The Path from Biomarker Discovery to Regulatory Qualification

The Path from Biomarker Discovery to Regulatory Qualification
Author: Federico Goodsaid,William B. Mattes
Publsiher: Academic Press
Total Pages: 206
Release: 2013-07-16
ISBN 10: 0123944082
ISBN 13: 9780123944085
Language: EN, FR, DE, ES & NL

The Path from Biomarker Discovery to Regulatory Qualification Book Review:

The Path from Biomarker Discovery to Regulatory Qualification is a unique guide that focuses on biomarker qualification, its history and current regulatory settings in both the US and abroad. This multi-contributed book provides a detailed look at the next step to developing biomarkers for clinical use and covers overall concepts, challenges, strategies and solutions based on the experiences of regulatory authorities and scientists. Members of the regulatory, pharmaceutical and biomarker development communities will benefit the most from using this book—it is a complete and practical guide to biomarker qualification, providing valuable insight to an ever-evolving and important area of regulatory science. For complimentary access to chapter 13, 'Classic' Biomarkers of Liver Injury, by John R. Senior, Associate Director for Science, Food and Drug Administration, Silver Spring, Maryland, USA, please visit the following site: http://tinyurl.com/ClassicBiomarkers Contains a collection of experiences of different groups taking different types of biomarkers to different levels of qualification and provides insightful case studies of an important area of regulatory science Focuses on practical advice, concepts, strategies and overall outcomes to support those working toward biomarker qualification for clinical use Offers a valuable resource for members of the regulatory, pharmaceutical and biomarker development communities.

Handbook of Biomarkers and Precision Medicine

Handbook of Biomarkers and Precision Medicine
Author: Claudio Carini,Mark Fidock,Alain van Gool
Publsiher: CRC Press
Total Pages: 631
Release: 2019-04-16
ISBN 10: 0429576730
ISBN 13: 9780429576737
Language: EN, FR, DE, ES & NL

Handbook of Biomarkers and Precision Medicine Book Review:

"The field of Biomarkers and Precision Medicine in drug development is rapidly evolving and this book presents a snapshot of exciting new approaches. By presenting a wide range of biomarker applications, discussed by knowledgeable and experienced scientists, readers will develop an appreciation of the scope and breadth of biomarker knowledge and find examples that will help them in their own work." -Maria Freire, Foundation for the National Institutes of Health Handbook of Biomarkers and Precision Medicine provides comprehensive insights into biomarker discovery and development which has driven the new era of Precision Medicine. A wide variety of renowned experts from government, academia, teaching hospitals, biotechnology and pharmaceutical companies share best practices, examples and exciting new developments. The handbook aims to provide in-depth knowledge to research scientists, students and decision makers engaged in Biomarker and Precision Medicine-centric drug development. Features: Detailed insights into biomarker discovery, validation and diagnostic development with implementation strategies Lessons-learned from successful Precision Medicine case studies A variety of exciting and emerging biomarker technologies The next frontiers and future challenges of biomarkers in Precision Medicine Claudio Carini, Mark Fidock and Alain van Gool are internationally recognized as scientific leaders in Biomarkers and Precision Medicine. They have worked for decades in academia and pharmaceutical industry in EU, USA and Asia. Currently, Dr. Carini is Honorary Faculty at Kings’s College School of Medicine, London, UK. Dr. Fidock is Vice President of Precision Medicine Laboratories at AstraZeneca, Cambridge, UK. Prof.dr. van Gool is Head Translational Metabolic Laboratory at Radboud university medical school, Nijmegen, NL.

