University of California at San Francisco CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTE

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University of California at San Francisco
CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTE
Mike McCune Clinical Research Forum April 26, 2007
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UCSF Clinical and Translational Science
Institute
Aimed at providing infrastructure and support
for clinical and translational
research

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UCSF Clinical and Translational Science
Institute
Aimed at providing infrastructure and support
for clinical and translational research
Designed to meet the needs of all
individuals/units doing CT research, in all four
UCSF professional schools

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UCSF Clinical and Translational Science
Institute
Aimed at providing infrastructure and support
for clinical and translational research
Designed to meet the needs of all
individuals/units doing CT research, in all four
UCSF professional schools Incorporated three
existing CRCs and two existing Roadmap training
programs

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Questions

• What were three major obstacles confronting a
  successful CTSA application?
• How were these obstacles met?
• What has been the most positive impact of the
  grant since it was awarded?
• What has been the most negative impact?
• How might the CTSA program be modified going
  forward?

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Three Major Obstacles
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Three Major Obstacles

• People
• Time
• Money

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Three Major Obstacles

• People
• Too many
• How to engage all of those who should be
  involved?
• Time
• Money

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Three Major Obstacles

• People
• Too many
• How to engage all of those who should be
  involved?
• Time
• Too little
• How to make plans, set priorities, and write the
  grant?
• Money

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Three Major Obstacles

• People
• Too many
• How to engage all of those who should be
  involved?
• Time
• Too little
• How to make plans, set priorities, and write the
  grant?
• Money
• Not enough
• How to pay for all of the plans?

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Two Solutions

• Inclusivity in planning
• Transparency in making decisions

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Construction of the UCSF CTSIPhase I (Oct-Nov,
2005)
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Construction of the UCSF CTSIPhase I (Oct-Nov,
2005)

• Formation of Planning Group
• Recruited by Deans of Schools of Dentistry,
  Medicine, Nursing, and Pharmacy
• Enlisted by broadly and repeatedly disseminated
  communications

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Construction of the UCSF CTSIPhase I (Oct-Nov,
2005)

• Formation of Planning Group
• Recruited by Deans of Schools of Dentistry,
  Medicine, Nursing, and Pharmacy
• Enlisted by broadly and repeatedly disseminated
  communications
• Development of a general strategy for submission
  of the grant

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Construction of the UCSF CTSIPhase I (Oct-Nov,
2005)

• Formation of Planning Group
• Recruited by Deans of Schools of Dentistry,
  Medicine, Nursing, and Pharmacy
• Enlisted by broadly and repeatedly disseminated
  communications
• Development of a general strategy for submission
  of the grant
• Establishment of an overall mission

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Mission Statement
Bringing better health care to more people more
quickly
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The StrategyPhase II (Dec-Jan, 2005)

• Creation of an organizational structure
• Identification of PI and Program Directors Team
• Definition of specific aims
• Alignment of program functions with specific aims
• Dividing out the work

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Creation of an Organizational Structure
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Identification of Program Directors Team
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Definition of Specific Aims
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Definition of Specific Aims

• Training programs

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Definition of Specific Aims

• Training programs
• Infrastructure for design and implementation

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Definition of Specific Aims

• Training programs
• Infrastructure for design and implementation
• Career advancement

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Definition of Specific Aims

• Training programs
• Infrastructure for design and implementation
• Career advancement
• Home/communication

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Alignment of Specific Aims with Program Functions
Research Implementation
Career Advancement
Research Design
Training

• Research education training
• Training in other program functions

• Design, biostatistics, ethics
• Translational methodologies

• Participant interactions
• Translational technologies
• Regulatory
• Informatics
• Community

• Pilot studies

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Alignment of Specific Aims with Program Functions
Research Implementation
Career Advancement
Research Design
Training

• Research education training
• Training in other program functions

• Design, biostatistics, ethics
• Translational methodologies

• Participant interactions
• Translational technologies
• Regulatory
• Informatics
• Community
• Global health
• Health policy

• Pilot studies
• Career advancement

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Alignment of Specific Aims with Program Functions
Research Implementation
Career Advancement
Research Design
Training

• Research education training
• Training in other program functions

• Design, biostatistics, ethics
• Translational methodologies

• Participant interactions
• Translational technologies
• Regulatory
• Informatics
• Community
• Global health
• Health policy

• Pilot studies
• Career advancement

CREATION OF A VIRTUAL HOME Central
Administration Web-based home Collaborative AV
Environments
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Division of Labor

• Overall Integrated Approach
• Tracking Evaluation

Program Directors Team
Mike McCune Deborah Grady Joel Palefsky Dan
Lowenstein

• Informatics
• Design, Biostat, Ethics
• Translational Methods
• Research Training
• Global Health
• Career Advancement

