Drug Development RFP - Combination Therapies

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 non-clinical studies 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.

For the Fall 2024 RFP cycle, only proposals focused on the evaluation of combination therapy of two or more drugs to be administered together or development of combination products will be considered.

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

This funding opportunity prioritizes diverse drug mechanisms and modes of action related to the biology of aging and other emerging therapeutic areas for dementia.

STAGE OF DEVELOPMENT

1. 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
• Substudies or specific defined scope of work within Phase 2b or Phase 3 studies

2. Non-clinical studies evaluating potential combination therapies (ex: non-GLP and GLP-pharmacology, drug interaction assessment, safety assessment)

3. GMP manufacturing and testing of API and/or drug product required to move into clinical studies

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 cell-based treatments. A detailed landscape analysis to compare competition related to the mode or mechanism of action is strongly encouraged.

Non-pharmacologic interventions, such as diet, meditation, and exercise, will not be considered.

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

Overhead

Not allowable as per foundation policy.

Pre-application deadlines

RSO internal deadline

Pre-application program deadline

Application deadlines

RSO detailed review deadline

RSO final internal review deadline

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.

APPLICATIONS

Review the Application Instructions for steps on applying.

The ADDF encourages potential applicants to contact them if you would like to discuss your proposed project and receive initial feedback.

For scientific inquiries, please contact:
Aaron Burstein, PharmD, Head of Search & Evaluation
aburstein@alzdiscovery.org

For inquiries related to contracting and the online funding portal, please contact:
Mission Related Investments Team
grants@alzdiscovery.org
 

ADDITIONAL RESOURCES

Support for projects involving Indigenous Research:

Support with the development of your grant application is available internally 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.

Support for Knowledge Engagement:

Support for knowledge mobilization/engagement/translation is available internally through the Knowledge Engagement Team. Applicants can reach out by email to the KE team at knowledge.engagement@ucalgary.ca in advance of the RSO internal deadline. For more information, please visit the KE team webpage.

Support for Research Data Management:

For information on research data management plans, processes, or best practices for your research program, please contact research.data@libanswers.ucalgary.com and/or visit https://libguides.ucalgary.ca/researchdatamanagement.

Support for 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 Erin.OToole@ucalgary.ca for more information.

RMS: Creating a Pre-Award LOI

RMS: Creating a Pre-Award Application