Biomarkers in Drug Development

Biomarkers in Drug Development
Author: Michael R. Bleavins,Claudio Carini,Mallé Jurima-Romet,Ramin Rahbari
Publsiher: John Wiley & Sons
Total Pages: 784
Release: 2011-09-20
ISBN 10: 1118210425
ISBN 13: 9781118210420
Language: EN, FR, DE, ES & NL

Biomarkers in Drug Development Book Review:

Discover how biomarkers can boost the success rate of drugdevelopment efforts As pharmaceutical companies struggle to improve the success rateand cost-effectiveness of the drug development process, biomarkershave emerged as a valuable tool. This book synthesizes and reviewsthe latest efforts to identify, develop, and integrate biomarkersas a key strategy in translational medicine and the drugdevelopment process. Filled with case studies, the bookdemonstrates how biomarkers can improve drug development timelines,lower costs, facilitate better compound selection, reducelate-stage attrition, and open the door to personalizedmedicine. Biomarkers in Drug Development is divided into eightparts: Part One offers an overview of biomarkers and their role in drugdevelopment. Part Two highlights important technologies to help researchersidentify new biomarkers. Part Three examines the characterization and validation processfor both drugs and diagnostics, and provides practical advice onappropriate statistical methods to ensure that biomarkers fulfilltheir intended purpose. Parts Four through Six examine the application of biomarkers indiscovery, preclinical safety assessment, clinical trials, andtranslational medicine. Part Seven focuses on lessons learned and the practical aspectsof implementing biomarkers in drug development programs. Part Eight explores future trends and issues, including dataintegration, personalized medicine, and ethical concerns. Each of the thirty-eight chapters was contributed by one or moreleading experts, including scientists from biotechnology andpharmaceutical firms, academia, and the U.S. Food and DrugAdministration. Their contributions offer pharmaceutical andclinical researchers the most up-to-date understanding of thestrategies used for and applications of biomarkers in drugdevelopment.

Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease

Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease
Author: Institute of Medicine,Food and Nutrition Board,Board on Health Sciences Policy,Board on Health Care Services,Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease
Publsiher: National Academies Press
Total Pages: 334
Release: 2010-06-25
ISBN 10: 0309157277
ISBN 13: 9780309157278
Language: EN, FR, DE, ES & NL

Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease Book Review:

Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process.

Rare Diseases and Orphan Products

Rare Diseases and Orphan Products
Author: Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development
Publsiher: National Academies Press
Total Pages: 442
Release: 2011-04-03
ISBN 10: 0309158060
ISBN 13: 9780309158060
Language: EN, FR, DE, ES & NL

Rare Diseases and Orphan Products Book Review:

Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

Accelerating the Development of Biomarkers for Drug Safety

Accelerating the Development of Biomarkers for Drug Safety
Author: Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publsiher: National Academies Press
Total Pages: 100
Release: 2009-08-20
ISBN 10: 0309131243
ISBN 13: 9780309131247
Language: EN, FR, DE, ES & NL

Accelerating the Development of Biomarkers for Drug Safety Book Review:

Biomarkers can be defined as indicators of any biologic state, and they are central to the future of medicine. As the cost of developing drugs has risen in recent years, reducing the number of new drugs approved for use, biomarker development may be a way to cut costs, enhance safety, and provide a more focused and rational pathway to drug development. On October 24, 2008, the IOM's Forum on Drug Discovery, Development, and Translation held "Assessing and Accelerating Development of Biomarkers for Drug Safety," a one-day workshop, summarized in this volume, on the value of biomarkers in helping to determine drug safety during development.

Global Approach in Safety Testing

Global Approach in Safety Testing
Author: Jan Willem van der Laan,Joseph J DeGeorge
Publsiher: Springer Science & Business Media
Total Pages: 315
Release: 2013-02-11
ISBN 10: 1461459508
ISBN 13: 9781461459507
Language: EN, FR, DE, ES & NL

Global Approach in Safety Testing Book Review:

This volume will consider one of ICH’s major categories, Safety i.e. topics relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.). Since the start of the ICH process, many guidelines have been written, but even after ICH6 no explanations have been given during a formal Congress about the background of the ICH Guidance documents. Even more important than what has been written, might have been those thoughts of the experts that are not included in the Guidance documents. Why has the guideline been written as it is written, and why have some aspects been deleted. These and other related questions are the contents of this book, written by experts who were involved in the ICH process. Furthermore, the chapters will contain discussions on the “lessons learnt” and “future developments”.

