1. ©2006, The Aerospace Corporation, All Rights Reserved For Volpe Center and FAA/AST Use Only 1 Vernon McDonald, Ph.D. Wyle Laboratories DOT Volpe Center Contract DTRT57-05-D-30103, Task Order #6 Summary Presentation: FAA/AST COMSTAC RLV Working Group 17 May 2007 AST Commercial Human Space Flight Biomedical Data Collection

2. ©2006, The Aerospace Corporation, All Rights Reserved For Volpe Center and FAA/AST Use Only 2 Outline Participants/Contacts Scope Approach Subtasks 1 – 3 Process Findings Recommendations Recommended Next Steps

3. ©2006, The Aerospace Corporation, All Rights Reserved For Volpe Center and FAA/AST Use Only 3 Scope Scope: The Commercial Space Launch Amendments Act of 2004 requires that space flight participants be fully informed of the risks associated with commercial space flight operations. The intent of this task was to assist the AST Commercial Human Space Flight Biomedical Data Collection Program in defining the risks required for disclosure to space flight participants and in proactively developing corrective actions to reduce such risks.

4. ©2006, The Aerospace Corporation, All Rights Reserved For Volpe Center and FAA/AST Use Only 4 Subtasks 1.Identify in-flight and ground biomedical parameters that will enable characterization of medical and biological effects experienced by the human body during spaceflight. 2.Identify in-flight and ground biomedical equipment and requirements necessary to monitor, measure and record the recommended parameters identified in Subtask 1. 3.Create a biomedical safety database, and identify the information technology equipment and requirements needed by AST to continuously analyze sensitive safety data generated from commercial space transportation activities. Identify compatibility with importing existing NASA data.

5. ©2006, The Aerospace Corporation, All Rights Reserved For Volpe Center and FAA/AST Use Only 5 What we did NOT do Did NOT address recommendations for medical standards to be used in certifying participants for the purpose of suborbital flight. Did NOT define any data acquisition requirements –It is assumed that implementation of these recommendations would be on a voluntary basis by the commercial human space flight industry. –In addition, the recommendations made in this report consider biomedical monitoring of those individuals who are permitted to fly suborbital flights. Consequently, one must assume that there will be a certain number of medical conditions that will not be seen in the suborbital flight participants, because operator medical qualification standards deem them to contraindicate suborbital space flight. –The recommendations, if followed, should result in a more complete understanding of the effects of suborbital flight on human physiology. Were NOT asked to consider vehicle/environmental data acquisition recommendations

6. ©2006, The Aerospace Corporation, All Rights Reserved For Volpe Center and FAA/AST Use Only 6 Approach Goal: Identification and recommendation of specific biomedical data, equipment, and a database that will increase the knowledge and understanding of how short duration exposure to microgravity affects the human body Objective: Recommend acquisition of biomedical parameters to characterize the cohort that is permitted to fly suborbital flights. Underlying Question: How widely can the window of acceptable health can be opened and still provide a safe spaceflight experience for passengers?

7. ©2006, The Aerospace Corporation, All Rights Reserved For Volpe Center and FAA/AST Use Only 7 Approach (cont’d) Review existing spaceflight data to ascertain those medical events occurring during launch, the first few minutes of microgravity flight, and reentry. Review planned G profiles of commercial suborbital reusable spaceflight vehicles, where available, to ascertain the most likely G profile anticipated for spaceflight passengers. Review existing data from human centrifuge testing to identify those medical events occurring during G x / G z profiles similar to those likely to be seen in commercial spacecraft. Review demographics and anticipated medical history of individuals most likely to constitute the passengers for commercial suborbital spaceflight. Develop matrix of potential health risks across various flight profiles.

8. ©2006, The Aerospace Corporation, All Rights Reserved For Volpe Center and FAA/AST Use Only 8 Approach (cont’d) Based on these initial data reviews, as well as as our experience in supporting astronauts during training and spaceflight, identify those ground-based and in-flight biomedical parameters that will allow for characterization of the biomedical effects to be experienced by commercial suborbital spaceflight passengers. Evaluate the capabilities of existing COTS/GOTS hardware used to monitor the identified biomedical parameters both in ground-based testing and in-flight monitoring. Develop requirements for ground-based and in-flight monitoring equipment. Compare existing equipment to the requirements and identify new equipment requirements, if any. Identify operator requirements for use of the equipment.

9. ©2006, The Aerospace Corporation, All Rights Reserved For Volpe Center and FAA/AST Use Only 9 Approach (cont’d) Database requirements definition: Review existing databases used to record and analyze astronaut biomedical parameters. Define requirements for a database suitable for commercial suborbital spaceflight passenger data: –Data elements –Confidentiality protection –Data analysis and comparison requirements Identify information technology equipment requirements to assure compatibility with and importability from existing databases.

