SOLICITATION NOTICE
A -- Triazine Drug Formulation
- Notice Date
- 3/20/2018
- Notice Type
- Presolicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of the Army, U.S. Army Medical Research Acquisition Activity, U.S. Army Medical Research Acquisition Activity, Attn: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014, Maryland, 21702-5014, United States
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH-18-R-0047_PRESOLICITATION
- Archive Date
- 4/19/2018
- Point of Contact
- Sharew Hailu,
- E-Mail Address
-
sharew.hailu.civ@mail.mil
(sharew.hailu.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- THIS IS A RESEARCH AND DEVELOPMENT NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. The Experimental Therapeutics (ET) Branch of the Military Malaria Research Program (MMRP) is part of the Walter Reed Army Institute of Research (WRAIR). The mission of the ET Branch is to discover and develop new pharmaceutical agents to protect military members from death, disease, and injury. The ET Branch is the nation's primary developer of new drugs to prevent and/or treat malaria and leishmaniasis. Collectively, ET engages in drug discovery, drug efficacy and mechanism evaluation, and formal preclinical and clinical development. The ET branch is currently developing anti-malarial drugs to address current and projected unmet medical needs (requirements). Their most advanced class of compounds is the Triazine class. ET will be evaluating one Triazine compound in clinical studies to assess its safety and efficacy. The active pharmaceutical ingredient is being prepared by a separate vendor, but there is a need for the formulation of this Triazine compound as well as the production of a placebo to be used in future clinical testing. The scope of work includes all the activities required for Good Manufacturing Practices (cGMP) compliant formulation/fill, finish, and testing of a Triazine anti-malarial final drug product; and manufacture, formulation, fill/finish, and testing of a placebo as specified in the following tasks: Task 1 - Quality Control Plan with WRAIR and U.S. Army Medical Material Development Activity (USAMMDA) Task 2 - Analytical Test Methods Task 3 - Base Period - Phase 1 & 2a •Produce Final Drug Product (FDP) •Produce a Placebo BDS and FDP Task 4 - Option Period 1 - Phase 2b •Produce Final Drug Product •Produce a Placebo BDS and FDP •OPTIONAL - Formulation of triazine and placebo BDS into an alternate solid oral dosage form Task 5 - Option Period 2 - Phase 3 •Produce Final Drug Product •Validation Lot Production •Produce a Placebo BDS and FDP •OPTIONAL - Formulation of triazine and placebo BDS into an alternate solid oral dosage form Task 6 - Shipping and Storage Task 7- Technical Data Package (TDP) Task 8- eCTD-Compliant Module 2 summaries and Module 3 Quality sections Each stage of the project shall be performed through collaborative interaction with the WRAIR Integrated Product Team (IPT) scientists. The contractor must comply with all applicable cGMP and other regulations, and all cGMP-grade lots shall be produced in compliance with International Conference on Harmonization (ICH) Q8 guidelines as applicable to pharmaceutical development. The contractor shall ensure it has adequate resources and staffing to complete the project. The contractor shall be responsible for the following: 1)Development of the synthetic method of a placebo; 2)Formulation and packaging of the Active Pharmaceutical Ingredient (API) and placebo into capsules (optional: alternate solid dosage form) for oral administration in clinical testing; 3)Investigational product release and stability testing (to include analytical method validation) 4)Developing a technical data package 5)Shipment and storage of the final drug product and placebo The quantities of bulk drug substances (BDS) and drug products will be listed in a SOW and are current estimates. Actual quantities will be determined as development proceeds based on preclinical, clinical, manufacturing, and testing data; and Food and Drug Administration (FDA) requirements for preclinical, clinical, and chemistry, manufacturing, and controls (CMC)-related testing. PERIOD OF PERFORMANCE The periods of performance for this contract are as follows: Base period- Phase 1 and 2a18 August 2018 - 17 October 2022 Option period 1- Phase 2b18 October 2022 - 17 October 2024 Option period 2- Phase 318October 2024 - 17 October 2027 WORK SCHEDULE AND LOCATION All work associated with this effort shall be performed and completed at the contractor's facilities following the contractor's work hours and schedule. QUALITY STANDARDS Performance and Quality Standards will be outlined in the Request for Proposal. It is anticipated that solicitation W81XWH-18-R-0047 will be electronically available on or about May 1, 2018 in draft form. The RFP may be accessed through the FedBizOpps website, https://www.fbo.gov. All responsible sources may submit proposals. This is not a request for proposals. This requirement is defined as code 541990 under the North American Industry Classification System (NAICS).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH-18-R-0047_PRESOLICITATION/listing.html)
- Place of Performance
- Address: Contractor Facility, United States
- Record
- SN04861393-W 20180322/180320231900-e04610fb285f6d59003cace108926376 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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