Voice of Regenerative Medicine : Bureaucratic CIRM and Alan Trounson Retaliate Regenerative Medicine Startups for Harsh Criticisms

Sunday, June 10, 2012

Bureaucratic CIRM and Alan Trounson Retaliate Regenerative Medicine Startups for Harsh Criticisms

California Institute for Regenerative Medicine (CIRM) definitely has not bothered to seek any input from Regenerative Medicine Startups & Industry or any expertise on human embryonic stem cell (hESC) research of the law Proposition 71 (Prop 71). So, it is not surprise that CIRM would come up with such an incredibly bureaucratic new strategic plan with ~ $ 20 millions annual spending budget of public funds. Just by simply looking at the list of CIRM future plan, anyone can easily tell who were those Ellen Feigal/CIRM closely consulted for their money plan, and who were not. The most key element is actually missing in CIRM’s new strategic plan or has never been consulted by Ellen Feigal/CIRM. Where is Prop 71 in CIRM future plan? Where is stem cell research in CIRM future plan?

As a hESC researcher who supports Prop 71, I really want to say something positive about CIRM. As positive as we were when we said “YES” to Prop 71, however, our experiences with CIRM have barely had anything positive. Not only our inquires and questions regarding giving inputs & grant applications have barely got any positive responses or helps or even any responses from CIRM, but no transparency and accountability have also let CIRM recklessly abuse its power to give California’s lawful hESC research hardship that can only be found in the world’s most bureaucratic agency. Alan Trounson would not consider Regenerative medicine startups’ reasonable and lawful request to remove CIRM RFA’s unlawful “sunk costs” for the sake of Prop 71 stem cell research is just one example of CIRM bureaucracy, which shows CIRM has never changed under its new leadership (see below). We would like to ask Dr. Trounson why you are sitting on half million a year public funds and why bureaucratic CIRM sitting on ~ $ 20 millions annual spending budget of public funds, NOT to ensure Prop 71 stem cell research & cure act funds go to California’s most advanced hESC research for crucial life-saving stem cell research and therapy development to be able to continue, NOT to preserve California’s existing vital stem cell research human resources and research lab resources, but to misappropriate public funds for stem cell research to CIRM internal conflict of interest connections, frauds, and misconducts to destroy valuable stem cell research resources?

From: Alan Trounson [mailto:ATrounson@cirm.ca.gov]
Cc: Jon Thomas; Ellen Feigal
Subject: RE: Request for removal of large up-front investment requirement of co-funding or extending the deadline of co-funding requirement to clinical trial stage of CIRM RFA 12-05 for Regenerative Medicine Start-Up

Dear Dr. Parsons:

In response to your request for a Presidential exception to the Strategic Partnership RFA, I have decided on the following: CIRM will be unable to grant your request for an exception to the commercial validation requirements. I wish you good luck in your endeavors.

Sincerely,

Alan Trounson

From: Xuejun H Parsons [parsons@SDRMI.org]
To: Alan Trounson
Cc: Jon Thomas; Ellen Feigal; parsons@SDRMI.org
Subject: Request for removal of large up-front investment requirement of co-funding or extending the deadline of co-funding requirement to clinical trial stage of CIRM RFA 12-05 for Regenerative Medicine Start-Up

Dear CIRM President Dr. Trounson,

San Diego Regenerative Medicine Institute (SDRMI) LOI for CIRM RFA 12-05 (CIRM Strategic Partnership I Awards), titled “Neuronal Specification of Human Embryonic Stem Cells (hESC) for Developing Nerve Regeneration Cell Therapy Against Spinal Cord Injury (SCI)”, develops novel hESC cell therapy that will enable clinical practice of innovative stem cell therapy for major unmet medical need, extend independent healthy life, reduce the burden of illness and disability for SCI patients, reduce health care burden of major health problems, and meet the mission of CIRM and the goal of California Stem Cell Research & Cure Act (Prop71). Fulfilling the goal of this project will lead to a significant improvement in SCI patient care, dramatically improving the function, wellness, and overall quality of life for SCI patients, compared to no treatment option available at present time to improve the neurologic and motor functions, particularly in patients at the chronic stage. However, CIRM RFA 12-05 contains large up-front investment, notably sunk costs, requirement to small Regenerative Medicine Start-Ups, which creates high barriers to entry for start-ups and is prohibited by the United States antitrust law. Prop71 fund/capital is earmarked for new promising pluriprotent stem/progenitor therapy development. Such large up-front investment requirements would only become a block or high barrier for stem cell start-ups & novel stem cell therapy development and make it difficult for better and more affordable stem cell therapy of Prop71 enter clinical trials and the therapeutic market, and would not become incentives to Prop71’s stem cell therapy development and entry of clinical trials as this CIRM RFA intends to be.

