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Source Code HHS 2020 Vision Rebuilt Archive With Extra Info.

SingularityUtopia May 9th, 2014 363 Never
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  6. <title>HHS Regenerative Medicine 2020 Future Vision</title>
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  11. <meta property="og:title" content="Regenerative Medicnine Info via Singularity 2045." />
  12. <meta property="og:description" content="Rebuilt fair use archive of delelted HHS page, 2020 vision. Includes extra regenerative medicine info up to May 2014." />
  13.  
  14. <meta itemprop="name" content="Regenerative Medicine. Forecasts and progress. HHS and other sources.">
  15. <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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  290.  
  291. <a name="bigthink"></a>
  292.  
  293. <div class="bodystyle">
  294.  
  295.  
  296. <br><br>
  297.  
  298.  
  299. <!-- SU INTRO FINAL COLLATION-->
  300.  
  301.  
  302. <div class="suboxed">
  303. 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.
  304. </div>
  305.  
  306.  
  307.  
  308.  
  309. <div class="subox">
  310. <div class="ar">Archive</div>
  311.  
  312.  
  313. <!-- SU INTRO ARCHIVE -->
  314.  
  315. <div style="width:580px;">
  316. &#x25CF; HHS page first published <b style="text-align: left;">Jan 2005</b>. See also
  317. <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>.
  318. <br>
  319.  
  320. 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>).
  321. <br><br>
  322.  
  323. 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>.
  324.  
  325. <br><br>
  326. <a href="https://twitter.com/intent/tweet?screen_name=2045singularity" class="twitter-mention-button" data-size="large" data-related="2045singularity">Tweet to @2045singularity</a>
  327. <script>!function(d,s,id){var js,fjs=d.getElementsByTagName(s)[0],p=/^http:/.test(d.location)?'http':'https';if(!d.getElementById(id)){js=d.createElement(s);js.id=id;js.src=p+'://platform.twitter.com/widgets.js';fjs.parentNode.insertBefore(js,fjs);}}(document, 'script', 'twitter-wjs');</script>
  328. </div>
  329. <div class="home"><a class="homecol" href="http://singularity-2045.org" title="2045 Home">Singularity 2045</a></div>
  330.  
  331.  
  332.  
  333.  
  334. </div>
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  341. <script type="text/javascript">var addthis_config = {data_use_cookies:false}</script> <div class="addthis_toolbox addthis_default_style"> <a class="addthis_counter addthis_pill_style" addthis:title="#Singularity #RegenerativeMedicine" addthis:description="Immortality"></a> </div> <script type="text/javascript" src="http://s7.addthis.com/js/300/addthis_widget.js#pubid=xa-5174ed8f2a525770#async=1"></script>
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  359.  
  360.  
  361. <!-- SEAL HSS LOGO -->
  362.  
  363. <td rowspan="3" style="color: black; cursor: pointer; font-family: verdana, arial, helvetica, sans-serif; font-size: 13px; font-style: normal; font-weight: normal; padding:  0px 0px 7px; text-align: left; vertical-align: bottom; width: 101px;"><a href="http://www.hhs.gov/" target="_blank" style="text-align: left;"><img alt="United States Department of Health &amp; Human Services" src="data:image/gif;base64,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" style="border-width: 0px; height: 104px; text-align: left; width: 101px;" /></a></td>
  364.  
  365.  
  366. <!-- TEXT HHS LOGO below -->
  367.  
  368. <td style="color: black; cursor: pointer; font-family: verdana, arial, helvetica, sans-serif; font-size: 13px; font-style: normal; font-weight: normal; height: 87px; padding: 0px 0px 9px; text-align: left; vertical-align: bottom;"><a href="http://www.hhs.gov/" target="_blank" style="text-align: left;"><img alt="United States Department of Health &amp; Human Services" src="data:image/gif;base64,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" style="border-width: 0px; height: 70px; text-align: left; width: 363px;" /></a></td>
  369.  
  370.  
  371. <!-- 270 then 295 below is width of search box area div -->
  372.  
  373. <td style="color: black;
  374. font-family: verdana, arial, helvetica, sans-serif;
  375. font-size: 13px;
  376. font-style: normal;
  377. font-weight: normal;
  378. padding: 0px;
  379. position: relative;
  380. text-align: left;
  381. vertical-align:
  382. bottom; width: 320px;">
  383.  
  384.  
  385.  
  386.  
  387. <div style="font-size: 13px; line-height: 1.2em; margin-bottom: 5px; margin-top: 5px; padding: 2px; text-align: left;">
  388. <br /></div>
  389.  
  390.  
  391. <ul style="line-height: 1.2em; list-style-image: url(data:image/gif; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
  392. <li style="font-size: 13px; line-height: 1.4em; text-align: left;"><b style="text-align: left;"><a href="http://www.hhs.gov/ocr/privacy/hipaa/faq/index.html" style="text-align: left;" target="_blank">Frequent Questions</a></b></li>
  393. </ul><br>
  394.  
  395.  
  396.  
  397. <!-- GOLD BOX AROUND SEARCH -->
  398.  
  399. <div style="border-radius: 5px 8px 2px 0px; text-align:left;font-size:12px;margin: 10px 34px -13px -26px; padding: 1px 30px 13px 10px;background-color: rgb(253, 204, 104); position:relative;">
  400.  
  401. <p style="text-align:left;font-size:13px;line-height:1.2em;margin: 0px; padding: 5px 0px 0px; ">
  402. </p>
  403.  
  404.  
  405. <!--below moves inner search-box and button -->
  406.  
  407. <form action="http://search.hhs.gov/search" method="GET" style="text-align:left;margin: 0px 0px -6px 5px; padding: 0px; ">
  408.  
  409.  
  410. <label for="searchbox" style="text-align:left;z-index:-1;position:relative;margin-right:-50px;">Search</label>
  411. <input maxlength="256" name="q" value="" style="text-align:left;font-size:13px;">
  412. <input name="Submit" value="Search" title="Search Button" style="font-size:13px;background-color: rgb(251, 245, 206); " type="submit">
  413. <input name="entqr" value="0" style="text-align:left;font-size:13px;" type="hidden">
  414. <input name="ud" value="1" style="text-align:left;font-size:13px;" type="hidden">
  415. <input name="sort" value="date:D:L:d1" style="text-align:left;font-size:13px;" type="hidden">
  416. <input name="output" value="xml_no_dtd" style="text-align:left;font-size:13px;" type="hidden">
  417. <input name="site" value="HHS" style="text-align:left;font-size:13px;" type="hidden">
  418. <input name="ie" value="UTF-8" style="text-align:left;font-size:13px;" type="hidden">
  419. <input name="oe" value="UTF-8" style="text-align:left;font-size:13px;" type="hidden">
  420. <input name="lr" value="lang_en" style="text-align:left;font-size:13px;" type="hidden">
  421. <input name="client" value="HHS" style="text-align:left;font-size:13px;" type="hidden">
  422. <input name="proxystylesheet" value="HHS" style="text-align:left;font-size:13px;" type="hidden">
  423.  
  424.  
  425. </form>
  426. </div>
  427. </td>
  428. </tr>
  429.  
  430. <!-- length of thin bar below 855 00000000000000 -->
  431.  
  432. <tr style="color: black; font-family: verdana, arial, helvetica, sans-serif; font-size: 13px; font-style: normal; font-weight: normal; text-align: left;">
  433. <td colspan="2" style="color: black; font-family: verdana, arial, helvetica, sans-serif; font-size: 13px; font-style: normal; font-weight: normal; padding: 0px; text-align: left;"><img alt="line" src="data:image/gif;base64,R0lGODlhAQAHAIAAAP3MaP///yH5BAEAAAEALAAAAAABAAcAAAIDhA8FADs=" style="height: 7px; text-align: left; width: 815px;" /></td>
  434. </tr>
  435.  
  436. <tr style="color: black; font-family: verdana, arial, helvetica, sans-serif; font-size: 13px; font-style: normal; font-weight: normal; text-align: left;">
  437. <td colspan="2" style="color: black; font-family: verdana, arial, helvetica, sans-serif; font-size: 13px; font-style: normal; font-weight: normal; height: 8px; padding: 0px; text-align: left;"><br /></td>
  438. </tr>
  439.  
  440. </tbody></table>
  441.  
  442.  
  443. <!-- PRINT and PDF-->
  444.  
  445. <div style="float: right; font-size: 13px; line-height: 1.2em; margin-bottom: 21px; margin-top: -5px; padding: 0px 122px; text-align: left;">
  446. Print
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  463. <h1 style="font-size: 1.4em; font-weight: 600; text-align: left;">
  464. 2020: A New Vision - A Future for Regenerative Medicine</h1>
  465. <h2 style="font-size: 1.2em; font-weight: 600; margin-bottom: 5px; text-align: left;">
  466. U.S. Department of Health and Human Services</h2><br>
  467. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  468. The
  469.  following document addresses a specific area of biotechnology that
  470. shows great promise for treatment and cure of life-threatening diseases.
  471.  The report delineates one particular approach of how America can best
  472. maintain its preeminence in the field of biomedical engineering. The
  473. suggested timelines and endpoints are examples of a strategy that our
  474. nation can use to secure our leadership in the field of regenerative
  475. medicine.</div>
  476. <h3 style="font-size: 1em; font-weight: 900; margin-bottom: 0px; text-align: left;">
  477. Table of Contents</h3><br><br>
  478. <ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
  479. <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;" />
  480. </li>
  481. <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;" />
  482. <ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
  483. <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;" />
  484. </li>
  485. <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;" />
  486. </li>
  487. <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;" />
  488. </li>
  489. <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;" />
  490. </li>
  491. <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;" />
  492. </li>
  493. <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>
  494. </li>
  495. </ul>
  496. </li>
  497. <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;" />
  498. </li>
  499. </ul><br>
  500. <a name="exsum" style="text-align: left;"></a>
  501. <br><h3 style="font-size: 1em; font-weight: 900; margin-bottom: 0px; text-align: left;">
  502. Executive Summary</h3><br>
  503. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  504. Regenerative medicine is the next evolution of medical treatments.
  505. Derived from the fields of tissue engineering, tissue science, biology,
  506. biochemistry, physics, chemistry, applied engineering and other fields,
  507. regenerative medicine is the first truly interdisciplinary field that
  508. utilizes and brings together nearly every field in science. This new
  509. field holds the realistic promise of regenerating damaged tissues and
  510. organs <i style="text-align: left;">in vivo (in the living body)</i>
  511. through reparative techniques that stimulate previously irreparable
  512. organs into healing themselves. Regenerative medicine also empowers
  513. scientists to grow tissues and organs <i style="text-align: left;">in vitro (in the laboratory)</i>
  514. and safely implant them when the body is unable to be prompted into healing itself. </div><br>
  515. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  516. This revolutionary technology has the potential to develop therapies for
  517.  previously untreatable diseases and conditions. Examples of diseases
  518. regenerative medicine can cure include diabetes, heart disease, renal
  519. failure, osteoporosis and spinal cord injuries. Virtually any disease
  520. that results from malfunctioning, damaged, or failing tissues may be
  521. potentially cured through regenerative medicine therapies. Having these
  522. tissues available to treat sick patients creates the concept of "tissues
  523.  for life." </div><br>
  524. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  525. Beyond the obvious health benefits of regenerative medicine, this
  526. technology is desperately needed to combat rising healthcare costs.
  527. Current national healthcare costs are in excess of $1.5 trillion
  528. annually, or 13 percent of Gross Domestic Product (GDP). The 2000 census
  529.  report finds that there are 35 million Americans aged 65 or older. In
  530. 10 years, this number is expected to increase dramatically as the 56.6
  531. million Americans who are currently aged 55-64 join the senior citizen
  532. age group. By 2040, as the last baby boomer becomes a senior citizen,
  533. the population of senior citizens over the age of 65 in the U.S. will be
  534.  double today's number, for a total of 70 million. Accordingly, as much
  535. as 25 percent of the U.S. GDP would be devoted to healthcare by 2040.
  536. The majority of these projected costs stem from recurring treatments for
  537.  diseases that arise from tissue failure commonly seen in the elderly.
