United States - Manufacturing and Nonclinical Studies Support for the Development of Therapeutic Biotechnology Products (Biologics) for Neurological related Disorders

Description

The National Institutes of Neurological Disorders and Stroke (NINDS) has a need for current Good Manufacturing Practices (cGMP) manufacturing and Good Laboratory Practice (GLP) nonclinical (preclinical) support services to support translational development of therapeutic biotechnology products (Biologics) for National Institutes of Health (NIH) drug discovery and development programs. To that end, several NIH programs are being implemented or expanded to provide support for academic and industry investigators developing medical interventions for neurological disorders.
This requirement supports the NIH biologics development projects for the NIH Blueprint Neurotherapeutics Network Biologics (BPN-Biologics) program, the NINDS Ultra-Rare Gene Therapy (URGenT) program, the Helping to End Addiction Long-term Pain Therapeutics Development Program (HEAL-PTDP), as well as other extramural or intramural NIH drug discovery and development programs.
The Contractor shall provide support for both Biologics current good manufacturing practices (cGMP) manufacturing and GLP nonclinical services, including execution of the studies and completing study reports and documentation that will enable regulatory filing and evaluation of biological therapeutics in clinical trials for NIH drug development programs. These services may be provided through a combination of internally executed studies and subcontracted work. Throughout the contract ordering period and awarded task order (TO) periods of performance, the Contractor must maintain the technical capabilities, subcontractor network, minimum resources and organizational compliances with which to successfully perform the range of activities under both Task Area 1: Manufacturing and Task Area 2: Nonclinical Studies. Additionally, unless otherwise requested, any assigned research must be performed in compliance with all current Food and Drug Administration (FDA), and International Committee on Harmonization (ICH) policies, practices, procedures, guidelines and regulations specific to GLP and cGMP, as may be applicable. Data and documentation shall be prepared in a form acceptable to the FDA for inclusion in a Drug Master File (DMF), Investigational New Drug (IND) application, or New Drug Application (NDA).
In its own facilities and/or through its subcontractors, the Contractor shall conduct and/or oversee all manufacturing activities and nonclinical therapeutics evaluation and characterization in appropriate in vitro, in vivo, and/or ex vivo models, including cGMP manufacturing and preclinical IND-enabling and related studies. Nonclinical activities may include, but not are limited to, bioassay development, and/or efficacy studies, and/or absorption, distribution, metabolism, and elimination (ADME) studies, and/or pharmacokinetic (PK) and/or pharmacodynamic (PD) characterization, and/or GLP toxicology studies or other preclinical IND-enabling studies in support of requirements for IND applications. The Contractor shall provide Chemistry, manufacturing, and controls (CMC) and nonclinical study documentation to enable regulatory interactions, IND filing and evaluation of biological therapeutics in clinical trials for NIH drug development programs.
PLEASE NOTE: This solicitation is a Ramp-On re-opening and re-soliciting of Request for Proposals (RFP) No. 75N95022R00013 that was issued on January 25, 2022, with the purpose of adding one or more contractors to the existing Indefinite Delivery / Indefinite Quantity (IDIQ) contract pool supporting this program. The ordering period of the IDIQ contracts expire on September 29, 2030 and any new awards made under RFP No. 75N95024R00050 will have an ordering period that expires on September 29, 2030.
See attached Request for Proposals and attachments for complete information.

Opportunity closing date

08 July 2024

Value of contract

to be confirmed