Presidents Report

C. Randal Mills, Ph.D.

President and Chief Executive Officer
California Institute for Regenerative Medicine


September 10, 2014

Topics
Staying FOCUSED on the MISSION
Budget Commentary
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Our Mission
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It is all about the patients.
The Four Part Test
Will it speed up the development of a stem cell
treatment?
Will it increase the likelihood of success?
Will it meet an unmet medical need?
Is it efficient?
BUDGET REVIEW
Two Separate Funds
$180M
Administrative
Budget
$2.75B
Award Budget
Grants Administration Budget
$180M
Administrative
Cost
$89 million spent
$91 million remaining
Current spending rate is
about $13 million per year
Funded until 2021 at current
spend rate
Award Budget
$2.75B
Award Budget
$1.9 B awarded (not all spent)
Estimated $50-100M of the
$1.9B awarded will be
recovered
$880M not awarded
Leaves approximately $1B
available to award
Sufficient funding at current
rate until 2020
Key Issues
All the Kings Horses
Spending money faster does not necessarily speed up the
development process
A Penny Saved?
Our goal is not to save money it is to find cures
Quality Matters
Uncertain CIRM will be able to maintain a $190 million annual
award rate with our current pipeline we need more high quality
projects

CIRM 2.0
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CIRM 2.0: Purpose
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If successful, this should lead to:
More high quality applications
Reduced cycle time
Accelerated progression of funded projects
Clarity
The Overall Process
Application Contracting Administration Review
Example process
for clinical stage
projects
The Overall Process
Application Contracting Administration Review
Concept plan approval, RFA
generation, LOI review, and
application submission.
The Overall Process
Application Contracting Administration Review
Includes eligibility evaluation,
COI checks, GWG review and
Board approval.
The Overall Process
Application Contracting Administration Review
Budget reconciliation, plan
amendments, milestone and
financial term agreement.
The Overall Process
Application Contracting Administration Review
Disbursement, progress
reporting, CDAP, and
milestone evaluation.
The Overall Process
Application Contracting Administration Review
9-15 months
The Overall Process
Application Contracting Administration Review
9-15 months 5-7 months
The Overall Process
Application Contracting Administration Review
9-15 months 5-7 months 5-7 months
The Overall Process
Application Contracting Administration Review
9-15 months 5-7 months 5-7 months
Overall Cycle Time
19-29 months
The Overall Process
Application Contracting Administration Review
9-15 months 5-7 months 5-7 months
Overall Cycle Time
19-29 months
4 years
Significant Opportunities
Timing
! More frequent calls
! Shorter review time
Structure
! Agreements that better motivate the behavior we want
! Clear success criteria
Accelerating Activities
! More frequent interaction where we can help (FDA, BD, etc.)
! Seamless transitions
CIRM 2.0 Rollout Plan
Now October
Continue to meet with stakeholders
Refine working ideas
Meet with the Scientific Subcommittee
October Board Meeting
Present concept plan to the Board
December Board Meeting
Adopt necessary policy and procedure modifications
January 1
st
Launch first phase
Thank you!
C. Randal Mills, Ph.D.
President and Chief Executive Officer
California Institute for Regenerative Medicine