@BOOK{NAP title = "Sustainable Federal Facilities: A Guide to Integrating Value Engineering, Life-Cycle Costing, and Sustainable Development", isbn = "978-0-309-07299-1", abstract = "In the late 1990s, several of the sponsor agencies of the Federal Facilities Council began developing and implementing initiatives and policies related to sustainable development. Guidance related to life-cycle costing and value engineering was recognized as being supportive of sustainable development, in particular when used in the conceptual planning and design phases of acquisition, where decisions are made that substantially effect the ultimate performance of a building over its life cycle. However, specific concerns were raised that when federal agencies apply value engineering in the final stages of design or during construction in response to cost overruns, design features that support sustainable development may be eliminated. The primary objective of this study, therefore, was to develop a framework to show how federal agencies can use value engineering and life-cycle costing to support sustainable development for federal facilities and meet the objectives of Executive Order 13123.", url = "https://nap.nationalacademies.org/catalog/10093/sustainable-federal-facilities-a-guide-to-integrating-value-engineering-life", year = 2001, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", title = "Forum on Regenerative Medicine: 2021 Annual Report", abstract = "The National Academies of Sciences, Engineering, and Medicine's Forum on Regenerative Medicine (the forum) provides a convening mechanism for interested parties from academia, industry, government, patient and provider organizations, regulatory bodies, foundations, societies, associations, and others. The forum identifies existing and potential barriers to scientific and therapeutic advances; discusses opportunities to assist in facilitating more effective partnerships among key stakeholders; examines the impact that current policies have on the discovery, development, and translation of regenerative medicine therapies; considers the unique challenges of identifying, validating, and bringing regenerative medicine applications to market; and explores the ethical, legal, and social issues posed by advances in regenerative medicine.\nDuring 2021, the forum members continued to focus on two broad areas through their two working groups: Regenerative Engineering and Gene Therapy and Systems Thinking. The members and staff also continued to explore challenges and discuss possible solutions in a number of other areas relevant to the development of regenerative medicines, including communication, workforce development, cost of and access to therapies, and regulatory and legislative affairs. This publication describes the activities of the forum during 2021. ", url = "https://nap.nationalacademies.org/catalog/26583/forum-on-regenerative-medicine-2021-annual-report", year = 2022, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "Adam C. Berger and Steve Olson", title = "Genome-Based Therapeutics: Targeted Drug Discovery and Development: Workshop Summary", isbn = "978-0-309-26024-4", abstract = "The number of new drug approvals has remained reasonably steady for the past 50 years at around 20 to 30 per year, while at the same time the total spending on health-related research and development has tripled since 1990. There are many suspected causes for this trend, including increases in regulatory barriers, the rising costs of scientific inquiry, a decrease in research and development efficiency, the downstream effects of patient expirations on investment, and the lack of production models that have successfully incorporated new technology. Regardless, this trajectory is not economically sustainable for the businesses involved, and, in response, many companies are turning toward collaborative models of drug development, whether with other industrial firms, academia, or government. Introducing greater efficiency and knowledge into these new models and aligning incentives among participants may help to reverse the trends highlighted above, while producing more effective drugs in the process.\n\nGenome-Based Therapeutics explains that new technologies have the potential to open up avenues of development and to identify new drug targets to pursue. Specifically, improved validation of gene-disease associations through genomics research has the potential to revolutionize drug production and lower development costs. Genetic information has helped developers by increasing their understanding of the mechanisms of disease as well as individual patients' reactions to their medications. There is a need to identify the success factors for the various models that are being developed, whether they are industry-led, academia-led, or collaborations between the two.