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Fogarty, Jennifer A.

Publications and source records attributed to Fogarty, Jennifer A..

Open Collaboration: A Problem Solving Strategy That is Redefining NASA's Innovative Spirit

In 2010, NASA's Space Life Sciences Directorate announced the successful results from pilot experiments with open innovation methodologies. Specifically, utilization of internet based external crowdsourcing platforms to solve challenging problems in human health and performance related to the future of spaceflight. The follow-up to this success was an internal crowdsourcing pilot program entitled NASA@work, which was supported by the InnoCentive@work software platform. The objective of the NASA@work pilot was to connect the collective knowledge of individuals from all areas within the NASA organization via a private web based environment. The platform provided a venue for NASA Challenge Owners, those looking for solutions or new ideas, to pose challenges to internal solvers, those within NASA with the skill and desire to create solutions. The pilot was launched in 57 days, a record for InnoCentive and NASA, and ran for three months with a total of 20 challenges posted Agency wide. The NASA@work pilot attracted over 6,000 participants throughout NASA with a total of 183 contributing solvers for the 20 challenges posted. At the time of the pilot's closure, solvers provided viable solutions and ideas for 17 of the 20 posted challenges. The solver community provided feedback on the pilot describing it as a barrier breaking activity, conveying that there was a satisfaction associated with helping co-workers, that it was fun to think about problems outside normal work boundaries, and it was nice to learn what challenges others were facing across the agency. The results and the feedback from the solver community have demonstrated the power and utility of an internal collaboration tool, such as NASA@work.

Rando, Cynthia M.↗

A New Business Model for Problem Solving-Infusing Open Collaboration and Innovation Health and Human Services

This slide presentation reviews the Space Life Sciences Directorate (SLSD) new business model for problem solving, with emphasis on open collaboration and innovation. The topics that are discussed are: an overview of the work of the Space Life Sciences Directorate and the strategic initiatives that arrived at the new business model. A new business model was required to infuse open collaboration/innovation tools into existing models for research, development and operations (research announcements, procurements, SBIR/STTR etc). This new model involves use of several open innovation partnerships: InnoCentive, Yet2.com, TopCoder and NASA@work. There is also a new organizational structure developed to facilitate the joint collaboration with other NASA centers, international partners, other U.S. Governmental organizations, Academia, Corporate, and Non-Profit organizations: the NASA Human Health and Performance Center (NHHPC).

Davis, Jeffrey R.↗

Open Collaboration: A Problem Solving Strategy That Is Redefining NASA's Innovative Spirit

In 2010, NASA?s Space Life Sciences Directorate announced the successful results from pilot experiments with open innovation methodologies. Specifically, utilization of internet based external crowd sourcing platforms to solve challenging problems in human health and performance related to the future of spaceflight. The follow-up to this success was an internal crowd sourcing pilot program entitled NASA@work, which was supported by the InnoCentive@work software platform. The objective of the NASA@work pilot was to connect the collective knowledge of individuals from all areas within the NASA organization via a private web based environment. The platform provided a venue for NASA Challenge Owners, those looking for solutions or new ideas, to pose challenges to internal solvers, those within NASA with the skill and desire to create solutions. The pilot was launched in 57 days, a record for InnoCentive and NASA, and ran for three months with a total of 20 challenges posted Agency wide. The NASA@work pilot attracted over 6000 participants throughout NASA with a total of 183 contributing solvers for the 20 challenges posted. At the time of the pilot?s closure, solvers provided viable solutions and ideas for 17 of the 20 posted challenges. The solver community provided feedback on the pilot describing it as a barrier breaking activity, conveying that there was a satisfaction associated with helping co-workers, that it was "fun" to think about problems outside normal work boundaries, and it was nice to learn what challenges others were facing across the agency. The results and the feedback from the solver community have demonstrated the power and utility of an internal collaboration tool, such as NASA@work.

Rando, Cynthia M.↗

Johnson Space Center Health and Medical Technical Authority

1.HMTA responsibilities: a) Assure program/project compliance with Agency health and medical requirements at identified key decision points. b) Certify that programs/projects comply with Agency health and medical requirements prior to spaceflight missions. c) Assure technical excellence. 2. Designation of applicable NASA Centers for HMTA implementation and Chief Medical Officer (CMO) appointment. 3. Center CMO responsible for HMTA implementation for programs and projects at the center. JSC HMTA captured in "JSC HMTA Implementation Plan". 4. Establishes specifics of dissenting opinion process consistent with NASA procedural requirements.

