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Neuroinflammation is a burgeoning area of interest in academia and biopharma, with a broadly acknowledged role in many central nervous system (CNS) disorders. However, there is little agreement on the pathophysiological mechanisms that underlie the manifestations of neuroinflammation in the CNS compartment and how neuroinflammation operates as a driver and also as a consequence of disease in the brain. Moreover, another unclear area is how to translate increased understanding of the mechanisms that underlie neuroinflammation and its manifestations in the CNS to therapeutics. To address these gaps in understanding mechanisms and how to translate that understanding into therapeutics, the Forum on Neuroscience and Nervous System Disorders of the National Academies of Sciences, Engineering, and Medicine convened a workshop on March 20-21, 2017, bringing together key leaders in the field from industry, academia, and governmental agencies to explore the role and mechanisms of neuroinflammation in a variety of CNS diseases. The workshop also considered strategies to advance the identification and validation of biomarkers of neuroinflammation that could accelerate development of therapies, bringing much-needed treatments to patients with disorders ranging from neuroinflammatory diseases such as multiple sclerosis (MS) to neuropsychiatric disorders such as depression. This publication summarizes the presentations and discussions from the workshop.
Randomized controlled trials (RCTs) have traditionally served as the gold standard for generating evidence about medical interventions. However, RCTs have inherent limitations and may not reflect the use of medical products in the real world. Additionally, RCTs are expensive, time consuming, and cannot answer all questions about a product or intervention. Evidence generated from real-world use, such as real-world evidence (RWE) may provide valuable information, alongside RCTs, to inform medical product decision making. To explore the potential for using RWE in medical product decision making, the National Academies of Sciences, Engineering, and Medicine planned a three-part workshop series. The series was designed to examine the current system of evidence generation and its limitations, to identify when and why RWE may be an appropriate type of evidence on which to base decisions, to learn from successful initiatives that have incorporated RWE, and to describe barriers that prevent RWE from being used to its full potential. This publication summarizes the discussions from the entire workshop series.
The Department of Homeland SecurityaEURO (TM)s (DHSaEURO (TM)s) BioWatch program aims to provide an early indication of an aerosolized biological weapon attack. The first generation of BioWatch air samplers were deployed in 2003. The current version of this technology, referred to as Generation 2 (Gen-2), uses daily manual collection and testing of air filters from each monitor, a process that can take 12 to 36 hours to detect the presence of biological pathogens. Until April 2014, DHS pursued a next-generation autonomous detection technology that aimed to shorten the time from sample collection to detection to less than 6 hours, reduce the cost of analysis, and increase the number of detectable biological pathogens. Because of concerns about the cost and effectiveness of the proposed Generation 3 system (Gen-3), DHS cancelled its acquisition plans for the next-generation surveillance system. In response to the cancellation announcement, Congress asked the Government Accountability Office (GAO) to conduct a review of the program and the proposed system enhancements that would have been incorporated in BioWatch Gen-3. However, Mike Walter, BioWatch Program manager, Office of Health Affairs, DHS, said that DHS did not agree with all of GAOaEURO (TM)s characterizations of the BioWatch program efforts described in this review. In response to this, DHS requested that the National Academies of Sciences, Engineering, and Medicine conduct a workshop to further explore the findings of the 2015 GAO report and discuss the impact these findings may have with regard to the future development of the technical capabilities of the BioWatch program. Workshop participants also discussed existing and possible collaborations between BioWatch, public health laboratories, and other stakeholders that could contribute to the enhancement of biosurveillance capabilities at the federal, state, and local levels. This publication summarizes the presentations and discussions from the workshop.
On June 26, 2017, the Forum on Regenerative Medicine hosted a public workshop in Washington, DC, titled Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies in order to examine and discuss the challenges, opportunities, and best practices associated with defining and measuring the quality of cell and tissue products and raw materials in the research and manufacturing of regenerative medicine therapies. The goal of the workshop was to learn from existing examples of the manufacturing of early-generation regenerative medicine products and to address how progress could be made in identifying and measuring critical quality attributes. The workshop also addressed the challenges of designing and adhering to standards as a way of helping those who are working to scale up processes and techniques from a research laboratory to the manufacturing environment. This publication summarizes the presentations and discussions from the workshop.
The organ donation and transplantation system strives to honor the gift of donated organs by fully using those organs to save and improve the quality of the lives of their recipients. However, there are not enough donated organs to meet the demand and some donated organs may not be recovered, some recovered organs may not be transplanted, and some transplanted organs may not function adequately. Organ donor intervention research can test and assess interventions (e.g., medications, devices, and donor management protocols) to maintain or improve organ quality prior to, during, and following transplantation. The intervention is administered either while the organ is still in the deceased donor or after it is recovered from the donor but before it is transplanted into a recipient. Organ donor intervention research presents new challenges to the organ donation and transplantation community because of ethical questions about who should be considered a human subject in a research study, whose permission and oversight are needed, and how to ensure that such research does not threaten the equitable distribution of a scarce and valuable resource. Opportunities for Organ Donor Intervention Research focuses on the ethical, legal, regulatory, policy, and organizational issues relevant to the conduct of research in the United States involving deceased organ donors. This report provides recommendations for how to conduct organ donor intervention research in a manner that maintains high ethical standards, that ensures dignity and respect for deceased organ donors and their families, that provides transparency and information for transplant candidates who might receive a research organ, and that supports and sustains the publicaEURO (TM)s trust in the process of organ donation and transplantation.
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