\n\nGenome-Based Therapeutics summarizes a workshop that was held on March 21, 2012, titled New Paradigms in Drug Discovery: How Genomic Data Are Being Used to Revolutionize the Drug Discovery and Development Process. At this workshop the goal was to examine the general approaches being used to apply successes achieved so far, and the challenges ahead.", url = "https://nap.nationalacademies.org/catalog/13436/genome-based-therapeutics-targeted-drug-discovery-and-development-workshop-summary", year = 2012, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", editor = "Morgan L. Boname and Amanda Wagner Gee and Theresa Wizemann and Siobhan Addie and Sarah H. Beachy", title = "Enabling Precision Medicine: The Role of Genetics in Clinical Drug Development: Proceedings of a Workshop", isbn = "978-0-309-46263-1", abstract = "Those involved in the drug development process face challenges of efficiency and overall sustainability due in part to high research costs, lengthy development timelines, and late-stage drug failures. Novel clinical trial designs that enroll participants based on their genetics represent a potentially disruptive change that could improve patient outcomes, reduce costs associated with drug development, and further realize the goals of precision medicine. \n\nOn March 8, 2017, the Forum on Drug Discovery, Development, and Translation and the Roundtable on Genomics and Precision Health of the National Academies of Sciences, Engineering, and Medicine hosted the workshop Enabling Precision Medicine: The Role of Genetics in Clinical Drug Development. Participants examined successes, challenges, and possible best practices for effectively using genetic information in the design and implementation of clinical trials to support the development of precision medicines, including exploring the potential advantages and disadvantages of such trials across a variety of disease areas. This publication summarizes the presentations and discussions from the workshop.", url = "https://nap.nationalacademies.org/catalog/24829/enabling-precision-medicine-the-role-of-genetics-in-clinical-drug", year = 2017, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Research Council", title = "Controlling Cost Growth of NASA Earth and Space Science Missions", isbn = "978-0-309-15737-7", abstract = "Cost and schedule growth is a problem experienced by many types of projects in many fields of endeavor. Based on prior studies of cost growth in NASA and Department of Defense projects, this book identifies specific causes of cost growth associated with NASA Earth and space science missions and provides guidance on how NASA can overcome these specific problems. \n\nThe recommendations in this book focus on changes in NASA policies that would directly reduce or eliminate the cost growth of Earth and space science missions. Large cost growth is a concern for Earth and space science missions, and it can be a concern for other missions as well. If the cost growth is large enough, it can create liquidity problems for NASA's Science Mission Directorate that in turn cause cost profile changes and development delays that amplify the overall cost growth for other concurrent and\/or pending missions. Addressing cost growth through the allocation of artificially high reserves is an inefficient use of resources because it unnecessarily diminishes the portfolio of planned flights. The most efficient use of resources is to establish realistic budgets and reserves and effective management processes that maximize the likelihood that mission costs will not exceed reserves. NASA is already taking action to reduce cost growth; additional steps, as recommended herein, will help improve NASA's mission planning process and achieve the goal of ensuring frequent mission opportunities for NASA Earth and space science.", url = "https://nap.nationalacademies.org/catalog/12946/controlling-cost-growth-of-nasa-earth-and-space-science-missions", year = 2010, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Transportation Research Board and National Academies of Sciences, Engineering, and Medicine", editor = "Michael K. Payne and Rita A. Smith and Deborah Murphy Lagos and Jack Freytag and Mark Culverson and Jean Lesicka and James Leana and Robert R. Smith and A. Vernon Woodworth and Robert Valerio", title = "Guidelines for Airport Sound Insulation Programs", abstract = "TRB\u2019s Airport Cooperative Research Program (ACRP) Report 89: Guidelines for Airport Sound Insulation Programs provides updated guidelines for sound insulation of residential and other noise-sensitive buildings. The report is designed to help airports and others develop and effectively manage aircraft noise insulation projects.In February 2014 TRB released ACRP Report 105: Guidelines for Ensuring Longevity of Airport Sound Insulation Programs, which complements ACRP Report 89.", url = "https://nap.nationalacademies.org/catalog/22519/guidelines-for-airport-sound-insulation-programs", year = 2013, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", title = "A 21st Century Cyber-Physical Systems Education", isbn = "978-0-309-45163-5", abstract = "Cyber-physical systems (CPS) are \"engineered systems that are built from, and depend upon, the seamless integration of computational algorithms and physical components.