predictable partner in this enterprise.
    As a consequence, the current U.S. approach to biodefense medicine 
and vaccine development relies almost completely on small biotech 
companies. These companies are innovative and focused, but few have 
demonstrated the capability to produce licensed vaccines or medicines, 
and few have in house the technical expertise and/or regulatory 
experience needed to do this work. These companies must raise money to 
build dedicated factories to make these products. They must have the 
plans and capacity to manufacture a batch of their products annually to 
maintain their FDA license, with the result that many of these 
manufacturing plants will be idle most of the year, with a very limited 
ability to surge production.
    It is in this context that I would strongly urge this subcommittee 
to initiate a new public-private partnership within HHS BARDA, the 
mission of which would be to establish and run flexible, multiproduct 
medical countermeasure development and manufacturing facilities that 
would address these issues and challenges.
    This public-private partnership would make maximal use of flexible 
technologies that do not require building highly capital-intensive 
facilities. It would be capable of developing and manufacturing 
multiple products concurrently in different suites, using disposable 
technology that can easily be changed depending on the needs and 
requirements of the Government. In time of national crisis, such as 
after a substantial bioattack on a U.S. city, all suites of the 
multiple-suite vaccine plant could be converted to the manufacture of a 
single drug, providing critical surge capacity not now available.
    Another key feature of this public-private partnership would be 
that it would provide and concentrate ``big pharma'' development 
expertise--high-level expertise that is not easy to find for the 
biotechnology companies now working to develop these products. This 
would not only increase the odds of success substantially, but also 
would reduce risk of failure midway through a complex product 
development life cycle.
    In this partnership, key responsibilities of the Government would 
include setting requirements for medicines and vaccines, making 
decisions about procurement, and providing part of the funding. The 
private sector partner would provide the remainder of funding and bring 
pharmaceutical and technological know-how, and would provide workforce 
training and education. A range of professional backgrounds and 
educational levels would be required to operate this facility, from top 
scientific and professional training to high-school-educated workers. 
The design, construction, and operation of this facility would provide 
thousands of jobs.
    An economic analysis undertaken by UPMC demonstrates that this 
approach would save the U.S. Government--that is, American taxpayers--
$28 billion over the next 25 years, an estimated 80 percent of the 
development costs for making the current DOD/HHS requirements for 
vaccines and medicines. In addition, adoption of such an approach to 
this challenge would help maintain the U.S. industry in 
biomanufacturing, an industry that has provided excellent jobs, but 
that has been steadily moving overseas and will continue to do so 
unless U.S. policy changes.
    Finally, this public-private partnership model can and should be 
used to develop noncommercial medicines and vaccines for emerging 
infectious diseases--a group of diseases that is of great importance to 
the world, but for which many of the same market conditions and risks 
have prevented progress.
    We fully anticipate that a project of this importance and scope 
would be competitively bid. In all likelihood, UPMC and its partners 
would participate in this competition. We have a proven track record of 
superb execution and success, but we would anticipate top-level 
competition from others as well.
    In closing, let me again thank you for the subcommittee's 
leadership on these issues. These are critical issues for the country. 
The nature and seriousness of the biological threats have been clearly 
stated for years. The importance of making medicines and vaccines to 
counter these threats has been similarly recognized for quite some 
time. There are concrete and innovative steps the country can and 
should be taking to deal with these vulnerabilities and challenges that 
will make us far better prepared for a range of crises. We can make new 
medicines and vaccines for these threats more quickly, more reliably, 
with less risk and at less cost to the Government. The private sector 
is capable of being a much more active and effective partner with BARDA 
and the U.S. Government on these efforts. In the last year, there has 
been growing discussion in Washington about the vital importance of 
establishing new public-private partnerships to solve problems that 
neither the Government nor the private sector can solve alone. My 
judgment is that countermeasure development and production is the 
archetype of such a problem, and that the elements of the public-
private partnership I have described in this testimony are central to 
addressing it.

    Senator Specter. Thank you, Mr. Romoff.
    We turn now to Dr. Philip K. Russell, Trustee and Senior 
Scientific Advisor to the Sabin Vaccine Institute in 
Washington. He served in the U.S. Army Medical Corps from 1959 
to 1990, some extended period of time. Following the anthrax 
attacks in 2001, Dr. Russell led an HHS effort to develop and 
stockpile vaccines and other medical countermeasures against 
bioterrorism agents. Thank you for coming in today, Dr. 
Russell, and we look forward to your testimony.
STATEMENT OF PHILIP K. RUSSELL, M.D., RETIRED MAJOR 
            GENERAL, ARMY MEDICAL CORPS; BOARD OF 
            TRUSTEES AND SENIOR SCIENTIFIC ADVISOR, 
            SABIN VACCINE INSTITUTE, WASHINGTON, DC
    Dr. Russell. Good morning, Senator, Congressman. Thank you 
very much for the opportunity to be here today and provide my 
views on the urgent need for a major improvement in the 
capability of the U.S. Government to develop and acquire 
biomedical countermeasures that are needed to protect our 
citizens against bioterrorism.
    The experiences that I have more than 40 years of research 
and development in infectious diseases, including senior 
leadership positions in both the U.S. Army and HHS medical 
biodefense programs, has provided me with some insight into the 
deficiencies of our current programs and the urgent need for 
change.
    The successful development and licensure and utilization of 
several vaccines by the Walter Reed Army Institute of Research, 
including meningitis type C and type A--vaccines, unattenuated 
adenovirus type 4 and 7 vaccines, and hepatitis A vaccines, 
were made possible by several critical factors. First, a 
recognized need and adequate funding. Second, a strong internal 
research base including scientists capable of process 
development. An associated availability of a pilot-scale GMP 
manufacturing capability. Partnerships with large vaccine 
manufacturers, and clinical trial capability.
    Without these elements, those complex vaccine development 
programs would not have succeeded.
    Another vaccine, the leading malaria vaccine, now 
undergoing a final phase III trial in Africa, and a similar 
product--development program in partnership with GSK. 
Industrial partnership plus adequate funding from the Gates 
Foundation is critical to this important vaccine.
    The success of the military in developing vaccines against 
recruit camp diseases and natural disease threats has not been 
matched by success in developing medical countermeasures 
against biologic threat agents, although we have made enormous 
investments in basic research, notably in DARPA, and the NIH 
program, and the Centers of Excellence. We have not been able 
to translate the results of that research into new products 
licensed for use. This is in spite of the magnitude of the 
threat of bioterrorism and its potential devastating impacts on 
our Nation.
    The deficiencies of the DOD biodefense program, as well as 
regulative changes that have been outlined by several 
independent studies and reports over the past 2 decades 
beginning with the Tri-Service Task Force report in 1990. It 
included an independent study known as the--Report in 2001 and 
two Institute of Medicine studies, the last in 2004. The common 
themes of the recommendations in the reports were manufacturing 
capacity and the need for industrial capability.
    In HHS there is a similar problem. The gap between basic 
research and industrial development and manufacturing, is only 
partly felt by BARDA funding, that is dependent on an 
increasingly reluctant and fragile biotechnology industry. The 
very impressive results that HHS has had with influenza 
vaccines underlines two issues: capability that exists within 
the vaccine industry if properly utilized and the fact that 
vaccine manufacturing is increasingly moving overseas.
    The success of HHS's biodefense field is the very rapid 
development and licensure of ACAM 2000 smallpox vaccine. That 
was made possible by very solid funding from Congress, a 
partnership of the small developer with a large pharmaceutical 
manufacturer with bulk manufacturing capability in Europe and a 
strong capability in process development and regulatory 
affairs. Process development capability, as well as 
manufacturing capability and surge capacity, are necessary to 
provide the biologic products needed to counter the very real 
threat of bioterrorism. The best way to provide that capability 
within the context of a biodefense program is a facility 
designed and managed to be responsive to Government needs.