  538. The baby boomer demographic is one that has seen continual medical
  539. advancement in their lifetime. This group expects the best from
  540. healthcare and will have the greatest need for regenerative medicine.
  541. Regenerative medicine therapies will help combat common diseases in the
  542. elderly such as diabetes, osteoporosis and cardiovascular disease. Baby
  543. boomers would almost certainly rally behind the efforts to advance
  544. regenerative medicine as it offers them the greatest hope for the most
  545. effective medical treatment and quality of life in their senior years. </div><br>
  546. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  547. Approximately $4 billion has been spent to date by the U.S. private
  548. sector on regenerative medicine, with precious few products on the
  549. market. The only products to date are first generation skin and
  550. cartilage substitutes. Further innovation has been stymied by a lack of
  551. fundamental building block research in regenerative medicine. Other
  552. major scientific advancements, such as the Human Genome Project, the
  553. National Nanotechnology Initiative, and semiconductor research have seen
  554.  major support from the U.S. Government, with the private sector
  555. augmenting Government driven research with great efficacy. Despite this
  556. historically proven formula for success, regenerative medicine has
  557. received more than ten times as much private funding as Government
  558. funding. To create complex tissues and organs, Government resources and
  559. coordination are essential for driving the research effort in an
  560. efficient and swift manner. </div><br>
  561. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  562. Regenerative medicine, if driven by a cohesive Federal initiative, has
  563. the opportunity to begin producing complex skin, cartilage and bone
  564. substitutes in as little as 5 years. Tissue and organ patches, designed
  565. to help regenerate damaged tissues and organs such as the heart and
  566. kidneys are within reach in 10 years. Within 20 years, with appropriate
  567. Federal funding and direction, the goal of "tissues on demand" is
  568. realistic. Additionally, efforts to advance regenerative medicine offers
  569.  the opportunity to create a tremendous new global industry led by the
  570. U.S. The current world market for replacement organ therapies is in
  571. excess of $350 billion, and the projected U.S. market for regenerative
  572. medicine is estimated at $100 billion. Furthering this field would
  573. create jobs and grow a new sector of the healthcare industry while
  574. creating a new generation of life-saving products. </div><br>
  575. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  576. Already, Japan, the European Union (EU), China and Australia have begun
  577. national initiatives and efforts to spur the advancement of their
  578. regenerative medicine programs. These commitments range from policy
  579. directives in the EU to extensive financial investment by the Japanese
  580. government focused on the city of Kobe and surrounding Kansai region
  581. targeted to develop a region of expertise in tissue engineering and
  582. regenerative medicine. Despite this strong foreign commitment to
  583. regenerative medicine, the U.S. presence in regenerative medicine is in
  584. danger of being eclipsed. More than 40 percent of the regenerative
  585. medicine firms founded since 2000 have been outside of the U.S., and
  586. many existing firms have had financial and technical difficulty. To
  587. remain scientifically competitive, it is essential that there be strong
  588. U.S. leadership and research in this new field. </div><br>
  589. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  590. To achieve the aggressive goal of tissues on demand within 20 years, the
  591.  Federal Initiative for Regenerative Medicine (FIRM) is proposed. </div><br>
  592. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  593. Appropriate annual funding is critical to the success of this
  594. initiative. In conjunction with this substantial resource commitment,
  595. FIRM would establish a guidance and governance council including all
  596. Government agencies currently involved in regenerative medicine. These
  597. agencies thus far include the Department of Health and Human Services
  598. (including the National Institutes of Health and the Food and Drug
  599. Administration), the Department of Defense (including the Defense
  600. Advanced Research Projects Agency), the Department of Commerce
  601. (including the National Institute of Standards and Technology), the
  602. White House Office of Science and Technology Policy, the National
  603. Aeronautics and Space Administration, the President's Council of
  604. Advisors on Science and Technology, and the National Science Foundation;
  605.  and would be open to any other agencies interested in furthering
  606. regenerative medicine. This council would set milestones to advance
  607. regenerative medicine and then funding and ensuring that these
  608. milestones come to fruition. Milestones will range from "pure science"
  609. techniques such as studying cellular and tissue interactions, to
  610. "challenge problems" such as curing diabetes by replacing pancreatic
  611. islets. The fruits of FIRM research will be disseminated to academia and
  612.  private industry, allowing quicker product and therapy development. By
  613. adopting the formula of Government, academic and industry cooperation
  614. that has pushed many other technological initiatives forward, FIRM will
  615. advance regenerative medicine quickly and efficiently. The Semiconductor
  616.  Manufacturing Technology Consortium (SEMATECH) used this same model of
  617. government and industry cooperation and funding in the late 1980s and
  618. early 1990s. SEMATECH received about $2 billion in Government funding
  619. and helped grow from an $8 billion yearly U.S. semiconductor industry in
  620.  1987 to the $170 billion, 50 percent global market share industry
  621. today. Regenerative medicine is a field primed for this same Government
  622. driven growth and success. </div><br>
  623. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  624. Without a Federal initiative, regenerative medicine as an
  625. American-driven science faces a precarious future. Although there has
  626. been strong private investment, returns thus far have been almost
  627. nonexistent. The products that the regenerative medicine industry
  628. currently produces are very simple and questionably justify the
  629. tremendous private investment to date. If private investment money
  630. ceases and there is no Government initiative, regenerative medicine will
  631.  be driven by foreign efforts and companies, leaving U.S. ingenuity and
  632. influence absent from the future of regenerative medicine and increasing
  633.  the cost of care to access this technology in the U.S. Even worse,
  634. without support from FIRM, regenerative medicine could take 40-50 years
  635. to be realized. The U.S. Government has always been on the forefront of
  636. new technology and regenerative medicine should be no different. It is
  637. time for the U.S. Government to embark upon an initiative that will make
  638.  this technology a reality. </div><br>
  639. <div style="font-size: 10px; line-height: 1.2em; padding: 2px; text-align: left;">
  640. <a href="#skip" style="text-align: left;">Back to Top</a></div>
  641. <a name="intro" style="text-align: left;"></a>
  642. <h3 style="font-size: 1em; font-weight: 900; margin-bottom: 0px; text-align: left;">
  643. Introduction</h3><br>
  644. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  645. Regenerative medicine is the vanguard of 21st century healthcare. We are
  646.  on the cusp of a worldwide explosion of activity in this rapidly
  647. growing field of biomedicine that will revolutionize health care
  648. treatment. Regenerative medicine will lead to the creation of fully
  649. biological or biohybrid tissues and organs that can replace or
  650. regenerate tissues and organs damaged by disease, injury, or congenital
  651. anomaly. Because of the economic potential of this industry (the
  652. worldwide market for regenerative medicine is conservatively estimated
  653. to be $500 billion by 2010)1, initiatives to capture significant shares
  654. of this market are multiplying around the world and competition is
  655. mounting. </div><br>
  656. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  657. In the U.S., the symbiotic relationship between Government and science
  658. is vital in understanding and developing cures for disease. This
  659. relationship is an essential aspect of assuring the safety and well
  660. being of U.S. citizens. Perhaps because of the enormous medical advances
  661.  fostered through Government-funded research and the public's trust in
  662. the Government's role in improvement and oversight of medical care,
  663. Americans not only embrace medical technology and medical advances, but
  664. have come to expect the best that clinical care and medical research can
  665.  offer. The average American has come of age with remarkable medical
  666. advances - from the polio vaccine, to multi-organ transplants, to the
  667. real prospect of nerve regeneration. Regenerative medicine, with its
  668. promise of repairing damaged tissues and growing replacement tissues and
  669.  whole organs, is the new frontier to capture the imagination and employ
  670.  the famous American "can do" spirit of easing human suffering. </div><br>
  671. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  672. In the spirit of ingenuity, regenerative medicine is a collaborative
  673. effort. Leadership in this field will come from people who are willing
  674. to work across disciplinary lines and Federal and private sector
  675. boundaries. A successful regenerative medicine initiative requires the
  676. expert knowledge of scientists, engineers, physicians, researchers, and
  677. many others in a multidisciplinary effort focused through a Federal
  678. initiative that provides the framework and resources to fully realize
  679. the potential of this revolutionary new field. Other nations have
  680. already begun to realize that focused national initiatives are vital to
  681. advancing this promising science. It is now up to the U.S. to do the
  682. same and create a Federal Initiative for Regenerative Medicine (FIRM) to
  683.  make this science a reality. </div><br>
  684. <div style="font-size: 10px; line-height: 1.2em; padding: 2px; text-align: left;">
  685. <a href="#skip" style="text-align: left;">Back to Top</a></div>
  686. <a name="head1" style="text-align: left;"></a>
  687. <h3 style="font-size: 1em; font-weight: 900; margin-bottom: 0px; text-align: left;">
  688. What is regenerative medicine?</h3><br>
  689. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  690. <b style="text-align: left;">Summary</b><br style="text-align: left;" />
  691. Regenerative medicine is an applied field of tissue engineering that
  692. holds the realistic promise of regenerating damaged tissues <i style="text-align: left;">in vivo (in the living body)</i>
  693. and externally creating "tissues for life" available for implantation.
  694. Through research and products developed from this field, previously
  695. untreatable diseases will become easily and routinely cured.</div><br>
  696. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  697. <b style="text-align: left;">How regenerative medicine works</b><br style="text-align: left;" />
  698. Regenerative medicine is the application of tissue science, tissue
  699. engineering, and related biological and engineering principles that
  700. restore the structure and function of damaged tissues and organs. This
  701. new field encompasses many novel approaches to treatment of disease and
  702. restoration of biological function through the following methods: <br><br></div>
  703. <ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
  704. <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;" />
  705. </li>
  706. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Using tissue engineered implants to prompt regeneration<br style="text-align: left;" />
  707. </li>
  708. <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;" />
  709. </li>
  710. </ul><br>
  711. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  712. 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>
  713. regenerate currently irreparably damaged tissues so that they return to
  714. full functionality. The second advance is to be able to produce tissues <i style="text-align: left;">in vitro (in the laboratory)</i>
  715. to be used for transplantation purposes when regeneration is not
  716. possible. This technology has the potential to cure diseases ranging
  717. from diabetes (through regeneration of islets) to the repair of
  718. cancerous tissues (by replacing the removed cancerous tissue with
  719. externally grown healthy tissue). By creating these "tissues for life,"
  720. regenerative medicine treatments will undoubtedly lead to a tremendous
  721. improvement in quality of life and healthcare. </div><br>
  722. <div style="font-size: 10px; line-height: 1.2em; padding: 2px; text-align: left;">
  723. <a href="#skip" style="text-align: left;">Back to Top</a></div>
  724. <a name="head2" style="text-align: left;"></a>
  725. <h3 style="font-size: 1em; font-weight: 900; margin-bottom: 0px; text-align: left;">
  726. Why do we need Regenerative Medicine?</h3><br>
  727. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  728. <b style="text-align: left;">Summary</b><br style="text-align: left;" />
  729. Regenerative medicine is a revolutionary approach that focuses on curing
  730.  conditions as opposed to treating them. Regenerative medicine empowers
  731. doctors with the ability to replace damaged tissue in patients with
  732. healthy organic tissue that is accepted and functions like (and in some
  733. cases, is) the body's own. These therapies will cure a variety of
  734. diseases ranging from diabetes to cancer. Regenerative medicine will
  735. lead to improved patient care while eliminating the cost of treatments
  736. such as insulin injections or dialysis. </div><br>
  737. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  738. <b style="text-align: left;">Regenerative Medicine is a cure, not a treatment</b><br style="text-align: left;" />
  739. What truly differentiates regenerative medicine from many current
  740. therapies is that regenerative medicine has the potential to provide a
  741. cure to failing or impaired tissues. Many of today's increasing
  742. healthcare costs stem from recurring treatments for chronic diseases and
  743.  their subsequent complications. One such example is insulin therapy for
  744.  type(<a href="#1" style="text-align: left;">1</a>)
  745.  diabetes, and glucose therapy for type 2 diabetes. While insulin and
  746. glucose can help patients manage diabetes, these therapies do not cure
  747. diabetes, nor do they prevent long-term complications, such as kidney
  748. failure. Despite insulin, glucose and dialysis treatments, diabetes was
  749. the underlying cause of more than 68,000 deaths and the contributing
  750. cause of death in more than another 141,000 individuals.(<a href="#2" style="text-align: left;">2</a>)
  751. </div><br>
  752. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  753. Through regenerative medicine, insulin-producing pancreatic islets (in
  754. diabetics, pancreatic islets do not produce the proper insulin levels),
  755. could be regenerated <i style="text-align: left;">in vivo</i>
  756. or grown <i style="text-align: left;">in vitro</i>
  757. and implanted, creating the potential for curing the patient and completely eliminating the need for future treatments. </div><br>
  758. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  759. Other potential regenerative medical advances include the ability to
  760. improve myocardial (heart) functions, which would help combat heart
  761. failure. Regenerative medicine will enable doctors to grow new blood
  762. vessels through vascular endothelial growth factor (VEGF) techniques,
  763. and by improving myocyte growth. With these techniques, heart damage
  764. could be repaired, saving countless lives. Another benefit of
  765. regenerative medicine will be the advancement of our knowledge of the
  766. immune system as scientists work with immunosuppression and other issues
  767.  associated with implantation of organs and tissues. Such knowledge will
  768.  have numerous applications in combating the HIV virus and other immune
  769. deficient conditions. These examples are but a few of the potential
  770. applications and benefits regenerative medicine will bring. </div><br>
  771. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  772. By providing tissues and organs on demand, regenerative medicine serves a
  773.  dual purpose: increasing quality of life and care for patients, and
  774. reducing healthcare costs by eliminating chronic disease. This medical
  775. advance of always having tissues available for patients can be thought
  776. of as "tissues for life." </div><br>
  777. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  778. <b style="text-align: left;">Regenerative medicine can combat end-organ failure</b><br style="text-align: left;" />
  779. One of the greatest needs for regenerative therapy is in the field of
  780. whole organ replacement. Despite broad public education about organ
  781. donation, there remains a large and growing gap in the number of organ
  782. donors versus the demand for organs. In 2002 alone, there were: </div><br>
  783. <ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
  784. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">12,800 organ donors (deceased and living)<br style="text-align: left;" />
  785. </li>
  786. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">24,900 life saving transplants<br style="text-align: left;" />
  787. </li>
  788. <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;" />
  789. </li>
  790. <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;" />
  791. </li>
  792. </ul><br>
  793. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  794. These numbers do not take into account the estimated 100,000 potential
  795. 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>)
