Solid Hook-Up: California Stem Cell Agency and Calibr Connection

Highlights

Creating pathway to clinic

The Calibr approach

Problematic pharma-academic ties

As of today, the California stem cell agency has a $4 million hook into a San Diego research enterprise that also has ties to a glittering array of partners, ranging from Merck to Bristol-Myers Squibb. 

The connections fit with the state stem cell agency’s new goal of creating a clear pathway from the basic research bench to the use of stem cell cures in clinics for millions of people.

The signal event came routinely and quickly this morning when directors of the California Institute for Regenerative Medicine (CIRM), as the agency is formally known, approved a $1.7 million award.

The cash is going to the California Institute for Biomedical Research (Calibr) and its director, Peter Schultz.

The funds will be used for pushing into clinical trials a treatment that would -- for the first time -- modify the progress of osteoarthritis, which afflicts 27 million Americans. The therapy could also be used to treat damaged cartilage in knees and elbows.

CIRM has now invested $10 million in Schultz, a reknown chemist and biotech entrepreneuer. Six million of that went for research that was performed at Scripps. All of the funds involve the proposed arthritis therapy. Including today’s award to Schultz and funds to other researchers, the agency has now handed out $19.5 million to find a therapy for arthritis.

Schultz founded Calibr three years ago with up to $90 million, promised over seven years by Merck. The Big Pharma firm has first refusal rights on treatments developed by Calibr. If Merck passes, then other enterprises can make an offer. Calibr has additional partnerships, including a $28.9 million, five-year relationship with the Gates Foundation.

Peter Schultz, catching a big one

Schultz says “our mission is a little bit arrogant.” In a lengthy piece in March by Bradley Fikes of San Diego Union-Tribune, Schultz said Calibr has “a very broad spectrum of interest and we hope to have a significant impact on a number of diseases."

Fikes wrote,  

"'There are a lot of discoveries being made in life science, and many of these discoveries are made in academic institutions and basic research institutions,’ Schultz said. ‘The process of translating those discoveries into new medicines has become somewhat difficult.’

“These institutions have trouble collaborating with big pharma because of differences in culture and regulatory challenges of for-profit and not-for-profit collaboration.

"'That's left the universities try to do drug discovery themselves,’ Schultz said. ‘The problem there is they don't have the knowledge, experience or even the processes to do drug discovery, which is a lot different than a cottage industry approach to basic research."

Fikes continued,

“Meanwhile, big pharma is becoming more risk-averse, looking for validated drug targets and in-licensing compounds. That makes pharma collaboration with basic research centers even more problematical, Schultz said.

"’We have to come up with other ways to really facilitate and accelerate the translation of new research into new medicines,’ Schultz said. ‘Universities are trying to set up their own drug discovery units. Scripps has done that in Florida, Vanderbilt, we see Cornell, Rockefeller and Sloan-Kettering teaming up to do that. They're building something from scratch, and usually without having the experience of having been there and done that. And in some cases what they wind up doing is hiring a lot of people from pharma industry and recreating a pharma-like process.’"

Calibr has 110 employees, Fikes reported, including 60 postdocs. Its annual operating budget for 50 projects totals $25 million. Calibr is still busy hiring with seven positions open on its Web site as of this afternoon.

Neil Littman: New Business Development Officer at the California Stem Cell Agency

The California stem cell agency this week mentioned the hiring of a business development officer as part of its plan to engage industry more robustly but did not identify him.

Neil Littman
Linked In photo

The California Stem Cell Report queried the agency about the new hire. Kevin McCormack, the agency spokesman, identified him as Neil Littman, who most recently worked as a senior associate in the merchant banking group at Burrill & Co. in San Francisco.

Littman's responsibilities will include “facilitating opportunities for outside investment in stem cell research in California for both CIRM-funded and non CIRM-funded programs by biopharmaceutical strategic partners, equity investors and disease foundations.”

McCormack said that Littman's “strategic advisory experience includes buy-side and sell-side M&A, as well as in-licensing and out-licensing of both development stage and commercial products.”

Littman also worked at Thomas Weisel Partners and at Deutsche Bank Securities. He received a M.S. in biotechnology with a concentration in biotechnology enterprise from The Johns Hopkins University, and a B.A. in molecular, cellular and development biology from the University of Colorado Boulder in 2002. 

Littman's salary at CIRM is $160,000 annually.

$40 Million High-Risk Stem Cell Research; IOM and CIRM on Engaging Biotech Biz

Directors of the California stem cell agency this Wednesday will be asked to approve initiation of a $40 million, high-risk research program aimed at filling “key gaps” in knowledge about human stem cell behavior.

The concept plan for the round – called Basic Biology V – will come up for approval at the governing board meeting in Los Angeles.  Pre-applications are expected to be due in March.

The staff proposal calls for as many as 30 awards, but did not specify a limit on the total dollars for each award. The competition is open to both business and academics and non-profit organizations.

The proposal said that the round is targeting “high-risk, exploratory pursuits.” The goal is to fill “key gaps in our understanding of fundamental human stem cell behaviors that hinder the pace of discovery, and ultimately prevent the potential of this research from being fully realized.”

Additionally up for consideration at this week's meeting is a “blueprint” for “engaging industry and supporting commercialization” of CIRM research. A blue-ribbon study by the Institute of Medicine last week also recommended that CIRM engage industry more warmly. However, there were striking differences between what the IOM recommended and what CIRM proposed. The CIRM plan was prepared prior to the release of the IOM report. 

The CIRM proposal laid out the following objectives that were prompted by an “external review” two years ago.

•  “Attract Follow-On Financing and Co-funding of CIRM Funded Research
•  “Support of Company Creation/Growth/Relocation
• “Early Engagement of Top Tier Biopharmaceutical Companies in Order to Access Critical Expertise
• “Assume a Leadership Role in Business Related Areas the are Critical for Supporting the Field”

The CIRM memo listed a number of initiatives that the agency has already started and said more are expected to come. They include the already enacted, new business-friendly award program, the recent hire of an unidentified business development officer, designation of industry “collaborators,” relocation support for high impact companies and participation with industry in developing “reimbursement pathways” that will benefit the regenerative medicine industry.

“Reimbursement” is the euphemistic term that industry prefers instead of saying “beefing up profits.”

Last week, the report by the Institute of Medicine, which cost CIRM $700,000,  noted that biotech firms have received only about 6 percent of the $1.7 billion handed out by CIRM, a figure not mentioned by the eight-year-old agency's industry engagement plan.

The IOM said that industry representation on the agency's critical, decision-making boards (the governing board and standards and grant reveiew groups) should be enhanced. Additionally, a new scientific advisory board with substantial industry presence should be created to replace existing advisory groups. All of which would be aimed at enhancing and leveraging industry “expertise and resources in product development, manufacturing, and regulatory approval in support of the ultimate goal of bringing therapies to patients,” according to the IOM.