Hindu Business Line

Bio-security, an emerging challenge Hindu Business Line Freedom to research in biotechnology shouldn't be hampered, but the risks must be dealt with. Advancements in biotechnology can be used to alarmingly destructive effect. Recently, in September 2011, researchers in Rotterdam succeeded in modifying the ... Biotechnology Can Provide Foundation for a US Economy "Built To Last"MarketWatch (press release) 2012 BIO International Convention to Highlight Insights from Senior Biotech ...EON: Enhanced Online News (press release) all 20 news articles »

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Uncategorized Comments Off on Bio-security, an emerging challenge – Hindu Business Line | February 5th, 2012

Portfolio.com

Biotechnology Funding Hits 4-Year High as Startups Suffer BusinessWeek 20 (Bloomberg) -- Venture capital investment in biotechnology increased 22 percent last year, while the number of those receiving their first funding declined. Funding for medical-device and equipment companies also rose 20 percent, with first-time ... Start-ups saw big rise in funding during '11The Boston Globe Biotech Venture Funding Jumped in 2011International Business Times all 197 news articles »

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Uncategorized Comments Off on Biotechnology Funding Hits 4-Year High as Startups Suffer – BusinessWeek | February 5th, 2012

Health Newstrack

New lung cancer test could accurately guide treatment for people with lung cancer Health Newstrack by Anil Kumar In the two largest clinical studies ever conducted on the molecular genetics of lung cancer, an international team led by scientists at the University of California, San Francisco (UCSF) has demonstrated that an available molecular test ... Possible life-saving test for lung cancerABC7Chicago.com all 5 news articles »

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Uncategorized Comments Off on New lung cancer test could accurately guide treatment for people with lung cancer – Health Newstrack | February 5th, 2012

Scientist

More Research on Virus Mutations Published Occupational Health and Safety Graduate student Justin Meyer and Richard Lenski, Hannah Distinguished Professor of Microbiology and Molecular Genetics at Michigan State University, have published a new paper in the journal Science that adds to the current debate about research that ... How new viruses evolve potentially dangerous traitsTruthDive all 29 news articles »

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Uncategorized Comments Off on More Research on Virus Mutations Published – Occupational Health and Safety | February 5th, 2012

PhysOrg.com

2012 Japan Prize honors cancer fighters, magnet man Network World This year's prize for Healthcare and Medical Technology went to American medical experts, Janet Rowley, MD, Blum-Riese Distinguished Service Professor of Medicine, Molecular Genetics & Cell Biology and Human Genetics of the University of Chicago; ... Rowley to receive Japan Prize for her role in the development of targeted ...EurekAlert (press release) Dr. Brian Druker honored with Japan PrizePhysOrg.com (press release) all 12 news articles »

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Uncategorized Comments Off on 2012 Japan Prize honors cancer fighters, magnet man – Network World | February 5th, 2012

DigitalJournal.com

'Flesh-eating' USA300 MRSA strain spread by sneezes and coughs DigitalJournal.com Metro reports Professor Chris Thomas, professor of molecular genetics at the University of Birmingham, said: "If you're on a crowded tube or bus and you sneeze you can spread the bacteria. But your sneeze can also land on a metal surface and when ... Flesh-eating bug USA300 spread by sneezes and coughsMetro Flesh-Eating Strain Of MRSA Reaches UKHuffington Post UK all 12 news articles »

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http://news.google.com/news?q=molecular-genetics&output=rss

Uncategorized Comments Off on ‘Flesh-eating’ USA300 MRSA strain spread by sneezes and coughs – DigitalJournal.com | February 5th, 2012

ABC News

New lung cancer test predicts survival PhysOrg.com In the two largest clinical studies ever conducted on the molecular genetics of lung cancer, an international team led by scientists at the University of California, San Francisco (UCSF) has demonstrated that an available molecular test can predict the ... Molecular test more accurate in predicting lung cancer survivalTruthDive Gene test may aid early-stage lung cancer patientsSan Francisco Chronicle Genetics test could help treat cancer patientsabc7news.com French Tribune -Daily Gossip all 72 news articles »

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Uncategorized Comments Off on New lung cancer test predicts survival – PhysOrg.com | February 5th, 2012

The Cancer Stem Cell Consortium (CSCC) is a partner in the 2012 Large-Scale Applied Research Project Competition of Genome Canada, in collaboration with the first phase of the Personalized Medicine Signature Initiative of the Canadian Institutes of Health Research (CIHR). Genome Canada is leading the research competition. An excerpt from Fact Sheet: The Potential of Personalized Medicine:

Funding of $67.5M will come from Genome Canada ($40 million), CIHR ($22.5 million) and the Cancer Stem Cell Consortium ($5 million). Projects will be funded for a maximum of four years. To qualify for funding, researchers must obtain matching funding that at is least equal to that provided through the competition, which will bring the total investment in this research area to close to $140 million. Matching funding is typically derived from provincial, academic, private sector or international sources.

Details about the competition are available here.

Press releases, dated January 31, 2012, about the federal government's support for personalized medicine, are available here and here.

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http://cancerstemcellnews.blogspot.com/feeds/posts/default?alt=rss

Stem Cell Therapy Comments Off on Funding for Personalized Medicine Research | February 5th, 2012

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http://intlstemcell.blogspot.com/feeds/posts/default?alt=rss

Stem Cell Therapy Comments Off on PRWEB: Absorption Systems Expands In Vivo Drug and Medical Device Testing Capabilities | February 5th, 2012

The Center for Genetics and Society has filed a brief statement with the Institute of Medicine panel examining the performance of the California stem cell agency, expressing the hope that the inquiry will include "a broader range of sources."

Marcy Darnovsky, associate executive director of the Berkeley group, said that "a meaningful review by (the IOM) committee could make an important contribution to needed changes at the agency." Darnovsky's organization has followed the stem cell effort since its inception.

She noted that CIRM is "a public agency spending increasingly scarce public resources" and has raised the possibility of seeking another multibillion dollar bond measure from voters.

The IOM inquiry has finished half of its public process and is yet to hear an independent analysis of the stem cell agency, which is paying $700,000 for the study.

Earlier Darnovsky told the California Stem Cell Report that the Institute of Medicine has not contacted her organization for comments, although she has spoken with the public relations person for the IOM.

Here is the text of Darnovsky's statement sent to the IOM.

"The Center for Genetics and Society is a public interest organization working to ensure responsible uses and effective societal governance of human genetic and reproductive technologies.  We support embryonic stem cell research, but have been concerned for some years about a number of aspects of the field, and of the California Institute of Regenerative Medicine in particular.

"We have been closely following CIRM since the campaign for Proposition 71 that established it in 2004. We have attended numerous meetings of the agency’s governing board and Standards Working Group, worked with other public interest groups who share our concerns about CIRM, written frequently about CIRM in our publications, and been cited dozens of times in articles about CIRM in key state and national news outlets.

"In 2006, we published The California Stem Cell Program at One Year: A Progress Report, which assessed CIRM's performance to that date and offered recommendations. See http://www.geneticsandsociety.org/downloads/200601report.pdf

"In 2008, CGS policy analyst Jesse Reynolds gave invited testimony to the Little Hoover Commission’s hearing on CIRM. See http://www.geneticsandsociety.org/article.php?id=4386

"We are encouraged that the Institute of Medicine is undertaking an independent assessment of CIRM, though we hope that you will invite input from a broader range of sources than were represented at the meeting last month in San Francisco. With key questions about the future of CIRM unresolved, and its leadership contemplating a campaign for another bond measure.

"As I wrote in a recent commentary that expressed our disappointment with the roster of speakers at last month’s hearing,

"Ballot measure or no ballot measure, CIRM will continue to disperse the public money it controls – another billion and a half dollars. This is a public agency spending increasingly scarce public resources. It is funding a field of research in which we place great hopes for medical and scientific advances. These factors make it all the more crucial that CIRM follow the basics of good governance and public accountability, and eschew the hyperbole and exaggerated promises that have tainted stem cell research for so long.

"See  http://www.geneticsandsociety.org/article.php?id=6045

"Please let us know if we can be of help. We would be very glad to share our insights and recommendations."

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

Stem Cell Therapy Comments Off on CGS: Broader Perspective Needed in IOM-CIRM Performance Evaluation | February 5th, 2012

Here is the text of questions from the California Stem Cell Report and answers from the Institute of Medicine concerning its plans to secure independent perspectives during the IOM's examination of the California stem cell agency. So far, the IOM has not heard publicly from any independent sources.

Christine Stencel, a spokeswoman for the IOM, responded for the IOM. She first gave an overall statement. Then she answered the specific queries. We have inserted the questions from the California Stem Cell Report into her text  in order to make the Q&A easier to follow.

The IOM's general comment:

"The committee and staff are planning their next info gathering sessions. Specifics of these events haven't all been worked out yet, but one overall point is that the committee believes it is important to hear the full range of perspectives and experiences with CIRM and the committee members are actively pursuing sources of information that will allow them to adequately answer the questions they've been tasked to explore. The study is ongoing and there are still a lot of people and resources to tap and information to learn.

"To your specific questions:"

California Stem Cell Report:

"Does the IOM have plans to talk with or seek statements from such groups as the Little Hoover Commission and the Center for Genetics and Society or state Controller John Chiang?"

