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Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The California Institute for Regenerative Medicine: Science, Governance, and the Pursuit of Cures. Washington, DC: The National Academies Press. doi: 10.17226/13523.
×

Appendix A

Data Sources and Methods

The Committee on a Review of the California Institute for Regenerative Medicine (CIRM) was asked to assess CIRM’s initial processes, programmatic and scientific scope, organizational and management systems, funding model, and intellectual property policies. To respond comprehensively to its charge, the committee examined data from a variety of sources. These sources included documents pertaining to the establishment and initial operation of CIRM and numerous evaluation reports commissioned during the Institute’s initial 5- to 6-year period of operation. Valuable input also was obtained through CIRM’s responses to the committee’s data requests, three public meetings, two adjunct meetings, site visits to CIRM-funded research facilities, telephone interviews, and written public comments in response to online questionnaires targeting various stakeholders. The study was conducted over a 17-month period.

STUDY COMMITTEE

The study committee comprised 13 individuals with expertise in stem cell research, developmental biology, bioethics, research administration, financial structures for biomedical research, program evaluation, economics and finance, business administration, and intellectual property. Appendix E provides biographical sketches of the committee members. The committee convened for a total of 10 days on five different occasions in October 2011, January 2012, April 2012, June 2012, and August 2012.

Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The California Institute for Regenerative Medicine: Science, Governance, and the Pursuit of Cures. Washington, DC: The National Academies Press. doi: 10.17226/13523.
×

DOCUMENT REVIEW

The committee reviewed background documents and evaluation reports pertaining to CIRM, including Proposition 71 and Senate Bill (SB) 1064; 2004 Economic Impact Analysis reports; the 2006 CIRM Scientific Strategic Plan; CIRM annual reports from 2007 through 2010; the 2008 Interim Economic Impact Review and addendum; the 2009 Strategic Plan Update; the 2009 Little Hoover Commission Review of CIRM; 2010 External Advisory Panel (EAP) evaluation reports; the 2011 CIRM publication on the economic impact of research funded by CIRM; and the 2012 CIRM transition plan. The committee also reviewed published reports on stem cell research.

DATA REQUESTS TO CIRM

The committee made a total of 79 requests for data, reports, and information from CIRM. These requests were on topics related to CIRM’s initial processes and planning, grants and programs, grant management and resources, reviews and evaluations, governance and management, finances, collaborations, intellectual property policies, and conflict of interest policies.

PUBLIC MEETINGS

The committee hosted three public meetings to obtain additional information on specific aspects of the study charge. These meetings were held in conjunction with the committee’s October (Washington, DC), January (San Francisco, California), and April (Irvine, California) meetings. The committee determined the topics and speakers for these public meetings. As part of the two public meetings in California, the committee held open forums at which members of the public were invited to provide testimony on any topics related to the study charge.

At the first public meeting, CIRM delivered the charge to the committee and provided a general overview of its structure and programs. At the second meeting, representatives from CIRM’s leadership and governing board provided information on the Institute’s scientific priorities and transition plan, standards working group, and intellectual property policies. In addition, CIRM principal investigators provided their perspectives on the Institute. The third public meeting included presentations from individuals with varying perspectives on CIRM—investigators who applied for but did not receive funding from the Institute, current Disease Team grantees, industry representatives, and a technology transfer officer. The agendas for the public meetings are presented in Boxes A-1 through A-3.

Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The California Institute for Regenerative Medicine: Science, Governance, and the Pursuit of Cures. Washington, DC: The National Academies Press. doi: 10.17226/13523.
×

ADJUNCT MEETINGS

A subgroup of the committee hosted two meetings with stem cell scientists outside of California to obtain their perspectives on the work funded by CIRM and the Institute’s scientific impact. Discussions centered on the scientists’ view of CIRM’s accomplishments and goals as articulated in the 2012 Strategic Plan. The first meeting was held May 30, 2012, in Toronto, Canada, and the second in Boston, Massachusetts, on June 26, 2012. These sites were selected as the committee considered them to be major hubs of activity in stem cell research. Scientists participating in these meeting are listed below.

