NIA 22-011696

Post Date/ Solicitation Issue Date

August 24, 2022 12:00 pm

Closing Response Date

September 3, 2022 5:00 pm

Proposed Award Date

September 9, 2022 12:00 pm

Project Title

Support Services for the Synthesis of (-)-Phenserine Tartrate Clinical Grade Material

Contracting Office

National Institute on Aging (NIA)

Small Business Size Standard

$16.5M

FPDS Classification Code

Q301

Estimated Period of Performance

September 12, 2022 - September 11, 2023

Delivery of Goods

N/A

Competition Status

Non-Competitive

Single-Sole Source Determination

Acquisition Authority: This acquisition is conducted under the authority of Federal Authority Regulation (FAR) Part 13 - Simplified Acquisition Procedures, Subpart 13. 106-1 (b)(1 ), Soliciting from a single source and is not expected to exceed the Simplified Acquisition threshold. Contracts awarded using FAR Part 13- Simplified Acquisition Procedures and at a dollar value less than the simplified acquisition threshold are exempt from the requirements of FAR Part 6- Competition Requirements.

This notice of proposed acquisition is posted as an intent to award a purchase order on a non-competitive basis to the Regents of the University of Minnesota. Dr. Vadim Gurvich, Associate Director of the Institute of Therapeutics Discovery & Development, and Associate Professor of the Department of Medicinal Chemistry at the University of Minnesota is the only source with the expertise necessary to satisfy the requirements of this solicitation. Dr. Gurvich has confirmed expertise in this area based on the fact that Dr. Vadim Gurvich generated the most recent batch of (-)-Phenserine tartrate clinical grade material – and FDA requirements indicate that the material generated in this contract MUST match the prior material. Dr. Vadim Gurvich is currently storing under FDA approved conditions clinical grade (-)-Phenserine tartrate that he previously generated from 2016 and more recently in 2020 – this is the only available clinical grade (-)-Phenserine tartrate worldwide. He hence has prior successful experience in the generation of (-)-Phenserine tartrate.

Background/Description of Requirement

This acquisition is being conducted under Federal Acquisition Regulations (FAR) Part 13 – Simplified Acquisition Procedures, and the resultant contract award will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2202-07 dated August 10, 2022.

Statement of Need, Purpose, and/or Objective: The purpose of this acquisition is to procure commercial support services to generate phenserine tartrate that meets specifications for use in humans and is in line with the ‘Certificate of Analyses’ of the material previously generated and used in clinical trials.
 

Background Information:  (-)-Phenserine tartrate is a small synthetic compound developed for the treatment of Alzheimer’s disease (AD) and related degenerative disorders by the scientists within the National Institute on Aging (NIA), NIH. The target for the drug is the enzyme acetylcholinesterase; however, the agent additionally has demonstrated neurotrophic and neuroprotective actions across animal models of neurodegeneration – suggesting that it may have a combination of properties as both a symptom and disease progression-modifying drug for neurodegenerative disorders. Clinical grade material is required to support the clinical development of the agent in humans with AD and other neurodegenerative disorders, and this material must importantly match existing clinical grade material as well as be in line with prior clinical grade material that has previously met regulatory standards for use in humans. 

SCOPE OF WORK: 

General Requirements: Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:

Specific Requirements: The Contractor will generate a clinical grade (-)-phenserine tartrate that meets FDA approved standards for human use. Contractor will undertake chemical characterization of material to provide a ‘Certificate of Analysis’ that is in line with prior clinical grade material.

• Acquisition of starting materials: The purchase of starting materials in line with synthetic needs – for synthesis of clinical grade (-)-Phenserine tartrate – and with appropriate documentation to meet FDA approval.
• The contractor must be at a facility that is accredited with FDA Current Good Manufacturing Practices (cGMP) to support manufacture and storage of clinical grade pharmaceutical material (i.e., clinical grade (-)-Phenserine tartrate).
• Synthesis of clinical grade (-)-Phenserine tartrate: The Contractor shall synthesize (-)-phenserine tartrate from (-)-eseroline or a different rational starting material, using a synthetic strategy and analytical methodology to meet clinical grade standard, as defined within the Chemistry Manufacturing and Controls (CMC) data within the initial FDA approved Investigational New Drug (IND) No. 56,004 (this synthetic route is provided at the end of this document or a different one can be used that meets requirements). The final API should be similar to the existing (-)-phenserine tartrate clinical batches and reference standards. The services should be completed within twelve months from initiation and include a Batch Production Record (BPR) as well as associated Standard Operating Procedures for the Active Pharmaceutical Ingredient (API). Documentation shall include quality assurance efforts and confirmation of compliance of processes and materials with FDA regulations for clinical grade compounds (CMC shall be in line with IND 56,004).
• Certificate of Analysis - chemical characterization: Chemical characterization is required to provide a Certificate of Analysis (CoA) that defines the purity of the clinical grade (-)-phenserine tartrate.