SDRMI is a emerging hESC research and stem cell therapy start-up committed to the mission of Prop71, and has > $10M of assets of clinical-grade human stem cell therapy products and technology platforms, include: Product Prototype: Xcel-hNuP001 & Xcel-hNu001 (Clinical-grade hESC-derived neuronal progenitors & neurons by small molecule induction; Therapeutic sector: Cell therapy products for neurological diseases & injuries). Product Prototype: Xcel-hCardP001 & Xcel-hCM001 (Clinical-grade hESC-derived cardiac precursors & cardiomyocytes by small molecule induction; Therapeutic sector: Cell therapy products for cardiovascular/heart disease). Technology Prototype: PluriXcel-DCS (Defined culture systems for derivation and maintenance of clinical-grade hESCs); PluriXcel-SMI (Lineage-specific differentiation of pluripotent hESCs by small molecule induction, Direct conversion of human pluripotent cells into neuronal progenitors or cardiac precursors and functional neuronal cells and cardiomyocytes). We believe SDRMI’s hESC-based novel stem cell technologies and therapies, targeting to $B of unmet health problems & health care markets, will eventually attract large investment and partnership from pharmaceutical and biotechnology partners.

Therefore, I’d like to request CIRM to remove of the large up-front investment requirement of co-funding or extend the deadline of co-funding requirement to clinical trial stage of CIRM RFA 12-05 for SDRMI’s hESC cell therapy development proposal for spinal cord injury. Given the urgency of this hESC-based cell therapy development project to CIRM’s mission and to SCI patients, I appreciate it if CIRM considers our request.

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Public Interest

The successful derivation of human embryonic stem cell (human ES cell) lines from the in vitro fertilization (IVF) leftover embryos is considered as one of the major breakthroughs of the life sciences. The pluripotent human ES cells, derived from the inner cell mass (ICM) or epiblast of human blastocyst or human embryos, have both the unconstrained capacity for long-term stable undifferentiated growth in culture and the intrinsic potential for differentiation into all somatic cell types in the human body, holding tremendous potential for human tissue and function restoration. Therefore, human ES cells have been regarded as an ideal source to provide an unlimited supply of large-scale well-characterized human specialized cell types for cell-based therapies to resolve some worldwide major health problems, such as neurodegenerative diseases, paralysis, diabetes, and heart diseases. A small portion of the millions of excess embryos currently stored in the IVF clinics worldwide, which are otherwise destined for destruction, could potentially be an unlimited source to deliver in the future a whole range of therapeutic treatments for tissue and function restoration in patients with life-threatening diseases and injuries. However, human ES cell research has generated intense public interest as well as controversy due to concerns of products of human ES cell cultures that can only be obtained by the use, involving their destruction, of human embryos. The recent years’ court battles on Federal funding for human ES cell research in the United State (US) as well as the patentability of US and international patents directed to human ES cell technologies have also highlighted the decade long ethical, moral, social, and legal controversy surrounding the public interest of human ES cells involving destruction, commercial or industrial uses of human embryos. As neurodegenerative and heart diseases incur exorbitant costs on the healthcare system worldwide, there is a strong focus on providing newer and more efficient solutions for these therapeutic needs. Millions of people are pinning their hopes on human ES cell research. California voters have passed Proposition 71 to designate $3B public fund to support pluripotent human ES cell research and therapy development for the benefit of public health. In spite of ethical debates surrounding the ownership and funding issues of human ES cells, in the case of many incurable or hitherto untreatable life-threatening or devastating diseases, supporting human ES cell research is crucial to driving the advance of medicine to provide optimal regeneration and reconstruction treatment options to improve the function, wellness, and overall quality of life. To answer the intense public interest surrounding human ES cell research and enormous public healthcare benefits thereof, Voice of Regenerative Medicine provides a ground of public debate or voice or blog for the controversies surrounding public interest of human ES cells centering on scientific, economic, ethical, moral, social, financial conflict of interest, and legal issues, to increase public awareness and understanding of the scientific advancement of human ES cell research, and of the importance, urgency, and tangible benefits of human ES cell-based regenerative medicine to improving the function, wellness, and overall quality of life for patients suffering from incurable or hitherto untreatable life-threatening or devastating diseases; to increase public support for human ES cell research; to improve policy making and funding situation for human ES cell research, and to identify and disclose publicly those scientific, economic, ethical, moral, social, financial conflict of interest, and legal issues that have impeded the progress of human ES cell research and stem cell therapy development, introduction of medical innovations and new business opportunities based on human ES cell research, and bringing new therapeutics into the market.

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