Biosimulation In Biomedical Research Health Care And Drug Development

Biosimulation is an approach to biomedical research and the treatment of patients in which computer modeling goes hand in hand with experimental and clinical work. Constructed models are used to interpret experimental results and to accumulate information from experiment to experiment. This book explains the concepts used in the modeling of biological phenomena and goes on to present a series of well-documented models of the regulation of various genetic, cellular and physiological processes. The way how the use of computer models allows optimization of cancer treatment for individual patients is discussed and models of interacting nerve cells that can be used to design new treatments for patients with Parkinson's disease are explained. Furthermore this volume provides an overview on the use of models in industry, and presents the view of regulatory agencies on the topic.

Biosimulation is an approach to biomedical research and the treatment of patients in which computer modeling goes hand in hand with experimental and clinical work. Constructed models are used to interpret experimental results and to accumulate information from experiment to experiment. This book explains the concepts used in the modeling of biological phenomena and goes on to present a series of well-documented models of the regulation of various genetic, cellular and physiological processes. The way how the use of computer models allows optimization of cancer treatment for individual patients is discussed and models of interacting nerve cells that can be used to design new treatments for patients with Parkinson's disease are explained. Furthermore this volume provides an overview on the use of models in industry, and presents the view of regulatory agencies on the topic.

The pharmaceutical industry is currently operating under a business model that is not sustainable for the future. Given the high costs associated with drug development, there is a vital need to reform this process in order to provide safe and effective drugs while still securing a profit. Re-Engineering Clinical Trials evaluates the trends and challenges associated with the current drug development process and presents solutions that integrate the use of modern communication technologies, innovations and novel enrichment designs. This book focuses on the need to simplify drug development and offers you well-established methodologies and best practices based on real-world experiences from expert authors across industry and academia. Written for all those involved in clinical research, development and clinical trial design, this book provides a unique and valuable resource for streamlining the process, containing costs and increasing drug safety and effectiveness. Highlights the latest paradigm-shifts and innovation advances in clinical research Offers easy-to-find best practice sections, lists of current literature and resources for further reading and useful solutions to day-to-day problems in current drug development Discusses important topics such as safety profiling, data mining, site monitoring, change management, increasing development costs, key performance indicators and much more

Research in the Biomedical Sciences: Transparent and Reproducible documents the widespread concerns related to reproducibility in biomedical research and provides a best practices guide to effective and transparent hypothesis generation, experimental design, reagent standardization (including validation and authentication), statistical analysis, and data reporting. The book addresses issues in the perceived value of the existing peer review process and calls for the need for improved transparency in data reporting. It reflects new guidelines for publication that include manuscript checklists, replication/reproducibility initiatives, and the potential consequences for the biomedical research community and societal health and well-being if training, mentoring, and funding of new generations of researchers and incentives for publications are not improved. This book offers real world examples, insights, and solutions to provide a thought-provoking and timely resource for all those learning about, or engaged in, performing and supervising research across the biomedical sciences. Provides a “big picture perspective on the scope of reproducibility issues and covers initiatives that have potential as effective solutions Offers real-world research context for transparent, reproducible experimental design, execution and reporting of biomedical research with the potential to address aspects of the translational gap in drug discovery Highlights the importance of reproducibility and the necessary changes in biomedical and pharmaceutical research training and incentives to ensure sustainability

This textbook covers all the steps in manufacturing a biomedical product from bench to bedside. It specifically focuses on quality assurance and management and explains the different good practice principles in the various phases of product development as well as how to fulfill them: Good laboratory practice, good manufacturing practice and good clinical practice. It provides readers with the know-how to design biomedical experiments to ensure quality and integrity, to plan and conduct standard preclinical studies and to assure the quality of the final manufactured biomedical products. Importantly, it also addresses ethical concerns and considerations. The book discusses the guidelines and ethical considerations for preclinical and clinical studies, to allow readers to identify safety concerns regarding biomedical products and to improve pre-clinical studies for the development of better products. This textbook is a valuable guide for biomedical students (B.Sc., M.S., and Ph.D. students) in the field of molecular medicine, medical biotechnology, stem cell research and related areas, as well as for professionals such as quality control staff, tissue bankers, policy-makers and health professionals.

