A $70 million race was kicked off last
month as the California stem cell agency invited eight institutions
to compete to create what it calls Alpha Clinics, enterprises that
would attract patients from throughout the world for stem cell
therapies.
The agency hopes the plan will lay a
foundation for the stem cell industry in California and capitalize on
the growing allure of stem cell treatments. CIRM President Alan
Trounson, who plans to leave the agency this year, has been pushing
the Alpha Clinic plan since 2011.
Beyond the agency's millions, CIRM has
told applicants rather delicately that they have an obligation as
well. “Show us the money” is the message obliquely contained in the
agency's request for applications (RFA) for the Alpha awards.
The issue of matching funds is a tender
spot for the agency this week given the flap that arose in the recent
$40 million stem cell genomics round. A requirement for contributions
was not mentioned in that RFA, leading some unsuccessful applicants
to not include any. Stanford won with what it says is $7 million in
matching funds.
CIRM's Alpha Clinic RFA does
not mention cash, matching or money. But it does say the selection
criteria involves in-kind or “other forms of support” and
“sustainability,” which usually means a plan for raising cash or
showing that cash is in hand. A coupled RFA is a tad more explicit.
It mentions criteria involving “financial strength,” leveraging
“assets” and “effectiveness in attracting a funding steam”
after the award runs out. One or more applicants may think that the
best way to show effectiveness in funding is to demonstrate it from
the very beginning with a handsome sum.
Eight existing academic centers with hospitals were invited to apply last month to become Alpha Clinics, which will be one of
CIRM's signature efforts, given the size of the round and its scope. Up to five awards will be made in that $55 million plan.
In a related RFA, five applicants have
been invited to apply for one $15 million award to create a stem cell
information and data management center. Not all of the five have
been invited to apply in the clinic round. Awards in both categories
will be for five years.
Kevin McCormack, senior director for
communications at CIRM, said the invitations to compete were culled
from 14 letters of intent to apply. The stem cell agency generally
declines to disclose the identities of applicants for awards,
although it has done so on at least one occasion in the past.
CIRM says its Alpha Clinic plan is
aimed at providing “critical operational support for the conduct of
clinical trials for investigational stem cell therapies” and to
create “centers of excellence” for approved stem cell therapies.
Applicants should show that at least two “lead clinical trials”
will be conducted at their institutions along with a “committed
source of funding” for each trial. CIRM said it would not pay for
the trials or construction or renovation of facilities.
In addition to gathering medical data,
the $15 million information center will be involved in marketing to
potential patients and public communication. The RFA calls for the
center to campaign against the “dangers of stem cell tourism,”
which is increasingly growing overseas. The information center will
also be involved in developing data to convince insurance companies
and governments to cover the cost of stem cell therapies, which are
predicted to be very expensive.
Because no more than five clinics may
be funded, the chances for the eight are good. However, the CIRM
governing board is increasingly feeling financially pinched as the
agency's funds dwindle. Cash for new grants is expected to run out in
the latter part of 2017. The board could back away from the idea of
five clinics depending on what grant reviewers say.
Applications are due March 14. Board
action is expected this summer with funds going out next fall or
shortly thereafter.
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