IOM response:

"Yes. And the committee is reading all the past reviews of CIRM."

California Stem Cell Report:

"Does the IOM plan to seek comments from grant applicants rejected by CIRM, particularly businesses? If so how many? How would such applicants be selected by the IOM for interviews or comments?"

IOM response:

"Yes, the committee wishes to hear these perspectives and is seeking ways to get them."

California Stem Cell Report:

"Does the IOM plan to do more than passively post forms for comment from others? Does it plan to email those forms, for example, to all CIRM grant recipients and applicants who were rejected? Does it plan to follow up to be sure an adequate response is generated?"

IOM response:

"The IOM is proactively working to get survey responses and encouraging people to respond."

California Stem Cell Report:

"What does the IOM mean by 'industry partners' on its (online) forms for comment?"

IOM response:

"Industry partners means CIRM investigators representing for-profit companies."

California Stem Cell Report:

"Does the IOM plan to examine both public and private complaints about conflicts of interest on the part of CIRM grant reviewers? By private, I mean written complaints to CIRM that the agency retains but has not made public."

IOM response:

"The committee is looking into the grants review process and working to make sure that the members obtain all relevant insights and information. The committee members intend to invite people who can provide a broad range of experiences with and perspectives of CIRM to the upcoming meeting in April."

The California Stem Cell Report later asked the IOM if it wanted to comment on a quote that we were considering using, which said,

"In the eyes of the IOM, scientists who draw funding from CIRM and other sources are 'independent.' They look at these things differently than regular people would."

The IOM responded,

"As to the quote you sent, as a response we would just reiterate that the committee is methodically going about its task and during the course of the study aims to gather the full range of information, experiences, and insights relevant to CIRM from a full range of sources."

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

Stem Cell Therapy Comments Off on Text of IOM Responses to Questions about Lack of Independent Analysis | February 5th, 2012

The blue-ribbon panel examining the performance of the $3 billion California stem cell agency is midway through its public process and is yet to hear from a single independent witness during its open sessions.

The panel's report and recommendations are due this fall and are expected to have a major impact on the seven-year-old agency and its future.

So far, the IOM panel has heard only from employees or directors of the agency and persons representing institutions that have received $418 million in CIRM cash.

The panel of scientists and academics was put together by the prestigious Institute of Medicine under a $700,000 contract with the stem cell agency itself. At the 2010 meeting during which agency directors approved the contract, they expressed hope that the IOM panel's findings would bolster public support for another multibillion dollar bond measure for the agency, which expects to run out of funds for new grants in 2017.

Last week, the California Stem Cell Report asked the IOM about its plans to gather independent or critical information about the stem cell agency's performance. With only one more California public meeting scheduled, the IOM said that it is seeking the "full range of perspectives" but did not respond directly to questions about the specifics of how it is going to fulfill that task.

None of the four organizations in California that have an independent perspective on CIRM have been contacted by the IOM, the California Stem Cell Report has been told. They are the state's Little Hoover Commission, the Center for Genetics and Society, Consumer Watchdog and the Citizens Financial Accountability and Oversight Committee, which is the only state body specifically charged with oversight of CIRM and its directors and which is chaired by the state's top fiscal officer, Controller John Chiang. A spokeswoman for the IOM panel said, however, it plans to touch base with at least some of the four.

In response to questions from the California Stem Cell Report, Christine Stencel, the IOM spokeswoman, said the IOM also wants to hear comments from businesses whose applications have been rejected by CIRM. However, she said the panel is still working on "ways to get them." She did not respond directly to questions about how many of such businesses would be interviewed or how they would be selected. The tiny number of CIRM grants to business is a sore spot with industry. Even directors and CIRM's own "external review" panel have said much more is needed.

In response to a question about complaints about conflicts of interest on the part of CIRM reviewers, Stencel was also non-specific, saying only that the panel wants to "obtain all relevant insights." She did not respond directly to a question about whether the panel would examine "private complaints" filed with CIRM by rejected applicants.

Currently the IOM has forms posted online that interested parties, if they know about the existence of the forms, can use to comment on CIRM. We asked whether the panel plans to do more than passively post the forms, specifically whether it plans to email them to all CIRM applicants who were rejected. We also asked about IOM plans to follow up to generate an adequate response. Stencel said the IOM is "proactively working" to get survey responses but did not say what specific steps it was taking.

Our comment?

The IOM has a well-deserved reputation for rigor and thoroughness. However, the IOM is all but unknown to 99 pecent of the public, which will be the ultimate consumer of its findings on the stem cell agency. The fact that the IOM is being paid $700,000 by CIRM will undoubtedly raise questions in the minds of some about IOM's own objectivity. The panel itself consists of persons who have like-minded interests and sympathy with CIRM and its 485 grant recipients. No member of the panel is likely to publicly discourage more scientific research, even if CIRM is deemed to be failing to fulfill the voters expectations in 2004 when they created the agency. All the more reason to aggressively seek out those with contrary views about CIRM's performances, if the IOM's report is to have maximum credibility.

Earlier this week we heard from a knowledgeable and longtime observer of the research scene, who said that the IOM looks at things "differently than regular people" and views scientists who receive funding from CIRM as "independent." The IOM's Stencel responded by reiterating that the IOM is seeking the full range of information from the full range of sources.

The IOM evaluation of CIRM's performance is much too far along not to have progressed further with its attempts to hear from independent and critical voices about CIRM. Generalizations to the effect that "we are going to get to it" do not serve the panel well. The IOM should lay out publicly and quite specifically its plans to aggressively seek thoughtful analysis from parties that do not have financial or professional links to CIRM, as well as from those who feel they have received a short shrift from the $3 billion enterprise.

You can read the full text of the questions from the California Stem Cell Report and the IOM responses here.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

Stem Cell Therapy Comments Off on IOM Coming Up Short on Independent Analysis of the California Stem Cell Agency | February 5th, 2012

The prestigious journal Nature today said that asking California voters for more billions for stem cell research in a few years "may strike residents as a luxury that they can ill afford."

The comment came in a piece by Erika Check Hayden dealing with the future of the California stem cell agency, which is expected to run out of money for new grants in about 2017. She wrote,

"Given that California is facing severe budget shortfalls, several billion dollars more for stem-cell science may strike residents as a luxury that they can ill afford. It may also prove difficult for CIRM’s supporters to point to any treatments that have emerged from the state’s investment. So far, the agency has funded only one clinical trial using embryonic stem cells, and that was halted by its sponsor, Geron of Menlo Park, California, last November.

"Yet the institute has spent just over $1 billion on new buildings and labs, basic research, training and translational research, often for projects that scientists say are crucial and would be difficult to get funded any other way. So the prospect of a future without CIRM is provoking unease. 'It would be a very different landscape if CIRM were not around,' says Howard Chang, a dermatologist and genome scientist at Stanford University in California."

Chang was a scheduled witness recently at a public meeting in California of the blue-ribbon Institute of Medicine panel examining the performance of the Golden State's $3 billion stem cell research effort. Chang is the recipient of $3.2 million in CIRM funding. Hayden wrote,

"Chang has a CIRM grant to examine epigenetics in human embryonic stem cells, and is part of another CIRM-funded team that is preparing a developmental regulatory protein for use as a regenerative therapy. Both projects would be difficult to continue without the agency, he says. Federal funding for research using human embryonic stem cells remains controversial, and could dry up altogether after the next presidential election (see Nature 481, 421–423; 2012). And neither of Chang’s other funders — the US National Institutes of Health (NIH) and the Howard Hughes Medical Institute in Chevy Chase, Maryland — supports his interdisciplinary translational work. Irina Conboy, a stem-cell engineer at the University of California, Berkeley, who draws half of her lab’s funding from CIRM, agrees that in supporting work that has specific clinical goals, the agency occupies a niche that will not easily be filled by basic-research funders. 'The NIH might say that the work does not have a strong theoretical component, so you’re not learning anything new,' she says."

Conboy was also a scheduled witness at the IOM hearing. She holds $2.2 million in CIRM grants.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

Stem Cell Therapy Comments Off on Stem Cell Researchers ‘Uneasy" in California | February 5th, 2012

Be The Match donor registry drive in Cokato Saturday

By Kristen Miller
News Editor

COKATO, MN – By age 14, Taylor Tenhoff had already been diagnosed with severe aplastic anemia and had undergone two bone marrow transplants; one that was unsuccessful.

Fortunately for Taylor’s sake, he was able to find a match in one of his six siblings. However, there are many patients in need of bone marrow transplants who don’t have a sibling match and rely Be The Match Registry, operated by the nonprofit, National Marrow Donor Program.

In an effort to raise awareness for the need of bone marrow donors, the Tenhoff family of Cokato is hosting a Be The Match donor registry drive Saturday, Feb. 11 from 9 a.m. to 1 p.m. in the community room of Cokato City Hall. It is also the one year anniversary of Taylor’s second bone marrow transplant.

“We want to increase the amount of donors available,” Taylor’s mother, Monica, said. “The more people that get on the registry, the more potential donors there are.”

In 2008, Katie (Tenhoff) Richter donated bone marrow to her brother, only for it to fail months later. She donated again last February.

