STEM CELLS, REGENERATIVE MEDICINE, AND SOCIETY
Federal Funding of Stem Cell
Research: Past, Present and Future
By Lawrence A. Soler, J.D.
n March 9, 2009 President Barack Obama
O signed an Executive Order expanding
federal funding for research using
embryonic stem cells in a White House signing
ceremony packed with legislators, scientists, and
people who have suffered from a range of
diseases and medical conditions that could
benefit from the research. The President’s
executive order was a major milestone in the 10-
year effort by those patients, scientists,
academics, and others who have argued in
support of a broader federal stem cell policy.1
In some ways, the most telling aspect of the ceremony was that
when President Obama signed the Executive Order, numerous
members of Congress were in attendance. Their presence signaled a
significant shift in public opinion regarding the use of federal funding
for embryonic stem cell research; further, it demonstrated the
attitudinal changes regarding stem cell science that have taken place
since 1998, when embryonic stem cells were first derived.
Today, for many Americans, stem cell science is viewed as
potentially beneficial – not just for people suffering from disease –
but in maintaining the country’s prominence and preeminence in
scientific leadership. In a remarkably short timeframe, stem cell
science has made the unusual transformation from a non-issue to a
political hot button – and to an issue that transcends politics.
Background
Embryonic stem cells were first discovered in 1998 by Dr. Jamie
Thomson of the University of Wisconsin and Dr. John Gearhart of
the Johns Hopkins University.2, 3 While widely applauded for its
potential in the scientific community, their discoveries very quickly
set off a firestorm affecting researchers, ethicists, politicians and, most
importantly, patients in the United States (US) and around the
world. In fact, the first series of congressional hearings on the science
followed quickly, beginning in January 1999, when the Senate
Committee on Health, Education, Labor, and Pensions convened
sessions involving a series of top researchers and ethicists.4
What became clear at the outset was that most US policymakers
did not have an understanding of stem cell research and therefore
were uncomfortable with the concept. Almost immediately, the
source of embryonic stem cells became a key issue in the discussion
and debate and initially there were broad misunderstandings about
the origin of stem cells – with many assuming the issue to be
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associated with abortion.
At the time, relatively few legislators had a clear understanding
of the reality; the stem cells at the center of the issue were cells derived
from embryos created for in vitro fertilization (IVF) procedures. In
fact, the cells in question were not going to be used and were slated
to be discarded.
More often than not, the creation of embryonic stem cells was
erroneously linked to abortion, and the corresponding political,
moral, and religious issues that it entailed. To compound the
problem, there were a handful of legislators and others that might
have understood that abortion was not tied to stem cells, but did not
have a detailed understanding of or were uncomfortable with the IVF
process itself. As a result, the immediate political reaction to the 1998
Thomson/Gearhart discoveries leaned toward a ban on the research.
The Role of Patient Advocacy
In response to initial fears and negative reactions (often based on
misunderstanding), an organized effort was launched on the part of
patient advocacy groups to delay any potential federal ban on
embryonic stem cell research. The aim was to provide education on
the role of stem cells, the science, and their potential for therapies and
cures for leading conditions. In addition, time was needed to enable
discussion and debate related to surrounding ethical and religious
implications. This effort started with Patient’s Cure, originally formed
by Dan Perry, who was the Executive Director of the Alliance for
Aging Research. Patient’s Cure’s major focus was to slow the
momentum of any amendments that might surface in Congress
restricting federal funding and support for stem cell research.
Patient advocacy in the area of stem cell research emerged among
the campaign promises made by then Presidential candidate George
W. Bush, who pledged to impose a ban on federal funding for
embryonic stem cell research. Once elected, it was clear that a larger
scale and more comprehensive effort would be required to preserve
federal funding for the research – if not the ability to conduct stem
cell research itself.
Formation of the Coalition for the
Advancement of Medical Research (CAMR)
The result was the creation of the Coalition for the
Advancement of Medical Research (CAMR). Today, CAMR
comprises more than 100 nationally recognized patient organizations,
universities, scientific societies, and foundations, and conducts
advocacy and education outreach focused on developing better
treatments and cures for people with life-threatening illnesses and
disorders.
