This notice is issued to help determine the availability of qualified companies technically capable of meeting the 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 because of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only.

Background / Purpose / Objective:
(-)-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. 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. Clinical grade material is required to support a clinical trial of the agent in humans with AD, and this material must importantly match existing clinical grade material as well as be in line with prior clinical grade material that has met regulatory standards for use in humans.

Purpose or Objective of the Requirement:
The purpose of this acquisition is to procure commercial support services to generate clinical grade (-)-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.

Project Requirements:
The Contractor will generate 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.
A. Phase 1: 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).

B. Phase 2: Synthesis of clinical grade (-)-Phenserine tartrate
The Contractor shall synthesize (-)-phenserine tartrate from (-)-eseroline, using the existing 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). The final API should be identical 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 full compliance of processes and materials with FDA regulations for clinical grade compounds (CMC shall be in line with IND 56,004).

C. Phase 3: 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.

Technical Criteria
1. 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).
2. The contractor must have prior experience in the manufacture of clinical grade material - and specifically in the generation of (-)-Phenserine tartrate that meets clinical grade standards
3. The contractor's facility must be FDA accredited and in accord with FDA regulations <as per: https://www.fda.gov/downloads/drugs/guidances/ucm073369.pdf

Anticipated period of performance / delivery date: The Government anticipates the month of award is September 2019 for a 1-year period of performance.

Other important considerations: The response may cite any other information that is necessary for potential respondents to understand the nature of the potential requirement or proposed acquisition.

Capability statement /information sought. The government is interested in soliciting capability statements from all qualified Offerors demonstrating their ability to perform this effort. At a minimum, respondents to this notice must provide, as part of their response, a capability statement to include the following: (1) information regarding 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 a similar nature; (d) corporate experience and management capability; and, (e) examples of prior completed Government contracts, references, and other related information; (2) respondents' 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, (3) any other information that may be helpful in developing or finalizing the acquisition requirement.

INFORMATION SUBMISSION INSTRUCTIONS:
Respondents should provide responses accordingly: (1) submit information electronically. No telephone or facsimile responses will be accepted; (2) format capability statements using Microsoft Word or Adobe PDF including attachments, resumes, charts, etc. Use single space, 12 font minimum and 8 ½ x 11 size paper; (3) organize material in such a manner that clearly identifies and address capability requirements and provide an executive summary; (4) capability statement should not exceed ten (10) pages including references; (5) DUNS number; (6) respondents must send via email to Debra C. Hawkins Contractor, Acquisition Policy Analyst II, at [email protected]; (7) responses should be received no later than August 5, 2019, 12:00 Noon Eastern Time; and (8) include respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses.

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 provide the product or perform the services specified herein. 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 presolicitation 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).