“If I had to do it again, I would,” Katie said. “The feeling you get knowing he’s alive because of you is amazing.”

Thousands of patients with life-threatening diseases and blood cancers, such as leukemia, lymphoma, and sickle cell anemia depend on the Be The Match Registry to find a bone marrow match.

According to Be The Match, 70 percent of patients needing a marrow transplant do not have a matching donor within their family.

“Siblings are the best match, but it’s not always a guarantee . . that’s when the patient comes to us,” said Kristine Reed, account executive of recruitment and development for Be The Match, the only marrow registry in the US.

Unlike blood donations, bone marrow does not match according to blood type. Instead, matches are based on the same racial and ethnic background, Reed explained.

“Not a lot of people are aware of that,” she said. “Right now, we are extremely low on the registry of non-caucasion donors,” she added.

The matching process is extremely specific, Reed said. If the recipient’s body doesn’t recognize the marrow type, it will try and fight it, a fight that could actually be fatal, she said.

There are requirements and limits for being on the registry. Donors need to be between the ages of 18 and 60, be willing to donate to any patient in need, and meet the health guidelines.

Reed, who is a leukemia survivor and marrow transplant recipient since 1999, will be leading the registry Saturday. She recommends those interested in joining the registry learn more about it beforehand.

“We want to make sure they are comfortable and willing to donate when they get the call,” Reed said. “If they get the call, it’s because they match a patient who is dying.”

It also costs the organization roughly $100 every time someone is placed on the registry, Reed said, adding that donors are encouraged to give what they can.

The registry process is painless and only takes between 20 to 30 minutes. It includes completing a confidential consent form and a cheek swab. No blood is drawn.

How the bone marrow donation process works

Once the donor has been called upon, there are two possible ways for bone marrow to be drawn.

The most common process is the peripheral blood stem cell donation. Similar to donating plasma or platelets, this is a non-surgical procedure and is requested by doctors 76 percent of the time.

For five days before donation, the donor receives daily injections of a drug that increases blood-forming cells in the bloodstream. On the last day, the donor’s blood is removed through a needle in one arm and passed through a machine that separates out the blood-forming cells. The remaining blood is returned to the donor through the other arm.

The second process is a surgical procedure of marrow donation, and it is requested by doctors 24 percent of the time.

During this procedure, the donor is under anesthesia while the doctor uses a needle to withdraw liquid marrow from the back of the pelvic bone.

Once the marrow is drawn, it is immediately transported to the intended recipient.

Half of the donors on the registry benefit patients from another country, and half of the patients that come to the registry receive a donor from another country, Reed explained. “It works both ways,” she said.

Marrow donors can expect to feel some soreness in the lower back for a few days to several weeks. Reed describes the pain similar to having fallen after slipping on ice.

Marrow donors are typically back to their unusual routine tin two to seven days. All costs are the recipient’s responsibility.

“There could be temporary discomfort,” Reed said, “but keep in mind, you’re giving someone a second chance at life.”

The temporary discomfort the donor may experience doesn’t compare to what the recipient has to go through before the transplant, Reed said, who received her sister’s bone marrow 12 years ago.

Just to put it in perspective, the patient needs full body radiation and intense chemotherapy to eradicate as much existing marrow as possible to make room for new, healthy marrow, Reed explained. “It’s like draining out a tank of gas,” she said.

Even after the transplant, there is a long road to recovery for the recipient, she commented.

To become a potential donor:

For those interested in being on the Be The Match Registry, visit http://www.tinyurl.com/TaylorTenhoff to learn more about becoming a donor.

To register, come to the donor registry drive Saturday, Feb. 11 from 9 a.m. to 11 p.m. at Cokato City Hall. Baked goods will be available with a free will offering and Dairy Queen coupons will be given to anyone who donates to the cause.

If becoming a donor isn’t a possibility, there is still an opportunity to donate cash toward the cause, which will be used to help cover lab costs associated with being on the registry.

More information can be found on http://marrow.org.

Read more:
Becoming a bone marrow donor could save a life

Bone Marrow Stem Cells Comments Off on Becoming a bone marrow donor could save a life | February 4th, 2012

Morning After The Morning's Trash

In my last post, I focused on flaws in the medical device approval process. The Union of Concerned Scientists’ “FDA at a Crossroads” meeting also covered problems with drug approval. This is perhaps no better illustrated than by the disappointing decision by Secretary of Health Kathleen Sebelius’ to deny the emergency contraceptive, Plan B, over-the-counter status for women under the age of 17. This was a particular disappointment to many because President Obama had promised that decisions at the FDA would be made based on science, rather than politics. Some of us, naively, hoped that “change we can believe in” was real, having forgotten that the Tooth Fairy wasn’t.

Two of the speakers at the recent FDA at a Crossroads meeting were formerly at the FDA; both left because of political pressures. Dr. David Ross, was an FDA reviewer for Ketek (an antibiotic). In a Congressional hearing, Dr. Ross testified that he had been pressured to soften his findings about liver toxicity due to the drug and threatened by FDA Commissioner von Eschenbach, who said, “If you don’t follow the team, if you don’t do what you’re supposed to do, the first time you’ll be spoken to, the second time you’ll be benched, and the third time, you’ll be traded,” according to Ross.

The other was Dr. Susan Wood, former assistant FDA commissioner for women’s health and director of the Office of Women’s Health, who resigned from the FDA after Plan B’s approval was initially denied.

The Tradition of Politics at the FDA

Before we delve into the specific discussion of Plan B, let’s look at the context of the politicization of the FDA, under the recent Bush administration in particular, which led to the characterization of the “broken FDA.” During that period access to healthcare information, health services, and medical research became limited by two growing trends: the infusion of increasingly restrictive religious doctrines and the implementation of ideology-driven—rather than scientific, evidence-based—public policies. Initially, access to science-based information was limited through censorship and even distortion in government sources (e.g., data regarding the efficacy of condoms in preventing HIV infections and STDs were removed from the CDC’s Web site). This neither helped reduce the teen birthrate nor STDs. They used the same misinformation tactic with the now discredited breast cancer-abortion link.

Ideologic shifts were also demonstrated by resource allocations. For example, HIV prevention programs at the CDC were reduced by $4 million while funding for abstinence-only programs rose from $20 million to $167 million, despite the lack of evidence of effectiveness, in contrast to the previous peer-review, scientific-merit-based process of NIH grant funding. No federal money is spent on comprehensive sex education. Even worse, since 1982, “Over $1 billion in government funding has been granted to abstinence-only programs…[which] are expressly forbidden from discussing contraception…and often contain factually inaccurate and distorted information. Those who design and operate these programs are often inexperienced, religiously-motivated and frequently have close ties to the anti-abortion movement.”

The trend away from evidence-based medicine affects healthcare practitioners in numerous areas, ranging from patient education and disturbingly eroding standards of medical care to selection of research topics, grant writing, and the research funding process. Upon her dismissal from the President’s Council on Bioethics in 2004 for disagreeing with the administration’s stance on stem cell research, Dr. Elizabeth Blackburn, a prominent cancer researcher and one of only three full-time biomedical researchers on the council, wrote, “When prominent scientists must fear that descriptions of their research will be misrepresented and misused by their government to advance political ends, something is deeply wrong.” Among her many honors, incidentally, is the 2009 Nobel Prize in Medicine.

A brief history of the FDA commissioners and other key persons over the past 20 years illustrates politics at work in the FDA.

David Kessler (commissioner,1990–1997) took a great deal of heat for trying to have the FDA regulate tobacco products and for trying to gain approval for RU-486 (mifepristone).(He lost on both counts.) He was also notable for being appointed by President George H. W. Bush and retained by President Clinton.

Jane Henney (commissioner, 1998–2001), also appointed by Clinton, authorized FDA approval of RU-486. She was, not surprisingly, ousted when George W. Bush took office. She also tried to change business as usual by filling positions with career appointees rather than political ones, actively demonstrating her goal of “leading policy and making enforcement decisions based on science, not on political whims.”

An infamous nominee for chairing Bush’s FDA advisory panel on women’s health policy was Dr. W. David Hager, an obstetrician-gynecologist. He had helped prepare a “citizens’ petition” calling for the FDA to reverse its approval of RU-486. He was perhaps more widely known for his reported refusal to prescribe contraceptives to married women and as author of a book that “recommends specific Scripture readings and prayers for such ailments as headaches and premenstrual syndrome.” After the outcry of critics, he was not appointed chair of the advisory panel but did serve on it in 2002–2005, despite bipartisan opposition.

Mark McClellan (commissioner, 2002–2004) was an economist appointed by George W. Bush. McClellan reportedly had decided against approving Plan B for emergency contraception even before his staff completed its analysis.

Lester Crawford (commissioner, July–September 2005) was a veterinarian also appointed by George W. Bush. His term is perhaps best remembered for three features: the audacity of a veterinarian making decisions about women’s health and reproduction, his vehement opposition to Plan B’s approval, and the criminal charges against him for false reporting about holdings relevant to his appointment (that he and his wife owned stocks in food, beverage, and medical device companies that he was in charge of regulating). He got off with probation and a fine.

