Written Public Comment to REGULAR MEETING OF ICOC AND THE APPLICATION REVIEW SUBCOMMITTEE CIRM on Jan. 25 2024

Little is known to the public that, for over 15 years, CIRM Vice President of Portfolio Development and Review Gil Sambrano, a California State employee hired by a California stem cell agency (California Institute for Regenerative Medicine) even though he has zero experience and background in stem cell research and regenerative medicine, has violated the conflict-of-interest (COI) law of the State of California about its employees and abused his CIRM grants officer position to intentionally block or bury human embryonic stem cell (hESC) research applications of the California stem cell research and cures act against scientific merits and CIRM eligibility criteria, but instead deliberately select and lead selecting induced pluripotent stem cells (iPSC) Ponzi scheme projects and other fraudulent projects for full review and ICOC award, by using CIRM behind closed door, biased, flawed, and unaccountable pre-application selection process. He is directly responsible for today’s vast wasteland of CIRM billion-dollar grants portfolio dominated by fraudulent awards such as iPSC Ponzi scheme projects he shamelessly touts on CIRM website as “the highest quality stem cell-based projects” that have actually produced absolutely nothing and continue producing absolutely nothing to resolve the health and economy burdens of major unmet medical needs promised by the California stem cell research and cures act, from Discovery to Clinical programs to CIRM Training/Infrastructure programs (e.g., CIRM COMPASS, CIRM shared resource labs). His preferential treatment to his close ties against COI policy of the CA State and CIRM is directly responsible for the bleak promise of today’s CIRM billion-dollar grants portfolio that is void of hESC research and technology innovations to address the bottlenecks of regenerative medicine for major health problems, as the result of his intense scrutiny to hESC applications with medical innovations of any competitors of his close ties behind closed doors. However, he has never disclosed to the public about his ties to UCSF Nobel Prize winning iPSC Ponzi scammer Shinya Yamanaka and Deepak Srivastava of UCSF Cardiovascular Research Institute who directed the NIH iPSC Center grant in collaboration with MIT reprogramming professor Rudy Jaenisch, the founder of the iPSC Company Fate therapeutics and ISSCR former President. He has never disclosed to the public that, later on, Shinya Yamanaka and Deepak Srivastava were found scientific misconduct that resulted in termination of their NIH iPSC grants. He has never disclosed to the public about his COI to those iPSC projects he selected for full review and ICOC awards, from Discovery to Clinical programs to CIRM Training/Infrastructure programs, including multiple iPSC awards to Shinya Yamanaka’s collaborator Joseph Wu and his Company Greenstone and Rudy Jaenisch’s student Marius Wernig in Standford University even though they have no technology no patent to turn iPSC into cardiomyocytes or neurons, to Fate Therapeutics, to UCSF even after Shinya Yamanaka and Deepak Srivastava were found scientific misconduct. He has also ensured CIRM only hire people just like him, who have no or little experience and expertise of stem cell research and regenerative medicine but are directly linked to iPSC, including CIRM Vice President of Therapeutic Development Abla Creasey and CIRM Vice President of Scientific Programs Rosa Canet-Avilés. The public