The ALS Association

RELEASE DATE: February 12, 2016

Translational Research Advancing Therapy for ALS (TREAT ALS™) Drug Development Contract

Deadline for submission of Letter of Intent: March 21, 2016

PROGRAM RECEIPT DATES:

Letter of Intent- March 21, 2016
Request to submit full application- April 12, 2016
Submission of full application- May 16, 2016
Notification of award- July 2016
Funding commences on receipt of all relevant signatures.

E-mail researchgrants@alsa-national.org for queries.

Program Description

There is currently one FDA-approved drug for the treatment of Amyotrophic Lateral Sclerosis (ALS), riluzole (Rilutek), improving survival by two to three months. Other treatments are available that relieve the symptoms associated with ALS and improve the quality of life for patients living with the disease by providing comfort to the patient. However, there is an urgent need for improved therapies. With the recent progress in understanding ALS, the increased effort to develop tools to identify novel treatments for the disease and advances in technology, the opportunity to discover improved treatments for ALS could not be better. The ALS Association’s TREAT ALS™ program funds research from early target identification to preclinical research and early pilot clinical trials. As part of the program, The Association is requesting letters of intent for its drug development contract program, milestone driven research to develop new treatments for ALS. The program compliments the Department of Defense ALS research program and the translational programs at the National Institutes of Health.

Contract Information

The Drug Development for ALS Contract Program supports the preclinical assessment of therapeutics for ALS. The proposed studies are expected to be product-driven and focused on therapeutics. It is anticipated that the agents and/or data generated from these awards will lead to the advancement of new therapies for ALS. The program is designed to support preclinical testing and development of therapeutics for ALS. Applications must include preliminary data relevant to the phase(s) of the preclinical development process covered by the proposed research. Applicants must clearly and explicitly articulate what impact the project may have on therapeutic development for ALS. Clinical trials will not be supported with this funding opportunity.

The contracts are limited to the areas of programmatic interest listed below. Applications must focus on one or more of these areas to be considered for funding. Applications that do not focus on at least one of the following areas will be administratively withdrawn. Preliminary data supporting the choice of target for drug development for ALS must be provided both in the letter of intent and the full application. Priority is given to applications focused on developing compounds directed towards the most attractive targets for ALS with significant data to support the relevance of the chosen target for ALS therapy. Industry partnerships are encouraged.

  • Testing of compounds in mouse models of ALS. (NOTE: Design of mouse model study and approaches to measure target engagement will be critically assessed and relevant details must be included in the letter of intent. Additional studies in human tissue and/or IPS lines are encouraged to strengthen mouse data). High throughput screening efforts will NOT be supported through this mechanism.
  • Development of pharmacologic agents through Adsorption, Distribution, Metabolism, Excretion, and Toxicity (ADMET) phase. This can be performed by a contract research organization in collaboration with the PI
  • Design and implementation of full-scale, pilot current Good Manufacturing Practice (cGMP) production of therapeutics and/or delivery systems for use in advanced preclinical and initial clinical trials;
  • Development of pharmacologic agents to the Investigational New Drug (IND) stage in order to initiate Phase I clinical trials after the award’s completion.

The preclinical drug development process may require resources beyond those available at a single organization. Therefore, the contracts are open to investigators participating in synergistic collaborations focused on testing and developing lead agents for the treatment of ALS. Collaborations should be dedicated to a single, synergistic preclinical development project or study rather than an additive set of subprojects (i.e., the combined efforts of the collaboration must provide greater benefit than the sum of individual research initiatives). If a collaboration is proposed, letters confirming/supporting the collaboration are required. If the collaboration is multi-organizational, participating organizations will ensure the success of the collaboration by resolving potential intellectual and material property issues and by removing organizational barriers that might interfere with achieving high levels of cooperation. Biotechnology or pharmaceutical companies are encouraged to apply. Whether a biotechnology or pharmaceutical company applies for this mechanism as an individual applicant or as part of a collaboration, the company is expected to leverage its own resources to complement the funding provided by this contract.

Funding

  • The maximum period of performance is 2 years.
  • The maximum allowable cost for the entire period of performance is $500,000. The association will provide a maximum of 10% indirect costs however this must be included in the maximum allowable budget.
  • More cost-effective studies that do not request the full available funding amount are encouraged. The applicant may request the entire maximum funding amount for a project that may have a period of performance less than the maximum 2 years. (time-lines must be clearly described with go/no go milestones)
  • Regardless of the period of performance proposed, the applicant may not exceed the maximum allowable costs.
  • Travel costs of up to $1,500 per year to attend scientific/technical meetings are allowed
  • Salary for PI will not be supported.

Payment structure is based on achievement of milestones which will be finalized jointly with the investigators and the scientific advisory board if the study is approved for funding.

Letter of Intent

Download here: http://www.alsa.org/assets/pdfs/drug-development-contract-letter-of-intent-form-021216.doc

Due Date: March 21, 2016

E-mail LOI to researchgrants@alsa-national.org

Review Criteria for letter of intent.

  1. Scientific merit: Priority of therapeutic target as compared with other proposals. Design of mouse study
  2. Research Strategy and Objectives: How the scientific rationale supports the project objectives and feasibility.
  3. Impact: How the project will make an important contribution to ALS therapeutic development.
  4. Personnel: How the qualifications of the PI and key personnel are appropriate to perform the proposed research project.
  5. Consultants and Collaborators: How the overall collaboration will be most effective at achieving milestones and progressing the therapeutic towards clinical trials.
  6. Industry partner will be favorably reviewed.
  7. Timeline for development of therapeutic to be ready for phase I clinical trial.

Notification of Pre-Application Screening Results: April 12, 2016

Following the pre-application screening, PIs will be notified as to whether or not they are invited to submit an application; however, they will not receive feedback (e.g., a critique of strengths and weaknesses) on their pre-application.

Full Application due May 16, 2016

Powered by Blackbaud
nonprofit software