Susan F. Wood was another casualty of Crawford’s brief and divisive tenure at the FDA. As noted, she resigned because of the politicization of the agency—specifically, having the approval of Plan B emergency contraception denied, despite scientific evidence of the pill’s safety and recommendations from the FDA’s own advisory committee.

Andrew C. von Eschenbach (commissioner, 2005–2009) had been the head of the National Cancer Institute before being appointed as FDA commissioner. He was also tied to the decision of the FDA to deny emergency contraceptives over-the-counter status, despite the recommendation of the FDA’s advisory group and its own staff members, as well as that of many medical organizations.17 The FDA had followed advisory committee recommendations in every other case in the past decade. He is also known for reportedly threatening FDA reviewers who disagreed with him. Von Eschenbach’s ideologic, rather than evidence- based, decisions were so egregious that on March 23, 2009, the U.S. District Court (Tummino v. Torti) ordered the FDA to reconsider its decision blocking access to Plan B. It also ordered the FDA to act within 30 days to extend over-the-counter access to 17-year-olds. The court’s conclusions about the FDA’s behavior were damning.

The FDA’s ability to function and its reputation have been seriously hurt in the past decade. In a 2006 survey of FDA scientists, about 18 percent responded that they had been asked to exclude or alter information or their report’s conclusions for nonscientific reasons. A further 60 percent were aware of cases where industry “inappropriately induced or attempted to induce the reversal, withdrawal or modification of FDA determinations or actions.” One-fifth (20 percent) said they had been “asked explicitly by FDA decision makers to provide incomplete, inaccurate or misleading information to the public, regulated industry, media, or elected/senior government officials.” Lest you think this survey was markedly biased, even Senator Chuck Grassley, a staunch Republican, commented on the survey report, “The responses of these scientists reinforce the findings of the independent Government Accountability Office, which said the process for reviewing drugs on the market is deeply flawed.”

As a result of the politicization, the FDA staff has reportedly become greatly demoralized, interfering with its ability to function and protect the public. FDA whistle-blowers have testified that the agency considers the drug companies its clients, and its decision-making furthers the interests of those clients.

Many experienced and valuable clinicians have left the agency, leaving a void. Equally importantly, the FDA has lost considerable respect and authority in the eyes of both the public and important members of Congress.

From 2001 to 2009, the most obvious politicization at the FDA was related to women’s health issues, and especially access to contraception.

In March 2009, President Obama issued a memorandum on scientific integrity. A further encouraging sign of change was the May 2009 appointment of two well-respected physicians to lead the FDA, Drs. Margaret Hamburg and Joshua Sharfstein. Dr. Sharfstein has since left. Dr. Hamburg, the opening speaker at the UCS conference, noted that it was imperative to build trust in FDA’s integrity, and that it is science-based. Dr. Hamburg concluded that “I agree with the Center [for Drug Evaluation and Research (CDER)] that there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.”

Unfortunately, Dr. Hamburg—and all women—just had the rug pulled out from them by Sebelius’ overtly political, evidence-be-damned stance.

Plan B Perspective

The irrational decision to overrule the recommendation of numerous experts appears based on the idea that young girls would be buying the pill without parental consent, and that such girls could not do so safely. They ignore that kids can readily buy Tylenol, which has significant liver toxicity and is often a component of deadly drug overdoses. Plan B is far safer—and also unlikely to be used routinely because, at ~$50, it is relatively expensive.

Even the conservative American Academy of Pediatrics urged approval of the morning-after pill for young teens, recognizing Plan B as being a safer alternative to abortions or unwanted pregnancies.

Plan B has the same hormone found in birth control pills, progestin, but in a larger dose. It works primarily by preventing ovulation. In contrast, mifepristone, or RU-486, is used to induce a medical abortion in a process similar to a miscarriage.

What were the arguments against Plan B this time? President Obama expressed his concern as a parent, that his daughters must not have access to such a medicine without adult guidance. His personal preferences are not “evidence-based science”. And he is deluding himself. We can guide our children, but we cannot control their behavior. My hope has been to educate my kids and offer them counsel knowing that, for better or worse, they will make many mistakes along the way. Prevention of pregnancy through ready access to contraceptives is far safer than an abortion or unwanted pregnancy. . .which may doom a teen to a lifetime of poverty and misery. There is a superb cartoon capturing the debate, Matt Davies,’ “Which of these responsibilities is a 15 year old too young to be handed?”—a screaming baby or Plan B pill.

Even the digital world seems to be biased, as now even Siri is getting into the act. Siri conveniently can direct you where to buy Viagra, but feigns ignorance when asked to direct to a reproductive health center offering abortion counseling or services.

The Plan B Decision has been characterized as “Sacrificing ‘Change We Can Believe In’ for Expediency?” “Only half of the nation’s teen moms ever earn a diploma; more than half go on welfare; and more than half of the families started by teens live in poverty.” The Ft. Wayne paper has it right stating, “Plan B politics ignore human toll.” I have never understood how many conservatives can demand censorship, restriction of contraceptives, and control of women’s bodies, all in the name of being “pro-life.” Fetal rights trump a woman’s…but then these people take no responsibility for the care, feeding, and education of these unwanted children. The sanctity of life ends at the womb. A life sentence is a huge price for a moment’s mistake.

Mechai Viravaidya

Even Thailand, which many US citizens likely would (erroneously) consider to be a third-world country, is more enlightened in some health-related ways. For example, Mechai Viravaidya, a former Thai senator and founder of the Population and Community Development Association (PDA), and enormously successful family planning NGO, made a brilliant educational campaign focused on reducing both the birthrate and the AIDS epidemic, by making sex education fun and promoting condoms to be as readily available as cabbages. He even has a restaurant and resort known as “Cabbages and Condoms.” It was a wonderful place to visit. (insert pic)

So why did Obama and Sebelius kill OTC Plan B—the first time that the Health and Human Services Commission has ever overruled the FDA? Only two reasons come to mind. The first is that Obama is overtly campaigning for the conservative vote. The second is similar, but a bit less overt—that OTC Plan B was sacrificed to take a firmer stance on having contraceptive coverage as part of all insurance plans.

And Plan B’s got it right, too, in their ad: “I chose a condom but it broke. Now I Have A Second Chance.”