The Handbook of Biomarkers

The Handbook of Biomarkers
Author: Kewal K. Jain
Publsiher: Springer Science & Business Media
Total Pages: 492
Release: 2010-02-06
ISBN 10: 9781607616856
ISBN 13: 1607616858
Language: EN, FR, DE, ES & NL

The Handbook of Biomarkers Book Review:

Of the thousands of biomarkers that are currently being discovered, relatively few are being validated for further applications, and the potential of a biomarker can be quite difficult to evaluate. To aid in this imperative research, Dr. Kewal K. Jain’s Handbook of Biomarkers thoroughly describes many different types of biomarkers and their discovery using various "-omics" technologies, such as proteomics and metabolomics, along with the background information needed for the evaluation of biomarkers as well as the essential procedures for their validation and use in clinical trials. With biomarkers described first according to technologies and then according to various diseases, this detailed book features the key correlations between diseases and classifications of biomarkers, which provides the reader with a guide to sort out current and future biomarkers. Comprehensive and cutting-edge, The Handbook of Biomarkers serves as a vital guide to furthering our understanding of biomarkers, which, by facilitating the combination of therapeutics with diagnostics, promise to play an important role in the development of personalized medicine, one of the most important emerging trends in healthcare today.

Predictive Biomarkers in Oncology

Predictive Biomarkers in Oncology
Author: Sunil Badve,George Louis Kumar
Publsiher: Springer
Total Pages: 642
Release: 2018-12-06
ISBN 10: 3319952285
ISBN 13: 9783319952284
Language: EN, FR, DE, ES & NL

Predictive Biomarkers in Oncology Book Review:

“Precision/personalized or stratified medicine” refers to the tailoring of medical treatment or drug administration to the individual characteristics of each patient treatment. It does not literally mean that a pharmaceutical company makes a drug for an individual patient for consumption and treatment but rather means the ability to stratify (or classify) individuals into sub-populations that differ in their responsiveness to a specific drug. A marker that provides information on the likely response to therapy, i.e., either in terms of tumor shrinkage or survival of the patient is termed “predictive biomarker”. Despite their promise in precision medicine and the explosion of knowledge in this area, there is not a single source on this subject that puts all this evidence together in a concise or richly illustrated and easy to understand manner. This book provides a collection of ingeniously organized, well-illustrated and up-to-date authoritative chapters divided into five sections that are clear and easy to understand. Section one provides an overview of biomarkers, introduces the basic terminologies, definitions, technologies, tools and concepts associated with this subject in the form of illustrations/graphics, photographs and concise texts. Several recent biomarker endeavors that have been initiated and funded by the National Cancer Institute, National Institutes of Health, FDA and other International organizations are presented. Section two involves the signaling pathways controlling cell growth and differentiation altered in cancer. This section analyzes how predictive biomarkers are altered (expressed or amplified) across cancer types. Section three explores how predictive biomarkers play a role in patient stratification and tailored treatment in relationship to specific cancers. In addition, it includes discussion on the various precision medicine initiatives that are going on across the globe (e.g. TARGET, NCI-MATCH, BATTLE, SHIVA, etc.). Section four discusses: (a) how pharmaceutical companies validate predictive biomarker assays and accompanying companion diagnostics either internally or externally with partner companies such as central laboratories or clinical research organizations, and (b) how predictive biomarker tests fall under the oversight of US FDA, Centers for Medicare & Medicaid Services (CMS) and state laws. Section five wraps up novel agents and targets that are being used as targets for cancer therapeutics. The biomarkers associated with these protocols will also be presented. Throughout the book, sidebars, special interest boxes and illustrations are used to explain terms that are either newly introduced, uncommon, or specialized. Predictive Biomarkers in Oncology will serve as a definitive guide for practicing pathologists, oncologists, basic researchers, and personnel in the pharmaceutical or diagnostic industry interested in learning how “predictive biomarkers” are used in precision cancer therapy.