are often puzzled by CIRM CLIN awards to those trivial clinical trials that address neither any bottleneck nor any major unmet medical need (e.g., CIRM $15 million to the eye Secretome of Combangio linked to MIT) in the staggering amounts of tens of millions of California taxpayer dollars, to those Company that has neither technology nor patent (e.g., CIRM $4 million to Ryne Bio that does not even have technology or patent to turn iPSC into DA neurons), some not even in California. However, little is known to the public that CIRM Vice President of Therapeutic Development Abla Creasey and CIRM Vice President of Scientific Programs Rosa Canet-Avilés are directly linked to those CIRM CLIN awards, including CIRM $15 million to the eye Secretome of Combangio, CIRM $4 Million to Ryne Bio, CIRM $12 million to Regenerative Patch Technologies, and CIRM CLIN award to one patient of UCSD iPSC professor Joseph Gleeson shown on the top list of my former mentor Sanford Director Evan Snyder’s “Letter to the Board”. CIRM Vice President of Therapeutic Development Abla Creasey also has never disclosed to the public her tie to Fujifilm and Fujifilm cellular dynamics that resulted in ~$25 millions of CIRM awards to iPSC Ponzi scheme of Fujifilm cellular dynamics without any competition, and her tie to HEALIOS of Japan that resulted in CIRM TRAN award of millions of CA taxpayer dollars to iPSC Ponzi scheme of a Company not even in California, against the California stem cell research and cures act. CIRM Vice President of Therapeutic Development Abla Creasey also has never disclosed to the public about her/CIRM involvement in the $50M J&J/Janssen deal with Fate Therapeutics that led to pump and dump of Fate stock and lawsuit. CIRM Vice Presidents are directly responsible for those unscientific, biased, discriminative, anti-California-Propositions, flawed, and COI eligibility criteria, guidelines, and instructions specifically written for iPSC Ponzi scheme or scam in CIRM program announcements and application packages, from Discovery to Clinical programs to CIRM Training/Infrastructure programs (e.g., CIRM COMPASS, CIRM shared resource labs). CIRM Vice Presidents are directly responsible for the application packages of CIRM, a California stem cell agency, only having guidelines and instructions for deriving allogeneic (donor-derived) cancer cells or reprogrammed cells – iPSC, but no guidelines and instructions for deriving any stem cells, such as embryo-derived hESC. CIRM Vice Presidents are directly responsible for CIRM exclusively selecting iPSC Ponzi scheme projects of their close ties for full review and award in round after round of CIRM press releases. CIRM Vice Presidents are directly responsible for CIRM massive misappropriation of the taxpayer money of a “Blue” State to a scarlet “Red” adult stem cell Ponzi scheme of the Bush Administration (iPSC) against the California stem cell research and cures act. CIRM Vice Presidents are all California State employees and paid by California taxpayers, but they have never disclosed to the public about their connection to the scientific misconduct of UCSF Nobel Prize winning iPSC Ponzi scammer Shinya Yamanaka and NIH iPSC Center Director of UCSF Cardiovascular Research Institute Deepak Srivastava, their complicity to iPSC Ponzi scheme or scam of California taxpayer dollars, and their preferential treatment to their close ties in the staggering amounts of tens and hundreds of millions of taxpayer dollars, which have violated the COI policy of both the CA State and CIRM. ?

