CURE Epilepsy: Catalyst Award

Overview

CURE Epilepsy’s grant programs seek to accelerate promising research leading to new treatments and cures for people living with epilepsy. CURE Epilepsy prioritizes innovative projects that address our mission, affirming our core belief that the only acceptable final goal is “no seizures, no side effects.”

The CURE Epilepsy Catalyst Award supports nimble development of data necessary to advance ideas toward larger commercialization funding opportunities and is not intended to replace those opportunities.

Please refer to the Request for Proposals for an overview of the priority areas, application instructions, and FAQs.

Eligibility

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Application Details

CURE EPILEPSY CATALYST AWARD
CURE Epilepsy’s grant programs seek to accelerate promising research leading to new treatments and
cures for people living with epilepsy. CURE Epilepsy prioritizes innovative projects that address our
mission, affirming our core belief that the only acceptable final goal is “no seizures, no side effects.”
CURE Epilepsy: Our mission is to cure epilepsy, by promoting and funding
patient-focused research.
We identify and fund cutting-edge research that may lead to new approaches for curing epilepsy,
challenging scientists worldwide to collaborate and innovate in pursuit of this goal.
Our commitment is unrelenting.
We encourage applications from groups identified as nationally underrepresented in the biomedical
sciences. These groups include individuals with disabilities, veterans, persons from underrepresented
racial and ethnic groups and gender-diverse groups, women in biomedical-related disciplines, or any
other characteristic protected by federal, state, or local law.
Researchers outside the U.S. are encouraged to apply. U.S. citizenship is not required.
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CURE Epilepsy Catalyst Award Guidelines

TABLE OF CONTENTS
Priority Areas ......................................................................................................................................... 3
Eligibility Requirements ........................................................................................................................ 3
Award Timeline ..................................................................................................................................... 4
Budget ................................................................................................................................................... 4
Letter of Intent Instructions ............................................................................................................... 4-6
Formatting Guidelines ................................................................................................................ 5
proposalCENTRAL Instructions ................................................................................................... 5
Full Proposal Narrative Instructions .............................................................................................. 6 - 12
Formatting Guidelines ................................................................................................................ 8
Full Proposal Instructions for proposalCENTRAL ....................................................................... 9
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CURE Epilepsy Catalyst Award Guidelines

PRIORITY AREAS
CURE Epilepsy funds research that has the potential to truly transform and save lives. The purpose of
this funding opportunity is to stimulate and accelerate discovery and development of new,
transformative therapies for epilepsy, moving promising, well-supported preclinical and/or clinical
research closer to clinical application. The award is intended to support the nimble development of data
necessary to attract larger commercialization funding opportunities and is not intended to replace those
opportunities. Projects based on novel biological pathways and/or highly differentiated therapeutic
approaches which are likely to have a high probability of successfully transitioning to clinical
development are strongly encouraged. The award is not intended to fund basic research on the
mechanisms underlying epilepsy.
This funding mechanism prioritizes projects that advance research to clinical trial readiness. This
includes the development of biomarkers and optimization of promising new entities with established
proof-of-concept to improve pharmacokinetics/pharmacodynamics, safety profiles, and/or
formulations to advance these new entities further in development.
Prospective pilot clinical trials where limited testing of a novel intervention is needed to inform the
next step in translational research are encouraged. Projects adding critical data to ongoing or funded
clinical studies will also be considered, provided the request does not duplicate existing funding.
Proof-of-concept of the entity being developed is required. Proposals lacking proof-of-concept data
will not be evaluated.
Priority areas include:
 Innovative approaches to prevent, modify and/or arrest the development of acquired epilepsy.
 Development of novel approaches to prevent the onset or halt the progression of severe
pediatric epilepsies.
 New, effective treatments for the >30% of the epilepsy population who are pharmaco-resistant.
 Translational or clinical approaches aimed at normalizing sleep disturbances or circadian
rhythms to treat seizures.
 New approaches, biomarkers, or therapies to predict and/or prevent SUDEP.
ELIGIBILITY REQUIREMENTS
This award is available to independent researchers at or above the level of Assistant Professor (or
equivalent) at universities and non-academic research institutions, including small biotechnology
companies, who seek to develop new interventions for epilepsy. International applicants are welcome.
Postdoctoral fellows may not apply for this award. All materials must be submitted in English.
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CURE Epilepsy Catalyst Award Guidelines