Fogarty, Jennifer A.↗

From Shuttle Main Engine to the Human Heart: A Presentation to the Federal Lab Consortium for Technology Transfer

A NASA engineer received a heart transplant performed by Drs. DeBakey and Noon after suffering a serious heart attack. 6 months later that engineer returned to work at NASA determined to use space technology to help people with heart disease. A relationship between NASA and Drs. DeBakey and Noon was formed and the group worked to develop a low cost, low power implantable ventricular assist device (VAD). NASA patented the method to reduce pumping damage to red blood cells and the design of a continuous flow heart pump (#5,678,306 and #5,947,892). The technology and methodology were licensed exclusively to MicroMed Technology, Inc.. In late 1998 MicroMed received international quality and electronic certifications and began clinical trials in Europe. Ventricular assist devices were developed to bridge the gap between heart failure and transplant. Early devices were cumbersome, damaged red blood cells, and increased the risk of developing dangerous blood clots. Application emerged from NASA turbopump technology and computational fluid dynamics analysis capabilities. To develop the high performance required of the Space Shuttle main engines, NASA pushed the state of the art in the technology of turbopump design. NASA supercomputers and computational fluid dynamics software developed for use in the modeling analysis of fuel and oxidizer flow through rocket engines was used in the miniaturization and optimization of a very small heart pump. Approximately 5 million people worldwide suffer from chronic heart failure at a cost of 40 billion dollars In the US, more than 5000 people are on the transplant list and less than 3000 transplants are performed each year due to the lack of donors. The success of ventricular assist devices has led to an application as a therapeutic destination as well as a bridge to transplant. This success has been attributed to smaller size, improved efficiency, and reduced complications such as the formation of blood clots and infection.

Fogarty, Jennifer A.↗

Investment in Open Innovation Service Providers: NASA's Innovative Strategy for Solving Space Exploration Challenges

In an effort to expand routes for open communication and create additional opportunities for public involvement with NASA, Open Innovation Service Provider (OISP) methodologies have been incorporated as a tool in NASA's problem solving strategy. NASA engaged the services of two OISP providers, InnoCentive and Yet2.com, to test this novel approach and its feasibility in solving NASA s space flight challenges. The OISPs were chosen based on multiple factors including: network size and knowledge area span, established process, methodology, experience base, and cost. InnoCentive and Yet2.com each met the desired criteria; however each company s approach to Open Innovation is distinctly different. InnoCentive focuses on posting individual challenges to an established web-based network of approximately 200,000 solvers; viable solutions are sought and granted a financial award if found. Based on a specific technological need, Yet2.com acts as a talent scout providing a broad external network of experts as potential collaborators to NASA. A relationship can be established with these contacts to develop technologies and/or maintained as an established network of future collaborators. The results from the first phase of the pilot study have shown great promise for long term efficacy of utilizing the OISP methodologies. Solution proposals have been received for the challenges posted on InnoCentive and are currently under review for final disposition. In addition, Yet2.com has identified new external partners for NASA and we are in the process of understanding and acting upon these new opportunities. Compared to NASA's traditional routes for external problem solving, the OISP methodologies offered NASA a substantial savings in terms of time and resources invested. In addition, these strategies will help NASA extend beyond its current borders to build an ever expanding network of experts and global solvers.

Fogarty, Jennifer A.↗

Visual Impairment/Intracranial Pressure Risk Assessment

Since 2006 there have been 6 reported cases of altered visual acuity and intracranial pressure (ICP) in long duration astronauts. In order to document this risk and develop an integrated approach to its mitigation, the NASA Space Life Sciences Directorate (SLSD) and Human Research Program (HRP) have chosen to use the Human System Risk Board (HSRB) and the risk management analysis tool (RMAT). The HSRB is the venue in which the stakeholders and customers discuss and vet the evidence and the RMAT is the tool that facilitates documentation and comparison of the evidence across mission profiles as well as identification of risk factors, and documentation of mitigation strategies. This process allows for information to be brought forward and dispositioned so that it may be properly incorporated into the RMAT and contribute to the design of the research and mitigation plans. The evidence thus far has resulted in the identification of a visual impairment/intracranial pressure (VIIP) project team, updating of both short and long duration medical requirements designed to assess visual acuity, and a research plan to characterize this issue further. In order to understand this issue more completely, a plan to develop an Accelerated Research Collaboration (ARC) has been approved by the HSRB. The ARC is a novel research model pioneered by the Myelin Repair Foundation. It is a patient centered research model that brings together researchers and clinicians, under the guidance of a scientific advisory panel, to collaborate and produce results much quickly than accomplished through traditional research models. The data and evidence from the updated medical requirements and the VIIP ARC will be reviewed at the HSRB on a regular basis. Each review package presented to the HSRB will include an assessment and recommendation with respect to continuation of research, countermeasure development, occupational surveillance modalities, selection criteria, etc. This process will determine the course of the VIIP project and ultimately how SLSD and HRP mitigate this emerging human health and performance risk.

