Pharmacology Studies and Animal Model Development and Related Services for Drug Development   6

AMENDMENT 2: This amendment adds solicitation questions and responses. The solicitation questions and responses are attached.

AMENDMENT 1: This amendment:
1. Extends the deadline for questions until 2:00pm ET on August 1, 2023.
2. Extends the date for the Proposal Intent Response Form until August 1, 2023.
3. Extends the due date for proposals until 2:00pm ET on August 25, 2023.

An amended Solicitation and an amended Proposal Intent Response Form (Attachment 2) are attached.

DESCRIPTION

The Therapeutic Development Branch (TDB) within the Division of Preclinical Innovation (DPI) at the National Centerfor Advancing Translational Sciences (NCATS), National Institutes of Health (NIH), conducts translational researchon human therapeutics development by moving small molecule and biologic drug candidates forward in the drug development pipeline. Upon reaching predetermined milestones, TDB hands off clinical candidates to external partners to bring these novel therapies to patients. In addition to developing new candidate drugs, TDB seeks to advance the entire field of drug discovery and development by encouraging scientific and technological innovations aimed at improving success rates in the crucial preclinical stage of drug development. The TDB model is to operate as a comprehensive small molecule and biologics drug development organization, moving therapeutic candidates through each phase of the preclinical development process until an Investigational New Drug (IND) application is filed with the US Food and Drug Administration (FDA). For certain drug development campaigns, TDB will support studies up to human Phase IIb. TDB conducts drug development through collaborations, with therapeutic candidates originating from academia, industry, non-profit foundations, or internally from NCATS and other NIH institutes. TDB's operational strategy is to combine the capabilities of in-house staff and collaborative partners with complementary support from contract research organizations (CROs). Each development program operates in a multi-disciplinary matrix team environment, with NCATS responsible for overall planning and execution.

The scope of this requirement is to provide pharmacology services related to the execution of in vivo and in vitro/exvivo and related studies, including the optimization and/or development of animal models. The objectives are to obtain information about the biological effects of test articles on cellular and organismal function during the drug discoveryand development process; to provide expertise in designing, executing, interpreting, and reporting on such studies, including in support of regulatory filings; and to optimize or develop relevant in vivo animal models and/or in vitro / ex vivo animal model replacement systems that support preclinical drug development efforts.

See attached Solicitation and Solicitation Attachments for complete requirement details.