AWARD TIMELINE
Activity Key Dates
Open call for Letters of Intent Tuesday, May 14, 2024
Letter of Intent deadline Tuesday, June 11, 2024, 9 PM ET
Full proposal invitations Friday, July 26, 2024
Full proposals due Wednesday, August 28, 2024, 9 PM ET
Anticipated awardee notification December 2024-January 2025
Anticipated award start date Spring 2025
BUDGET
Funding requests must be itemized and based on specific, milestone-based scientific aims. Requests
may be made for up to a maximum of $250,000 paid over 2 years. Awards of lesser amounts and
shorter duration that will accomplish key milestones needed for clinical advancement are strongly
encouraged. CURE Epilepsy reserves the right to fund only select specific aims or stage funding of
proposals based on achievement of milestones.
Budgets may include salary support for the Principal Investigator (PI), technical staff and/or co-PIs,
supplies, animal costs, vendor costs, limited equipment costs, and travel to an epilepsy-related
conference only if the PI is presenting his/her CURE Epilepsy-funded research. Indirect costs are not
supported.
LETTER OF INTENT INSTRUCTIONS (3-PAGE LIMIT)
All applicants must submit a Letter of Intent (LOI). The LOI should clearly and succinctly outline the
specific aims and include a brief description of the justification and research plan according to the
guidelines in this announcement.
Letter of Intent Instructions:
Below are instructions for the required scientific summary and future directions sections, which
together can be no longer than three pages in length. Proof-of-concept data demonstrating validity
and efficacy of the approach, biomarker, treatment entity or device are required. LOIs exceeding three
pages of text will not be reviewed.
1. Scientific Summary: Clearly and succinctly outline the milestone-based specific aims and
anticipated outcomes based on go/no-go criteria. Include a brief description of the proposed
research plan and how it aligns with the intent of this funding mechanism (1 ½-page maximum).
2. Proof-of-concept data: Data demonstrating a) the validity of the approach and b) preliminary
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CURE Epilepsy Catalyst Award Guidelines

data showing the value of the entity being developed must be presented. LOIs lacking this
information will not be considered.
3. Future Directions: Describe what next steps will be taken once the goals of your proposed
project have been achieved (1/2-page maximum). This must include clear steps to critical next
stages in the development process such as scale-up, engagement of a patient cohort and a
potential funding plan.
A few points to note:
 Lower scores will be given to proposals that are not milestone-based with stated go/no-go
criteria that are achievable within a 2-year timeframe.
 Graphs and charts are highly recommended.
 Literature references are not required at the LOI phase. However, if you decide to include
references, they do not count towards the page limit.
FORMATTING GUIDELINES
 Type font: 12-point.
 Type density: No more than 15 characters per inch (including spaces). For proportional spacing,
the average for any representative section of text should not exceed either 15 characters per
inch or 114 characters per line.
 Spacing: Single-spaced between lines of text, no more than five lines of type within a vertical
inch.
 Margins: Minimum of 0.5-inch top, bottom, right, and 1-inch left.
PROPOSAL CENTRAL INSTRUCTIONS
LOIs must be submitted through proposalCENTRAL (https://proposalcentral.altum.com). To begin an
application, applicants will need to create a professional profile, if one does not already exist.
Instructions for each section of the application in proposalCENTRAL:
1. Title Page: Enter the proposal title (maximum 150 characters, including spaces).
2. Download Templates and Instructions: Download guidelines and other available instructions (if
provided) as needed.
3. Enable Other Users to Access this Proposal: Use this optional section to grant access to a
collaborator or co-investigator.
4. Applicant/Principal Investigator (PI): This section should auto-populate from the applicant’s
professional profile. Double-check that the information is complete and correct. If it is not, click
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CURE Epilepsy Catalyst Award Guidelines