\" CPS can be small and closed, such as an artificial pancreas, or very large, complex, and interconnected, such as a regional energy grid. CPS engineering focuses on managing inter- dependencies and impact of physical aspects on cyber aspects, and vice versa. With the development of low-cost sensing, powerful embedded system hardware, and widely deployed communication networks, the reliance on CPS for system functionality has dramatically increased. These technical developments in combination with the creation of a workforce skilled in engineering CPS will allow the deployment of increasingly capable, adaptable, and trustworthy systems. \n\nEngineers responsible for developing CPS but lacking the appropriate education or training may not fully understand at an appropriate depth, on the one hand, the technical issues associated with the CPS software and hardware or, on the other hand, techniques for physical system modeling, energy and power, actuation, signal processing, and control. In addition, these engineers may be designing and implementing life-critical systems without appropriate formal training in CPS methods needed for verification and to assure safety, reliability, and security. \n\nA workforce with the appropriate education, training, and skills will be better positioned to create and manage the next generation of CPS solutions. A 21st Century Cyber-Physical Systems Education examines the intellectual content of the emerging field of CPS and its implications for engineering and computer science education. This report is intended to inform those who might support efforts to develop curricula and materials; faculty and university administrators; industries with needs for CPS workers; and current and potential students about intellectual foundations, workforce requirements, employment opportunities, and curricular needs.", url = "https://nap.nationalacademies.org/catalog/23686/a-21st-century-cyber-physical-systems-education", year = 2016, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Transportation Research Board and National Academies of Sciences, Engineering, and Medicine", editor = "Jorge Rueda-Benavides, Auburn University Highway Research Center and Arizona State University Cliff Schexnayder and California State University Ghada Gad and Daniel D’Angelo, Applied Research Associates, Inc. and Auburn University Cesar Mayorga", title = "Improving Mid-Term, Intermediate, and Long-Range Cost Forecasting for State Transportation Agencies", abstract = "Predicting the future of the construction market is always a challenging task - regardless of whether it is over the next one or 20 years - since it involves several uncertainties.The TRB National Cooperative Highway Research Program's NCHRP Web-Only Document 283: Improving Mid-Term, Intermediate, and Long-Range Cost Forecasting for State Transportation Agencies documents the research that led to the development of a Cost Forecasting Approach Selection Framework that can assist state transportation agencies to select and implement effective mid-term (3 to 5 years), intermediate-range (up to 15 years), and long-range (more than 15 years) cost forecasting procedures.Supplemental information to the technical report includes NCHRP Research Report 953: Improving Mid-Term, Intermediate,and Long-Range Cost Forecasting: Guidebook for State Transportation Agencies, a presentation, and videos.", url = "https://nap.nationalacademies.org/catalog/25974/improving-mid-term-intermediate-and-long-range-cost-forecasting-for-state-transportation-agencies", year = 2020, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Transportation Research Board and National Academies of Sciences, Engineering, and Medicine", editor = "Kathryn A. Zimmerman", title = "Pavement Management Systems: Putting Data to Work", abstract = "TRB's National Cooperative Highway Research Program (NCHRP) Synthesis 501: Pavement Management Systems: Putting Data to Work documents current pavement management practices in state and provincial transportation agencies. The report focuses on the use of pavement management analysis results for resource allocation, determining treatment cost-effectiveness, program development, and communication with stakeholders.", url = "https://nap.nationalacademies.org/catalog/24682/pavement-management-systems-putting-data-to-work", year = 2017, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Transportation Research Board and National Academies of Sciences, Engineering, and Medicine", editor = "Garnet Erdakos, Shih Ying Chang, Douglas Eisinger, Sonoma Technology, Inc. and Adrienne Heller, Heather Unger, Louis Berger", title = "Zero Emission Vehicles: Forecasting Fleet Scenarios and