Why don’t the politicians get it?

~~~

Images: Morning After The Morning’s Trash, from waltarrrrr on Flickr; pictures of condom bouqets and t-shirt by the author; Mechai Viravaidya holding a t-shirt, from Gates Foundation on Flickr;

Previously in this series:

Molecules to Medicine: Clinical Trials for Beginners
Molecules to Medicine: From Test-Tube to Medicine Chest
Lilly’s Shocker, or the Post-Marketing Blues
Molecules to Medicine: Pharma Trumps HIPAA?
Molecules to Medicine: Should pepper spray be put on (clinical) trial?
Molecules to Medicine: FDA at a Crossroads—a Tough Place to Be

Link:
Molecules to Medicine: Plan B: The Tradition of Politics at the FDA

Uncategorized Comments Off on Molecules to Medicine: Plan B: The Tradition of Politics at the FDA | February 3rd, 2012

NEW YORK, Jan. 30, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Biobanking for Medicine: Technology and Market 2012-2022

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Report Details

What does the future hold for biobanks? Visiongain's report shows you potential revenues and trends to 2022. Find data, forecasts and discussions for biobanking in medicine.

Discover sales predictions at overall market, submarket and national levels to 2022. Our study gives you business research, analysis and opinion for applications in medical research, pharmaceuticals and diagnostics. 

How will the biobanking industry perform? Receive forecasts for human tissue banking, stem cell banking, private cord banking, other services (e.g., DNA and RNA storage), commercial biobanks, academic collections and other operations. You find revenues and discussions.

R&D applications are multiplying and widening. Assess contributions of biobanks in understanding disease, drug discovery, drug development and biomarkers. This decade will result in technological and organisational progress, public and private, benefiting healthcare. 

Our report discusses Cryo-Cell International, Cord Blood America, Tissue Solutions, Asterand, ViaCord, LifebankUSA, China Cord Blood and other organisations. See activities and outlooks. 

Biobanks and biorepositories will become more important to medical R&D and human healthcare. Biological science and technology stand to benefit. Discover the prospects. 

Visiongain's study provides data, analysis and opinion aiming to help your research, calculations, meetings and presentations. You can find answers now in our work.

Revenue forecasts, market shares, developmental trends, discussions and interviews

In the report you find revenue forecasting, growth rates, market shares, qualitative analyses (incl. SWOT and STEP), news and views. You receive 72 tables and charts and six research interviews.

Advantages of Biobanking for Medicine: Technology and Market 2012-2022 for your work

In particular, this study gives you the following knowledge and benefits:• Find revenue predictions to 2022 for the overall world market and submarkets, seeing growth trends• Assess companies in medical biobanking, discovering activities and outlooks• See revenue forecasts to 2022 in leading countries for human tissue banking - US, Japan, Germany,France, UK, Spain, Italy, China and India• Review developmental trends for biobanks - technologies and services• Investigate competition and opportunities influencing commercial results• Find out what will stimulate and restrain that industry and market• View expert opinions from our survey of that biotechnology sector.

There, you receive a distinctive mix of quantitative and qualitative work with independent predictions. We analyse developments and prospects, helping you to stay ahead.

Gain business research, data and analysis for medical biobanking Our study is for everybody needing industry and market analyses for medical biobanks. Find data, trends and answers. Avoid missing out - please order our report now.

Visiongain is a trading partner with the US Federal GovernmentCCR Ref number: KD4R6 

Table of Contents1. Executive Summary

1.1 Summary Points of this Report

1.2 Aims, Scope and Format of the Report

1.2.1 Speculative Aspects of Assessing the Biobanking Market

1.2.2 Chapter Outlines

1.3 Research and Analysis Methods

1.3.1 Human Tissue Banking Market

1.3.2 Stem Cell Banking Market

2. Introduction to Biobanking2.1 Biobanking2.1.1 Processes Involved in Biobanking2.2 Biobanks: A Two-Fold Character2.3 Key Features2.4 Classification of Biobanks2.4.1 Volunteer Groups2.4.1.1 Population-Based Biobanks2.4.1.2 Disease-Oriented Biobanks2.4.2 Ownership or Funding Structure2.5 Guidelines and Standards2.5.1 Guidelines for Biobanks and Use of Biological Samples for Research2.5.2 Industry Standards for Biobanks2.5.3 Biobanking Processes Governed by Guidelines2.6 Laws and Regulations for Biobank-Based Research

3. Biobanking and the Pharmaceutical Industry

3.1 Scientific and Commercial Use of Biobanking in the Pharmaceutical Industry

3.1.1 Research and Drug Development

3.1.1.1 Understanding Disease Pathways

3.1.1.2 Drug Discovery

3.1.1.3 Biomarker Discovery

3.1.2 Therapeutics

3.1.3 Clinical Trials

3.2 Biobanks Operated by Pharmaceutical Companies

4. Biobanking Associated Market: Systems, Software, Consumables and Services Associated with Biobanking4.1 Overview4.2 Systems/Technologies4.2.1 Automated Liquid Handling4.2.1.1 Frozen Aliquotting: New Technology in Development4.2.2 Storage4.2.2.1 Ultra-Low Temperature Freezing4.2.2.2 Room-Temperature Storage4.2.3 RFID and Tagging Technologies4.3 Software4.3.1 Laboratory Information Management System (LIMS)4.3.1.1 LIMS Functions4.4 Consumables4.5 Services

5. The World Medical Biobanking Market to 2022

5.1 Current State of the Biobanking Market

5.2 Geographical Footprint

5.3 Growing Demand for Biobank Resources

5.4 Revenue Forecast for Overall Market

5.4.1 Scope and Limitations

5.4.2 Biobanking Market, 2011-2022

5.4.2.1 Sales Forecasts for Biobanking Market, 2011-2016

5.4.2.2 Sales Forecasts for Biobanking Market, 2017-2022

5.5 Commercial Biobanks: New Resources for Research

6. Human Tissue Banking Market6.1 Revenue Forecast for Overall Human Tissue Banking Market, 2011-20226.1.1 Revenue Forecast for Overall Human Tissue Banking Market, 2011-20166.1.2 Revenue Forecast for Overall Human Tissue Banking Market, 2017-20226.2 Revenue Forecasts for Human Tissue Banking Market by Type of Biobank, 2011-20226.2.1 Revenue Forecast for Commercial Human Tissue Banking Market, 2011-20166.2.2 Revenue Forecast for Commercial Human Tissue Banking Market, 2017-20226.2.3 Revenue Forecast for Academic & Other Human Tissue Banking Market, 2011-20166.2.4 Revenue Forecast for Academic & Other Human Tissue Banking Market, 2017-20226.3 Revenue Forecasts for Human Tissue Banking in Leading National Markets, 2011-20226.4 Some Commercial Participants in the Human Tissue Banking Market6.4.1 Business Models of Companies in the Biobanking Market6.4.2 Tissue Solutions6.4.2.1 Overview6.4.2.2 Global Presence6.4.2.3 Products and Services6.4.2.3.1 Banked Samples6.4.2.3.2 Prospective Samples6.4.2.3.3 Fresh Samples6.4.2.3.4 Freshly Isolated and Primary Cells6.4.2.3.5 Services6.4.2.4 Strengths and Capabilities6.4.2.5 Future Outlook6.4.3 Asterand6.4.3.1 Overview6.4.3.2 Global Presence6.4.3.3 Products and Services6.4.3.3.1 XpressBANK6.4.3.3.2 ProCURE6.4.3.3.3 PhaseZERO6.4.3.3.4 BioMAP6.4.3.4 Asterand: Raised Barriers for New Market Entrants?6.4.3.5 Financial Performance6.4.3.6 Future Outlook

7. Stem Cell Banking

7.1 Overview

7.2 Revenue Forecast for Overall Stem Cell Banking Market, 2011-2022

7.2.1 Revenue Forecast for Stem Cell Banking Market, 2011-2016

7.2.2 Revenue Forecast for Stem Cell Banking Market, 2017-2022

7.3 Stem Cell Banks for Research: High Growth Possible

7.4 Umbilical Cord Blood Banking for Stem Cells

7.4.1 Blood Banks: Private vs. Public

7.4.2 Biological Insurance: Private Blood Banking

7.4.3 Umbilical Cord Banking: The Controversies

7.4.3.1 US Oversight of Cord Blood Stem Cells

7.4.4 Revenue Forecast for Private Cord Blood Banking Market, 2011-2016

7.4.5 Revenue Forecast for Private Cord Blood Banking Market, 2017-2022

7.4.6 Companies in the Field

7.4.6.1 Cord Blood America: Looking Towards the Chinese Market

7.4.6.2 ViaCord: 145,000 Blood Units in Storage

7.4.6.3 Cryo-Cell International: The First Cord Blood Bank

7.4.6.4 Stem Cell Authority: Exclusive Stem Cells

7.4.6.5 LifebankUSA: Placenta-Cord Banking

7.4.6.6 Biogenea-Cellgenea

7.4.6.7 China Cord Blood Corp

7.4.6.8 Cryo-Save

7.4.6.9 Thermogenesis

7.5 Gene/DNA Banking

8. Industry Trends8.1 Automated Biobanking8.1.1 Increased Uptake of Laboratory Information Management Systems (LIMS) in Biobanking8.1.2 Addressing Sample Storage and Tracking Issues8.2 Green Banking8.3 Creation of National Biobanks8.4 HIPAA Amendments

9. Qualitative Analysis of the Biobanking Sector

9.1 Strengths

9.1.1 Wealth of Information for Genetic Research

9.1.2 Potential to Change Treatments

9.1.3 Many Governments Support Biobanking

9.2 Weaknesses

9.2.1 Quality Concerns for Some Existing Biospecimen Collections

9.2.2 Lack of Standardisation and Harmonisation of Best Practices

9.2.3 Limited Sharing and Linkage of Biobanks

9.3 Opportunities

9.3.1 Genome-Wide Association Studies (GWAS)

9.3.2 Personalised Medicine

9.3.3 Pharmacogenomics: Driving the Personalised Medicine Approach

9.4 Threats

9.4.1 Ethical and Regulatory Issues

9.4.1.1 Limitations of Informed Consent in Biobanking

9.4.1.2 Confidentiality and Security to Prevent Improper Use

9.4.2 Social and Cultural Issues

9.4.3 Ownership Issues

9.4.4 Funding

