Inactive

THIS IS A RESEARCH AND DEVELOPMENT (R&D) SOURCES SOUGHT NOTICE. THIS IS NOT A SOLICITATION FOR PROPOSALS, PROPOSAL ABSTRACTS, OR QUOTATIONS. THE PURPOSE OF THIS NOTICE IS TO OBTAIN INFORMATION REGARDI... THIS IS A RESEARCH AND DEVELOPMENT (R&D) SOURCES SOUGHT NOTICE. THIS IS NOT A SOLICITATION FOR PROPOSALS, PROPOSAL ABSTRACTS, OR QUOTATIONS. THE PURPOSE OF THIS NOTICE IS TO OBTAIN INFORMATION REGARDING THE AVAILABILITY AND CAPABILITY OF ALL QUALIFIED SOURCES TO PERFORM A POTENTIAL R&D REQUIREMENT. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Please note to qualify as an eligible small business for purposes of a small business set-aside, at least 50% of the cost of contract performance incurred for personnel must be expended for employees of the small business awardee (see FAR 52.219-14 Limitations on Subcontracting). Background: The Division of Preclinical Innovation (DPI) at the National Center for Advancing Translational Sciences (NCATS) conducts translational research on human therapeutics development by moving small molecule and biologic drug candidates forward in the drug development pipeline. Upon reaching predetermined milestones, DPI hands off clinical candidates to external partners to bring these novel therapies to patients. In addition to developing new candidate drugs, DPI 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. DPI’s model is to operate as a comprehensive small molecule and biologic 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, DPI will support studies up to human Phase IIb. DPI conducts drug development through collaborations, with therapeutic candidates originating from academia, industry, non-profit foundations, or internally from NCATS and other NIH institutes. DPI’s operational strategy is to combine the capabilities of in-house staff and collaborative partners, who may be the drug originators, with complementary support from contract research organizations (CROs). Purpose and Objectives: Safety assessment of the therapeutics and diagnostics is an important component of the drug and device discovery and development efforts in DPI. These assessments play a pivotal role in determining and evaluating therapeutic targets; selecting and optimizing therapeutic lead candidates; and establishing first in human starting doses, dose limiting toxicities, safety/pharmacodynamic biomarkers and therapeutic indexes. To support safety assessments, DPI intends to award multiple contracts for the conduct of in vitro and in vivo exploratory and IND-directed toxicology studies. Contractors will be required to perform in vitro and in vivo safety studies for small and large molecules to support the submission of regulatory filings to the US Food and Drug Administration (FDA) or other regulatory bodies, such as Investigational New Drug (IND) applications, New Drug Applications (NDA) and Biologics License Applications (BLA). In addition, in vitro tests and in vivo exploratory studies will be carried out to aid therapeutic target evaluation, lead optimization, and compound selection processes on a case-by-case basis. Therapeutic modalities may include new and repurposed chemical entities and biological products (e.g., monoclonal antibodies, enzymes, gene vectors, etc.). Project requirements: Exploratory and Genetic Toxicology In vitro toxicity testing (GLP and non-GLP) including but not limited to: mitochondrial toxicity, phospholipidosis and steatosis assay, hemolysis assay, lysosomal trapping assay (to assess the test article effect of lysosomotropism), membrane integrity assay, oxidative stress assay, apoptosis assay, hERG assay, Ames assay, mouse lymphoma assay, chromosome aberration assay; In vivo assays, including micronucleus assay and single cell gel electrophoresis (Comet Assay) in relevant species; and In vivo animal dosing studies, formulation and biological fluid analysis, clinical observations, clinical pathology, and histopathology evaluations in relevant species. In Vivo Toxicity and Pharmacology Testing In vivo toxicology studies (GLP and non-GLP) and or pharmacology studies in relevant species with datasets adhering to the CDISC Standard for the Exchange of Nonclinical Data (SEND) guidelines; In vivo general toxicology and safety pharmacology studies via multiple routes of administration in support of IND/NDA/BLA-enabling toxicology packages including but not limited to: Non-GLP range finding studies; Formulation and biological fluid method development, validation, and analysis and defining pharmacokinetic/pharmacodynamic (PK/PD) relationships; Evaluating a range of endpoints and biomarkers in response to therapeutic candidates; GLP studies; GLP single-dose safety pharmacology studies; Reproductive toxicology studies; and Carcinogenesis studies. In vivo exploratory assays: Non-GLP exploratory toxicology studies in relevant species to aid therapeutic target evaluation, lead optimization, and compound selection. In vivo studies under this technical area will include, but not be limited to, animal dosing, formulation and biological fluid analysis, clinical observations, clinical pathology, and histopathology evaluations. Contractors shall also perform activities related to the overall administration of the contract including administrative reporting and deliverable requirements. Contractors shall have current certifications for conducting toxicology studies in accordance with appropriate regulatory guidelines and policies. Data and documentation from the above studies shall be prepared in a form acceptable to the Food and Drug administration (FDA) for inclusion in an IND application or New Drug Application and Biologic License Application. Contractors may be required to conduct any of the tests listed above to support the development of a therapeutic agent under development by DPI. Anticipated period of performance: The Government anticipates making multiple Indefinite Delivery, Indefinite Quantity (IDIQ) type contract awards with five-year ordering periods each under the future solicitation. Projects will then be performed by contractors under individual task orders awarded under these IDIQ contracts. The Government anticipates awards will be made in the third quarter of FY 2022. Other important considerations: The ID/IQ contracts may include a Declaration of Exceptional Circumstances (DEC) to the Federal Acquisition Regulations clauses. The DEC would transfer rights to inventions developed under the contract to the Federal Government and enable contributors of the therapeutic candidates to retain control of intellectual property created under these contracts. Instructions: If your organization has the potential capacity to perform these contract services, please provide the following information: DUNS number, organization name, address, points of contact with phone numbers and email addresses, organization website address, size and type of business (e.g., 8(a), HubZone, etc.) pursuant to the applicable NAICS code, and type of ownership; Tailored capability statement addressing the specifics of this requirement and providing: Organizational and staff capability and expertise to perform the work and which resources are available in-house; If significant subcontracting or teaming is expected and how it will be administered and managed; Current certifications for conducting toxicology studies in accordance with appropriate regulatory guidelines and policies; Prior completed projects of similar nature including any government contracts and references; Corporate experience and management capability; and If applicable, any information regarding innovative ideas or concepts. All responses to this notice must be submitted by email to Contracting Officer Mark McNally, mark.mcnally@nih.gov. Responses must be received by 11:59 AM, Eastern Time, June 1, 2021. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After assessment of the responses received, a pre-solicitation synopsis and solicitation may be published on beta.SAM.gov. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).