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Written Public Comment to REGULAR MEETING OF THE INDEPENDENT CITIZENS OVERSIGHT COMMITTEE AND THE APPLICATION REVIEW SUBCOMMITTEE CALIFORNIA INSTITUTE FOR REGENERATIVE MEDICINE Organized Pursuant To The CALIFORNIA STEM CELL RESEARCH, TREATMENTS, AND CURES INITIATIVE OF 2020 on Jan. 25, 2024.

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Dear ICOC and THE APPLICATION REVIEW SUBCOMMITTEE CIRM,

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Thanks for the meeting notice and thank you for this opportunity to present my Public Comment. I’d like to make a public comment regarding the shocking revelation of double-standards and corruption by those terrible CIRM awards, from Discovery to Clinical programs, presented by CIRM President/Vice-Presidents/Staff to ICOC, which reveals to the public a totally dysfunctional, biased, conflict-of-interest (COI), even flawed CIRM pre-application selection by 3 panelists and review processes run by CIRM leadership that completely lacks the expertise of stem cell research and regenerative medicine essential to the California stem cell research and cures act, including CIRM Vice President of Portfolio Development and Review Gil Sambrano, CIRM Vice President of Therapeutic Development Abla Creasey, CIRM Vice President of Scientific Programs Rosa Canet-Avilés, and other associated Directors, who do not even have the scientific knowledge and scientific integrity to select the highest quality stem cell-based projects for CIRM funding based on scientific merits and consistent CIRM eligibility criteria. For example, CIRM Vice President of Portfolio Development and Review Gil Sambrano has zero experience and background in stem cell research and regenerative medicine, but actually touts on CIRM website that he “leads the team responsible for selecting the highest quality stem cell-based projects for CIRM funding from Discovery to Clinical programs”, if he could count those iPSC Ponzi scheme CIRM awards he personally selected for his close tie UCSF as “the highest quality stem cell-based projects” against the conflict-of-interest (COI) policy of the CA State and CIRM; if he could count > $300 million of misappropriation of CA taxpayer money to the iPSC Ponzi scheme projects he selected as “the highest quality stem cell-based projects”; if he could count those scientifically-flawed projects (e.g., the CIRM CLIN directly linked to CIRM vice chair Maria Bonneville) he selected as “the highest quality stem cell-based projects”; if he could count those not original, not competitive, lack-novelty, even fraudulent CIRM awards (e.g., the Oct-4 project, the iPSC defined medium of UCSD stem cell director Alysson Muotri) he selected as “the highest quality stem cell-based projects”. Such unaccountable, biased, and flawed CIRM pre-application selection by CIRM Staff or panelists who have absolutely no background and expertise in stem cell research and regenerative medicine relevant to CIRM’s mission has resulted in widespread mismanagement of CIRM grant applications/awards/portfolio and massive misappropriation of California taxpayer dollars that eventually led to CIRM former President’s resignation.

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Those terrible CIRM awards not based on scientific merits and consistent CIRM eligibility criteria, from Discovery to Clinical programs, presented by CIRM President/Vice-Presidents/Staff to ICOC only shows the public that CIRM, a supposedly CA State agency established and sustained by California Propositions with taxpayer money to fund human embryonic stem cell (hESC) research in order to find treatment or cure for many unmet medical needs, actually do not comply with the California stem cell research and cures act that promises treatment or cure for very costly and devastating diseases affecting millions and costing trillions, and CIRM Presidents/Staff/Panelists even would not bring those innovative hESC research projects that overcome the major bottleneck in neuron regeneration and have tremendous health and economy impact on CA and CA diverse populations for full review after multiple resubmissions (please see CIRM communications below). However, do we just witness CIRM President/Vice-Presidents/Staff present a CIRM CLIN award for one patient (n 1) directly linked to ICOC board member Larry Goldstein and CIRM Vice President Abla Creasey to ICOC meeting for award? Do we just witness CIRM President/Vice-Presidents/Staff present a scientifically-flawed CIRM CLIN award directly linked to CIRM vice chair Maria Bonneville to ICOC meeting for award? ?Do we just witness CIRM President/Vice-Presidents/Staff present more immuno-therapy and small molecule therapy CIRM CLIN awards without any scientific merits to ICOC meeting for award after wide-spread clinical trials failure in the Bio-Tech world? CIRM Presidents/Staff/Panelists would not even select my innovative hESC research projects that provide currently only available source of scalable human neurons for spinal cord repair for full review after multiple resubmissions. However, do we just witness CIRM President/Vice-Presidents/Staff present the hESC oligodendrocyte therapy for spinal cord injury directly linked to ICOC board member Larry Goldstein and CIRM Vice President Abla Creasey after the highly publicized Geron failure story of their oligodendrocyte therapy over 10 years ago? I am sure you all know that oligodendrocytes alone cannot repair the damaged/lost motor neurons in the spinal cord or regenerate damaged/lost axons associated with SCI as falsely stated in CIRM press release. ?

