FRONTAGE LABORATORIES.NOTICE OF INTENT.NICHD-23-231.pdf

NICHD-23-231

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 Acquisition of Services Related to Compound 21 and In Vivo Pharmacokinetics Studies.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 541380 Testing Laboratories and Services with a Size Standard of $19.0.

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 2023-04 Effective June 2, 2023.

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

The period of performance is listed below. Payment terms will be per the vendor allowance with the vendor being a small business (Net 30).

Period of Performance:

Synthesis, analysis and delivery of compound 21

10 g of compound 21 90 days from award of Contract

Pharmacokinetic and metabolism studies Reports on the bioactivity

150 days from completion of synthesis

PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS

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.

Chemists in the NIDDK Synthetic Bioactive Molecules Section (HNK6MA) have designed and synthesized a new molecule called compound 21. This molecule has antiviral activity against HIV and has the potential to become a new drug to treat or prevent HIV infection in humans. The development of a new treatment for HIV could be of great benefit to human health and thus to NIDDK's mission. In order to make compound 21 and study its properties in animals, it is essential to have a sufficient amount of material. The Appella lab has developed a small scale synthesis of compound 21, but the lab cannot make enough material to study in animals. Our research on the potential of compound 21 to become a future treatment for HIV infection therefore depends on the purchase of the custom synthesis in this order. Substantial in vitro work has been done to select compound 21 to move forward as an anti-HIV molecule, which has incurred substantial investment that will be applied to the further study of the molecule.

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 objective of the research is to advance the testing of compound 21 to determine its ability to become a new treatment for HIV infection. To properly make the molecule for this work, the lab must have the molecule synthesis in sufficient quantities to test in animals. Using the procedures provided by the NIDDK chemists, the company must scale up the production of compound 21 and deliver 10 g to the NIDDK lab. The compound 21 produced must also be tested for pharmacokinetics in rats and mice, and its metabolism studied. Results from each set of tests done are added to the file that will eventually be submitted for FDA approval as an investigational new drug. The continuity of the project is enhanced using as few CRO’s as possible and only ones technically qualified to meet the specific needs of the research.

SALIENT / REQUIRED FEATURES AND SPECIFICATIONS

Contractor must carefully follow confidential synthetic protocols from the NIDDK lab and provide written documentation of all deviations from established protocols. Experience in drug synthesis and compliance with FDA requirements and drug development protocols is required. Final products must be delivered with requested quantity for each molecule, with purity in excess of 98%. Final product will be analytically tested by NIDDK before final acceptance. Scale of synthesis for the target molecules is not possible in NIDDK labs due to space limitations. Obtaining synthesis service will allow NIDDK lab to pursue advanced experiments without needing to continually repeat established protocols over and over again. The Contractor shall:

• Starting with the synthetic routes provided by the NIDDK, scale up the synthesis of compound 21 to produce 10 g of the molecule.

• Purify each molecule via recrystallization or silica gel chromatography

• Synthesis may be performed in batches. A complete certificate of testing (Analysis) will be provided for each synthetic batch

• Provide 10 g of the final compound a glass or plastic canister inside a protected shipping box or package to NIDDK investigator

• Perform characterization by NMR and check purity by MS for COT

• Provide a Certificate of Analysis (COA) for each molecule synthesized (per batch)

• Perform pharmacokinetic studies in rats

• Perform pharmacokinetic studies in mice

• Perform metabolic stability of lead molecules in liver microsomes and hepatocytes

TASK AREAS:

Task Area 1 – Delivery: The Contractor shall deliver final products to NIDDK 90 days after purchase order is received.

Task Area 2 – Shipping: The Contractor shall ship the required materials to National Institutes of Health, NIDDK, Bldg 8, Room 404, 9000 Rockville Pike, Bethesda, Maryland 20892.

Task Area 3 – Requirements: The Contractor shall prepare compound 21 (10 grams) for NIH. The protocol will be provided by NIH/NIDDK.

Any previously synthesized reference compounds of interest will be provided by NIH/NIDDK, if readily available.

