The Therapeutic Pipeline Program for Academic and Industry Teams: Evolving the Foundation’s Strategy of Funding Research
This summer, The Michael J. Fox Foundation (MJFF) launched a new program for researchers, called the Therapeutic Pipeline Program, designed to integrate three previous Foundation funding opportunities — the Therapeutics Development Initiative, Clinical Intervention Awards and Repositioning Drugs for Parkinson’s Disease — into a single streamlined initiative.
Since launching in 2000, MJFF has grown and adapted, in the ongoing search to find the best strategies for bringing new treatments to pharmacy shelves, faster. The hope is that the Therapeutic Pipeline Program will streamline this process by asking researchers from academia and industry to present a well-defined plan for driving their therapeutic strategy through pre-clinical testing and into the clinic. MJFF is committing up to $10 million to this program this year. Applications are due September 12, 2012.
MJFF sat down with our own Sonal Das, PhD, to further discuss the thinking behind the new program, and how we hope it could more efficiently drive progress toward better treatments for Parkinson’s disease (PD).
MJFF: Why the Therapeutic Pipeline Program?
SD: The Therapeutic Pipeline Program supports PD drug development at various stages along the pipeline; from early stage pre-clinical laboratory work to early stage clinical trials. By identifying roadblocks along the way, and sharing the risk of drug development with researchers from academia and industry, we hope to keep promising research moving forward along this pipeline.
The new program asks researchers to think holistically about this entire process. We want researchers thinking early on about potential partners with whom they could work at various stages along the way. This may include other investigators, drug developers with particular industry expertise, or even contract research organizations. By evaluating all the pieces that may be needed to drive a project, and conveying this to us in the application stage, our applicants and grantees can also help us as a Foundation to better understand what we can do to assist in the effort. This may include connecting industry leaders with projects ripe for investment.
MJFF: Who can apply to the program, and must research begin at a specific stage of development?
SD: Proposals can be pre-clinical or clinical in nature. They can center around small molecule drug candidates, but MJFF is also open to proposals that investigate all therapeutic development (including gene therapy, surgical intervention, and device development). Proposals may focus on targets that are new to PD, or candidates for repositioning drugs already approved by the FDA for another indication. They can come from academic or industry teams.
Again, what’s most interesting to us is that these proposals show a clear plan for how to move forward along each of the various steps necessary to bring the therapeutic closer to market. We’re asking applicants to also include what they would deem to be “go/no go” milestones, which can help to clearly delineate these steps. Of course, these decisions would also allow us to re-direct time and money toward other novel ideas should the science break down.
MJFF: Please explain more about what might be included in such a plan.
SD: Let’s begin with the pre-clinical phases of development. A clear plan that involves small molecules would potentially start with screening drug candidates against an identified biological target that researchers believe may play a role in PD. The idea is to then narrow down which compounds these researchers are working with have the best chance of being effective in subsequent pre-clinical studies. These pre-clinical studies would then aim to lay the groundwork for human testing, by concentrating on dosing, safety, and the drug’s ability to get into the brain.
Projects could then move from pre-clinical into human testing, or they may have their genesis in the early stages of the clinic. The major question we would hope to see answered here is, have applicants identified appropriate partners with whom to conduct clinical research? Do they have the proper support base to know how to conduct a clinical trial, and if they don’t, have they identified someone that can help them through this rigorous process? Have the applicants thought about the kind of support network they might need to recruit patients for the study?
Tell us more about the support that MJFF will provide throughout the life of each grant.
SD: Though we don’t expect applicants to have expertise in each area along the pipeline, we’d like for them to have a general knowledge of the steps involved. As investigators (from academia or industry) begin to identify these steps, it will ultimately help them determine the resources that will be necessary for their project to move forward through the pipeline. And we’re happy to provide feedback, counsel, and contacts along the way.
In the past, our programs have mostly focused on small sections along the extensive pathway that stretches from target validation to pharmacy shelves. We’re hopeful that the Therapeutic Pipeline Program will help us to better see a broader viewpoint, so we too can better understand what it takes to speed the process, and where we can best work to help our awardees find success. We want to know where our impact can be the greatest, and we’re optimistic that this program will help us to better zero in on the best opportunities.
To learn more about the Therapeutic Pipeline Program, or to apply for a grant, visit https://www.michaeljfox.org/research/grant-detail.php?id=9#crumb.
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The Therapeutic Pipeline Program will support both industry and academic groups at key steps along the entire therapeutic pipeline.
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