Source Code HHS 2020 Vision Rebuilt Archive With Extra Info.

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<title>HHS Regenerative Medicine 2020 Future Vision</title>

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<meta itemprop="description" content="Rebuilt fair use archive of delelted HHS page, 2020 vision. Includes extra regenerative medicine info up to May 2014.">
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<div class="suboxed">
I created a HHS archive page, but this devleoped into something greater. I added an <a href="http://archive.today/MEbku" target="_blank" cite="http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm393030.htm" title="Adult Stem Cell Research Shows Promise, 23rd April 2014.">FDA link</a> about stem cells, then a Big Think <a title="Jump to video embed, page bottom." class="plusposthigh" href="#video">video.</a> Finally I added <a class="plusposthigh" href="#gplus_posts" title="Jump to embedded G+ posts, page bottom.">12 G+ posts</a> regarding regenerative medicine, thereby creating a handy summary up to May 2014, so we can see how accurate HHS forecasting is.
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<div class="ar">Archive</div>


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<div style="width:580px;">
&#x25CF; HHS page first published <b style="text-align: left;">Jan 2005</b>. See also
<a href="http://medicine.osu.edu/regenerativemedicine/documents/2020vision.pdf" style="text-align: left;" target="_blank" title="Via Ohio State University College of Medicine.">2020 a New Vision PDF</a>.
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Note also <a href="http://archive.today/MEbku" target="_blank" cite="http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm393030.htm" title="Adult Stem Cell Research Shows Promise, 23rd April 2014.">FDA stem cell news April 2014</a>, and <a href="http://bigthink.com/think-tank/the-regeneration-of-organs-can-soon-be-commonplace" target="_blank" cite="https://plus.google.com/112564607617850290297/posts/h8bM6u3Nbpo" title="The Regeneration of Organs Can Soon Be Commonplace, 22nd April 2014.">Big Think April 2014</a> (<a name="bigthink" title="Jump to video embed, page bottom." href="#video">video</a>).
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This HHS-page (<a href="http://www.hhs.gov/reference/newfuture.shtml" style="text-decoration:none;color:black;" target="_blank" title="http://www.hhs.gov/reference/newfuture.shtml">original deleted</a>) is a <a href="http://en.wikipedia.org/wiki/Fair_use" title="Wikipedia explanation of fair use" target="_blank">fair use</a> archive by <a href="http://plus.google.com/114822617931706904248" target="_blank" title="Follow Singularity Utopia on G+">Singularity Utopia</a>.

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<a name="top" style="text-align: left;">
</a><a name="skip" style="text-align: left;"></a>
<h1 style="font-size: 1.4em; font-weight: 600; text-align: left;">
2020: A New Vision - A Future for Regenerative Medicine</h1>
<h2 style="font-size: 1.2em; font-weight: 600; margin-bottom: 5px; text-align: left;">
U.S. Department of Health and Human Services</h2><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
The
 following document addresses a specific area of biotechnology that
shows great promise for treatment and cure of life-threatening diseases.
 The report delineates one particular approach of how America can best
maintain its preeminence in the field of biomedical engineering. The
suggested timelines and endpoints are examples of a strategy that our
nation can use to secure our leadership in the field of regenerative
medicine.</div>
<h3 style="font-size: 1em; font-weight: 900; margin-bottom: 0px; text-align: left;">
Table of Contents</h3><br><br>
<ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
<li style="font-size: 13px; line-height: 1.4em; text-align: left;"><a href="#exsum" style="text-align: left;">Executive Summary</a><br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;"><a href="#intro" style="text-align: left;">Introduction</a><br style="text-align: left;" />
<ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
<li style="font-size: 13px; line-height: 1.4em; text-align: left;"><a href="#head1" style="text-align: left;">What is regenerative medicine?</a><br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;"><a href="#head2" style="text-align: left;">Why do we need Regenerative Medicine?</a><br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;"><a href="#head3" style="text-align: left;">What is the current state of regenerative medicine?</a><br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;"><a href="#head4" style="text-align: left;">What is the future of regenerative medicine technology?</a><br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;"><a href="#head5" style="text-align: left;">How could the United States get there?</a><br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;"><a href="#head6" style="text-align: left;">Increasing Public Awareness and Support</a>
</li>
</ul>
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;"><a href="#conclusion" style="text-align: left;">Conclusion</a><br style="text-align: left;" />
</li>
</ul><br>
<a name="exsum" style="text-align: left;"></a>
<br><h3 style="font-size: 1em; font-weight: 900; margin-bottom: 0px; text-align: left;">
Executive Summary</h3><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Regenerative medicine is the next evolution of medical treatments.
Derived from the fields of tissue engineering, tissue science, biology,
biochemistry, physics, chemistry, applied engineering and other fields,
regenerative medicine is the first truly interdisciplinary field that
utilizes and brings together nearly every field in science. This new
field holds the realistic promise of regenerating damaged tissues and
organs <i style="text-align: left;">in vivo (in the living body)</i>
through reparative techniques that stimulate previously irreparable
organs into healing themselves. Regenerative medicine also empowers
scientists to grow tissues and organs <i style="text-align: left;">in vitro (in the laboratory)</i>
and safely implant them when the body is unable to be prompted into healing itself. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
This revolutionary technology has the potential to develop therapies for
 previously untreatable diseases and conditions. Examples of diseases
regenerative medicine can cure include diabetes, heart disease, renal
failure, osteoporosis and spinal cord injuries. Virtually any disease
that results from malfunctioning, damaged, or failing tissues may be
potentially cured through regenerative medicine therapies. Having these
tissues available to treat sick patients creates the concept of "tissues
 for life." </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Beyond the obvious health benefits of regenerative medicine, this
technology is desperately needed to combat rising healthcare costs.
Current national healthcare costs are in excess of $1.5 trillion
annually, or 13 percent of Gross Domestic Product (GDP). The 2000 census
 report finds that there are 35 million Americans aged 65 or older. In
10 years, this number is expected to increase dramatically as the 56.6
million Americans who are currently aged 55-64 join the senior citizen
age group. By 2040, as the last baby boomer becomes a senior citizen,
the population of senior citizens over the age of 65 in the U.S. will be
 double today's number, for a total of 70 million. Accordingly, as much
as 25 percent of the U.S. GDP would be devoted to healthcare by 2040.
The majority of these projected costs stem from recurring treatments for
 diseases that arise from tissue failure commonly seen in the elderly.
The baby boomer demographic is one that has seen continual medical
advancement in their lifetime. This group expects the best from
healthcare and will have the greatest need for regenerative medicine.
Regenerative medicine therapies will help combat common diseases in the
elderly such as diabetes, osteoporosis and cardiovascular disease. Baby
boomers would almost certainly rally behind the efforts to advance
regenerative medicine as it offers them the greatest hope for the most
effective medical treatment and quality of life in their senior years. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Approximately $4 billion has been spent to date by the U.S. private
sector on regenerative medicine, with precious few products on the
market. The only products to date are first generation skin and
cartilage substitutes. Further innovation has been stymied by a lack of
fundamental building block research in regenerative medicine. Other
major scientific advancements, such as the Human Genome Project, the
National Nanotechnology Initiative, and semiconductor research have seen
 major support from the U.S. Government, with the private sector
augmenting Government driven research with great efficacy. Despite this
historically proven formula for success, regenerative medicine has
received more than ten times as much private funding as Government
funding. To create complex tissues and organs, Government resources and
coordination are essential for driving the research effort in an
efficient and swift manner. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Regenerative medicine, if driven by a cohesive Federal initiative, has
the opportunity to begin producing complex skin, cartilage and bone
substitutes in as little as 5 years. Tissue and organ patches, designed
to help regenerate damaged tissues and organs such as the heart and
kidneys are within reach in 10 years. Within 20 years, with appropriate
Federal funding and direction, the goal of "tissues on demand" is
realistic. Additionally, efforts to advance regenerative medicine offers
 the opportunity to create a tremendous new global industry led by the
U.S. The current world market for replacement organ therapies is in
excess of $350 billion, and the projected U.S. market for regenerative
medicine is estimated at $100 billion. Furthering this field would
create jobs and grow a new sector of the healthcare industry while
creating a new generation of life-saving products. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Already, Japan, the European Union (EU), China and Australia have begun
national initiatives and efforts to spur the advancement of their
regenerative medicine programs. These commitments range from policy
directives in the EU to extensive financial investment by the Japanese
government focused on the city of Kobe and surrounding Kansai region
targeted to develop a region of expertise in tissue engineering and
regenerative medicine. Despite this strong foreign commitment to
regenerative medicine, the U.S. presence in regenerative medicine is in
danger of being eclipsed. More than 40 percent of the regenerative
medicine firms founded since 2000 have been outside of the U.S., and
many existing firms have had financial and technical difficulty. To
remain scientifically competitive, it is essential that there be strong
U.S. leadership and research in this new field. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
To achieve the aggressive goal of tissues on demand within 20 years, the
 Federal Initiative for Regenerative Medicine (FIRM) is proposed. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Appropriate annual funding is critical to the success of this
initiative. In conjunction with this substantial resource commitment,
FIRM would establish a guidance and governance council including all
Government agencies currently involved in regenerative medicine. These
agencies thus far include the Department of Health and Human Services
(including the National Institutes of Health and the Food and Drug
Administration), the Department of Defense (including the Defense
Advanced Research Projects Agency), the Department of Commerce
(including the National Institute of Standards and Technology), the
White House Office of Science and Technology Policy, the National
Aeronautics and Space Administration, the President's Council of
Advisors on Science and Technology, and the National Science Foundation;
 and would be open to any other agencies interested in furthering
regenerative medicine. This council would set milestones to advance
regenerative medicine and then funding and ensuring that these
milestones come to fruition. Milestones will range from "pure science"
techniques such as studying cellular and tissue interactions, to
"challenge problems" such as curing diabetes by replacing pancreatic
islets. The fruits of FIRM research will be disseminated to academia and
 private industry, allowing quicker product and therapy development. By
adopting the formula of Government, academic and industry cooperation
that has pushed many other technological initiatives forward, FIRM will
advance regenerative medicine quickly and efficiently. The Semiconductor
 Manufacturing Technology Consortium (SEMATECH) used this same model of
government and industry cooperation and funding in the late 1980s and
early 1990s. SEMATECH received about $2 billion in Government funding
and helped grow from an $8 billion yearly U.S. semiconductor industry in
 1987 to the $170 billion, 50 percent global market share industry
today. Regenerative medicine is a field primed for this same Government
driven growth and success. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Without a Federal initiative, regenerative medicine as an
American-driven science faces a precarious future. Although there has
been strong private investment, returns thus far have been almost
nonexistent. The products that the regenerative medicine industry
currently produces are very simple and questionably justify the