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 STEM CELLS, REGENERATIVE MEDICINE, AND SOCIETY
In 2001, Tim Leshan of the American Society for Cell Biology
and I created CAMR to bring together patients, scientists, academia,
industry and others to pool resources and build public support for
embryonic stem cell research. Building on the efforts of Patient’s
Cure, CAMR provided a voice for the widespread interests that saw
the potential of embryonic stem cells to better understand a range of
diseases, from diabetes to spinal cord injuries, and perhaps even one
day create therapies to alleviate their suffering. Most important,
CAMR provided a rallying point for not only people impacted by
diseases that stem cells could possibly help, but for the medical
research community, which – understandably, given that it was so
new – did not have a unified voice vis a vis stem cell research at the
time.
During the initial months, CAMR operated with frantic effort.
First and foremost, its advocacy activities focused on attempting to
make it difficult for the Administration to quickly implement an
executive order that would simply stop embryonic stem cell research
– a quite likely outcome at the time. These efforts were combined
with a larger strategy to educate policymakers and the American
people about embryonic stem cell research, with a particular focus on
the relationship between stem cell research and IVF, and the fact that
stem cell research is not related to the abortion issue but more
analogous to organ donation.
As expected, scientific journals and research publications focused
intently on stem cells. But in just a few short months, stem cells
became one of the top general media issues as well. The issue was
featured regularly on the front pages of the nation’s largest
newspapers, and was a regular topic on cable television news and
opinion programming. And the just-exploding blogosphere took up
the call, and stem cells were a regular topic for political and news-
related websites. As more was explained about the research – what it
was, and particularly, what it was not – support for it and opposition
to the President’s potential banning of funding for the research
gradually began to grow.
Transparency around the issue, as it turned out, mattered.
Ultimately, President Bush, in his first nationally televised address to
the nation, did not ban embryonic stem cell research or federal
funding for it; drawing a political, rather than a scientific, distinction,
he allowed limited funding for embryonic stem cell science – just for
those stem cell lines that had been created prior to his address on
August 9, 2001. Any chance of changing the policy ended on
September 11, 2001. The front page of the New York Times on that
day included a story on stem cell research policy, but given the events
of that day, the issue was driven from the headlines – for a while.
While seen by many at the time as the best possible outcome
given the circumstances, the President’s decision unfortunately
created an extended holding pattern for embryonic stem cell research.
While not restricting its expansion, per se, limiting federal funding to
the lines existing before August 9, 2001 made it significantly more
difficult for stem cell research to expand at the rate one might have
expected, given the promise of the science. Within a matter of years,
it became clear that the stem cell lines actually available for federal
funding were far fewer than those that were meant to be included. As
it turns out, only 21 of the approximately 70 lines that were initially
promised by the Administration for federal research dollars were
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actually usable for research, because they didn’t exist or had other
technical problems. The result was that scientific progress was
delayed.
With a President opposed to expanding funding for stem cell
research and a Congress increasingly supportive, the remaining years
of the two terms of the Bush presidency were essentially seven years
of stalemate. The science became an issue in the 2004 Presidential
election – but with the re-election of President Bush, there was no
movement in either direction. But as a result of continued advocacy
activities by the research community, CAMR, and others, Congress
twice introduced legislation and passed bills, with strong support,
that would overturn the 2001 policy and expand the funding
available for embryonic stem cell research. Twice, however, these bills
were vetoed by the President, which Congress was unable to override
because it lacked the two-thirds vote to do so. Progress in stem cell
research was increasingly limited as federal support became more
technologically slowed.
Recent Policy Changes and Claims to Pave
the Way for Stem Cell Research
The issue again bubbled to the top of the political consciousness
during the 2008 Presidential campaign, but with little of the
prominence or vehemence that had typified previous political
outbreaks – owing in large part to stem cells no longer being the
polarizing political issue that they had been earlier in the decade.
Candidate Barack Obama noted early and often in his campaign that
among his first acts, if elected, would be to expand federal funding for
embryonic stem cell science. Senator McCain also was on record in
support of the research.