This edition includes both updates and new uses and issues concerning CTS, along with case studies of how clinical trial simulations are being applied in various therapeutic and application areas. Importantly, the book expands on the utility of CTS for informing decisions during drug development and regulatory review. Each chapter author was selected on the basis of demonstrated expertise in state-of-the-art application of CTS. The target audience for this volume includes researchers and scientists who wish to consider use of simulations in the design, analysis, or regulatory review and guidance of clinical trials. This book does not embrace all aspects of trial design, nor is it intended as a complete recipe for using computers to design trials. Rather, it is an information source that enables the reader to gain understanding of essential background and knowledge for practical applications of simulation for clinical trial design and analysis. It is assumed that the reader has a working understanding of pharmacokinetics and pharmacodynamics, modeling, pharmacometric analyses, and/or the drug development and regulatory processes.

“I thoroughly enjoyed reading this book as it has taken me on a journey through time, across the globe and through multiple disciplines. Indeed, we need to be thinking about these concepts and applying them every day to do our jobs better.” Farah Magrabi, Macquarie University, Australia “The reader will find intriguing not only the title but also the content of the book. I’m also pleased that public health, and even more specifically epidemiology has an important place in this ambitious discussion.” Elena Andresen, Oregon Health & Science University, USA “This book is very well written and addresses an important topic. It presents many reasons why basic scientists/researchers should establish collaborations and access information outside traditional means and not limit thinking but rather expand such and perhaps develop more innovative and translational research ventures that will advance science and not move it laterally.” Gerald Pepe, Eastern Virginia Medical School, USA “This book gathers logically and presents interestingly (with many examples) the qualities and attitudes a researcher must possess in order to become successful. On the long run, the deep and carefully reexamined research will be the one that lasts.” Zoltán Néda, Babeş-Bolyai University, Romania “I really liked the five pillars delineating the components of humanism in research. This book has made a major contribution to the research ethics literature.” David Fleming, University of Missouri, USA A comprehensive review of the research phase of life sciences from design to discovery with suggestions to improve innovation This vital resource explores the creative processes leading to biomedical innovation, identifies the obstacles and best practices of innovative laboratories, and supports the production of effective science. Innovative Research in Life Sciences draws on lessons from 400 award-winning scientists and research from leading universities. The book explores the innovative process in life sciences and puts the focus on how great ideas are born and become landmark scientific discoveries. The text provides a unique resource for developing professional competencies and applied skills of life sciences researchers. The book examines what happens before the scientific paper is submitted for publication or the innovation becomes legally protected. This phase is the most neglected but most exciting in the process of scientific creativity and innovation. The author identifies twelve competencies of innovative biomedical researchers that described and analyzed. This important resource: Highlights the research phase from design to discovery that precedes innovation disclosure Offers a step by step explanation of how to improve innovation Offers solutions for improving research and innovation productivity in the life sciences Contains a variety of statistical databases and a vast number of stories about individual discoveries Includes a process of published studies and national statistics of biomedical research and reviews the performance of research labs and academic institutions Written for academics and researchers in biomedicine, pharmaceutical science, life sciences, drug discovery, pharmacology, Innovative Research in Life Sciences offers a guide to the creative processes leading to biomedical innovation and identifies the best practices of innovative scientists and laboratories.

This book brings together a range of academic, industry and practitioner perspectives on translational medicine (TM). It enhances conceptual and practical understanding of the emergence and progress of the field and its potential impact on basic research, therapeutic development, and institutional infrastructure. In recognition of the various implications TM has for public health policy and commercial innovation, the book addresses the major systemic aspects of the field. The contributors explore the dynamic interactions and key challenges in translating new science into viable therapies for the clinic, which includes recognizing the importance of social, commercial, and regulatory environments in addition to good science.