tremendous private investment to date. If private investment money
ceases and there is no Government initiative, regenerative medicine will
 be driven by foreign efforts and companies, leaving U.S. ingenuity and
influence absent from the future of regenerative medicine and increasing
 the cost of care to access this technology in the U.S. Even worse,
without support from FIRM, regenerative medicine could take 40-50 years
to be realized. The U.S. Government has always been on the forefront of
new technology and regenerative medicine should be no different. It is
time for the U.S. Government to embark upon an initiative that will make
 this technology a reality. </div><br>
<div style="font-size: 10px; line-height: 1.2em; padding: 2px; text-align: left;">
<a href="#skip" style="text-align: left;">Back to Top</a></div>
<a name="intro" style="text-align: left;"></a>
<h3 style="font-size: 1em; font-weight: 900; margin-bottom: 0px; text-align: left;">
Introduction</h3><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Regenerative medicine is the vanguard of 21st century healthcare. We are
 on the cusp of a worldwide explosion of activity in this rapidly
growing field of biomedicine that will revolutionize health care
treatment. Regenerative medicine will lead to the creation of fully
biological or biohybrid tissues and organs that can replace or
regenerate tissues and organs damaged by disease, injury, or congenital
anomaly. Because of the economic potential of this industry (the
worldwide market for regenerative medicine is conservatively estimated
to be $500 billion by 2010)1, initiatives to capture significant shares
of this market are multiplying around the world and competition is
mounting. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
In the U.S., the symbiotic relationship between Government and science
is vital in understanding and developing cures for disease. This
relationship is an essential aspect of assuring the safety and well
being of U.S. citizens. Perhaps because of the enormous medical advances
 fostered through Government-funded research and the public's trust in
the Government's role in improvement and oversight of medical care,
Americans not only embrace medical technology and medical advances, but
have come to expect the best that clinical care and medical research can
 offer. The average American has come of age with remarkable medical
advances - from the polio vaccine, to multi-organ transplants, to the
real prospect of nerve regeneration. Regenerative medicine, with its
promise of repairing damaged tissues and growing replacement tissues and
 whole organs, is the new frontier to capture the imagination and employ
 the famous American "can do" spirit of easing human suffering. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
In the spirit of ingenuity, regenerative medicine is a collaborative
effort. Leadership in this field will come from people who are willing
to work across disciplinary lines and Federal and private sector
boundaries. A successful regenerative medicine initiative requires the
expert knowledge of scientists, engineers, physicians, researchers, and
many others in a multidisciplinary effort focused through a Federal
initiative that provides the framework and resources to fully realize
the potential of this revolutionary new field. Other nations have
already begun to realize that focused national initiatives are vital to
advancing this promising science. It is now up to the U.S. to do the
same and create a Federal Initiative for Regenerative Medicine (FIRM) to
 make this science a reality. </div><br>
<div style="font-size: 10px; line-height: 1.2em; padding: 2px; text-align: left;">
<a href="#skip" style="text-align: left;">Back to Top</a></div>
<a name="head1" style="text-align: left;"></a>
<h3 style="font-size: 1em; font-weight: 900; margin-bottom: 0px; text-align: left;">
What is regenerative medicine?</h3><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
<b style="text-align: left;">Summary</b><br style="text-align: left;" />
Regenerative medicine is an applied field of tissue engineering that
holds the realistic promise of regenerating damaged tissues <i style="text-align: left;">in vivo (in the living body)</i>
and externally creating "tissues for life" available for implantation.
Through research and products developed from this field, previously
untreatable diseases will become easily and routinely cured.</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
<b style="text-align: left;">How regenerative medicine works</b><br style="text-align: left;" />
Regenerative medicine is the application of tissue science, tissue
engineering, and related biological and engineering principles that
restore the structure and function of damaged tissues and organs. This
new field encompasses many novel approaches to treatment of disease and
restoration of biological function through the following methods: <br><br></div>
<ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Using therapies that prompt the body to autonomously regenerate damaged tissues<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Using tissue engineered implants to prompt regeneration<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Direct transplantation of healthy tissues into damaged environments<br style="text-align: left;" />
</li>
</ul><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Collectively, these treatments allow for two substantial advances over current medicine. The first advance is the potential to <i style="text-align: left;">in vivo (in the living body)</i>
regenerate currently irreparably damaged tissues so that they return to
full functionality. The second advance is to be able to produce tissues <i style="text-align: left;">in vitro (in the laboratory)</i>
to be used for transplantation purposes when regeneration is not
possible. This technology has the potential to cure diseases ranging
from diabetes (through regeneration of islets) to the repair of
cancerous tissues (by replacing the removed cancerous tissue with
externally grown healthy tissue). By creating these "tissues for life,"
regenerative medicine treatments will undoubtedly lead to a tremendous
improvement in quality of life and healthcare. </div><br>
<div style="font-size: 10px; line-height: 1.2em; padding: 2px; text-align: left;">
<a href="#skip" style="text-align: left;">Back to Top</a></div>
<a name="head2" style="text-align: left;"></a>
<h3 style="font-size: 1em; font-weight: 900; margin-bottom: 0px; text-align: left;">
Why do we need Regenerative Medicine?</h3><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
<b style="text-align: left;">Summary</b><br style="text-align: left;" />
Regenerative medicine is a revolutionary approach that focuses on curing
 conditions as opposed to treating them. Regenerative medicine empowers
doctors with the ability to replace damaged tissue in patients with
healthy organic tissue that is accepted and functions like (and in some
cases, is) the body's own. These therapies will cure a variety of
diseases ranging from diabetes to cancer. Regenerative medicine will
lead to improved patient care while eliminating the cost of treatments
such as insulin injections or dialysis. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
<b style="text-align: left;">Regenerative Medicine is a cure, not a treatment</b><br style="text-align: left;" />
What truly differentiates regenerative medicine from many current
therapies is that regenerative medicine has the potential to provide a
cure to failing or impaired tissues. Many of today's increasing
healthcare costs stem from recurring treatments for chronic diseases and
 their subsequent complications. One such example is insulin therapy for
 type(<a href="#1" style="text-align: left;">1</a>)
 diabetes, and glucose therapy for type 2 diabetes. While insulin and
glucose can help patients manage diabetes, these therapies do not cure
diabetes, nor do they prevent long-term complications, such as kidney
failure. Despite insulin, glucose and dialysis treatments, diabetes was
the underlying cause of more than 68,000 deaths and the contributing
cause of death in more than another 141,000 individuals.(<a href="#2" style="text-align: left;">2</a>)
</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Through regenerative medicine, insulin-producing pancreatic islets (in
diabetics, pancreatic islets do not produce the proper insulin levels),
could be regenerated <i style="text-align: left;">in vivo</i>
or grown <i style="text-align: left;">in vitro</i>
and implanted, creating the potential for curing the patient and completely eliminating the need for future treatments. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Other potential regenerative medical advances include the ability to
improve myocardial (heart) functions, which would help combat heart
failure. Regenerative medicine will enable doctors to grow new blood
vessels through vascular endothelial growth factor (VEGF) techniques,
and by improving myocyte growth. With these techniques, heart damage
could be repaired, saving countless lives. Another benefit of
regenerative medicine will be the advancement of our knowledge of the
immune system as scientists work with immunosuppression and other issues
 associated with implantation of organs and tissues. Such knowledge will
 have numerous applications in combating the HIV virus and other immune
deficient conditions. These examples are but a few of the potential
applications and benefits regenerative medicine will bring. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
By providing tissues and organs on demand, regenerative medicine serves a
 dual purpose: increasing quality of life and care for patients, and
reducing healthcare costs by eliminating chronic disease. This medical
advance of always having tissues available for patients can be thought
of as "tissues for life." </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
<b style="text-align: left;">Regenerative medicine can combat end-organ failure</b><br style="text-align: left;" />
One of the greatest needs for regenerative therapy is in the field of
whole organ replacement. Despite broad public education about organ
donation, there remains a large and growing gap in the number of organ
donors versus the demand for organs. In 2002 alone, there were: </div><br>
<ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">12,800 organ donors (deceased and living)<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">24,900 life saving transplants<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">88,242 patients still on the waiting list at the end of the year<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">6,439 people who died while waiting for a transplant(<a href="#3" style="text-align: left;">3</a>)<br style="text-align: left;" />
</li>
</ul><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
These numbers do not take into account the estimated 100,000 potential
candidates who die before being placed on a waiting list.(<a href="#4" style="text-align: left;">4</a>) In total, the cost of all organ replacement therapies in the U.S. is estimated to exceed $100 billion per year.(<a href="#5" style="text-align: left;">5</a>)
 Organ demand is a major health care issue that is growing in magnitude.
 Over the past 10 years, while organ donations have increased, the
waiting list has grown even more:
</div><br>
<ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">In 1992, there were 28,952 patients on the transplant list and 7,092 donors<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">In 1996, there were 49,381 patients on the transplant list and 9,172 donors<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">In 2001, there were 81,528 patients on the transplant list and 12,607 donors(<a href="#6" style="text-align: left;">6</a>)<br style="text-align: left;" />
</li>
</ul><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Despite organ donation education campaigns, the rate of donations has
been greatly outstripped by the increase in need. Tissue and organ
failure is clearly a serious problem that will only increase as our
population grows and ages. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Regenerative medicine confronts this problem from multiple fronts.
First, through regenerative therapies, diseases and conditions that
result from tissue failure can be stopped and healed by regenerating the
 damaged tissues. This regeneration is brought on by therapies that
prompt the body to heal itself by recruiting the proper reparative cells
 <i style="text-align: left;">in vivo</i>, or by implanting small amounts
 of engineered tissue "patches" that prompt the damaged tissues to heal.
 Regenerative medicine also holds promise in transplanting and growing
replacement organs. With regenerative medicine, waiting for a tissue or
organ transplant will become a worry of the past.
</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
<b style="text-align: left;">Regenerative medicine will dramatically alter the U.S. healthcare industry</b><br style="text-align: left;" />
The potential benefits of regenerative medicine - in improved health
care and economic savings - are enormous. Already, the direct healthcare
 costs of organ replacement are about $350 billion globally (about 8
percent of global healthcare spending). These costs arise from therapies
 that keep people alive (such as kidney dialysis), implanted replacement
 devices, and very few (due to lack of donors) organ transplants.(<a href="#7" style="text-align: left;">7</a>)
 With a $350 billion global industry already built on first generation
tissue and organ therapy products and substitutes, regenerative medicine
 has potential to exceed $500 billion in the next 20 years.
