Phase I Oncology Drug Development

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Phase I Oncology Drug Development

Timothy A. Yap,Jordi Rodon,David S. Hong
Phase I Oncology Drug Development Book PDF

Author : Timothy A. Yap,Jordi Rodon,David S. Hong
Publisher : Springer Nature
Page : 352 pages
File Size : 52,8 Mb
Release : 2020-09-16
Category : Medical
ISBN : 9783030476823

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Phase I Oncology Drug Development by Timothy A. Yap,Jordi Rodon,David S. Hong Pdf

This book provides a detailed review of how oncology drug development has changed over the past decade, and serves as a comprehensive guide for the practicalities in setting up phase I trials. The book covers strategies to accelerate the development of novel antitumor compounds from the laboratory to clinical trials and beyond through the use of innovative mechanism-of-action pharmacodynamic biomarkers and pharmacokinetic studies. The reader will learn about all aspects of modern phase I trial designs, including the incorporation of precision medicine strategies, and approaches for rational patient allocation to novel anticancer therapies. Circulating biomarkers to assess mechanisms of response and resistance are changing the way we are assessing patient selection and are also covered in this book. The development of the different classes of antitumor agents are discussed, including chemotherapy, molecularly targeted agents, immunotherapies and also radiotherapy. The authors also discuss the lessons that the oncology field has learnt from the development of hematology-oncology drugs and how such strategies can be carried over into therapies for solid tumors. There is a dedicated chapter that covers the specialized statistical approaches necessary for phase I trial designs, including novel Bayesian strategies for dose escalation. This volume is designed to help clinicians better understand phase I clinical trials, but would also be of use to translational researchers (MDs and PhDs), and drug developers from academia and industry interested in cancer drug development. It could also be of use to phase I trial study coordinators, oncology nurses and advanced practice providers. Other health professionals interested in the treatment of cancer will also find this book of great value.

The Drug Development Paradigm in Oncology

National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,National Cancer Policy Forum
The Drug Development Paradigm in Oncology Book PDF

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,National Cancer Policy Forum
Publisher : National Academies Press
Page : 145 pages
File Size : 52,5 Mb
Release : 2018-02-12
Category : Medical
ISBN : 9780309457972

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The Drug Development Paradigm in Oncology by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,National Cancer Policy Forum Pdf

Advances in cancer research have led to an improved understanding of the molecular mechanisms underpinning the development of cancer and how the immune system responds to cancer. This influx of research has led to an increasing number and variety of therapies in the drug development pipeline, including targeted therapies and associated biomarker tests that can select which patients are most likely to respond, and immunotherapies that harness the body's immune system to destroy cancer cells. Compared with standard chemotherapies, these new cancer therapies may demonstrate evidence of benefit and clearer distinctions between efficacy and toxicity at an earlier stage of development. However, there is a concern that the traditional processes for cancer drug development, evaluation, and regulatory approval could impede or delay the use of these promising cancer treatments in clinical practice. This has led to a number of effortsâ€"by patient advocates, the pharmaceutical industry, and the Food and Drug Administration (FDA)â€"to accelerate the review of promising new cancer therapies, especially for cancers that currently lack effective treatments. However, generating the necessary data to confirm safety and efficacy during expedited drug development programs can present a unique set of challenges and opportunities. To explore this new landscape in cancer drug development, the National Academies of Sciences, Engineering, and Medicine developed a workshop held in December 2016. This workshop convened cancer researchers, patient advocates, and representatives from industry, academia, and government to discuss challenges with traditional approaches to drug development, opportunities to improve the efficiency of drug development, and strategies to enhance the information available about a cancer therapy throughout its life cycle in order to improve its use in clinical practice. This publication summarizes the presentations and discussions from the workshop.

Anticancer Drug Development Guide

Beverly A. Teicher
Anticancer Drug Development Guide Book PDF

Author : Beverly A. Teicher
Publisher : Springer Science & Business Media
Page : 315 pages
File Size : 50,9 Mb
Release : 2013-11-11
Category : Medical
ISBN : 9781461581529

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Anticancer Drug Development Guide by Beverly A. Teicher Pdf

Experienced cancer researchers from pharmaceutical companies, government laboratories, and academia comprehensively review and describe the arduous process of cancer drug discovery and approval. They focus on using preclinical in vivo and in vitro methods to identify molecules of interest, detailing the targets and criteria for success in each type of testing and defining the value of the information obtained from the various tests. They also define each stage of clinical testing, explain the criteria for success, and outline the requirements for FDA approval. A companion volume by the same editor (Cancer Therapeutics: Experimental and Clinical Agents) reviews existing anticancer drugs and potential anticancer therapies. These two volumes in the Cancer Drug Discovery and Development series reveal how and why molecules become anticancer drugs and thus offer a blueprint for the present and the future of the field.

