Procurement of Services for the Synthesis of Thyclotides (R,R) and (S,S)-trans-Tetrahydrofuran- and Cyclopentane constrained peptide nucleic acids

INTRODUCTION
THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Office of Acquisitions (OA) on behalf of the on behalf of the National Institute of Digestive, Diabetes & Kidney Diseases intends to award a purchase order without providing for full and open competition (Including brand-name) to FRONTAGE LABORATORIES INC for the Synthesis of Thyclotides (R,R) and (S,S)-trans-Tetrahydrofuran- and Cyclopentane constrained peptide nucleic acids.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE
The intended procurement is classified under NAICS code 541380 with a Size Standard of $16.50.

REGULATORY AUTHORITY
The resultant contract will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2021-06 Effective July 12, 2021.

This acquisition is conducted under the procedures as prescribed in FAR subpart 13—Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($250,000).

STATUTORY AUTHORITY
This acquisition is conducted under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302- FAR 6.302-1—Only one responsible source and no other supplies or services will satisfy agency requirements 41 U.S.C. 253(c)(1).

PERIOD OF PERFORMANCE
Within 90 Days of Award

Place of Performance
National Institutes of Health 
National Institute of Digestive, Diabetes & Kidney Diseases 
8 Center Drive
Bethesda MD 20892

DESCRIPTION OF REQUIREMENT

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) conducts and supports research on many of the most serious diseases affecting public health. The Institute supports much of the clinical research on the diseases of internal medicine and related subspecialty fields, as well as many basic science disciplines. 

The Institute's Division of Intramural Research encompasses the broad spectrum of metabolic diseases such as diabetes, obesity, inborn errors of metabolism, endocrine disorders, mineral metabolism, digestive and liver diseases, nutrition, urology and renal disease, and hematology. Basic research studies include biochemistry, biophysics, nutrition, pathology, histochemistry, bioorganic chemistry, physical chemistry, chemical and molecular biology, and pharmacology. 

NIDDK extramural research is organized into 4 divisions: Diabetes, Endocrinology, and Metabolic Diseases; Digestive Diseases and Nutrition; Kidney, Urologic, and Hematologic Diseases; and Extramural Activities.  The Institute supports basic and clinical research through investigator-initiated grants, program project and center grants, and career development and training awards. The Institute also supports research and development projects and large-scale clinical trials through contracts.
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Chemists in the NIDDK Synthetic Bioactive Molecules Section (HNK6MA) have designed and synthesized a series of new molecules called thyclotides.  Some of these molecules are potential components for diagnostic kits to be used for the rapid detection of nucleic acids associated with diseases.  The development of new diagnostic kits to signal the early stages of infections or cancers could be of great benefit to human health and thus to NIDDK's mission. In order to make thyclotides and cyclopentane peptide nucleic acids and study their binding to nucleic acid sequences, it is essential to have the correct starting materials.  The Appella lab has shown that the incorporation of trans-cyclopentanediamine into PNA backbones improves binding to target nucleic acid sequences. Our research on cyPNA and thyclotide development for the detection of nucleic acids associated with diseases therefore depends on the purchase of the chemicals to be custom synthesized in this order. Substantial in vitro work has been done to select cyPNAs to move forward as probes for diseases, which has incurred substantial investment that will be applied to the new class of thyclotide molecules. 

The company, Frontage, is a full-service contract research organization (CRO) fully familiar with the technical documentation required by the Food and Drug Administration (FDA).  Frontage was originally recommended by the chemists at NCATS who work on the drug development program for orphan diseases.  This is a highly specific research-based contract to make materials that are not commonly produced. These are synthetic materials that do not occur naturally and must be made using custom protocols developed by the NIDDK chemists. We have tried other sources and encountered technical difficulties, therefore a highly recommend and experienced contractor is essential.

PURPOSE AND OBJECTIVES

The National Institutes of Health (NIH)’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has a requirement for the Synthesis of Thyclotides (R,R) and (S,S)-trans-Tetrahydrofuran- and Cyclopentane constrained peptide nucleic acids.. The objective of the research is to advance the testing of thyclotides and cyclopentane peptide nucleic acids as probes to signal the presence of infection or disease. To properly make the oligomers for this work, the lab must have the correct building blocks that will be made in the proposed contract. Using the procedures provided by the NIDDK chemists, the company must scale up the production of the thyclotides and cyclopentane monomer building blocks and deliver 10 g of each monomer as the methyl ester to the NIDDK lab. Monomers received will be used to make thyclotides probes to target specific nucleic acids sequences associated with infection or disease. Results from each set of tests done are added to the file that will eventually be submitted for FDA approval as a new diagnostic test.  The continuity of the project is enhanced by the use of as few CRO’s as possible and only ones technically qualified to meet the specific needs of the research. 

CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION

The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10—Market Research.  Only one source is available: Per FAR 13.106-1(b)(1) the Contracting Officer has determined FRONTAGE LABORATORIES INC to be only reasonable available source to provide the Synthesis of Thyclotides (R,R) and (S,S)-trans-Tetrahydrofuran- and Cyclopentane constrained peptide nucleic acids.   

This acquisition was pursued on a sole source basis centered on the following.  The NIDDK is unable to scale up synthesis beyond specific scales.  The thyclotides and cyclopentane molecules must be produced on scales larger than what is capable in the NIDDK labs. The incumbent company, Frontage, is a full-service contract research organization (CRO) familiar with the technical documentation required by the Food and Drug Administration (FDA).  This is a highly specific research-based contract to make materials that are not commonly produced. These are synthetic materials that do not occur naturally and must be made using custom protocols developed by the NIDDK chemists. It is important to work with a qualified vendor to avoid issues with data consistency when the package is submitted to the FDA. Frontage has also developed proprietary chemical expertise to make the target molecules that other companies/contractors will not have access to.

The FDA will evaluate the data and expect consistency in how it was compiled and by whom.  In order to preserve all the prior investment in the research work done so far it is critical to select a highly skilled contractor with the expertise to make the proposed molecules. Frontage has developed proprietary chemical expertise to make the target molecules that other companies/contractors will not have access to.
There is no patent protection yet on the compound since a patent application is best filed at the end of data collection, not at the beginning.  Frontage is aware of and respects the confidentiality requirement.

Therefore, the procurement of the Synthesis of Thyclotides (R,R) and (S,S)-trans-Tetrahydrofuran- and Cyclopentane constrained peptide nucleic acids is necessary for continued research analysis. Failure to procure this deliverable from FRONTAGE LABORATORIES INC would result in a significant loss of research. 

CLOSING STATEMENT
This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include: descriptive literature, delivery timeframe, warranties and/or other information that demonstrates that the offer meets all the foregoing requirements, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.”

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

All responses to this notice shall be submitted electronically by 9:00 am Eastern Standard Time, on Wednesday, July 28, 2021 to the Contracting Officer, Amber Harris, at amber.harris@nih.gov.

Assessment of Capability
Lowest Price Technically Acceptable