SATPC0030663 Tab 04 4 SOW_Redacted.pdf

STATEMENT OF WORK

Assessment of Efficacy and Safety for Pharmaceuticals for Long Duration 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.) to assess the efficacy and safety of pharmaceuticals. This assessment intends on incorporating additional consideration from previous approaches of the unique factors present in space craft environments. Such considerations include sustained impacts of differences from typical commercial levels of carbon dioxide, relative humidity, levels of cosmic sources of electromagnetic energy, among others. The overall goal is to develop an assessment framework, validate the utility of the framework using case studies, and publish the findings.

2. Characteristics, Scope, and Specs

The contractor shall perform the following duties:

• Task One (Months 1-8) o Meet with NASA personnel (e.g., the ExMC Pharm Strategist, Pharm Project

Manager) monthly to review findings, scientific developments and progress focused to the successful completion of the goals of the project.

• Task Two (Months 1-3) o Perform a summary of existing literature and assessment methods.

o Develop a critical analysis of the current state of science regarding aspects of pharmaceutical degradation

▪ Impacts of radiation and atmosphere on drug stability

▪ Including a description of current in silico tools for predicting pharmaceutical degradation profiles and their applicability, relevance, and limitations for the NASA medical formulary and space flight conditions.

o Provide current methodologies used for assessment of drug degradation and impurity safety assessment.

▪ Analysis will cover current International Council for Harmonisation of

Technical Requirements for Pharmaceuticals for Human Use (ICH), FDA, and European Medicines Agency (EMA) methodologies.

▪ Analysis of common best practices will be included, as many of the degradants formed would not have existing toxicology testing data.

o The deliverable is the product of the state of the science analysis will be a written as a technical report that is developed in a style that amenable to submission for publication in a peer-reviewed journal. The report will be revised per two rounds of comments from NASA ExMC staff.

• Task Three (Months 4-6) o Develop assessment framework to be applied for diverse drug products and exposure assumptions relevant to the NASA medical formulary.

o The deliverable is the assessment framework will be developed as a second technical report that is developed in a style that amenable to submission for publication in a peer-reviewed journal. The report will be revised per two rounds of comments from ExMC staff.

• Task Four (Months 7-8) o Application of the framework developed in Task 3 will be demonstrated through a case study approach. Four drugs of interest to NASA utilized in development of the framework will be selected as case studies to demonstrate the utility of the full framework.

o The four case study assessments will be included in a third technical report that is developed in a style that amenable to submission for publication in a peer-reviewed journal. Assessment dossiers for each drug will be developed as a technical appendix to this report. The report will be revised per two rounds of comments from ExMC staff.

3.

4. Period of Performance

Eight months from award