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| Mahendra Rao NIH photo |
Speculation surfaced this week but was
quickly squelched that Mahendra Rao, until recently the head of the
federal Center for Regenerative Medicine, is a candidate to become
the new president of the $3 billion California stem cell agency.
Rao's departure from the NIH's $52
million stem cell effort took many by surprise yesterday when it
surfaced in an online story from Nature. The piece by Sara Reardon said that Rao left the NIH on March 28 and that the move has left NIH
researchers “in the dark.”
She wrote,
“Relations seem to have soured last month owing to an NIH decision to award funding to only one project aiming to move iPS cells into a clinical trial. Rao says he resigned after this became clear. He says that he had hoped that five trials would be funded, especially because the centre had already sorted out complex issues relating to tissue sources, patents and informed consent.”
In the wake of the story, the California Stem Cell Report learned that Rao is not a current candidate for the California stem
cell agency position. He is also not expected to take a fulltime
research position in California. Rao did not respond to an email inquiry about the matter. (The New York Stem Cell Foundation announced later that it has hired Rao as vice president for regenerative medicine.)
Rao's departure from the NIH was
reported as early as March 3 in a little-noticed press release from
Cesca Therapeutics of Rancho Cordova, Ca.. The Sacramento-area firm
was formerly known as Thermogenesis. The company said that Rao was
joining its board of directors April 1 following his “planned departure” in March from the NIH.
Yesterday, Stemedica Cell Technologies
of San Diego announced that Rao was joining its scientific advisory
board. Stemedica was mentioned in a New York Times story last September involving international medical tourism. The company's Web site says it “is currently supporting clinical trials in Kazakhstan
and Mexico and anticipates supporting similar initiatives in several
other countries in 2013.”
Meanwhile, the agency is still on
schedule to hire a new CEO by the end of May, according to Kevin
McCormack, senior director of public communications. The current
president, Alan Trounson, announced last fall that he was leaving to
return to his family in Australia.
The agency's presidential search
committee has scheduled a two-day, closed-door meeting for next
Tuesday and Wednesday to screen candidates. According to the agency's
timetable, the teleconference session is intended to produce the
finalists for the job, who will undergo additional interviews either
late this month or early next month. A vote by the agency's
29-member governing board is expected at its meeting in San Diego May
29.
Next week's meeting does provide for
comment from members of the public, who can attend the public portion
of the meeting. The main location is in Los Angeles, The address can
be found on the meeting agenda.
NIH Center for Regenerative Medicine (CRM) Closure: acknowledgement, but no real commentary from the blogosphere on this potentially important development.
ReplyDeleteAre bloggers fearful of questioning NIH?
Was NIH CRM a non-entity to the stem cell community?
Was NIH CRM an obvious money pit ($23.4MM in contracts for iPS cell lines)?
DID CIRM initiatives make NIH CRM redundant/obsolete?
...
Was the goal of NIH CRM to get autologous iPS cell therapies into clinical trials? If so, why was so much money (~$23.4MM; see links below) spent on iPS cell lines? In any case, unless California Institute for Regenerative Medicine (CIRM) is simply throwing money out the window (~$15MM being spent to get each Disease Team Therapeutic JUST TO the clinic) the remaining money at NIH CRM ($28.6MM: $52MM minus $23.4MM; see links below) was insufficient to push forward more than 2 therapies (IF the above mentioned contracts are the only money spent of the NIH CRM allocated funds, AND sequestration did not alter the budget at all).
ReplyDeleteIt would seem that the budget realities were consistent with the reviewer opinions that only a single project could be moved forward toward the clinic. This problem is even more acute if, as quoted (“he had hoped that five trials would be funded”) the funds were designed to get clinical trials funded as well as completing preclinical work.
PAST, PRESENT, FUTURE OF NIH CRM ACCORDING TO NIH:
Program Snapshot http://commonfund.nih.gov/stemcells/index
The Common Fund Center for Regenerative Medicine (CRM) is at a transition point. With an overarching goal of working through hurdles to the development of iPS cell therapies, the CRM will focus in two ways. First, translational hurdles will be assessed and resolved through the conduct of a translational project led by Dr. Kapil Bharti (described below). Second, cross-cutting challenges will be addressed through partnership with the NIH National Center for Advancing Translational Sciences (NCATS). These challenges will be considered with input from experts in stem cell translational research via a May, 2014 workshop [Who is invited? CIRM should be represented?]. A set of objectives stemming from this workshop and an implementation plan for the NCATS-CRM activities will be developed and posted on this website this summer.
OVERVIEW http://commonfund.nih.gov/stemcells/overview
In 2010, the NIH Common Fund launched the NIH Center for Regenerative Medicine (NIH CRM) to serve as a national resource for stem cell science to accelerate the development of new medical applications and cell-based therapies… From Fiscal Year 2010 to Fiscal Year 2013, the NIH CRM supported pilot projects within the NIH Intramural Research Program to bring unique resources at the NIH to bear to help translate iPSC research into the clinic. In addition, the NIH CRM has developed multiple stem cell lines, set up contracts for stem cell services and storage, developed standard consent forms, compiled the supporting protocols and standard operating procedures used to derive, culture, and differentiate stem cells into different cell types, and developed training courses. In 2014, the NIH CRM awarded a Therapeutic Challenge Award to Dr. Kapil Bharti (NEI) to move his work beyond the pilot stage toward the clinic… Dr. Barti will work towards the goal of a Phase 1 clinical trial using patient-derived cells…
CELL LINE CONTRACT ANNOUNCEMENTS:
http://www.europeanpharmaceuticalreview.com/15213/news/featured-news/lonza-awarded-contract-to-generate-clinical-grade-ipscs-by-the-nih-crm/#.U0gxtqKfh8E
Lonza awarded contract to generate clinical grade iPSCs by the NIH CRM
10 October 2012
The Lonza contract is a five year agreement with a value of approximately $9.5 million dollars.
http://www.cellulardynamics.com/news/pr/2012_10_24.html
NIH-CRM Awards Cellular Dynamics up to $7 Million to Produce Human Induced Pluripotent Stem Cells and Differentiated Tissue Cells
24 October 2012
The contract is worth up to $7.0 million for the three year life of the agreement.
http://www.lonza.com/about-lonza/media-center/news/2013/130220-ipsc-e.aspx
Lonza Awarded Contract to Generate Research Grade iPSCs by the National Institutes of Health Center for Regenerative Medicine
20 February 2013
The Lonza contract is a three year agreement with a value up to $6.9 million dollars.