Candidate Obama became President Obama, and true to his
word, acted to get the research back on track, with his historic
Executive Order, which brings us full circle to the beginning of this
article.
Current Policy Changes and Controversies:
Questions for Consideration
But does President Obama’s March Executive Order signal that
the public policy controversies surrounding embryonic stem cell
research are over, once and for all?
Perhaps. But perhaps not.
In July 2009, the National Institutes of Health issued its final
guidelines governing federal funding for embryonic stem cell
research, after a 90 day public comment period on its initial
guidelines. JDRF and others in the research community have
applauded the guidelines, particularly for including a provision under
which existing stem cell lines derived in an ethically-responsible
manner would be eligible for federally funded research. This
provision will ensure that a process is in place so researchers can build
on the stem cell advancements made to date and accelerate research
on cell lines with the greatest potential to facilitate treatment of the
disease.
So where does that leave us? After 10 years of uncertainty, the
scientific community finally has clear direction and support for a
substantially expanded platform for embryonic stem cell research.
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 STEM CELLS, REGENERATIVE MEDICINE, AND SOCIETY

That is undeniably positive for researchers and patients alike. But Necessary “Next Steps”
there will still be some limitations. For example, the President’s
As positive as the Executive Order is for moving stem cell
executive order and the NIH guidelines do not include research
research forward, the possibility always exists that it could be
involving stem cells created through somatic cell nuclear transfer
overturned by a future president who opposes the science. Another
(SCNT) or parthenogenesis – alternatives to the “traditional” method
president could simply issue a new Executive Order that returns to
of creating embryonic stem cells that could potentially speed the
the Bush Administration restrictions – or worse.
progress of utilizing these cells for research or replacement purposes.
As such, a critical next step is to pass legislation in both the
Today the advantages of where the scientific community stands
House and Senate, codifying federal funding for stem cell research
surely outweigh the disadvantages of the past. In fact, compared with
that can be signed by President Obama. Such legislation would make
just a few years ago, there are a number of advantages in moving
it extremely difficult for research to be stopped by a future president.
forward, both scientific and attitudinal. For example, researchers
In fact, once legislation is approved, the only way a future
today have the freedom to effectively work on many additional stem
Administration could reverse it would be for a new law to be passed
cell lines, this creates cost efficiencies, opening the door for disease-
through the House and Senate and signed by the President. Given the
specific science, and encouraging collaboration among researchers
strong public support that has grown for embryonic stem cell research
from different organizations, with different backgrounds, and with
over the years, that seems extremely unlikely.
different aims. All this is a major step forward for research in
Based on the previous two bills that were introduced during the
combating a wide range of diseases and medical issues.
past decade, there would most likely be enough votes to approve a bill
Just as important, a more transparent and positive policy towards
funding this research. But the legislative process includes pitfalls that
federal funding for stem cell research means that young scientists will
always need to be considered, such as anti-research amendments that
now begin to see a future in the field, and add to the talent pool of
could be proposed that may not be adequately explained in a
researchers working towards cures and treatments. Before, with
congressional debate and could lead to limitations on other types of
limited federal support and the constant threat of a possible overall
research.
ban on stem cell research, only the most optimistic young scientists
would have considered stem cell research as a growth industry. The Conclusion
increased talent devoted to the field will, undoubtedly, have a
multiplier effect on the pace of progress in stem cells in the near and Moving forward, it remains important for patients, scientists,
longer-term future. universities, physicians, and others to continue to build support
That impact will be felt on the institutional level, as well. Until among policymakers so that an embryonic stem cell bill can be
now, more than a few universities have been very conservative in passed.
determining whether to allow private embryonic stem cell research – Since the discovery of embryonic stem cells a little more than a
science using non-federally approved stem cell lines – to be decade ago, we have seen dramatic shifts in public perception of and
conducted in university buildings that receive federal indirect costs political support for the research. Clearly, both are at a high point
reimbursement. The fear was that given the intricate accounting and today. But now and throughout the darkest days of the past decade,
procedural issues surrounding research funding, non-approved there has been a constant – the people with diseases that might one
research conducted in buildings supported by federal funds, even if day benefit from this science. Our focus should be on them – and on
the accounting was done exactly right, could in some way jeopardize moving this science forward quickly, effectively, and ethically.
the university’s federal funding eligibility. The broadening of the
policy should substantially alleviate many of these concerns. But we
are not done yet.