10. Research Interviews from Our Survey10.1 Dr Morag McFarlane, Chief Scientific Officer, Tissue Solutions10.1.1 On the Use of Biobank Samples in the Pharmaceutical Industry 10.1.2 On Commercial Aspects of Biobanking10.1.3 On the Business of Tissue Solutions10.1.4 On the Attractiveness of Human Tissue Banking10.1.5 On the Future of the Biobanking Market10.2 Dr Angel García Martín, Director, Inbiomed10.2.1 On the Importance of Biobanking in the Pharmaceutical Industry 10.2.2 On the Use of Technology in Biobanking 10.2.3 On Increased Recognition of Biobanking and Harmonisation of Samples 10.2.4 On the Use of Biobanks by the Pharmaceutical Industry 10.2.5 On Private Biobanks and Scale of Operations 10.2.6 On Commercial and Public Biobanking and Legislation 10.2.7 On the Most Attractive Segment in Commercial Biobanking10.2.8 On the Future of Biobanking: Drivers and Challenges10.3 Dr Piet Smet, Director, Business Development, BioStorage Technologies10.3.1 On Defining Biorepositories and Biobanks10.3.2 On the Services of Biostorage10.3.3 On Main Customers for Biostorage10.3.4 On the Importance of Biorepositories in Research and Industry10.3.5 On Technology Use in Biobanks10.3.6 On Increased Recognition of Biobanking and Harmonisation of Samples 10.3.7 On the Use of Biobanks by the Pharmaceutical Industry 10.3.8 On Private Biobanks and Scale of Operations 10.3.9 On Commercial and Public Biobanking and Legislation 10.3.10 On the Most Attractive Segment in Commercial Biobanking10.3.11 On Biobanking in 202010.3.12 On Drivers and Challenges in the Sector10.4 Dr Tom Hoksbergen, Marketing and Sales, SampleNavigator Laboratory Automation Systems10.4.1 On the Services of SampleNavigator10.4.2 On Main Customers for SampleNavigator10.4.3 On the Importance of Biorepositories in Research and Industry10.4.4 On Technology Use in Biobanks10.4.5 On Increased Recognition of Biobanking and Harmonisation of Samples 10.4.6 On the Use of Biobanks by the Pharmaceutical Industry 10.4.7 On Commercial Biorepositories/Banks and Scale of Operations 10.4.8 On Commercial and Public Biobanking10.4.9 On the Most Attractive Segment in Commercial Biobanking10.4.10 On Biobanking in 202010.4.11 On Drivers and Challenges in the Sector10.5 Mr Rob Fannon, Clinical Operations Manager, BioServe10.5.1 On the Services of BioServe10.5.2 On Main Customers for BioServe10.5.3 On the Importance of Biorepositories in Research and Industry10.5.4 On Technology Use in Biobanks10.5.5 On Increased Recognition of Biobanking and Harmonisation of Samples 10.5.6 On the Use of Biobanks by the Pharmaceutical Industry 10.5.7 On Commercial Biorepositories/Banks and Scale of Operations 10.5.8 On Commercial and Public Biobanking10.5.9 On the Most Attractive Segment in Commercial Biobanking10.5.10 On Biobanking in 202010.5.11 On Drivers and Challenges in the Sector10.6 Dr Frans A.L. van der Horst, Chairman, Dutch Collaborative Biobank10.6.1 On Importance of Biorepositories in Research and Industry10.6.2 On Increased Recognition of Biobanking and Harmonisation of Samples 10.6.3 On the Services of Dutch Collaborative Biobank10.6.4 On Commercial Drivers for Bio-Repositories/Biobanking Market10.6.5 On Commercial and Public Biobanking10.6.6 On Sustaining/Recovering Costs10.6.7 On the Most Attractive Segment in Commercial Biobanking10.6.8 On Ethical, Legal and Social Issues in Biorepositories/Biobanks

11. Conclusions

11.1 Biobanking for Research and Therapeutics

11.2 Biobanking: The Future for Drug Discovery and Personalised Medicine

11.3 Commercial Drivers of the Biobanking Market

11.4 The Sector Has Marked Challenges, but Many Opportunities for Growth

List of TablesTable 2.1 Prominent Population-Based Biobanks, 2011

Table 2.2 Prominent Disease-Oriented Biobanks, 2011

Table 2.3 Some Guidelines and Recommendations for Biobanks, 2011

Table 2.4 Laws and Regulations for Biobank-Based Research, Consent Requirements, and Privacy/ Data Protection, 2011

Table 3.1 Some Pharmaceutical and Biotechnology Companies with In-House Biobanks, 2011

Table 4.1 Prominent Companies in the Automated Liquid Handling Market, 2011

Table 4.2 Prominent Companies in Ultra-Low Temperature Freezer Market, 2011

Table 4.3 Prominent LIMS Vendors, 2011

Table 4.4 Prominent Consumables Suppliers for Biobanking, 2011

Table 4.5 Prominent Biorepository Service Providers, 2011

Table 5.1 Estimated Number of Biobanks in Europe, 2011

Table 5.2 Biobanking Market: Grouped Revenue Forecasts, 2010-2016

Table 5.3 Biobanking Market: Grouped Revenue Forecasts, 2017-2022

Table 6.1 Human Tissue Banking Market: Overall Revenue Forecast, 2010-2016

Table 6.2 Human Tissue Banking Market: Overall Revenue Forecast, 2017-2022

Table 6.3 Human Tissue Banking Market: Revenue Forecasts by Type of Biobank, 2010-2016

Table 6.4 Human Tissue Banking Market: Revenue Forecasts by Type of Biobank, 2017-2022

Table 6.5 Human Tissue Banking Market: Revenue Forecasts for Leading National Markets, 2010-2016

Table 6.6 Human Tissue Banking Market: Revenue Forecasts for Leading National Markets, 2017-2022

Table 6.7 Some Leading Companies in the World Biobanking Market, 2011

Table 6.8 Asterand: Revenue by Segment, 2009 and 2010

Table 6.9 Asterand: Revenue by Geographical Area, 2010

Table 7.1 Stem Cell Banking Market: Overall Revenue Forecast, 2010-2016

Table 7.2 Stem Cell Banking Market: Overall Revenue Forecast, 2017-2022

Table 7.3 Prominent Stem Cell Banks Serving the Research Community, 2011

Table 7.4 Costs of Various Private Cord Blood Banks Worldwide, 2011

Table 7.5 Private Cord Blood Banking Market: Revenue Forecast, 2010-2016

Table 7.6 Private Cord Blood Banking Market: Revenue Forecast, 2017-2022

Table 7.7 Cord Blood Banking Market: Drivers and Restraints, 2012-2022

Table 7.8 Some Prominent Companies in the Cord Blood Banking Market, 2011

Table 7.9 Cryo-Cell International Revenue, 2009-2010

Table 7.10 China Cord Blood Corp Revenue and Subscribers, 2009-2010

Table 7.11 Cryo-Save Revenue and Operating Profit, 2009-2010

Table 7.12 Cryo-Save Revenue by Region, 2010

Table 9.1 SWOT Analysis of the Biobanking Market: Strengths and Weaknesses, 2012-2022

Table 9.2 SWOT Analysis of the Biobanking Market: Opportunities and Threats, 2012-2022

Table 9.3 Information for a Biobank Donor, 2011

Table 11.1 Human Tissue Biobanking Market by Country, 2010, 2016, 2019 & 2022

List of FiguresFigure 2.1 Main Processes Involved in Biobanking, 2011

Figure 2.2 Classification of Biobanks, 2011

Figure 3.1 Biobanking and Pharmaceutical Development, 2011

Figure 4.1 Biobanking, Applications and Users, 2011

Figure 4.2 Functions of LIMS, 2011

Figure 5.1 Overall Biobanking Market: Revenue Forecast, 2010-2016

Figure 5.2 Overall Biobanking Market: Revenue Forecast, 2017-2022

Figure 6.1 Human Tissue Banking Market: Overall Revenue Forecast, 2010-2016

Figure 6.2 Human Tissue Banking Market: Overall Revenue Forecast, 2017-2022

Figure 6.3 Human Tissue Banking Market: Forecast by Type of Biobank, 2010-2016

Figure 6.4 Human Tissue Banking Market: Forecast by Type of Biobank, 2017-2022

Figure 6.5 Human Tissue Banking Market: Share by Type of Biobank, 2010

Figure 6.6 Human Tissue Banking Market: Share by Type of Biobank, 2022

Figure 6.7 World and US Human Tissue Banking Markets: Revenue Forecasts, 2010-2022

Figure 6.8 Japan, EU 5 and Other Leading Human Tissue Banking Markets: National Revenue Forecasts, 2010-2022

Figure 6.9 Human Tissue Banking: National Market Shares, 2010

Figure 6.10 Human Tissue Banking: National Market Shares, 2016

Figure 6.11 Human Tissue Banking: National Market Shares, 2019

Figure 6.12 Human Tissue Banking: National Market Shares, 2022

Figure 6.13 Commercial Sourcing of Biological Samples, 2011

Figure 6.14 Commercial Banking of Biological Samples, 2011

Figure 6.15 Asterand: Revenues, 2009 & 2010

Figure 6.16 Asterand: Revenue Shares by Region of Destination, 2010

Figure 6.17 Asterand: Revenue Shares by Region of Origin, 2010

Figure 7.1 Stem Cell Banking Market: Revenue Forecast, 2010-2016

Figure 7.2 Stem Cell Banking Market: Revenue Forecast, 2017-2022

Figure 7.3 Twenty-Year Storage Costs at Various Private Cord Blood Banks Worldwide, 2011

Figure 7.4 Cord Blood Banking Market: Revenue Forecast, 2010-2016

Figure 7.5 Cord Blood Banking Market: Revenue Forecast, 2017-2022

Figure 7.6 Cryo-Cell International Revenue, 2009-2010

Figure 7.7 China Cord Blood Corp Revenue and Subscribers, 2009-2010

Figure 7.8 Cryo-Save Revenue and Operating Profit, 2009-2010

Figure 7.9 Cryo-Save Revenue Shares by Region, 2010

Figure 11.1 Biobanking Market: World Sales Forecast, 2010, 2012, 2016, 2019 & 2022 

Companies ListedAbcellute

Abgene

Adnexus Therapeutics

AFNOR Groupe

AKH Biobank

AlloSource

American National Bioethics Advisory Commission 

American Type Culture Collection

Amgen

Analytical Biological Services

ARCH Venture Partners

Asterand

AstraZeneca

Australasian Biospecimen Network (ABN)

Autoscribe

AXM Pharma 

Bayer-Schering

Beckman Coulter

Beike Biotechnology 

Biobank Ireland Trust

Biobank Japan

Biobanking and Biomolecular Resources Research Infrastructure (BBMRI) 

BioFortis

Biogen Idec

Biogenea-CellGenea 

BioLife Solutions

Biomatrica

Biopta

BioRep

BioSeek

BioServe

BioStorage LLC

BioStorage Technologies

BrainNet Europe

Caliper LifeSciences

Canadian Partnership for Tomorrow

CARTaGENE

Cellgene Corporation

Cells4Health

Chemagen

China Cord Blood Corp

Chinese Ministry of Health

CLB/Amsterdam Medical Center

CorCell

Cord Blood America

Cord Blood Registry 

CORD:USE (US Public Cord Blood Bank) 

CordLife

Cordon Vital (CBR) 

Coriell Institute for Medical Research

Council of Europe (CoE)

Covance

Cryo Bio System

Cryo-Cell International

Cryometrix

Cryo-Save

Cureline

Cybrdi

Danubian Biobank Foundation

deCODE Genetics

Department of Health (DoH, UK)

Draper Laboratory

Duke University Medical Center

Dutch Collaborative Biobank

EGeen

Eli Lilly

Eolas Biosciences 

Estonian Genome Project

EuroBioBank

European Commission (EC)

European Health Risk Monitoring (EHRM)

European Medicines Agency (EMA/EMEA)

European Union Group on Ethics (EGE)

Fisher BioServices

Fondazione I.R.C.C.S. Istituto Neurologico C. Besta

Food and Drug Administration (US FDA)

Foundation for the National Institutes of Health 

Fundación Istituto Valenciano de Oncología