</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
An example of some conditions and diseases that could be easily cured by
 regenerative medicine and their current cost of treatment include: </div><br>
<ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">250,000 patients receive heart valves, at a cost of $27 billion annually<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">950,000 people die of heart disease or stroke, at a cost of $351 billion annually(<a href="#8" style="text-align: left;">8</a>)<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">17 million patients with diabetes, at a cost of $132 billion annually(<a href="#9" style="text-align: left;">9</a>)<br style="text-align: left;" />
</li>
</ul><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Regenerative medicine has the ability to prevent many of these
conditions by replacing or repairing malfunctioning tissues. Currently,
U.S. healthcare costs are more than $1.5 trillion, or 13 percent of
GDP.(<a href="#10" style="text-align: left;">10</a>)
 A large fraction of these costs is attributable to tissue loss or organ
 failure, with approximately 8 million surgical procedures being
performed annually in the U.S. to treat these disorders.(<a href="#11" style="text-align: left;">11</a>)
 By 2040, the population of senior citizens in the U.S. will be double
today's number, for a total of 70 million. As much as 25 percent of the
U.S. GDP could be devoted to healthcare by 2040. Because regenerative
medicine focuses on functional restoration of damaged tissues, not
abatement or moderation of symptoms, this field cuts healthcare costs.
Without regenerative medicine, the U.S. faces a future of rising
healthcare costs and inefficient treatments.
</div><br>
<div style="font-size: 10px; line-height: 1.2em; padding: 2px; text-align: left;">
<a href="#skip" style="text-align: left;">Back to Top</a></div>
<a name="head3" style="text-align: left;"></a>
<h3 style="font-size: 1em; font-weight: 900; margin-bottom: 0px; text-align: left;">
What is the current state of regenerative medicine?</h3><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
<b style="text-align: left;">Summary</b><br style="text-align: left;" />
Regenerative medicine to date has made a number of advances in the field
 of simple tissues such as skin, bone, and cartilage. Progress toward
more complex therapies has been limited due to the reliance on private
sector funding and a lack of understanding of fundamental tissue
interactions. Private sector funding has led to a productoriented
approach that does not focus on research or consider the fundamental
science issues in regenerative medicine. Without this fundamental
research, it will be exceedingly difficult for the regenerative medicine
 field to develop more advanced tissues and organs. To accommodate new
biomedical technology, the FDA has created the Office of Combination
Products and the Office of Cellular, Tissue and Gene Therapies. These
new offices solve the problem of regulating complex combination products
 that typically fell under two or more of the FDA's traditional offices.
 These changes help prepare the FDA for regenerative medicine product
regulation and product approvals.</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
<b style="text-align: left;">Current technological accomplishments in regenerative medicine</b><br style="text-align: left;" />
Regenerative medicine research is a new science, with a many new
concepts being researched and tested but few effective products are on
the market. From a research standpoint, several key methods and
approaches have been established including: </div><br>
<ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Direction of cell expansion and differentiation, which explains the processes of how tissues and organ grow<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Development
 of techniques for assembly of cells into large, three dimensional
tissue-like structures, which will lead to the physical creation of
three dimensional organs<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Custom-designed biomaterials to serve as structural templates for tissue development, which helps scientists build organs
<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Automated bioreactor culture vessels, which allows scientists to mass produce cells and tissues(<a href="#12" style="text-align: left;">12</a>)
</li>
</ul><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
These techniques have allowed researchers to begin to understand at a
very basic level how cells and tissues function and interact. At a
functional level, regenerative medicine researchers have been able to
grow heart arteries(<a href="#13" style="text-align: left;">13</a>) and create artificial blood in the laboratory. Engineered bladders(<a href="#14" style="text-align: left;">14</a>),
 ligaments and stem cell therapies are in various stages of preclinical
and clinical tests. However, the only FDA-approved and available
products are much simpler tissues, such as dermal and joint substitutes,
 and bone marrow for orthopedics.(<a href="#15" style="text-align: left;">15</a>) Many skin substitutes have been used successfully, but cartilage and bone replacement techniques have been more difficult.(<a href="#16" style="text-align: left;">16</a>)
 As shown by the limited scope and inconsistent performance of the
products available, regenerative medicine is at a very early stage of
development, hampered by a lack of cohesive fundamental research to
advance the field. It is this research that is needed for the science of
 regenerative medicine to realize its full potential of restoring even
the most complex of tissues to full health.
</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
<b style="text-align: left;">Current barriers to progress in regenerative medicine
</b><br style="text-align: left;" />
There are two major barriers facing regenerative medicine. The first
barrier is a lack of research related to the fundamental "building
block" areas of the science. The second barrier is the lack of
interdisciplinary study, which can be attributed to the focus of private
 funding in the field. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Fundamental building block science is gaining the necessary
understanding to manipulate the technology of a given field for a
desired result. In regenerative medicine, the fundamental research
focuses on cellular interactions at a micro and macro level, which can
then be applied to creating and integrating tissues. Historically,
primarily academia and the Government, in conjunction with private
industry have performed fundamental research, and the discoveries are
then applied by industry to create viable products.(<a href="#17" style="text-align: left;">17</a>)
 The lack of a Federal funding strategy in regenerative medicine has
inhibited fundamental research. While more than $4 billion in private
capital has been invested in the field (without producing a single
profitable product),(<a href="#18" style="text-align: left;">18</a>) cumulative Federal investment in regenerative medicine over the 13 year span from 1988 to 2001 was only about $250 million.(<a href="#19" style="text-align: left;">19</a>)
 This is important for two reasons. First is the obvious disparity of
funding. Second, and equally important, is the type of research
performed by each of these groups. Private industry research is focused
on the end product, and how to get there in the quickest and most cost
efficient manner. Private research also is focused around a singular
field: biology, chemistry, and so on. Government research, however,
tends to be in the form of grants to laboratories that are focused more
on fundamental research that deepens knowledge in a field. It is because
 of this disparity in funding that the current situation exists: $4
billion invested by private industry and no profitable products, and an
extremely limited understanding of how complex tissues function. This
industry that has the potential economic impact of $500 billion
annually, and the Federal investment should be strategically focused.
</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Similar Federal investment has occurred in the past. In the late 1980s
and early 1990s, the Semiconductor Manufacturing Technology consortium
(SEMATECH) and National Electronics Manufacturing Initiatives served to
successfully revive and then lead U.S. industries to become global
market leaders in the semiconductor and electronics industries. More
recent projects are just beginning to come to fruition. Treatments based
 on gene therapies from the Human Genome Project are beginning to arrive
 on the market, and the results of this project will undoubtedly have an
 enormous impact on the future of healthcare. A Federal initiative
providing direction and resources in regenerative medicine would ensure
that the U.S. would be the unquestioned pioneer and leader in this
promising field. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
The lack of a Government initiative has also led to the isolation of
regenerative medicine research by each individual field. There is very
little collaboration and communication among biologists, clinicians,
engineers, biochemists, materials scientists and other related fields
due to the emphasis on private, product-focused funding.(<a href="#20" style="text-align: left;">20</a>)
 Unfortunately, regenerative medicine is a field that requires
cooperation and communication among these different disciplines in order
 to advance the general science. Biologists and biochemists must use
their knowledge of how the body works in conjunction with tissue
engineers to generate products that actually function. Furthermore, all
of these groups must coordinate with clinicians and the FDA to set
priorities of what tissues are in highest demand and how to implant them
 and to ensure that they are safe for humans.(<a href="#21" style="text-align: left;">21</a>)
 Without a Government funding initiative to pull these groups together,
organizational culture issues will continue to inhibit collaboration. It
 is absolutely essential that this coordination happen in order to
expeditiously further the knowledge in the field.
</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
<b style="text-align: left;">Regulatory environment</b><br style="text-align: left;" />
The FDA has begun working towards creating an environment that
accelerates the approval of combination products. Therapies are
classified by the FDA as either a device, biologic, or drug. Each
classification has differing regulations and its own review Center
consisting of experts in a given field. Regenerative medicine products
fall under some or all of these classifications, requiring regulators to
 appropriately integrate different regulations to ensure adequate
product safety and effectiveness. In the past, this added complexity led
 to combination products requiring longer approval times than standard
products. To accommodate the advancements of medicine, the FDA created
its Office of Combination Products (OCP). The Medical Device User Fee
and Modernization Act of 2002 established this new office on December
24, 2002. Under this law, the OCP is given the power to ensure the
timely review of drug-device, drug-biologic, and devicebiologic
combination products.(<a href="#22" style="text-align: left;">22</a>) Examples of some combination products that OCP has handled include:
</div><br>
<ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Dermagraft, which uses an absorbable scaffold to deliver collagen and other skin tissues to wounds<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">InFUSE
 Bone Graft/T-CAGE lumbar tapered fusion device, which is a treatment
for a degenerative disc disease by stabilizing the spacing in the spine
and then forming new bone<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Antibiotic bone cement, used for fixating prosthesis to living bone(<a href="#23" style="text-align: left;">23</a>)<br style="text-align: left;" />
</li>
</ul><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
These products are all combinations of drug, biologic and devices. While
 these products are considerably simpler than organ tissues, thus far
the FDA has shown that it is prepared to efficiently regulate
regenerative medicine products as they become available. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
The FDA has also established the Office of Cellular, Tissue and Gene
Therapies (OCTGT). The OCTGT consolidates a number of regulatory
programs into a single entity with a single expert staff. These
consolidated groups include: </div><br>
<ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Human tissues<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Cellular therapies<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Xenotransplantation<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Gene therapies<br style="text-align: left;" />
</li>
</ul><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
By creating these new offices for regulation, the FDA has begun to
evolve into a more nimble approval agency capable of handling the
advances of the 21st century. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
To complement these new offices, the FDA has also begun collaborating
with various NIH Institutes and participating in the Multi-Agency Tissue
 Engineering Sciences Working Group to raise awareness of FDA guidelines
 and procedures. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Another innovative initiative the FDA has begun in conjunction with the
National Cancer Institute allows cancer researchers to link their
investigational new drug (IND) applications to the FDA. This program has
 the goal of reducing process and submission times for researchers. If
successful, this program will provide a model for IND applications in
other fields, including regenerative medicine. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
While the FDA has made great strides towards embracing new technologies,
 the private sector still views the regulatory process as somewhat
difficult. FIRM will provide a cohesive framework whereby public and
private funding organizations will partner with the FDA very early in
the development of regenerative medicine products to facilitate
transparency in the regulatory oversight process for these new products.