Neuroscience Biomarkers and Biosignatures

Neuroscience Biomarkers and Biosignatures
Author: Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders
Publsiher: National Academies Press
Total Pages: 128
Release: 2008-01-08
ISBN 10: 9780309178280
ISBN 13: 0309178282
Language: EN, FR, DE, ES & NL

Neuroscience Biomarkers and Biosignatures Book Review:

Biomarkers, or biological markers, are quantitative measurements that offer researchers and clinicians valuable insight into diagnosis, treatment and prognosis for many disorders and diseases. A major goal in neuroscience medical research is establishing biomarkers for disorders of the nervous system. Given the promising potential and necessity for neuroscience biomarkers, the Institute of Medicine Forum on Neuroscience and Nervous System Disorders convened a public workshop and released the workshop summary entitled Neuroscience Biomarkers and Biosignatures: Converging Technologies, Emerging Partnerships. The workshop brought together experts from multiple areas to discuss the most promising and practical arenas in neuroscience in which biomarkers will have the greatest impact. The main objective of the workshop was to identify and discuss biomarker targets that are not currently being aggressively pursued but that could have the greatest near-term impact on the rate at which new treatments are brought forward for psychiatric and neurological disorders.

Translational Medicine Tools And Techniques

Translational Medicine  Tools And Techniques
Author: Aamir Shahzad
Publsiher: Academic Press
Total Pages: 196
Release: 2015-11-24
ISBN 10: 0128034947
ISBN 13: 9780128034941
Language: EN, FR, DE, ES & NL

Translational Medicine Tools And Techniques Book Review:

Translational Medicine: Tools and Techniques provides a standardized path from basic research to the clinic and brings together various policy and practice issues to simplify the broad interdisciplinary field. With discussions from academic and industry leaders at international institutions who have successfully implemented translational medicine techniques and tools in various settings, readers will be guided through implementation strategies relevant to their own needs and institutions. The book also addresses regulatory processes in USA, EU, Japan and China. By providing details on omics sciences techniques, biomarkers, data mining and management approaches, case reports from industry, and tools to assess the value of different technologies and techniques, this book is the first to provide a user-friendly go-to guide for key opinion leaders (KOLs), industry administrators, faculty members, clinicians, researchers, and students interested in translational medicine. Includes detailed and standardized information about the techniques and tools used in translational medicine Provides specific industry case scenarios Explains how to use translational medicine tools and techniques to plan and improve infrastructures and capabilities while reducing cost and optimizing resources

Pharmaceutical Medicine and Translational Clinical Research

Pharmaceutical Medicine and Translational Clinical Research
Author: Divya Vohora,Gursharan Singh
Publsiher: Academic Press
Total Pages: 526
Release: 2017-11-14
ISBN 10: 0128020989
ISBN 13: 9780128020982
Language: EN, FR, DE, ES & NL

Pharmaceutical Medicine and Translational Clinical Research Book Review:

Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features. As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource. Includes detailed coverage of current trends and key topics in pharmaceutical medicine, including biosimilars, biobetters, super generics, and Provides a comprehensive look at current and important aspects of the science and regulation of drug and biologics discovery

Ensuring Innovation in Diagnostics for Bacterial Infection

Ensuring Innovation in Diagnostics for Bacterial Infection
Author: Chantal Morel,Lindsay McClure,Suzanne Edwards,Dale Sandberg
Publsiher: World Health Organization
Total Pages: 317
Release: 2016
ISBN 10: 9289050365
ISBN 13: 9789289050364
Language: EN, FR, DE, ES & NL

Ensuring Innovation in Diagnostics for Bacterial Infection Book Review:

The inappropriate use of antibiotics is a primary cause of the ongoing increase in drug resistance among pathogenic bacteria. The resulting decrease in the efficacy of antibiotics threatens our ability to combat infectious diseases. Rapid, point-of-care tests to identify pathogens and better target the appropriate treatment could greatly improve the use of antibiotics. Yet there are few such tests currently available or being developed despite the rapid pace of medical innovation. Clearly something is inhibiting the much-needed development of new and more convenient diagnostic tools. This study delineates priorities for developing diagnostics to improve antibiotic prescription and use with the goal of managing and curbing the expansion of drug resistance. It calls for new approaches, particularly in the provision of diagnostic devices, and, in doing so, outlines some of the inadequacies in health, science and policy initiatives that have led to the dearth of such devices. The authors make the case that there is a clear and urgent need for innovation, not only in the technology of diagnosis, but also in public policy and medical practice to support the availability and use of better diagnostic tools. This book explores the complexities of the diagnostics market from the perspective of both supply and demand, unearthing interesting bottlenecks, some obvious, some more subtle. It calls for a multifaceted and broad policy response, and an overhaul of current practice, so that the growth of bacterial resistance can be stemmed.

Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development

Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development
Author: Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publsiher: National Academies Press
Total Pages: 118
Release: 2012-04-04
ISBN 10: 0309222176
ISBN 13: 9780309222174
Language: EN, FR, DE, ES & NL

Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development Book Review:

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.

Oral Formulation Roadmap from Early Drug Discovery to Development

Oral Formulation Roadmap from Early Drug Discovery to Development
Author: Elizabeth Kwong
Publsiher: John Wiley & Sons
Total Pages: 272
Release: 2017-02-06
ISBN 10: 1118907337
ISBN 13: 9781118907337
Language: EN, FR, DE, ES & NL

Oral Formulation Roadmap from Early Drug Discovery to Development Book Review:

Detailing formulation approaches by stage of discovery to early development, this book gives a “playbook” of practical and efficient strategies to formulate drug candidates with the least chance of failing in clinical development. • Comes from contributing authors with experience developing formulations on the frontlines of the pharmaceutical industry • Focuses on pre (or non-) clinical and early stage development, the phases where most compounds are used in drug research • Features case studies to illustrate practical challenges and solutions in formulation selection • Covers regulatory filing, drug metabolism and physical and chemical properties, toxicology formulation, biopharmaceutics classification system (BCS), screening approaches, early stage clinical formulation development, and outsourcing

Pain in Osteoarthritis

Pain in Osteoarthritis
Author: David T. Felson,Hans-Georg Schaible
Publsiher: John Wiley & Sons
Total Pages: 320
Release: 2010-08-03
ISBN 10: 9780470930557
ISBN 13: 0470930551
Language: EN, FR, DE, ES & NL

Pain in Osteoarthritis Book Review:

An authoritative investigation of the sources andtreatment of osteoarthritic joint pain Millions of people throughout the world suffer from osteoarthritis (OA)—a medical condition causing its sufferers excruciating pain that is often disabling. This is the first book to offer clinicians an in-depth understanding of the biological sources of osteoarthritic pain and how they can be treated. Here, a team of leading international authorities has contributed state-of-the-art information on: The Neuroscience of Articular Pain—spinal and peripheral mechanisms of joint pain; experimental models for the study of osteoarthritic pain; inflammatory mediators and nociception in arthritis; phantoms in rheumatology; and more Osteoarthritis and Pain—joint mechanisms and neuromuscular aspects of OA; bone pain and pressure in OA joints; structural correlates of OA pain; and more Treatment of Osteoarthritic Pain—general approaches to treatment; treatments targeting pain receptors; treatments targeting biomechanical abnormalities; and treatments targeting inflammation Whether you're a medical professional, researcher, student, or a generalist or specialist focusing on pain or arthritis, this is your one-stop reference for understanding and treating joint pain in osteoarthritis.