                           PREPARED STATEMENT

    A very important additional benefit would be the capability 
to develop and manufacture vaccines against emerging infectious 
diseases such as Rift Valley Fever, chikungunya, and 
hemorrhagic fever. That would be a very valuable contribution 
to global health and to medical diplomacy, as well as meet the 
response to something like the next SARS epidemic.
    Thank you for your time. I will be happy to answer 
questions.
    [The statement follows:]
                Prepared Statement of Philip K. Russell
    Good morning Senator Specter, thank you for the opportunity to 
appear here today and provide my views on the urgent need for 
improvement in the capability of the U.S. Government to develop and 
acquire biologic medical countermeasures needed to protect our citizens 
against bioterrorism. I am Dr. Philip Russell, a retired Army Medical 
Corps Major General. My medical specialty is infectious diseases and I 
have been involved in research and development for my entire medical 
career. For 2\1/2\ years following September 11, 2001, I served as a 
senior advisor to the Department of Health and Human Services (HHS). In 
that capacity I was deeply involved in the acquisition of medical 
countermeasures against smallpox, botulism, and anthrax, as well as the 
experimental H5N1 avian influenza vaccine. As Acting Director of the 
Office of Research and Development Coordination within the Office of 
the Assistant Secretary for Public Health Emergency Preparedness I was 
responsible for coordination of the initial purchases made under 
Project BioShield.
    During my military service, I served as Director of Walter Reed 
Army Institute of Research (WRAIR) and later as Commander of the U.S. 
Army Medical Research and Development Command. I was responsible for 
the management of the biodefense research and development program from 
1985 until 1990. As a research scientist and R&D manger, I was involved 
in the successful development of several licensed vaccines including 
meningitis, adenovirus and hepatitis A vaccines by the U.S. Army as 
well as the development of the ACAM 2000 smallpox vaccine. Through this 
experience I learned what is needed to move a potential new medical 
product from the laboratory through the development process to 
licensure, manufacturing and utilization.
    The successful development of several vaccines by WRAIR was made 
possible because of several critical factors:
  --A recognized need and adequate funding;
  --A strong internal research base including scientists capable of 
        process development;
  --Pilot-scale GMP manufacturing capability;
  --Partnerships with large vaccine manufacturers; and
  --Clinical trial capability.
    The success of the military in developing vaccines against recruit 
camp diseases and other natural disease threats, however, has not been 
matched by success in developing medical countermeasures against 
biological threat agents.
    The investment in basic science by the Department of Defense (DOD) 
through the service laboratories, notably the U.S. Army Medical 
Research Institute of Infectious Diseases (USAMRIID), by contractors, 
as well as the immense investment by NIH through its university Centers 
of Excellence, has produced a wealth of new technical opportunities for 
development of new and improved vaccines and therapeutics to counter 
the very real threat of bioterrorism. Yet in spite of the magnitude of 
the bioterror threat, neither DOD nor HHS has been very successful in 
moving potential products from the research laboratory to the field or 
to the national stockpile. We still mainly depend on products developed 
in the 1950's and 1960's for prevention of casualties while the results 
of research efforts by both the basic scientists and the biotechnology 
companies go largely undeveloped.
    Both DOD and HHS depend on product development through contracts 
with contractors that lack the experience, capabilities and resources 
of the large vaccine manufacturers. The large manufacturers have shown 
little interest in the high-risk, low-volume, and low-profit medical 
countermeasures needed to combat bioterrorism.
    Several studies of the DOD program have detailed the weaknesses 
inherent in the current approach. In 1990, a DOD task force entitled 
Project Badger (``Tri-Service Task Force for the Expansion of the 
Industrial Base for Production of Biological Defense Vaccines'') 
analyzed the shortage of medical countermeasures for anticipated 
threats.\1\ Continuing concerns over the lack of a stable pipeline of 
medical countermeasures to protect troops led to the creation of 
another task force to focus on assessing the need for a Vaccine 
Production Facility (VPF). This additional task force was to determine 
a solution for DOD biodefense medical countermeasure manufacturing.
---------------------------------------------------------------------------
    \1\ Chronology of Project Badger (Long Term). October 24, 1990. 
CMAT Control # 1998337-0000036.
---------------------------------------------------------------------------
    In 1993, this VPF task force recommended a Government-owned, 
contractor-operated (GOCO) facility that could manufacture a variety of 
medicines and could surge production in times of crisis.\2\ The task 
force recommendation reflected the view that the private sector lacked 
the means to provide medical countermeasures to the military on its own 
without adequate incentives. The choice of a GOCO model also reflected 
a then common DOD acquisition strategy to procure military equipment 
(e.g., ammunition, tanks) from GOCO facilities. A high-level conceptual 
design of the facility proposed by the task force was also 
completed.\3\ At the time of the recommendation DOD concluded that the 
VPF concept was too costly to implement.
---------------------------------------------------------------------------
    \2\ DOD Vaccine Production Facility Task Force Final Report, U.S. 
Department of Defense, 1991 (draft), 1993.
    \3\ DOD Vaccine Production Facility. LF-0445.00. Conceptual Design 
Submittal. Life Sciences International. November 27, 1993.
---------------------------------------------------------------------------
    DOD vaccine acquisition strategy then evolved to a prime systems 
contractor approach, one in which a single contractor is dedicated to 
the development and licensure of biologic products. This was executed 
in anticipation of the biopharmaceutical industry ultimately supporting 
DOD production requirements. Over time, however, very little commercial 
interest in producing biodefense medical countermeasures emerged, thus 
DOD still had no assurance that existing producers would provide 
vaccines and novel medical countermeasures.
    Consequently, the prime systems contractor approach proved 
insufficient. Biopharmaceutical companies were discouraged from medical 
countermeasure development by such factors as low profit margins, the 
risk of liability for adverse reactions to the products, marginal 
Federal funding for medical countermeasure programs, and inconsistent 
U.S. Government priorities for product acquisition. Examples of that 
troubled process include the loss of availability of Wyeth 
Laboratories' adenovirus vaccine in 1996, which caused an increase of 
respiratory disease in military trainees; the loss of the Greer 
Laboratories' plague vaccine in 1997, which had proven extremely 
effective in Vietnam against bubonic plague; and temporary loss of 
Bioport's (now Emergent Biosolutions) anthrax vaccine in 1997.
    In July 2001, a study by an independent panel of experts provided 
the Report on Biological Warfare Defense Vaccine Research and 
Development Programs to the Deputy Secretary of Defense.\4\ The report 
recommended the overhaul of DOD biodefense program management and the 
construction of a GOCO VPF, advising integration with the industry and 
the national scientific community. The recommendations in the report 
were not implemented.
---------------------------------------------------------------------------
    \4\ Report on Biological Warfare Defense Vaccine Research and 
Development Programs.
---------------------------------------------------------------------------
    In 2004, the Institute of Medicine and National Research Council of 
the National Academies completed a report critical of DOD's efforts in 
developing drugs and vaccines against biological agents.\5\ This 
report, entitled Giving Full Measure to Countermeasures describes the 
substantial efforts to develop new drugs, vaccines, and other medical 
interventions against biological agents and made recommendations for 
major revisions in the structure of the DOD effort including the 
creation of a new agency within the Office of the Secretary of DOD. 
This subcommittee recognized the problems inherent in developing and 
manufacturing medical countermeasures and the need for major changes.
---------------------------------------------------------------------------
    \5\ Giving Full Measure to Countermeasures: Addressing Problems in 
the DoD Program to Develop Medical Countermeasures Against Biological 
Warfare Agents. Authors: Lois M. Joellenbeck, Jane S. Durch, and Leslie 
Z. Benet, Editors, Committee on Accelerating the Research, Development, 
and Acquisition of Medical Countermeasures Against Biological Warfare 
Agents, National Research Council.
---------------------------------------------------------------------------
    Major progress has been made in recent years by HHS' Biomedical 
Advanced Research and Development Authority (BARDA) through the use of 
the special appropriations for Project Bioshield and for influenza 
preparedness. The success of the influenza vaccine program managed by 
BARDA underlines the critical importance of industrial partners with 
vaccine development and manufacturing experience. Influenza, however, 
is a special case with significant market incentives due to an 
expanding annual market.
    It is very clear from reviewing the progress made in the past two 
decades and the several pertinent reports from independent reviews that 
major changes are needed to provide the protection the country needs 
from a bioterrorist attack. It is also very clear that the threat is 
very real and the countermeasures currently in the stockpile will be 
insufficient to provide the protection that would be made possible by 
an effective product development effort making maximum use of recent 
and future scientific advances in the field.
    A Government-funded capability to carry out process development, 
pilot manufacturing as well as surge manufacturing capacity would be 
immensely valuable and would remove the present bottleneck in 
development of medical countermeasures. Industrial experience in 
process development and biomanufacturing must be incorporated into any 
proposed facility. In addition, a proposed facility should take 
advantage of advances in manufacturing technology to achieve maximum 
flexibility and surge production capability.
    A Government-controlled capability to develop and manufacture 
biologics for defense against bioterrorism could also provide a very 
important capacity to make vaccines against emerging infectious 
diseases such as Rift Valley Fever, chikungunya and hemorrhagic fevers 
for both emergency use and as an important medical diplomacy option. 
This could be a very important ancillary role.
    I appreciate the invitation to discuss these issues and will be 
happy to take questions.

