75N95022R00005 ETSP Pre Solicitation Notice SAM.pdf

THIS IS NOT A REQUEST FOR PROPOSALS (RFP). THIS IS A PRE-SOLICITATION

ANNOUNCEMENT ONLY. A REQUEST FOR PROPOSALS WILL BE ISSUED VIA

SAM.GOV ON OR ABOUT 15 DAYS FROM THE DATE OF THIS ANNOUNCMENT

(ON OR ABOUT NOVEMBER 2021).

FULL TITLE: "Screening of Investigational Compounds to Treat, Modify or Prevent Epilepsy for the NINDS Epilepsy Therapy Screening Program (ETSP)"

The 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. Since its inception, the program has been supported through contracts to the University of Utah. 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 acute and chronic animal (rodent) 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 provides advice on future steps for promising compounds, while protecting confidentiality and intellectual property. Approximately, 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 program is routinely reviewed, most recently in 2020, by Working Groups commissioned by the National Advisory Neurological Disorders and Stroke (NANDS) Council. The 2011 and 2014 Working Group reviews recommended prioritizing treatments for drug resistant epilepsy and disease prevention and modification (anti-epileptogenesis) over the identification of additional undifferentiated anti-seizure drugs.

The new name of the program given in 2015 emphasizes that a major focus is going beyond the symptomatic treatment of seizures to identifying agents that have the potential to prevent seizure development or disease progression. Additional details on the reports containing the Working Group’s recommendations are available for review at https://www.ninds.nih.gov/Current-Research/Focus-Research/Focus-Epilepsy/ETSP.

The envisioned contract award is a re-competition/follow-on requirement to the current NINDS ETSP requirement currently being performed under NINDS contract https://www.ninds.nih.gov/Current-Research/Focus-Research/Focus-Epilepsy/ETSP

HHSN271201600048C at the University of Utah, where the requirement has been performed since the inception of this program in 1975.

The Contractor during the performance period of the contract shall perform various preclinical pharmacological evaluations of potential therapeutic agents (small molecules, natural products, synthetic peptides, biologics and referred to hereafter as ETSP “investigational compounds”) for the treatment of epilepsy and conduct supporting pharmacokinetic studies using normal and epileptic animals. On an “as needed” basis, Contractor shall also adapt, develop, validate, and implement new models to support the ETSP mission. This contract shall require the Contractor to conduct studies evaluating investigational compounds in the following performance areas: 1) established workflow for drug resistant epilepsy, 2) models of disease prevention and modification (anti-epileptogenesis), and 3) Pharmacokinetic studies. In addition, the Contractor shall be required to perform ancillary studies and optional tasks to support the evolving requirements of the ETSP. Please refer to the NINDS Public Access to Neuroactive & Anticonvulsant Chemical Evaluations (PANAChE) public website (https://panache.ninds.nih.gov) for a more detailed description of the ETSP, screening workflow for drug resistant epilepsy and for current animal models and test protocols used by the program.

It is anticipated that one award will be made for a base 9-month term, plus four (4) successive 12-month Term Option periods, and (1) 3-month transition-out option, for a total potential performance period of 5 years.

Subject solicitation will be issued on the basis of full and open competition whereby all responsible sources may submit a proposal which shall be considered by the agency.

The RFP will be made available electronically, on or about 15 days from the date of this announcement (on or about November 2021) via the SAM.GOV website https://www.sam.gov. Offerors are responsible for routinely checking the SAM.GOV website for any possible solicitation amendments that may be issued.