 By partnering in this manner, FIRM will set a new standard for industry
 and FDA cooperation that will lead to faster product approvals without
sacrificing safety or efficacy. </div><br>
<div style="font-size: 10px; line-height: 1.2em; padding: 2px; text-align: left;">
<a href="#skip" style="text-align: left;">Back to Top</a></div>
<a name="head4" style="text-align: left;"></a>
<h3 style="font-size: 1em; font-weight: 900; margin-bottom: 0px; text-align: left;">
What is the future of regenerative medicine technology?</h3><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
<b style="text-align: left;">Summary</b><br style="text-align: left;" />
Despite the availability of some first generation products, researchers
know very little about the underlying science of regenerative medicine.
In order to build complex tissues and organs, scientists first must
understand how tissues interact with each other. To achieve the
envisioned goals of regenerative medicine, a strong Federally-directed
initiative is needed to ensure that this fundamental research is
realized. If a directed and well-funded research effort were to begin,
regenerative medicine could begin producing results within 5 years. At
the 5-year mark, complex skin, cartilage, bone, and blood vessel
products would begin to reach markets. Within 10 years, organ patches
that repair damaged tissues would potentially be available. Within 20
years, full organ regeneration is a strong possibility. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
For these products to be regulated safely and efficiently, the FDA must
continue its recent admirable moves to embrace new technology. The FDA
has recognized the challenge of new medical technology and has worked to
 improve outreach and education about the regulation process, created a
new office for handling the evaluation of combination products, and
created sub-offices for handling tissue and genetic therapies. This
commitment to the future is encouraging and the FDA remains involved in
developments relating to regenerative medicine research. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Other countries have already embarked upon national initiatives of their
 own with hopes of making regenerative medicine a reality for
themselves. Several members of the European Union (EU), including Great
Britain, Germany, and Sweden, as well as Japan, China and Australia have
 all begun making strong national commitments with hopes of achieving
their own advances in regenerative medicine technology. It is time for
the U.S. to commit its own resources and work with these nations as a
leading partner in driving this technology forward. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
<b style="text-align: left;">Next steps for regenerative medicine</b><br style="text-align: left;" />
Although regenerative medicine as a field has existed for over 10 years,
 surprisingly little basic research has been done. In order for the
field to advance, scientists must research fundamental cellular
relationships and develop techniques for cellular production and
preservation. In order to eventually realize the concept of tissues on
demand, interim research steps must be achieved. Examples of interim
research goals that must be achieved include: </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Understand the processes involved in mechanical signaling and cellular
mechanotransduction, which explains how cells and systems communicate
with each other(<a href="#24" style="text-align: left;">24</a>)
</div><br>
<ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Improve control of organogenisis, which is the control of tissue development(<a href="#25" style="text-align: left;">25</a>)<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Create tissues
<i style="text-align: left;">in vitro (in the laboratory)</i>
and then bringing these tissues <i style="text-align: left;">in situ (in the natural environment)</i>, which teaches scientists how to integrate laboratory grown cells into actual living bodies<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Develop
 handling and storage procedures for regenerative medicine applications,
 in order to effectively manage and preserve tissue supplies(<a href="#26" style="text-align: left;">26</a>)<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Increase
 scalability of engineered cells, that enables scientists to
mass-produce engineered cells ensuring enough heart, skin, pancreas, and
 other needed tissues are available<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Develop tissue quality assurance procedures, to ensure tissues are safe and consistent like any mass-produced item(<a href="#27" style="text-align: left;">27</a>)
</li>
</ul><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Despite 10 years of study in regenerative medicine, there has been a
lack of directed research. Although much has been learned on these
subjects the field is still in an embryonic stage. Without this
fundamental research, the potential of fully engineered complex tissues
will never be realized. If regenerative medicine researchers and
clinicians are able to gain a detailed understanding of how cells
interact with each other and how to mass-produce, preserve, catalogue,
and build these cells, they can then apply this knowledge towards
developing tissue and organ based therapies. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
One example of a complex regenerative medicine issue that scientists
must solve is the growth of vasculature in tissues and organs. These
vascular tissues are blood vessels responsible for transporting
nutrients and waste through tissue. Due to a lack of understanding of
cellular interaction, scientists have not been successful in creating
vasculature in tissues and organs, limiting regenerative medicine
products to "two dimensional" materials, such as skin and bone, which do
 not require vascular tissue support.(<a href="#28" style="text-align: left;">28</a>)
 To achieve the promise of regenerative medicine, growing vascularized
tissues is a necessary next step. To do this, scientists must gain a
better understanding of tissue interactions and scaffold technology.
Once scientists understand these concepts, they will be able to apply
this knowledge and create more advanced tissue systems.(<a href="#29" style="text-align: left;">29</a>)
 Ultimately, the application of knowledge of cellular interactions and
tissue growth will culminate in two branches of regenerative medicine
research,
<i style="text-align: left;">in vivo</i>
cell based therapy and <i style="text-align: left;">in vitro</i>
grown tissues and organs. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Cell-based therapy focuses on cellular treatments that lead to
regeneration by having the body "gather" the necessary reparative cells
and bring them to the damaged site. The second branch is the <i style="text-align: left;">in vitro</i>
growth of tissues and organs that are then implanted within the body,
either to prompt regeneration or to replace damaged tissue.(<a href="#30" style="text-align: left;">30</a>)
 Each branch of research offers substantial advances over current
medicine, and discoveries from one branch may be directly applicable to
the other. Both of these research branches are vital for fully realizing
 all of the potential therapies of regenerative medicine. For example,
preliminary research has shown that spinal cord regeneration through
implantation of seeded scaffolds is feasible.(<a href="#31" style="text-align: left;">31</a>)
 Seed-driven regeneration is a form of cell-driven therapy that will not
 require transplantation of a new tissue or organ. On the other hand, it
 is believed that treatment of a cancerous lung would require removing
the lung and replacing it with a laboratory grown healthy lung. In the
case of cancer, seeding the lung for regeneration would not work, as the
 cancer would still be present.
</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
These two different applications of regenerative medicine demonstrate
why it is essential to research both cellular therapies and full organ
growth techniques to maximize the potential of regenerative medicine. It
 may be possible to use regenerative medicine to cure a diseased lung
without removing it, or to cure spinal injuries through neural cell
transplants. What is most important is that these two branches be
investigated fully: findings from both will further our knowledge of
regenerative medicine. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Fulfilling these goals will create a foundation for future regenerative
medicine products and work. A cohesive effort focused on advancing the
science and the field as a whole is essential. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
<b style="text-align: left;">Projected timeline of regenerative medicine</b><br style="text-align: left;" />
With a cohesive Government initiative and appropriate funding, within 20
 years regenerative medicine will be the standard of care for replacing
all tissue/organ systems in the body in addition to extensive industrial
 use for pharmaceutical testing.(<a href="#32" style="text-align: left;">32</a>) The ultimate goal at the end of 20 years is to have real time mass customization of tissues on demand,
<i style="text-align: left;">in vivo</i>. During those 20 years, as our
knowledge of tissues grows, it is reasonable to expect to see treatments
 discovered along the way, roughly at the 5, 10 and 20 year marks. In 5
years the following milestones are hoped for:
</div><br>
<ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Develop multiple applications for skin, cartilage, bone, blood vessel, and some urological products(<a href="#33" style="text-align: left;">33</a>)<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Develop insurance reimbursable regenerative therapies
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Establish standards for FDA regenerative medicine therapy product approvals<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Solve cell sourcing issues, giving researchers access to the materials they need to design new therapies<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Establish cost-effective means of production, paving the way for future products<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Establish specialized cell banks for tissue storage, allowing storage of viable "off the shelf" products
</li>
</ul><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
In 10 years, effective regenerative medicine therapies will be available
 for patient care and industrial research and development purposes. At
this time, the following may be achieved: </div><br>
<ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Further understand stem cell and progenitor cell biology<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Engineer smart degradable biocompatible scaffolding<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Develop microfabrication and nanofabrication technologies to produce tissues with their own complete vascular circulation(<a href="#34" style="text-align: left;">34</a>)<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Develop complex organ patches, that could repair damaged pieces of the heart or other organs(<a href="#35" style="text-align: left;">35</a>)<br style="text-align: left;" />
</li>
</ul><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Ultimately, within 20 years the full benefits of regenerative medicine
therapies will be reached. Some of the applications of regenerative
medicine could be: </div><br>
<ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Harness regenerative medicine materials to produce
<i style="text-align: left;">in situ</i>
regeneration of diseased and damaged structures in many areas of the body<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Regenerate most damaged tissues and organs either
<i style="text-align: left;">in vivo</i>
or through implanted regeneration therapies<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Produce
<i style="text-align: left;">in vitro</i>
sophisticated 3-D tissues and organs that cannot be regenerated through <i style="text-align: left;">in vivo</i>
techniques, such as an entire heart or lung<br style="text-align: left;" />
</li>
</ul><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Without a Federal initiative supporting this research, this timeline
could extend over the next 40 to 50 years. Considering the many economic
 and health advances this technology may bring, it is absolutely vital
that regenerative medicine advance as quickly as possible. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
<b style="text-align: left;">Future regulatory challenges and potential issues</b><br style="text-align: left;" />
One of the most challenging aspects of developing new medical treatments
 is ensuring that these treatments are safe as well as effective. What
might be safe in Japan or Sweden may not be considered safe in the U.S.
As with any new medical advance, regenerative medicine products will be
complex and require a great deal of laboratory study in order to confirm
 their safety. Regenerative medicine is a new field that will pose new
challenges for the FDA. In order to ensure efficient and effective
regulation, it is important the FDA continue to make their review
processes transparent and easy to follow so that clear expectations for
product safety and quality of clinical evidence needed for approval are
in place. If a researcher takes a misstep early in the complex
regulatory process, a great deal of time and money can be wasted.(<a href="#36" style="text-align: left;">36</a>)
 Rigorous testing to ensure product safety is crucial. However, it is
important to streamline processes where possible to foster innovation
and new product development.