    Senator Specter. Thank you very much, Dr. Russell.
    Our next witness is Dr. Philip Gomez, the Director of PRTM 
Management Consultants and President of the 21st Century 
Biodefense Industry. He holds a bachelor degree from Dartmouth, 
a master of science and doctor of philosophy from Lehigh, and 
an MBA from the University of Maryland. We appreciate your 
joining us here today, Dr. Gomez, and we look forward to your 
testimony.
STATEMENT OF PHILIP GOMEZ, Ph.D., DIRECTOR, BIODEFENSE 
            AND PUBLIC HEALTH PRACTICE, PRTM MANAGEMENT 
            CONSULTANTS, WASHINGTON, DC
    Dr. Gomez. Thank you, Senator Specter, and thank you, 
Congressman Altmire, for the opportunity to speak here today. 
As I described in my written testimony, I had the privilege of 
working in the private sector for nearly 10 years and then 
working at the NIH on vaccine development for nearly 7 years. 
So I hope my perspectives will be helpful in this discussion 
today.
    I have been working with UPMC for almost 2 years now in 
examining this problem and greatly have been impressed and 
thank UPMC for taking the leadership on this important issue.
    What I will describe today is my support of a study that 
was sponsored in a cooperative agreement with the Defense 
Advanced Research Projects Agency, DARPA, which UPMC conducted 
with a variety of experts on that team to perform that study.
    The current U.S. Government procurement model relies on 
industry to development biodefense countermeasures through the 
Food and Drug Administration (FDA) licensure, followed by 
procurement on a product-by-product basis as products become 
available. This is an incremental approach, whereby the 
Government identifies the highest priority threats and then 
issues an RFP to purchase doses. History has shown, however, 
that in lieu of the participation of large, well-established 
pharmaceutical companies, the advanced development and 
manufacture falls on the academic laboratories and innovative 
small biotech companies that perform the initial research and 
development of the product. Lacking extensive experience, 
infrastructure, and resources, these laboratories and smaller 
companies face extraordinary challenges moving candidate 
medical countermeasures successfully through advanced 
development that includes both clinical trials and the complex 
time-consuming and costly licensure process. Because of the 
limited investment in advanced development, the current 
Government approach in biodefense has yielded few successes of 
novel drugs or vaccines.
    The UPMC study analyzed the feasibility and potential 
technical and economic advantages of building capabilities for 
advanced development and manufacture of biologics for the 
Government. A key finding was that the Government demand does 
exist for these countermeasures that have yet to be developed. 
Although some countermeasures have substantial requirements 
that have already been procured, for example, anthrax vaccine, 
therapeutics, and the smallpox vaccine discussed, most of the 
countermeasures needed for national security require much 
smaller quantities, especially when compared with the demand 
needed for commercial drugs or vaccines that you highlighted, 
Senator. Because these lower volume countermeasures have no 
viable commercial market, unlike flu, as Dr. Gellin reported, 
it is left to these smaller biotechnology companies to license 
and produce them over the long term.
    Although the Government has had a need for many different 
biologics, there is only a limited number of core suitable 
manufacturing technologies to actually produce them. This now, 
for the first time, technologically allows us to incorporate 
these core technologies in flexible, multi-product development 
and manufacturing capability. And we believe in the study this 
would greatly reduce the cost and other constraints, enabling 
the manufacture of medical countermeasures for both stockpiling 
and, most importantly, surge production.
    Implementation of this approach can be pursued via one of 
many options for structuring and operating the capability. 
These options range from a wholly private sector approach, a 
contractor-owned and operated entity, to a wholly public sector 
approach; i.e., the Government could own and operate an entity. 
Our study concluded that combining the Government and private 
sector resources would significantly reduce the long-term costs 
and the technical and strategic risks commonly associated with 
licensing and producing required medical countermeasures in a 
dedicated capability.
    The UPMC study included an industry outreach to determine 
the factors necessary to encourage industry participation in 
medical countermeasure development. The results of this 
outreach indicated a preference for operating models that 
enhance collaboration among all stakeholders, with the most 
support aligned behind those models that include elements of 
collocation of advanced development with manufacturing. This is 
a very important point. Our study started with manufacturing 
but quickly realized that advanced development, the process of 
getting ready for FDA licensure, was a very critical aspect 
that could not be ignored and only from the analysis.
    Successful procurement requires the participation of both 
biodefense innovators and experienced biopharmaceutical firms. 
Biopharmaceutical firms have the experience, but have avoided 
the U.S. Government medical countermeasure market because of 
its perceived low profitability and high risk. They also cite a 
critical shortage of scientists and engineers to work in this 
field and that they cannot afford to assign these valuable 
individuals to noncommercial projects. Therefore, a successful 
dedicated capability would leverage the development expertise 
of experienced biopharma while retaining the innovation of 
small biotech companies and other innovators. It must also 
focus on training the next generation of scientists and 
engineers to develop the new drugs that NIH research so capably 
supports. To succeed, it is critical that the U.S. Government 
demonstrate a long-term fiscal commitment to medical 
countermeasure development and procurement so all industry 
partners have the economic incentive to become and remain 
engaged.
    The major conclusion of the study was that a flexible, 
multi-product capability to accomplish advanced development and 
production of biologic countermeasures would offer numerous 
scientific, technical, economic, and strategic benefits not 
provided by the current system. Operated as a public/private 
partnership, a capability supporting both advanced development 
and manufacturing would provide the Nation with a much-needed 
expansion of its domestic industrial base for vaccines and 
therapeutics. In addition, it would streamline the 
effectiveness of advanced development while simultaneously 
reducing technological risk. Analysis suggests that such a 
capability would also significantly lower the Government's 
costs of acquisition while enabling the Nation's first domestic 
flexible surge production capability for both CBRN and 
noncommercial public health threats.

                           PREPARED STATEMENT

    Finally, in my view, it is important that the job of 
executing this concept be awarded through a competitive 
process. This will ensure the best-qualified coalition of 
private sector partners is brought to bear in helping the U.S. 
Government meet this important challenge.
    Thank you for your support in highlighting these national 
security and public health needs at this time. I would be 
pleased to answer any questions you may have.
    [The statement follows:]
                   Prepared Statement of Philip Gomez
    Mr. Chairman, Ranking Member, Senator Specter and other 
distinguished members of the subcommittee, I thank you for the 
opportunity to discuss the Nation's capabilities in the area of 
biologics development and manufacturing. Senator Specter, I appreciate 
your leadership and focus on this issue, and hope my testimony will be 
informative.
    I have been fortunate to work for more than 15 years as a 
biochemical engineer bringing drugs and biologics to market, both in 
industry and the U.S. Government. I hold a Bachelor of Arts from 
Dartmouth College in Engineering Science, a Master of Science and 
Doctor of Philosophy in Chemical Engineering from Lehigh University, 
and a Master of Business Administration from the Smith School of 
Business at the University of Maryland.
    I am currently a Director at PRTM Management Consultants, where I 
work in the field of drug development, helping clients develop 
operational strategies for successfully developing and manufacturing 
biologics. Previously, I was employed at the Vaccine Research Center at 
NIAID/National Institutes of Health (NIH), where I established the 
Vaccine Production Program Laboratory in 2001. My laboratory developed 
the Vaccine Pilot Plant for production of vaccines for clinical trials. 
During my 6 years at NIH, my laboratory oversaw the manufacturing of 
more than 40 bulk pharmaceutical compounds and more than 15 candidate 
vaccines utilizing innovative collaborations with industry to advance 
the development of vaccines against HIV, Ebola, Marburg, West Nile 
Virus, SARS, and influenza. In 2007, I was awarded the NIH Director's 
Award for the establishment of the Vaccine Pilot Plant and rapid 
production of a pandemic influenza vaccine.
    Prior to NIH, I spent nearly a decade in the pharmaceutical 
industry at Abbott Laboratories, Sanofi Pasteur, and Baxter Healthcare 
in positions of increasing responsibility, leading process/product 
development organizations and project teams for multiple biologics.
    In industry, I saw first-hand the enormous benefits that can flow 
when the public and private sectors collaborate to address the need for 
vaccines like meningitis and influenza, and I believe in areas like 
biodefense, these partnerships can play a critical role in enabling the 
development and production of new vaccines and drugs. I believe this 
combination of NIH and industry experience qualifies me to participate 
in this hearing and contribute uniquely to this discussion.
    For nearly 2 years, I have been working under contract for UPMC as 
it has examined the challenge of vaccine and biologics development and 
procurement for biodefense, and as it has sought to identify options 
for addressing that challenge. Medical countermeasures are needed to 
protect military and civilian populations against chemical, biological, 
radiological, and nuclear (CBRN) attacks and naturally occurring 
emerging infectious diseases. As part of my work, I was assigned to 
assist UPMC in conducting a Defense Advanced Research Projects Agency 
(DARPA) sponsored study, which examined the U.S. Government's ability 
to rapidly develop, license, and manufacture biologics required by the 
Department of Health and Human Services and the Department of Defense. 
The study was performed under a Cooperative Agreement with UPMC and 
DARPA. DARPA is currently reviewing the final report and has therefore 
not yet released the full report to the public. However, I am pleased 
to provide a high-level overview of the scope and findings of the study 
as submitted. Please keep in mind that the study content does not 
necessarily represent the position or the policy of the U.S. 
Government, and no Government endorsement should be inferred.
    The current U.S. Government procurement model relies on industry to 
develop biodefense countermeasures through Food and Drug Administration 
(FDA) licensure, followed by procurement on a product-by-product basis 
as products become available. This is an incremental approach, whereby 
the Government identifies the highest priority threats and then issues 
a request for proposal to purchase doses. History has shown, however, 
that in lieu of the participation of large well-established 
pharmaceutical companies, the advanced development and manufacture 
falls on the academic laboratories and innovative small biotech 
companies that performed the initial research and development of the 
product. Lacking extensive experience, infrastructure, and resources, 
these laboratories and smaller companies face extraordinary challenges 
moving candidate medical countermeasures successfully through advanced 
development that includes both clinical trials and the complex, time-
consuming, and costly licensure process. Because of limited investment 
in advanced development, the current Government approach in biodefense 
has yielded few successes for novel drugs or vaccines.
    The UPMC study analyzed the feasibility and potential technical and 
economic advantages of building capabilities for advanced development 
and manufacture of biologics for the Government. A key finding was that 
Government demand exists for CBRN biologic countermeasures that have 
yet to be developed. Although some countermeasures have substantial 
requirements that have already been procured (e.g., anthrax vaccine and 
therapies, smallpox vaccine), most countermeasures needed for national 
security require small quantities when compared to quantities needed to 
fulfill the demand for a commercial drug or vaccine.
    Because these lower volume countermeasures have no viable 
commercial market, it is left to the small biotech companies to 
develop, license, and produce them over the long term.
    Although the Government has a need for many different biologics, 
there is only a limited number of core technologies suitable for 
manufacturing them. Incorporation of these core technologies in a 
flexible, multi-product, development and manufacturing capability would 
reduce cost and other constraints, enabling the manufacture of medical 
countermeasures for both stockpiling and surge production purposes. 
Recent technological advances in disposable manufacturing equipment and 
associated changes in the regulatory environment have greatly enhanced 
prospects for a multi-product capability by both reducing the overall 
capital costs and the time necessary to change over from producing one 
biologic to another. It also provides additional production capacity 
with reduced technical and strategic risks.
    Implementation of this approach can be pursued via one of many 
options for structuring and operating the capability. These options 
range from a wholly private sector approach (i.e., a contractor-owned 
and -operated entity) to a wholly public sector approach (i.e., a 
Government-owned and operated entity). The study concluded that 
combining Government and private sector resources would significantly 
reduce long-term costs and the technical and strategic risks commonly 
associated with licensing and producing required medical 
countermeasures in a dedicated capability.
    The UPMC study included an industry outreach to determine the 
factors necessary to encourage industry participation in medical 
countermeasure development. The results of this outreach indicated a 
preference for operating models that enhance collaboration among all 
stakeholders, with the most support aligned behind those models that 
include the element of co-location of advanced development with 
manufacturing. Successful procurement requires the participation of 
both biodefense innovators and experienced biopharmaceutical firms.
    Biodefense innovators have researched promising early stage medical 
countermeasure candidates, yet they often lack the advanced development 
expertise to produce FDA-approved products. Biopharmaceutical firms 
have this expertise, but have avoided the U.S. Government medical 
countermeasure market because of perceived low profitability and high 
risk. They also cite a critical shortage in scientists and engineers to 
work in this field, and that they cannot afford to assign these 
valuable individuals to noncommercial projects. Therefore, a successful 
dedicated capability would leverage the development expertise of 
experienced biopharma interests, while retaining the innovation of 
small biotech companies and other innovators. It must also focus on 
training the next generation of scientists and engineers to develop the 
new drugs that NIH research so capably supports. To succeed, it is 
critical that the U.S. Government demonstrate a long-term fiscal 
commitment to medical countermeasure development and procurement so all 
industry partners have the economic incentive to become and remain 
engaged.
    The major conclusion of the study was that a flexible, multi-
product capability to accomplish advanced development and production of 
biologic countermeasures would offer numerous scientific, 
technological, economic and strategic benefits not provided by the 
current system. Operated as a public-private partnership, a capability 
supporting both advanced development and manufacturing would provide 
the Nation with a much-needed expansion of its domestic industrial base 
for vaccines and therapeutics. In addition, it would streamline the 
effectiveness of advanced development while simultaneously reducing 
technological risk.
    Analysis suggests that such a capability would also significantly 
lower the Government's cost of acquisition while establishing the 
Nation's first domestic, flexible, surge production capability for both 
CBRN and noncommercial public health threats.
    Finally, in my view, it is important that the job of executing this 
concept be awarded through a competitive process. This will ensure the 
best-qualified coalition of private sector partners is brought to bear 
in helping the U.S. Government meet this important challenge.
    Thank you for your support in highlighting these national security 
and public health needs at this time. I would be pleased to answer any 
questions you may have.