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 STEM CELLS, REGENERATIVE MEDICINE, AND SOCIETY
Lawrence A. Soler, J.D.
Lawrence (Larry) A. Soler is Executive
Vice President, Government Relations &
Operations for the Juvenile Diabetes
Research Foundation, his fourth position
at the organization since joining it in
1998.
In January, 2009, Mr. Soler was
appointed to his most recent position which added oversight of
information technology, international development, and legal issues
to his previous areas of responsibility, government relations and the
organization’s Artificial Pancreas Project.
During his time at JDRF, Mr. Soler has been responsible for leading
the effort to secure $1.4 billion in type 1 diabetes research funding
through the congressionally mandated Special Diabetes Program. In
addition, Mr. Soler has a been a leader in embryonic stem cell policy,
creating and chairing the Coalition for the Advancement of Medical
Research, a coalition of one hundred national organizations who
support embryonic stem cell research. In this role, he oversaw the
national campaign which successfully convinced President Bush to
reverse a campaign commitment to ban the research. He also was
References
1. Remarks of President Barack Obama – As Prepared for Delivery,
March 9, 2009:
http://www.whitehouse.gov/the_press_office/Remarks-of-the-
President-As-Prepared-for-Delivery-Signing-of-Stem-Cell-Executive-
Order-and-Scientific-Integrity-Presidential-Memorandum/
2. Thomson J, Itskovitz-Eldor J, Shapiro S, Waknitz M, Swiergiel J,
Marshall V, Jones J (1998). Embryonic stem cell lines derived from
human blastocysts. Science 282 (5391): 1145-7
(http://www.sciencemag.org/cgi/content/full/282/5391/1145); M.J.
3. M.J. Shamblott, J. Axelman, S. Wang, E.M. Bugg, J.W. Littlefield,
P.F. Donovan, P.D. Blumenthal, G.R. Huggins, J.D. Gearhart.
Derivation of Pluripotent Stem Cells from Cultured Human
Primordial Germ Cells. Proceedings of the National Academy of
Sciences U.S.A. 95
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instrumental in building public support for the issue over the years,
culminating in President Obama issuing an executive order to allow
more funding for the research. JDRF has received recognition and
honors for its government relations program from the New York
Times, Wall Street Journal, Time Magazine, Research!America,
National Journal among others.
Mr. Soler has also played a leading role in establishing JDRF’s
Artificial Pancreas Project, a research initiative that combines work
in regulatory and reimbursement policy, physician and patient
acceptance, and JDRF/industry research partnerships to accelerate
the development of a closed loop artificial pancreas. JDRF-led
research related to this project was named a top 10 medical news
story in 2008 by ABC News. Prior to joining JDRF in 1998, he
worked for eight years in federal relations positions at the Association
of American Universities, focusing on education, health and
immigration issues.
Mr. Soler received a B.A. with honors from Clark University and
his J.D. from George Washington University. He is a member of the
Maryland and D.C. Bar Associations.
4. Melton, D. Testimony on Stem Cell Research before the Senate
Labor-HHS Appropriations Subcommittee, January 10, 1999:
http://www.mcb.harvard.edu/Melton/testimony.html.
5. Perry, D. (2000). Patients’ Voices: The Powerful Sound in the Stem
Cell Debate. Science, 287, p. 1423:
http://www.sciencemag.org/cgi/content/abstract/287/5457/1423?hi
ts=20&RESULTFORMAT=&titleabstract=report+patient&maxtoshow
=&andorexacttitle=or&HITS=20&
6. President George W. Bush’s address on stem cell research, August
9, 2001:
http://archives.cnn.com/2001/ALLPOLITICS/08/09/bush.transcript/.
7. National Institutes of Health Guidelines on Human Stem Cell
Research, http://stemcells.nih.gov/policy/2009guidelines.htm.