  796.  Organ demand is a major health care issue that is growing in magnitude.
  797.  Over the past 10 years, while organ donations have increased, the
  798. waiting list has grown even more:
  799. </div><br>
  800. <ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
  801. <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;" />
  802. </li>
  803. <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;" />
  804. </li>
  805. <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;" />
  806. </li>
  807. </ul><br>
  808. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  809. Despite organ donation education campaigns, the rate of donations has
  810. been greatly outstripped by the increase in need. Tissue and organ
  811. failure is clearly a serious problem that will only increase as our
  812. population grows and ages. </div><br>
  813. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  814. Regenerative medicine confronts this problem from multiple fronts.
  815. First, through regenerative therapies, diseases and conditions that
  816. result from tissue failure can be stopped and healed by regenerating the
  817.  damaged tissues. This regeneration is brought on by therapies that
  818. prompt the body to heal itself by recruiting the proper reparative cells
  819.  <i style="text-align: left;">in vivo</i>, or by implanting small amounts
  820.  of engineered tissue "patches" that prompt the damaged tissues to heal.
  821.  Regenerative medicine also holds promise in transplanting and growing
  822. replacement organs. With regenerative medicine, waiting for a tissue or
  823. organ transplant will become a worry of the past.
  824. </div><br>
  825. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  826. <b style="text-align: left;">Regenerative medicine will dramatically alter the U.S. healthcare industry</b><br style="text-align: left;" />
  827. The potential benefits of regenerative medicine - in improved health
  828. care and economic savings - are enormous. Already, the direct healthcare
  829.  costs of organ replacement are about $350 billion globally (about 8
  830. percent of global healthcare spending). These costs arise from therapies
  831.  that keep people alive (such as kidney dialysis), implanted replacement
  832.  devices, and very few (due to lack of donors) organ transplants.(<a href="#7" style="text-align: left;">7</a>)
  833.  With a $350 billion global industry already built on first generation
  834. tissue and organ therapy products and substitutes, regenerative medicine
  835.  has potential to exceed $500 billion in the next 20 years.
  836. </div><br>
  837. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  838. An example of some conditions and diseases that could be easily cured by
  839.  regenerative medicine and their current cost of treatment include: </div><br>
  840. <ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
  841. <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;" />
  842. </li>
  843. <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;" />
  844. </li>
  845. <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;" />
  846. </li>
  847. </ul><br>
  848. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  849. Regenerative medicine has the ability to prevent many of these
  850. conditions by replacing or repairing malfunctioning tissues. Currently,
  851. U.S. healthcare costs are more than $1.5 trillion, or 13 percent of
  852. GDP.(<a href="#10" style="text-align: left;">10</a>)
  853.  A large fraction of these costs is attributable to tissue loss or organ
  854.  failure, with approximately 8 million surgical procedures being
  855. performed annually in the U.S. to treat these disorders.(<a href="#11" style="text-align: left;">11</a>)
  856.  By 2040, the population of senior citizens in the U.S. will be double
  857. today's number, for a total of 70 million. As much as 25 percent of the
  858. U.S. GDP could be devoted to healthcare by 2040. Because regenerative
  859. medicine focuses on functional restoration of damaged tissues, not
  860. abatement or moderation of symptoms, this field cuts healthcare costs.
  861. Without regenerative medicine, the U.S. faces a future of rising
  862. healthcare costs and inefficient treatments.
  863. </div><br>
  864. <div style="font-size: 10px; line-height: 1.2em; padding: 2px; text-align: left;">
  865. <a href="#skip" style="text-align: left;">Back to Top</a></div>
  866. <a name="head3" style="text-align: left;"></a>
  867. <h3 style="font-size: 1em; font-weight: 900; margin-bottom: 0px; text-align: left;">
  868. What is the current state of regenerative medicine?</h3><br>
  869. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  870. <b style="text-align: left;">Summary</b><br style="text-align: left;" />
  871. Regenerative medicine to date has made a number of advances in the field
  872.  of simple tissues such as skin, bone, and cartilage. Progress toward
  873. more complex therapies has been limited due to the reliance on private
  874. sector funding and a lack of understanding of fundamental tissue
  875. interactions. Private sector funding has led to a productoriented
  876. approach that does not focus on research or consider the fundamental
  877. science issues in regenerative medicine. Without this fundamental
  878. research, it will be exceedingly difficult for the regenerative medicine
  879.  field to develop more advanced tissues and organs. To accommodate new
  880. biomedical technology, the FDA has created the Office of Combination
  881. Products and the Office of Cellular, Tissue and Gene Therapies. These
  882. new offices solve the problem of regulating complex combination products
  883.  that typically fell under two or more of the FDA's traditional offices.
  884.  These changes help prepare the FDA for regenerative medicine product
  885. regulation and product approvals.</div><br>
  886. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  887. <b style="text-align: left;">Current technological accomplishments in regenerative medicine</b><br style="text-align: left;" />
  888. Regenerative medicine research is a new science, with a many new
  889. concepts being researched and tested but few effective products are on
  890. the market. From a research standpoint, several key methods and
  891. approaches have been established including: </div><br>
  892. <ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
  893. <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;" />
  894. </li>
  895. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Development
  896.  of techniques for assembly of cells into large, three dimensional
  897. tissue-like structures, which will lead to the physical creation of
  898. three dimensional organs<br style="text-align: left;" />
  899. </li>
  900. <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
  901. <br style="text-align: left;" />
  902. </li>
  903. <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>)
  904. </li>
  905. </ul><br>
  906. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  907. These techniques have allowed researchers to begin to understand at a
  908. very basic level how cells and tissues function and interact. At a
  909. functional level, regenerative medicine researchers have been able to
  910. 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>),
  911.  ligaments and stem cell therapies are in various stages of preclinical
  912. and clinical tests. However, the only FDA-approved and available
  913. products are much simpler tissues, such as dermal and joint substitutes,
  914.  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>)
  915.  As shown by the limited scope and inconsistent performance of the
  916. products available, regenerative medicine is at a very early stage of
  917. development, hampered by a lack of cohesive fundamental research to
  918. advance the field. It is this research that is needed for the science of
  919.  regenerative medicine to realize its full potential of restoring even
  920. the most complex of tissues to full health.
  921. </div><br>
  922. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  923. <b style="text-align: left;">Current barriers to progress in regenerative medicine
  924. </b><br style="text-align: left;" />
  925. There are two major barriers facing regenerative medicine. The first
  926. barrier is a lack of research related to the fundamental "building
  927. block" areas of the science. The second barrier is the lack of
  928. interdisciplinary study, which can be attributed to the focus of private
  929.  funding in the field. </div><br>
  930. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  931. Fundamental building block science is gaining the necessary
  932. understanding to manipulate the technology of a given field for a
  933. desired result. In regenerative medicine, the fundamental research
  934. focuses on cellular interactions at a micro and macro level, which can
  935. then be applied to creating and integrating tissues. Historically,
  936. primarily academia and the Government, in conjunction with private
  937. industry have performed fundamental research, and the discoveries are
  938. then applied by industry to create viable products.(<a href="#17" style="text-align: left;">17</a>)
  939.  The lack of a Federal funding strategy in regenerative medicine has
  940. inhibited fundamental research. While more than $4 billion in private
  941. capital has been invested in the field (without producing a single
  942. 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>)
  943.  This is important for two reasons. First is the obvious disparity of
  944. funding. Second, and equally important, is the type of research
  945. performed by each of these groups. Private industry research is focused
  946. on the end product, and how to get there in the quickest and most cost
  947. efficient manner. Private research also is focused around a singular
  948. field: biology, chemistry, and so on. Government research, however,
  949. tends to be in the form of grants to laboratories that are focused more
  950. on fundamental research that deepens knowledge in a field. It is because
  951.  of this disparity in funding that the current situation exists: $4
  952. billion invested by private industry and no profitable products, and an
  953. extremely limited understanding of how complex tissues function. This
  954. industry that has the potential economic impact of $500 billion
  955. annually, and the Federal investment should be strategically focused.
  956. </div><br>
  957. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  958. Similar Federal investment has occurred in the past. In the late 1980s
  959. and early 1990s, the Semiconductor Manufacturing Technology consortium
  960. (SEMATECH) and National Electronics Manufacturing Initiatives served to
  961. successfully revive and then lead U.S. industries to become global
  962. market leaders in the semiconductor and electronics industries. More
  963. recent projects are just beginning to come to fruition. Treatments based
  964.  on gene therapies from the Human Genome Project are beginning to arrive
  965.  on the market, and the results of this project will undoubtedly have an
  966.  enormous impact on the future of healthcare. A Federal initiative
  967. providing direction and resources in regenerative medicine would ensure
  968. that the U.S. would be the unquestioned pioneer and leader in this
  969. promising field. </div><br>
  970. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  971. The lack of a Government initiative has also led to the isolation of
  972. regenerative medicine research by each individual field. There is very
  973. little collaboration and communication among biologists, clinicians,
  974. engineers, biochemists, materials scientists and other related fields
  975. due to the emphasis on private, product-focused funding.(<a href="#20" style="text-align: left;">20</a>)
  976.  Unfortunately, regenerative medicine is a field that requires
  977. cooperation and communication among these different disciplines in order
  978.  to advance the general science. Biologists and biochemists must use
  979. their knowledge of how the body works in conjunction with tissue
  980. engineers to generate products that actually function. Furthermore, all
  981. of these groups must coordinate with clinicians and the FDA to set
  982. priorities of what tissues are in highest demand and how to implant them
  983.  and to ensure that they are safe for humans.(<a href="#21" style="text-align: left;">21</a>)
  984.  Without a Government funding initiative to pull these groups together,
  985. organizational culture issues will continue to inhibit collaboration. It
  986.  is absolutely essential that this coordination happen in order to
  987. expeditiously further the knowledge in the field.