    Senator Specter. Thank you, Dr. Gomez.
    We now turn to Dr. Donald S. Burke, Dean of the Graduate 
School of Public Health, and Director of the Center for Vaccine 
Research, and Associate Vice Chancellor for Global Health at 
the University of Pittsburgh. First occupant of the UPMC Jonas 
Salk Chair in Global Health. Bachelor degree from Western 
Reserve University and M.D. from Harvard Medical School.
    Thank you for coming in today, Dr. Burke, and the floor is 
yours.
STATEMENT OF DONALD S. BURKE, M.D., DEAN, GRADUATE 
            SCHOOL OF PUBLIC HEALTH; ASSOCIATE SENIOR 
            VICE CHANCELLOR FOR GLOBAL HEALTH; 
            DIRECTOR, CENTER FOR VACCINE RESEARCH, 
            UNIVERSITY OF PITTSBURGH, PITTSBURGH, 
            PENNSYLVANIA
    Dr. Burke. Senator Specter and Congressman Altmire, thank 
you for the opportunity to discuss the pressing needs of the 
U.S. Government to find a better way to develop and produce 
countermeasures for our country's health security.
    And Senator Specter, on behalf of health scientists and 
patients here in Pittsburgh and around the Nation, I also thank 
you for your extraordinary efforts to provide increased funding 
for biomedical research through the NIH.
    Senator Specter. Thank you.
    Dr. Burke. I currently serve as the UPMC Jonas Salk Chair 
on Global Health and work at the Center for Vaccine Research. 
In every research setting in which I have worked, I have 
witnessed personally the difficulty of translation of advances 
in basic scientific research into medical products.
    The University of Pittsburgh is committed to joining with 
UPMC and other partners in developing a flexible, multi-product 
vaccine facility, and indeed, the university could bring 
exceptional strengths to this partnership. As you know, the 
University of Pittsburgh has a long and proud tradition of 
vaccine research, dating back to Jonas Salk's extraordinary 
achievements in development of the polio vaccine.
    The Center for Vaccine Research that I direct is evidence 
of the university's resurgent excellence in the field of 
vaccines. The establishment of the center was made possible by 
a $10 million contribution by UPMC, a visionary step toward 
this process we are engaged in now. It is housed on two floors 
of the new, state-of-the-art biomedical science tower. We have 
31 full-time and affiliate doctoral-level research academics 
and occupy 32,000 square feet of laboratory space. We also have 
a regional biocontainment laboratory, a high containment 
facility that was constructed with NIH support. This lab is 
designed to permit research on vaccine development for avian 
influenza and swine influenza, tuberculosis, dengue, tularemia, 
and other highly infectious disease threats.
    The Pittsburgh Regional Biocontainment Laboratory at our 
university also serves as a core laboratory for the NIH-
supported Regional Centers of Excellence for Biodefense. This 
laboratory houses the animal model core for the Mid-Atlantic 
Regional Center of Excellence and Biosafety Level 3 
laboratories in one facility and supports a full spectrum of 
investigations from basic microbiological and immunological 
manipulations to animal challenge studies.
    Another strength here in Pittsburgh is our leadership in 
developing and using computational modeling simulations to 
optimize vaccine development and deployment strategies. 
Recently the university was recognized as one of two NIH 
National Centers of Excellence for modeling of infectious 
diseases to serve the country.
    We also serve as the home to the Vaccine Modeling 
Initiative which is supported by the Bill and Melinda Gates 
Foundation.
    Pitt also has an excellent research and training 
collaboration between the School of Medicine and the School of 
Engineering, especially as related to the design and production 
of medical devices and more recently the development of novel 
biomanufacturing processes. These interdisciplinary medical-
engineering programs create a unique environment for academic 
consultations and training of biotechnology personnel related 
to vaccine design and manufacturing.
    Thus, the University of Pittsburgh today demonstrates 
excellence in many disciplines that are critical in vaccine 
research. However, university professors who conduct early 
preclinical and clinical stage research are not able to bring 
the candidate product all the way to licensure on their own. 
Product development, as opposed to basic discovery, requires a 
different set of skills and expertise, and this product 
development expertise resides primarily within large 
biopharmaceutical companies whose business it is to bring drugs 
and vaccine discoveries from the lab to the consumer market.