Edit Professional Profile to update the information. Indicate whether you are an early-career or
established investigator.
5. Institution and Contacts: Information should auto-populate from the applicant’s profile.
6. Co-Principal Investigator/Collaborators: Please enter information for any co-investigators or
collaborators, if applicable.
7. Keywords: Select at least 3 keywords from the list that best describe the specific focus of your
research proposal.
8. Current and Pending Support: List all current and pending support for you and any co-
investigators. Pending support includes any grant applications that you have submitted, but for
which decisions have not yet been communicated. Current and pending support is required for
the PI and co-PI but is not required for collaborators.
9. Upload Attachments: Once the LOI is finalized, attach it by uploading the PDF into this section of
proposalCENTRAL.
Biosketch for PI: Applicants may use NIH biosketch format if preferred over the provided
template. Please include a statement that clearly describes your interaction(s) with an
epilepsy-related patient community and how your proposed work will benefit them.
Optional
 Applicants are encouraged to provide statements regarding their commitment to fostering
diversity, equity, and inclusion in their research environment (100 words or less).
 Applicants may include within their biosketch a ½ page section describing any life events or
circumstances that contributed to delays or gaps in their career trajectory. This may include
information that may not otherwise be apparent to reviewers and can help provide context
as they evaluate your professional trajectory and achievements. Examples include but are
not limited to; being a member of a community underrepresented in biomedical research,
having experienced a life event that impacted career trajectory (such as parenthood, family,
or medical leave), COVID-19 pandemic-related effects, having a learning or other disability,
coming from a low-income family, and being the first in your family to go to college.
10. Validate: The system will check for required components that have not been completed.
Applicants will not be able to submit until all required components are completed.
11. Submit: Click Submit after your application has been successfully validated.
FULL PROPOSAL NARRATIVE INSTRUCTIONS (10-PAGE LIMIT*)
Invited applicants should submit full proposals and include the following in the proposal narrative:
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CURE Epilepsy Catalyst Award Guidelines

Specific Aims: Clearly state the specific aims that will be addressed by this work, e.g., improved
selectivity, specificity or pharmacokinetics of a new entity based on established proof-of-concept of an
existing entity, improved safety or formulation, validation of a biomarker that will enable clinical
testing, etc. Each specific aim should be associated with a clearly articulated, measurable milestone in
the development process and be defined by clear go/no-go criteria. Each aim and milestone must have
a clearly identified budget.
Background: Describe the project background including the biological rationale and patient population
for which the transformative research is intended. Describe how the proposed approach is significantly
different from existing approaches to treatment or will significantly enable treatment or prevention
strategies.
Preliminary Data: Provide preliminary data including but not limited to the following: potency,
selectivity, sensitivity, oral bioavailability, pharmacokinetics, efficacy against stated specific endpoints
or outcome measures, and/or preliminary safety/toxicology data that are available at the time of
submission.
Research and Development Plan: Describe the specific experiments that will be done to address each
specific scientific milestone including details of research design, methods, and endpoints in sufficient
detail for scientific peer review. Specifically:
 Describe the experimental paradigm including specific endpoints that will clearly differentiate
the new entity or therapeutic approach from existing approaches. Provide a justification for
those endpoints and describe how data will be collected and statistically analyzed. As
appropriate, provide key assay metrics that help establish go/no-go decision criteria, for
example, measures of assay sensitivity, specificity, and reproducibility. Include a power analysis
to demonstrate that sample size is appropriate.
 Articulate expected outcomes with outcome metric(s) and clear go/no-go criteria for each
milestone, how results will be interpreted, and note potential pitfalls.
 Describe key collaborations and expertise that will help ensure the appropriate advancement of
the work.
 Regardless of the stage of work, applicants must present a plan that describes availability of and
access to a suitable patient population that would support meaningful progression of the work.
Access to patients may be enabled through patient advocacy groups, specific clinical consortia,
inpatient populations, etc.
 If human subjects will be used, describe the plan for recruitment over the course of the study as
well as inclusion/exclusion criteria and the process for seeking informed consent. Identify all
study risks and safety measures that will be utilized to minimize risk to human subjects and
study personnel.
 Applicants must clearly describe the steps that will be taken to advance the intervention/
approach into the next stage of development including potential funding mechanisms following
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CURE Epilepsy Catalyst Award Guidelines