  988. </div><br>
  989. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  990. <b style="text-align: left;">Regulatory environment</b><br style="text-align: left;" />
  991. The FDA has begun working towards creating an environment that
  992. accelerates the approval of combination products. Therapies are
  993. classified by the FDA as either a device, biologic, or drug. Each
  994. classification has differing regulations and its own review Center
  995. consisting of experts in a given field. Regenerative medicine products
  996. fall under some or all of these classifications, requiring regulators to
  997.  appropriately integrate different regulations to ensure adequate
  998. product safety and effectiveness. In the past, this added complexity led
  999.  to combination products requiring longer approval times than standard
  1000. products. To accommodate the advancements of medicine, the FDA created
  1001. its Office of Combination Products (OCP). The Medical Device User Fee
  1002. and Modernization Act of 2002 established this new office on December
  1003. 24, 2002. Under this law, the OCP is given the power to ensure the
  1004. timely review of drug-device, drug-biologic, and devicebiologic
  1005. combination products.(<a href="#22" style="text-align: left;">22</a>) Examples of some combination products that OCP has handled include:
  1006. </div><br>
  1007. <ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
  1008. <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;" />
  1009. </li>
  1010. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">InFUSE
  1011.  Bone Graft/T-CAGE lumbar tapered fusion device, which is a treatment
  1012. for a degenerative disc disease by stabilizing the spacing in the spine
  1013. and then forming new bone<br style="text-align: left;" />
  1014. </li>
  1015. <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;" />
  1016. </li>
  1017. </ul><br>
  1018. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1019. These products are all combinations of drug, biologic and devices. While
  1020.  these products are considerably simpler than organ tissues, thus far
  1021. the FDA has shown that it is prepared to efficiently regulate
  1022. regenerative medicine products as they become available. </div><br>
  1023. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1024. The FDA has also established the Office of Cellular, Tissue and Gene
  1025. Therapies (OCTGT). The OCTGT consolidates a number of regulatory
  1026. programs into a single entity with a single expert staff. These
  1027. consolidated groups include: </div><br>
  1028. <ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
  1029. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Human tissues<br style="text-align: left;" />
  1030. </li>
  1031. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Cellular therapies<br style="text-align: left;" />
  1032. </li>
  1033. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Xenotransplantation<br style="text-align: left;" />
  1034. </li>
  1035. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Gene therapies<br style="text-align: left;" />
  1036. </li>
  1037. </ul><br>
  1038. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1039. By creating these new offices for regulation, the FDA has begun to
  1040. evolve into a more nimble approval agency capable of handling the
  1041. advances of the 21st century. </div><br>
  1042. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1043. To complement these new offices, the FDA has also begun collaborating
  1044. with various NIH Institutes and participating in the Multi-Agency Tissue
  1045.  Engineering Sciences Working Group to raise awareness of FDA guidelines
  1046.  and procedures. </div><br>
  1047. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1048. Another innovative initiative the FDA has begun in conjunction with the
  1049. National Cancer Institute allows cancer researchers to link their
  1050. investigational new drug (IND) applications to the FDA. This program has
  1051.  the goal of reducing process and submission times for researchers. If
  1052. successful, this program will provide a model for IND applications in
  1053. other fields, including regenerative medicine. </div><br>
  1054. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1055. While the FDA has made great strides towards embracing new technologies,
  1056.  the private sector still views the regulatory process as somewhat
  1057. difficult. FIRM will provide a cohesive framework whereby public and
  1058. private funding organizations will partner with the FDA very early in
  1059. the development of regenerative medicine products to facilitate
  1060. transparency in the regulatory oversight process for these new products.
  1061.  By partnering in this manner, FIRM will set a new standard for industry
  1062.  and FDA cooperation that will lead to faster product approvals without
  1063. sacrificing safety or efficacy. </div><br>
  1064. <div style="font-size: 10px; line-height: 1.2em; padding: 2px; text-align: left;">
  1065. <a href="#skip" style="text-align: left;">Back to Top</a></div>
  1066. <a name="head4" style="text-align: left;"></a>
  1067. <h3 style="font-size: 1em; font-weight: 900; margin-bottom: 0px; text-align: left;">
  1068. What is the future of regenerative medicine technology?</h3><br>
  1069. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1070. <b style="text-align: left;">Summary</b><br style="text-align: left;" />
  1071. Despite the availability of some first generation products, researchers
  1072. know very little about the underlying science of regenerative medicine.
  1073. In order to build complex tissues and organs, scientists first must
  1074. understand how tissues interact with each other. To achieve the
  1075. envisioned goals of regenerative medicine, a strong Federally-directed
  1076. initiative is needed to ensure that this fundamental research is
  1077. realized. If a directed and well-funded research effort were to begin,
  1078. regenerative medicine could begin producing results within 5 years. At
  1079. the 5-year mark, complex skin, cartilage, bone, and blood vessel
  1080. products would begin to reach markets. Within 10 years, organ patches
  1081. that repair damaged tissues would potentially be available. Within 20
  1082. years, full organ regeneration is a strong possibility. </div><br>
  1083. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1084. For these products to be regulated safely and efficiently, the FDA must
  1085. continue its recent admirable moves to embrace new technology. The FDA
  1086. has recognized the challenge of new medical technology and has worked to
  1087.  improve outreach and education about the regulation process, created a
  1088. new office for handling the evaluation of combination products, and
  1089. created sub-offices for handling tissue and genetic therapies. This
  1090. commitment to the future is encouraging and the FDA remains involved in
  1091. developments relating to regenerative medicine research. </div><br>
  1092. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1093. Other countries have already embarked upon national initiatives of their
  1094.  own with hopes of making regenerative medicine a reality for
  1095. themselves. Several members of the European Union (EU), including Great
  1096. Britain, Germany, and Sweden, as well as Japan, China and Australia have
  1097.  all begun making strong national commitments with hopes of achieving
  1098. their own advances in regenerative medicine technology. It is time for
  1099. the U.S. to commit its own resources and work with these nations as a
  1100. leading partner in driving this technology forward. </div><br>
  1101. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1102. <b style="text-align: left;">Next steps for regenerative medicine</b><br style="text-align: left;" />
  1103. Although regenerative medicine as a field has existed for over 10 years,
  1104.  surprisingly little basic research has been done. In order for the
  1105. field to advance, scientists must research fundamental cellular
  1106. relationships and develop techniques for cellular production and
  1107. preservation. In order to eventually realize the concept of tissues on
  1108. demand, interim research steps must be achieved. Examples of interim
  1109. research goals that must be achieved include: </div><br>
  1110. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1111. Understand the processes involved in mechanical signaling and cellular
  1112. mechanotransduction, which explains how cells and systems communicate
  1113. with each other(<a href="#24" style="text-align: left;">24</a>)
  1114. </div><br>
  1115. <ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
  1116. <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;" />
  1117. </li>
  1118. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Create tissues
  1119. <i style="text-align: left;">in vitro (in the laboratory)</i>
  1120. 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;" />
  1121. </li>
  1122. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Develop
  1123.  handling and storage procedures for regenerative medicine applications,
  1124.  in order to effectively manage and preserve tissue supplies(<a href="#26" style="text-align: left;">26</a>)<br style="text-align: left;" />
  1125. </li>
  1126. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Increase
  1127.  scalability of engineered cells, that enables scientists to
  1128. mass-produce engineered cells ensuring enough heart, skin, pancreas, and
  1129.  other needed tissues are available<br style="text-align: left;" />
  1130. </li>
  1131. <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>)
  1132. </li>
  1133. </ul><br>
  1134. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1135. Despite 10 years of study in regenerative medicine, there has been a
  1136. lack of directed research. Although much has been learned on these
  1137. subjects the field is still in an embryonic stage. Without this
  1138. fundamental research, the potential of fully engineered complex tissues
  1139. will never be realized. If regenerative medicine researchers and
  1140. clinicians are able to gain a detailed understanding of how cells
  1141. interact with each other and how to mass-produce, preserve, catalogue,
  1142. and build these cells, they can then apply this knowledge towards
  1143. developing tissue and organ based therapies. </div><br>
  1144. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1145. One example of a complex regenerative medicine issue that scientists
  1146. must solve is the growth of vasculature in tissues and organs. These
  1147. vascular tissues are blood vessels responsible for transporting
  1148. nutrients and waste through tissue. Due to a lack of understanding of
  1149. cellular interaction, scientists have not been successful in creating
  1150. vasculature in tissues and organs, limiting regenerative medicine
  1151. products to "two dimensional" materials, such as skin and bone, which do
  1152.  not require vascular tissue support.(<a href="#28" style="text-align: left;">28</a>)
  1153.  To achieve the promise of regenerative medicine, growing vascularized
  1154. tissues is a necessary next step. To do this, scientists must gain a
  1155. better understanding of tissue interactions and scaffold technology.
  1156. Once scientists understand these concepts, they will be able to apply
  1157. this knowledge and create more advanced tissue systems.(<a href="#29" style="text-align: left;">29</a>)
  1158.  Ultimately, the application of knowledge of cellular interactions and
  1159. tissue growth will culminate in two branches of regenerative medicine
  1160. research,
  1161. <i style="text-align: left;">in vivo</i>
  1162. cell based therapy and <i style="text-align: left;">in vitro</i>
  1163. grown tissues and organs. </div><br>
  1164. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1165. Cell-based therapy focuses on cellular treatments that lead to
  1166. regeneration by having the body "gather" the necessary reparative cells
  1167. and bring them to the damaged site. The second branch is the <i style="text-align: left;">in vitro</i>
  1168. growth of tissues and organs that are then implanted within the body,
  1169. either to prompt regeneration or to replace damaged tissue.(<a href="#30" style="text-align: left;">30</a>)
  1170.  Each branch of research offers substantial advances over current
  1171. medicine, and discoveries from one branch may be directly applicable to
  1172. the other. Both of these research branches are vital for fully realizing
  1173.  all of the potential therapies of regenerative medicine. For example,
  1174. preliminary research has shown that spinal cord regeneration through
  1175. implantation of seeded scaffolds is feasible.(<a href="#31" style="text-align: left;">31</a>)
  1176.  Seed-driven regeneration is a form of cell-driven therapy that will not
  1177.  require transplantation of a new tissue or organ. On the other hand, it
  1178.  is believed that treatment of a cancerous lung would require removing
  1179. the lung and replacing it with a laboratory grown healthy lung. In the
  1180. case of cancer, seeding the lung for regeneration would not work, as the
  1181.  cancer would still be present.