their Emissions Implications", abstract = "Vehicle electrification is one of the emerging and potentially disruptive technologies that are being considered to reduce emissions of criteria pollutants, mobile source air toxics (MSATs), and greenhouse gases (GHGs) from motor vehicles.The TRB National Cooperative Highway Research Program's NCHRP Web-Only Document 274: Zero Emission Vehicles: Forecasting Fleet Scenarios and their Emissions Implications analyzes a set of scenarios of infrastructure development, policy changes, and cost parameters, with a suite of 49 simulations across those scenarios conducted to assess their impact on nationwide zero emission vehicle (ZEV) adoption and the corresponding levels of exhaust emissions.The model used in the scenarios analysis is a consumer choice model that estimates future sales, populations, and fuel consumption of advanced technology vehicles (ATVs), including ZEVs.There is also a Power Point presentation accompanying the document.", url = "https://nap.nationalacademies.org/catalog/25709/zero-emission-vehicles-forecasting-fleet-scenarios-and-their-emissions-implications", year = 2019, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Transportation Research Board and National Research Council", title = "Terrorism and the Chemical Infrastructure: Protecting People and Reducing Vulnerabilities", isbn = "978-0-309-09721-5", abstract = "The chemical sector is a key part of the national economy and has been designated by the Department of Homeland Security (DHS) as one of 17 sectors comprising the nation's Critical Infrastructure. Although its products represent only 2 percent of the U.S. gross domestic product, those products underpin most other manufactured goods. To assist DHS in characterizing and mitigating the vulnerabilities faced by the nation from the chemical industry, this study examines classes of chemicals and chemical processes that are critical to the nation's security, economy, and health. It identifies vulnerabilities and points of weakness in the supply chain for these chemicals and chemical processes; assesses the likely impact of a significant disruption in the supply chain; identifies actions to help prevent disruption in the supply chain and mitigate loss and injury should such disruption occur; identifies incentives and disincentives to preventative and mitigating actions; and recommends areas of scientific, engineering, and economic research and development. The report concludes that the consequences of a deliberate attack on the chemical infrastructure would be expected to be similar in nature to the accidents we have already experienced. Under limited circumstances, such an attack could cause catastrophic casualties and loss of life, but it would take several simultaneous events to cause catastrophic economic consequences. Poor communication could amplify societal response. Overall, the recommendations in this report emphasize the benefit of investments to improve emergency preparedness for and response to chemical events. They also highlight the potential to minimize the physical hazards through development of cost-effective, safer processes that reduce the volume, toxicity, or hazardous conditions under which chemicals are processed.", url = "https://nap.nationalacademies.org/catalog/11597/terrorism-and-the-chemical-infrastructure-protecting-people-and-reducing-vulnerabilities", year = 2006, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Transportation Research Board and National Academies of Sciences, Engineering, and Medicine", title = "A Review of Human Services Transportation Plans and Grant Programs", abstract = "TRB\u2019s National Cooperative Highway Research Program (NCHRP) Research Results Digest 354: A Review of Human Services Transportation Plans and Grant Programs explores the level of effort and costs associated with the development of coordinated public transit-human services transportation plans.The report also discusses the perceived success of the Coordination Plans and the perceived success states and other grantees are having in awarding funds and meeting the Coordination Plan objectives.Pursuant to the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU), the Federal Transit Administration (FTA) instituted a planning requirement as a condition of federal funding for its human services related grant programs for individuals with disabilities, older adults, and individuals with lower incomes.As a result, since 2007, FTA has required the establishment of a locally developed, coordinated public transit\/ human services transportation plan (Coordination Plan) for all FTA human services transportation programs.The Coordination Plan must be developed through an inclusive process that involves representatives from public, private, and nonprofit transportation and human services providers, as well as the public.The intent of this requirement is to bring the right people to the table to discuss