Fogarty, Jennifer A.↗

Visual Impairment and Intracranial Hypertension: An Emerging Spaceflight Risk

What is the risk? Given that astronauts exposed to microgravity experience a cephalad fluid shift, and that both symptomatic and asymptomatic astronauts have exhibited optic nerve sheath edema on MRI, there is a high probability that all astronauts have some degree of increased intracranial pressure (ICP; intracranial hypertension), and that those susceptible (via eye architecture, anatomy, narrow optic disc) have a high likelihood of developing papilledema (optic disc edema, globe flattening), choroidal folds, and/or hyperopic shifts and that the degree of edema may determine long-term or permanent vision impairment or loss. Back to back panels on this topic have been developed to address this emerging risk. The first panel will focus on the 6 clinical cases with emphasis on ophthalmic findings and imaging techniques used pre-, in-, and post-flight. The second panel will discuss the operational mitigation and medical requirements, the potential role of CO2 on ISS, and the research approach being developed. In total these back to back panels will explore what is known about this risk, what has been done immediately to address it, and how an integrated research model is being developed.

Fogarty, Jennifer A.↗

Impact of CO2 on Intracranial Hypertension in Spaceflight. Visual Impairment and Intracranial Hypertension: An Emerging Spaceflight Risk [Part 1 and 2]

A. CO2 - Acute: Given the history of uneven removal of CO2 from spacecraft areas, there is a history of acute illness that impacts short-term health and performance. 1) Acute CO2 symptoms occur in space flight due to a combination of CO2 scrubbing limitations, microgravity-related lack of convection, and possibly interaction with microgravity-related physiological changes. 2) Reported symptoms mainly include headaches, malaise, and lethargy. Symptoms are treatable with analgesics, rest, temporarily increasing scrubbing capability, and breathing oxygen. This does not treat the underlying pathology. 3)ld prevent occurrence of symptoms. B. CO2 - Chronic: Given prolonged exposure to elevated CO2 levels, there is a history that the long-term health of the crew is impacted. 1) Chronic CO2 exposures occur in space flight due to a combination of CO2 scrubbing limitations and microgravity-related lack of convection, with possible contribution from microgravity-related physiological changes. 2) Since acute symptoms are experienced at levels significantly lower than expected, there are unidentified long-term effects from prolonged exposure to elevated CO2 levels on orbit. There have been long term effects seen terrestrially and research needed to further elucidate long term effects on orbit. 3) Recommended disposition: Research required to further elucidate long term effects. In particular, elucidation of the role of elevated CO2 on various levels of CO2 vasodilatation of intracranial blood vessels and its potential contribution to elevation of intracranial pressure.

Fogarty, Jennifer A.↗

Research to Operations: The Critical Transition

Space Life Sciences Directorate (SLSD) specializes in transitioning technology and knowledge to medical operations. This activity encompasses funding a spectrum of research and technology efforts, such as understanding fundamental biological mechanisms altered by microgravity and executing technology watches for state of the art diagnostic imaging equipment. This broad spectrum approach to fulfilling the need to protect crewmember health and performance during long and short duration missions to the International Space Station, moon and Mars is made possible by having a line of site between research and operations. Currently, SLSD's line of site is articulated in a transition to medical practice (TMP) process. This process is designed to shepherd information and knowledge gained through fundamental and mechanistic research toward the development of an operational solution such as a pre-flight selection criteria; an in-flight countermeasure, monitoring capability or treatment; or a post-flight reconditioning program. The TMP process is also designed to assist with the customization of mature hardware or technology for NASA specific use. The benefits of this process are that the concept of operational usability is interjected early in the research, design, or acquisition phase, and stakeholders are involved early to identify requirements and also periodically asked to assess requirements compliance of research or technology development project. Currently a device known as the actiwatch is being assessed for the final transition to operational use. Specific examples of research to operations transition success help to illustrate the process and bolster communication between the research and medical operations communities.