Toronto

Mick Bhatia, Stem Cell and Cancer Research Institute, McMaster University (by phone)

James Ellis, Department of Molecular Genetics, University of Toronto

Andras Nagy, Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Janet Rossant, Department of Medical Genetics and Microbiology, University of Toronto

Molly Shoichet, Department of Chemical Engineering and Applied Chemistry, University of Toronto (by phone)

William Stanford, Department of Cellular and Molecular Medicine, University of Ottawa

Peter Zandstra, Institute of Biomaterials and Biomedical Engineering, University of Toronto

Boston

Fernando Camargo, Stem Cell and Regenerative Biology, Harvard University

Konrad Hochedlinger, Stem Cell and Regenerative Biology, Harvard University

Jerome Ritz, Connell O’Reilly Cell Manipulation and Gene Transfer Laboratory, Dana-Farber Cancer Institute, Harvard Medical School

Anthony Rosenzweig, Beth Israel Deaconess Medical Center, Harvard Medical School

David Scadden, Stem Cell and Regenerative Biology, Harvard University

Ramesh Shivdasani, School of Medicine, and Dana-Farber Cancer Institute, Harvard Medical School

Les Silberstein, Joint Program in Transfusion Medicine, Harvard Medical School

Amy Wagers, Stem Cell and Regenerative Biology, Harvard University

Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The California Institute for Regenerative Medicine: Science, Governance, and the Pursuit of Cures. Washington, DC: The National Academies Press. doi: 10.17226/13523.
×

Clifford Woolf, FM Kirby Neurobiology Center, Children’s Hospital, Harvard Medical School

Leonard Zon, Stem Cell and Regenerative Biology, Harvard University

SITE VISITS

Individual members of the committee conducted three site visits to CIRM-funded research facilities to obtain information about stem cell programs funded by the Institute. The committee selected one private university, one medical school, and one public university to visit. In January 2012, committee members visited CIRM facilities at the University of California, Davis (UC Davis), the University of California, San Francisco (UCSF), and Stanford University. The visits included tours of the stem cell facilities and discussions with principal investigators about the CIRM-funded work being conducted at the institutions. Investigators and university leadership who participated in each site visit are listed below. In addition, in August 2012, the committee chair and vice chair visited Celgene, a biopharmaceutical company in Summit, New Jersey. The purpose of this visit was to help the committee better understand the process of discovery, development, and commercialization of products to treat disease.

UC Davis

Gerhard Bauer, Stem Cell Research Program, UC Davis Institute for Regenerative Cures (IRC)

Paul Knoepfler, Department of Cell Biology and Human Anatomy, School of Medicine

Kit Lam, Department of Biochemistry and Molecular Medicine, UC Davis Comprehensive Cancer Center

Claire Pomeroy, CEO, UC Davis Health System and Dean of School of Medicine

Mark Zern, Transplant Research Institute

Min Zhao, Department of Dermatology, School of Medicine

UCSF

Arturo Alvarez-Bullya, Department of Neurological Surgery, Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research

Sam Hawgood, Dean of the UCSF School of Medicine and Vice Chancellor for Medical Affairs

Diana Laird, Department of Obstetrics, Gynecology and Reproductive Sciences, UCSF Medical Center

Daniel Lim, Department of Neurological Surgery, Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research

Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The California Institute for Regenerative Medicine: Science, Governance, and the Pursuit of Cures. Washington, DC: The National Academies Press. doi: 10.17226/13523.
×

Emmanuelle Passegue, Division of Hematology/Oncology, Department of Medicine, Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research

Holger Willenbring, Department of Surgery, Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research

Stanford University

Michael Longaker, Department of Surgery

Ravi Majeti, Division of Hematology, School of Medicine

Norma Neff, Research Technical Manager

Renee A. Reijo-Pera, Center for Human Embryonic Stem Cell Research and Education

Yuval Rinkevich, Institute for Stem Cell Biology and Regenerative Medicine

Chris Shay, Space and Renovations Project Management

Judy Shizuru, Department of Blood & Marrow Transplantation, School of Medicine

Irving Weissman, Department of Pathology, Institute for Stem Cell Biology and Regenerative Medicine, School of Medicine