  1182. </div><br>
  1183. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1184. These two different applications of regenerative medicine demonstrate
  1185. why it is essential to research both cellular therapies and full organ
  1186. growth techniques to maximize the potential of regenerative medicine. It
  1187.  may be possible to use regenerative medicine to cure a diseased lung
  1188. without removing it, or to cure spinal injuries through neural cell
  1189. transplants. What is most important is that these two branches be
  1190. investigated fully: findings from both will further our knowledge of
  1191. regenerative medicine. </div><br>
  1192. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1193. Fulfilling these goals will create a foundation for future regenerative
  1194. medicine products and work. A cohesive effort focused on advancing the
  1195. science and the field as a whole is essential. </div><br>
  1196. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1197. <b style="text-align: left;">Projected timeline of regenerative medicine</b><br style="text-align: left;" />
  1198. With a cohesive Government initiative and appropriate funding, within 20
  1199.  years regenerative medicine will be the standard of care for replacing
  1200. all tissue/organ systems in the body in addition to extensive industrial
  1201.  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,
  1202. <i style="text-align: left;">in vivo</i>. During those 20 years, as our
  1203. knowledge of tissues grows, it is reasonable to expect to see treatments
  1204.  discovered along the way, roughly at the 5, 10 and 20 year marks. In 5
  1205. years the following milestones are hoped for:
  1206. </div><br>
  1207. <ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
  1208. <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;" />
  1209. </li>
  1210. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Develop insurance reimbursable regenerative therapies
  1211. </li>
  1212. <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;" />
  1213. </li>
  1214. <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;" />
  1215. </li>
  1216. <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;" />
  1217. </li>
  1218. <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
  1219. </li>
  1220. </ul><br>
  1221. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1222. In 10 years, effective regenerative medicine therapies will be available
  1223.  for patient care and industrial research and development purposes. At
  1224. this time, the following may be achieved: </div><br>
  1225. <ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
  1226. <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;" />
  1227. </li>
  1228. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Engineer smart degradable biocompatible scaffolding<br style="text-align: left;" />
  1229. </li>
  1230. <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;" />
  1231. </li>
  1232. <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;" />
  1233. </li>
  1234. </ul><br>
  1235. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1236. Ultimately, within 20 years the full benefits of regenerative medicine
  1237. therapies will be reached. Some of the applications of regenerative
  1238. medicine could be: </div><br>
  1239. <ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
  1240. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Harness regenerative medicine materials to produce
  1241. <i style="text-align: left;">in situ</i>
  1242. regeneration of diseased and damaged structures in many areas of the body<br style="text-align: left;" />
  1243. </li>
  1244. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Regenerate most damaged tissues and organs either
  1245. <i style="text-align: left;">in vivo</i>
  1246. or through implanted regeneration therapies<br style="text-align: left;" />
  1247. </li>
  1248. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Produce
  1249. <i style="text-align: left;">in vitro</i>
  1250. sophisticated 3-D tissues and organs that cannot be regenerated through <i style="text-align: left;">in vivo</i>
  1251. techniques, such as an entire heart or lung<br style="text-align: left;" />
  1252. </li>
  1253. </ul><br>
  1254. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1255. Without a Federal initiative supporting this research, this timeline
  1256. could extend over the next 40 to 50 years. Considering the many economic
  1257.  and health advances this technology may bring, it is absolutely vital
  1258. that regenerative medicine advance as quickly as possible. </div><br>
  1259. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1260. <b style="text-align: left;">Future regulatory challenges and potential issues</b><br style="text-align: left;" />
  1261. One of the most challenging aspects of developing new medical treatments
  1262.  is ensuring that these treatments are safe as well as effective. What
  1263. might be safe in Japan or Sweden may not be considered safe in the U.S.
  1264. As with any new medical advance, regenerative medicine products will be
  1265. complex and require a great deal of laboratory study in order to confirm
  1266.  their safety. Regenerative medicine is a new field that will pose new
  1267. challenges for the FDA. In order to ensure efficient and effective
  1268. regulation, it is important the FDA continue to make their review
  1269. processes transparent and easy to follow so that clear expectations for
  1270. product safety and quality of clinical evidence needed for approval are
  1271. in place. If a researcher takes a misstep early in the complex
  1272. regulatory process, a great deal of time and money can be wasted.(<a href="#36" style="text-align: left;">36</a>)
  1273.  Rigorous testing to ensure product safety is crucial. However, it is
  1274. important to streamline processes where possible to foster innovation
  1275. and new product development.
  1276. </div><br>
  1277. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1278. The most frequently cited concerns by industry are the lack of clarity
  1279. about the regulatory requirements and the level of efficacy that must be
  1280.  demonstrated to get a product on the market. </div><br>
  1281. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1282. More specific criticisms include: </div><br>
  1283. <ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
  1284. <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;" />
  1285. </li>
  1286. <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;" />
  1287. </li>
  1288. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Shifting
  1289.  requirements, which confuses companies regarding the timeframes of
  1290. deliverables, creating frustration about the process requirements and
  1291. expectations<br style="text-align: left;" />
  1292. </li>
  1293. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Lack
  1294. of direction about the regulatory pathway (drug, biologic, device),
  1295. which has been largely answered by the creation of the OCP<br style="text-align: left;" />
  1296. </li>
  1297. <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;" />
  1298. </li>
  1299. </ul><br>
  1300. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1301. From the FDA's perspective, the process for approving new products is
  1302. slowed by companies who delay discussions until much of the product and
  1303. clinical development plan has already been established. With new
  1304. technology or novel products like regenerative medicine therapies, the
  1305. approval process is enhanced and expedited when the FDA is included in
  1306. the discussions about product and clinical development at an early
  1307. stage. This allows the FDA to provide more instructive feedback about
  1308. the products and better understand the technology behind them. It is
  1309. therefore critical that the FDA be involved early in regenerative
  1310. medicine research so that the regulatory scientists can learn about the
  1311. technology congruently with the academic and private sectors. This
  1312. understanding will ultimately lead to quicker approvals as familiarity
  1313. with regenerative medicine technology increases.(<a href="#38" style="text-align: left;">38</a>)
  1314. </div><br>
  1315. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1316. The FDA has and continues to make a strong effort to stay on the cutting
  1317.  edge of new technology. The most important goal of the FDA is to remain
  1318.  fluid in their structure and to embrace new technology by creating
  1319. appropriate venues as opposed to forcing new technology into old
  1320. paradigms, while upholding the necessary standards of safety and
  1321. efficacy. Thus far, the FDA has performed admirably in preparing for the
  1322.  next generation of medicine. As long as regenerative medicine companies
  1323.  are willing to involve the FDA in their product design process from
  1324. inception to completion, the regulatory process will be no more
  1325. burdensome than is necessary to ensure product safety. </div><br>
  1326. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1327. <b style="text-align: left;">Foreign efforts in regenerative medicine</b><br style="text-align: left;" />
  1328. The U.S.' preeminence in the field of regenerative medicine is in
  1329. jeopardy. A study led by the National Science Foundation and released in
  1330.  January 2002 noted that the U.S. lead in cross-disciplinary research is
  1331.  shrinking as compared to Japan and Europe, who are the next most
  1332. advanced players in regenerative medicine, respectively.(<a href="#39" style="text-align: left;">39</a>)
  1333.  In 1995, only 5 percent of companies involved in regenerative medicine
  1334. research were based outside the U.S. By 2002, this percentage of
  1335. non-U.S. regenerative medicine companies had increased to 46 percent.(<a href="#40" style="text-align: left;">40</a>)
  1336.  It is apparent that regenerative medicine's promise of revolutionary
  1337. curative treatments has been recognized by other nations who are now
  1338. moving to embrace this technology through both private industry and
  1339. national government resource commitments.
  1340. </div><br>
  1341. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1342. The Japanese government has committed resources to the city of Kobe in
  1343. the Kansai region of Japan. The Kobe Medical Industry Development
  1344. Project aims to nurture an industry in the fields of advanced medical
  1345. care and welfare to meet the new requirements of Japan's rapidly aging
  1346. society.(<a href="#41" style="text-align: left;">41</a>)
  1347.  The plan includes spending a total of ¥91 trillion ($831 billion) by
  1348. the year 2010 on assorted therapies and infrastructure to raise the
  1349. standard of living of Japan's elderly. One of the key components of the
  1350. Kobe Medical Industry Development program is cell therapy and
  1351. regenerative medicine research.(<a href="#42" style="text-align: left;">42</a>)
  1352.  Japan, faced with one of the largest populations of the elderly, has
  1353. seen the benefits of regenerative medicine technology and appropriately
  1354. embraced them.
  1355. </div><br>
  1356. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1357. The European Union is still working to establish an infrastructure for
  1358. regenerative medicine. Currently, the Enterprise Directorate-General in
  1359. the European Commission is writing the first regenerative medicine
  1360. regulation for Europe and will have the responsibility to develop and
  1361. organize regenerative medicine efforts in the EU.(<a href="#43" style="text-align: left;">43</a>)
  1362.  A total of 436 tissue-engineering related companies currently exist in
  1363. the EU, with 40 percent located in the United Kingdom and Germany.
  1364. British firms are focusing on integration between technologies and
  1365. applications, whereas German firms are focusing on vertical
  1366. specializations in technologies and applications.(<a href="#44" style="text-align: left;">44</a>)
  1367.  While the EU has a strong commercial base, their national support
  1368. program is limited. However, they have taken the first step by having
  1369. the European Commission formulate a regenerative medicine strategy for
  1370. the EU.
  1371. </div><br>
  1372. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1373. Other notable foreign efforts include Australia, which boasts a growing
  1374. regenerative medicine industry, and China, which has committed a $1
  1375. billion initial investment towards establishing regenerative medicine
  1376. research.(<a href="#45" style="text-align: left;">45</a>)
  1377.  It is very apparent that the international community views regenerative
  1378.  medicine as a priority over the next 20 years. In the next 15-20 years,
  1379.  there will be 300 foreign companies competing in the field of
  1380. regenerative medicine.(<a href="#46" style="text-align: left;">46</a>)
  1381.  It is essential that the U.S. join these efforts as a leading partner
  1382. to ensure that our internal resources and expertise helps to shape this
  1383. revolutionary new technology. Without direction and resources from the
  1384. U.S. Government, regenerative medicine is a technology that will not be
  1385. fully realized for 40 to 50 years.
  1386. </div><br>
  1387. <div style="font-size: 10px; line-height: 1.2em; padding: 2px; text-align: left;">
  1388. <a href="#skip" style="text-align: left;">Back to Top</a></div>
  1389. <a name="head5" style="text-align: left;"></a>
  1390. <h3 style="font-size: 1em; font-weight: 900; margin-bottom: 0px; text-align: left;">
  1391. How could the United States get there?</h3><br>
  1392. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1393. <b style="text-align: left;">Summary</b><br style="text-align: left;" />
  1394. In order to assure that the U.S. has the most effective and
  1395. comprehensive regenerative medicine program in the world, the Federal
  1396. government must take a direct hand in regenerative medicine. By creating
  1397.  a Federal initiative focused on researching the fundamentals of
  1398. regenerative medicine, the resources will be available to fill in the
  1399. "research gaps" of the field and allow private industry to focus on what
  1400.  it does best, creating products that meet the needs of consumers. </div><br>
  1401. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1402. An initiative in Regenerative Medicine would involve more than simply an
  1403.  allocation of funds. This initiative could be known as the Federal
  1404. Initiative for Regenerative Medicine (FIRM). It would stretch beyond
  1405. simply being an allocation of resources. The true strength of the
  1406. program will be the funding combined with a synchronization and
  1407. collaboration of the agendas of the Federal agencies already involved in
  1408.  regenerative medicine research and bringing the fruits of this research
  1409.  to academia and private industry. Research will focus around "building
  1410. block" technologies that advance the science as a whole and "challenge
  1411. problems" which produce tangible results such as functional organs. In
  1412. conjunction with advancing the science of regenerative medicine, FIRM
  1413. will also take a strong hand in ensuring that the U.S. public is both
  1414. excited about and understanding of the capabilities of regenerative
  1415. medicine. </div><br>
  1416. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1417. <b style="text-align: left;">What FIRM is and how it advances regenerative medicine</b><br style="text-align: left;" />
  1418. The goal of FIRM would be to advance regenerative medicine to the point
  1419. of providing real time, mass-customization of tissues on demand, <i style="text-align: left;">in vivo</i>, within the next 20 years.
  1420. </div><br>
  1421.  