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In CIRM eligibility criteria, there is a statement about health and economy impact on CA and CA diverse populations. The CIRM CLIN award for one patient (n 1) in your presentation has absolutely no health and economy impact on CA and CA diverse population, how did they get pass CIRM eligibility check, how did they address the DEI issue of the disease that CIRM requires? Or do we just witness the double standards of CIRM eligibility criteria in CIRM President/Vice-Presidents/Staff selection for full review and CIRM award process again? CIRM eligibility criteria clearly say, to be eligible for CIRM Application and Awards: “human stem or progenitor cells either comprise the product/tool or are used to manufacture the product/tool”, and technically and scientifically, the reprogrammed/cancer cells – induced pluripotent stem cells (iPSC) -- are not even stem cells, not even meet the eligibility criteria of CIRM applications. However, CIRM President/Vice-Presidents/Staff still would only lead selecting and continue only select iPSC fraud and waste applications, but not the true pluripotent stem cell – human embryonic stem cell (hESC) -- applications that completely meet CIRM eligibility criteria and pursue California stem cell research and cures act, to full review and for CIRM awards, which has resulted in the massive misappropriation of CA taxpayer money to the iPSC Ponzi scheme in the staggering amount of over $300 million during the term of CIRM former Chair and now interim President Jon Thomas.

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For example, I am the person who has already developed defined media for pluripotent hESC and techniques for derivation and maintenance of clinical-grade pluripotent stem cell lines with publications and patents. Alysson Muotri, the UCSD Stem Cell Center Director and Fred Gage’s student, shamelessly stole the idea from me, a woman and a minority woman, to waste on iPSC fraud and scam, and has already wasted millions of NIH SBIR grants to develop this iPSC defined medium of CIRM TRAN-15298 that I and others have already developed, but he still could not develop and needs to waste more taxpayer dollars on it. Since Irving Weissman, Fred Gage, Geroge Daley, Alysson Muotri, CIRM Presidents, ISSCR Presidents and Vice Presidents, including ISSCR’s current President Amanda Clark of UCLA, and all the other iPSC professors, all insist on that “induced pluripotent stem cells (iPSC) is the alternative of pluripotent human embryonic stem cells (hESC)”, and “hESC and iPSC are identical”. So, this low-cost, clinical-grade iPSC maintenance medium of CIRM TRAN-15298 of Alysson Muotri has already existed, actually even sold by Life-Tech/Thermo-Fisher. Instead of pursuing CA stem cell research and cure act of CIRM to derive clinical-grade hESC lines for patients, CIRM Presidents/Staff and General Counsel and Vice Presidents of Portfolio Development and Review Gil Sambrano and Therapeutic Development Abla Creasey are so unbelievably ignorant, still give their close ties or COI preferential treatment for selection for full review of a Defined media to waste on something already existing, on technology already developed. Alysson Muotri’s iPSC projects are not only scientifically-flawed and directly linked to CIRM former President, CIRM Vice Presidents, and ICOC board member Larry Goldstein, but also plagiarizing existing idea and technology, even commercialized technology, such as the defined media sold by Thermo-Fisher/Life-Tech.

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CIRM eligibility criteria clearly say, to be eligible for CIRM Application and Awards, the organization or company needs to be in California. It is outrageous that CIRM President/Staff and Vice Presidents of Portfolio Development and Review Gil Sambrano and Therapeutic Development Abla Creasey do not select California organizations and companies that already have innovative defined technology to derive and maintain clinical-grade pluripotent stem cell lines for research and therapies in order to find treatments and cures as compelled by California voters for full review and award, instead gives California taxpayer dollars to a Japanese Company directly linked to CIRM President and Vice Presidents to waste on making cancer cells/reprogrammed cells – iPSC -- that are falsely called stem cells, and those big Company/Pharms outside California that do not even meet CIRM application eligibility, like the $15 million to the eye Secretome of Combangio, a subsidiary of Kala Bio, Bob Langer of MIT’s Company.

