Letter of Intent Due: August 15, 2014 by 11:59 PM Eastern Time
If LOI is accepted, Proposal is Due: September 30, 2014 by 11:59 PM Eastern Time
New Therapy Commercialization Grants Program
The Epilepsy Foundation - New Therapy Commercialization Grants Program supports the development of more effective therapies by serving as a catalyst for moving innovative therapies from the laboratory to the patient. Investigators must hold a relevant advanced degree (M.D., and/or Ph.D.), and have completed all research training. This call for proposals is open to investigators at corporations as well as the academic/university arena.
For the New Therapy–Commercialization Grants, the Epilepsy Foundation encourages 1:1 matching grants to academic and commercial entities to support the commercialization of novel approaches to the treatment of epilepsy. These matching funds seek to leverage other resources, and accelerate the pace of therapeutic advances. Preference will be given to proposals that already have a commercial partner engaged to assist with development and to proposals that have committed or matched funding from the sponsoring institution, commercial partner or other third party source. For the New Therapy Commercialization Grants, applicants must demonstrate background work beyond the basic science discovery stage.
Epilepsy Innovation Seal of Excellence
The Epilepsy Innovation Seal of Excellence award is similar to the Epilepsy Foundation - New Therapy Commercialization Grants (NTCG) Program above, designed to accelerate the advancement of research from the laboratory to the patient. SEALs are provided to academic and commercial groups worldwide. The program seeks to advance the development of new therapies including but not limited to medicines, biologics or devices. All proposals must demonstrate a clear path from the lab to the patient and are evaluated with consideration for their potential value to patients, likelihood of successful development including regulatory approval and the timeframe of development. Drug development may be stimulated at the early phases leading to an IND.
The Epilepsy Innovation Seal of Excellence award is not primarily a grant program. The program provides a competitive, in-depth review by the Scientific and Business Advisory Boards, an actual SEAL that may be used by the awardee to generate interest in the project, and a one-time $25,000 grant for the research. The SEAL is awarded for one year, renewable upon application, for up to a total of four years; the funding for this award is only provided for the first year. The applicants will typically have a research budget of between 1 and $5M for the overall project--amounts that currently exceed the resources of the Epilepsy Foundation. The Epilepsy Foundation will assist the awardees in finding funds for the selected projects.
For the Epilepsy Innovation Seal of Excellence award, the project will typically be in need of investment ranging between one and five million dollars—beyond the resources of the Epilepsy Foundation. Preference will be given to projects that are beyond the basic phase. Although a wide variety of projects may be supported, new drug projects may apply in the pre-IND stage.
We welcome a broad span of proposals from anywhere in the world
All proposals for both the New Therapy-Commercialization Grants and the Epilepsy Innovation Seal of Excellence award will be evaluated by our Business and Scientific Advisory Boards based on specific criteria:
Business Advisory Board criteria:
- Intellectual Property Strategy & Status; Freedom To Operate
- Can this Get to Patients: Investment Potential & Likelihood of Ongoing Funding Support
- Probability of Success / Time Factor
- Fit with Program Mission / Patient Impact
- Overall Impression
Scientific Advisory Board criteria:
- Quality of Science
- Probability of Successful Completion of Milestones / Outlined Program
- Timeframe of Success
- Fit with Program Mission / Impact on Patients
- Overall Impression
Contact Roger J. Porter, MD with scientific questions, email@example.com
LOI Content and Layout for New Proposals
- Title of proposed project (maximum 75 characters)
- Principal Investigator (name, title, affiliation, address, telephone, email address)
- Co-Investigators (names, titles, affiliations) (only key co-PIs)
- Anticipated total budget
- Brief summary of project goals and plans/approaches (not to exceed ½ page)
- Brief description of intellectual property position and potential for commercialization (one paragraph)
- Brief description of what is unique about the project, and how it compares to any competitor (2 sentences)
LOI Submission for Revised Proposals (resubmissions)
Items 5-7. Briefly explain changes from previous application that addresses key critiques.
Must not exceed 2 pages, inclusive of all information listed above (#5, #6, #7)
Minimum 10 point font
Convert LOI document to a PDF and then upload in proposalCENTRAL either for the grant or for the award.
Submit the completed LOI through proposalCENTRAL: https://proposalcentral.altum.com
Once there, click ‘Applicants: Click Here to Login, Register to Apply’, and setup an account.
Click on ‘Validate’ to make sure all required fields have been filled in Click on the ‘Submit’ link to submit LOI in proposalCENTRAL.