  1422. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1423. Following on the footsteps of past successful government initiatives,
  1424. such as SEMATECH and the Human Genome Project, FIRM will provide
  1425. direction through a council dedicated to reaching the goal of tissues on
  1426.  demand. Composed of representatives of Government agencies involved in
  1427. FIRM, the governance council will be responsible for setting milestones
  1428. to advance the science of regenerative medicine and empower industry to
  1429. take this knowledge and technology to create effective regenerative
  1430. medicine products. This centralized, coordinated effort also will allow
  1431. FIRM to develop standards for cellular data, reference materials and
  1432. other protocols that will enable different U.S. research teams to easily
  1433.  compare data with each other. This standardization could potentially
  1434. extend to global efforts as well, allowing regenerative medicine
  1435. research to overcome many of the protocol issues that have impaired
  1436. communications between research groups in other fields. </div><br>
  1437. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1438. FIRM will also take advantage of supplemental funding for regenerative
  1439. medicine research. This money will be used for intramural research at
  1440. Government labs (NIH, NASA, NIST, etc) as well as in the form of
  1441. extramural research funding through existing Government mechanisms (NIH,
  1442.  DARPA). This commitment will continue over 20 years and is a flexible
  1443. number: if more opportunities for research in the field are discovered,
  1444. additional funds can be appropriated to take advantage of such
  1445. breakthroughs. With current funding to date of only $250 million over
  1446. the past decade, an increase in government resources will provide the
  1447. necessary commitment to make this technology a reality. </div><br>
  1448. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1449. The benefits of realizing regenerative medicine will be two-fold. The
  1450. first benefit will be bringing our Nation the next generation of
  1451. healthcare by preventing and curing tissue and organ failure. The second
  1452.  will be to help grow the first new "decade defining" industry of the
  1453. millennium. Past Government initiatives, such as SEMATECH, helped grow
  1454. the worldwide semiconductor industry from an $8 billion annual industry
  1455. into a $170 billion annual industry with only approximately $2 billion
  1456. in government funding. FIRM offers the chance for a similar payoff, with
  1457.  the end product bringing a higher quality of life to Americans as well
  1458. as growing a new industry. </div><br>
  1459. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1460. <b style="text-align: left;">How FIRM will be structured</b><br style="text-align: left;" />
  1461. FIRM will crosscut the programs of a number of Federal agencies,
  1462. affording opportunities for the sharing of expertise, specialized
  1463. facilities, and best practices in research and research management. The
  1464. current regenerative medicine stakeholders represent a multitude of
  1465. organizational structures and functions. Each of these groups, such as
  1466. the Department of Health and Human Services (including NIH and FDA), the
  1467.  Department of Defense (including DARPA), the National Aeronautics and
  1468. Space Administration, Department of Commerce (including NIST), the White
  1469.  House Office of Science and Technology Policy, the President's Council
  1470. of Advisors on Science and Technology, and the National Science
  1471. Foundation, as well as academia and industry have distinct practices and
  1472.  goals in implementing their regenerative medicine activities. It is
  1473. important for the FDA to play an active role in the development of
  1474. regenerative medicine technology. If safety and efficacy expectations
  1475. are transparent, clinical studies can be designed and carried out with
  1476. FDA requirements clearly understood, leading to more efficient approval
  1477. processes.(<a href="#47" style="text-align: left;">47</a>)
  1478. </div><br>
  1479. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1480. A governance council will manage FIRM. This council will include members
  1481.  of all participating Government agencies, with each member agency
  1482. having representation on the council. Any Government agency with an
  1483. interest in advancing regenerative medicine will be welcome to join. By
  1484. cross-cutting multiple agencies, the council can take advantage of the
  1485. strengths and expertise of each member agency. For example, NSF and NIH
  1486. are principally invested in fundamental discovery, while NIST and DARPA
  1487. focus on exploratory development. NASA and DOD are more specifically
  1488. mission-oriented, requirement-driven organizations and thus are more
  1489. focused on applied development. The strength of FIRM will be to leverage
  1490.  and focus the resources and strengths of these agencies to advance
  1491. regenerative medicine. </div><br>
  1492. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1493. The FIRM council will decide research priorities and milestones to
  1494. accomplish this research through distribution of funds and Government
  1495. resources. By continually monitoring the state of regenerative medicine
  1496. research, setting new research goals and seeing these goals through to
  1497. completion, FIRM will aggressively advance regenerative medicine. The
  1498. research developed through FIRM-driven programs will be disseminated to
  1499. academia and business for development of regenerative medicine
  1500. therapies. Research milestones will range in scope from fundamental
  1501. science issues, such as: </div><br>
  1502. <ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
  1503. <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;" />
  1504. </li>
  1505. <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;" />
  1506. </li>
  1507. <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;" />
  1508. </li>
  1509. </ul><br>
  1510. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1511. These research goals serve the very important goal of advancing the
  1512. science of regenerative medicine leading to products and therapies.
  1513. "Challenge problems" will serve to complement these research-oriented
  1514. goals. These challenge problems are similar to the "Grand Challenges" of
  1515.  the National Nanotechnology Initiative, which include goals such as
  1516. containing the entire contents of the Library of Congress on a device no
  1517.  bigger than a sugar cube.(<a href="#48" style="text-align: left;">48</a>) Examples of FIRM "challenge problems" are:
  1518. </div><br>
  1519. <ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
  1520. <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;" />
  1521. </li>
  1522. <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;" />
  1523. </li>
  1524. <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;" />
  1525. </li>
  1526. </ul><br>
  1527. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1528. These challenge problems serve as a powerful marketing tool that
  1529. captures the imagination of end-users who will ultimately benefit from
  1530. this technology. Both the research and challenge problem goals will be
  1531. achieved with a combination of intramural research at Government labs,
  1532. FIRM-funded centers of excellence, and externally-funded ventures. FIRM
  1533. must constantly assess these goals and ensure that they are on-task and
  1534. that milestones are being met. Resources will be allocated in the best
  1535. interest of FIRM's goals, taking into account the scope, payoff, and
  1536. difficulty of each project. From a research standpoint, it is important
  1537. that the FIRM council recognize that regenerative medicine research will
  1538.  focus more on breakthrough advances than incremental ones. Accordingly,
  1539.  funding and research must be shaped in a format that supports
  1540. breakthrough style research. One such format is that seen in DARPA
  1541. programs.(<a href="#49" style="text-align: left;">49</a>)
  1542. </div><br>
  1543. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1544. The DARPA model of funding involves about 80 program managers who
  1545. distribute between $2 billion and $2.5 billion annually. These program
  1546. managers are typically experienced professionals from industry or
  1547. academia. They report to one of six office directors who in turn report
  1548. to the Director of DARPA. DARPA's management structure is very lean and
  1549. allows for a rapid flow of communication between layers. This funding
  1550. model has shown itself to be extremely advantageous in certain
  1551. situations, including: </div><br>
  1552. <ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
  1553. <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;" />
  1554. </li>
  1555. <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;" />
  1556. </li>
  1557. <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;" />
  1558. </li>
  1559. <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>)
  1560. <br style="text-align: left;" />
  1561. </li>
  1562. </ul><br>
  1563. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1564. Very clearly, regenerative medicine falls under all of these proposed
  1565. categories. It would be worthwhile, in advancing this initiative, to
  1566. consider disbursing at least some of FIRM's funding through a DARPA-like
  1567.  model positioned out of NIH. </div><br>
  1568. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1569. <b style="text-align: left;">FIRM research will be focused through theme-based centers of excellence</b><br style="text-align: left;" />
  1570. To maximize the leverage of existing regenerative medicine research at
  1571. NIH, FIRM will create a Center for Regenerative Medicine to bring
  1572. experts from all the Institutes together under one organizational unit.
  1573. In addition to this Center and existing Government laboratories,
  1574. additional research will be done at "centers of excellence" which will
  1575. be created through pairing Government efforts and resources with
  1576. universities, research hospitals and other research centers. Each of
  1577. these centers will be responsible for a particular type of regenerative
  1578. medicine research, thereby creating focal points for private industry to
  1579.  work with in generating regenerative medicine therapies. </div><br>
  1580. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1581. A Future for Regenerative Medicine January 2005 These centers of
  1582. excellence would also focus on forming multidisciplinary teams that are
  1583. vital to the advancement of regenerative medicine. Such teams bring
  1584. together the following experts: </div><br>
  1585. <ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
  1586. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Engineers<br style="text-align: left;" />
  1587. </li>
  1588. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Physicians<br style="text-align: left;" />
  1589. </li>
  1590. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Cell Biologists<br style="text-align: left;" />
  1591. </li>
  1592. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Computational biologists<br style="text-align: left;" />
  1593. </li>
  1594. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Nanotechnology fabrication experts<br style="text-align: left;" />
  1595. </li>
  1596. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Developmental Biologists<br style="text-align: left;" />
  1597. </li>
  1598. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Immunologists<br style="text-align: left;" />
  1599. </li>
  1600. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Materials scientists<br style="text-align: left;" />
  1601. </li>
  1602. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Economists<br style="text-align: left;" />
  1603. </li>
  1604. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Structural biologists<br style="text-align: left;" />
  1605. </li>
  1606. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Educators<br style="text-align: left;" />
  1607. </li>
  1608. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Social scientists<br style="text-align: left;" />
  1609. </li>
  1610. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Psychologists<br style="text-align: left;" />
  1611. </li>
  1612. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Ethicists<br style="text-align: left;" />
  1613. </li>
  1614. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Vascular biologists<br style="text-align: left;" />
  1615. </li>
  1616. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Chemists<br style="text-align: left;" />
  1617. </li>
  1618. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Biochemists<br style="text-align: left;" />
  1619. </li>
  1620. </ul><br>
  1621. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1622. Some of the greatest advancements in science have grown from new
  1623. discoveries in one field leading to advances in others. The invention of
  1624.  the steam engine, an engineering accomplishment is often credited with
  1625. being the primary reason for the growth of thermodynamics. By bringing
  1626. together engineers and other material scientists with biologists and
  1627. other life sciences scientists, these centers will increase the spectrum
  1628.  of available knowledge for regenerative medicine by providing varied
  1629. viewpoints that lead to a more balanced research approach.(<a href="#51" style="text-align: left;">51</a>)
  1630.  Due to logistical issues, only a few academic and commercial
  1631. laboratories have assembled such groups. With FIRM, these teams will be
  1632. more commonplace, allowing FIRM researchers to take a broader and more
  1633. encompassing view than has been seen thus far. These teams can then turn
  1634.  their collective resources towards a variety of regenerative medicine
  1635. themes.
  1636. </div><br>
  1637. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1638. Potential themes might include: </div><br>
  1639. <ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
  1640. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Tooth and Maxillo-Facial Repair and Replacement<br style="text-align: left;" />
  1641. </li>
  1642. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Cardiac Tissue Repair and Replacement<br style="text-align: left;" />
  1643. </li>
  1644. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">GI and Urinary Tract Repair and Replacement<br style="text-align: left;" />
  1645. </li>
  1646. <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;" />
  1647. </li>
  1648. </ul><br>
  1649. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1650. Encouraging and promoting cross-center information sharing and
  1651. innovative design advances, each center would provide secondary support
  1652. to other themes to foster exchange of ideas. For example, the skin and
  1653. muscle repair and replacement center might support the cardiac tissue
  1654. repair and replacement center, as some muscle growth techniques might
  1655. apply to growing muscles in the heart. These centers will ultimately
  1656. become the primary source of regenerative medicine research for industry
  1657.  to draw upon in creating new products. </div><br>
  1658. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1659. <b style="text-align: left;">FIRM Funding</b><br style="text-align: left;" />
  1660. Proposed is an exponential change, not an incremental increase in
  1661. Federal dollars allocated for regenerative medicine. An
  1662. order-of-magnitude upsurge is needed to drive this field forward. Such
  1663. an increase will ensure U.S. success in regenerative medicine by
  1664. providing a strong underpinning, a thorough scientific-knowledge
  1665. foundation, and the training for the first true generation of
  1666. regenerative medicine scientists and engineers.</div><br>
  1667. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1668. This
  1669.  money will be controlled by the FIRM council and then allocated to
  1670. subsidiary agencies in accordance with the goals set by the FIRM
  1671. council. Funds allocated by FIRM will be placed as a line item into
  1672. member agency budgets, and the member agencies will then be responsible
  1673. for accomplishing the goals set by the council. For example, DARPA
  1674. (through DOD) might be assigned to research skin grafts for combat
  1675. wounds. DARPA would then receive funding from the FIRM council yearly
  1676. until the project is completed. The FIRM council would oversee this
  1677. effort to ensure that research data is shared and the project is being
  1678. managed properly. In the event that a program is not performing up to
  1679. task or research is not being shared, the FIRM council has the power to
  1680. rectify these problems in the best possible manner.</div><br>
  1681. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1682. Goals
  1683.  along the roadmap will be monitored as milestones, and phase-out
  1684. mechanisms will be included to ensure that old projects are efficiently
  1685. closed down, allowing new projects to be started. Methods to measure
  1686. success of specific activities need to be developed, and performance
  1687. measures need to be established and continually monitored.</div><br>
  1688. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1689. Choreographing
  1690.  a such an initiative will be challenging; however, a multi-agency
  1691. framework coordinated through a FIRM council with active and strong
  1692. leadership would ensure a successful utilization of resources.
