Eight years after its founding, the Tucson-based Critical Path Institute is going global in a big way.
The mission of the nonprofit institute — formed as a public-private partnership including the University of Arizona and the U.S. Food and Drug Administration — is to accelerate drug development by acting as a neutral third party through which drug companies and researchers can share data and build better research tools.
C-Path has undergone some major changes in recent years, including two new CEOs and a transition to a partly industry-funded model.
But it has also moved forward with its mission on several fronts — including a recent agreement to share data with a counterpart European drug-safety research consortium.
And last month, C-Path’s international efforts got a boost when the FDA and the European Medicines Agency both approved an Alzheimer’s disease clinical trials simulation tool developed by a C-Path consortium.
The Alzheimer’s trials tool is a prime example of what drug companies can do when they share data on neutral ground, said Martha Brumfield, who was named interim CEO of C-Path in February and full CEO in June.
“No one company has enough data to really assess all the nuance of disease progression,” said Brumfield, who joined C-path in 2010 after retiring early from a 20-year career with drug giant Pfizer. “We think this is really going to be a game-changer, going forward.”
The culmination of four or five years’ work, the Alzheimer’s trial-simulation tool was developed by C-Path’s Coalition Against Major Diseases — one of several research consortia hosted by the institute — using data shared by 10 companies from 22 clinical trials encompassing more than 6,000 patients.
The tool will allow researchers to simulate clinical trials to adjust things like duration of trial therapies, frequency of patient testing and the timing of placebo use, Brumfield said. That should not only speed up the trials process but lead to much better results, she said.
“If the trial fails, you now will know it wasn’t because the trial design was flawed; it was because the drug didn’t work, and that’s a huge point of distinction,” Brumfield said.
Look for more international collaborations in the near future.
In May, C-Path announced a memorandum of understanding between its Predictive Safety Testing Consortium and the Safer and Faster Evidence-based Translation (SAFE-T) consortium, which is sponsored by the European Union’s Innovative Medicines Initiative (IMI).
C-Path also is discussing collaboration with a Netherlands-based drug-research institute and is exploring links with China’s drug agency and industry, Brumfield said.
While C-Path’s programs have been going full-bore, the organization itself has been in transition.
Brumfield became interim CEO of C-Path in February to replace Dr. Carolyn Compton, who left after about a year as CEO to join the National Biomarkers Development Alliance, based at Arizona State University. Brumfield joined C-path as a consultant in 2010 and soon became director of regulatory and international programs.
In a process that began under Compton, who took C-Path’s helm in February 2012 to replace founding CEO Dr. Raymond Woosley, C-Path has set up a new business model as initial local public and private funding waned. For its first five years, C-Path was founded with about $9 million in public and private donations. Subsequently, Science Foundation Arizona granted C-Path $14 million over several years.
Under the new business model, Brumfield said, about a third of C-Path’s roughly $7.5 million budget comes from ongoing FDA grants, another third comes from grants from foundations like the Bill and Melinda Gates Foundation, and a third comes from new fees assessed to companies that participate in drug-research consortia.
There was some reluctance within C-Path to start charging consortia fees, since C-Path wanted to avoid potential conflicts of interest, Brumfield said. But Brumfield said C-Path has earned the trust to remain impartial even with fee support.
At the same time, C-Path has cut costs, trimming a few administrative positions and closing its office in Rockville, Md. The institute employs about 35 people in Tucson at 1730 E. River Road.
C-Path board member Shaun Kirkpatrick said he’s pleased with C-Path’s evolution and Brumfield’s leadership.
“It’s really firing on all cylinders — it’s actually exceeded my expectations, where it is today,” said Kirkpatrick, president and CEO of the Tucson-based technology investment and management firm Research Corporation Technologies.
Kirkpatrick, who has managed RCT’s biosciences investments for 20 years, said Brumfield inherited some strong programs led by top-quality talent, including herself. She has continued to move the organization forward, he said, noting that C-Path’s consortia are flourishing.
“We’ve had consortia now that have had multiple projects that have generated multiple guidelines at the FDA, so success breeds success,” he said, adding that C-Path’s new funding model is properly balanced among the interests of government, private donors and industry.
Meanwhile, Brumfield, 59, said she has no plans to leave her post or Tucson anytime soon.
“I have some things I want to achieve, and I want to make sure C-Path is well-positioned for just incredible success in the future,” she said.