human services transportation issues and identify opportunities to assist more people, reduce service gaps and overlaps, and increase the cost effectiveness of the services provided.Appendixes A, B, and C to NCHRP RRD 354 are only available in electronic format. Appendix A - Blank Internet Survey Form Appendix B - Telephone Interview Questionnaire Appendix C - Detailed Telephone Interview Summaries", url = "https://nap.nationalacademies.org/catalog/14527/a-review-of-human-services-transportation-plans-and-grant-programs", year = 2011, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Transportation Research Board and National Academies of Sciences, Engineering, and Medicine", editor = "Douglas D. Gransberg and H. David Jeong and Emily K. Craigie and Jorge A. Rueda-Benavides and K. Joseph Shrestha", title = "Estimating Highway Preconstruction Services Costs - Volume 2: Research Report", abstract = "TRB's National Cooperative Highway Research Program (NCHRP) Report 826: Estimating Highway Preconstruction Services Costs presents guidance for state departments of transportation (DOTs) and other agencies for estimating preconstruction services (PCS) costs for transportation project development. PCS refers to a varied assortment of project-specific engineering and other professional services required before construction begins on a bridge, highway, or other transportation project, whether provided by agency staff or consultants.Volume 2: Research Report documents the development, testing, validation, and packaging of an accurate, consistent, and reliable method for estimating PCS costs.Accompanying Volume 2, Volume 1: Guidebook addresses principal sources and components of PCS costs, PCS estimating methodologies, trends (such as changes in design and construction technology, design standards, program requirements, and professional workforce) likely to affect PCS costs, and advice on agency policies and practices that can help control program risk through improved PCS cost estimation.", url = "https://nap.nationalacademies.org/catalog/23627/estimating-highway-preconstruction-services-costs-volume-2-research-report", year = 2016, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Transportation Research Board and National Academies of Sciences, Engineering, and Medicine", editor = "Douglas D. Gransberg and H. David Jeong and Emily K. Craigie and Jorge A. Rueda-Benavides and K. Joseph Shrestha", title = "Estimating Highway Preconstruction Services Costs - Volume 1: Guidebook", abstract = "TRB's National Cooperative Highway Research Program (NCHRP) Report 826: Estimating Highway Preconstruction Services Costs presents guidance for state departments of transportation (DOTs) and other agencies for estimating preconstruction services (PCS) costs for transportation project development. PCS refers to a varied assortment of project-specific engineering and other professional services required before construction begins on a bridge, highway, or other transportation project, whether provided by agency staff or consultants.Volume 1: Guidebook addresses principal sources and components of PCS costs, PCS estimating methodologies, trends (such as changes in design and construction technology, design standards, program requirements, and professional workforce) likely to affect PCS costs, and advice on agency policies and practices that can help control program risk through improved PCS cost estimation.Accompanying Volume 1, Volume 2: Research Report documents the development, testing, validation, and packaging of an accurate, consistent, and reliable method for estimating PCS costs.", url = "https://nap.nationalacademies.org/catalog/23590/estimating-highway-preconstruction-services-costs-volume-1-guidebook", year = 2016, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academy of Engineering", title = "Technological Options for User-Authorized Handguns: A Technology-Readiness Assessment", isbn = "978-0-309-09699-7", abstract = "Misuse of handguns is a significant factor in deaths, morbidity, and crime in the United States. One approach to reducing certain types of handgun misuse is to create a user-authorized handgun (UAHG), a firearm that can be operated only by an authorized user(s). Technological Options for User-Authorized Handguns clarifies the technical challenges of developing a reliable UAHG. This report determines the requirements and specifications of UAHGs for those concerned with public and\/or personal safety, and identifies technologies that could satisfy these needs. \n", url = "https://nap.nationalacademies.org/catalog/11394/technological-options-for-user-authorized-handguns-a-technology-readiness-assessment", year = 2005, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Research Council", title = "Strategic Engagement in Global S&T: Opportunities for Defense Research", isbn = "978-0-309-30622-5", abstract = "According to recent reports, the United States currently accounts for less than one-third of global research and development spending, and it is projected that this fraction will decline to 18% by 2050. These statistics, compounded by the recognition that the United States no longer maintains technological superiority across all research fields, highlight the need for the U.S. research community to stay abreast of emerging science and technology (S&T) around the world, to leverage others' investments, and to seek out collaborations in areas where researchers need to remain at the leading edge.