  1693. Implementing lessons learned from the National Nanotechnology Initiative
  1694.  and other complex multi-agency Government R&amp;D efforts will also be
  1695. critical. With planning and strong direction, FIRM has the power to
  1696. bring regenerative medicine to the U.S. public, enhancing their welfare
  1697. and leading people to live fuller, richer lives.</div><br>
  1698. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1699. <b style="text-align: left;">Benefits of FIRM</b><br style="text-align: left;" />
  1700. FIRM brings two major benefits to the American public. The first is a
  1701. leap to a new generation of healthcare therapies that will have
  1702. countless applications towards curing an assortment of diseases and
  1703. conditions. Second is an opportunity to establish a new global industry
  1704. that has the potential for $100 billion to $500 billion in worldwide
  1705. annual revenues. Both of these reasonsmake FIRM an essential Federal
  1706. program.</div><br>
  1707. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1708. Regenerative
  1709.  medicine has the potential to treat nearly every tissue and organ
  1710. failure condition and disease that currently plagues our society. This
  1711. technology is arriving at a crucial time in American healthcare.
  1712. Currently, there are 35 million people over the age of 65 in the U.S.(<a href="#53" style="text-align: left;">53</a>),
  1713.  12 percent of the approximate 281 million people in the U.S. However,
  1714. due to the immense baby boomer population, there are about 57 million
  1715. Americans aged 55-64.(<a href="#54" style="text-align: left;">54</a>)
  1716.  Within 10 years, there will be more than 70 million Americans, more
  1717. than one-fifth of the population, over the age of 65. People in the
  1718. senior citizen age group face a variety of diseases that require
  1719. regenerative medicine therapies including:</div><br>
  1720. <ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
  1721. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Diabetes<br style="text-align: left;" />
  1722. </li>
  1723. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Osteoporosis<br style="text-align: left;" />
  1724. </li>
  1725. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Heart Disease<br style="text-align: left;" />
  1726. </li>
  1727. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Strokes<br style="text-align: left;" />
  1728. </li>
  1729. <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;" />
  1730. </li>
  1731. </ul><br>
  1732. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1733. Baby
  1734.  boomers have watched medical technology advance substantially during
  1735. their lifetime. As they age into the senior citizen category, their
  1736. health is one of their top concerns, as is the desire to remain capable
  1737. of leading an active lifestyle.(<a href="#56" style="text-align: left;">56</a>)
  1738.  Regenerative medicine offers the increase of quality of healthcare that
  1739.  baby boomers both need and are seeking. If FIRM were to begin today,
  1740. the program would be at the 10 year mark as the last baby boomer crosses
  1741.  into senior citizen status. At this point, regenerative medicine could
  1742. potentially be offering skin, bone, and joint replacement products as
  1743. well as organ patches capable of slowing or reversing organ failure and
  1744. degradation. Without these regenerative medicine therapies to cure
  1745. tissue failure-related diseases, healthcare costs will rise. However,
  1746. with these therapies, the baby boomer population will be the first group
  1747.  to experience regenerative medicine's benefit to quality of life. Baby
  1748. boomers will almost assuredly embrace regenerative medicine and the
  1749. promises it brings them.</div><br>
  1750. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1751. The
  1752.  second major benefit that FIRM has to offer is growing a new,
  1753. multibillion-dollar global industry. While computers and semiconductors
  1754. defined the 1980s, the Internet dominated the 1990s; the 2000s have seen
  1755.  economic challenge and thus far lack a defining cutting-edge industry.
  1756. While biotechnology has offered the promise of new therapies and
  1757. treatments, the biotechnology industry has yet to produce many products
  1758. and even fewer profits. Government investment has led to innovation and
  1759. new markets in the past.</div><br>
  1760. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1761. One
  1762.  story of resounding success of government-industry partnership is that
  1763. of SEMATECH. In the late 1980s, to counteract the slipping performance
  1764. of the $8 billion(<a href="#57" style="text-align: left;">57</a>)
  1765.  a year American semiconductor industry, an industry-government
  1766. consortium known as SEMATECH was created, comprised of 14 U.S.
  1767. semiconductor manufacturers and the U.S. Government.(<a href="#58" style="text-align: left;">58</a>)
  1768.  Together, industry and Government leveraged common resources (including
  1769.  laboratories an funding), created industry roadmaps advancing
  1770. technology, and shared risks to advance and rais the quality of American
  1771.  semiconductor technology. During the next decade, the consortium worked
  1772.  with a $1.5 billion Federal commitment over 6 years in conjunction
  1773. industry manufacturing and funding to create faster, cheaper, and better
  1774.  chips.(<a href="#59" style="text-align: left;">59</a>)
  1775.  By 1996, Federal funding was voluntarily stopped by SEMATECH, as the
  1776. industry no longer neede the funds. The U.S. had restored its lead in th
  1777.  semiconductor industry. SEMATECH remains active today, mapping out
  1778. future research and coordinating industry activities.(<a href="#60" style="text-align: left;">60</a>)
  1779.  This partnersh strengthened and ensured the strength of the American
  1780. semiconductor industry, and had the positive effect of making the U.S.
  1781. the leading nation in semiconductor technology today with $70 billion in
  1782.  sales and 50 percent of global market share in 2002.(<a href="#61" style="text-align: left;">61</a>)
  1783.  While one could rightful argue that the global semiconductor industry
  1784. would have grown to its current size today without SEMATECH, it is
  1785. almost certain that without SEMATECH the U.S. would not be the market
  1786. leader in semiconductors today. Without a doubt, the SEMATECH consortium
  1787.  was one of the biggest and most successful partnerships between
  1788. industry and Government. SEMATECH was able to right a damaged industry
  1789. and reached self-sufficiency within a decade of inception. This
  1790. successful story provides a powerful case study for how FIRM could
  1791. potentially be structured.</div><br>
  1792. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1793. Another
  1794.  example of successful Government-industry partnership is the hard disk
  1795. storage manufacturing industry, today a $50 billion industry. In the
  1796. late 1980s Japan was poised to dominate this market. But in 1990,
  1797. specificall response to the opportunity to receive funding from the
  1798. Department of Commerce, U.S. participants in this industry formed the
  1799. National Storage Industry consortium and the National Science Foundation
  1800.  established an enginee research center on data storage. This
  1801. technological investment by key government agencies led to hard drive
  1802. storage densities growing at twice the pre-investment rate, and allowing
  1803.  the U.S. hard drive storage industry to remain competitive.(<a href="#62" style="text-align: left;">62</a>)</div><br>
  1804. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1805. Funding
  1806.  from other Government agencies has made substantial impacts as well.
  1807. The Departme of Energy's Office of Industrial Technologies shares the
  1808. cost of developing new energy efficie technology with a number of
  1809. industries (including steel, agriculture, chemicals, among others);
  1810. enabling these industries to cost-efficiently develop new technologies.(<a href="#63" style="text-align: left;">63</a>)
  1811.  This program has benefited the U.S. steel industry in particular new
  1812. technologies that could potentially save steel industry 70 trillion
  1813. BTU/year, or about 30 percent of the industry's energy cost.(<a href="#64" style="text-align: left;">64</a>)</div><br>
  1814. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1815. The
  1816.  U.S. Government has a tremendous history of spurring forward innovation
  1817.  and growth of industries. Regenerative medicine is the industry waiting
  1818.  to be focused and grown through Government investment and leadership.</div><br>
  1819. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1820. Regenerative
  1821.  medicine offers a field that presents the opportunity for concrete
  1822. solutions to diseases through the replacement of failing tissues. If
  1823. supported bt the Federal government regenerative medicine has the
  1824. opportunity to become the defining industry of the 21st Century.
  1825. Government initiatives and research funding have in the past been shown
  1826. to lend support to indusrty and consumer confidence. While economic
  1827. benefits from FIRM would not be realized overnight, it does provide the
  1828. opportunity to lay the foundation for an industry with huge potential.</div><br>
  1829.  
  1830. <div style="font-size: 10px; line-height: 1.2em; padding: 2px; text-align: left;">
  1831. <a href="#skip" name="head6" style="text-align: left;">Back to Top</a></div><br>
  1832. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1833. <b style="text-align: left;">Increasing Public Awareness and Support</b><br style="text-align: left;" />
  1834. Participants at an HHS-sponsored conference in March 2003 larg that,
  1835. with a few exceptions, regenerative medici endeavors have not resulted
  1836. in economically viable products and have not aroused tremendo public
  1837. interest. With perception often being reality, it is important that
  1838. regenerative medici receive the appropriate attention and arouses the
  1839. excitement merited from the public. It is esse that FIRM contain a large
  1840.  education and outreach component charged with the task of instilling
  1841. enthusiasm and excitement for the initiative in American culture.</div><br>
  1842. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1843. As
  1844.  one potential strategy to pique public interest and to attract bright
  1845. researchers, the education and outreach arm of FIRM could focus on the
  1846. "Challenge Problems" previously mentioned. Particularly marketable are
  1847. challenge problems that involve tangible products that the public can
  1848. appreciate. Examples of such "Challenge Problem" products might be:</div><br>
  1849. <ul style="line-height: 1.2em; margin-bottom: 0px; margin-left: 25px; margin-top: 0px; padding: 0px; text-align: left;">
  1850. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">A retinal patch<br style="text-align: left;" />
  1851. </li>
  1852. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">A living tooth<br style="text-align: left;" />
  1853. </li>
  1854. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Tissue engineere<br style="text-align: left;" />
  1855. </li>
  1856. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">Tissue to repair injured or damaged<br style="text-align: left;" />
  1857. </li>
  1858. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">A functioning human liver<br style="text-align: left;" />
  1859. </li>
  1860. <li style="font-size: 13px; line-height: 1.4em; text-align: left;">A functioning human bladder<br style="text-align: left;" />
  1861. </li>
  1862. </ul><br>
  1863. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1864. These
  1865.  challenges present an oppportunity to show the public tangible
  1866. accomplishments to excite them. Further, by creating milestones that
  1867. build up expectations, such as first repairing heart tissue
  1868. <i style="text-align: left;">in vivo</i>, then developing a heart
  1869. "patch," and finally creating a working heart, the public has time to
  1870. get accustomed and comfortable with the technology.</div><br>
  1871. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1872. Equally
  1873.  important is the education of the public on how regenerative medicine
  1874. science works and the risks of the technology. Particularly in the field
  1875.  of medicine, the American public is very risk adverse. In order to
  1876. ensure that the technology is accepted, outreach and educational
  1877. programs targeted at people of all ages should be developed and
  1878. administered. The concept of therapies that repair and replace damaged
  1879. organs is wondrous, but to some might be viewed as invasive. Therefore
  1880. it is the FIRM's duty to ensure that questions are answered and that the
  1881.  program and its goals are transparent.</div><br>
  1882. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1883. In
  1884.  order to achieve the proper levels of education and acceptance, FIRM
  1885. must be publicly marketed and branded at a level not seen since the
  1886. Apollo program. FIRM must become a part of the public school systems,
  1887. have high-profile spokesperson and have a logo as well recognized as the
  1888.  breast cancer ribbon or the double helix of the Human Genome Project.
