Tuesday, February 04, 2014

California's $70 Million Alpha Stem Cell Clinic Competition Ratchets Up

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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