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CIRM eligibility criteria clearly requires the proposals to address technology bottleneck of unmet medical need. However, CIRM Presidents/Staff/Panelists, CIRM Vice Presidents Gil Sambrano and Abla Creasey, CIRM Senior Science Review Officers Liz Noblin and Linda Nevin would not even select our innovative hESC research projects that overcome the major technology bottlenecks in CNS and heart regeneration for full review, after multiple resubmissions, even though we own patents. And almost no CIRM awards selected by CIRM Presidents/Staff/Panelists, CIRM Vice Presidents, CIRM Senior Science Review Officers Liz Noblin and Linda Nevin have addressed any technology bottleneck, including all the CIRM iPSC awards directly linked to CIRM former President/General-Counsel/CIRM Vice Presidents/CIRM Senior Science Review Officers; including all the CIRM MSC/HSC awards directly linked to CIRM former President and her mentor Irving Weissman; including CIRM TRAN awards to Defined Biosciences of UCSD stem cell center director Alysson Muotri (TRAN-15298) and HEALIOS NA of Japan directly linked to CIRM former President/General-Counsel/CIRM Vice Presidents/CIRM Senior Science Review Officers and ICOC board member Larry Goldstein; including the $15M to the eye Secretome of Combangio, a subsidiary of Kala Bio, Bob Langer of MIT’s Company directly linked to CIRM Vice President of Portfolio Development and Review Gil Sambrano/CIRM Vice President of Therapeutic Development Abla Creasey/CIRM Senior Science Review Officers Linda Nevin.

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Lack of a scalable human cardiac stem cell source with adequate heart muscle regeneration potential remains a major setback for heart replacement, and fabricating a human heart is still beyond reach. It is shocking that our Defined hESC Platform Enabling Large Scale Manufacturing of Clinical-Grade Cardiomyocytes for Heart Regenerative Therapy and Biofabrication (TRAN4-16090) is not even eligible for applying for CIRM TRANS even though it is translational by nature, urgently needed stem cell technology to address major bottleneck in regenerative medicine, completely meet CIRM TRAN4 eligibility criteria (Please see CIRM communication below). We proposed to continue evaluate and refine the criteria that our PluriXcel SMI-Heart Platform must meet to adequately address the unmet medical need of cardiovascular disease, exactly match the allowable activities for a TRAN4 award. However, the senior science office in CIRM review Linda Nevin baselessly misinterpreted my proposal as we intend to validate the preliminary findings that is stated in nowhere of my proposal. The proposed tool the hESC defined Platform – PluriXcel-SMI-Heart Platform, has been patented, and consistent, robust, repudiable, and effective data has been published, all shown and listed in the eligibility form and the proposal. There are no preliminary findings with regard to our tool need to be validated. It just shows how ignorant the senior science office in CIRM review Linda Nevin is, how little scientific knowledge she has, how unqualifying she is as even a grants officer of CIRM to baselessly misinterpret scientific proposals in CIRM official grants communication against scientific merits and openly compromise the scientific integrity of CIRM. The senior science office in CIRM review Linda Nevin and CIRM Vice Presidents Gil Sambrano and Abla Creasey have not only intentionally made CIRM instructions and guidelines very confusing against scientific integrity and fundamental science, but also deliberately misinterpreted CIRM own instructions and guidelines in order to block the most translational research – human embryonic stem cell research -- from translating to clinics to meet the urgent needs of diverse Californians for treatments and cures, instead to aid the misappropriation of CA taxpayer dollars to their own close ties, including all those iPSC tool awards that really intended to validate preliminary findings with regard to their tools because none of those CIRM awarded iPSC tools are even patented, nor their tools consistently, robustly, and effectively meets performance characteristics required to address the bottleneck. For example, no CIRM iPSC awards have provided any robust and reproducible data to show iPSC could even differentiate into a large supply of functional cells (e.g., neurons, cardiomyocytes), how did those iPSC awards directly linked to senior science office in CIRM review Linda Nevin and CIRM Presidents/Vice Presidents pass CIRM eligibility check? ?