Marius Wernig, Department of Pathology, Institute for Stem Cell Biology and Regenerative Medicine, School of Medicine

Joanna Wysocka, Department of Chemical and System Biology

INTERVIEWS

Committee members spoke with many individuals during the course of this study. These formal and informal conversations, which took place by phone between the committee’s in-person meetings, were intended to gather information to inform the committee’s deliberations and to clarify questions. The individuals who provided this information are listed below.

Cindy Bell, Genome Canada and former Director of Cancer Stem Cell Consortium

Alan Bernstein, former Executive Director, Global HIV Vaccine Enterprise

Genc Bülent, Bundesministerium für Bildung und Forschung (BMBF) (Federal Ministry of Education and Research), Germany

George Daley, Stem Cell Transplantation at the Children’s Hospital

Kristen Doyle, Cancer Prevention and Research Institute of Texas

Bill Gimson, Cancer Prevention and Research Institute of Texas

Dan Gincel, Maryland Stem Cell Research Fund

Zach W. Hall, former president, CIRM

Marianne Horn, Connecticut Department of Public Health

Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The California Institute for Regenerative Medicine: Science, Governance, and the Pursuit of Cures. Washington, DC: The National Academies Press. doi: 10.17226/13523.
×

Richard Klausner, The Column Group

Bob Klein, former board chair, CIRM

Bernard Lo, UCSF School of Medicine, CIRM Standards Working Group

Jeff Lomax, CIRM

Bert Lubin, Children’s Hospital and Research Center Foundation

David Magnus, Stanford University School of Medicine

Ed Penhoet, Alta Partners, former vice chair of CIRM’s Governing Board

Mahendra S. Rao, National Institutes of Health (NIH) Intramural Center for Regenerative Medicine

Beth Roxland, New York State Task Force on Life and the Law

Christopher Scott, Stanford University School of Medicine

Michael Stöcker, BMBF

Lawrence S. Sturman, New York State Stem Cell Science

Alan Trounson, CIRM

BOX A-1
Committee on a Review of the California Institute for
Regenerative Medicine (CIRM)

The National Academies Keck Building
500 Fifth Street, NW

Washington, DC 20001
Room 110

AGENDA FOR PUBLIC SESSION
October 19, 2011

11:15 a.m. WELCOME AND COMMITTEE INTRODUCTIONS
   
  Harold T. Shapiro, Ph.D.
  OM Committee Chair
   
11:25 a.m. OVERVIEW OF CIRM: INITIAL PROCESSES, FUNDING MODEL, ORGANIZATION, AND MANAGEMENT SYSTEMS
   
  Robert Klein II, J.D.
  Chair Emeritus, CIRM Governing Board
Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The California Institute for Regenerative Medicine: Science, Governance, and the Pursuit of Cures. Washington, DC: The National Academies Press. doi: 10.17226/13523.
×

ONLINE QUESTIONNAIRES

The committee used online questionnaires to obtain public input from a variety of stakeholders on topics related to the study charge. A total of seven questionnaires in different topic areas targeting different stakeholders were placed on the Institute of Medicine (IOM) website. These questionnaires were intended to help the committee understand perspectives of a variety of stakeholders on CIRM and its work. The questionnaires were constructed for CIRM Independent Citizens Oversight Committee (ICOC) members, leadership from CIRM-funded institutions, CIRM principal investigators, university technology transfer professionals, investigators who applied for but did not receive funding from CIRM, CIRM for-profit industry partners, CIRM international partners, and stakeholders and members of the general public. A summary of themes from the responses to the questionnaires can be found in Appendix B.

