Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development

Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 118
Release: 2012-04-04
Genre: Medical
ISBN: 0309222176

The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.

The Changing Economics of Medical Technology

The Changing Economics of Medical Technology
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 225
Release: 1991-02-01
Genre: Medical
ISBN: 030904491X

Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.

Regulating Pesticides in Food

Regulating Pesticides in Food
Author: National Research Council
Publisher: National Academies Press
Total Pages: 288
Release: 1987-02-01
Genre: Medical
ISBN: 0309037468

Concern about health effects from exposure to pesticides in foods is growing as scientists learn more about the toxic properties of pesticides. The Delaney Clause, a provision of the Food, Drug and Cosmetic Act, prohibits tolerances for any pesticide that causes cancer in test animals or in humans if the pesticide concentrates in processed food or feeds. This volume examines the impacts of the Delaney Clause on agricultural innovation and on the public's dietary exposure to potentially carcinogenic pesticide residues. Four regulatory scenarios are described to illustrate the effects of varying approaches to managing oncogenic pesticide residues in food.

Preparing for Future Products of Biotechnology

Preparing for Future Products of Biotechnology
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Total Pages: 231
Release: 2017-07-28
Genre: Science
ISBN: 0309452058

Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5â€"10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.

Life Cycle Assessment in the Chemical Product Chain

Life Cycle Assessment in the Chemical Product Chain
Author: Simone Maranghi
Publisher: Springer Nature
Total Pages: 172
Release: 2020-02-05
Genre: Science
ISBN: 303034424X

This book outlines the methodologies, approaches and tools for modelling chemicals in a Life Cycle Assessment (LCA) perspective, and also covers the main advantages and drawbacks of applying LCA to chemical processes. In the first part of this book, authors pay close attention to the limitations of modelling the environmental and social impacts of chemical processes, providing valuable insights to the problems of the Life Cycle Inventory (LCI) analysis for chemical processes. In the second part of this book, readers will learn about the LCA application to chemical processes in the laboratory and industrial scale. In each chapter of this book, readers will also find specific case studies on the modelling and application of LCA in the chemical industry.

Industrialization of Biology

Industrialization of Biology
Author: National Research Council
Publisher: National Academies Press
Total Pages: 158
Release: 2015-06-29
Genre: Science
ISBN: 0309316553

The tremendous progress in biology over the last half century - from Watson and Crick's elucidation of the structure of DNA to today's astonishing, rapid progress in the field of synthetic biology - has positioned us for significant innovation in chemical production. New bio-based chemicals, improved public health through improved drugs and diagnostics, and biofuels that reduce our dependency on oil are all results of research and innovation in the biological sciences. In the past decade, we have witnessed major advances made possible by biotechnology in areas such as rapid, low-cost DNA sequencing, metabolic engineering, and high-throughput screening. The manufacturing of chemicals using biological synthesis and engineering could expand even faster. A proactive strategy - implemented through the development of a technical roadmap similar to those that enabled sustained growth in the semiconductor industry and our explorations of space - is needed if we are to realize the widespread benefits of accelerating the industrialization of biology. Industrialization of Biology presents such a roadmap to achieve key technical milestones for chemical manufacturing through biological routes. This report examines the technical, economic, and societal factors that limit the adoption of bioprocessing in the chemical industry today and which, if surmounted, would markedly accelerate the advanced manufacturing of chemicals via industrial biotechnology. Working at the interface of synthetic chemistry, metabolic engineering, molecular biology, and synthetic biology, Industrialization of Biology identifies key technical goals for next-generation chemical manufacturing, then identifies the gaps in knowledge, tools, techniques, and systems required to meet those goals, and targets and timelines for achieving them. This report also considers the skills necessary to accomplish the roadmap goals, and what training opportunities are required to produce the cadre of skilled scientists and engineers needed.

Industrial Environmental Performance Metrics

Industrial Environmental Performance Metrics
Author: National Academy of Engineering and National Research Council
Publisher: National Academies Press
Total Pages: 264
Release: 1999-08-24
Genre: Science
ISBN: 0309173000

Industrial Environmental Performance Metrics is a corporate-focused analysis that brings clarity and practicality to the complex issues of environmental metrics in industry. The book examines the metrics implications to businesses as their responsibilities expand beyond the factory gateâ€"upstream to suppliers and downstream to products and services. It examines implications that arise from greater demand for comparability of metrics among businesses by the investment community and environmental interest groups. The controversy over what sustainable development means for businesses is also addressed. Industrial Environmental Performance Metrics identifies the most useful metrics based on case studies from four industriesâ€"automotive, chemical, electronics, and pulp and paperâ€"and includes specific corporate examples. It contains goals and recommendations for public and private sector players interested in encouraging the broader use of metrics to improve industrial environmental performance and those interested in addressing the tough issues of prioritization, weighting of metrics for meaningful comparability, and the longer term metrics needs presented by sustainable development.

Green Techniques for Organic Synthesis and Medicinal Chemistry

Green Techniques for Organic Synthesis and Medicinal Chemistry
Author: Wei Zhang
Publisher: John Wiley & Sons
Total Pages: 1127
Release: 2018-01-18
Genre: Science
ISBN: 1119288584

An updated overview of the rapidly developing field of green techniques for organic synthesis and medicinal chemistry Green chemistry remains a high priority in modern organic synthesis and pharmaceutical R&D, with important environmental and economic implications. This book presents comprehensive coverage of green chemistry techniques for organic and medicinal chemistry applications, summarizing the available new technologies, analyzing each technique’s features and green chemistry characteristics, and providing examples to demonstrate applications for green organic synthesis and medicinal chemistry. The extensively revised edition of Green Techniques for Organic Synthesis and Medicinal Chemistry includes 7 entirely new chapters on topics including green chemistry and innovation, green chemistry metrics, green chemistry and biological drugs, and the business case for green chemistry in the generic pharmaceutical industry. It is divided into 4 parts. The first part introduces readers to the concepts of green chemistry and green engineering, global environmental regulations, green analytical chemistry, green solvents, and green chemistry metrics. The other three sections cover green catalysis, green synthetic techniques, and green techniques and strategies in the pharmaceutical industry. Includes more than 30% new and updated material—plus seven brand new chapters Edited by highly regarded experts in the field (Berkeley Cue is one of the fathers of Green Chemistry in Pharma) with backgrounds in academia and industry Brings together a team of international authors from academia, industry, government agencies, and consultancies (including John Warner, one of the founders of the field of Green Chemistry) Green Techniques for Organic Synthesis and Medicinal Chemistry, Second Edition is an essential resource on green chemistry technologies for academic researchers, R&D professionals, and students working in organic chemistry and medicinal chemistry.