::Sigh:: Unfortunately, not at all a surprise.
Mallory McLaren, J.D.http://ift.tt/1jxi5B4
On Fri, Jul 25, 2014 at 2:39 PM, wrote:
Jul 25, 2014
New CIRM President Makes Cuts
California’s stem cell agency voted yesterday to slice $5 million
from the $70 million it approved last year toward opening a
statewide network of stem cell clinics, with the new president and
CEO saying that the program was unwieldy and needed to be refocused.
Last year, the California Institute for Regenerative Medicine
(CIRM) agreed to spend the $70 million to create the Alpha Stem
Cell Clinics Network. The network was conceived as consisting of
five sites operating across California and functioning as a hub for
stem cell clinical trials.
The governing board of CIRM acted at the urging of President C.
Randal Mills, Ph.D. Dr. Mills took office earlier this year,
succeeding Alan Trounson, Ph.D., who had championed the Alpha
clinic program, declaring: “These clinics have the potential to
revolutionize how we deliver stem cell therapies to patients.”
The $5 million reduction eliminated funding for the Coordinating
and Information Management Center (CIMC) portion of the Alpha
clinics’ concept plan. The center was conceived as carrying out a
variety of functions that include clinical operations, data
sharing, healthcare reimbursement modeling, and promotion of
California as a destination for stem-cell “tourism” by patients
seeking regenerative medicine therapies.
CIMC was envisioned as the hub of the Alpha Stem Cell Clinics
Network, whose sites were supposed to share information and
expertise “to enhance efficiencies and accelerate clinical trials
for stem cell therapies, and delivery of approved therapies,”
according to background materials furnished to the board.
The network’s duties included improving public understanding of
stem cell clinical trials and therapies; entering into contracts
with academic and corporate sponsors of stem cell clinical trials;
and provide consulting services to those sponsors that were
designed to “streamline and provide economies of scale for
clinical, data management, and regulatory processes.”
“While all of the aims of the concept plan are individually
laudable, it is my firm belief that the proposal as written is too
broad and overly complex to be successful. In a word, it lacks
focus,” Dr. Mills wrote in a memo to members of the governing
board, formally called the Independent Citizens’ Oversight
“As a result of its overly wide-ranging scope, I also believe that
there is a real possibility of incurring significant duplicative
costs,” Dr. Mills added. “It is my opinion that the $70 million
price tag is not clearly justified in terms of the benefits it will
deliver to the people of California.”
Instead, Dr. Mills proposed a revised concept plan for a scaled-
back CIMC with a focus on early stage clinical operations,
specifically efforts related to ensuring high-quality stem cell
clinical trials. That center, he said, would open in an unspecified
“limited number” of locations and evaluated for effectiveness
before it is expanded. A single principal investigator would
administer CIMC after demonstrating “appropriate management
experience to provide leadership for CIMC staff, as well as across
the network to facilitate network activities.”
Dr. Mills proposed that the stem-cell agency spend up to
approximately $10 million to fund the revised CIMC for five years.