   
12:30 p.m. LUNCH
   
1:15 p.m. OVERVIEW OF THE SCIENCE AND CIRM’S PROGRAMMATIC AND SCIENTIFIC SCOPE
   
  Ellen G. Feigal, M.D.
  Senior Vice President, Research and Development, CIRM
   
2:00 p.m. INTELLECTUAL PROPERTY AND BUSINESS DEVELOPMENT
   
  Elona Baum, J.D.
  General Counsel and Vice President, Business Development, CIRM
   
2:20 p.m. CHARGE TO THE COMMITTEE
   
  Jonathan Thomas, J.D., D.Phil.
  Chair, CIRM Governing Board
   
2:35 p.m. QUESTIONS AND DISCUSSION OF STUDY CHARGE
   
3:30 p.m. ADJOURN OPEN SESSION
Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The California Institute for Regenerative Medicine: Science, Governance, and the Pursuit of Cures. Washington, DC: The National Academies Press. doi: 10.17226/13523.
×

BOX A-2
Committee on a Review of the California Institute for
Regenerative Medicine (CIRM)

South San Francisco Conference Center
255 South Airport Boulevard
South San Francisco, CA 94080

AGENDA FOR PUBLIC SESSION
January 24, 2012

9:00 a.m. WELCOME AND COMMITTEE INTRODUCTIONS
   
  Harold T. Shapiro, Ph.D.
  IOM Committee Chair
   
9:10 a.m. EVOLVING SCIENTIFIC PRIORITIES AT CIRM
   
  Alan Trounson, Ph.D.
  CIRM President
   
10:10 a.m. OVERVIEW OF CIRM SCIENTIFIC AND MEDICAL ACCOUNTABILITY STANDARDS WORKING GROUP
   
  Bernard Lo, M.D.
  Standards Working Group Co-Chair
   
10:50 a.m. BREAK
   
11:00 a.m. CIRM INTELLECTUAL PROPERTY POLICIES
   
  Duane J. Roth
  CIRM Governing Board Vice Chair and Intellectual Property/Industry Subcommittee Member
   
11:40 a.m. OVERVIEW OF CIRM TRANSITION PLAN
   
  Jonathan Thomas, J.D., D.Phil.
  Chair, CIRM Governing Board
   
12:20 p.m. LUNCH
Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The California Institute for Regenerative Medicine: Science, Governance, and the Pursuit of Cures. Washington, DC: The National Academies Press. doi: 10.17226/13523.
×
   
1:15 p.m. PERSPECTIVES ON CIRM FROM THE PATIENT ADVOCACY COMMUNITY
   
  Jeff Sheehy
  Co-Vice Chair of the Scientific and Medical Research Funding Working Group and CIRM Patient Advocate Board Member
  Director of Communications
  AIDS Research Institute
  University of California, San Francisco
   
1:50 p.m. PERSPECTIVES ON CIRM FROM PRINCIPAL INVESTIGATORS
   
  Irina Conboy, Ph.D.
  Assistant Professor, Department of Bioengineering
  University of California, Berkeley
   
  John P. Murnane, Ph.D.
  Professor, Department of Radiation Oncology
  University of California, San Francisco
   
  Howard Y. Chang, M.D., Ph.D.
  Stanford University School of Medicine, Howard Hughes Medical Institute
   
  Helen M. Blau, Ph.D.
  Donald E. and Delia B. Baxter Professor
  Director, Baxter Laboratory for Stem Cell Biology
  Stanford University School of Medicine
   
  Frederick J. Meyers, M.D., M.A.C.P. (by phone—invited)
  Executive Associate Dean, University of California, Davis, School of Medicine
   
  Alice F. Tarantal, Ph.D. (by phone)
  Professor and Vice-Chair for Research, Department of Pediatrics
  University of California, Davis, School of Medicine
   
3:15 p.m. BREAK
Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The California Institute for Regenerative Medicine: Science, Governance, and the Pursuit of Cures. Washington, DC: The National Academies Press. doi: 10.17226/13523.
×
   
3:30 p.m. RECAP/DISCUSSION OF MORNING AND AFTERNOON PRESENTATIONS
   
4:00 p.m. PUBLIC COMMENT
   
  Individuals register for a slot and have 5 minutes for comments on any topic related to the study charge.
   