The Contractor shall provide supporting mass spectral, NMR spectroscopy and purity data (HPLC/UV, % area) for the subject compounds. An analytical HPLC/MS/UV method will be set up to characterize compound 21.

The Contractor shall deliver 10 g of the final compound in a glass or plastic canister inside a protected shipping box or package to NIDDK investigator (agreed to by the Contractor and Program Officer) on NIH campus.

The Contractor shall take approximately 10-12 weeks to synthesize and purify the compounds from approval of the work order. The syntheses schemes are shown below.

All batch experimentation and observations will be documented in laboratory notebooks as appropriate. Any materials produced in the laboratory will be deemed as “Not for Human or Animal Use.” All electronic and written data will be archived.

All work will be conducted according to applicable Standard Operating Procedures (SOPs). The reaction conditions and subsequent purification of the final products shall be developed by the Contractor.

Sponsor is responsible for providing the test compound and any pertinent information (such as stability of the compounds in light or a specific medium) which could be useful prior to the conduct of studies.

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 Services Related to Compound 21 and In Vivo Pharmacokinetics Studies.

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 molecule 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. The molecule is a synthetic material that does 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. 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. Frontage also has the expertise to study the molecule’s behavior in vivo in pharmacokinetic studies in rats and mice, and also to examine the metabolism of the molecule.

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. NIDDK has tried other sources and encountered technical difficulties, therefore the recommended contractor is essential to the success off the project.

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. No other vendor is able to fulfill the requirements needed for this project.

Therefore, the procurement of Services Related to Compound 21 and In Vivo Pharmacokinetics Studies is necessary for continued research analysis. Failure to procure these services 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. Any submitted capability statements must demonstrate relevant experience, skills and ability to fulfill the Government's requirements for the above. The capability statement should contain sufficient detail for the Government to make an informed decision regarding your capabilities. The capability statement should not exceed 15 pages using a font size 10 or larger. 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.

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.

All responses to this notice shall be submitted electronically by 9:00 am Eastern Standard Time, on Monday, July 10, 2023 to the Contract Specialist, Amber Harris, at amber.harris@nih.gov.

INVOICING PROCESSING PLATFORM (IPP)

Vendor/Contractor Must be able to accept payments via IPP (Invoice Processing Platform) The contractor may submit a request for an exception. See below for IPP, IPP helpdesk information and applicable Health and Human Services addendum clause.

INVOICING PROCESSING PLATFORM (IPP) In compliance with the Office of Management and Budget (OMB) M-15-19 memorandum "Improving Government Efficiency and Saving Taxpayer Dollars through Electronic Invoicing" directing Federal agencies to adopt electronic invoicing as the primary means to disburse payment to vendors. Invoices submitted under any award resulting from this solicitation will be required to utilize the

Invoice Processing Platform (IPP) in accordance with HHSAR 352.232-71, Electronic Submission and Processing of Payment Requests" IPP is a secure, web-based electronic invoicing system provided by the U.S. Department of the Treasury's Bureau of the Fiscal Service, in partnership with the Federal Reserve Bank of St. Louis (FRSTL). Respondents to this solicitation are encouraged to register an account with IPP if they have not already done so. If your organization is already registered to use IPP, you will not be required to re-register however, we encourage you make sure your organization and designated IPP user accounts are valid and up to date. The IPP website address is: https://www.ipp.gov If you require assistance registering or IPP account access, please contact the IPP Helpdesk at (866) 973-3131 (M-F 8AM to 6PM ET), or IPPCustomerSupport@fiscal.treasury.gov Note: Should an Offeror feel that use of the IPP would be unduly burdensome, the response to this solicitation should include an explanation of this position for a determination by the contracting officer.

HHSAR 352.232-71 Electronic Submission of Invoice Payment Requests (Feb 2022) will apply when this requirement is solicited and awarded. As stated: (a) Definitions. As used in this clause, Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract. (b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site. (c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures. (d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request. (END OF CLAUSE)

Assessment of Capability

Lowest Price Technically Acceptable