Screening of Investigational Agents through the "NINDS Preclinical Screening Platform for Pain" (PSPP)

THIS IS NOT A REQUEST FOR PROPOSALS (RFP). THIS IS A PRE-SOLICITATION ANNOUNCEMENT ONLY. A REQUEST FOR PROPOSALS (RFP) NUMBER NIH-NINDS-75N95019R00027, ENTITLED: "Screening of Investigational Agents through the NINDS PRECLINICAL SCREENING PLATFORM FOR PAIN (PSPP)" WILL BE ISSUED VIA FEDBIZOPPS ON OR ABOUT February 14, 2019. The National Institutes of Neurological Disorders and Stroke (NINDS) is establishing the Preclinical Screening Platform for Pain (PSPP) in response to the National Institutes of Health (NIH) Helping to End Addiction Long-term (HEAL) initiative. The HEAL initiative (https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative) is a trans-NIH effort to fast-track basic, translational, and clinical research in the field of addiction and pain to address the national opioid crisis. The goal of the PSPP is to foster the development of opioid alternatives to treat all types of pain conditions. As part of this HEAL Initiative, the PSPP will provide pain researchers from the academic and industry community with a centralized resource for testing compounds, biologics, natural products, and devices for their potential as opioid alternatives. Contributors with a promising non-addictive therapeutic for pain (Contributors) will be invited to submit bioactive investigational agents to the PSPP for testing. These investigational agents will be evaluated to determine if they are non-opiate, metabolically stable compounds that show promise in established and newly developed models of pain. The Contractor shall provide screening of potentially viable investigational agents submitted through the PSPP. NINDS will send investigational agents to the Contractor in a blinded fashion (without structures), and the Contractor shall perform progressive testing funnel established in collaboration with NINDS staff and the External Consultants Board for the PSPP (ECB.) The testing will include in-vitro evaluation, including opioid receptor activity, followed by testing in a series of acute and chronic pain models. Selected testing models of tolerability and/or side effect liability shall also be performed to determine therapeutic index. Additional testing in models of abuse liability shall also be investigated to evaluate the test agents for addictive potential. The Contractor shall provide resources and expertise in not only the execution of existing models available in the labs presently but also in establishing new in-vivo pain models to create a standardized panel of preclinical pain models and behavioral tests that shall be used to evaluate potential efficacy as well as the side effects and abuse liability of Contributor-submitted investigational agents. The Contractor shall evaluate the efficacy, pharmacokinetics, side effects and abuse liability of new investigational agents, perform in-vitro pharmacological profiling and determine target selectivity, execute formulation research studies and establish Absorption, Distribution, Metabolism and Excretion (ADME) profiles of candidate agents submitted to the NINDS by Contributors. The Contractor in their own facilities or through subcontractors shall also provide the complete array of in-vitro and in-vivo assays to evaluate the potential side effects (in-vitro and in-vivo), drug abuse liability, in-vitro pharmacological profiling and target selectivity, ADME (in-vitro and in-vivo) profiling, formulation research studies and pharmacokinetic studies of the investigational agents. The goal of the NIH programs served by this contract is to bring new drugs to the market. To this end, the NIH has been granted a Determination of Exceptional Circumstances (DEC) to the Federal Acquisition Regulation (FAR) for this contract. The DEC enables the Contributors to retain control of the intellectual property for investigational agents evaluated through the PSPP. The Contractor shall be required to demonstrate a platform of a wide-range of established and validated models of pain conditions and in-house expertise for testing new investigational agents and devices in models of pain conditions. The Contractor shall provide a platform of in-vivo testing in models to cover the broad spectrum of pain conditions to measure efficacy, abuse liability and sensory or motor side effects of investigational agents (small molecules, biologics, natural products, and devices). The Contractor shall also demonstrate capabilities in the areas of supportive in-vitro pharmacological screening against opioid receptors and other molecular targets associated with off-target effects, ADME profiling, formulation research and pharmacokinetic and bioanalytical studies (in animal model species) in establish exposures in the proposed efficacy studies. Evaluation of new investigational agents will be conducted under the following three performance areas: 1) In-vivo testing in pain conditions, abuse liability and side effects assessment models including supporting studies or establishing new pain-related models to support the evolving requirements of the PSPP as needed; 2) In-vitro pharmacological profiling against opioid receptors and/or other molecular target(s) of safety; and 3) ADME and formulation studies as well as pharmacokinetic (PK) assessment and bioanalytical testing of samples. Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities, not otherwise provided by the Government, as needed, to conduct services in the following Performance Areas. Performance Area 1: In-vivo testing in pain conditions, abuse liability and side effects models Performance Area 2: In-vitro pharmacological profiling Performance Area 3: ADME and formulation studies as well as PK assessment and bioanalytical testing of samples The NINDS anticipates awarding one (1) Indefinite Delivery Indefinite Quantity (IDIQ) type contract under this program with a five-year ordering period to allow for the issuance of level of effort and completion type cost-reimbursement task orders. It is also anticipated that the IDIQ award will be made in the fourth quarter of Fiscal Year 2019. Offerors are required to be registered in the System for Award Management (SAM) when submitting an offer or quotation, and shall continue to be registered until time of award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from a solicitation. Processing time should be taken into consideration when registering. Offerors who are not registered in SAM should consider applying for registration immediately upon receipt of this pre-solicitation. See FAR 52.204-7 System for Award Management (Oct 2018) and https://www.sam.gov for information on registration. This is NOT a Request for Proposals (RFP). Request for Proposals (RFP) No. NIH-NINDS-75N95019R00027 will be available electronically and may be accessed through the FedBizOpps (URL: http://www.fedbizopps.gov) 15 or more calendar days after the issuance of this synopsis. THIS SOLICITATION WILL BE AVAILABLE ELECTRONICALLY ONLY. OFFERORS ARE RESPONSIBLE FOR ROUTINELY CHECKING THE FEDBIZOPPS WEBSITE FOR ANY POSSIBLE SOLICITATION AMENDMENTS THAT MAY BE ISSUED. NO INDIVIDUAL NOTIFICATION OF ANY AMENDMENTS WILL BE PROVIDED. All responsible sources may submit a proposal, which shall be considered by the agency.