                           PREPARED STATEMENT

    The formation of a public/private partnership such as UPMC 
is proposing is the only real alternative that has the 
possibility of success in fixing the critical problem that has 
faced our Nation for many years. The University of Pittsburgh 
with its outstanding research and training capacities stands 
ready to support these public/private partnerships.
    Thank you very much.
    [The statement follows:]
                 Prepared Statement of Donald S. Burke
    Mr. Chairman, Ranking Member, Senator Specter, and other esteemed 
subcommittee members and staff, thank you for the opportunity to 
discuss the pressing need for the U.S. Government to find a better way 
to develop and produce biologic medical countermeasures for our 
country's health security. This endeavor represents a key component in 
the larger biodefense and public health framework and will certainly 
help ensure a safer and more resilient America. And on behalf of health 
scientists here in Pittsburgh and around the Nation, I also thank you 
for your extraordinary efforts to provide increased funding for 
biomedical research through the National Institutes of Health (NIH).
    I am a physician, an infectious disease expert, an epidemiologist, 
and vaccine researcher. I have worked on prevention and control of 
epidemic infectious diseases for my entire career. Previously, I served 
23 years on active duty in the U.S. Army, including service as the 
Associate Director for Emerging Threats and Biotechnology at Walter 
Reed Institute of Research (WRAIR). I currently serve as the Director 
of the University of Pittsburgh's Center for Vaccine Research. In every 
research setting, I have witnessed the difficulty in translation of 
advances in basic scientific research into medical products to protect 
people from serious health threats. I am here today to discuss the 
exciting idea of a new facility to solve this pressing national 
problem.
    As you are aware, the first step in producing any effective drug to 
counter a bioweapon or epidemic begins in the research lab. Initial 
research and testing, if successful, then requires the crucial step of 
applied research. Translational research is a term used to describe the 
process by which a drug or vaccine candidate moves from early basic 
research, through the various stages of development, and eventually 
into a licensed product.
    Both the NIH and Department of Defense (DOD) have made tremendous 
investments in basic research, with significant progress achieved in 
understanding disease threats, and identifying potential drugs and 
vaccines to mitigate their impact. Although there have been remarkable 
advances in the diagnosis and treatment of many medical conditions, 
infectious diseases remain the leading cause of deaths worldwide. Few 
discoveries in biomedical research are as important as those that 
revolve around vaccines for infectious agents that pose risks to global 
public health and global security.
    The University of Pittsburgh is committed to joining with UPMC and 
other partners in developing a flexible multi-product vaccine facility, 
and indeed the University brings exceptional strengths to that 
partnership. Out of more than 3,000 institutions nationwide, Pitt now 
ranks fifth in NIH funding and fifth in the number of individual grants 
received. Last year the University and its affiliates received more 
than $450 million in NIH support.
    The Center for Vaccine Research (CVR) that I direct is evidence of 
the University's growing excellence in the field of vaccines. The 
Center is housed on two floors of the new, state-of-the-art biomedical 
science tower. The CVR consists of the research teams of 31 full-time 
and affiliate doctoral level researchers, and occupies 32,000 square 
feet of laboratory space. A key component is the Pittsburgh Regional 
Biocontainment Lab, a high-containment facility that was constructed 
with NIH support. This lab is designed to permit research on vaccine 
development for avian influenza and swine influenza, tuberculosis, 
dengue, tularemia, and other highly infectious disease threats.
    The Pittsburgh Regional Biocontaiment Lab (RBL) also serves as a 
core laboratory for the NIH-supported Regional Centers of Excellence 
for Biodefense. The RBL houses the nonhuman primate core of Mid-
Atlantic RCE and Biosafety Level 3 (BSL3) research labs on a single 
floor, thus supporting a full spectrum of investigations from basic 
microbiological and immunological manipulations to animal challenge 
studies.
    We have also gained national recognition for our exceptional 
collaborations between the School of Medicine and the School of 
Engineering, especially as related to the design and production of 
medical devices and more recently to the development of novel bio-
manufacturing processes. These internal collaboration have been further 
enhanced by inclusion of engineering faculty from Carnegie Mellon 
University. We have NIH training grants for the Medical Scientist 
Training Program (MD/Ph.D.) and for biotechnology, the latter focused 
on vaccine development with the CVR. These interdisciplinary medical-
engineering programs create a unique environment for academic 
consultations and training of biotechnology personnel related to 
vaccine design and manufacturing.
    Those performing early clinical stage research such as is done in 
the CVR are typically not able to bring a product candidate all the way 
to licensure on their own. Discovery and development require different 
expertise. Product development expertise resides primarily with large 
biopharmaceutical companies whose business it is to bring drugs and 
vaccines all the way from lab to the consumer market. However, because 
most biodefense products are noncommercial by nature, there is no 
market-based incentive for biopharmaceutical companies to pursue their 
development and they have accordingly been reluctant to engage.
    As products are developed and brought into early human clinical 
testing by the NIH or DOD there currently is not a clear path to 
licensure and procurement for the U.S. Government. Despite attempts by 
the U.S. Government to attract experienced biopharmaceutical companies 
to the process, few have entered.
    For this reason, commercial partnering with the U.S. Government is 
essential to bringing biologic medical countermeasure candidates to 
full licensure. Without such a partnership, only the biopharmaceutical 
industry retains the ability and know-how for scaling production levels 
of biologics up to required levels. Larger biopharmaceutical companies 
possessing this experience and expertise in advanced development must 
be incentivized to engage if the U.S. Government wants to fulfill its 
biodefense requirements.
    It is clear that given the lack of commercial incentives for these 
products, we cannot expect industry to enter alone. The formation of a 
public-private partnership between industry and the USG is the only 
alternative that has the real possibility of success in fixing a 
challenges that has been at the DOD and HHS for many years, one that I 
have personally encountered. I encourage the subcommittee and the 
Government to continue to develop this concept, and ultimately compete 
it implementation to ensure the best and most current ideas are 
incorporated.

    Senator Specter. Thank you very much, Dr. Burke.
    Our final witness is Dr. Nigel Darby, Vice President, 
Biotechnologies and Chief Technology Officer at GE Life 
Sciences. These products are used in the manufacturing of more 
than 90 percent of registered biopharmaceutical products. He 
has been the Vice President for Chemistry Technology at Astra 
Zeneca, 16 years in academic research in medicine and molecular 
biology. He has a master's degree in natural science from the 
University of Cambridge, UK, in 1981 and a Ph.D. in 
biochemistry from the University of Kent in 1985.
    Thank you for coming in today, Dr. Darby, and we look 
forward to your testimony.
STATEMENT OF NIGEL DARBY, Ph.D., VICE PRESIDENT, 
            BIOTECHNOLOGIES, LIFE SCIENCES, GE 
            HEALTHCARE BIO-SCIENCES AB, UPPSALA, SWEDEN
    Dr. Darby. Thank you. Senator Specter, Congressman Altmire, 
firstly, thank you for the opportunity to testify today.
    GE Healthcare provides much of the technology which is used 
in the discovery and manufacturing of lifesaving 
pharmaceuticals. Relevant to the testimony today, as you just 
mentioned, GE provides the technology which is used in the 
manufacturing of more than 90 percent of registered 
biopharmaceuticals and many vaccines.
    Now, we have heard today from our colleagues about the 
importance of manufacturing biological countermeasures such as 
vaccines in response to biological threats. I am here today to 
outline the current state of the technologies used to 
manufacture these countermeasures and the importance in 
developing a partnership between the public and the private 
sector to deploy these technologies to provide an effective 
response to future biological threats.
    Any manufacturing solution addressing biological threats 
needs to address four key issues which relate to the 
development of countermeasures: quality, safety, flexibility, 
and speed. I will briefly address the primary considerations 
about each of these areas.
    Traditional manufacturing facilities for biopharmaceuticals 
and vaccines are, indeed, expensive. There are often 
constructed from ``hard-plumbed,'' permanent, stainless steel 
technology and they are dedicated to a single product. They can 
cost up to $1 billion to construct and take up to 5 years to 
build and validate. Between manufacturing runs in these 
facilities, the equipment must be extensively cleaned and 
tested to ensure that there is no contamination, a time-
consuming and costly process reducing productivity but ensuring 
the safety of the final end product.
    So how do you go about achieving some more flexibility? 
Clearly, a $1 billion biological countermeasure production 
facility dedicated to a single biological threat is not a 
viable response to a threat which is as yet not well-defined. 
Recent advances in developments in biomanufacturing, however, 
mean that we can design more flexible facilities that can 
manufacture a number of medicines and still retain the quality 
and safety profiles of traditional facilities and, in addition, 
achieve this at a lower cost and with improved efficiency.
    New developments are allowing us to replace the traditional 
stainless steel manufacturing technology with disposable 
plastic technologies. These allow us to rapidly reconfigure the 
manufacturing process, using off-the-shelf, ready-to-use 
components. After a manufacturing run, components are simply 
discarded and a new set installed for the next manufacturing 
cycle. Expensive cleaning and validation processes required in 
traditional facilities are significantly reduced, improving the 
facility productivity substantially, but retaining the overall 
level of safety in manufacturing.
    The use of this disposable technology improves 
manufacturing safety. It reduces contamination risk and 
increases the outputs of the facility, and that adds the 
crucial element of flexibility. It also reduces the capital 
expenditure and lowers the start-up costs.
    If we turn to speed, in a pandemic or biological attack, 
reaction time inevitably must be short. Preparedness, 
therefore, should focus on solutions that deliver a 
significantly more likely response. Disposable, ready-to-use 
manufacturing technologies bring unprecedented speed to both 
the development and manufacturing of biopharmaceuticals and 
vaccines. In collaboration with the vaccine developer, we have 
demonstrated that disposable technologies can reduce the time 
it takes to get a flu vaccine into production by up to 60 
percent.
    In summary, then our four critical manufacturing 
challenges--safety, quality, flexibility, and speed--can be 
addressed by implementation of the new disposable manufacturing 
technologies being developed by GE and our industry peers. 
Virtually all manufacturing steps required can be carried out 
with disposables.
    While currently not capable of achieving the manufacturing 
scales of the largest fixed stainless steel installations, the 
technology is evolving rapidly enough to deliver significant 
volumes of therapeutic agents and vaccines in a safe and timely 
manner.

