G
Please note that 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
Researchers nationwide and across the globe face common barriers in translational research that can delay the development of new interventions for patients in need. The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) studies translation on a system-wide level as a scientific and operational problem to accelerate the development of treatments and preventive strategies for a wide range of diseases. Within NCATS, the Division of Pre-Clinical Innovation (DPI) plans, conducts and uses both internal and contract resources to advance collaborative research projects across the pre-clinical phases of the translational science spectrum. Contract research organizations (CROs) provide manufacturing, pharmacology, toxicology, regulatory, and clinical operations services to DPI to assist with probe and assay development, lead selection and optimization, and Investigational New Drug (IND)-directed studies.
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 leads; and establishing first in human starting doses, dose limiting toxicities, safety/pharmacodynamic biomarkers, and therapeutic indexes.
To support safety evaluations, DPI intends to award multiple contracts for the conduct of in vitro and in vivo exploratory and IND-directed toxicology studies. Contractors will help identify, develop, and perform in vitro and in vivo IND-enabling safety studies to support IND applications for small and large molecules. In-vivo studies will involve animal dosing, formulation and biological fluid analysis, clinical observations, clinical pathology and histopathology evaluations.
Project Requirements
Written capability statements should demonstrate your organization's ability and related experience in one or more of the following areas. If you organization has capabilities in more than one of the listed areas, your response must separately describe the organization's ability and related experience for each separate area.
Tests for an IND-enabling toxicology package:
(1) In-vitro genetic toxicology tests in presence or absence of metabolic activation:
- Ames assay
- Mouse lymphoma assay
- Chromosomal aberration assay
(2) In-vitro Safety Pharmacology tests such as hERG
(3) In-vivo General toxicology and safety pharmacology studies:
- Non-GLP range finding studies in rodent and non-rodent species
- GLP studies in rodent (FOB and Micronucleus/comet assays will be either built-in or conducted stand-alone) and non-rodent species
- Single-dose safety pharmacology studies (pulmonary, cardiovascular)
- Reproductive toxicology studies
- Carcinogenesis studies in rodent and non-rodent
Non-GLP tests under discovery / exploratory toxicology (including but not limited to):
(1) Toxicity testing (In vitro):
- Mitochondrial toxicity
- Phospholipidosis and steatosis assay
- Hemolysis assay
- Lysosomal Trapping assay: To assess the test-article effect of lysosomotropism (trapping of the test article in lysosomes).
- Membrane integrity assay
- Oxidative stress assay
- Apoptosis assay
(2) F. Toxicology studies (In vivo exploratory):
- Non-GLP exploratory toxicology studies in rodent and non-rodent species to aid therapeutic target evaluation, lead optimization and compound selection process.
Capability statements should include current certifications for conducting toxicology studies in accordance with appropriate regulatory guidelines and policies. Data and documentation from the above studies should 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 (ID/IQ) type contract awards under the future solicitation-each with a five year ordering period. The Government anticipates awards will be made in the fourth quarter of FY2016.
Other Important Considerations
Capability statements should indicate how many staff members the small business would potentially dedicate to such a contract and which resources are available in-house. The requirements that would be performed in-house versus those that would be performed outside the responding organization should be clearly identified. The ability to rapidly scale staff capacity up or down in order to support the anticipated workload should also be addressed.
The ID/IQ contracts may include 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 agent to retain control of intellectual property created under these contracts.
Required Information
All capability statements must provide the following: (1) DUNS number; (2) organization name; (3) organization address; (4) point of contact; (5) point of contact title, address, telephone, and email address; and (6) size and type of business (e.g., 8(a), HUBZone, etc.) pursuant the applicable NAICS code.
Submission Instructions and Due Date
Written capability statements must be SUBMITTED NO LATER THAN OCTOBER 8, 2015 to the below Contracting Office Address, Attn: Jeffrey Schmidt. Electronic capability statements will be accepted by the primary point of contact.
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 pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. 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).
Contracting Office Address
NINDS R&D Contracts Management Branch
NCATS Section
6001 Executive Boulevard
Suite 3287, MSC 9531
Bethesda, Maryland 20892-9531*
*Use Rockville, MD 20852 for Fed-Ex/USPS/Courier/Hand-Delivery