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The senior science office in CIRM review Linda Nevin, just like CIRM Vice President of Portfolio Development and Review Gil Sambrano and CIRM Vice President of Therapeutic Development Abla Creasey, has absolutely no experience and expertise of stem cell research and regenerative medicine. They have absolutely no knowledge, skill, and qualification for the jobs of Senior Science Officer for Grant Review at CIRM and Vice Presidents of Portfolio Development and Review and Therapeutic Development. They landed their jobs in CIRM because of their close ties, not because of their experience, expertise, and qualification, as demonstrated by how much grants money they have personally selected and facilitated to flow into their own close ties, many of which are frauds and wastes, at the cost of CA taxpayers and against the conflict-of-interest law of the CA State about its employees.

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As the senior science office in CIRM review, Linda Nevin could not even give consistent, robust, clear, easy to understand interpretation of CIRM eligibility criteria, deliberately interpret or misinterpret CIRM eligibility criteria in order to block the most translation research – human embryonic stem cell research – from translating to clinics to meet the urgent needs of diverse Californians for treatments and cures as CIRM is compelled by California voters to pursue, instead to give stem cell scams and Ponzi schemes (e.g., iPSC) of her own close ties preferential treatment for taxpayer money and CIRM awards, including all the CIRM previous iPSC awards that are directly linked to Linda Nevin and CIRM Vice Presidents Gil Sambrano and Abla Creasey --- iPSC are in fact cancer cells or reprogrammed cells, which do not even meet CIRM eligibility criteria for stem cells; the $15M to the eye Secretome of Combangio, a subsidiary of Kala Bio, Bob Langer of MIT’s Company and Healios of Japan that are directly linked to Linda Nevin and CIRM Vice Presidents Gil Sambrano and Abla Creasey --- not only not meet CIRM eligibility for stem cells and CA organization, but also not meet CIRM eligibility criteria to address technology bottleneck of unmet medical need; and the iPSC TRAN Tool of Defined Biosciences of UCSD stem cell center director Alysson Muotri that is also directly linked to Linda Nevin and CIRM Vice Presidents Gil Sambrano and Abla Creasey --- not only not meet CIRM eligibility for stem cells and address technology bottleneck of unmet medical need, but also against scientific integrity to steal existing technology and idea. How did those CIRM awards of the close ties of CIRM senior review officers and Vice Presidents that really did not meet CIRM eligibility criteria pass the eligibility check for CIRM ICOC to misappropriate hundreds of millions of CA taxpayer dollars? ?

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Those scientifically-flawed, Ponzi scheme, or lack-novelty CIRM awards selected and presented by CIRM President/Vice Presidents/Staff to ICOC do not even meet CIRM own eligibility criteria. It is such a huge embarrassment for such terrible CIRM awards not based on scientific merits and consistent CIRM eligibility criteria even showing up in CIRM ICOC meetings. It just shows the public a dysfunctional, biased, conflict-of-interest, and unaccountable CIRM grant selection and review not complying with the California stem cell research and cures act and any laws, which has resulted in widespread mismanagement of CIRM grant applications/awards/portfolio and massive misappropriation of California taxpayer dollars that eventually led to CIRM former President resignation. Larry Goldstein and Maria Bonneville should also resign for such revelation of their corruption and conflict of interest. There are many qualified people out there. We know CIRM former President only hired their close ties who have not only minimal background or little experience in stem cell research, but also have absolutely no knowledge, skill, and qualification for the jobs of CIRM grants review or portfolio development. Those scientifically-flawed, Ponzi scheme, or lack-novelty CIRM awards selected and presented by CIRM Presidents/Vice-Presidents/Staff to ICOC also demonstrate how ignorant they are. If CIRM President/Staff, CIRM panelists, CIRM senior science office in CIRM review Linda Nevin, CIRM Senior Science Officer Liz Noblin, CIRM Vice President of Portfolio Development and Review Gil Sambrano, CIRM Vice President of Therapeutic Development Abla Creasey could not do their job, they should resign or be fired, they should feel ashamed for getting paid so much by CA taxpayers, but could not even comply with the COI law of the CA State, could not even do their simple job that is to select the highest quality stem cell-based projects for CIRM funding based on scientific merits and consistent CIRM eligibility criteria, to fund the best stem cell research that has impact on millions of lives and CA economy, but not to corrupt CIRM by only selecting or leading selecting their own close ties.