                           PREPARED STATEMENT

    In conclusion, biopharmaceutical and vaccine manufacturing 
technology is at an exciting and important point in its 
development. What we now need at this point is a commitment 
from Government to help bring these technologies to the 
forefront at a time when we have the capacity to do so and when 
the need has never been greater. We believe this presents a 
unique opportunity for the public and the private sector to 
come together and ensure that these critical technologies can 
be in place to deal with the threats of biological agents which 
we face potentially in the near future.
    That concludes the testimony that I have. Once more, thank 
you for allowing me to participate today, and I welcome any 
questions that you have. Thank you.
    [The statement follows:]
                   Prepared Statement of Nigel Darby
    Chairman Specter, distinguished guests, thank you for your 
attention to the important issue before us today. My name is Dr. Nigel 
Darby. I am the Vice President for BioTechnologies of GE Healthcare's 
Life Sciences division and have worked extensively in the 
pharmaceutical and biotechnology industries, both as an executive and 
in research and development. Today I manage a large product portfolio 
of tools and technologies that support research, discovery and drug and 
biopharmaceutical manufacturing.
    Prior to entering industry, I spent 16 years in academic research 
in medicine and molecular biology at the National Institute for Medical 
Research in London, the M.R.C. Laboratory of Molecular Biology, 
Cambridge and at the European Molecular Biology Laboratory in 
Heidelberg, Germany. I have an M.A. in Natural Sciences from the 
University of Cambridge and a Ph.D. in biochemistry from the University 
of Kent in the UK.
    GE Healthcare provides much of the technology used in the discovery 
and manufacturing of pharmaceuticals. Most relevant today is our 
expertise in manufacturing of biopharmaceuticals and vaccines. 
Biopharmaceuticals are drugs such as insulin and monoclonal antibodies, 
often based on proteins, and are among the most rapidly growing groups 
of medicines today. More than 90 percent of registered 
biopharmaceuticals and many vaccines rely on GE-developed technologies 
or processes for their manufacture.
    We have heard a lot today about the risk and the threats biological 
weapons and pandemics pose to national security and the necessity to 
develop and manufacture biological countermeasures. I am here to 
outline the current state of the relevant manufacturing technology that 
can be brought to bear on these threats, the key issues that need to be 
addressed, and how that technology is evolving.
    Any technological solution addressing biological threats, whether 
natural outbreaks or terrorist actions, needs to address four key 
issues in manufacturing biological countermeasures: quality and safety, 
flexibility, and speed.
                           quality and safety
    For reasons of patient safety, quality and consistency in 
pharmaceutical manufacturing is critical and this is particularly the 
case for biopharmaceuticals and vaccines. These are complex medicines, 
usually produced in biological systems, such as cell culture, and they 
require a series of purification steps to deliver a safe end product. 
The quality and safety of the end product is assured by robust control 
and validation of the manufacturing process. The aim is to deliver as 
reproducible a process as possible and to exclude all possible sources 
of contamination.
    Biopharmaceutical and vaccine manufacturing requires established, 
validated equipment and highly skilled, fully trained individuals to 
perform the procedures. Production must meet standards as set out by 
FDA approval guidelines and ISO standards, including complying with 
cGMP biocontainment requirements for aseptic production, and biosafety 
regulations. These standards must be maintained throughout all stages 
of the development process to ensure that the product remains the same 
and retains high quality. Development of systems and standard operating 
procedures are vital to promote stability, reduce costs, and ensure 
quality.
    Traditional manufacturing facilities for biopharmaceuticals and 
vaccines are expensive, partly, and rightly, because of the time and 
effort spent controlling the facility's environment, the cleaning and 
maintenance required to avoid contamination of the end product. These 
are often `hard-plumbed' stainless steel facilities, dedicated to a 
single product, and can cost up to $1 billion and take 5 years to build 
and validate. Between manufacturing runs, the equipment must be 
extensively cleaned and tested to ensure there is no contamination; a 
time-consuming and expensive process.
    While reasonable for mainstream commercial pharmaceuticals and 
vaccines, where volumes are high and demand is predictable, a billion 
dollar biological countermeasure production facility dedicated to a 
single biological threat is not a viable response to an as-yet 
nonspecific threat. Recent developments in bio-manufacturing mean we 
can design flexible facilities that can manufacture a number of 
medicines and vaccines and yet retain the quality and safety profiles 
of traditional facilities.
                              flexibility
    To achieve this flexibility, manufacturing must move beyond the 
dedicated ``hard-plumbed'' stainless steel plants focused on a specific 
product. Ideally, we should be able to rapidly manufacture different 
products in a single facility, and do this without compromising product 
safety.
    New developments are allowing us to replace much of this stainless 
steel technology with disposable plastic technologies. These allow us 
to rapidly reconfigure the manufacturing process, using off-the-shelf 
ready-to-use components, for example pre-sterilized where appropriate. 
After a manufacturing run, components are simply disposed of, with a 
new set brought in to manufacture the next batch, or even a different 
medicine or vaccine.
    The use of this disposable technology improves manufacturing 
safety, reduces contamination risk and increases the throughput of the 
facility, and adds that crucial element of flexibility. They also 
reduce capital expenditure and lower start-up costs.
    When compared with traditional stainless steel production 
facilities, the ``ready-to-use'' system combines the advantages of 
single-use technology--at its simplest, offering plug-and-play ease of 
use--with cost-efficiency and additional safety aspects. In the event 
of an emergency, a flexible and modular production approach would 
facilitate rapid capacity deployment in a cost-effective and robust 
manner.
    Additional benefits of ready-to-use and single-use technology are 
numerous. By eliminating many of the time-consuming steps from initial 
set-up, cleaning, analysis and documentation--downtime can be turned 
into uptime and production capacity within such a facility increased. 
In cases where rapid facility change-over is demanded, single-use 
products will be especially useful eliminating the risk for cross-
contamination and operator exposure, especially important when 
manufacturing processes are based on the production of biological 
pathogens.
    Adaptability is a key advantage of ready-to-use systems. Many of 
our customers are switching to systems with these components as a more 
flexible option, allowing the user to quickly change the target 
molecule, and providing some flexibility in batch volume.
    In summary, single-use components offer many benefits beyond speed 
and flexibility, including reduced risk of contamination, minimized 
downtime for cleaning, sterilization and corresponding validation 
procedures, reduced operation costs and minimal maintenance.
                                 speed
    In the event of an incident such as an outbreak of an influenza 
pandemic or other pathogen, reaction time is inevitably short. 
Therefore preparedness efforts should be directed at implementing 
solutions that will facilitate a rapid response. Simplifying 
development and accelerating manufacture of a biological countermeasure 
are critical challenges, and GE Healthcare has allocated significant 
investment to lead technological progress in this area.
    To effectively protect a target population, a biological 
countermeasure must be developed in such a way that it can be produced 
and delivered in large volumes. For example, when faced with the threat 
of seasonal and pandemic influenza, vaccine manufacturers face the 
challenge of scaling up production to deliver large batches of product 
in the shortest possible time. Currently, in the event of a pandemic, 
existing global manufacturing capacity would provide sufficient 
influenza vaccine for only around 4.6 percent of the world's 
population.\1\
---------------------------------------------------------------------------
    \1\ Heuer A., Editor's Note. The Bridge. 2006 Fall: 36(3):3.
---------------------------------------------------------------------------
    Understanding both the biological and production hurdles, much of 
our focus has been on developing more cost-effective, quicker, modular 
ready-to-use manufacturing solutions, to both help traditional 
manufacturers gain efficiencies, but also to meet the growing need for 
flexibility in development, as governments search for solutions that 
would enable production capabilities to be implemented at speed and low 
cost.
    Take the current influenza epidemic as an example: Traditionally 
many vaccines such as flu vaccines, rely on an inactivated or weakened 
attenuated pathogen that is produced in eggs and purified. With normal 
seasonal lead-times, flu vaccine demands can be met, however in a 
crisis situation, even if all the current manufacturing plants were to 
concentrate on producing a ``pandemic'' vaccine, a serious capacity gap 
would still exist.
    Responsible health planners around the world are looking to 
increase manufacturing speed and capacity and vaccine stockpiles to 
counter the threat of a flu pandemic: the global demand for pandemic 
influenza vaccine has been reported as possibly approaching 7 billion 
doses, and according to the WHO with current world capacity, the 
potential vaccine supply would fall several billion doses short of the 
amount needed to provide protection to the global population.
    Disposable and ready-to-use manufacturing technologies bring 
unprecedented speed to both the development and manufacturing of 
biopharmaceuticals and vaccines. As an example, working with a vaccine 
developer as a partner, we have shown that it is possible, with 
disposable technologies, to reduce the time it takes to get a flu 
vaccine into production, after the isolation of the relevant viral 
strain, by up to 60 percent.
    Safety and quality, flexibility, and speed--all three of these 
critical elements can be addressed by the advent of new disposable and 
ready-to-use manufacturing technologies being developed by GE and our 
industry peers. Virtually all manufacturing steps can be carried out 
with disposables, from cell culture to purification steps such as 
chromatography and filtration.
    While currently not capable of achieving the manufacturing scales 
of the largest fixed stainless steel installations, the technology is 
evolving rapidly enough to be able to deliver significant volumes of 
therapeutic agents and vaccines. This is aided as the flexibility of 
disposable technology allows the economic and rapid set up of multiple 
production lines in parallel.
    In conclusion, biopharmaceutical and vaccine manufacturing 
technology is at an exciting point of development, increasing speed and 
flexibility in manufacturing, while assuring product safety and 
quality. Interest in these developments is high, as pharmaceutical 
companies, governments, and their national health and security 
organizations recognize the new capabilities that this technology can 
deliver in the challenging circumstances of an emerging infectious 
disease or other biological threat.
    Mr. Chairman, thank you for the leadership you've shown and for 
calling attention to this important issue.