10. ©2006, The Aerospace Corporation, All Rights Reserved For Volpe Center and FAA/AST Use Only 10 Subtask 1 - Process Identify in-flight and ground biomedical parameters that will enable characterization of medical and biological effects experienced by the human body during spaceflight. Identified medical conditions and environmental parameters of concern to support rationale for proposed biomedical parameters Obtained information from space tourist operators about their vehicles’ G profile and cabin atmosphere parameters (limited information available) Reviewed literature and military sources for data on centrifuge/high G tests on human subjects other than healthy, young fighter aircraft pilots – no research data found in populations similar to the space tourist population Reviewed existing launch, in-flight, and landing medical and performance data from prior suborbital missions (Mercury, X15), Reviewed data from orbital spaceflight launches for relevant medical data

11. ©2006, The Aerospace Corporation, All Rights Reserved For Volpe Center and FAA/AST Use Only 11 Subtask 1 - Findings Limited human suborbital data –No significant physiological effects –No performance impairment Astronaut population and centrifuge study participants generally young, healthy, and have already passed stringent medical standards Commercial vehicle flight profiles are not generally available – assumed max of 4G-7G, predominantly x-axis (eyes in) Factors likely impacting passenger health/comfort –G-loads –Cabin atmosphere (composition/pressure/temperature/humidity) –Thermal load –Dehydration –Multi-axis motion –Confinement –Anxiety

12. ©2006, The Aerospace Corporation, All Rights Reserved For Volpe Center and FAA/AST Use Only 12 Subtask 1 – Findings (cont’d) Recommended systems of interest –Cardiac Pre (+ centrifuge) In Post –Pulmonary Pre (+ centrifuge) In Post –Musculoskeletal Pre Post –Neurovestibular Pre Post Recommended systems of interest (cont’d) –Psychological Pre Post –Gastrointestinal Pre Post –Hematological Pre Post –Vehicle/environmental In

13. ©2006, The Aerospace Corporation, All Rights Reserved For Volpe Center and FAA/AST Use Only 13 Subtask 1 Recommendations In sequential order: 1.Perform and evaluate medical history and physical exam data 2.Design & perform client specific pre-flight testing protocol 3.Perform provocative pre-flight testing where required 4.Perform centrifuge testing on all clients 5.Design client specific post-flight testing protocol 6.Perform in-flight monitoring on all clients 7.Perform post-flight testing

14. ©2006, The Aerospace Corporation, All Rights Reserved For Volpe Center and FAA/AST Use Only 14 Subtask 2 - Process Identify in-flight and ground biomedical equipment and requirements necessary to monitor, measure and record the recommended parameters identified in Subtask 1. Developed requirements driven by Subtask 1 and knowledge of the environment/use Reviewed existing NASA equipment for biomedical monitoring Reviewed COTS equipment for biomedical monitoring Reviewed available R&D efforts in this area

15. ©2006, The Aerospace Corporation, All Rights Reserved For Volpe Center and FAA/AST Use Only 15 Subtask 2 - Findings Basic system requirements: Built-in power supply (no vehicle power needed) Built-in data storage capability – minimum 3 hours Include sensors for: –Pulse rate –Blood Pressure –Electrocardiogram, ECG (Frank electrodes or equivalent) –Oxygen saturation –Respiration rate Portable (can be carried by participant) Noninvasive Technology Readiness Level (TRL) 6-7 Recording Bandwidth: (ECG – 0.47 Hz to 40 Hz) Analog-to-Digital (A/D) resolution: no less than 10 bits

16. ©2006, The Aerospace Corporation, All Rights Reserved For Volpe Center and FAA/AST Use Only 16 Subtask 2 – Findings (cont’d) Unknowns: No definitive design/concept of operations data are available for the commercial space flight vehicles. Cannot define the operating environment No timeline, procedures, or plan to instrument the space flight participants currently exists. The exact vehicle seating configuration, Whether participants will be wearing a pressure suit, and to what degree participants will be able/allowed to leave their seat during the weightless portion of the flight. Without this information, it is challenging to identify a single ideal system compatible with the potentially diverse design and operating specifications. Also, it is most certainly desirable to collect the data during flight in a manner similar to ground-based controls.

17. ©2006, The Aerospace Corporation, All Rights Reserved For Volpe Center and FAA/AST Use Only 17 Subtask 2 – Findings (cont’d) Fully integrated patient monitoring systems –Good pedigree/proven technology –FDA approval –Not certified for suborbital flight environment –Limited flexibility Wearable systems –Some flexibility –No/partial FDA approval –Still developing pedigree –Lower TRL OEM system –Design specifically to meet requirements –Components FDA approved; system not –Requires design/development –Maximum flexibility

18. ©2006, The Aerospace Corporation, All Rights Reserved For Volpe Center and FAA/AST Use Only 18 Subtask 3 - Process Create a biomedical safety database, and identify the information technology equipment and requirements needed by AST to continuously analyze sensitive safety data generated from commercial space transportation activities. Identify compatibility with importing existing NASA data. Reviewed NASA biomedical databases Defined requirements for necessary IT infrastructure Reviewed and prepared set of recommendations for hardware and software to support an FAA database for commercial space transportation biomedical data

