The Department of Health and Human Services, National Institutes for Health, National Institute of Neurological Disorders, and Stroke has a continuing requirement for Epilepsy Therapy Screening Program.

The National Institute of Neurological Disorders and Stroke (NINDS)  Epilepsy Therapy Screening Program (ETSP), until recently known as the Anticonvulsant Screening Program (ASP), was established in 1975 to address a critical need for new anti-seizure medications and to promote industry interest in their development. The screening process involves researchers from academia and industry in the U.S. and abroad (“ETSP participants”) submitting compounds to the ETSP for investigation in a series of animal (rodent) acute and chronic seizure models. These tests are performed blinded by the contract laboratory and on a confidential basis through a written agreement between the NINDS and the ETSP participant at no cost to the ETSP participant.  The NINDS ETSP program office reports test results to participants and provide advice on future steps for promising compounds while protecting confidentiality and intellectual property.  Over 32,000 compounds have been screened to date, and the ETSP has contributed to bringing 11 anti-seizure drugs to market since 1990, with a major role in some and a minor role in others.

The ETSP was reviewed by Working Groups commissioned by the National Advisory Neurological Disorders and Stroke (NANDS) Council in 2011, 2014, and most recently in 2020.   The Working Groups’ recommendations were consistent in each review in favor of prioritizing the identification of treatments for drug-resistant epilepsy, epileptogenesis, and disease modification over the identification of additional undifferentiated anti-seizure drugs.  The new name of the program (ETSP) is meant to emphasize that a major focus is going beyond the symptomatic treatment of seizures to identifying agents that have the potential to prevent their development.  Additional details on the reports containing the Working Groups’ recommendations are available for review at https://www.ninds.nih.gov/Current-Research/Focus-Research/Focus-Epilepsy/ETSP.

• The Contractor during the performance period of the contract shall perform various preclinical pharmacological evaluations of potential new therapeutic agents for the treatment of epilepsy and related disorders using human-focused assays, in vivo tests and in vitro assays. In addition, the Contractor shall conduct supporting pharmacokinetic studies. On an “as needed” basis, Contractor shall also adapt, develop, validate, and implement new testing approaches, including human-based research approaches such as organoids, iPSCs, or human brain slices to support the ETSP mission.