Fundeni Clinical Institute

Genentech

Generation Scotland

GeneSaver

GeneSys

Genetic Association Information Network (GAIN)

Genizon Biosciences

Genome Quebec Biobank 

GenomEUtwin

Genomic Studies of Latvian Population

GenVault

German Dementia Competence Network

GlaxoSmithKline (GSK)

H. Lee Moffitt Cancer Center and Research Institute 

Hamilton

Hopital Necker Paris - Necker DNA Bank

Human Tissue Authority (HTA)

Hungarian Biobank

HUNT, Norway

ILSBio LLC

Inbiobank

Inbiomed

Indivumed

INMEGEN

Institut National de la Santé et de la Recherche Médicale (INSERM)

Integrated BioBank of Luxembourg

International Agency for Research on Cancer (IARC)

International Air Transport Association (IATA)

International Organization for Standardization (ISO)

International Society for Biological and Environmental Repositories (ISBER)

International Stem Cell Corporation

Kaiser Permanente

KORA-gen

LabVantage Solutions

LabWare

Leiden University Medical Center

LifebankUSA

LifeGene

LifeStem

Malaysian Cohort Project

Matrical Biosciences

Matrix

Medical Research Council (MRC)

Medical University of Gdansk

Merck & Co.

Merck Sharp & Dohme Limited (MSD)

Merck-Serono

Micronic

Millennium (Takeda Oncology Company)

MVE-Chart

National Cancer Institute (NCI)

National DNA Bank (US)

National Human Genome Research Institute (NHGRI)

National Institute of Environmental Health

National Institutes of Health (NIH)

National Public Health Institute 

National Research Ethics Service (NRES) 

NeoCodex

NeoStem

Neuromuscular Bank of Tissues and DNA Samples

New Brunswick Scientific

NEXUS Biosystems

Northwest Regional Development Agency

Novacare Bio-Logistics

Novartis

NUgene Project

Ocimum Biosolutions

Office of Biorepositories and Biospecimen Research (OBBR)

OnCore UK

Organisation for Economic Co-operation and Development (OECD)

OriGene

Oxagen

Pacific Bio-Material Management

PathServe

Perkin Elmer

Pfizer

Pharmagene Laboratories Trustees Limited

Polaris Ventures 

Pop-Gen (University Hospital Schleswig-Holstein)

PrecisionMed

Prevention Genetics

ProMedDx

Promoting Harmonisation of Epidemiological Biobanks in Europe (PHOEBE)

ProteoGenex

Public Population Projects in Genomics (P3G Consortium)

Qiagen

RAND Corporation

Regenetech

REMP

Reproductive Genetics Institute (RGI)

Research Centre of Vascular Diseases, University of Milan

Rhode Island BioBank, Brown University

Roche

RTS Life Science

Saga Investments LLC

SampleNavigator Laboratory Automation Systems

Sanofi

SANYO Biomedical

Scottish Government

Seattle Genetics

Sejtbank (Hungarian Cord Blood Bank) 

SeqWright DNA Technology Services

SeraCare Life Sciences

Singapore Tissue Network

StarLIMS

Steelgate

Stem Cell Authority

Stem Cells for Safer Medicine (SC4SM)

Stem Cells Research Forum of India

Stemride International

Taiwan Biobank

Taizhou Biobank

TAP

Tecan

The Automation Partnership

The Sorenson Molecular Genealogy Foundation (SMGF)

Thermo Fisher Scientific

Thermogenesis

Tissue Bank Cryo Center (Bulgaria)

Tissue Solutions

Titan Pharmaceuticals

TotipotentSC

Trinity Biobank

Tumorothèque Necker-Entants Malades

UK Biobank

UK Stem Cell Bank

UmanGenomics

Umeå University

University Hospital Angers

University Medical Center Gent

University of Massachusetts Stem Cell Bank

University of Tuebingen, Department of Medical Genetics

US Biomax

Västerbotten County Council

ViaCord

Wellcome Trust

Wellcome Trust Case-Control Consortium (WTCCC)

Western Australian Genome Health Project

Wheaton Science International

Wisconsin International Stem Cell (WISC) Bank

World Health Organization (WHO)

Zhejiang Lukou Biotechnology Co 

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Biobanking for Medicine: Technology and Market 2012-2022

Uncategorized Comments Off on Biobanking for Medicine: Technology and Market 2012-2022 | February 3rd, 2012

MINNEAPOLIS--(BUSINESS WIRE)-- Please replace the release dated January 23, 2012 with the following corrected version due to multiple revisions.

The corrected release reads:

LEADING GLOBAL CELL THERAPY ORGANIZATIONS SUPPORT U.S. DEPARTMENT OF JUSTICE APPEAL OF RULING ON DONOR COMPENSATION

Coalition says PBSC donor compensation poses health risks to patients and donors

A coalition of eight leading international health organizations today issued a statement supporting the U.S. Department of Justice’s appeal of the Ninth Circuit Court ruling that allows certain marrow donors to be compensated. Filed Jan. 17, the Justice Department’s appeal cites the potential for serious health risks to patients and donors if the ruling stands.

Approximately 5,000 patients each year in the United States receive marrow transplants from unrelated donors to treat leukemia, lymphoma and a number of other diseases. The marrow is a source of stem cells that are critical to restoring the immune system for these patients. Two techniques are used to extract these stem cells. The first draws marrow directly from the donor’s hip bone and the second moves the stem cells out of the bone marrow and into the bloodstream using a stimulating hormone, and then collects peripheral blood stem cells (PBSCs) in a procedure similar to the collection of platelets from blood donors.

Since 1984, the National Organ Transplant Act (NOTA) has banned payment for all marrow stem cell donations. However, a Dec. 1, 2011, Ninth Circuit Court of Appeals ruling legalized compensation for PBSC donations, but upheld the ban on compensation for marrow donation through aspiration.

“The world’s leading cell therapy organizations oppose compensating people who sell their stem cells, however collected, and believe the Ninth Circuit made an erroneous distinction between marrow stem cells extracted directly from bone or from blood,” said Jeffrey W. Chell, M.D., chief executive officer of the National Marrow Donor Program® (NMDP), a coalition member that operates the Be The Match Registry®, the world’s largest listing of volunteer marrow donors. “We fully support the Justice Department’s decision to protect patients and their donors by challenging the ruling. Those motivated by self-gain are more likely to withhold health information that would make them unsafe donors. The blood banking experience in the United States shows that this results in donations that are unacceptable from a clinical standpoint.”

The coalition includes the nonprofit NMDP, the World Marrow Donor Association, America’s Blood Centers, AABB, the American Society for Blood and Marrow Transplantation, American Society of Histocompatibility and Immunogenetics, International Society of Cellular Therapy and The Transplantation Society. Those seeking to overturn the ban against selling stem cells argue that payment for donors might increase patients’ access to bone marrow; however, the coalition asserts the opposite is true.

Paying for stem cells also would mean the U.S. no longer follows standards recognized throughout developed countries in Europe and Asia, which use volunteer donors in cell therapies. As a result, patients may not be able to use the worldwide search process. These international partnerships are vital to helping increase patients’ access to potential donors. In 2011, nearly half of the transplants facilitated by the NMDP involved either an international donor or patient.

The coalition cites the following reasons in its position against donor compensation:

Protecting Recipient and Donor Safety
A complete and truthful health history is critical to ensure that individuals are eligible to donate and that donated cells are free from infectious diseases. There is substantial scientific evidence that people wanting to sell their blood or body parts are more likely to withhold medical details and information that could harm patients. Ensuring Physicians’ Ability to Provide Quality Care
The decision of whether the donation occurs through the traditional method of bone marrow extraction or PBSC donation should be based on the best clinical judgment of the patient’s physician and will vary from patient to patient. While the donor always has the last say on whether and how to donate, PBSCs may not be in the best interests of the patient in many cases. Paying for PBSCs may cause donors to choose this method instead of a marrow extraction recommended by the recipient’s physician. Maintaining Altruistic Motivations
Compensating donors could deter those who are willing to donate for purely altruistic reasons. The more than 9.5 million members of the Be The Match Registry, as well as an additional 9 million potential donors available on international registries, are proof positive that people do not need financial incentive to save a life. Avoiding the Creation of Markets in Marrow Donation
Patients may promote donor drives with the promise of compensation, appealing to those with financial need, and not fully disclose the risks associated with the donation. For profit organizations also have an incentive to exploit their donors over a patient’s unique needs. In addition, markets put physicians in the morally dubious position of carrying out medical procedures solely for monetary profit.

For these reasons, the members of the coalition remain opposed to the selling of stem cells.

About the Coalition
The coalition includes the NMDP, America’s Blood Centers, AABB, the American Society for Blood and Marrow Transplantation, American Society for Histocompatibility and Immunogenetics, International Society of Cellular Therapy, The Transplantation Society, and the World Marrow Donor Association.

About the National Marrow Donor Program®(NMDP)
