Making sure medicine is used safely in critically ill babies; developing tests to detect drug-resistant tuberculosis; working toward cures for Alzheimer’s, Parkinson’s and multiple sclerosis.
These are among the ambitious goals of the Tucson-based nonprofit Critical Path Institute and its partners, which have had a busy few months.
Founded in 2005 as a public-private partnership with the U.S. Food and Drug Administration, C-Path was created to address the gap between medical discovery and its application to patient care. The company serves as a neutral party through which drug companies and researchers can share information.
Earlier this month, C-Path announced a $1 million grant from the Flinn Foundation to continue its work in data collection and sharing, designed to aid in the evaluation of drug safety and effectiveness.
In September, the U.S. Food and Drug Administration renewed its funding of C-Path for another five years and issued a letter of support for kidney biomarkers identified through C-Path’s research.
The same week, the institute received a three-year grant from the Bill and Melinda Gates Foundation to continue their research on tuberculosis treatment.
Overseeing it all is CEO Martha Brumfield, who came to C-Path in 2010 after early retirement from a 20-year career with Pfizer.In June of 2013, Brumfield was named CEO of Critical Path Institute after serving as the interim CEO for four months.
A Q&A with Brumfield:
Q: After so many years in the pharmaceutical industry, what made you decide to take the job at C-Path?
A: While I was at Pfizer, some of my staff had actually been involved with a number of C-Path’s projects, so I was aware of the organization and the important work that it did, and had always been impressed with it. When the opportunity arrived to leave Pfizer, I thought it was a chance to be involved with C-Path in a larger capacity and help advance the science behind the drug development and regulatory policies, two areas where I have a lot of experience and about which I care very much. And also it was appealing to me, coming from the for-profit sector, to be able to work in the pre-competitive collaborative space which C-Path really leads in its role as a neutral and independent third party.
Q: What do you think is different about C-Path’s work?
A: It focuses on the gaps between the emerging science and technology coming out of basic research and their practical applications in the drug development process and also the regulatory review process. There aren’t many organizations that have this as their priority. Many scientists and scientific organizations focus on basic research, which is incredibly important, but if that basic research doesn’t translate into something that can be practically applied in a drug development plan, and can’t be something accepted by regulators as having the necessary rigor and evidence for that medicine to be proved, then there’s not as much value coming out of those findings of basic research.
Q: How does C-Path’s work impact the larger medical community?
A: Critical Path operates in a space where there isn’t as much activity as we believe there needs to be, and we know that advancing the types of innovative methods and tools that we do will help to save time and cost of developing medicines and also will de-risk the development programs which are quite lengthy and costly. And that all means that new medicines can more quickly get to those people who need them the most. Critical Path, as an independent and neutral third party, is able to bring unusual bedfellows together to collaborate in ways that other organizations can’t.
Q: What are some of the ways in which C-Path collaborates with the FDA?
A: We’re very proud to have the opportunity to work with the FDA on scientific areas where there’s unmet needs and which the FDA deem as priority areas. We also believe that the FDA continues to have confidence in what we’re doing, in our ability to deliver and the credibility we bring to these programs because of our neutral status. FDA has identified over 55 disease areas where they need data standards to be developed and we’ve worked very closely with them and our other partner organizations to achieve those very specific goals that the FDA has set. That’s just one example of an area that’s a priority for them where we’re able to help them achieve their goals.
Q: How important is the FDA funding to C-Path’s work?
A: As important as their financial support is to us, we’re very fortunate to have generous funding from some private foundations, such as the National Multiple Sclerosis Society, The Bill and Melinda Gates Foundation and other partners. And I’d be remiss not to acknowledge the incredible support we’ve had from the state. Science Foundation Arizona has provided us with several grants through the years, and also the Flinn Foundation is currently providing us with a grant. The FDA funding is very important ... but it’s healthy for an organization to also have a fairly diverse array of funding.
Q: What kinds of projects does C-Path have in the works right now?
A: I just returned from Washington, D.C., where we at C-Path co-sponsored with the FDA and the Burroughs Welcome Fund a two-day meeting with over 100 neonatologists, pediatricians and other scientists, to begin the process of mapping out a plan for how to best evaluate the safe use of medicine in babies who are in neonatal intensive care units. This is an international array of experts from academia, the pharmaceutical industry, the National Institutes of Health, governments from Europe, Canada and the U.S. We all plan to continue to work together in a collaborative model to try and establish standards for treatment and identify potential biomarkers that will be useful to monitor the safe use of medicine in this very special population of babies. We’re very excited that we’ll be collaborating with the University of Arizona Medical Center on this project as well.
Q: What would you like to see happen in the short-term for C-Path?
A: We’ve achieved great success with our collaborative research and I see opportunity for that to continue and for us to move into some new disease areas. We’re expecting to launch a couple of products that are very specific to aggregating large sets of clinical trials data in some disease areas. I can’t say a lot about it at this point, but we have gained much expertise in being a secured partner to collect data, to curate it, to put it into the appropriate standards, aggregate it and then be the custodian for that data going forward. We house approximately 20,000 individual patient level data sets from multiple programs. We’re expecting this to expand pretty exponentially in the coming year. One example is, working with the Bill and Melinda Gates Foundation, we’ll be starting a project to gather, curate and aggregate data on a clinical specimen that contains the tuberculosis mycobacteria that are resistant to many drugs. The goal of that project is to help other researchers and diagnostic companies develop new tests, which can detect drug resistant TB very rapidly, so that we can ensure that patients are being put on the right combination of treatment that they need.
Q: What do you see in the long-term for Critical Path?
A: We’re all anxious to have cures for some of these horribly debilitating diseases, particularly in the neurodegenerative space, like Alzheimer’s, Parkinson’s disease, multiple sclerosis, areas where we have a lot of expertise, but we know that we have to continue on the path to developing these innovative tools that are going to help the process go faster.
We’re going to stay true to our core competencies; we’re expanding in areas that it makes sense to expand.