5:00 p.m. ADJOURN OPEN SESSION
Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The California Institute for Regenerative Medicine: Science, Governance, and the Pursuit of Cures. Washington, DC: The National Academies Press. doi: 10.17226/13523.
×

BOX A-3
Committee on a Review of the California Institute for
Regenerative Medicine (CIRM)

Arnold and Mabel Beckman Center
of the National Academies of Sciences and Engineering
Huntington Room
100 Academy
Irvine, CA 92617

AGENDA FOR PUBLIC SESSION
April 10, 2012

9:00 a.m. WELCOME AND COMMITTEE INTRODUCTIONS
   
  Harold T. Shapiro, Ph.D.
  IOM Committee Chair
   
9:10 a.m. OVERVIEW OF LITTLE HOOVER COMMISSION REPORT
   
  Stuart Drown (by phone)
  Executive Director, Little Hoover Commission
   
10:00 a.m. PERSPECTIVES ON CIRM FROM STAKEHOLDERS
   
  Ruth Holton-Hodson
  California Deputy State Controller
   
  Ken Taymor, J.D. (by phone)
  Executive Director, Berkeley Center for Law, Business and Economy
   
  John Simpson (by phone)
  Director, Stem Cell Oversight and Accountability Project Consumer Watchdog
   
  Marcy Darnovsky, Ph.D. (by phone)
  Associate Executive Director, Center for Genetics and Society
   
  David Jensen
  Publisher-Editor, California Stem Cell Report
Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The California Institute for Regenerative Medicine: Science, Governance, and the Pursuit of Cures. Washington, DC: The National Academies Press. doi: 10.17226/13523.
×
   
11:30 a.m. LUNCH
   
12:00 p.m. PERSPECTIVES FROM CIRM APPLICANTS
   
  Leonard H. Rome, Ph.D. (by phone)
  Senior Associate Dean for Research and Professor of Biological Chemistry, David Geffen School of Medicine University of California, Los Angeles
   
  Xuejun H. Parsons, Ph.D.
  Associate Professor of Regenerative Medicine and Scientific Director in Cardiovascular and Neural Regeneration
  San Diego Regenerative Medicine Institute
   
12:45 p.m. PERSPECTIVES ON CIRM FROM DISEASE TEAM INVESTIGATORS
   
  Donald Kohn, M.D.
  Professor, Department of Microbiology, Immunology, and Molecular Genetics and Department of Pediatrics University of California, Los Angeles
   
  Larry Goldstein, Ph.D.
  Professor, Department of Cellular and Molecular Medicine and Department of Neurosciences
  University of California, San Diego School of Medicine
   
  Dennis Clegg, Ph.D.
  Professor, Molecular, Cellular, and Developmental Biology University of California, Santa Barbara
   
  Catriona Jamieson, M.D., Ph.D.
  Associate Professor, Division of Hematology-Oncology University of California, San Diego Moores Cancer Center
Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The California Institute for Regenerative Medicine: Science, Governance, and the Pursuit of Cures. Washington, DC: The National Academies Press. doi: 10.17226/13523.
×
   
2:00 p.m. PERSPECTIVES ON CIRM FROM INDUSTRY
   
  Gregory A. Bonfiglio, J.D., Panel Moderator
  Managing Partner, Proteus Venture Partners
   
  Michael D. West, Ph.D.
  Chief Executive Officer, BioTime, Inc.
   
  Allan Robins, Ph.D.
  Acting Chief Executive Officer, Vice President and Chief Technical Officer, ViaCyte, Inc.
   
  Gail K. Naughton, Ph.D.
  CEO, Chairman of the Board, Histogen, Inc.
   
