Harrington Discovery Institute

The ADDF-Harrington Scholar Program is designed to accelerate the translation of innovative research to prevent or treat Alzheimer's disease.

The ADDF-Harrington Scholar Program is a collaboration between the Alzheimer's Drug Discovery Foundation (ADDF) and Harrington Discovery Institute. The goal of developing new therapies will be achieved by providing award recipients with both research funding and committed project support by a team of pharmaceutical industry experts within the Harrington Discovery Institute Innovation Support Center. The Innovation Support Center's Advisory Panel is staffed by drug development experts who have held senior management positions in established pharmaceutical companies. They have significant experience in commercial drug development, have broad, established networks, and collectively span a wide range of knowledge in drug discovery and development.

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DEADLINES

Must be received by 11:59 pm ET on the deadline date.

Letter of Intent: May 25, 2018
Full Proposal: August 10, 2018

AWARD

Up to $300,000 per year for 2 years


Eligibility Criteria

  • Academic investigators at accredited medical centers, research institutions, and universities in the United States only are eligible to apply.
  • Lead investigator must have an MD and/or PhD or equivalent (e.g. PharmD, DVM).
  • Proposals must show potential to advance discovery into meaningful therapeutics designed to treat, prevent, slow, or cure people with Alzheimer's disease, other dementias, or cognitive decline associated with aging.
  • Team must possess intellectual property (IP) or have potential for new IP.

Funding Priorities

Novel targets are highly encouraged. Current target areas of interest include, but are not limited to:

  • Neuroprotection
  • Inflammation
  • Vascular function
  • Mitochondria & metabolic function
  • Proteostasis
  • ApoE
  • Epigenetics
  • Synaptic activity & neurotransmitters

The ADDF-Harrington Scholar Program does not support anti-amyloid (e.g., anti-amyloid aggregation, beta-amyloid vaccines, beta- or gamma-secretase inhibitors) or cholinesterase inhibitor approaches.

 

Drug Targets
Proposed molecular targets will be evaluated based on the strength of available evidence that links the target to the disease and demonstrates that target modulation will be disease-modifying. Examples of target criteria include:

  • Is there human genetic evidence linking the target to the disease?
  • Is the target expressed in disease-relevant regions of the brain (or where applicable, in the periphery) in humans and/or animal models?
  • Are there changes in target expression or activity in human disease specimens that correlate with disease severity and cognitive functions?
  • Does genetic and/or pharmacological manipulation of the target improve phenotype in disease-relevant in vitro (e.g. primary cultured neurons/glia or cells derived from patient iPSCs) or in vivo models?
  • Are there direct measures of target engagement that can be used experimentally and in humans?
  • How is the target unique or more compelling than other related targets that have been tested for the disease? In cases where there are already drugs targeting a specific receptor or pathway, what is the compelling case for a new approach to the target (e.g., positive allosteric modulator as opposed to full agonists, etc.)?
 

Stage of Discovery
The ADDF-Harrington Scholar Program aims to support hit-to-lead optimization through Investigational New Drug (IND)-enabling studies. Priority is given to novel programs that have:

  • Identified a lead molecule or chemical series of molecules with data on in vitro potency (including secondary screens in relevant cell models), selectivity, and toxicity
  • Assessed lead chemical structure of potential liabilities
  • Conducted in vitro ADME (absorption, distribution, metabolism, excretion) characterization (e.g. solubility, microsomal stability, Caco-2, MDCK, CYP profiling)
  • Possessed novel composition of matter IP

For in vivo efficacy studies, proposals should:

  • Demonstrate blood-brain barrier penetration in cases of CNS targets
  • Justify dosing regimen and route of administration with in vivo PK/PD data
  • Include measures of target engagement

The ADDF-Harrington Scholar Program does not support target discovery, assay development, or high throughput screening campaigns.


Submission and Selection Process

Review the Application Instructions for steps on applying.

In addition to the above criteria, projects will be assessed on:
• Quality of the science and the scientists
• Novelty and innovative quality of the work
• Potential for impact on human health


Confidentiality

Members of the ADDF and Harrington Discovery Institute review panels and Scientific Advisory Boards complete mutual Confidentiality & Disclosure Agreements to protect confidential applicant submissions.