    Senator Specter. Thank you very much, Dr. Darby.
    We will now proceed with 5-minute rounds of questions from 
the panel.
    I begin with a statement made by Dr. Gomez commenting that 
they started with manufacturing and then quickly moved to 
advanced development, emphasizing the need not only for 
manufacturing capabilities but also to keep abreast on 
technological development. UPMC, the University of Pittsburgh 
Medical Center, has the advantage of having the University of 
Pittsburgh research at its side, and the University of 
Pittsburgh has the advantage of having UPMC as well. There is a 
little mutuality.
    Dr. Burke had testified of his appreciation for the 
increase in funding by the NIH, and just a comment about that. 
When I was elected to the Senate in 1980, the first committee I 
chose was Appropriations because of its power, candidly, in 
bringing money back to the State. And the first subcommittee 
was the Subcommittee on Labor, Health and Human Services, and 
Education, which is the subcommittee with this hearing. In my 
first year in the Senate, the NIH budget was $3.6 billion, but 
when I became chairman, in collaboration with Senator Harkin, 
now the chairman--he was then the ranking minority member--the 
NIH budget was $12 billion, and we took the lead in increasing 
it to $30 billion, some years as much as $3.5 billion added. 
And during those years, there was a marked decrease in 
fatalities or morbidity due to stroke and many other maladies.
    I have taken a look here at the funding for the University 
of Pittsburgh from NIH, which has been considerable. In 1998, 
it was $169 million, and then with the increases, it went as 
high as $386 million. A lot of money. And in the span from 1998 
to 2007, it was--I want to be sure these figures are right. It 
is $3,020,000,000, which has really been--well, how would you 
characterize it, Dr. Burke? What has that done for the 
University of Pittsburgh?
    Why should I characterize it when I have a witness at hand?
    Dr. Burke. I would characterize it as a lot of money, sir.
    Senator Specter. Well, what has it enabled you to do?
    Dr. Burke. During this time, there has been the explosion 
in biotechnology is probably the most important change in----
    Senator Specter. And it was not only the University of 
Pittsburgh. It happened across the country.
    Dr. Burke. That is correct. The entire country has had this 
explosion of biotechnology that now allows us to move some of 
these vaccine technologies into the advanced development that 
would permit this kind of facility to be useful where 
previously we relied on the traditional steel technologies, the 
larger-scale technologies, and here I think we now have 
flexible, fast-moving technologies. So it not only affects 
these. It is across the board. There has been an incredible 
impact on biomedicine.
    Senator Specter. And in recent years, it has been cut back 
as a result of budget constraints, no cost-of-living 
adjustments, across-the-board cuts so that there was a decline 
on NIH in real dollars of $5.2 billion. But then with the 
stimulus package, the amendment, which I offered, got into the 
bill for $10 billion extra. What has that done in terms of 
reawakening a whole generation of research scientists?
    Dr. Burke. As you point out, in the last 2 or 3 years, we 
have had a flattening and an actual decline, and it has been 
very difficult to sustain first-rate biomedical research, and 
the additional funding that was provided in the last year, the 
additional $10 billion, has allowed us now to take up some of 
those projects that otherwise would not have been funded and 
carried forward. So it has been an incredible stimulus. The 
money is being well-spent and being spent quickly.
    Senator Specter. I am going to move through the 5-minute 
round, if it is okay with you, Congressman Altmire.
    Mr. Altmire. Yes, sir.
    Senator Specter. You will have equal time. But I am on a 
line of questioning which I want to pursue further with Mr. 
Romoff.
    Comment on the relationship between the University of 
Pittsburgh Medical Center and the University of Pittsburgh. You 
are separate but how do you interact?
    Mr. Romoff. We are two separate, independent organizations 
but intimately joined at the hip. I think using the 21st 
century biodefense project as an example, as Dr. Burke stated 
before, we contributed $10 billion--$10 million--excuse me----
    Senator Specter. You are getting your zeroes mixed up, Mr. 
Romoff.
    Mr. Romoff. These days it is too easy, I am sorry to say.
    We contributed $10 million to develop, under Dr. Burke's 
leadership, the Center for Vaccine Research, and Dr. Burke and 
his colleagues bring the scientific underpinnings, both the 
basic science and political science, to figuring out and 
solving----
    Senator Specter. So tell me why is it that UPMC undertakes 
this kind of a project as opposed to having the University of 
Pittsburgh do it?
    Mr. Romoff. Because UPMC has the capacity to take science 
and translate that science into products and then to, say, a 
vaccine factory or to translate into patient care innovations. 
The university does a good deal of the science and research. We 
take the research and translate it into things that work for 
patients, work for society in general.
    Senator Specter. Well, that is the unique opportunity which 
I wanted Dr. Gellin to hear in detail. May the record show he 
saluted and raised his hand and acknowledged the information. 
Well, that is what hearings are about. Dr. Gellin is going to 
play a key role in what is going to be done here in his 
position.
    The joinder of the University of Pittsburgh and UPMC is 
very unique. I look for a competitive bidding at the end of the 
rainbow, and I am going to be pushing hard to land it for 
Pittsburgh in the 7,000 jobs, which I commented about earlier, 
and also the expertise to really contribute to the national 
welfare. There are two edges of the sword. We are not going to 
spend the money foolishly, but when you can produce this kind 
of a product, you produce the jobs to an area which needs them, 
there is a lot to be said for that. And the synergy between the 
University of Pittsburgh and UPMC to get the job done I think 
is really significant.
    Mr. Romoff. Can I just add one point, Senator? In addition 
to thanking you once again not only for--or $10 billion in NIH 
funding which produced the science, but for your extraordinary 
efforts on behalf of this project here.
    But to focus in on the economic development aspect, this 
project, if done, would bring 1,000 jobs directly and 6,000 
jobs indirectly, but that is really just the beginning. As is 
clear from testimony here, we are talking about creating an 
industry and an industry without significant bounds, and that 
is, if we were able to, through competitive bidding, land this 
public/private partnership with your assistance here in 
Pittsburgh, I have no doubt that we would then be able to 
attract around that other private biotechnology companies to 
come to Pittsburgh who would set up laboratories----
    Senator Specter. Do you have any idea as to what the dollar 
figure would be or the employment opportunity figure would be?
    Mr. Romoff. It is all speculation, but I think----
    Senator Specter. Go ahead. Speculate a little.
    Mr. Romoff. Well, I think we are talking about multiplier 
effects of at least 10 times what the initial investment is.
    Senator Specter. So something like 70,000 jobs and----
    Mr. Romoff. I think you can certainly imagine that because 
everyone understands that these small biotechnology companies 
do not have the resources, do not have a place to turn to 
develop--do not have a flexible facility that is able to 
produce small batches, not just large batches, of different 
kinds of vaccines and other kinds of drugs that they need to go 
to clinical trials and to develop things that become 
commercially viable. A facility like this serves not only the 
Government's needs, but it serves an enormous amount of 
proprietary needs, and that is where you get the influx into 
the region of this kind of money, energy, people, and jobs.
    Senator Specter. Dr. Russell, you said in 1993 that the 
task force recommended a Government-owned, contractor-operated 
facility for manufacturing medical countermeasures, and that 
kind of an organization would avoid the kind of the problem 
that we have with Australian manufacturers for vaccines. They 
look out for Australia not for the United States. But the DOD 
determined that it was too expensive.
    Now, I commented earlier about the kind of funding which 
has been produced here, that in 2004, when I chaired the 
subcommittee, we put up $6.4 billion and the President now has 
additional discretion from further appropriations for $5.8 
billion. And considering the severity of the problem, would you 
continue to recommend, as you did in 1993, that it be a 
Government-owned facility or at least a public/private 
partnership where the Government could have a determinative 
voice in manufacturing for the welfare of the United States in 
light of the kind of threat we face now after 9/11, the kind of 
money which the Congress has already been willing to put up?
    Dr. Russell. At the time that decision was made by the DOD, 
I disagreed with it. I was in support of the Government-owned, 
contractor-operated. The technology at the time was more 
expensive and the methodology required dedicated facilities. It 
was not as efficient as we can do today with today's 
technology. I would argue very strongly that the decision by 
the DOD to move to a prime contractor method of operation 
basically failed to produce the product effectively.
    Senator Specter. So the old system failed, and you stand by 
your approach for Government participation?
    Dr. Russell. I think it definitely requires that we have a 
facility that the Government has sufficient control over to 
meet its needs when it is required and it has the flexibility 
to develop new products as they come out of the research base 
in the universities.
    Senator Specter. Dr. Darby, I have run a little long on 
time, but Congressman Altmire will have equal time.
    GE has a patent on an operation on plastics which enables 
to shift from one vaccine to another very promptly, contrasted 
with having stainless steel equipment which takes an amount of 
time to clean. May the record show the witness is upward 
nodding in the affirmative. That is true, is it not?
    Dr. Darby. Yes.
    Senator Specter. I am asking you a leading question, but I 
want to move forward with some speed here so we can conclude in 
a reasonable time.
    Senator Specter. But GE does have that patent. Right?
    Dr. Darby. Yes. GE has technology which is surrounded by 
patents.
    Senator Specter. And that enables GE's participation to 
move from one vaccine to another with disposable plastic as 
opposed to a lengthy cleaning process.
    Dr. Darby. Yes, sir.
    Senator Specter. And you have been working with UPMC to 
