Genomics and Pharmacogenomics in Anticancer Drug Development and Clinical Response provides the most comprehensive body of knowledge available on the role of genetic and genomic variation in the individualization of drug therapies in cancer patients. As a consequence of the intrinsic chromosomal and genetic instability of the tumor genome, it is generally believed that tailoring of chemotherapy in cancer - tients might be achieved by molecular analysis of patient tumor DNA. In addition, to reduce the toxicity risk of patients, the tumor DNA information should be in- grated with the available data on polymorphic drug-metabolizing enzyme and tra- porter genes mediating the exposure of patients to active drugs and/or their active metabolites. The chapters of this book clearly show how DNA information from both the host (germline) and the tumor should be taken into account for rational selection of drug therapies in cancer patients, an aspect that received little attention, despite its importance. The availability of new molecular approaches to the selection of drug therapy is an emerging need, because the traditional approach based on the evaluation of patient and tumor characteristics is clearly far from optimal. Many treated patients do not experience signi?cant bene?ts from the treatment, while they often experience moderate to severe toxicities. In addition, the development and clinical use of novel molecularly targeted agents (alone or in combination with classical cytotoxic therapy) requires the und- standing of the molecular features of the tumors and the identi?cation of tumor markers of response.

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. On 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.

Early characterization of toxicity and efficacy would significantly impact the overall productivity of pharmaceutical R&D and reduce drug candidate attrition and failure. By describing the available platforms and weighing their relative advantages and disadvantages, including microarray data analysis, Genomics in Drug Discovery and Development introduces readers to the biomarker, pharmacogenomic, and toxicogenomics toolbox. The authors provide a valuable resource for pharmaceutical discovery scientists, preclinical drug safety department personnel, regulatory personnel, discovery toxicologists, and safety scientists, drug development professionals, and pharmaceutical scientists.

Pharmacogenomics: Challenges and Opportunities in Therapeutic Implementation includes discussions and viewpoints from the academic, regulatory, pharmaceutical, clinical, socio-ethical and economic perspectives. Each chapter presents an overview of the potential or opportunity within the areas discussed and also outlines foreseeable challenges and limitations in moving pharmacogenomics into drug development and direct therapeutic applications. This edited book contains review questions for a more in-depth analysis of the implications of pharmacogenomics and discussion points to generate ideas on best to move the field forward. Clinical pearls and case studies are used to illustrate real-life experiences and both successful and unsuccessful applications. Tables, figures, and annotations are included throughout the book to facilitate understanding and further reference. Multi-contributed book and chapters are written by contributors who are experts in their field Provides perspectives from those involved in all aspects of pharmacogenomics—including academic, regulatory, economic, industry and medical—to illustrate how all of the pieces fit together and where the challenges may be Includes case studies of both successful and unsuccessful applications so readers can consider the potential and challenges in moving the science into drug development and direct therapeutic applications Chapters contain discussion questions and clinical pearls and enable readers to reflect on how to move pharmacogenomics forward and apply these observations and useful tips to their own work and research

Pharmacogenomics: Challenges and Opportunities in Therapeutic Implementation, Second Edition, provides comprehensive coverage of the challenges and opportunities facing the therapeutic implications of pharmacogenomics from academic, regulatory, pharmaceutical, socio-ethical and economic perspectives. While emphasis is on the limitations in moving the science into drug development and direct therapeutic applications, this book also focuses on clinical areas with successful applications and important initiatives that have the ability to further advance the discipline. New chapters cover important topics such as pharmacogenomic data technologies, clinical testing strategies, cost-effectiveness, and pharmacogenomic education and practice guidelines. The importance of ethnicity is also discussed, which highlights phar,acogenomic diversity across Latin American populations. With chapters written by interdisciplinary experts and insights into the future direction of the field, this book is an indispensable resource for academic and industry scientists, graduate students and clinicians engaged in pharmacogenomics research and therapeutic implementation. Provides viewpoints that focus on the scientific and translational challenges and opportunities associated with advancing the field of pharmacogenomics Highlights progress in both the research and clinical areas of pharmacogenomics, as well as relevant implementation experience, challenges, and perspectives on direct-to-consumer genetic testing Includes, where applicable, discussion points, review questions, and cases for self-assessment purposes and to facilitate in-depth discussion

This new edition offers a state-of-the-art and integrative vision of pharmacogenomics by exploring new concepts and practical methodologies focusing on disease treatments, from cancers to cardiovascular and neurodegenerative disorders and more. The collection of these theoretical and experimental approaches facilitates problem-solving by tackling the complexity of personalized drug discovery and development. Written by leading experts in their fields for the highly successful Methods in Molecular Biology series, the book aims to provide across-the-board resources to support the translation of pharmacogenomics into better individualized health care. Authoritative and up-to-date, Pharmacogenomics in Drug Discovery and Development, Third Edition aims to aid researchers in approaching the challenges in pharmacogenomics and personalized medicine with the introduction of these novel ideas and cutting-edge methodologies.

The Advances in Cancer Research series provides invaluable information on the exciting and fast-moving field of cancer research. This volume stands as the first ever thematic volume in the series, focusing on the topic of genomics in cancer drug development. The chapters included in this book represent the cutting-edge information in the field and span such topics as Mass Spectrometry: Uncovering the Cancer Proteome for Diagnostics; Biomarker Discovery in Epithelial Ovarian Cancer by Genomic Approaches; The Application of siRNA Technology to Cancer Biology Discovery; Ribozyme Technology for Cancer Gene Target Identification and Validation; Cancer Cell-Based Genomic and Small Molecule Screens; Tumour Antigens as Surrogate Markers and Targets for Therapy and Vaccines; Practices and Pitfalls of Mouse Cancer Models in Drug Discovery; Biomarker Assay Translation from Discovery to Clinical Studies in Cancer Drug Development – Quantification of Emerging Protein Biomarkers; Molecular Optical Imaging of Therapeutic Targets of Cancer; Cancer Drug Approval in the United States, Europe and Japan.