Non-public applicant information is always kept confidential (and limited in distribution to the reviewers and Harrington Discovery Institute and ADDF administrative teams). The executive summary, project title, applicant's name, and institutional affiliation for those selected as ADDF-Harrington Scholars may be used by ADDF and Harrington Discovery Institute for publicity and marketing purposes (on the ADDF and Harrington Discovery Institute website, news releases, etc.) at ADDF's and Harrington Discovery Institute's sole discretion.


Sponsoring Institution Requirements

Investigators may apply from accredited academic medical centers, research institutions, or universities in the U.S.

Institutions must provide the necessary facilities and infrastructure for the research, and accept the conditions of the Award, including the Budget & Use of Funds. They must assure compliance with the prevailing national guidelines for animal and human studies and provide proper oversight of the Award funds.

Sponsoring institutions must safeguard the rights and welfare of individuals who participate as subjects in research activities by reviewing proposed activities through an Institutional Review Board (IRB) as specified by the U.S. Department of Health and Human Services Office for Human Research Protections (HHS OHRP). Additionally, the Grantee's institution must assure appropriate governance of animal studies. IRB approval and IACUC numbers are not required at the time of application, but must be provided for final signature of the Grant Agreement, which will be sent to Awardees shortly after they have been selected.

Additionally, sponsoring institutions must adhere to current U.S. Department of Health and Human Services guidelines regarding financial conflict of interest, recombinant DNA, research misconduct and vertebrate animals.


Annual Scientific Symposium

Part of Harrington Discovery Institute's mission is to build a broad connected community of scientists to promote interaction among awardees and other preeminent scientists. Each May in Cleveland, Ohio, Harrington Discovery Institute holds an annual symposium. All Harrington Scholars, including ADDF-Harrington Scholars, are required to attend during each year of the grant period and present their projects and updated progress. Expenses for travel and lodging will be provided by Harrington Discovery Institute subject to the terms of the Harrington Discovery Institute Grant Agreement.

It is anticipated that Award recipients will be notified in November 2018. The next symposium will be held May 22-23, 2019.


Use of Funds

Funds are provided as milestone-driven payments totaling up to $600,000 over a two year timeframe. Progress will be reviewed regularly by an oversight committee.

Applications and award budgets should be built around key milestones. Milestones are key points in a project that represent reliable, quantifiable indicators/deliverables of the project's progress and are used to make decisions on further progress. If an award is made, the Harrington Discovery Institute Innovation Support Center will work with recipients to help refine and manage the milestones.

The project must be structured to deliver a lead product with strong potential for clinical and commercial application.

Awards are conditional on:

  • Willingness to work collaboratively with the Harrington Discovery Institute Innovation Support Center staff
  • Timely submission of financial and progress reports
  • Participation in the Annual Scientific Symposium, organized by Harrington Discovery Institute in Cleveland, Ohio in May of each year

Continued support is dependent upon favorable scientific review of progress reports, milestones being met appropriately, and continued relevance of the work to the mission of the ADDF.


Intellectual Property

Harrington Discovery Institute and ADDF do not claim rights to patents on discoveries, copyrights, or trademarks to other intellectual property created as a result of work sponsored by ADDF-Harrington Scholar Awards ("Intellectual Property").

On all aspects of Intellectual Property, Principal Investigators are encouraged to confer with their technology transfer office and/or office of sponsored programs for guidance. Grantees should take measures to ensure protection of Intellectual Property when appropriate, and then are required to make prompt disclosure of discoveries to the public.


Project Administration

Grants are funded by the ADDF upon recommendation of the ADDF-Harrington Program Joint Steering Committee. Innovation Support Center support is provided and underwritten by the Harrington Discovery Institute. The ADDF-Harrington Scholar Program and its review panels and Scientific Advisory Board members do not assume responsibility for the conduct of the project or the acts of the Principal Investigator, since both are under direction and control of the Principal Investigator's institution and subject to the institution's medical and scientific policies.

The ADDF-Harrington Initiative reserves the right to refine and amend policies as required.

 

 

For program-related inquiries, please contact:
Lauren Friedman, PhD, Director, Scientific Affairs
lfriedman@alzdiscovery.org

Bronwyn J. Monroe, Director, Programs
bronwyn.monroe@harringtondiscovery.org
Website: www.harringtondiscovery.org/addf

For application submission inquiries, please contact:
Grants and Contracts Team
grants@alzdiscovery.org

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