Companion and Complementary Diagnostics

Companion and Complementary Diagnostics
Author: Jan Trøst Jørgensen
Publsiher: Academic Press
Total Pages: 508
Release: 2019-05-08
ISBN 10: 0128135409
ISBN 13: 9780128135402
Language: EN, FR, DE, ES & NL

Companion and Complementary Diagnostics Book Review:

Companion and Complementary Diagnostics: From Biomarker Discovery to Clinical Implementation provides readers with in-depth insights into the individual steps in the development of companion diagnostic assays, from the early biomarker discovery phase straight through to final regulatory approval. Further, the clinical implementation of companion diagnostic testing in the clinic is also discussed. As the development of predictive or selective biomarker assays linked to specific drugs is substantially increasing, this book offers comprehensive information on this quickly-evolving area of biomedicine. It is an essential resource for those in academic institutions, hospitals and pharma, and biotech and diagnostic commercial companies. Covers all aspects, from biomarker discovery, to development and regulatory approval Explains the "how to" aspects of companion diagnostics Incorporates information on the entire process, allowing for easier and deeper understanding of the topic

Statistical Methods in Biomarker and Early Clinical Development

Statistical Methods in Biomarker and Early Clinical Development
Author: Liang Fang,Cheng Su
Publsiher: Springer Nature
Total Pages: 348
Release: 2020-02-24
ISBN 10: 3030315037
ISBN 13: 9783030315030
Language: EN, FR, DE, ES & NL

Statistical Methods in Biomarker and Early Clinical Development Book Review:

This contributed volume offers a much-needed overview of the statistical methods in early clinical drug and biomarker development. Chapters are written by expert statisticians with extensive experience in the pharmaceutical industry and regulatory agencies. Because of this, the data presented is often accompanied by real world case studies, which will help make examples more tangible for readers. The many applications of statistics in drug development are covered in detail, making this volume a must-have reference. Biomarker development and early clinical development are the two critical areas on which the book focuses. By having the two sections of the book dedicated to each of these topics, readers will have a more complete understanding of how applying statistical methods to early drug development can help identify the right drug for the right patient at the right dose. Also presented are exciting applications of machine learning and statistical modeling, along with innovative methods and state-of-the-art advances, making this a timely and practical resource. This volume is ideal for statisticians, researchers, and professionals interested in pharmaceutical research and development. Readers should be familiar with the fundamentals of statistics and clinical trials.

American Journal of Respiratory and Critical Care Medicine

American Journal of Respiratory and Critical Care Medicine
Author: Anonim
Publsiher: Unknown
Total Pages: 329
Release: 2007
ISBN 10:
ISBN 13: NWU:35558005650003
Language: EN, FR, DE, ES & NL

American Journal of Respiratory and Critical Care Medicine Book Review:

Advancing the Discipline of Regulatory Science for Medical Product Development

Advancing the Discipline of Regulatory Science for Medical Product Development
Author: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publsiher: National Academies Press
Total Pages: 104
Release: 2016-08-11
ISBN 10: 0309438845
ISBN 13: 9780309438841
Language: EN, FR, DE, ES & NL

Advancing the Discipline of Regulatory Science for Medical Product Development Book Review:

The field of endeavors known as "regulatory science" has grown out of the need to link and integrate knowledge within and among basic science research, clinical research, clinical medicine, and other specific scientific disciplines whose focus, aggregation, and ultimate implementation could inform biomedical product development and regulatory decision making. Substantial efforts have been devoted to defining regulatory science and communicating its value and role across the scientific and regulatory ecosystems. Investments are also being made in technology infrastructure, regulatory systems, and workforce development to support and advance this burgeoning discipline. In October 2015, the National Academies of Sciences, Engineering, and Medicine held a public workshop to facilitate dialogue among stakeholders about the current state and scope of regulatory science, opportunities to address barriers to the discipline's success, and avenues for fostering collaboration across sectors. Participants explored key needs for strengthening the discipline of regulatory science, including considering what are the core components of regulatory science infrastructure to foster innovation in medical product development. This report summarizes the presentations and discussions from the workshop.