LOI Acceptance Notification
LOIs will be reviewed within approximately two weeks after the LOI submission deadline, at which time Principal Investigators / Contact People will be notified if the proposal is or is not considered suitable for a full review. LOIs considered suitable must be submitted as full proposals by September 30, 2014 (see grant instructions, following).
Do not exceed the specified number of pages for each section, inclusive of all information
Cover – Page 1
- Title of proposed project (maximum 1 line)
- Institutional approvals for work involving humans or animals (project number and date of approval)
- Principal Investigator (name, titles, affiliation, address, telephone, email address)
- Key Co-Investigators (names, titles, affiliations)
- Contact person if other than Principal Investigator (name, address, telephone, email address)
- Institutional officers (financial officer and grant administrators) responsible for the proposal and award
Summary Statement – Page 2 (maximum 1 page)
- What is unique and significant from a therapeutic perspective about the project, how will it lead to new treatments for epilepsy, and how it compares to any competitor
- What proof of principle or indication of efficacy and safety currently exist
- A project summary written in lay language for consumers (approximately 50 words)
Commercialization Potential – Page 3 (maximum 1 page)
- Description of intellectual property position
- Potential pathway for commercialization, including potential (contacted) or actual commercial partners
- Timeline for work proposed; estimated time to reach patients
Proposal (maximum 6 pages, including references)
- Background describing this approach to treatment (suggested limit of ½ page; omit the unmet need)
- Procedures (most important section: emphasize what will be done during the first year). Include Go / No Go decision points and milestones, and specific milestones. (Note: grant funding will be based on achieving milestones)
- Sample size (as needed) and statistical analysis plan
- References (limit to a few abbreviated, essential references)
Bio Sketches & Other Support
- Bio for Principal Investigators
- Other Support: Title, role in grant, percent effort, amount of funding and years of current and pending support for each grant (including SBIR, STTR, RAID). Include all non-governmental funding (e.g. CURE, Epilepsy Foundation, American Epilepsy Society, other foundations) for work related to this proposal (past, present, pending) and how this impacts IP.
- Detailed budget and justifications for 1st year (and 2nd year, if needed). There is no specific limit for budgets. Ask for what you need and justify, including funding from other sources.
- Funds may only be used for direct costs, except in cases where the investigator's academic institution will not allow the investigator to submit without overhead. In these cases, up to 10% overhead can be provided to the institution. Funds may NOT be allocated for travel, administrative purposes, or equipment. Salary for pre/post-doctoral trainees should be justified based on full-time work on this proposal.
- Must describe milestones for payments
- Include letters from key collaborators indicating the extent of their participation (no bio sketches). Specifying their planned contributions (list only investigators who will actively participate in the program, not merely mentor, advisor, or extra name). They should be uploaded in the 'Upload Attachments' section of proposalCENTRAL. proposalCENTRAL.
Supplementary materials are discouraged, but may be included as an Appendix, IF ESSENTIAL.
Note: Save and upload the Summary Statement, Commercialization Potential, Proposal, Bio Sketches and Collaborators Letters as PDF files in the 'Upload Attachments' section.
Revised Proposal Content (resubmissions)
Provide a response to the critiques received from the earlier submission (maximum 4 pages) (ask for extra space, if necessary).
Respond to questions, and provide additional information to support the resubmission.
List Go / No Go decision points and milestones.
Update the project summary written in lay language for consumers (approximately 50 words).
Update budget. (Note: Save and upload this resubmission as 'Resubmission Response' in a single PDF file in the 'Upload Attachments' section.)
Submit the completed proposal through: https://proposalcentral.altum.com either for the New Therapy-Commercialization Grants or for the Epilepsy Innovation Seal of Excellence award.
Click on 'Validate' to ensure all required fields have been completed and all required attachments have been uploaded.
Click on 'Submit'. You will receive an email confirmation for your proposal submission.
DEADLINE FOR WEB SUBMISSION OF PROPOSALS IS 11:59 PM EASTERN TIME, SEPTEMBER 30, 2014
In order to guarantee review, applications MUST BE RECEIVED by the deadline date. NO additional information for an application will be accepted after the due date including supplemental data.
Applicants are strongly encouraged to complete, review, and submit their applications with sufficient time to allow for technical difficulties, varying time zones, human error, loss of power/internet, sickness, travel, etc. Applicants may review their submissions for accuracy until the application submission deadline. Extensions to the application submission deadline will not be granted, with the rare exception made for severe extenuating circumstances.