Fogarty, Jennifer A.↗

An Effective Health and Medical Technical Authority

The NASA Governance model directed the formation of three Technical Authorities, Engineering; Safety and Mission Assurance; and Health and Medical, to ensure that risks are identified and adjudicated efficiently and transparently in concert with the spaceflight programs and projects. The Health and Medical Technical Authority (HMTA) has been implemented at the Johnson Space Center (JSC) and consists of the Chief Medical Office (CMO), the Deputy CMO, and HMTA Delegates. The JSC HMTA achieves the goals of risk identification and adjudication through the discharge of the appropriate technical expertise to human space flight programs and projects and the escalation of issues within program and technical authority boards. The JSC HMTA relies on subject matter experts (SMEs) in the Space Life Sciences Directorate at JSC as well as experts from other Centers to work crew health and performance issues at the technical level, develop requirements, oversee implementation and validation of requirements, and identify risks and non-compliances. Once a risk or potential noncompliance has been identified and reported to the programs or projects, the JSC HMTA begins to track it and closely monitor the program's or project's response. As a risk is developed or a non-compliance negotiated, positions from various levels of decision makers are sought at the program and project control boards. The HMTA may support a program or project position if it is satisfied with the decision making and vetting processes (ex. the subject matter expert voiced his/her concerns and all dissenting opinions were documented) and finds that the position both acknowledges the risk and cost of the mitigation and resolves the issue without changing NASA risk posture. The HMTA may disagree with a program or project position if the NASA risk posture has been elevated or obfuscated. If the HMTA does disagree with the program or project position, it will appeal to successively higher levels of authority so that risk acceptance and risk trades will be acknowledged and sanctioned at the highest appropriate level; this includes Program Managers, Mission Directorate Associate Administrators and the Agency Administrator.

Fogarty, Jennifer A.↗

Bisphosphonate Treatment: Risk Management in Long Duration Spaceflight

Bisphosphonates are a class of pharmaceuticals used to treat diverse bone disorders such as osteoporosis, Paget's disease, and multiple myeloma. They constitute a class of drugs which adhere to bony surfaces and interfere with the resorptive activity of osteoclasts. They also represent a potential countermeasure towards the loss of bone mass experienced by astronauts during spaceflight. Recently, the medical literature has revealed cases of osteonecrosis of the jaw in individuals receiving intravenous bisphosphonate therapy with a smaller number of cases occurring in individuals receiving the oral form of the medication. Risk management for long duration missions requires consideration of mission success and lifetime health care of astronauts. We performed MEDLINE and PubMed searches (1966 December 2006) using the following keywords: osteonecrosis, jaw, bisphosphonates. Additional references were obtained from the citations of the retrieved articles. Injectable bisphosphonates such as pamidronate and zoledronic acid have been highlighted recently in the literature due to a possible link with osteonecrosis of the jaw. The mechanism of action remains unclear but may be linked to physiologic microdamage in the jawbones resulting from suppression of bone metabolism. The most predisposing factors appear to be the type and dose of bisphosphonate used, a history of dental surgery, trauma, and/or dental infection. In addition, patients diagnosed with a malignancy such as breast cancer or multiple myeloma, who have been on intravenous bisphosphonate therapy for several months seem to be at increased risk. The use of oral bisphosphonates appears to place patients more at risk from acute events such as gastrointestinal tract injury or perforation. Although some studies report little to no increase in GI events compared to placebo, we must remember that in microgravity, astronauts may be unable to comply with medication instructions. They may have difficulty remaining upright for the required 30-45 minutes post-ingestion. We are currently unaware if this inability to comply with instructions on the package insert may lead to an increased risk for GI events. There is a potential long-term complication that resides with both forms of bisphosphonate therapy. In order to repair normally occurring physiologic microdamage to bone, both osteoclastic resorption and osteoblastic bone deposition must be functional. Controversy exists in the literature regarding whether prolonged use of bisphosphonates may lead to the suppression of bone turnover and accumulation of microdamage. Bisphosphonates are a powerful class of drugs that suppress bone turnover, but may cause serious adverse clinical events such as gastrointestinal tract injury or osteonecrosis of the jaw. Unfortunately, little to no data exists currently which may help us provide answers regarding the risks of their use in a healthy astronaut cohort. While controversy exists in the literature regarding their mechanism and long-term consequences, the potential mission impact or lifetime health care impact of an adverse clinical event resulting from bisphosphonate therapy must be considered.

Fogarty, Jennifer A.↗