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 STEM CELLS, REGENERATIVE MEDICINE, AND SOCIETY

The Alliance for Regenerative

Medicine: Securing Favorable
Research, Regulatory and
Reimbursement Policies to
Advance Important Technologies
By Michael J. Werner, Esq.

or many years, scientists, patient advocates, therapeutic and diagnostic companies, investors, and patient

F entrepreneurs, and politicians have claimed

that regenerative medicine holds enormous
promise. In some cases, this promise has already
been realized as companies have commercialized
regenerative therapies that have successfully
treated diseases and disabilities. Other products,
while not yet approved for marketing, have shown
success in academic labs or in clinical trials.
Moreover, the potential of regenerative medicine to lead to cures
and treatments for diseases and disabilities such as diabetes,
Parkinson’s disease, ALS and spinal cord injury is the principal reason
human embryonic stem cell research has received widespread political
and popular support for the past several years.
Regenerative Medicine Technologies:
New Opportunities for Improving Healthcare
Successes to date represent just the tip of the iceberg.
Regenerative medicine technologies represent the opportunity to not
only respond to currently unmet medical needs, but also to provide
better care to patients in a cost effective manner. Thus, regenerative
medicine could dramatically change the way health care is provided
in the years ahead.
To reach that objective, however, will require a partnership
between academia, industry, and the government. Specifically, the
federal government needs to adopt policies that will facilitate and
support the development of regenerative medicine. For example, the
government should support a research agenda – including both basic
and translational research. In addition, we need a predictable and
science-based regulatory approach that provides an appropriate
pathway for product approval. Moreover, a market-based
reimbursement system that rewards innovation is essential. The
regenerative medicine community (in this article, the term
“regenerative medicine community” means academic researchers,
advocacy groups that will benefit from regenerative medicine
technologies) should advocate for these policies.
Just as importantly, it should participate in the current
congressional debates about health care reform and comparative
effectiveness research. The decisions being made over the next several
months on these topics will impact the development of regenerative
medicine.
While there has been congressional support for funding of stem
cell research for the past several years, the regenerative medicine
community needs to seek broader gains from Congress that will
create a policy environment conducive to long-term success. That
means funding for basic research and translational research, as well as
appropriate regulatory and reimbursement policies.
How well the regenerative medicine community engages policy
makers in Congress, at the Food and Drug Administration (FDA),
CMS and private insurers, and other government agencies, will be
key to whether this technology will lead to cures and treatments for
patients.
To be most effective, the regenerative medicine community
needs a specific advocacy effort. In this paper, I describe a new
advocacy organization – the Alliance for Regenerative Medicine –
that will fulfill this mission.
What is the Alliance for Regenerative
Medicine (“the Alliance”)?
The Alliance is a non-profit organization whose mission is to
educate key policy makers about the potential for regenerative
medicine, and to advocate for public policies – funding, regulatory,
reimbursement and others – that will facilitate advances in the field.
It will be operated by Holland & Knight, LLP, a law firm with
expertise in health care and government relations with offices in
Washington, DC and many other cities and Adjuvant Global
Advisors, a business development and commercial strategy consulting
firm based in Bethesda, MD.
The Alliance defines “regenerative medicine” as the National

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 STEM CELLS, REGENERATIVE MEDICINE, AND SOCIETY
Institutes of Health (NIH) does: the process of creating living,
functional tissue to repair or replace tissue or organ function lost due
to age, disease, damage or congenital defect. It includes regenerating
damaged tissues and organs in the body by stimulating previously
irreparable organs to heal themselves, using stem cells to grow cells,
tissues and organs to repair damaged or destroyed cells and tissue the
body cannot heal by itself, and potentially solving the problem of the
shortage of organs available for donation compared to the number of
patients that require life-saving organ transplantation.
The Alliance is the first advocacy organization exclusively
dedicated to representing the regenerative medicine community with
a focus on product development. Its membership will consist of
biotechnology and pharmaceutical companies, university-based
research organizations, independent research organizations, venture
capital firms, patient advocacy organizations, and service
organizations that share the goal of advancing cell-based therapies,
biomaterials and tissue engineering products to the marketplace.