\nThe United States' Department of Defense (DoD) has long relied on its historical technological superiority to maintain military advantage. However, as the U.S. share of S&T output shrinks and as the U.S. defense research enterprise struggles to keep pace with the expanding challenges of the evolving security environment and the increased speed and cost of global technology development, the DoD must reexamine its strategy for maintaining awareness of emerging S&T developments occurring around the world. To fully leverage these advances and to make strategic research investments, the DoD must assess with whom and in which areas it should collaborate. To delve more deeply into the implications of the globalization of S&T and of international S&T engagement for the DoD, the Office of Naval Research, the Air Force Office of Scientific Research , and the Office of the Deputy Assistant Secretary of the Army for Research and Technology asked the National Research Council to assess current DoD strategies in the three Services - Army, Air Force, and Navy - for leveraging global S&T and for implementing and coordinating these strategies across the department.\nStrategic Engagement in Global S&T assesses the opportunities and challenges stemming from the globalization of S&T and the implications for the DoD and its Services. This report considers DoD strategies in the three Services for leveraging global S&T and implementation and coordination of these strategies across DoD. The report explores models for global Samp;T engagement utilized by other domestic and foreign organizations.Strategic Engagement in Global S&T assesses how the ongoing globalization of S&T may impact research funding and priorities and workforce needs, as well as issues of building and maintaining trusted relationships and avoiding technology surprises. This report will be of interest to researchers and industry professionals with expertise in the globalization of science and technology, international engagement, the defense research enterprise, program evaluation, and national security. ", url = "https://nap.nationalacademies.org/catalog/18816/strategic-engagement-in-global-st-opportunities-for-defense-research", year = 2014, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", title = "Negative Emissions Technologies and Reliable Sequestration: A Research Agenda", isbn = "978-0-309-48452-7", abstract = "To achieve goals for climate and economic growth, \"negative emissions technologies\" (NETs) that remove and sequester carbon dioxide from the air will need to play a significant role in mitigating climate change. Unlike carbon capture and storage technologies that remove carbon dioxide emissions directly from large point sources such as coal power plants, NETs remove carbon dioxide directly from the atmosphere or enhance natural carbon sinks. Storing the carbon dioxide from NETs has the same impact on the atmosphere and climate as simultaneously preventing an equal amount of carbon dioxide from being emitted. Recent analyses found that deploying NETs may be less expensive and less disruptive than reducing some emissions, such as a substantial portion of agricultural and land-use emissions and some transportation emissions. \n\nIn 2015, the National Academies published Climate Intervention: Carbon Dioxide Removal and Reliable Sequestration, which described and initially assessed NETs and sequestration technologies. This report acknowledged the relative paucity of research on NETs and recommended development of a research agenda that covers all aspects of NETs from fundamental science to full-scale deployment. To address this need, Negative Emissions Technologies and Reliable Sequestration: A Research Agenda assesses the benefits, risks, and \"sustainable scale potential\" for NETs and sequestration. This report also defines the essential components of a research and development program, including its estimated costs and potential impact.", url = "https://nap.nationalacademies.org/catalog/25259/negative-emissions-technologies-and-reliable-sequestration-a-research-agenda", year = 2019, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "Theresa Wizemann and Sally Robinson and Robert Giffin", title = "Breakthrough Business Models: Drug Development for Rare and Neglected Diseases and Individualized Therapies: Workshop Summary", isbn = "978-0-309-12088-3", abstract = "The process for developing new drug and biologic products is extraordinarily expensive and time-consuming. Although large pharmaceutical companies may be able to afford the cost of development because they can expect a large return on investment, organizations developing drugs to treat rare and neglected diseases are unable to rely on such returns.