</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
The most frequently cited concerns by industry are the lack of clarity
about the regulatory requirements and the level of efficacy that must be
 demonstrated to get a product on the market. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
More specific criticisms include: </div><br>
<ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Requirements for large clinical trials, which are expensive for companies to run<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Necessity for more than one efficacy trial for some products, which adds to expenses<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Shifting
 requirements, which confuses companies regarding the timeframes of
deliverables, creating frustration about the process requirements and
expectations<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Lack
of direction about the regulatory pathway (drug, biologic, device),
which has been largely answered by the creation of the OCP<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Level of proof needed to demonstrate effectiveness, which is used in designing clinical trials(<a href="#37" style="text-align: left;">37</a>)<br style="text-align: left;" />
</li>
</ul><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
From the FDA's perspective, the process for approving new products is
slowed by companies who delay discussions until much of the product and
clinical development plan has already been established. With new
technology or novel products like regenerative medicine therapies, the
approval process is enhanced and expedited when the FDA is included in
the discussions about product and clinical development at an early
stage. This allows the FDA to provide more instructive feedback about
the products and better understand the technology behind them. It is
therefore critical that the FDA be involved early in regenerative
medicine research so that the regulatory scientists can learn about the
technology congruently with the academic and private sectors. This
understanding will ultimately lead to quicker approvals as familiarity
with regenerative medicine technology increases.(<a href="#38" style="text-align: left;">38</a>)
</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
The FDA has and continues to make a strong effort to stay on the cutting
 edge of new technology. The most important goal of the FDA is to remain
 fluid in their structure and to embrace new technology by creating
appropriate venues as opposed to forcing new technology into old
paradigms, while upholding the necessary standards of safety and
efficacy. Thus far, the FDA has performed admirably in preparing for the
 next generation of medicine. As long as regenerative medicine companies
 are willing to involve the FDA in their product design process from
inception to completion, the regulatory process will be no more
burdensome than is necessary to ensure product safety. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
<b style="text-align: left;">Foreign efforts in regenerative medicine</b><br style="text-align: left;" />
The U.S.' preeminence in the field of regenerative medicine is in
jeopardy. A study led by the National Science Foundation and released in
 January 2002 noted that the U.S. lead in cross-disciplinary research is
 shrinking as compared to Japan and Europe, who are the next most
advanced players in regenerative medicine, respectively.(<a href="#39" style="text-align: left;">39</a>)
 In 1995, only 5 percent of companies involved in regenerative medicine
research were based outside the U.S. By 2002, this percentage of
non-U.S. regenerative medicine companies had increased to 46 percent.(<a href="#40" style="text-align: left;">40</a>)
 It is apparent that regenerative medicine's promise of revolutionary
curative treatments has been recognized by other nations who are now
moving to embrace this technology through both private industry and
national government resource commitments.
</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
The Japanese government has committed resources to the city of Kobe in
the Kansai region of Japan. The Kobe Medical Industry Development
Project aims to nurture an industry in the fields of advanced medical
care and welfare to meet the new requirements of Japan's rapidly aging
society.(<a href="#41" style="text-align: left;">41</a>)
 The plan includes spending a total of ¥91 trillion ($831 billion) by
the year 2010 on assorted therapies and infrastructure to raise the
standard of living of Japan's elderly. One of the key components of the
Kobe Medical Industry Development program is cell therapy and
regenerative medicine research.(<a href="#42" style="text-align: left;">42</a>)
 Japan, faced with one of the largest populations of the elderly, has
seen the benefits of regenerative medicine technology and appropriately
embraced them.
</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
The European Union is still working to establish an infrastructure for
regenerative medicine. Currently, the Enterprise Directorate-General in
the European Commission is writing the first regenerative medicine
regulation for Europe and will have the responsibility to develop and
organize regenerative medicine efforts in the EU.(<a href="#43" style="text-align: left;">43</a>)
 A total of 436 tissue-engineering related companies currently exist in
the EU, with 40 percent located in the United Kingdom and Germany.
British firms are focusing on integration between technologies and
applications, whereas German firms are focusing on vertical
specializations in technologies and applications.(<a href="#44" style="text-align: left;">44</a>)
 While the EU has a strong commercial base, their national support
program is limited. However, they have taken the first step by having
the European Commission formulate a regenerative medicine strategy for
the EU.
</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Other notable foreign efforts include Australia, which boasts a growing
regenerative medicine industry, and China, which has committed a $1
billion initial investment towards establishing regenerative medicine
research.(<a href="#45" style="text-align: left;">45</a>)
 It is very apparent that the international community views regenerative
 medicine as a priority over the next 20 years. In the next 15-20 years,
 there will be 300 foreign companies competing in the field of
regenerative medicine.(<a href="#46" style="text-align: left;">46</a>)
 It is essential that the U.S. join these efforts as a leading partner
to ensure that our internal resources and expertise helps to shape this
revolutionary new technology. Without direction and resources from the
U.S. Government, regenerative medicine is a technology that will not be
fully realized for 40 to 50 years.
</div><br>
<div style="font-size: 10px; line-height: 1.2em; padding: 2px; text-align: left;">
<a href="#skip" style="text-align: left;">Back to Top</a></div>
<a name="head5" style="text-align: left;"></a>
<h3 style="font-size: 1em; font-weight: 900; margin-bottom: 0px; text-align: left;">
How could the United States get there?</h3><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
<b style="text-align: left;">Summary</b><br style="text-align: left;" />
In order to assure that the U.S. has the most effective and
comprehensive regenerative medicine program in the world, the Federal
government must take a direct hand in regenerative medicine. By creating
 a Federal initiative focused on researching the fundamentals of
regenerative medicine, the resources will be available to fill in the
"research gaps" of the field and allow private industry to focus on what
 it does best, creating products that meet the needs of consumers. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
An initiative in Regenerative Medicine would involve more than simply an
 allocation of funds. This initiative could be known as the Federal
Initiative for Regenerative Medicine (FIRM). It would stretch beyond
simply being an allocation of resources. The true strength of the
program will be the funding combined with a synchronization and
collaboration of the agendas of the Federal agencies already involved in
 regenerative medicine research and bringing the fruits of this research
 to academia and private industry. Research will focus around "building
block" technologies that advance the science as a whole and "challenge
problems" which produce tangible results such as functional organs. In
conjunction with advancing the science of regenerative medicine, FIRM
will also take a strong hand in ensuring that the U.S. public is both
excited about and understanding of the capabilities of regenerative
medicine. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
<b style="text-align: left;">What FIRM is and how it advances regenerative medicine</b><br style="text-align: left;" />
The goal of FIRM would be to advance regenerative medicine to the point
of providing real time, mass-customization of tissues on demand, <i style="text-align: left;">in vivo</i>, within the next 20 years.
</div><br>

<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Following on the footsteps of past successful government initiatives,
such as SEMATECH and the Human Genome Project, FIRM will provide
direction through a council dedicated to reaching the goal of tissues on
 demand. Composed of representatives of Government agencies involved in
FIRM, the governance council will be responsible for setting milestones
to advance the science of regenerative medicine and empower industry to
take this knowledge and technology to create effective regenerative
medicine products. This centralized, coordinated effort also will allow
FIRM to develop standards for cellular data, reference materials and
other protocols that will enable different U.S. research teams to easily
 compare data with each other. This standardization could potentially
extend to global efforts as well, allowing regenerative medicine
research to overcome many of the protocol issues that have impaired
communications between research groups in other fields. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
FIRM will also take advantage of supplemental funding for regenerative
medicine research. This money will be used for intramural research at
Government labs (NIH, NASA, NIST, etc) as well as in the form of
extramural research funding through existing Government mechanisms (NIH,
 DARPA). This commitment will continue over 20 years and is a flexible
number: if more opportunities for research in the field are discovered,
additional funds can be appropriated to take advantage of such
breakthroughs. With current funding to date of only $250 million over
the past decade, an increase in government resources will provide the
necessary commitment to make this technology a reality. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
The benefits of realizing regenerative medicine will be two-fold. The
first benefit will be bringing our Nation the next generation of
healthcare by preventing and curing tissue and organ failure. The second
 will be to help grow the first new "decade defining" industry of the
millennium. Past Government initiatives, such as SEMATECH, helped grow
the worldwide semiconductor industry from an $8 billion annual industry
into a $170 billion annual industry with only approximately $2 billion
in government funding. FIRM offers the chance for a similar payoff, with
 the end product bringing a higher quality of life to Americans as well
as growing a new industry. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
<b style="text-align: left;">How FIRM will be structured</b><br style="text-align: left;" />
FIRM will crosscut the programs of a number of Federal agencies,
affording opportunities for the sharing of expertise, specialized
facilities, and best practices in research and research management. The
current regenerative medicine stakeholders represent a multitude of
organizational structures and functions. Each of these groups, such as
the Department of Health and Human Services (including NIH and FDA), the
 Department of Defense (including DARPA), the National Aeronautics and
Space Administration, Department of Commerce (including NIST), the White
 House Office of Science and Technology Policy, the President's Council
of Advisors on Science and Technology, and the National Science
Foundation, as well as academia and industry have distinct practices and
 goals in implementing their regenerative medicine activities. It is
important for the FDA to play an active role in the development of
regenerative medicine technology. If safety and efficacy expectations
are transparent, clinical studies can be designed and carried out with
FDA requirements clearly understood, leading to more efficient approval
processes.(<a href="#47" style="text-align: left;">47</a>)
</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
A governance council will manage FIRM. This council will include members
 of all participating Government agencies, with each member agency
having representation on the council. Any Government agency with an
interest in advancing regenerative medicine will be welcome to join. By
cross-cutting multiple agencies, the council can take advantage of the
strengths and expertise of each member agency. For example, NSF and NIH
are principally invested in fundamental discovery, while NIST and DARPA
focus on exploratory development. NASA and DOD are more specifically
mission-oriented, requirement-driven organizations and thus are more
focused on applied development. The strength of FIRM will be to leverage
 and focus the resources and strengths of these agencies to advance
regenerative medicine. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
The FIRM council will decide research priorities and milestones to
accomplish this research through distribution of funds and Government
resources. By continually monitoring the state of regenerative medicine
research, setting new research goals and seeing these goals through to
completion, FIRM will aggressively advance regenerative medicine. The
research developed through FIRM-driven programs will be disseminated to
academia and business for development of regenerative medicine
therapies. Research milestones will range in scope from fundamental
science issues, such as: </div><br>
<ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Developing a greater understanding of cellular interactions in a given tissue<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Developing methods to store and preserve tissues for long periods of time<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Developing mass production techniques for a type of tissue<br style="text-align: left;" />
</li>
</ul><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
These research goals serve the very important goal of advancing the
science of regenerative medicine leading to products and therapies.
