SATPC0033436 Tab 07 SOW_Redacted.pdf
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- Solicitation number
- 80NSSC24852733Q
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This statement of work outlines requirements for a manuscript on the assessment of efficacy and safety for pharmaceuticals intended for long-duration space missions. The contractor will perform project management including monthly communication with NASA personnel and meetings to discuss manuscript revisions. The manuscript will present an assessment framework to evaluate potential for active pharmaceutical ingredient degradant formation and associated health risks, and demonstrate the framework's application through case studies of two diverse APIs from NASA's formulary. The contractor will draft the manuscript, incorporate existing introductory and discussion material as appropriate, revise the manuscript once in response to NASA feedback, submit the manuscript to a journal to be determined, and revise it once in response to journal reviewers' comments. The period of performance is seven months from award. The related federal contract opportunity is a special notice from the National Aeronautics and Space Administration Shared Services Center soliciting proposals for the preparation and submission of this manuscript.
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STATEMENT OF WORK
Manuscript on Assessment of Efficacy and Safety for Pharmaceuticals for Space Missions
1. Objective/Requirements
Human exploration of the Moon, Mars and other destinations beyond Earth orbit will present significant new challenges to crew health. During exploration missions, the crew will need medical capabilities to diagnose and treat injury or disease. The Exploration Medical Capability (ExMC) is the owner of the Pharmaceutical risk of ineffective or toxic medications during long-duration exploration spaceflight.
Engaging with Stantec Consulting Services Inc. (Cardno GS, Inc.) and their expertise in the assessment of the efficacy and safety of pharmaceuticals. The manuscript will present a developed assessment framework to evaluate the potential for active pharmaceutical ingredient (API) degradant formation and the potential associated health risks and demonstrate the application and utility of the framework through two case studies of diverse APIs selected from the NASA formulary.
2. Characteristics, Scope, and Specs
The contractor shall perform the following duties:
Task One Project Management o Communicate monthly with NASA personnel (e.g., the ExMC Pharm Strategist, Pharm Project Manager) on project goals and progress and call any meetings to discuss manuscript revisions.
Task Two o This manuscript will :
present the developed assessment framework to evaluate the potential for active pharmaceutical ingredient (API) degradant formation and the potential associated health risks demonstrate the application and utility of the framework through two case studies of diverse APIs selected from the NASA formulary o The information gathered in the previous state of the science review will be leveraged as introductory and discussion material where appropriate.
This task includes drafting the manuscript, one round of revisions from NASA (ExMC Pharm Strategist, Pharm PM, and ExMC Element Science), submission to the selected journal (TBD), and one round of revisions in response to the journal reviewers.
3.
4. Period of Performance
Seven months from award
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