An incorporated and non-profit organization, the Alliance will
act as the political and policy advocate of the regenerative medicine
community. It will be a source of information about the field of
regenerative medicine for policy makers , the media, and the general
public. The Alliance will provide a single, credible voice to represent
the regenerative medicine community. It will educate policy makers
– in Congress, at FDA, CMS, National Institutes of Health (NIH),
and elsewhere – about the key healthcare policy issues affecting
regenerative medicine.
Now is The Time for Creation of the Alliance
The time is right for creation of the Alliance. Scientifically,
regenerative medicine continues to demonstrate its promise. Almost
every day a new breakthrough is announced. In addition, there is a
track record of success as several regenerative medicine products are
on the market and have demonstrated their effectiveness.
It is an opportune time from a political and policy perspective as
well. The Congress and Obama Administration are currently
debating several relevant health care issues. Our nation is in the
midst of a national debate about health care reform and political
leaders are grappling with the details of designing a new health care
system. To this point, much of that debate has focused on health
insurance and taxes/financing issues.
However, this debate should not just be about providing health
insurance; it also provides an opportunity to enact policies that will
improve Americans’ health. The Alliance can play an important role
as Congress continues these deliberations to communicate the
importance of federal policies that support innovation and
commercialization of new technologies that are key to regenerative
medicine.
Another important ongoing debate surrounds government-
sponsored comparative effectiveness research. The American
Recovery and Reinvestment Act (ARRA or the so-called “economic
stimulus bill”) provided over $1 billion for comparative effectiveness
research. Funds are divided between the NIH, AHRQ and the
Secretary of Health and Human Services (HHS); some grant
proposals have already been issued by the agencies. In addition, the
Institute of Medicine (IOM) recently issued its recommended
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priorities for research topic areas to be addressed by ARRA funds.
Some of these topics – including use of biomarkers for treatment of
various cancers – are clearly relevant to regenerative medicine.
Thus, by educating federal policy makers about regenerative
medicine, the Alliance will help ensure that federal comparative
effectiveness research is done appropriately. For example, the NIH
has issued proposals for comparative effectiveness research in
regenerative medicine. The Alliance will engage the agency to discuss
research priorities for grants in this area.
Moreover, lawmakers are currently debating whether the results
of this research should be used only to improve clinical decision
making or can also be used as a basis for coverage and payment
decisions by Medicare and private insurers. The Alliance will engage
in that debate as well.
The Regenerative Medicine Advocacy
Agenda
In addition to the broader health care reform, medical research,
and comparative effectiveness research debates, the regenerative
medicine community should advocate on issues specific to facilitating
research and commercialization of regenerative technologies.
If these technologies are going to meet their potential and help
patients with diseases and disabilities, we need a comprehensive
strategy to make sure public policies are enacted that facilitate
continued success. Specifically, our nation must adapt:
• Research funding policies that support necessary research in
universities as well as in private companies;
• A responsible and predictable regulatory policy to ensure that
safe and effective products reach patients as soon as possible;
and
• A market-based reimbursement system that rewards
innovation and will ensure patient access to new products.
The Alliance will develop policies and an advocacy strategy in all
these areas.
Research Agenda
The federal government plays a critical role in supporting
scientific research. While NIH funding of human embryonic stem
cell research has been controversial (though still funded, albeit in a
limited way), the agency has been supporting other regenerative
medicine and tissue engineering research for many years. In fact, the
agency has provided hundreds of millions of dollars for regenerative
medicine projects. In addition, the Department of Defense (DoD)
launched the Armed Forces Institute for Regenerative Medicine
(AFIRM) in 2008. This program will provide up to $250 million for
regenerative medicine research that focuses on conditions faced by
military personnel.
As an organization that represents the regenerative medicine
community, the Alliance will have the necessary expertise to work
with NIH, DoD and other agencies to identify and recommend
research priorities, as well as to advocate for funding and
programmatic support from Congress. The Alliance will also work to
identify and advocate for new funding sources from Congress and
relevant agencies.
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