Month: October 2022

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.

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:

1. Exploratory and Genetic Toxicology        
   1. 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;
   2. In vivo assays, including micronucleus assay and single cell gel electrophoresis (Comet Assay) in relevant species; and
   3. In vivo animal dosing studies, formulation and biological fluid analysis, clinical observations, clinical pathology, and histopathology evaluations in relevant species.
2. In Vivo Toxicity and Pharmacology Testing
   1. In vivo toxicology studies (GLP and non-GLP) and or pharmacology studies in relevant species with datasets adhering to the Clinical Data Interchange Standards Consortium (CDISC) Standard for the Exchange of Nonclinical Data (SEND) guidelines;
   2. 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:
      1. Non-GLP range finding studies;
      2. Formulation and biological fluid method development, validation, and analysis and defining pharmacokinetic/pharmacodynamic (PK/PD) relationships;
      3. Evaluating a range of endpoints and biomarkers in response to therapeutic candidates;
      4. GLP studies;
      5. GLP single-dose safety pharmacology studies;
      6. Reproductive toxicology studies; and
      7. Carcinogenesis studies.
   3. 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 second quarter of FY 2024.

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.

In case domestic sources are available and capable of fulfilling the Government’s need, and a future solicitation is published, the Government will use evaluation preferences in accordance with FAR 25.

Capability statement /information sought:
Companies that believe they possess the capabilities to provide the required services should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements separately.  Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Capability statements must also include the Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses.

Interested companies are required to identify their type of business, applicable North American Industry Classification System (NAICS) Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number.

Your response must address the specifics of this requirement and the following:

• 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.

One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2” x 11” paper size, with 1” top, bottom, left and right margins, and with single or double spacing.

The information submitted must be in and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein.  A cover page and an executive summary may be included but is not required.

The response is limited to ten (10) page limit.  The 10-page limit does not include the cover page, executive summary, or references, if requested.

All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer.  Facsimile responses are NOT accepted.

The response must be submitted to Mark McNally, Contracting Officer, at e-mail address [email protected].

The response must be received by 11:59 AM, Eastern Daylight Time, November 11, 2022.

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 a review of the responses received, a presolicitation synopsis and solicitation may be published in www.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).