2024 ADDF Drug Development RFP

Eligibility

Funding is open to researchers and clinicians worldwide at:

• Academic medical centers and universities or nonprofits. Industry partnerships are strongly encouraged.
• Biotechnology companies. Existing companies and new startups are both eligible.
• NOTE: Funding is provided through mission-related investments that require return on investment based upon scientific and/or business milestones (refer to the ADDF Research Strategy for more information).

Summary

The Drug Development RFP supports investigational new drug (IND)-enabling studies (or the international equivalent) and early-phase clinical trials that test promising pharmacological interventions and devices for Alzheimer’s disease (AD) and related dementias. Both disease-modifying and symptomatic agents will be considered.

This funding opportunity prioritizes diverse drug mechanisms and modes of action related to the biology of aging and other emerging therapeutic areas for dementia. For this reason, amyloid targeted approaches and cholinesterase inhibitor proposals will not be considered for this RFP. Up to $5,000,000 in funding available based on stage and scope of research. For studies requiring additional support, co-funding from other funding agencies or investors is encouraged. Payment structure will be negotiated and based on milestone achievements and recruitment.

Stage of development:

1. Early-stage human clinical trials including:

• Phase 0 micro- or sub-therapeutic-dosing studies
• Phase 1 trials in healthy subjects or patients
• Biomarker-based proof-of-concept studies (generally phase 1b or phase 2a trials) designed to assess target engagement and downstream pharmacologic effects

2. IND (or international equivalent) – enabling studies including:

• Non-GLP and GLP pharmacology and toxicology studies, pre-formulation, and GMP manufacture of API and/or drug product required for regulatory packages. Funding is available for preparation of traditional and exploratory IND (or international equivalent) applications
• Long-term toxicology studies to enable longer-term dosing in phase 2 trials
• GMP manufacturing and testing of API and/or drug product required to move into phase 2 or phase 3 trials

For clinical trial applications, if IND-enabling work is in progress, funding for clinical studies would be contingent upon an IND (or equivalent) successfully going into effect.

Type of therapy: Novel, repurposed and repositioned drugs, as well as natural products and devices will be considered. Therapeutic modalities of interest include small molecules, peptides, antibodies, gene therapies, antisense oligonucleotides, and stem cells. Other non-pharmacologic interventions, such as diet, meditation, and exercise, will not be considered. A detailed landscape analysis to compare competition related to the mode or mechanism of action is strongly encouraged.

Drug mechanisms or modes of action: Novel drug mechanisms and modes of action related to the biology of aging and other emerging therapeutic areas for dementia are considered high priority. These include, but are not limited to:

• Epigenetics
• Inflammation
• Mitochondrial & metabolic function
• Neuroprotection
• Proteostasis
• Synaptic activity and neurotransmitters
• Vascular function
• Other mechanisms and modes of action related to the biology of aging (e.g. senescent cells)
• Other novel mechanisms or modes of action that are supported by compelling evidence demonstrating a rational biological connection to the disease process
• Please note: Anti-amyloid approaches (e.g., anti-amyloid aggregation, beta-amyloid vaccines, beta- or gamma-secretase inhibitors) and cholinesterase inhibitor proposals will not be considered

Application Submission

The application process will be completed in two-stages:

1. Letter of Intent (LOI). Applicants should submit a Letter of Intent (LOI) through the ADDF Funding Portal. An approved LOI is required prior to submission of a full proposal. ADDF’s science team will evaluate LOIs to determine whether the proposed project is consistent with the ADDF's mission and funding priorities. Generally, applicants can expect to be notified within 2-3 weeks of their LOI submission. The deadline for applicants to submit their Letter of Intent to the ADDF is 3:00pm MT, September 29, 2023.

2. Full Proposal. If invited, submit a full proposal through the ADDF Funding Portal. Applicants must obtain institutional approval from the University of Calgary prior to submitting their full proposal to the ADDF.  Initiate required University of Calgary internal approvals by completing a Pre-Award/Application record in RMS (https://my.rms.ucalgary.ca/). Attach a copy of your complete full proposal materials and submit for approvals. Please ensure that you allow time for academic approvals prior to the Research Services Office internal review deadline of 12:00pm MT, November 28, 2023.

Overhead

Not Applicable. ADDF funding is not provided for indirect costs/overhead. Refer to the ADDF Funding Policies.

Application deadlines

RSO detailed review deadline

RSO final internal review deadline

Program application deadline

Application deadlines

Letter of Intent (LOI) Deadline

NOTE: Consult your Faculty Associate Dean (Research) (ADR) regarding Faculty-specific deadlines and submission processes.

Principal Investigators: Complete a Research Management System (RMS) record, including a copy of your complete application, and submit this for approvals in RMS.

Postdocs, students, and trainees: For fellowships and externally-sponsored research training awards or opportunities, you must complete the Research Funding Application Approval (RFAA) Trainee PDF form, and submit it, along with a complete copy of the application, to Research Services at rsotrainee@ucalgary.ca. Trainees should not use RMS at this time.

Approvals: The University of Calgary requires that all funding applications be approved prior to submission. Approval requires signatures via either RMS or the RFAA Trainee form, in the following order:

• Principal Investigator
• Department Head
• Faculty ADR/Dean
• Research Services (on behalf of the Vice-President Research)

Read the Meaning of Grant Signatures policy to understand what your approval means. Please see the agency guidelines for details about which signatures are required on your application, as it may differ from internal requirements.

Late submissions: Late submissions will only be accepted in cases of medical or family emergencies, or other exceptional circumstances. If you submit your RMS record to Research Services after the internal deadline has passed, you must secure additional approvals. Please read: Late Applications Process.

Additional Resources

Request for Proposals

Application Instructions

ADDF Funding Portal

Application and Funding Policies