The National Marrow Donor Program (NMDP) is the global leader in providing marrow and umbilical cord blood transplants to patients with leukemia, lymphoma and other diseases. The nonprofit organization matches patients with donors, educates health care professionals and conducts research so more lives can be saved. The NMDP also operates Be The Match®, which provides support for patients, and enlists others in the community to join the Be The Match Registry® – the world’s largest listing of potential marrow donors and donated cord blood units – contribute financially and volunteer. For more information, visit marrow.org or call 1 (800) MARROW-2.

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CORRECTING and REPLACING Leading Global Cell Therapy Organizations Support U.S. Department of Justice Appeal of Ruling ...

Uncategorized Comments Off on CORRECTING and REPLACING Leading Global Cell Therapy Organizations Support U.S. Department of Justice Appeal of Ruling … | February 2nd, 2012

NEW YORK & PETACH TIKVAH, Israel--(BUSINESS WIRE)-- BrainStorm Cell Therapeutics Inc. (OTCBB: BCLI.OB - News), a leading developer of adult stem cell technologies and therapeutics, announced today that the prestigious Experimental Neurology Journal, published an article indicating that preclinical studies using cells that underwent treatment with Brainstorm’s NurOwn™ technology show promise in an animal model of Huntington’s disease. The article was published by leading scientists including Professor Melamed and Professor Offen of the Tel Aviv University.

In these studies, bone marrow derived mesenchymal stem cells secreting neurotrophic factors (MSC-NTF), from patients with Huntington’s disease, were transplanted into the animal model of this disease and showed therapeutic improvement.

“The findings from this study demonstrate that stem cells derived from patients with a neurodegenerative disease, which are processed using BrainStorm’s NurOwn™ technology, may alleviate neurotoxic signs, in a similar way to cells derived from healthy donors. This is an important development for the company, as it confirms that autologous transplantation may be beneficial for such additional therapeutic indications,” said Dr. Adrian Harel, BrainStorm’s CEO.

"These findings provide support once again that BrainStorm’s MSC-NTF secreting cells have the potential to become a platform that in the future will provide treatment for various neuro-degenerative diseases," says Chaim Lebovits, President of BrainStorm. "This study follows previously published pre-clinical studies that demonstrated improvement in animal models of neurodegenerative diseases such as Parkinson’s, Multiple Sclerosis (MS) and neural damage such as optic nerve transection and sciatic nerve injury. Therefore, BrainStorm will consider focusing on a new indication in the near future, in addition to the ongoing Clinical Trials in ALS.”

BrainStrom is currently conducting a Phase I/II Human Clinical Trial for Amyotrophic Lateral Sclerosis (ALS) also known as Lou Gehrig’s disease at the Hadassah Medical center. Initial results from the clinical trial (which is designed mainly to test the safety of the treatment), that were announced last week, have shown that the Brainstorm’s NurOwn™ therapy is safe and does not show any significant treatment-related adverse events and have also shown certain signs of beneficial clinical effects.

To read the Article entitled ‘Mesenchymal stem cells induced to secrete neurotrophic factors attenuate quinolinic acid toxicity: A potential therapy for Huntington's disease’ by Sadan et al. please go to:

http://www.sciencedirect.com/science/article/pii/S0014488612000295

About BrainStorm Cell Therapeutics, Inc.

BrainStorm Cell Therapeutics Inc. is a biotech company developing adult stem cell therapeutic products, derived from autologous (self) bone marrow cells, for the treatment of neurodegenerative diseases. The company, through its wholly owned subsidiary Brainstorm Cell Therapeutics Ltd., holds rights to develop and commercialize the technology through an exclusive, worldwide licensing agreement with Ramot at Tel Aviv University Ltd., the technology transfer company of Tel-Aviv University. The technology is currently in a Phase I/II clinical trials for ALS in Israel.

Safe Harbor Statement

Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements, including, inter alia, regarding safety and efficacy in its human clinical trials and thereafter; the Company's ability to progress any product candidates in pre-clinical or clinical trials; the scope, rate and progress of its pre-clinical trials and other research and development activities; the scope, rate and progress of clinical trials we commence; clinical trial results; safety and efficacy of the product even if the data from pre-clinical or clinical trials is positive; uncertainties relating to clinical trials; risks relating to the commercialization, if any, of our proposed product candidates; dependence on the efforts of third parties; failure by us to secure and maintain relationships with collaborators; dependence on intellectual property; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility, and risks that we may lack the financial resources and access to capital to fund our operations. The potential risks and uncertainties include risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect its technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. The Company does not undertake any obligation to update forward-looking statements made by us.

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Experimental Neurology Journal: BrainStorm's NurOwn™ Stem Cell Technology Shows Promise for Treating Huntington's ...

Bone Marrow Stem Cells Comments Off on Experimental Neurology Journal: BrainStorm's NurOwn™ Stem Cell Technology Shows Promise for Treating Huntington's … | February 1st, 2012

By Maureen Salamon
HealthDay Reporter

WEDNESDAY, Feb. 1 (HealthDay News) -- Treating stroke patients with stem cells taken from their own bone marrow appears to safely help them regain some of their lost abilities, two small new studies suggest.

Indian researchers observed mixed results in the extent of stroke patients' improvements, with one study showing marked gains in daily activities, such as feeding, dressing and movement, and the other study noting these improvements to be statistically insignificant. But patients seemed to safely tolerate the treatments in both experiments with no ill effects, study authors said.

"The results are encouraging to know but we need a larger, randomized study for more definitive conclusions," said Dr. Rohit Bhatia, a professor of neurology at the All India Institute of Medical Sciences in New Delhi, and author of one of the studies. "Many questions -- like timing of transplantation, type of cells, mode of transplantation, dosage [and] long-term safety -- need answers before it can be taken from bench to bedside."

The studies are scheduled to be presented Wednesday and Thursday at the American Stroke Association's annual meeting in New Orleans.

Stem cells -- unspecialized cells from bone marrow, umbilical cord blood or human embryos that can change into cells with specific functions -- have been explored as potential therapies for a host of diseases and conditions, including cancer and strokes.

In one of the current studies, 120 moderately affected stroke patients ranging from 18 to 75 years old were split into two groups, with half infused intravenously with stem cells harvested from their hip bones and half serving as controls. About 73 percent of the stem cell group achieved "assisted independence" after six months, compared with 61 percent of the control group, but the difference wasn't considered statistically significant.

In the other study, presented by Bhatia, 40 patients whose stroke occurred between three and 12 months prior were also split into two groups, with half receiving stem cells, which were dissolved in saline and infused over several hours. When compared to controls, stroke patients receiving stem cell therapy showed statistically significant improvements in feeding, dressing and mobility, according to the study. On functional MRI scans, the stem cell recipients also demonstrated an increase in brain activity in regions that control movement planning and motor function.

Neither study yielded adverse effects on patients, which could include tumor development.

But Dr. Matthew Fink, chief of the division of stroke and critical care neurology at New York-Presbyterian Hospital/Weill Cornell Medical Center, said that the therapy's safety is the only thing the two studies seemed to demonstrate.

"The thing to keep in mind is that these are really phase one trials," said Fink, also a professor of neurology at Weill Cornell Medical College. "I'm concerned that people get the idea that now stem cell treatment is available for stroke, and that's not the case."

Fink noted that the cells taken from study participants' hip bones can only be characterized as "bone marrow aspirates" since the authors didn't prove that actual stem cells were extracted.

"They haven't really analyzed if they're stem cells and what they turn into when they go into circulation," he added. "The best way to look at this is, it's very preliminary . . . when patients come to me to talk about it, I'm going to tell them it's years away before we know if this is going to work."

Studies presented at scientific conferences should be considered preliminary until published in a peer-reviewed medical journal.

More information

The U.S. National Institutes of Health has more information on stem cells.

Copyright © 2012 HealthDay. All rights reserved.

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Stem cell therapy shows promise for stroke

Bone Marrow Stem Cells Comments Off on Stem cell therapy shows promise for stroke | February 1st, 2012

15-01-2012 02:05 Spinal Cord Injury patient is able to walk again. - http://www.stemcellofamerica.com

Link:
Breakthrough Spinal Cord Injury Treatment - Stem Cell Of America - Video

Spinal Cord Stem Cells Comments Off on Breakthrough Spinal Cord Injury Treatment – Stem Cell Of America – Video | January 31st, 2012