To date, the Michael J. Fox Foundation for Parkinson’s Research has funded over $297 million in research, $77 million of which has been awarded to more than 160 unique, industry-led projects.
In June 2012, MJFF announced its newest funding mechanism, the Therapeutic Pipeline Program (TPP), which combines MJFF’s previous Therapeutics Development Initiative (TDI), Repositioning Drugs for PD, and Clinical Intervention Awards (CIA) programs into a single, streamlined funding opportunity. Open to both industry and academic investigators, TPP seeks to support research projects along the entire drug development pipeline. This comprehensive approach to funding encourages investigators to think holistically about the path towards therapeutic development, regardless of the current stage of their research.
MJFF will commit up to $10 million to TPP with the intention of supporting multiple awards. TPP will be launched annually with a two-stage review process, and Stage I proposals are due September 12, 2012 by 6:00 pm ET.
To learn more about TPP, we asked Sonal Das, PhD, associate director of research programs at MJFF, to explain more about the rationale behind the program, as well as who can apply. Check out an excerpt from the Q&A below, or read the entire conversation.
MJFF: Why the Therapeutic Pipeline Program?
Sonal Das: 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. 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.
MJFF: Who can apply to the program, and must research begin at a specific stage of development?
Sonal Das: 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.
More about Applying for TPP
TPP supports PD therapeutic development along the entire preclinical and clinical path. Although MJFF is open to any creative therapeutic strategy, ideal applications should focus on efforts to address one of the following treatment challenges:
- Strategies that protect or restore degenerating and/or dysfunctional neurons affected in PD
- Strategies to alleviate disabling motor and non-motor symptoms of PD (important non-motor symptoms include cognitive dysfunction/dementia, depression/mood disorders, autonomic dysfunction and sleep disorders)
- Strategies to alleviate complications of PD treatment including dyskinesias and other disabling side effects
Although most traditional therapies involve pharmacological approaches, MJFF is also open to alternative strategies, including gene therapy, biological, surgical and non-invasive/non-pharmaceutical approaches that can have significant impact for patients. Moreover, as drug targets may be shared among multiple diseases and/or drugs may hit multiple disease targets, MJFF is also interested in drug repositioning of molecules for PD that have been approved or shown to be clinically safe for other indications.
Proposals may seek support of key steps along the entire therapeutic pipeline, including:
- Therapeutic screening, identification and optimization
- Preclinical in vivo testing (e.g., efficacy, toxicity, PK/PD, ADME, pre-IND)
- Clinical testing (e.g., safety/tolerability, efficacy)
Applicants are asked to develop a clear plan, including major ‘go/no go’ decision milestones, for moving a therapeutic strategy toward ultimate clinical utility in people with PD. Investigators new to PD research are encouraged to collaborate with experienced PD scientists and/or companies to ensure the greatest chance for success.
Opportunities for Industry
To further explain the goals of this funding initiative and to answer applicant questions, MJFF held an informational conference call on August 1st. A recording and transcription of the call as well as more information on the program are available on the TPP Web page.
To learn more or apply for the Therapeutics Pipeline Program, visit https://www.michaeljfox.org/research/grant-detail.php?id=9.
In addition to our funding programs, the Michael J. Fox Foundation works with industry in a wide variety of ways. To learn more about these relationships, please visit our Opportunities for Industry page.
Listen to a podcast with Dr. Sonal Das, Associate Director of Research Programs at MJFF about the program.