"Challenge problems" will serve to complement these research-oriented
goals. These challenge problems are similar to the "Grand Challenges" of
 the National Nanotechnology Initiative, which include goals such as
containing the entire contents of the Library of Congress on a device no
 bigger than a sugar cube.(<a href="#48" style="text-align: left;">48</a>) Examples of FIRM "challenge problems" are:
</div><br>
<ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Demonstrate a fully functional working organ by the year 2010<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Cure for diabetes through the successful growth and implantation of islets by the year 2015<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Cure paralysis through spinal cord treatments by the year 2020<br style="text-align: left;" />
</li>
</ul><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
These challenge problems serve as a powerful marketing tool that
captures the imagination of end-users who will ultimately benefit from
this technology. Both the research and challenge problem goals will be
achieved with a combination of intramural research at Government labs,
FIRM-funded centers of excellence, and externally-funded ventures. FIRM
must constantly assess these goals and ensure that they are on-task and
that milestones are being met. Resources will be allocated in the best
interest of FIRM's goals, taking into account the scope, payoff, and
difficulty of each project. From a research standpoint, it is important
that the FIRM council recognize that regenerative medicine research will
 focus more on breakthrough advances than incremental ones. Accordingly,
 funding and research must be shaped in a format that supports
breakthrough style research. One such format is that seen in DARPA
programs.(<a href="#49" style="text-align: left;">49</a>)
</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
The DARPA model of funding involves about 80 program managers who
distribute between $2 billion and $2.5 billion annually. These program
managers are typically experienced professionals from industry or
academia. They report to one of six office directors who in turn report
to the Director of DARPA. DARPA's management structure is very lean and
allows for a rapid flow of communication between layers. This funding
model has shown itself to be extremely advantageous in certain
situations, including: </div><br>
<ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">An advance promising a major leap, not an incremental improvement<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">A capacity whose development requires substantial sustained funding<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">A field or technique that is unlikely to be developed quickly by ongoing academic efforts or within industrial firms<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">An emerging scientific field or technical area that lacks a natural disciplinary base(<a href="#50" style="text-align: left;">50</a>)
<br style="text-align: left;" />
</li>
</ul><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Very clearly, regenerative medicine falls under all of these proposed
categories. It would be worthwhile, in advancing this initiative, to
consider disbursing at least some of FIRM's funding through a DARPA-like
 model positioned out of NIH. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
<b style="text-align: left;">FIRM research will be focused through theme-based centers of excellence</b><br style="text-align: left;" />
To maximize the leverage of existing regenerative medicine research at
NIH, FIRM will create a Center for Regenerative Medicine to bring
experts from all the Institutes together under one organizational unit.
In addition to this Center and existing Government laboratories,
additional research will be done at "centers of excellence" which will
be created through pairing Government efforts and resources with
universities, research hospitals and other research centers. Each of
these centers will be responsible for a particular type of regenerative
medicine research, thereby creating focal points for private industry to
 work with in generating regenerative medicine therapies. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
A Future for Regenerative Medicine January 2005 These centers of
excellence would also focus on forming multidisciplinary teams that are
vital to the advancement of regenerative medicine. Such teams bring
together the following experts: </div><br>
<ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Engineers<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Physicians<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Cell Biologists<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Computational biologists<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Nanotechnology fabrication experts<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Developmental Biologists<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Immunologists<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Materials scientists<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Economists<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Structural biologists<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Educators<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Social scientists<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Psychologists<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Ethicists<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Vascular biologists<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Chemists<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Biochemists<br style="text-align: left;" />
</li>
</ul><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Some of the greatest advancements in science have grown from new
discoveries in one field leading to advances in others. The invention of
 the steam engine, an engineering accomplishment is often credited with
being the primary reason for the growth of thermodynamics. By bringing
together engineers and other material scientists with biologists and
other life sciences scientists, these centers will increase the spectrum
 of available knowledge for regenerative medicine by providing varied
viewpoints that lead to a more balanced research approach.(<a href="#51" style="text-align: left;">51</a>)
 Due to logistical issues, only a few academic and commercial
laboratories have assembled such groups. With FIRM, these teams will be
more commonplace, allowing FIRM researchers to take a broader and more
encompassing view than has been seen thus far. These teams can then turn
 their collective resources towards a variety of regenerative medicine
themes.
</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Potential themes might include: </div><br>
<ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Tooth and Maxillo-Facial Repair and Replacement<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Cardiac Tissue Repair and Replacement<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">GI and Urinary Tract Repair and Replacement<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Skin and Muscle Repair and Replacement(<a href="#52" style="text-align: left;">52</a>)<br style="text-align: left;" />
</li>
</ul><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Encouraging and promoting cross-center information sharing and
innovative design advances, each center would provide secondary support
to other themes to foster exchange of ideas. For example, the skin and
muscle repair and replacement center might support the cardiac tissue
repair and replacement center, as some muscle growth techniques might
apply to growing muscles in the heart. These centers will ultimately
become the primary source of regenerative medicine research for industry
 to draw upon in creating new products. </div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
<b style="text-align: left;">FIRM Funding</b><br style="text-align: left;" />
Proposed is an exponential change, not an incremental increase in
Federal dollars allocated for regenerative medicine. An
order-of-magnitude upsurge is needed to drive this field forward. Such
an increase will ensure U.S. success in regenerative medicine by
providing a strong underpinning, a thorough scientific-knowledge
foundation, and the training for the first true generation of
regenerative medicine scientists and engineers.</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
This
 money will be controlled by the FIRM council and then allocated to
subsidiary agencies in accordance with the goals set by the FIRM
council. Funds allocated by FIRM will be placed as a line item into
member agency budgets, and the member agencies will then be responsible
for accomplishing the goals set by the council. For example, DARPA
(through DOD) might be assigned to research skin grafts for combat
wounds. DARPA would then receive funding from the FIRM council yearly
until the project is completed. The FIRM council would oversee this
effort to ensure that research data is shared and the project is being
managed properly. In the event that a program is not performing up to
task or research is not being shared, the FIRM council has the power to
rectify these problems in the best possible manner.</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Goals
 along the roadmap will be monitored as milestones, and phase-out
mechanisms will be included to ensure that old projects are efficiently
closed down, allowing new projects to be started. Methods to measure
success of specific activities need to be developed, and performance
measures need to be established and continually monitored.</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Choreographing
 a such an initiative will be challenging; however, a multi-agency
framework coordinated through a FIRM council with active and strong
leadership would ensure a successful utilization of resources.
Implementing lessons learned from the National Nanotechnology Initiative
 and other complex multi-agency Government R&amp;D efforts will also be
critical. With planning and strong direction, FIRM has the power to
bring regenerative medicine to the U.S. public, enhancing their welfare
and leading people to live fuller, richer lives.</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
<b style="text-align: left;">Benefits of FIRM</b><br style="text-align: left;" />
FIRM brings two major benefits to the American public. The first is a
leap to a new generation of healthcare therapies that will have
countless applications towards curing an assortment of diseases and
conditions. Second is an opportunity to establish a new global industry
that has the potential for $100 billion to $500 billion in worldwide
annual revenues. Both of these reasonsmake FIRM an essential Federal
program.</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Regenerative
 medicine has the potential to treat nearly every tissue and organ
failure condition and disease that currently plagues our society. This
technology is arriving at a crucial time in American healthcare.
Currently, there are 35 million people over the age of 65 in the U.S.(<a href="#53" style="text-align: left;">53</a>),
 12 percent of the approximate 281 million people in the U.S. However,
due to the immense baby boomer population, there are about 57 million
Americans aged 55-64.(<a href="#54" style="text-align: left;">54</a>)
 Within 10 years, there will be more than 70 million Americans, more
than one-fifth of the population, over the age of 65. People in the
senior citizen age group face a variety of diseases that require
regenerative medicine therapies including:</div><br>
<ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Diabetes<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Osteoporosis<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Heart Disease<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Strokes<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Cancer(<a href="#55" style="text-align: left;">55</a>)<br style="text-align: left;" />
</li>
</ul><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Baby
 boomers have watched medical technology advance substantially during
their lifetime. As they age into the senior citizen category, their
health is one of their top concerns, as is the desire to remain capable
of leading an active lifestyle.(<a href="#56" style="text-align: left;">56</a>)
 Regenerative medicine offers the increase of quality of healthcare that
 baby boomers both need and are seeking. If FIRM were to begin today,
the program would be at the 10 year mark as the last baby boomer crosses
 into senior citizen status. At this point, regenerative medicine could
potentially be offering skin, bone, and joint replacement products as
well as organ patches capable of slowing or reversing organ failure and
degradation. Without these regenerative medicine therapies to cure
tissue failure-related diseases, healthcare costs will rise. However,
with these therapies, the baby boomer population will be the first group
 to experience regenerative medicine's benefit to quality of life. Baby
boomers will almost assuredly embrace regenerative medicine and the
promises it brings them.</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
The
 second major benefit that FIRM has to offer is growing a new,
multibillion-dollar global industry. While computers and semiconductors
defined the 1980s, the Internet dominated the 1990s; the 2000s have seen
 economic challenge and thus far lack a defining cutting-edge industry.
While biotechnology has offered the promise of new therapies and
treatments, the biotechnology industry has yet to produce many products
and even fewer profits. Government investment has led to innovation and
new markets in the past.</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
One
 story of resounding success of government-industry partnership is that
of SEMATECH. In the late 1980s, to counteract the slipping performance
of the $8 billion(<a href="#57" style="text-align: left;">57</a>)
 a year American semiconductor industry, an industry-government
consortium known as SEMATECH was created, comprised of 14 U.S.
semiconductor manufacturers and the U.S. Government.(<a href="#58" style="text-align: left;">58</a>)
 Together, industry and Government leveraged common resources (including
 laboratories an funding), created industry roadmaps advancing
technology, and shared risks to advance and rais the quality of American
 semiconductor technology. During the next decade, the consortium worked
 with a $1.5 billion Federal commitment over 6 years in conjunction
industry manufacturing and funding to create faster, cheaper, and better
 chips.(<a href="#59" style="text-align: left;">59</a>)
 By 1996, Federal funding was voluntarily stopped by SEMATECH, as the
industry no longer neede the funds. The U.S. had restored its lead in th
 semiconductor industry. SEMATECH remains active today, mapping out
future research and coordinating industry activities.(<a href="#60" style="text-align: left;">60</a>)
 This partnersh strengthened and ensured the strength of the American
semiconductor industry, and had the positive effect of making the U.S.
the leading nation in semiconductor technology today with $70 billion in
 sales and 50 percent of global market share in 2002.(<a href="#61" style="text-align: left;">61</a>)
 While one could rightful argue that the global semiconductor industry
would have grown to its current size today without SEMATECH, it is
almost certain that without SEMATECH the U.S. would not be the market
leader in semiconductors today. Without a doubt, the SEMATECH consortium
 was one of the biggest and most successful partnerships between
industry and Government. SEMATECH was able to right a damaged industry
and reached self-sufficiency within a decade of inception. This
successful story provides a powerful case study for how FIRM could
potentially be structured.</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Another
 example of successful Government-industry partnership is the hard disk
storage manufacturing industry, today a $50 billion industry. In the
late 1980s Japan was poised to dominate this market. But in 1990,
specificall response to the opportunity to receive funding from the
Department of Commerce, U.S. participants in this industry formed the
National Storage Industry consortium and the National Science Foundation
 established an enginee research center on data storage. This
technological investment by key government agencies led to hard drive
storage densities growing at twice the pre-investment rate, and allowing
 the U.S. hard drive storage industry to remain competitive.(<a href="#62" style="text-align: left;">62</a>)</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Funding
 from other Government agencies has made substantial impacts as well.