conclusion of the work proposed in this award. Strong consideration will be granted to
applicants who can provide specific regulatory milestones, e.g., submission of an application to
the FDA for obtaining Investigational New Drug (IND) approval and a feasible plan for achieving
milestones.
 If aspects of the project have been reviewed by another funding agency but not funded because
of articulated gaps in the research plan, applicants are encouraged to submit prior review
summary statements and describe how the revised proposed plan will address those gaps.
 CURE Epilepsy strongly encourages the use of Common Data Elements (CDEs) in your research.
Pre-clinical CDEs increase rigor, data standardization, and transparency across research studies.
Please include a statement in your grant application that depicts the incorporation of CDEs.
Guidance for Integration in Grant Proposals: Researchers are strongly urged to state in their
grant applications, where applicable, the procedure specific CDEs that will be used in their pre-
clinical studies. An example of the language is suggested below:
“Data collection for all in vivo experiments were captured using Case Report Forms (CRFs)
specific to each procedure. CDEs that will be used are listed and recorded as a supplemental
file”. This statement can be listed in the protocol section of your application. Files can be in .doc
or .xlsx format, or how the researcher sees most appropriate for their study. Data
standardization tools can be found here for the relevant pre-clinical CDEs.
(https://cureepilepsy.org/research-resources/).
Statement of Relevance to CURE Epilepsy’s Mission and the Intent of this Funding Mechanism: Include
one paragraph detailing how the proposed research addresses CURE Epilepsy’s goal of curing epilepsy
through transformative, clinically translatable research and/or clinical research.
References: Please list all literature cited within the proposal. References do not count toward the page
limit.
Proposals will be evaluated for innovation, feasibility, scientific merit, application to clinically relevant
steps of translational research and potential to be transformative.
*The 10-page limit of the Proposal Narrative is inclusive of figures, tables, graphs, photographs,
diagrams, chemical structures, pictures, pictorials, and other relevant information needed to judge the
proposal.
FORMATTING GUIDELINES
 Type font: 12-point.
 Type density: No more than 15 characters per inch (including spaces). For proportional spacing,
the average for any representative section of text should not exceed either 15 characters per
inch or 114 characters per line.
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CURE Epilepsy Catalyst Award Guidelines

 Spacing: Single-spaced between lines of text, no more than five lines of type within a vertical
inch.
 Margins: Minimum of 0.5-inch top, bottom, right, and 1-inch left.
FULL PROPOSAL INSTRUCTIONS FOR PROPOSAL CENTRAL
Full proposals must be submitted through proposalCENTRAL (https://proposalcentral.altum.com).
To access your application, log in to proposalCENTRAL and go to the Manage Proposals tab. Below are
instructions for each section of the online application:
1. Title Page: Enter proposal title (maximum 150 characters, including spaces).
2. Download Templates and Instructions: Access a copy of these guidelines and download a
biosketch template if you have not already completed one. Instructions on completing your
ORCID iD are also provided in this section.
3. Enable Other Users to Access this Proposal: Use this optional section to grant access to co-
investigators or collaborators, so they may review or enter information into the application.
4. Applicant/PI: This section should auto-populate from the professional profile. Double-check that
the information is complete and correct. If it is not, click Edit Professional Profile to update the
information. Indicate whether you are an early career or established investigator. CURE Epilepsy
now requires an ORCID iD with all full proposal submissions. If your ORCID iD is not already
provided on this page, enter your identifier in your Professional Profile by clicking Edit
Professional Profile. Detailed instructions may be accessed in Step 2 of the on-line application –
Download Templates and Instructions.
5. Institution and Contacts: Information should auto-populate from your profile.
6. Co-Principal Investigator/Collaborators: Enter contact information for co-PIs and/or
collaborators. Typically, Co-PIs are co-funded by the grant whereas collaborators are not.
7. Abstract and Keywords: Answer the questions in each box according to the instructions below:
a) Lay Summary: The lay summary will be reviewed by a person with lived experience of
epilepsy. Please take special care to describe the proposed work and its potential to
contribute to the development of a transformative therapy in language appropriate for a
non-scientific audience. Include the following:
i. Project Goals: Bulleted list of goal(s) for the project.
ii. Aims: Bulleted list of how those goals will be tested.
iii. Deliverables: Bulleted list of tangible deliverables to result from this work, if successful.
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CURE Epilepsy Catalyst Award Guidelines