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From: Liz Noblin <[email protected]> Sent: Thursday, January 18, 2024 3:14 PM Cc: Review <[email protected]>; Discovery Mailbox <[email protected]> Subject: DISC0 Positive Selection Outcome

Dear DISC0 Applicant,

Thank you for submitting your application under the California Institute for Regenerative Medicine’s (CIRM) DISC0 Foundation?Program.?

When the total number of submitted applications exceeds the capacity of a CIRM Grants Working Group (GWG) panel to review in a single session, GWG panelists screen the applications and select a subset to advance to full review. The CIRM staff and President examine non-selected applications to determine if any others merit full review based on programmatic priorities, and the remainder are not considered further. This process is described in the DISC0?Program Announcement, on pages 9-10.

In this DISC0?competition, 144 eligible applications were submitted and 48 advanced to GWG review.?Unfortunately, your application was not among those selected for review.?CIRM’s consideration of your application has concluded, and no further action will be taken or is required of you.?

CIRM ensures and verifies that each application is read by at least three panelists during this screening process. To make screening manageable for reviewers, CIRM does not require that reviewers provide any written critique or scoring at the screening stage. As a result,?we cannot provide feedback on your application. Review Summaries for those applications that did proceed to GWG review will be posted on CIRM’s website in April?and will be available via the following link:?https://www.cirm.ca.gov/about-cirm/funding-opportunities-discovery-stage-research. Scroll down to ‘Foundation Application Review Summaries'.

Please continue to check our website for new announcements and funding opportunities. You may also email?[email protected]?to discuss projects that could be the subject of a future Discovery stage application.

Kind regards,

Liz Noblin, PhD?(she/her/hers) Senior Science Officer, Portfolio Development and Review California Institute for Regenerative Medicine (CIRM) Phone: 510-775-0431 |?[email protected]

From: Linda Nevin <[email protected]> Sent: Monday, December 18, 2023 5:45 PM To: [email protected] Subject: Your TRAN Application

Dear Dr. Parsons,

Thank you for submitting your application TRAN4-16090: “A Defined hESC Platform Enabling Large Scale Manufacturing of Clinical-Grade Cardiomyocytes for Heart Regenerative Therapy and Biofabrication” to CIRM’s Translational Research (TRAN) Program.

Our team has completed the initial eligibility checks, and unfortunately your application is ineligible for review and/or further consideration at this time.

The expected outcome for a TRAN4 award, as outlined in the TRAN Program Announcement, is "[A] tool that consistently, robustly, and effectively meets performance characteristics required to address the bottleneck as documented in a comprehensive design history file AND that is ready to be transferred to manufacturing for commercialization." See Appendix D: Tools, pg. 25, for reference.

We don’t see this outcome in your proposal, nor do the activities proposed match the allowable activities for a TRAN4 award (PA pg. 25). The allowable activities in the PA are designed to lead to the expected outcome. Instead, your proposal appears intended to validate preliminary findings with regard to your tool, which is not equivalent to a completed design history file and/or readiness for transfer to manufacturing.

The tool itself seems potentially eligible, and appears poised to address a bottleneck in development of cell therapies derived from ESC. Your project is not necessarily permanently ineligible for TRAN funding; rather, we advise you to connect with CIRM’s Therapeutics Development team to discuss whether revising your application and applying in a future TRAN review is worthwhile. A future TRAN4 application should incorporate many or most of the allowable activities for a TRAN4 award, and thus lead to the expected project outcome for TRAN4.

Please reach out to me with any questions.

With best wishes,

Linda Nevin, PhD?(she/her/hers)? Senior Science Officer, Review Team? California Institute for Regenerative Medicine (CIRM)? Phone: 510-899-0467 |?[email protected]?