3:30 p.m. BREAK
   
3:45 p.m. PERSPECTIVES ON CIRM FROM TECHNOLOGY TRANSFER OFFICERS
   
  Casie Kelly, Ph.D.
  Technology Transfer Officer, Life Sciences, Office of Intellectual Property & Industry Sponsored Research University of California, Los Angeles
   
4:30 p.m. PUBLIC COMMENT
   
  Individuals register for a slot and have 5 minutes for comments on any topic related to the study charge.
   
5:30 p.m. ADJOURN OPEN SESSION
Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The California Institute for Regenerative Medicine: Science, Governance, and the Pursuit of Cures. Washington, DC: The National Academies Press. doi: 10.17226/13523.
×

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Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The California Institute for Regenerative Medicine: Science, Governance, and the Pursuit of Cures. Washington, DC: The National Academies Press. doi: 10.17226/13523.
×
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Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The California Institute for Regenerative Medicine: Science, Governance, and the Pursuit of Cures. Washington, DC: The National Academies Press. doi: 10.17226/13523.
×
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Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The California Institute for Regenerative Medicine: Science, Governance, and the Pursuit of Cures. Washington, DC: The National Academies Press. doi: 10.17226/13523.
×
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Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The California Institute for Regenerative Medicine: Science, Governance, and the Pursuit of Cures. Washington, DC: The National Academies Press. doi: 10.17226/13523.
×
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Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The California Institute for Regenerative Medicine: Science, Governance, and the Pursuit of Cures. Washington, DC: The National Academies Press. doi: 10.17226/13523.
×
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Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The California Institute for Regenerative Medicine: Science, Governance, and the Pursuit of Cures. Washington, DC: The National Academies Press. doi: 10.17226/13523.
×
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Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The California Institute for Regenerative Medicine: Science, Governance, and the Pursuit of Cures. Washington, DC: The National Academies Press. doi: 10.17226/13523.
×
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Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The California Institute for Regenerative Medicine: Science, Governance, and the Pursuit of Cures. Washington, DC: The National Academies Press. doi: 10.17226/13523.
×
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Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The California Institute for Regenerative Medicine: Science, Governance, and the Pursuit of Cures. Washington, DC: The National Academies Press. doi: 10.17226/13523.
×
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Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The California Institute for Regenerative Medicine: Science, Governance, and the Pursuit of Cures. Washington, DC: The National Academies Press. doi: 10.17226/13523.
×
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Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The California Institute for Regenerative Medicine: Science, Governance, and the Pursuit of Cures. Washington, DC: The National Academies Press. doi: 10.17226/13523.
×
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Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The California Institute for Regenerative Medicine: Science, Governance, and the Pursuit of Cures. Washington, DC: The National Academies Press. doi: 10.17226/13523.
×
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Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The California Institute for Regenerative Medicine: Science, Governance, and the Pursuit of Cures. Washington, DC: The National Academies Press. doi: 10.17226/13523.
×
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Suggested Citation:"Appendix A: Data Sources and Methods." Institute of Medicine. 2013. The California Institute for Regenerative Medicine: Science, Governance, and the Pursuit of Cures. Washington, DC: The National Academies Press. doi: 10.17226/13523.
×
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The California Institute for Regenerative Medicine (CIRM) was created in 2005 by The California Stem Cell Research and Cures Act (Proposition 71) to distribute $3 billion in state funds for stem cell research. The passage of Proposition 71 by the voters of California occurred at a time when federal funding for research involving human embryonic stem cells was uncertain, given the ethical questions raised by such research. During its initial period of operations, CIRM has successfully and thoughtfully provided more than $1.3 billion in awards to 59 California institutions, consistent with its stated mission.

As it transitions to a broadened portfolio of grants to stimulate progress toward its translational goals, the Institute should obtain cohesive, longitudinal, and integrated advice; restructure its grant application review process; and enhance industry epresentation in aspects of its operations. CIRM's unique governance structure, while seful in its initial stages, might diminish its effectiveness moving forward. The California Institute for Regenerative Medicine: Science, Governance, and the Pursuit of Cures recommends specific steps to enhance CIRM's organization and management, as well as its scientific policies and processes, as it transitions to the critical next stages of its research and development program.

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