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Grants to USA, Canada, and International Research and Development
Companies to Develop New Drugs for Individuals with Genetic Diseases

Therapeutics Development Award Program (TDA)

Agency Type:

Foundation / Corporation

Funding Source:

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Cystic Fibrosis Foundation (CFF)

Deadline Date:

10/31/21 5:00 PM (EST)

Description:

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Grants to USA, Canada, and International research and development companies to develop therapies for genetic diseases. Grant funds may be used to support early discovery, exploratory, and preclinical development studies as well as more advanced programs that are moving into investigational new drug enabling studies. Funding is intended to stimulate and de-risk drug development of novel therapies for cystic fibrosis.

The mission of the Cystic Fibrosis Foundation is to cure cystic fibrosis and to provide all people with CF the opportunity to lead long, fulfilling lives by funding research and drug development, partnering with the CF community, and advancing high-quality, specialized care. In an effort to stimulate the development of new pharmaceutical products for the benefit of persons with CF, CFF developed the "Therapeutics Development Award” Program. The purpose of this program is to provide funds to companies for the development of commercial products to benefit individuals with CF. 

Applications will be considered in any therapeutic area that could benefit people with CF but are particularly encouraged in areas related to treating CF infections, CFTR modulation, mucus clearance (mucolytics and airway surface hydration), inflammation, chronic lung allograft dysfunction, CF-related diabetes, CF liver disease, and nutrition. 

The TDA program provides two mechanisms of support:

  • Component I awards provide funds for early exploratory, discovery, and/or preclinical development studies. 
  • Component II awards are considered for more advanced programs that generally have identified a clinical candidate and are moving into investigational new drug (IND)-enabling studies such as PK/PD, GLP toxicology, and Phase 1/2 clinical trials in CF patients.

Awards will be made for either discovery (against certain CF airway pathogens) or preclinical and initial clinical development activities (all therapeutic areas relevant to CF).

Goals of Research Currently of Interest to CFF/Priority Areas:

Extensive survey input from the CF community (people with CF, family members, caregivers and key opinion leaders) have identified key research Areas of Encouragement that are most important to them. The areas selected by the CF community are listed below in order of prioritization. Applications may address any topic area advancing CF care, treatment, or research. However, applications addressing the following areas are particularly encouraged:

  1. Respiratory microorganism Treatment
  2. Inflammation
  3. Mucociliary clearance
  4. Gastrointestinal symptoms (including, but not limited to, GERD, DIOS, and pancreatitis)
  5. CF-related Diabetes
  6. CF-related Liver Disease (including cirrhosis and non-cirrhosis, gall stones, hepatic steatosis, and other clinical manifestations of portal hypertension)
  7. Diet and Nutrition

GrantWatch ID#:

GrantWatch ID#: 192741

Estimated Size of Grant:

Funding for Component I is for up to US $600,000 while Component II is in the range of US $3,000,000 to US $5,000,000.

Term of Contract:

Funding for Component I and Component II is for over no more than a three (3) year period.

Additional Eligibility Criteria:

Both U.S.-based and non-U.S. based (i.e. international) companies engaged in research and development are welcome to apply.

For more information, see https://www.cff.org/Research/Researcher-Resources/Awards-and-Grants/Research-Awards/TDA-Policies-and-Guidelines.pdf#page=3.

Generally, Foundation support may not be used for manufacturing and controls (CMC production), to conduct clinical trials in only healthy human subjects, or to support senior personnel engaged in administrative roles without specific approval by the Foundation.

CFF support may not be used for API manufacture or other chemistry, manufacturing and controls activities, clinical trials involving healthy human subjects, support of senior company personnel engaged in administrative roles or Phase III multi-center clinical trials.

Pre-Application Information:

Both LOI and full submissions are accepted throughout the calendar year, although it is highly unlikely that submissions not received by October 31 will be funded in that calendar year.

Key Dates:
- Published: February 24, 2021
- LOI Submission Deadline: Rolling
- LOI Applicant Notified: Ad-hoc basis
- Full Application Deadline: Rolling
- Committee Review Date: Ad-hoc basis
- Notification to Applicants: Ad-hoc basis
- Project Start Date: As agreed upon

CFF requires that investigators who seek support through TDA applications submit a Letter of Intent (LOI) in advance of a full funding application A Letter of Intent (LOI) must be submitted and approved prior to submitting a Full Application.

CFF will notify applicants once a funding decision has been made [with a goal of within four (4) months after receiving a full funding application]. Applications received in October or later are unlikely to obtain approval within the same calendar year.

To be funded through this mechanism, organizations are expected to provide internal funds that at least match the level of CF Foundation support.

Contact Information:

Before starting your grant application, please review the funding source's website listed below for updates/changes/addendums/conferences/LOIs.

Applicants are to submit LOIs and full applications online at proposalCENTRAL: https://awards.cff.org./s_Login.jsp?_ga=2.17009273.1781988843.1630328198-14618030.1630328198

For program/content information:
Lindsey Beaman lbeaman@cff.org or 240-200-3780
Maria Wang mwang@cff.org or 240-200-3777

For technical support with the online application:
Primary CFF Grants and Contracts contact mromeo@cff.org or 301-841-2614
Secondary CFF Grants and Contracts contact nmohaghegh@cff.org or 301-841-2614

URL for Full Text (RFP):

Geographic Focus:

USA: Alabama;   Alaska;   Arizona;   Arkansas;   California;   Colorado;   Connecticut;   Delaware;   Florida;   Georgia;   Hawaii;   Idaho;   Illinois;   Indiana;   Iowa;   Kansas;   Kentucky;   Louisiana;   Maine;   Maryland;   Massachusetts;   Michigan;   Minnesota;   Mississippi;   Missouri;   Montana;   Nebraska;   Nevada;   New Hampshire;   New Jersey;   New Mexico;   New York City;   New York;   North Carolina;   North Dakota;   Ohio;   Oklahoma;   Oregon;   Pennsylvania;   Rhode Island;   South Carolina;   South Dakota;   Tennessee;   Texas;   Utah;   Vermont;   Virginia;   Washington, DC;   Washington;   West Virginia;   Wisconsin;   Wyoming

USA Territories: American Samoa (USA)   Guam (USA)   Puerto Rico (USA)   Virgin Islands (USA)   Northern Mariana Islands (USA)

USA Compact Free Associations: The Federated States of Micronesia (USA)   Marshall Islands (USA)   Republic of Palau (USA)

Canada: Alberta;   British Columbia;   Manitoba;   New Brunswick;   Newfoundland and Labrador;   Northwest Territories;   Nova Scotia;   Nunavut;   Ontario;   Prince Edward Island;   Quebec;   Saskatchewan;   Yukon;

Israel

International country outside of the USA, Israel and Canada.

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