iv. Impact: Briefly explain how the work, if successful, will contribute a new, transformative
treatment or prevention that improves the lives of those with or at risk for epilepsy. In
this section, you may also explain the next steps in your research plan once the goals of
your proposed project have been achieved.
b. Scientific Summary: Please provide a brief (250 word) scientific abstract of your project.
c. Keywords: Please select at least three and no more than seven keywords that are
appropriate to the proposed project. The keywords will be used to align proposals with
appropriate scientific peer reviewers.
8. Specific Aims and Milestones: Each specific aim should have a clearly defined outcome or
milestone. For example, a specific aim testing the efficacy of a novel therapy in-vivo might have
a milestone such as: Identify a novel compound that results in >50% seizure reduction in at least
40-60% of treated animals after 3 months of treatment. For each aim and associated milestone
enter a short and long description.
9. Aims and Milestones Schedule: Enter budget, start date, and end date for each specific aim and
associated milestone. Each specific aim should be associated with only one milestone. Do not
enter multiple milestones per specific aim. The dates for different milestones can be
overlapping.
10. Budget Period Detail: The maximum budget for this award is $250,000 US dollars (USD) over 2
years. Provide a detailed budget that is itemized and aligned with the specific aims and
milestones identified in the proposal. Enter the proposed start and end date for Period 1. Enter
funds for personnel costs using the template provided. For each personnel item entered,
indicate the milestone(s) that will be associated with that item. Click Save to save changes. The
system will automatically calculate total cost for the section. Next, enter non-personnel costs for
each category listed e.g., materials, supplies, travel, disposables, etc., using the template
provided. Vendor costs (if work will be sourced to a third party) can be included in the ‘Other
Expenses’ category. Leave category blank if no expenses exist for that category. For each item
entered, indicate the milestone that will be associated with that item. Please note that there is a
travel cap of $1,500 USD for international applicants and $1,000 USD for U.S. applicants per
year, which can be budgeted for a maximum of 2 investigators (the PI and Co-PI). Limited
equipment purchases that are required to complete goals will be considered but must be clearly
justified in the next section.
Repeat steps above for Period 2. The ‘copy Period 1 Forward’ tab allows you to copy expenses
entered in Period 1 into Period 2 and then edit as needed. Please note that indirect costs and
institutional overhead are not provided. Funds cannot be used to cover institutional expenses
such as network charges, computer maintenance and services, insurance dues or other
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CURE Epilepsy Catalyst Award Guidelines

miscellaneous expenses not directly related to performing the project. All expenses must be
converted to U.S. dollars (USD).
11. Budget Summary and Justification: Review the summarized budget to ensure that details have
been entered correctly. Provide a budget justification that clearly details how and where the
funds will be used and why these expenditures are critical to the success of the proposed
research.
12. Current and Pending Support: Enter all current and pending support for all PIs on the proposal.
Please indicate if there is any overlap with the proposed work.
13. Organization Assurances: Answer the questions regarding use of human subjects, animals,
recombinant DNA, and the possession of a Schedule 1 license should the work involve Schedule
1 substances.
14. Proposal Narrative and Other Attachments: Upload the following documents:
a) Proposal Narrative.
b) Facilities/Institutional Assurances (do not exceed ½ page): Provide a description of facilities
available at the institution(s) where the work will be performed. If an institution does not
have an official assurance document, please provide, in writing, assurances from the
department chairperson or practice colleagues confirming the applicant’s time, facilities,
and future position, if research is funded. Please submit facilities/institutional assurances for
each PI.
c) Biosketch for PI: Applicants may use NIH biosketch format if preferred over the provided
template. Please include a statement that clearly describes your interaction(s) with an
epilepsy-related patient community and how your proposed work will benefit them.
Optional
 Applicants are encouraged to provide statements regarding their commitment to
fostering diversity, equity, and inclusion in their research environment (100 words or
less).
 Applicants may include within their biosketch a ½ page section describing any life
events or circumstances that contributed to delays or gaps in their career trajectory.
This may include information that may not otherwise be apparent to reviewers and can
help provide context as they evaluate your professional trajectory and achievements.
Examples include but are not limited to; being a member of a community
underrepresented in biomedical research, having experienced a life event that
impacted career trajectory (such as parenthood, family, or medical leave), COVID-19
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CURE Epilepsy Catalyst Award Guidelines

pandemic-related effects, having a learning or other disability, coming from a low-
income family, and being the first in your family to go to college.
d) Co-Investigator Biosketch: Upload biosketch for each co-investigator, if applicable.
e) Collaborator Letters of Support: Upload letters from collaborators indicating their support of
the proposed work, if applicable.
f) Informed consent form: If a clinical trial is included as part of the research plan, the
applicant conducting the trial must provide a copy of the informed consent form used to
enroll subjects.
g) Timeline for execution of the studies: In a simple graphic, depict the timeline for
accomplishing each specific aim and milestone.
h) Signed signature pages: Upload signed signature pages, which are generated in Step 15 of
the application.
15. Validate: The system will check for required components that have not been completed. You will
not be able to submit until all required components are completed.
16. Signature Pages: Click Print Signature Page to obtain a PDF of the document that needs to be
signed by you (the submitting PI) and an institutional representative. After signatures have been
collected, scan and upload to Section 13.
17. Submit: Please make sure to Click Submit once your application has been validated by the
system.
Inquiries: Questions regarding these guidelines are welcome and should be directed to the Research
Team at Research@CUREepilepsy.org or 312-255-1801.
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CURE Epilepsy Catalyst Award Guidelines