• Pilot Studies
• Community Engagement
• Virtual Home
• Health Policy

• Regulatory Support
• Participant Interaction
• Translational Tech

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Division of Labor

• Overall Integrated Approach
• McCune
• Tracking Evaluation Brindis

Program Directors Team
Mike McCune Deborah Grady Joel Palefsky Dan
Lowenstein

• Informatics Segal/Showstack
• Design, Biostat, Ethics
• Johnston/Bacchetti/Lo
• Translational Methods
• Johnston
• Research Training
• Hulley/Martin/Yamamoto
• Global Health
• McKerrow/Padian
• Career Advancement
• Damsky/Brown

• Pilot Studies
• Giacomini/Volberding
• Community Engagement
• Grumbach/Selby
• Virtual Home
• Butter/Schmidt
• Health Policy
• Luft/Kahn

• Regulatory Support
• Lee/Wiener-Kronish
• Participant Interaction
• Schambelan/Wara
• Translational Tech
• Nelson/Derynck/
• Waldman/Sinclair

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Establishment of Senior Leadership Group

• Charles Bertolami Dean, School of Dentistry
• Pat Calarco Interim Dean of Graduate Studies
• Russ Cucina Assistant Clinical Professor, School
  of Medicine
• Rik Derynck Professor, School of Dentistry
• Kathleen Dracup Dean, School of Nursing
• Donna Ferriero Vice Dean, School of Medicine
• Dina Halme Director of Science Policy, SOM
  Deans Office
• Steve Hauser Chair, Neurology
• Sam Hawgood Chair, Pediatrics
• Phil Hopewell Professor of Medicine, SFGH
• Richard Jordan Associate Professor, School of
  Dentistry
• David Kessler Dean, School of Medicine
• Talmadge King Acting Chair of Medicine
• John Greenspan Vice Dean, Dentistry
• Linda Giudice Chair, OB/Gyn/Reproductive
  Biology
• Mary Anne Koda-Kimble Dean, School of Pharmacy
• Bob Mahley President, The J. David Gladstone
  Institutes
• Jeff Martin Associate Professor, School of
  Medicine
• Frank McCormick Co-Director, Cancer Center

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Phase III (Feb-Mar, 2006) Resourcing the Plans

• Upfront decision maintain budgets of existing
  CRCs and Roadmap training programs
• Resource remaining programs with funds from NIH,
  the institution, the hospital, and external
  sources (philantrophy, biotech/pharma)
• Budget decisions made through an iterative and
  transparent process

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Resourcing the Projected Plans
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Resourcing the Projected Plans Existing NIH Money
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Resourcing the Projected PlansNew NIH Money
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Resourcing the Projected PlansMoney from the
Chancellor
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Resourcing the Projected PlansMoney from the
Deans
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Resourcing the Projected PlansMoney from
External Sources
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Final Product (Mar, 2006)

• 4 Specific Aims
• 14 Program Functions
• Over 200 senior faculty actively involved
• Resourced with funds from
• NIH 123.0 M request
• Institution 32.0 M
• External 1.7 M

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Major Positive Impact
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Major Positive Impact

• Many programs are now providing services!

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Major Positive Impact

• Many programs are now providing services!
• CT research is receiving ever more attention on
  campus
• School of Medicine Retreat on CT research
• UCSF Strategic Plan
• Emerging priority CT research

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Major Positive Impact

• Many programs are now providing services!
• CT research is receiving ever more attention on
  campus
• School of Medicine Retreat on CT research
• UCSF Strategic Plan
• Emerging priority CT research
• Existing CT units (e.g., Cancer Center, Immune
  Tolerance Network, Cardiovascular Research
  Institute, CTSI, etc) are developing more
  concrete plans for joining forces

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Major Negative Impact
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Major Negative Impact

• Financial constraints
• Loss of some pre-existing resources (e.g., in
  CRCs and in training grants)
• Lack of clarity in policies regarding
  carryforwards

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Major Negative Impact

• Financial constraints
• Loss of some pre-existing resources (e.g., in
  CRCs and in training grants)
• Lack of clarity in policies regarding
  carryforwards
• Growing pains instituting new ways to organize
  efforts within UCSF, between other CTSAs, and
  with NIH

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Suggestions for Future Modifications
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Suggestions for Future Modifications

• More explicit definition of budgetary
  constraints, e.g., justification of carryforwards

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Suggestions for Future Modifications

• More explicit definition of budgetary
  constraints, e.g., justification of carryforwards
• Creation of novel financial models to accommodate
  the start-up nature of the CTSAs

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Suggestions for Future Modifications

• More explicit definition of budgetary
  constraints, e.g., justification of carryforwards
• Creation of novel financial models to accommodate
  the start-up nature of the CTSAs
• Program management that facilitates coordination
  with other NIH-funded CT efforts (e.g., the
  Cancer Centers) and between CTSAs

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UCSF CTSI An Adventure
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UCSF CTSI An Adventure
5 INFRASTRUCTURE!
4 CONTENT!
3 ENGINE!
2 IGNITION!
1 BLAST OFF!
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