Novel Designs of Early Phase Trials for Cancer Therapeutics

Shivaani Kummar,Chris Takimoto
Novel Designs of Early Phase Trials for Cancer Therapeutics Book PDF

Author : Shivaani Kummar,Chris Takimoto
Publisher : Academic Press
Page : 234 pages
File Size : 45,6 Mb
Release : 2018-05-22
Category : Medical
ISBN : 9780128125700

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Novel Designs of Early Phase Trials for Cancer Therapeutics by Shivaani Kummar,Chris Takimoto Pdf

Novel Designs of Early Phase Trials for Cancer Therapeutics provides a comprehensive review by leaders in the field of the process of drug development, the integration of molecular profiling, the changes in early phase trial designs, and endpoints to optimally develop a new generation of cancer therapeutics. The book discusses topics such as statistical perspectives on cohort expansions, the role and application of molecular profiling and how to integrate biomarkers in early phase trials. Additionally, it discusses how to incorporate patient reported outcomes in phase one trials. This book is a valuable resource for medical oncologists, basic and translational biomedical scientists, and trainees in oncology and pharmacology who are interested in learning how to improve their research by using early phase trials. Brings a comprehensive review and recommendations for new clinical trial designs for modern cancer therapeutics Provides the reader with a better understanding on how to design and implement early phase oncology trials Presents a better and updated understanding of the process of developing new treatments for cancer, the exciting scientific advances and how they are informing drug development

Phase I Cancer Clinical Trials

Elizabeth A. Eisenhauer,Christopher Twelves,Marc Buyse
Phase I Cancer Clinical Trials Book PDF

Author : Elizabeth A. Eisenhauer,Christopher Twelves,Marc Buyse
Publisher : Oxford University Press
Page : 352 pages
File Size : 46,5 Mb
Release : 2015-03-20
Category : Medical
ISBN : 9780199359035

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Phase I Cancer Clinical Trials by Elizabeth A. Eisenhauer,Christopher Twelves,Marc Buyse Pdf

Phase I trials are a critical first step in the study of novel cancer therapeutic approaches. Their primary goals are to identify the recommended dose, schedule and pharmacologic behavior of new agents or new combinations of agents and to describe the adverse effects of treatment. In cancer therapeutics, such studies have particular challenges. Due to the nature of the effects of treatment, most such studies are conducted in patients with advanced malignancy, rather than in healthy volunteers. Further, the endpoints of these trials are usually measures adverse effects rather than molecular target or anti-tumor effects. These factors render the design, conduct, analysis and ethical aspects of phase I cancer trials unique. As the only comprehensive book on this topic, Phase I Cancer Clinical Trials is a useful resource for oncology trainees or specialists interested in understanding cancer drug development. New to this edition are chapters on Phase 0 Trials and Immunotherapeutics, and updated information on the process, pitfalls, and logistics of Phase I Trials

Principles of Anticancer Drug Development

Elizabeth Garrett-Mayer,Manuel Hidalgo,S. Gail Eckhardt,Neil J. Clendeninn
Principles of Anticancer Drug Development Book PDF

Author : Elizabeth Garrett-Mayer,Manuel Hidalgo,S. Gail Eckhardt,Neil J. Clendeninn
Publisher : Springer Science & Business Media
Page : 674 pages
File Size : 47,7 Mb
Release : 2010-12-29
Category : Medical
ISBN : 9781441973580

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Principles of Anticancer Drug Development by Elizabeth Garrett-Mayer,Manuel Hidalgo,S. Gail Eckhardt,Neil J. Clendeninn Pdf

A practical guide to the design, conduction, analysis and reporting of clinical trials with anticancer drugs.

Antibody-Drug Conjugates

Kenneth J. Olivier, Jr.,Sara A. Hurvitz
Antibody Drug Conjugates Book PDF

Author : Kenneth J. Olivier, Jr.,Sara A. Hurvitz
Publisher : John Wiley & Sons
Page : 560 pages
File Size : 48,8 Mb
Release : 2016-11-14
Category : Medical
ISBN : 9781119060802

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Antibody-Drug Conjugates by Kenneth J. Olivier, Jr.,Sara A. Hurvitz Pdf

Providing practical and proven solutions for antibody-drug conjugate (ADC) drug discovery success in oncology, this book helps readers improve the drug safety and therapeutic efficacy of ADCs to kill targeted tumor cells. • Discusses the basics, drug delivery strategies, pharmacology and toxicology, and regulatory approval strategies • Covers the conduct and design of oncology clinical trials and the use of ADCs for tumor imaging • Includes case studies of ADCs in oncology drug development • Features contributions from highly-regarded experts on the frontlines of ADC research and development

Statistical Approaches in Oncology Clinical Development

Satrajit Roychoudhury,Soumi Lahiri
Statistical Approaches in Oncology Clinical Development Book PDF

Author : Satrajit Roychoudhury,Soumi Lahiri
Publisher : CRC Press
Page : 243 pages
File Size : 52,9 Mb
Release : 2018-12-07
Category : Mathematics
ISBN : 9781351650472

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Statistical Approaches in Oncology Clinical Development by Satrajit Roychoudhury,Soumi Lahiri Pdf

