Alzheimer's Drug Discovery Foundation - Drug Development

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 (see Our 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. This funding opportunity concentrates on diverse drug mechanisms and modes of action related to the biology of aging and other emerging therapeutic areas for dementia.

ADDF strategic priorities include:

• Combination therapies of two or more drugs to be administered together or development of combination products. This may include:
  • co-development of two or more new investigational drugs
  • a single new investigational drug in combination with a previously approved anti-amyloid monoclonal antibody
  • fixed combinations of two previously approved drugs
• Disease-modifying and symptomatic agents

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

Full proposal deadline TBD. 

Overhead

Overhead costs are not supported. 

Pre-application deadlines

RSO internal deadline

Pre-application program deadline

Application deadlines

Program application 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.

RESOURCES

Reminder: The sooner the researcher engages with Research Services, the more help we can be!

Contact the following Research Service units for support with:

Projects Involving Indigenous Research:

Support with incorporating wise practices in Indigenous research, community engagement, and Indigenous data management is available through the Indigenous Research Support Team (IRST).

Applicants can reach out by email to IRST at IRST@ucalgary.ca in advance of the RSO internal deadline. For more information about IRST, please visit the IRST webpage.

Knowledge Mobilization, Research Impact Assessment, DORA:

Support for knowledge mobilization/engagement/translation, community partnerships, research impact, responsible research assessment (DORA), and open science, is available through the Knowledge to Impact team.

Applicants can reach out by email to the KI team at knowledge.impact@ucalgary.ca.

For more information and access to resource archives, please visit the KI team webpage.

Research Data Management:

For information on research data management plans, processes, or best practices for your research program, please contact research.data@ucalgary.ca.

EDI in Research:

RSO can provide resources and support to research teams on the integration of equitable and inclusive practices in research design and research practice.

Contact edi.rso@ucalgary.ca for more information.

Research Security:

The Research Security Division is available to ensure researchers adhere to research security guidelines and policies, including the National Security Guidelines for Research Partnerships (NSGRP) and the policy on Sensitive Technology Research and Affiliations of Concern (STRAC).

Visit the Research Security website to learn more or contact researchsecurity@ucalgary.ca.

Pre-Award Submissions:

RMS: Creating a Pre-Award LOI
RMS: Creating a Pre-Award Application