19. ©2006, The Aerospace Corporation, All Rights Reserved For Volpe Center and FAA/AST Use Only 19 Subtask 3 - Findings The main repositories of biomedical data pertaining to human space flight at NASA are: –The Electronic Medical Record (EMR) - astronaut digital health records in the Flight Medicine Clinic (supplemented by paper-based records) –The Longitudinal Study of Astronaut Health (LSAH) –The Life Sciences Data Archive (LSDA) These principal digital repositories are supplemented by several other sources of medical data including: –The Clinical Laboratory Information System (CLIS) –The Private Medical Conference (PMC) database –Medical Assessment Test (MAT) results Currently designing the Mission Medical Information System (MMIS)

20. ©2006, The Aerospace Corporation, All Rights Reserved For Volpe Center and FAA/AST Use Only 20 Subtask 3 – Findings (cont’d) To maximize compatibility with relevant NASA biomedical data, recommend archiving commercial human space flight medical data in a manner consistent with the design of pertinent NASA databases. The two specific databases that are most relevant are : –LSAH database - represents the best source for comparative analyses of coded medical data. –PMC database - To supplement the largely objective data elements of LSAH, we propose that the PMC database be used to capture verbal reports from space flight participants concerning their subjective health response during this experience, coupled with relevant mission operations data. Need to comply with Federal and State regulations concerning medical data management and privacy.

21. ©2006, The Aerospace Corporation, All Rights Reserved For Volpe Center and FAA/AST Use Only 21 Recent Progress Interest in pursuing implementation plan received from: –FAA/AST –FAA/CAMI –NASA –Operator Developed “Value Proposition” white paper and shared with number of stakeholders –Based on a collaborative effort between NASA, FAA, and Operators (perhaps represented by the PSF)

22. ©2006, The Aerospace Corporation, All Rights Reserved For Volpe Center and FAA/AST Use Only 22 Proposed Next Steps FAA &/or NASA secure funding for Phase 1 – Program Definition Phase 1 – Program Definition –Negotiate Stakeholder Agreements FAA/NASA MOU PSF Operators –Develop agreed to set of goals, requirements and deliverables –Develop detailed program plan, schedule and budget Phase 2 - Development & Implementation Phase 3 - Sustaining Operations –Develop milestones/decision points/metrics for program tracking –Develop criteria for providing authority to proceed FAA & NASA secure funding to initiate Phase 2 Initiate Phase 2 - Development & Implementation Review Phase 3 plan & revise if necessary based on current data FAA & NASA secure funding to initiate Phase 3 Initiate Phase 3 - Sustaining Operations

23. ©2006, The Aerospace Corporation, All Rights Reserved For Volpe Center and FAA/AST Use Only 23 BACKUP

24. ©2006, The Aerospace Corporation, All Rights Reserved For Volpe Center and FAA/AST Use Only 24 Contract Summary Contract: DTRT57-05-D-30103, Task Order #6 Subject: Identification and recommendation of specific biomedical data, equipment, and a database that will increase knowledge and understanding of how short duration exposure to microgravity affects the human body Purpose: To provide FAA/AST, through the Volpe Center, with technical support to the AST Commercial Human Space Flight Biomedical Data Collection Program in defining risks required for disclosure to space flight participants and in proactively developing corrective actions to reduce such risks Volpe Center COTR: Ann R. DiMare Volpe Center CO: Elizabeth A. Segal FAA/AST Technical POC: Michelle S. Murray Wyle Laboratories Program Manager: Dr. P. Vernon McDonald Wyle Laboratories Principal Investigator: Dr. James M. Vanderploeg Aerospace Program Manager: Robert W. Seibold Aerospace Contracts Administrator: Debra K. Smith

25. ©2006, The Aerospace Corporation, All Rights Reserved For Volpe Center and FAA/AST Use Only 25 Participants/Contacts Aerospace Corporation Program Manager: –Bob Seibold, (310) 336-1326, robert.w.seibold@aero.org Wyle Laboratories Program Manager: –P. Vernon McDonald, Ph.D., (281) 212-1362, vmcdonald@wylehou.com Wyle Laboratories Principal Investigator: –James Vanderploeg, M.D., (281) 212-1365, jvanderploeg@wylehou.com Wyle Laboratories Participants: –Kieran Smart, M.D., (281) 212-1305, ksmart@wylehou.com –Doug Hamilton, M.D., (281) 212-1391, dhamilton@wylehou.com –Ulf Baldin, M.D., (210) 536-6357, ulf.balldin@brooks.af.mil University of Texas Medical Branch (UTMB): –Richard T. Jennings, M.D., (409) 772-3458, rjenning@utmb.edu