  1889. With all of these efforts, FIRM will become a technology whose household
  1890.  name ensures it is a public priority, not just a Government priority.</div><br>
  1891. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1892. By
  1893.  integrating FIRM into the public school systems, the initiative will
  1894. gain support from today's youngsters who will grow up with regenerative
  1895. medicine breakthroughs during their lives. Additionally, parents they
  1896. hear about regenerative medicine from the children. It also will serve
  1897. to promote interest the researchers of tomorrow. A high school student
  1898. today could become a graduate student in 10 years who may choose to make
  1899.  regenerative medicine his or her life's work. By building a foundation
  1900. of people who understand and are comfortable with the technology, we can
  1901.  lay foundation for future research in regenerative medicine.</div><br>
  1902. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1903. By
  1904.  finding key spokespeople to promote FIRM the initiative will appeal to
  1905. the American public as a whole. Spokespeople can be an effective way of
  1906. garnering attention and support by putting a we known "fa on finding the
  1907.  appropriate celebrities who can push FIRM at public events, through
  1908. public service announcements and other major venues.</div><br>
  1909. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1910. Public
  1911.  support will dramatically affect future Government and private
  1912. commitment. If the public is aware of the benefits that regenerative
  1913. medicine brings, they will begin to expect and demand that this
  1914. technology become a reality.</div><br>
  1915. <div style="font-size: 10px; line-height: 1.2em; padding: 2px; text-align: left;">
  1916. <a href="#skip" style="text-align: left;">Back to Top</a></div>
  1917. <a name="conclusion" style="text-align: left;"></a>
  1918. <h3 style="font-size: 1em; font-weight: 900; margin-bottom: 0px; text-align: left;">
  1919. Conclusion</h3><br>
  1920. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1921. Regenerative medicine offers the potential to cure countless fatal and debilitating conditions through therapies that spur
  1922. <i style="text-align: left;">in vivo</i>
  1923. regeneration and <i style="text-align: left;">in vitro</i>
  1924. creation of healthy tissue for implantation. The next evolution of
  1925. medical technology is now in sight, and has the potential to become
  1926. reality in the next 20 years. Other nations have envisioned the
  1927. opportunities that regenerative medicine will bring to society. Our
  1928. Nation's private sector has seen the otential benefits, having spent $4
  1929. billion in hopes of making regenerative medicine a reality. Despite this
  1930.  tremendous private investment, there is little to show in terms of
  1931. viable products, due to the lack of scientific research and
  1932. coordination. The U.S. Government can provide direction and resources to
  1933.  the regenerative medicine effort to allow private industry to focus on
  1934. product development.</div><br>
  1935. <div style="font-size: 13px; line-height: 1.2em; padding: 2px; text-align: left;">
  1936. FIRM
  1937.  offers an opportunity to bring the U.S. to the forefront of
  1938. regenerative medicine. With a dedicated U.S. Government investment in
  1939. regenerative medicine for the next 20 years in conjunction with concise
  1940. goal setting and fulfillment as directed by the FIRM council, FIRM
  1941. provides the unique opportunity to leverage resources. This formula has
  1942. seen success when implemented with the Human Genome Project, and is the
  1943. model for the National Nanotechnology Initiative. FIRM will leverage
  1944. Government labs, funding mechanisms, and financial resources to give
  1945. regenerative medicine a vision and purpose, and bring this vision to the
  1946.  American public. While regenerative medicine is an inevitable evolution
  1947.  of science, without guidance the technology will take too long to
  1948. mature. FIRM is required to unravel the complexities of regenerative
  1949. medicine and to make this technology a reality in the next 20 years.
  1950. Other nations have seen the need for national direction. Now is the
  1951. U.S.' time to embrace this technology by making FIRM a framework for the
  1952.  next generation of healthcare. America's greatest natural resource is
  1953. ingenuity. Coupled with the necessary funding and direction, our Nation
  1954. can maintain its preeminence in biotechnology by paving the way to the
  1955. future with the evolving world of regenerative medicine. By doing so, we
  1956.  can make tissue and organ failure a relic of the past by 2020.</div><br>
  1957. <div style="font-size: 10px; line-height: 1.2em; padding: 2px; text-align: left;">
  1958. <a href="#skip" style="text-align: left;">Back to Top</a></div>
  1959. <center>
  1960.  
  1961. <h3 style="font-size: 1em; font-weight: 900; margin-bottom: 0px;">
  1962. Interagency Federal Working Group on Regenerative Medicine</h3><br>
  1963. <div style="font-size: 13px; line-height: 1.2em; padding: 2px;">
  1964. <b>Chair</b><br />
  1965. Howard Zucker, MD, JD<br />
  1966. Deputy Assistant Secretary for Health<br />
  1967. U.S. Department of Health and Human Services</div><br>
  1968. <div style="font-size: 13px; line-height: 1.2em; padding: 2px;">
  1969. <b>National Institutes of Health</b><br />
  1970. Donna Dean, PhD<br />
  1971. Colleen Guay-Broder, MPH<br />
  1972. Eleni Kousvelari, PhD<br />
  1973. Christine Kelley, PhD<br />
  1974. John Watson, PhD<br />
  1975. Josh Zimmerberg, PhD</div><br>
  1976. <div style="font-size: 13px; line-height: 1.2em; padding: 2px;">
  1977. <b>Food and Drug Administration</b><br />
  1978. Charles Durfor, PhD<br />
  1979. Donald Fink, PhD<br />
  1980. Joyce Frey, PhD<br />
  1981. Jesse Goodman, MD<br />
  1982. Darin Weber, PhD<br />
  1983. Celia Witten, PhD</div><br>
  1984. <div style="font-size: 13px; line-height: 1.2em; padding: 2px;">
  1985. <b>Department of Defense</b><br />
  1986. Joe Bielitzki, PhD<br />
  1987. Michael Goldblatt, PhD, JD<br />
  1988. Alan Rudolph, PhD<br />
  1989. Col. Robert Vandre, DDS</div><br>
  1990. <div style="font-size: 13px; line-height: 1.2em; padding: 2px;">
  1991. <b>National Aeronautics and Space Administration</b><br />
  1992. Steve Davison, PhD<br />
  1993. Neal Pellis, PhD</div><br>
  1994. <div style="font-size: 13px; line-height: 1.2em; padding: 2px;">
  1995. <b>Department of Commerce</b><br />
  1996. Angie Hight-Walker, PhD<br />
  1997. National Science Foundation<br />
  1998. Fred Heineken, PhD<br />
  1999. Michael Roco, PhD</div><br>
  2000. </center>
  2001. <hr style="text-align: left;" />
  2002. <ol style="text-align:left;">
  2003.  
  2004.  
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  2006. </p></a><li style="text-align:left;font-size:13px;line-height:100%;"><a name="1" style="text-align:left;">Ratner, Buddy. "What are the opportunities in 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
  2007. </a><a name="2" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2008. </p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="2" style="text-align:left;"><i style="text-align:left;">National Diabetes Statistics</i>. National Diabetes Information Clearinghouse (NDIC). 25 September 2003
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  2013. </p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="3" style="text-align:left;">OPTN Data. The Organ Procurement and Transplantation Network. 17 September 2003
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  2020. </a><a name="6" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2021. </p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="6" style="text-align:left;">OPTN Data. The Organ Procurement and Transplantation Network. 17 September 2003
  2022. </a><a href="http://www.optn.org/latestData/viewDataReports.asp" target="_blank" style="text-align:left;">
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  2024. </p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="7" style="text-align:left;">Lysaght, Michael J. Reyes, Joyce. "The growth of tissue engineering." Tissue Engineering 7 (2001): 485-493
  2025. </a><a name="8" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2026. </p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="8" style="text-align:left;">Centers for Disease Control and Prevention. Preventing Heart Disease and Stroke. 2 December 2003.
  2027. </a><a href="http://www.cdc.gov/nccdphp/bb_heartdisease/index.htm" target="_blank" style="text-align:left;">
  2028. http://www.cdc.gov/nccdphp/bb_heartdisease/index.htm</a>
  2029. <a name="9" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2030. </p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="9" style="text-align:left;">Hogan, P., Dall, T., Nikolov, P. "Economic costs of diabetes in the U.S. in 2002." Diabetes Care 26 (2003): 917-932
  2031. </a><a name="10" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2032. </p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="10" style="text-align:left;">
  2033. U.S. Census Bureau, Statistical Abstract of the United States. "National health expenditures by type, 1990-2000." P.92 </a><a name="11" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2034. </p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="11" style="text-align:left;">Niklason, Laura E. Langer, Robert. "Prospects for organ and tissue replacement." JAMA 285 (2001): 573-576
  2035. </a><a name="12" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2036. </p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="12" style="text-align:left;">Davison, Steven. "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
  2037. </a><a name="13" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2038. </p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="13" style="text-align:left;">Niklason, L.E. Gao, J. Abbott, W.M. Hirschl, K.K. Houser, S. Marini, R. Langer, R. "Functional arteries grown in vitro." Science 284 (1999): 489-493
  2039. </a><a name="14" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2040. </p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="14" style="text-align:left;">Oberpenning, Frank. Meng, Jun. Yoo, James J. Atala, Anthony. "De novo reconstitution of a functional mammalian urinary bladder by tissue engineering." Nature Biotechnology 17 (1999): 149-155
  2041. </a><a name="15" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2042. </p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="15" style="text-align:left;">Ferber, Dan. "Lab-grown organs begin to take shape." Science 284 (1999): 422-425
  2043. </a><a name="16" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2044. </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
  2045. </a><a name="17" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2046. </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
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  2049. </a><a name="19" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2050. </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.
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  2053. </a><a name="21" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2054. </p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="21" style="text-align:left;">Ibid.
  2055. </a><a name="22" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2056. </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
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  2058. http://www.fda.gov/bbs/topics/NEWS/2002/NEW00862.html</a>
  2059. <a name="23" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
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  2067. </a><a name="26" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
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  2069. </a><a name="27" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2070. </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
  2071. </a><a name="28" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2072. </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
  2073. </a><a name="29" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2074. </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
  2075. </a><a name="30" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2076. </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
  2077. </a><a name="31" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2078. </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
  2079. </a><a name="32" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2080. </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
  2081. </a><a name="33" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2082. </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
  2083. </a><a name="34" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2084. </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
  2085. </a><a name="35" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2086. </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
  2087. </a><a name="36" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2088. </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
  2089. </a><a name="37" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2090. </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.
  2091. </a><a name="38" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2092. </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
  2093. </a><a name="39" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2094. </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.
  2095. </a><a name="40" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2096. </p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="40" style="text-align:left;">Ibid.
  2097. </a><a name="41" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2098. </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.
  2099. </a><a name="42" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2100. </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
  2101. </a><a href="http://www.city.kobe.jp/cityoffice/06/015/iryo/contents/aramashi01_e.html#Project" target="_blank" style="text-align:left;">
  2102. http://www.city.kobe.jp/cityoffice/06/015/iryo/contents/aramashi01_e.html#Project</a>
  2103. <a name="43" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2104. </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
  2105. </a><a href="http://pharmacos.eudra.org/F3/f3com/mission.htm" target="_blank" style="text-align:left;">
  2106. http://pharmacos.eudra.org/F3/f3com/mission.htm</a>
  2107. <a name="44" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2108. </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
  2109. </a><a name="45" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2110. </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
  2111. </a><a name="46" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2112. </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
  2113. </a><a href="http://www.ptei.org/industry/pdf/industry.pdf" target="_blank" style="text-align:left;">
  2114. http://www.ptei.org/industry/pdf/industry.pdf</a>
  2115. <a name="47" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2116. </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
  2117. </a><a name="48" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2118. </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
  2119. </a><a href="http://www.nano.gov/nni11600/sld001.htm" target="_blank" style="text-align:left;">
  2120. http://www.nano.gov/nni11600/sld001.htm</a>
  2121. <a name="49" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2122. </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
  2123. </a><a name="50" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2124. </p></a></li><li style="text-align:left;font-size:13px;line-height:100%;"><a name="50" style="text-align:left;">Ibid.
  2125. </a><a name="51" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2126. </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
  2127. </a><a name="52" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2128. </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
  2129. </a><a name="53" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2130. </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.
  2131. </a><a name="54" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2132. </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
  2133. </a><a name="55" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2134. </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
  2135. </a><a href="http://www.nlm.nih.gov/medlineplus/seniorshealth.html" target="_blank" style="text-align:left;">
  2136. 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; ">
  2137. </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
  2138. </a><a name="57" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2139. </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
  2140. </a><a name="58" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2141. </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
  2142. </a><a href="http://www.sematech.org/public/corporate/history/history.htm" target="_blank" style="text-align:left;">
  2143. 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; ">
  2144. </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
  2145. </a><a name="60" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2146. </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
  2147. </a><a href="http://www.sematech.org/public/corporate/history/history.htm" target="_blank" style="text-align:left;">
  2148. 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; ">
  2149. </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
  2150. </a><a name="62" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2151. </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
  2152. </a><a name="63" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2153. </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.
  2154. </a><a href="http://www.oit.doe.gov/programs.shtml#fa" target="_blank" style="text-align:left;">
  2155. http://www.oit.doe.gov/programs.shtml#fa</a>
  2156. <a name="64" style="text-align:left;"><p style="text-align:left;font-size:12px;line-height:100%;padding: -2px; ">
  2157. </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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