The Departme of Energy's Office of Industrial Technologies shares the
cost of developing new energy efficie technology with a number of
industries (including steel, agriculture, chemicals, among others);
enabling these industries to cost-efficiently develop new technologies.(<a href="#63" style="text-align: left;">63</a>)
 This program has benefited the U.S. steel industry in particular new
technologies that could potentially save steel industry 70 trillion
BTU/year, or about 30 percent of the industry's energy cost.(<a href="#64" style="text-align: left;">64</a>)</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
The
 U.S. Government has a tremendous history of spurring forward innovation
 and growth of industries. Regenerative medicine is the industry waiting
 to be focused and grown through Government investment and leadership.</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Regenerative
 medicine offers a field that presents the opportunity for concrete
solutions to diseases through the replacement of failing tissues. If
supported bt the Federal government regenerative medicine has the
opportunity to become the defining industry of the 21st Century.
Government initiatives and research funding have in the past been shown
to lend support to indusrty and consumer confidence. While economic
benefits from FIRM would not be realized overnight, it does provide the
opportunity to lay the foundation for an industry with huge potential.</div><br>

<div style="font-size: 10px; line-height: 1.2em; padding: 2px; text-align: left;">
<a href="#skip" name="head6" style="text-align: left;">Back to Top</a></div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
<b style="text-align: left;">Increasing Public Awareness and Support</b><br style="text-align: left;" />
Participants at an HHS-sponsored conference in March 2003 larg that,
with a few exceptions, regenerative medici endeavors have not resulted
in economically viable products and have not aroused tremendo public
interest. With perception often being reality, it is important that
regenerative medici receive the appropriate attention and arouses the
excitement merited from the public. It is esse that FIRM contain a large
 education and outreach component charged with the task of instilling
enthusiasm and excitement for the initiative in American culture.</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
As
 one potential strategy to pique public interest and to attract bright
researchers, the education and outreach arm of FIRM could focus on the
"Challenge Problems" previously mentioned. Particularly marketable are
challenge problems that involve tangible products that the public can
appreciate. Examples of such "Challenge Problem" products might be:</div><br>
<ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">A retinal patch<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">A living tooth<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Tissue engineere<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">Tissue to repair injured or damaged<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">A functioning human liver<br style="text-align: left;" />
</li>
<li style="font-size: 13px; line-height: 1.4em; text-align: left;">A functioning human bladder<br style="text-align: left;" />
</li>
</ul><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
These
 challenges present an oppportunity to show the public tangible
accomplishments to excite them. Further, by creating milestones that
build up expectations, such as first repairing heart tissue
<i style="text-align: left;">in vivo</i>, then developing a heart
"patch," and finally creating a working heart, the public has time to
get accustomed and comfortable with the technology.</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Equally
 important is the education of the public on how regenerative medicine
science works and the risks of the technology. Particularly in the field
 of medicine, the American public is very risk adverse. In order to
ensure that the technology is accepted, outreach and educational
programs targeted at people of all ages should be developed and
administered. The concept of therapies that repair and replace damaged
organs is wondrous, but to some might be viewed as invasive. Therefore
it is the FIRM's duty to ensure that questions are answered and that the
 program and its goals are transparent.</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
In
 order to achieve the proper levels of education and acceptance, FIRM
must be publicly marketed and branded at a level not seen since the
Apollo program. FIRM must become a part of the public school systems,
have high-profile spokesperson and have a logo as well recognized as the
 breast cancer ribbon or the double helix of the Human Genome Project.
With all of these efforts, FIRM will become a technology whose household
 name ensures it is a public priority, not just a Government priority.</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
By
 integrating FIRM into the public school systems, the initiative will
gain support from today's youngsters who will grow up with regenerative
medicine breakthroughs during their lives. Additionally, parents they
hear about regenerative medicine from the children. It also will serve
to promote interest the researchers of tomorrow. A high school student
today could become a graduate student in 10 years who may choose to make
 regenerative medicine his or her life's work. By building a foundation
of people who understand and are comfortable with the technology, we can
 lay foundation for future research in regenerative medicine.</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
By
 finding key spokespeople to promote FIRM the initiative will appeal to
the American public as a whole. Spokespeople can be an effective way of
garnering attention and support by putting a we known "fa on finding the
 appropriate celebrities who can push FIRM at public events, through
public service announcements and other major venues.</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Public
 support will dramatically affect future Government and private
commitment. If the public is aware of the benefits that regenerative
medicine brings, they will begin to expect and demand that this
technology become a reality.</div><br>
<div style="font-size: 10px; line-height: 1.2em; padding: 2px; text-align: left;">
<a href="#skip" style="text-align: left;">Back to Top</a></div>
<a name="conclusion" style="text-align: left;"></a>
<h3 style="font-size: 1em; font-weight: 900; margin-bottom: 0px; text-align: left;">
Conclusion</h3><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
Regenerative medicine offers the potential to cure countless fatal and debilitating conditions through therapies that spur
<i style="text-align: left;">in vivo</i>
regeneration and <i style="text-align: left;">in vitro</i>
creation of healthy tissue for implantation. The next evolution of
medical technology is now in sight, and has the potential to become
reality in the next 20 years. Other nations have envisioned the
opportunities that regenerative medicine will bring to society. Our
Nation's private sector has seen the otential benefits, having spent $4
billion in hopes of making regenerative medicine a reality. Despite this
 tremendous private investment, there is little to show in terms of
viable products, due to the lack of scientific research and
coordination. The U.S. Government can provide direction and resources to
 the regenerative medicine effort to allow private industry to focus on
product development.</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
FIRM
 offers an opportunity to bring the U.S. to the forefront of
regenerative medicine. With a dedicated U.S. Government investment in
regenerative medicine for the next 20 years in conjunction with concise
goal setting and fulfillment as directed by the FIRM council, FIRM
provides the unique opportunity to leverage resources. This formula has
seen success when implemented with the Human Genome Project, and is the
model for the National Nanotechnology Initiative. FIRM will leverage
Government labs, funding mechanisms, and financial resources to give
regenerative medicine a vision and purpose, and bring this vision to the
 American public. While regenerative medicine is an inevitable evolution
 of science, without guidance the technology will take too long to
mature. FIRM is required to unravel the complexities of regenerative
medicine and to make this technology a reality in the next 20 years.
Other nations have seen the need for national direction. Now is the
U.S.' time to embrace this technology by making FIRM a framework for the
 next generation of healthcare. America's greatest natural resource is
ingenuity. Coupled with the necessary funding and direction, our Nation
can maintain its preeminence in biotechnology by paving the way to the
future with the evolving world of regenerative medicine. By doing so, we
 can make tissue and organ failure a relic of the past by 2020.</div><br>
<div style="font-size: 10px; line-height: 1.2em; padding: 2px; text-align: left;">
<a href="#skip" style="text-align: left;">Back to Top</a></div>
<center>

<h3 style="font-size: 1em; font-weight: 900; margin-bottom: 0px;">
Interagency Federal Working Group on Regenerative Medicine</h3><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px;">
<b>Chair</b><br />
Howard Zucker, MD, JD<br />
Deputy Assistant Secretary for Health<br />
U.S. Department of Health and Human Services</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px;">
<b>National Institutes of Health</b><br />
Donna Dean, PhD<br />
Colleen Guay-Broder, MPH<br />
Eleni Kousvelari, PhD<br />
Christine Kelley, PhD<br />
John Watson, PhD<br />
Josh Zimmerberg, PhD</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px;">
<b>Food and Drug Administration</b><br />
Charles Durfor, PhD<br />
Donald Fink, PhD<br />
Joyce Frey, PhD<br />
Jesse Goodman, MD<br />
Darin Weber, PhD<br />
Celia Witten, PhD</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px;">
<b>Department of Defense</b><br />
Joe Bielitzki, PhD<br />
Michael Goldblatt, PhD, JD<br />
Alan Rudolph, PhD<br />
Col. Robert Vandre, DDS</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px;">
<b>National Aeronautics and Space Administration</b><br />
Steve Davison, PhD<br />
Neal Pellis, PhD</div><br>
<div style="font-size: 13px; line-height: 1.2em; padding: 2px;">
<b>Department of Commerce</b><br />
Angie Hight-Walker, PhD<br />
National Science Foundation<br />
Fred Heineken, PhD<br />
Michael Roco, PhD</div><br>
</center>
<hr style="text-align: left;" />
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</a><a name="16" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="16" style="text-align:left;">Hentz, Vincent R. Chang, James. "Tissue Engineering for reconstruction of the thumb." The New England Journal of Medicine. 344 (2001): 1547- 1548
</a><a name="17" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="17" style="text-align:left;">Schwartz, Ketty. Vilquin, Jean-Thomas. "Building the translational highway: toward new partnerships between academia and the private sector." Nature Medicine 9 (2003): 493-495
</a><a name="18" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="18" style="text-align:left;">Lysaght, Michael J. Reyes, Joyce. "The growth of tissue engineering." Tissue Engineering 7 (2001): 485-493
</a><a name="19" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="19" style="text-align:left;">McIntire, Larry V. Greisler, Howard P. Griffith, Linda. Johnson, Peter C. Mooney, David J. Mrkisich, Milan. Parenteau, Nancy L. Smith, David. WTEC panel report on tissue engineering research. Maryland: Loyola College, 2002.
