TRND D3 Newman lead profiling in safety screen panels

This is a Small Business Sources Sought (SBSS) notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice.

This notice is issued to help determine the availability and type of qualified Small Business companies technically capable of meeting this potential 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. The notice is strictly for research and information purposes only.

The information requested will assist the Government in determining the appropriate acquisition method including small business socio-economic set-aside possibilities and to determine the availability of qualified Small Business companies technically capable of meeting the Government's potential requirement. All Small Business companies with the capability and availability to perform the requirement under the applicable NAICS code are invited to submit a response to this notice.

NORTH AMERICAN CLASSIFICATION SYSTEM (NAICS) CODE
The NAICS code applicable to this requirement is 541380-Testing Laboratories with associated small business size standard of 15 Million USD.
BACKGROUND
The National Institutes of Health (NIH) is the nation's leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people's health and save lives. The National Center for Advancing Translational Sciences (NCATS) is a translational science center that prides itself on its tremendously productive pipeline and is innovative in a number of ways. NCATS brings together a diverse range of scientists, including medicinal chemists, biologists, toxicologists, and engineers, in order to ultimately translate basic science into real products and services that help improve people's lives. Included in this process is the development of unique chemical material as a probe to investigate the mechanisms of diseases and to potentially assist in the development of new methods of treating such diseases.

Alzheimer's disease (AD) is a highly complex and rapidly progressive neurodegenerative disorder characterized by the systemic collapse of cognitive function and formation of dense amyloid plaques and neurofibrillary tangles. AD pathology is derived from the cholinergic, amyloid and tau hypotheses, respectively. Current pharmacotherapy with known anti-cholinesterases, such as Aricept and Exelon, only offer symptomatic relief without any disease-modifying effects. It is now clear that in order to prevent the rapid progression of AD, new therapeutic treatments should target multiple AD pathways as opposed to the traditional "one drug, one target" approach.
In one of our projects (c-Abl Kinase Project) here at NCTAS, our collaborators have identified the kinase c-Abl as playing a key role in neuronal cytoskeleton remodeling and apoptosis induced by toxic insults. The activation of c-Abl signaling by amyloid aggregates is related by tau pathology in the AD brain and is also involved in neuronal death, connecting the main hallmarks of AD neurodegeneration.

After many rounds of structure-activity relationship (SAR), we have narrowed down our compound selections and are close to deciding upon a preclinical candidate to move forward. To help us in this decision, we need to evaluate our top compounds for safety against unwanted off-target effects.

Purpose and Objectives
This Small Business Sources Sought notice seeks to determine eligible sources capable of achieving the essential features of this potential requirement. The purpose of this potential requirement is to obtain contractor results of compound testing from profiling panels that provide early identification of significant off-target interactions for the optimization of safety margins of various compounds. This project is to determine the percent inhibition values of six (6) compounds in lead optimization and safety profiling panels using 44 selected targets and four (4) compounds in lead optimization and safety profiling panels using 87 selected targets.

Project Requirements
This Small Business Sources Sought notice seeks responses from qualified sources that are capable of providing the following salient service requirements of this potential government requirement deemed as the essential features needing to be achieved. Specifically, Offerors to this Small Business Sources Sought notice shall possess the capability to provide safety profiling to check the potential off-target toxicity of the government's lead compounds. The selected targets associated with toxicity observed in drug discovery, recommended by major pharmaceutical companies in the drug discovery process.

1. Determine percent inhibition values of 6 compounds in the lead optimization and safety profiling panels of 44 selected targets and 4 compounds in the lead optimization and safety profiling panels of 87 selected targets.

2. The selected targets shall be gathered in a cost-effective panel that brings together both robustness (each assay is HTS-compatible) and the strategic choice of information-rich targets in the drug discovery process.

3. Item description includes Assay mode using Single Point, 2 compounds, 1 concentration, 2 replicates, quantity two (2) per batch consisting of default test Conc. 10 uM.

4. Profiling panels used shall provide the early identification of significant off-target interactions for the optimization of safety margins required.

Offerors submitting a response to this Small Business Sources Sought notice shall possess the ability to achieve the salient government essential features identified in this notice and provide documented evidence to be able to fully achieve the characteristicis of the subject requirement described herein.

Period of Performance
The contractor is expected to deliver results of work within two (2) weeks of the effective date of contract award and batch of material to analyze. The Government will send the contractor the material to synthesize after the effective date of contract award.

A Fixed-Price type of Purchase Order award not exceeding the Simplified Acquisition Threshold is anticipated for any contract resulting from this requirement. The anticipated award date is September 1, 2019.

Delivery/Warranty
Offerors should indicate an estimated delivery time in full after receipt of an order and any other training or warranty considerations applicable. Inspection and acceptance will be performed at NCATS located at 9800 Medical Center Drive, Rockville, MD 20852.

CAPABILITY STATEMENTS/INFORMATION SOUGHT
Interested parties are expected to review this notice to familiarize itself with the requirements of this project. Failure to do so will be at your firm's own risk.

Respondents must provide a capability statement with clear and convincing evidence of possessing the knowedge, skills, abilities and experience to successfully perform the requirements described in this announcement. Detailed prior experience in implementing similar requirements to the requirement described in this announcement shall be clearly delineated in any response provided. Technical experience may include, but is not limited to: Experience (> 5 years) in the testing of small molecule compounds as described in this announcement; evidence of published manuscripts in peer-reviewed journals of this or a related field; Access to all critical instrumentation necessary for this statement of work; Testing the aforementioned compounds in all the assays described above in 2 weeks time. Respondents must provide clear and convincing documentation of their capability in providing analytical quality control and any other requirements and services specified in this notice. Respondents must provide a general overview of the respondents' opinions about the difficulty and /or feasibility of the potential requirement, and any information regarding innovative ideas or concepts.

The Respondent must also provide information in sufficient detail of the respondents' (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, or other related information.

The respondent must also provide their DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc.) pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements.

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

The information submitted must be must be in and outline format that addresses each of the elements of the product requirement. A cover page and an executive summary may be included but is not required.

The response must include the respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses.

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

Respondents must reference the announcement number on all correspondence related to this Small Business Sources Sought notice. The response must be submitted to Hunter Tjugum electronically, at hunter.tjugum@nih.gov, and be received prior to the closing date specified in this announcement.

CONCLUDING STATEMENTS
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).

.