The Certificate of Analysis must compare the chemical characterization to a reference standard of the material being stored at the Institute for Therapeutics Discovery and Development (ITDD), Department of Medicinal Chemistry, University of Minnesota.

• The contractor must have prior experience in the generation of clinical grade material – and specifically in the generation of (-)-Phenserine tartrate that meets clinical grade standards (the contractor needs to demonstrate proof of this prior expertise)

Level of Effort:  Senior scientist/research team with background and knowledge in medicinal chemistry and generation of clinical grade material to support clinical trial evaluation in humans, in line with regulatory requirements.

Government Responsibilities: The Government will provide intellectual input as needed. Information related to a synthetic route is provided at the end of this document.

Place of Performance: The place of performance shall be the contractor’s site. This facility must be FDA accredited and in accord with FDA regulations <as per: https://www.fda.gov/downloads/drugs/guidances/ucm073369.pdf>

Delivery or Deliverables: The contractor shall provide a sample of final product for analysis together with a Certificate of Analysis.

The sample and information shall be submitted to the NIH Scientist/POC. The NIA POC for any questions relating to the synthesis of the clinical grade material, (-)-Phenserine tartrate will be provided at the time of award.

Travel: No travel is required. However, contractor should interact with the key NIA scientist/POC involved in these studies via phone and Email, as necessary.

Key Personnel: Experienced synthetic chemist with knowledge of FDA requirements (that additionally meets the “Specific Requirements” – detailed above)

Information System Security Plan: No ‘Federal Information System’ is required.

Data Rights: N/A

Section 508-Electronic and Information Technology Standards: N/A

Publications and Publicity: N/A

Confidentiality of Information: The Contractor will keep confidential any documents provided by the government that are not in the public domain and that are marked as ‘confidential’.

Contract Type: A Firm Fixed Price (FFP) Purchase Order award not exceeding the Simplified Acquisition Threshold is anticipated from any contract resulting from this requirement. 

Summary Statement:
The Unique Entity Identifier (UEI), the Taxpayer Identification Number (TIN),certification of country of ownership, and the certification of business size must be included in the response.
All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.”

Quoter Terms and Conditions (To be completed by the Offeror):

1.    Period of Performance OR Delivery Date After Receipt of Order:
2.    Shipping Point (F.O.B. OR Destination):
3.    Payment Discount Terms:
4.    NIH BPA Number
5.    SAM UEI No:

6.    Name of Company:
7.    Street Address, City, State, Zip code:

8.    Name of Person Authorized to Provide Quote:
9.    Telephone Number and Email Address of Person Authorized to Provide Quote:

Additional Terms and Conditions, Provisions, and Representations:

The FAR Clauses are incorporated by reference and are provided in full text at https://www.acquisition.gov/

• FAR Provision 52.212-1 Instructions to Offerors-Commercial Items (Sept 2021) is applicable to this solicitation.
• FAR Provision 52.212.2 Evaluation-Commercial Items (Oct 2014) is applicable to this solicitation. The Government will evaluate quotations or offers in accordance with FAR 13.106-2 and award a purchase order from this solicitation to the responsible offeror whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes: Technical capability of the item offered to meet the Government requirement; Price; and Past performance [see FAR 13.106-2(b)(3)]
• FAR Provision 52.212-3, Offeror Representations and Certifications-Commercial Items (Feb 2021), is applicable to this solicitation 
• FAR Clause 52.212-4, Contract Terms and Conditions-Commercial Items (November 2021), is applicable to this solicitation.
• FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (May 2022) is applicable to this solicitation. See attachment. 

In addition, the following FAR provisions and clauses are applicable to this solicitation and incorporated by reference: 

• 52.204-7 System for Award Management (Oct 2018), 
• 52.204-13 System for Award Management Maintenance (Oct 2018), 
• 52.204-16 Commercial and Government Entity Code Reporting (Aug 2020), 
• 52.204-18 Commercial and Government Entity Code Maintenance (Aug 2020),
• HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 2015).

The following provisions and clauses apply to this acquisition and are incorporated as an attachment. Offerors MUST complete the provision at 52.204-24 and 52.204-26 and submit a completed copy as a separate document with their quotation.

• FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Oct 2020)
• FAR 52.204-25, Prohibition on Contracting for Certain Video Surveillance Services or Equipment (Aug 2020)
• FAR 52.204-26, Covered Telecommunications Equipment or Services Representation (Oct 2020)
• NIH Invoice and Payment Provisions

All responses must be received by September 3, 2022 at 5 PM EST and must reference announcement/solicitation number 22-011696. Responses may be submitted electronically to Carla Blalock (carla.blalock@nih.gov).  Fax responses will not be accepted.