\nOn June 23, 2008, the Institute of Medicine's Forum on Drug Discovery, Development, and Translation held a public workshop, \"Breakthrough Business Models: Drug Development for Rare and Neglected Diseases and Individualized Therapies,\" which sought to explore new and innovative strategies for developing drugs for rare and neglected diseases.", url = "https://nap.nationalacademies.org/catalog/12219/breakthrough-business-models-drug-development-for-rare-and-neglected-diseases", year = 2009, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Transportation Research Board and National Academies of Sciences, Engineering, and Medicine", title = "Assessment of Hybrid-Electric Transit Bus Technology", abstract = "TRB\u2019s Transit Cooperative Research Program (TCRP) Report 132: Assessment of Hybrid-Electric Transit Bus Technology explores decision-making guidelines coupled with a comprehensive life cycle cost (LCC) model designed to assist transit managers in evaluating, selecting, and implementing hybrid-electric technology options for transit buses. The LCC model allows the user to compare the total life cycle costs across several cost categories for up to 6 different \u201cpurchase scenarios.\u201d The LCC model is contained on the accompanying CD-ROM (CRP-CD-71), with the printed version of the report and available for download as an ISO image online.Links to the ISO image and instructions for burning a CD-ROM from an ISO image are provided below. Help on Burning an .ISO CD-ROM ImageDownload the .ISO CD-ROM Image(Warning: This is a large and may take some time to download using a high-speed connection. Any software included is offered as is, without warranty or promise of support of any kind either expressed or implied. Under no circumstance will the National Academy of Sciences or the Transportation Research Board (collectively \u201cTRB\u201d) be liable for any loss or damage caused by the installation or operation of this product. TRB makes no representation or warranty of any kind, expressed or implied, in fact or in law, including without limitation, the warranty of merchantability or the warranty of fitness for a particular purpose, and shall not in any case be liable for any consequential or special damages.)", url = "https://nap.nationalacademies.org/catalog/22983/assessment-of-hybrid-electric-transit-bus-technology", year = 2009, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "Sally Robinson and Robert Pool and Robert Giffin", title = "Emerging Safety Science: Workshop Summary", isbn = "978-0-309-11012-9", abstract = "In recent years, the costs of new drug development have skyrocketed. The average cost of developing a new approved drug is now estimated to be $1.3 billion (DiMasi and Grabowski, 2007). At the same time, each year fewer new molecular entities (NMEs) are approved. DiMasi and Grabowski report that only 21.5 percent of the candidate drugs that enter phase I clinical testing actually make it to market. In 2007, just 17 novel drugs and 2 novel biologics were approved. In addition to the slowing rate of drug development and approval, recent years have seen a number of drugs withdrawn from the market for safety reasons. According to the Government Accountability Office (GAO), 10 drugs were withdrawn because of safety concerns between 2000 and March 2006 (GAO, 2006). Finding ways to select successful drug candidates earlier in development could save millions or even billions of dollars, reduce the costs of drugs on the market, and increase the number of new drugs with improved safety profiles that are available to patients.\n \nEmerging scientific knowledge and technologies hold the potential to enhance correct decision making for the advancement of candidate drugs. Identification of safety problems is a key reason that new drug development is stalled. Traditional methods for assessing a drug's safety prior to approval are limited in their ability to detect rare safety problems. Prior to receiving U.S. Food and Drug Administration (FDA) approval, a drug will have been tested in hundreds to thousands of patients. Generally, drugs cannot confidently be linked to safety problems until they have been tested in tens of thousands to hundreds of thousands of people. With current methods, it is unlikely that rare safety problems will be identified prior to approval.\n \nEmerging Safety Science: Workshop Summary summarizes the events and presentations of the workshop.", url = "https://nap.nationalacademies.org/catalog/11975/emerging-safety-science-workshop-summary", year = 2008, publisher = "The National Academies Press", address = "Washington, DC" }