CREAGEN BIOSCIENCES INC.NOTICE OF INTENT.NICHD-23-233.pdf

NICHD-23-233

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 CREAGEN BIOSCIENCES INC for the Acquisition of Services Related to Library of Bioactive Molecules.

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

Within 12 Weeks 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

Chemists in the NIDDK Synthetic Bioactive Molecules Section (HNK6MA) have designed and synthesized a new molecule with unique bioactivity that is active against both cancer and viruses. This molecule has the potential to treat patients with cancer or in some cases viral infections. The development of a new treatment for either disease could be of great benefit to human health and thus to NIDDK's mission. In order to make more biologically active versions of the initial molecule, many variants must be synthesized and then individually

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

tested to see if the potency improves. It is essential to have a sufficient amount of material for each molecule so that all biological tests can be performed. The Appella lab has developed a general synthesis of the initial lead molecule, but the lab cannot make enough variants of the original lead molecule due to workforce and space limitations. Our research on the potential of our initial lead molecule to become a new treatment for cancer or viral infection therefore depends on the purchase of the custom synthesis in this order. Substantial in vitro work has been done to find the initial lead molecule, which has incurred substantial investment that will be applied to the further study of the molecule.

The vendor Creagen, Inc., is a full-service contract research organization (CRO) fully familiar with the technical documentation required by the Food and Drug Administration (FDA). Creagen 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 a material 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 this requirement is to procure the Library of Bioactive Molecules and research to make several variants (a library) of the initial lead molecule to determine whether the variants have improved biological potency in biological assays that examine anti-cancer and anti-viral activity. To properly make the molecules for this work, the lab must have the molecules synthesized in sufficient quantities to test in several different biological assays. Using the procedures provided by the NIDDK chemists, the company must produce 50 analogs of each variant molecule and deliver 10 to 20 mg to the NIDDK lab. The molecules must be purified and characterized to prove the correct molecular structure. Results from each set of tests done with each molecule are added to the file that will eventually lead to an advanced molecule that will be submitted for FDA approval as an investigational new drug. 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.

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 repeatedly.

• The requirement for the Library of Bioactive Molecules is:

• Starting with the synthetic routes provided by the NIDDK, provide 50 analogs of the original lead molecule to produce 10 to 20 mg 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 to 20 mg of each 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)

TASK AREAS:

Task Area 1 – Delivery: The Contractor shall deliver final products to NIDDK no later than 3 months after award to: The National Institutes of Health, NIDDK, Bldg. 8, Room 404, 9000 Rockville Pike, Bethesda, Maryland 20892.

Task Area 2 –Requirements: The Contractor shall prepare each variant molecule 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 to 20 mg of each 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 CREAGEN BIOSCIENCES INC to be only reasonable available source to provide of Services Related to Library of Bioactive Molecules.

This acquisition was pursued on a sole source basis centered on the following. The NIDDK is unable to synthesize a wide variety of different molecules needed to optimize for biological activity. The initial molecule discovered by NIDDK needs optimization by making several different variants which will then be individual tested for biological activity in several different assays. The molecules tested have the potential to have both anti-cancer and anti-viral activity. The variety molecules must exceed what is capable of being produced in the NIDDK labs within the same timeframe. The incumbent company, Creagen, LLC., 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 molecules 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. It is important to work with a qualified vendor to avoid issues with data consistency when the package is submitted to the FDA.

CREAGEN BIOSCIENCES INC., has developed proprietary chemical expertise to make the target molecules that other companies/contractors will not have access to CREAGEN BIOSCIENCES INC., also has the expertise to characterize each molecule and verify its chemical structure and purity. To preserve all the prior investment in the research work done so far it is critical to select a highly skilled vendor such as CREAGEN BIOSCIENCES INC.

with the expertise to make the proposed molecules. The FDA will evaluate the data and expect consistency in how it was compiled and by whom. 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.

CREAGEN BIOSCIENCES INC., is aware of and respects the confidentiality requirement.

Therefore, the procurement of Services Related to Library of Bioactive Molecules is necessary for continued research analysis. Failure to procure these services from CREAGEN BIOSCIENCES 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 Wednesday, July 12, 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