Challenge <p>The SUDEP Institute Challenge: Developing Predictive Biomarkers of Epilepsy Seizures</p>

The SUDEP Institute Challenge: Developing Predictive Biomarkers of Epilepsy Seizures

Award:  $1,000,000 USD
Deadline: Oct 10 2020 23:59 EDT
Active Solvers: 259
Posted: Aug 08 2016
Challenge ID: 9933784
 
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Abstract

Nearly 3 million people in the United States and 65 million people worldwide have epilepsy, a neurological condition which affects the nervous system and causes seizures. One in 26 people will develop epilepsy at some point in their lifetime, with 150,000 new cases annually in the United States. Nearly 80% of the people with epilepsy live in low- and middle-income countries and three-quarters of these individuals do not get the treatment they need.

Among those living with epilepsy, nearly one-third have ongoing seizures despite existing therapies. Each year, more than 1 out of 1,000 people with epilepsy die from sudden unexpected death in epilepsy (SUDEP). If seizures are uncontrolled, the risk of SUDEP increases to more than 1 out of 150. SUDEP is the leading cause of death in young adults with uncontrolled seizures.

In order to accelerate the identification of effective treatments for SUDEP, the Epilepsy Foundation SUDEP Institute is sponsoring a Reduction to Practice Challenge to develop a predictive biomarker or panel of biomarkers to identify people at risk for SUDEP or seizures that compromise cardiac or respiratory function. The biomarker(s) must serve as an endpoint or surrogate endpoint that will drive human SUDEP interventions. For example, the biomarker(s) may identify a high risk patient group that could be used to test existing candidate interventions such as seizure detection devices.

Milestone 1 requires a detailed Project Plan of the proposed solution. Milestone 2 involves the production of proof-of-concept data. Milestone 3 requires results that demonstrate the predictive efficacy of the biomarker(s). The SUDEP Institute intends to make up to 10 awards from a total award pool of $100,000 for Milestone 1, up to 4 awards of $25,000 each for Milestone 2, and a final award at least $800,000 for successful completion of Milestone 3.

Solvers are encouraged to enter this Challenge even if they were not involved in The SUDEP Institute Challenge: Predictive Biomarkers of Epilepsy – Challenge 9933719. Participants from the previous Challenge may elect to expound upon their (winning) solution or pursue another idea. Solvers should note that the Center for SUDEP Research (CSR) is an NIH-funded research collaborative studying animal models of SUDEP and epilepsy patients who may be at high risk for SUDEP. Solvers may contact the CSR at info@sudepresearch.org to request data and/or biospecimens to be used in the execution of a Solution. Other resources that Solvers may access are through the North American SUDEP Registry and the Center for Disease Control and Prevention (CDC) Sudden Death in the Young Registry.

This is a Reduction to Practice Challenge that requires written documentation, experimental proof-of-concept data, and biomarker validation data.

Overview

Identifying biomarkers to predict SUDEP represents a major unmet medical need. Although there are several postulated causes of SUDEP, who is at risk of mortality from epilepsy and how to prevent it remains a mystery. Emerging research shows that SUDEP can be caused by physiological changes after seizures that depress brain activity and can impair respiratory and cardiac function. SUDEP usually occurs within an hour of one or more convulsive seizures.

There are few interventions that reliably predict and prevent SUDEP in people with epilepsy. Therefore, the Epilepsy Foundation SUDEP Institute desires the development of clinically relevant, specific and sensitive biomarkers of SUDEP and near-SUDEP to facilitate the development of a therapeutic intervention for people at high risk. Biomarkers may be genetic, structural, metabolic, physiological, or another modality. An ideal biomarker or biomarker panel will be easily and safely measured, cost-efficient to detect, modifiable with intervention, and consistently associated with SUDEP or near-SUDEP and will drive human SUDEP interventions. The Epilepsy Foundation SUDEP Institute recognizes that the severity and frequency of seizures (particularly convulsive seizures) is currently the leading risk factor for SUDEP, therefore a biomarker or biomarker panel that can be predictive of seizures that compromise cardiac or respiratory function will also be considered.  

Solvers are requested to develop clinically relevant, specific and sensitive biomarkers of SUDEP or near-SUDEP, with a specific focus on the types of seizure preceding SUDEP, particularly those that compromise cardiac or respiratory function. The proposed research may be based on their (winning) solution to The SUDEP Institute Challenge: Predictive Biomarkers of Epilepsy – Challenge 9933719 or may be another idea altogether. Participation in Challenge 9933719 is not a prerequisite. A submission to this new Challenge should include the following:

  1. Milestone 1 – The detailed Project Plan explaining the methods, materials, personnel, resources, schedule, capability to generate data, and potential limitations to completing Milestones 2 & 3. The Project Plan must be received by 11:59 PM (US Eastern Time) on October 10, 2016.
  2. Milestone 2 – Following guidance from the Seeker, Solvers will be required to submit proof-of-concept test in vitro and/or in vivo data by 11:59 PM (US Eastern Time) on October 10, 2017.
  3. Milestone 3 – Solvers must document their progress with quarterly reports. Final validation data of the predictive biomarker in vivo must be received by 11:59 PM (US Eastern Time) on October 10, 2020. Milestone 3 submissions will be reviewed as they are received and, at the discretion of the Seeker, the first submission which meets all of the Challenge criteria will be awarded the prize.

Solvers should note that the Center for SUDEP Research (CSR) is an NIH-funded research collaborative studying animal models of SUDEP and epilepsy patients who may be at high risk for SUDEP. Solvers may contact the CSR at info@sudepresearch.org to request data and/or biospecimens to be used in the execution of a Solution.

Awards are contingent upon theoretical evaluation of the Project Plan (Milestone 1), review of the proof-of-concept data (Milestone 2), and experimental confirmation of the results (Milestone 3).

To receive an award, the Solvers will not be required to transfer their exclusive IP rights to the Seeker. Instead, Solvers will grant to the Seeker a non-exclusive license to practice their solutions.

Submissions to this Challenge must be received by 11:59 PM (US Eastern Time) on October 10, 2020. Late submissions will not be considered.

ABOUT THE SEEKER

This challenge is driven by the Epilepsy Foundation SUDEP Institute. The mission of the Epilepsy Foundation is to stop seizures and sudden unexpected death in epilepsy (SUDEP), find a cure, and overcome the challenges created by epilepsy through efforts including education, advocacy, and research to accelerate ideas into therapies. 

The Epilepsy Foundation, a national non-profit with more than 50 affiliated organizations throughout the United States, has led the fight against epilepsy since 1968. The Foundation is an unwavering ally for individuals and families impacted by epilepsy and seizures. The Foundation works to prevent, control, and cure epilepsy through community services; public education; federal and local advocacy; and supporting research into new treatments and therapies. The Foundation works to ensure that people with epilepsy have the opportunity to live to their fullest potential. 

The SUDEP Institute is an initiative led by the Epilepsy Foundation that carries out SUDEP education and awareness programs for people affected by epilepsy and medical professionals; drives and supports research into the causes of and ways to prevent SUDEP; offers a support network providing counseling, community, and resources for individuals and families affected by SUDEP; and works together with many epilepsy organizations to find answers to SUDEP. 

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