bring that technology to bear in the kind of an operation which 
they have proposed.
    Dr. Darby. Yes. All the studies that UPMC has been putting, 
which have been mentioned, we have been involved in those 
studies with the technology knowledge that we have today. So I 
think we are reasonably satisfied that it can be made to work.
    Senator Specter. Congressman Altmire, you are entitled to 
equal time, and that is 14 minutes and 16 seconds.
    Mr. Altmire. Thank you, Senator, and I do not plan to use 
all that time, but I appreciate it.
    Very quickly to begin with, Dr. Gomez, you spoke at length 
about the study that you conducted, and as a management 
consultant at the firm, you obviously have a financial 
relationship with people that commissioned the studies. I am 
making no implication, but just for the public record, what is 
your relationship with UPMC as a consulting organization, and 
do you feel that that impacted that study and the results in 
any way?
    Dr. Gomez. So PRTM was under contract to support that 
study, so we certainly provided what we believed was the best 
advice and analysis of part of that study.
    Mr. Altmire. But do you believe that the outcome and the 
conclusions that you testified about today and that the study 
showed were in any way impacted by that relationship?
    Dr. Gomez. No. I certainly believe that we provided the 
best analysis of the industry based on certainly my experience, 
having been in industry for a long time, as well as being 
within the U.S. Government.
    Mr. Altmire. Thank you.
    Mr. Romoff, you spoke at length in your initial testimony 
about the need for this type of center, a national vaccination 
center, and in response to Senator Specter's question, about 
the assets that UPMC has to the region with its relationship 
with the University of Pittsburgh. And Dr. Burke spoke about 
their specific interest in the vaccination center and the long 
history going back to Dr. Salk that they have with that issue. 
I want to give you the opportunity to close the loop on these 
things because you talked about the benefit western 
Pennsylvania has, you talked about the need that exists, 
University of Pittsburgh's role in it. What are UPMC's assets 
specific to the vaccination center, and why is western 
Pennsylvania a good location, and why is UPMC a good 
organization to do this?
    Mr. Romoff. Well, thank you for the softball question.
    UPMC, as you know so well, Congressman, is an $8 billion 
organization with 50,000 employees and that does not include 
the enormous assets at the University of Pittsburgh. We manage 
20 hospitals, hundreds of clinics. We do a great deal of 
things. We have laboratories and we do international 
consultations with hospitals in Ireland and Italy. UPMC has 
developed an intellectual managerial power fundamentally in the 
health care sector and in the health research sector to get 
things done, to take the brilliance of the scientists and the 
consultants and convert it into things that happen and grow and 
develop, treat patients, come up with new products, and then 
they bring economic value. We have been very successful at 
doing that, and we have been enormously comfortable with--here 
in western Pennsylvania, with the workforce that is here, 
with--that is here, and when it came to this project, it was 
first and foremost needed in a way that I think was obvious for 
everyone.
    And secondly, western Pennsylvania just has such 
extraordinary natural resources and such a good climate for 
productivity and a good workforce that this became a natural 
thing for UPMC to do here.
    Mr. Altmire. Thank you.
    Dr. Darby, I was very impressed by your talking about the 
leadership that GE has in this issue and the expertise that you 
have. My question is, with regard to this project in specific, 
which is more important to GE? Is it the dollars, the Federal 
investment of $600 million or more, or is it the commitment 
that the Federal Government brings that this is an important 
project? And I ask it in the context of the obvious question is 
GE a company that historically has done very well. You have 
leadership on this issue. You have obviously made a substantial 
investment through the company. Why do you need public money? 
Is it a Federal commitment that you need that this is 
important? Is this something you can do yourself, or is this 
something that you really believe the public needs to play a 
role in financing?
    Dr. Darby. Well, I think one of the major elements of this 
is, of course, we bring the manufacturing technology, which is 
at the heart of the puzzle. I think we need Federal backing 
behind this to bring the different players together, GE, 
organizations such as UPMC, to create the whole structure that 
is required to make this actually happen. So we bring a part of 
the puzzle, but there is no way that we could provide a 
countermeasure solution simply by ourselves. We need to work in 
partnership with the Government and other players to help to 
deliver this to you.
    Mr. Altmire. And you feel that the players at this table, 
others in the country who are interested in these types of 
programs, universities, private companies, that there is not an 
ability to make this happen without a substantial Federal 
investment?
    Dr. Darby. I think the Federal investment puts a certain 
level of imperative behind it. One cannot say it will never 
happen without the Federal investment, but I think the Federal 
investment and sponsorship serves as a rallying point to make 
this happen. So it will happen far more quickly.
    Mr. Altmire. Thank you.
    Lastly, for Dr. Russell, you spoke about the industrial 
development in the United States for these types of centers. I 
wanted you to talk about the risk that exists if we do not do 
this, if we do not move forward. What are we putting 
ourselves--and I am not asking you a leading question. Perhaps 
you would say there is no risk, but I would suspect you would 
say that there is if that is the case. What is the cost of 
doing nothing? What is the cost of inaction?
    Dr. Russell. I think that the structure of cost of doing 
nothing is going to be the products that come out of the 
research community, potential products, will not be developed 
and we will not have the vaccines and other pharmaceuticals 
that are necessary to counter a bioterrorism attack or another 
emerging infectious disease situation. I think the current 
system has proven to be inadequate. It is slow, cumbersome. It 
is inefficient.
    And this concept that is being talked about today is a 
means of really streamlining the advanced development and the 
manufacturing and a means of providing the countermeasures that 
could be available based on our current scientific knowledge if 
we move ahead with this. If we do not, we are going to have a 
much longer period of vulnerability.
    Mr. Altmire. Thank you.
    No further questions, Senator.
    Senator Specter. Thank you very much, Congressman Altmire.
    Dr. Gellin, why do you not step forward and have a chair at 
the end? Just a question or two.
    What do you think about the proposal? You said earlier you 
did not have too much idea. I will not ask you a leading 
question. I will just ask you what do you think of it?
    Dr. Gellin. Well, I think I told you in a meeting--it was 
not in front of the microphone when we were speaking before--
that I was impressed with this proposal. I am also impressed 
that in a 45-minute period you can assemble this panel to tell 
you about the details of their proposal.
    You also heard in this period that there is a need to move 
forward. Dr. Russell has often told me that when things are 
more than 10 years away, they are going to stay 10 years away 
unless we begin to move them. So I think that there is a 
commitment clearly by the U.S. Government, as I mentioned 
before, by both HHS and DOD to begin to explore a path forward 
to fill some of the gaps that we recognize.
    Senator Specter. And what do you think of the synergy that 
you find here with the research capabilities of the University 
of Pittsburgh and the implementation capabilities of UPMC?
    Dr. Gellin. Well, in his opening remarks, the Congressman 
spelled out the attributes that this project brings forward and 
you were able to assemble the people to tell us all about that 
and just to really scratch the surface of what I know at least 
of some of the things that are going on here. So I think that 
what they presented to you is clearly an interesting proposal 
and is one that we are obviously aware of and need to move 
forward to make a decision on how to fill these gaps.
    Senator Specter. Especially with the joinder of GE and 
their capability with plastic disposables to expedite the 
production of vaccines?
    Dr. Gellin. It is clear, as Dr. Darby commented, that this 
requires a multitude of talents to be able to solve this 
problem, and I think that this is clearly an opportunity to 
show how different elements that come to a table in partnership 
are needed to do something like that.
    Senator Specter. I thank Senator Harkin, chairman of the 
subcommittee, and Senator Inouye, chairman of the full 
committee, and Ms. Ellen Murray, who has contributed mightily 
and done so much work in arranging for this hearing. She has 
the benefit of coming to her hometown. So thank you, Ms. 
Murray, and thank you, John Myers, for the work you have done.
    I think this has been a very important hearing to put a lot 
of pieces together, and my colleagues in Washington on the 
subcommittee and the full committee and the full Congress will 
be reviewing it. Congressman Altmire will carry the words in 
the House of Representatives because this is a matter of 
urgency for the country. I, obviously, have been explicit 
before in promoting this as a Senator from Pennsylvania, and I 
am authorized to say that Senator Casey joins me in this 
effort. But there is a very important national interest in 
public health and very important interests in economic 
development, which we have specified.
    And as I said, we are going to be introducing authorizing 
legislation, and I will be working with it on the 
Appropriations Committee where I serve. We will be coordinating 
with the DOD and HHS, which we have talked about. Secretary 
Sebelius is well aware of the program. I had a chance to talk 
to her about it a little more. We did have a quiet moment, 
believe it or not, 2 weeks ago in Philadelphia with the first 
of the public demonstrations. And I look forward to a chance to 
talk to Secretary Gates. One small personal, not irrelevant 
note. Secretary Gates and I went to the same grade school in 
Wichita, Kansas.

                         CONCLUSION OF HEARING

    Thank you all for coming, and that concludes our hearing.
    [Whereupon, at 11:57 a.m., Wednesday, August 21, the 
hearing was concluded, and the subcommittee was recessed, to 
reconvene subject to the call of the Chair.]

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