</a><a name="20" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="20" style="text-align:left;">Boyan, Barbara. "Where is the field of tissue engineering/regenerative medicine today?" Workshop on Tissue Engineering and Regenerative Medicine. U.S. Department of Health and Human Services. 28 March 2003
</a><a name="21" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="21" style="text-align:left;">Ibid.
</a><a name="22" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="22" style="text-align:left;">FDA Establishes Office of Combination Products. Food and Drug Administration. 15 September 2003
</a><a href="http://www.fda.gov/bbs/topics/NEWS/2002/NEW00862.html" target="_blank" style="text-align:left;">
http://www.fda.gov/bbs/topics/NEWS/2002/NEW00862.html</a>
<a name="23" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="23" style="text-align:left;">Office of Combination Products Recent Examplesof Combination Products List. Food and Drug Administration. 15 September 2003
</a><a href="http://www.fda.gov/oc/combination/approvals.html" target="_blank" style="text-align:left;">
http://www.fda.gov/oc/combination/approvals.html</a>
<a name="24" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="24" style="text-align:left;">Griffith, Linda G. Grodzinsky, Alan J. "Advances in biomedical engineering." JAMA 285 (2001): 556-561
</a><a name="25" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="25" style="text-align:left;">Mitka, Mike. "Tissue engineering approaches utility." JAMA 284 (2000): 2582-2583
</a><a name="26" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="26" style="text-align:left;">Bradbury, Jane. "Of tardigrades, trehalose, and tissue engineering". The Lancet, August 4, 2001 358 (9279): 392
</a><a name="27" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="27" style="text-align:left;">Goldblatt, Michael. "Where is the field of tissue engineering today and what is the future?" Workshop on Tissue Engineering and Regenerative Medicine. U.S. Department of Health and Human Services. 28 March 2003
</a><a name="28" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="28" style="text-align:left;">Wiesmann, William P. "What is the future of tissue engineering/regenerative medicine?" Workshop on Tissue Engineering and Regenerative Medicine. U.S. Department of Health and Human Services. 28 March 2003
</a><a name="29" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="29" style="text-align:left;">Zandonella, Catherine. "Tissue engineering: The beat goes on." Nature 421 (2003): 884-886
</a><a name="30" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="30" style="text-align:left;">Griffith, Linda G. Naughton, Gail. "Tissue engineering-current challenges and expanding opportunities." Science 295 (2002): 1005-1009
</a><a name="31" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="31" style="text-align:left;">Teng, Yang D. Lavik, Erin B. Qu, Xianlu. Park, Kook I. Ourednik, Jitka. Zurahowski, David. Langer, Robert. Snyder, Evan Y. "Functional recovery following traumatic spinal cord injury mediated by a unique polymer scaffold seeded with neural stem cells." Proceedings of the National Academy of Sciences of the USA Vol. 99 (2002): 3024-3029
</a><a name="32" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="32" style="text-align:left;">Ellisseff, Jennifer "What is the future of regenerative medicine?" Workshop on Tissue Engineering and Regenerative Medicine. U.S. Department of Health and Human Services. 28 March 2003
</a><a name="33" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="33" style="text-align:left;">Vacanti, Joseph P. "What is the future of regenerative medicine?" Workshop on Tissue Engineering and Regenerative Medicine. U.S. Department of Health and Human Services. 28 March 2003
</a><a name="34" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="34" style="text-align:left;">Vacanti, Joseph P. "What is the future of regenerative medicine?" Workshop on Tissue Engineering and Regenerative Medicine. U.S. Department of Health and Human Services. 28 March 2003
</a><a name="35" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="35" style="text-align:left;">Warren, William L. "What is the current State of Regenerative Medicine?" Workshop on Tissue Engineering and Regenerative Medicine. U.S. Department of Health and Human Services. 28 March 2003
</a><a name="36" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="36" style="text-align:left;">Heinz III, H. J. Implementing Tissue Engineering: Financial and Regulatory Guidance. Department of Engineering &amp; Public Policy, School of Public Policy and Management and Department of Social and Decision Sciences. Carnegie Mellon University
</a><a name="37" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="37" style="text-align:left;">"A Concept Paper for A Federal Initiative in Regenerative Medicine (FIRM), Tissues for Life." Department of Health and Human Services. July 2003.
</a><a name="38" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="38" style="text-align:left;">Frey-Vasconcells, Joyce, "What regulatory, policy, economic and other obstacles confront the field of tissue engineering/regenerative medicine?" Workshop on Tissue Engineering and Regenerative Medicine. U.S. Department of Health and Human Services. 28 March 2003
</a><a name="39" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="39" style="text-align:left;">Larry V. McIntire, "What is the Current State of Regenerative Medicine?" Workshop on Tissue Engineering and Regenerative Medicine. U.S. Department of Health and Human Services. 28 March 2003 40 Ibid.
</a><a name="40" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="40" style="text-align:left;">Ibid.
</a><a name="41" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="41" style="text-align:left;">Kyoto News. "Foreign investment across Japan." Journal of Japanese Trade &amp; Industry. September 1, 2003.
</a><a name="42" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="42" style="text-align:left;">The Kobe Medical Industry Development Project Outline. City of Kobe, Japan. 8 October 2003
</a><a href="http://www.city.kobe.jp/cityoffice/06/015/iryo/contents/aramashi01_e.html#Project" target="_blank" style="text-align:left;">
http://www.city.kobe.jp/cityoffice/06/015/iryo/contents/aramashi01_e.html#Project</a>
<a name="43" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="43" style="text-align:left;">Mission Statement. Enterprise Directorate-General Unit F3. 8 October 2003
</a><a href="http://pharmacos.eudra.org/F3/f3com/mission.htm" target="_blank" style="text-align:left;">
http://pharmacos.eudra.org/F3/f3com/mission.htm</a>
<a name="44" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="44" style="text-align:left;">"European Competitiveness report 2001." The European Commission. P. 110
</a><a name="45" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="45" style="text-align:left;">McIntire, Larry V. Nerem, Robert M. Ratner, Buddy D. Russell, Alan J. Vacanti, Joseph P. "Letter to the President Bush " Alliance for the Engineering of Replacement Tissues, December 13, 2002
</a><a name="46" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="46" style="text-align:left;">An Industry Emerges. Pittsburgh Tissue Engineering Institute. 10 October 2003
</a><a href="http://www.ptei.org/industry/pdf/industry.pdf" target="_blank" style="text-align:left;">
http://www.ptei.org/industry/pdf/industry.pdf</a>
<a name="47" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="47" style="text-align:left;">Frey-Vasconcells, Joyce, "What regulatory, policy, economic and other obstacles confront the field of tissue engineering/regenerative medicine?" Workshop on Tissue Engineering and Regenerative Medicine. U.S. Department of Health and Human Services. 28 March 2003
</a><a name="48" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="48" style="text-align:left;">National Nanotechnology Initiative: From Vision to Implementation. Roco, M.C. National Nanotechnology Initiative. 8 October 2003
</a><a href="http://www.nano.gov/nni11600/sld001.htm" target="_blank" style="text-align:left;">
http://www.nano.gov/nni11600/sld001.htm</a>
<a name="49" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="49" style="text-align:left;">Cook-Deegan, Robert Mullan. "Does NIH need a DARPA?" Issues in Science &amp; Technology, Winter 1996
</a><a name="50" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="50" style="text-align:left;">Ibid.
</a><a name="51" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="51" style="text-align:left;">Darrell J. Irvine "What Regulatory, Policy, Economic and other obstacles confront the field of tissue engineering/regenerative medicine?" Workshop on Tissue Engineering and Regenerative Medicine. U.S. Department of Health and Human Services. 28 March 2003
</a><a name="52" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="52" style="text-align:left;">Joseph Vacanti "Why should the American public support a National Tissue Engineering Initiative?" Workshop on Tissue Engineering and Regenerative Medicine. U.S. Department of Health and Human Services. 28 March 2003
</a><a name="53" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="53" style="text-align:left;">Hetzel, Lisa. Smith, Annetta. "The 65 Years and Over Population: 2000" United States Census Bureau. Issued October 2001.
</a><a name="54" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="54" style="text-align:left;">Smith, Denise. "The Older Population in the United States: March 2002", United States Census Bureau. Issued April 2003
</a><a name="55" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="55" style="text-align:left;">Seniors' Health Topic. MEDLINEplus. 23 September 2003
</a><a href="http://www.nlm.nih.gov/medlineplus/seniorshealth.html" target="_blank" style="text-align:left;">
http://www.nlm.nih.gov/medlineplus/seniorshealth.html </a><a name="56" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="56" style="text-align:left;">Kantrowitz, Barbara. "Health for Life." Newsweek. Special Edition Fall/Winter (2001): 5-10
</a><a name="57" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="57" style="text-align:left;">"U.S. EQUIPMENT AND MATERIALS SUPPLIERS TO PARTICIPATE IN SEMATECH" PR Newswire. May 27, 1987
</a><a name="58" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="58" style="text-align:left;">Corporate Information: History. International Sematech. 8 October 2003
</a><a href="http://www.sematech.org/public/corporate/history/history.htm" target="_blank" style="text-align:left;">
http://www.sematech.org/public/corporate/history/history.htm </a><a name="59" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="59" style="text-align:left;">Auerbach, Stuart. "Chip Firms Set 5-Year Timetable Project Seen Helping U.S. Regain Its Lead." The Washington Post. May 13, 1987
</a><a name="60" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="60" style="text-align:left;">Corporate Information: History. International Sematech. 8 October 2003
</a><a href="http://www.sematech.org/public/corporate/history/history.htm" target="_blank" style="text-align:left;">
http://www.sematech.org/public/corporate/history/history.htm </a><a name="61" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="61" style="text-align:left;">Tuttle, Molly (Director of Communications of the Semiconductor Industry Association). Personal Interview. 8 October 2003
</a><a name="62" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="62" style="text-align:left;">White, Robert M. "A message to Congress." MIT's Technology Review. 100 (1997): 5
</a><a name="63" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="63" style="text-align:left;">OIT Programs. Office of Industrial Technologies. 8 October 2003.
</a><a href="http://www.oit.doe.gov/programs.shtml#fa" target="_blank" style="text-align:left;">
http://www.oit.doe.gov/programs.shtml#fa</a>
<a name="64" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
</p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="64" style="text-align:left;">Valenti, Michael. "A cradle for new steel technologies." Mechanical Engineering. 120 (1998): 60-65</td>


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U.S. Department of Health &amp; Human Services · 200 Independence Avenue, S.W. · Washington, D.C. 20201 </div><br>
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