Objective:
This program seeks to advance therapeutic development through pre-clinical and/or clinical testing of approaches addressing unmet needs of people with Parkinson’s disease (PD). The program is set up to benefit therapeutics with clear potential to prevent, stop, or delay disease progression or to reduce the burden of daily symptoms.
Funding will support projects aimed at:
- Pre-Clinical: Identifying, validating and/or developing novel pharmacological and non-pharmacological interventions through pre-clinical development from early screening to pre-clinical characterization and testing.
- Clinical: Progressing promising interventions with strong pre-clinical packages into/through initial clinical assessment exploring pharmacokinetics and pharmacodynamics, safety/tolerability, or early proof of biology and/or clinical efficacy. For novel targets, MJFF is particularly interested in de-risking programs by supporting early proof of concept in patients to gain insight into the therapeutic potential, including exploration of biomarker-based or clinical endpoint-based efficacy.
MJFF will prioritize projects with the strongest therapeutic rationale, patient value and preclinical-to-clinical translation potential. Proposals should also fulfill the following criteria:
- The selected therapeutic target or mechanism should have strong biological rationale to be pursued as a therapeutic target for PD, such as a genetic link or based on prior validation data in relevant in vitro and/or in vivo models.
- The proposed therapeutic approach is sufficiently differentiating from and believed to be superior to any of the currently existing therapies in the market or in development.
- The proposal emphasizes how translational biomarkers will be used to monitor target engagement/modulation and hypothesized mechanism of action, as well as consideration of patient enrichment measures that can improve clinical trial design to de-risk further development.
- For applications proposing clinical testing, the proposal has a patient-centered approach incorporating patient voice in the clinical development plan.
For this program, MJFF will not consider:
- Applications seeking to identify new intervention targets (e.g., large-scale screening or genomic/transcriptomic analyses).
- Applications seeking to validate a target with only tool compounds or biological manipulations that have no viable path for further drug optimization and development.
- Applications seeking to test reformulation of commercially available drugs via a new route of administration.
- Application seeking to assess efficacy of dietary supplements.
The goal of this program is to increase the chances of moving therapies toward the clinic. To expedite the process, only industry and academia-industry partnerships in and outside the United States are welcome to apply. Applicants are permitted to submit multiple unique submissions but should NOT submit multiple pre-proposals supporting different stages or aspects of the same therapeutic development program. Applicants are also permitted and encouraged to re-submit a revised pre-proposal that addresses prior feedback provided by MJFF, if applicable.
The program will be divided into two stages with the goal of offering applicants frequent opportunities to propose novel and promising PD therapeutics:
- Applicants may submit a pre-proposal application at any time. Pre-proposals will be reviewed by MJFF within three weeks of submission. This stage is your first and best opportunity to determine if MJFF is the right partner for you.
- Applicants whose pre-proposal is selected for further consideration will be invited to submit a full proposal through one of the four review cycles (see full proposal due dates below). MJFF staff will work with applicants to define the most flexible and fastest option for review. Invited applicants will have the opportunity to consult with MJFF on proposal development. Funding decisions will be communicated within three months of full proposal submission.
MJFF will hold office hours to discuss the full proposal development for those invited to submit.
For questions about the application process or project suitability for this call for applications, please email grants@michaeljfox.org.