Tucson's Critical Path Institute recently got some good news - and some noteworthy recognition - when the U.S. Senate gave final approval to a budget reauthorization bill including the Food and Drug Administration partnership program that helps fund the institute.
The FDA Reform Act of 2012, passed and sent to the president June 26, authorizes $6 million for FDA public-private partnerships.
And C-Path was singled out for its work, by name, in a House committee report filed with the bill.
Since its founding in 2005 with $9 million in local donations, C-Path has gotten about $2 million a year from the FDA partnership to further its mission of improving the drug-development process.
But C-Path's new chief wants more, as part of a plan to move the institute from startup stage to a sustainable future.
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"I consider that now we are transitioning out of the startup period," said Dr. Carolyn Compton, who became president and CEO of C-Path in February.
Compton said C-Path will bid for a bigger share of the FDA partnership funding, and she believes she has a good case.
"We are in conversations with the FDA, making our case about our productivity and successes," she said, noting that formal appropriations and FDA allocations are still pending.
"Their return on investment has been quite substantial, so we're trying to convince them that this is worth more investment going forward," Compton said.
C-Path - which has about 50 employees and an annual budget of about $7 million - has set up six consortia to advance drug research, bringing together virtually all of the major drug companies to share clinical data, with the goal of speeding drugs to market.
C-Path's consortia have generated seven new biomarkers - genetic sequences or elements associated with specific diseases - for drug-induced renal toxicity approved for use in pre-clinical studies. An additional 66 biomarkers are under development.
C-Path also helped develop the first data standard for Alzheimer's disease, along with a 6,000- patient database and a new disease-progression model.
And recently, C-Path signed a partnership agreement with the Clinical Data Interchange Standards Consortium to establish the Coalition for Accelerating Standards and Therapies, an initiative to create and maintain data standards and tools to speed clinical research and drug development.
But that effort is just part of a larger strategy to retool C-Path's funding mix - including a plan to collect fees from drug companies that are members of the institute's consortia.
That's a departure from C-Path's founding principle of accepting no industry money.
But C-Path's business model is changing - by necessity - as initial funding commitments wind down and C-Path takes on a larger role, Compton said.
C-Path was founded in 2005 with a five-year commitment of more than $9 million in pledges from the Arizona community, including the University of Arizona, the city of Tucson and local philanthropies.
Science Foundation Arizona, funded by the state and by private donors, has awarded C-Path more than $14 million to boost the institute's work. Other major grants include a $3 million award from the Bill and Melinda Gates Foundation last year to set up a consortium to advance tuberculosis drugs.
Despite the lingering economic downturn, more than 98 percent of the initial funding pledges have been honored.
"Our challenge is when they run out," Compton said. "We are facing the end of those funds, the philanthropic funds, the city funds, Science Foundation funds, roughly in the same time frame of a year."
In February, Compton said, C-Path's board voted to allow the collection of fees from C-Path's 41 consortia partners - a who's-who list of Big Pharma including Abbott, Genentech, Eli Lilly, Merck, Pfizer, Roche and Sanofi.
The partners - who must agree to such fees - have so far been receptive to the idea, Compton said.
"The value is ginormous, so I don't think they'll have any problem seeing that," she said, noting that partnership agreements must be reworked to account for the fees.
Compton said it's a matter of sustainability for the institute, which she believes already has the credibility it needs to act as a neutral third party.
The mention of C-Path in the FDA authorization bill was an unexpected but gratifying recognition of the institute's value, she added.
"That's a big deal, that we're recognized at the highest level of government for doing important things for the nation," Compton said.
Contact Assistant Business Editor David Wichner at dwichner@azstarnet.com or 573-4181.