Statistical Approaches in Oncology Clinical Development : Current Paradigm and Methodological Advancement presents an overview of statistical considerations in oncology clinical trials, both early and late phase of development. It illustrates how novel statistical methods can enrich the design and analysis of modern oncology trials. The authors include many relevant real life examples from the pharmaceutical industry and academia based on their first-hand experience. Along with relevant references, the book highlights current regulatory views. The book covers all aspects of cancer clinical trial starting from early phase development. The early part of the book covers novel phase I dose escalation design, exposure response analysis, and innovative phase II design. This includes early development strategy for cancer immunotherapy trials. The contributors also emphasized the role of biomarker and modern era of precision medicine. The second part focuses on the late stage development. This includes the application of adaptive design, safety analysis, and quality of life (QoL) data analysis. The final part discusses current regulatory perspective and challenges. Features: Covers a wide spectrum of topics related to real-life statistical challenges in oncology clinical trials. Provides a comprehensive overview of novel statistical methods to improve trial design and statistical analysis. Detailed case studies illustrate the real life applications. Satrajit Roychoudhury is a Senior Director and a member of the Statistical Research and Innovation group in Pfizer Inc. Prior to joining; he was a member of Statistical Methodology and consulting group in Novartis. He has 11 years of extensive experience in working with different phases of clinical trial. His area of research includes early phase oncology trials, survival analysis, model informed drug development, and use of Bayesian methods in clinical trials. He is industry co-chair for the ASA Biopharmaceutical Section Regulatory-Industry Workshop and has provided statistical training in major conferences including the Joint Statistical Meetings, ASA Biopharmaceutical Section Regulatory-Industry Workshop, and ICSA Applied Statistics Symposium. Soumi Lahiri has 12 years of extensive experience in working different therapeutic areas. She is the former Director of Biostatistics in Clinical Oncology, GlaxoSmithKline. She has also worked in the oncology division of Novartis Pharmaceutical Company for two years. She is an active member of the ASA Biopharmaceutical section and former chair of the membership committee.

Cancer Drug Discovery

Kyu-Won Kim,Jae Kyung Roh,Hee-Jun Wee,Chan Kim
Cancer Drug Discovery Book PDF

Author : Kyu-Won Kim,Jae Kyung Roh,Hee-Jun Wee,Chan Kim
Publisher : Springer
Page : 276 pages
File Size : 48,5 Mb
Release : 2016-11-14
Category : Medical
ISBN : 9789402408447

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Cancer Drug Discovery by Kyu-Won Kim,Jae Kyung Roh,Hee-Jun Wee,Chan Kim Pdf

The reader will discover a comprehensive and multifaceted overview of the history of the development of anticancer drugs deeply influenced by the cell concept of cancer and future directions for the development of new anticancer drugs. First, this book documents the scientific progress in biological science over the last 70 years and the influence this progress had in cancer research. Summaries and charts of important discoveries complete this overview. Furthermore, this book outlines the process of anticancer drug development with a focus on the characteristic drug groups of each era, related to advancements of chemistry and biological sciences. This book also provides brief mechanism of action of drugs, illustrated by comprehensive timelines and conceptual cartoons. This book finally sums up the limitations of the current anticancer drug development and seeks new directions for anticancer drug discovery, considering under the systemic view of cancer.

Making Better Drugs for Children with Cancer

National Research Council,Institute of Medicine,National Cancer Policy Board,Committee on Shortening the Time Line for New Cancer Treatments
Making Better Drugs for Children with Cancer Book PDF

Author : National Research Council,Institute of Medicine,National Cancer Policy Board,Committee on Shortening the Time Line for New Cancer Treatments
Publisher : National Academies Press
Page : 56 pages
File Size : 51,9 Mb
Release : 2005-05-01
Category : Medical
ISBN : 9780309096089

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Making Better Drugs for Children with Cancer by National Research Council,Institute of Medicine,National Cancer Policy Board,Committee on Shortening the Time Line for New Cancer Treatments Pdf

The successes that have been achieved in treating childhood cancers stand as beacons against the less dramatic improvements for adults with cancer. Progress began to accelerate in the 1960s and 1970s, as treatment regimens were built up, primarily by building combinations of chemotherapeutic drugs. However the near absence of research in pediatric cancer drug discovery threatens to halt the progress in childhood cancer treatment achieved during the past four decades. Making Better Drugs for Children with Cancer identifies the major issues to be addressed in developing new agents for childhood cancers, the gaps in research and development, and the steps that have been suggested to move the process forward. This report also makes a new proposal to capitalize on today's science to bring new treatments to children's cancers.

Economic Evaluation of Cancer Drugs

Iftekhar Khan,Ralph Crott,Zahid Bashir
Economic Evaluation of Cancer Drugs Book PDF

Author : Iftekhar Khan,Ralph Crott,Zahid Bashir
Publisher : CRC Press
Page : 416 pages
File Size : 51,6 Mb
Release : 2019-06-14
Category : Mathematics
ISBN : 9781498761314

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Economic Evaluation of Cancer Drugs by Iftekhar Khan,Ralph Crott,Zahid Bashir Pdf

Cancer is a major healthcare burden across the world and impacts not only the people diagnosed with various cancers but also their families, carers, and healthcare systems. With advances in the diagnosis and treatment, more people are diagnosed early and receive treatments for a disease where few treatments options were previously available. As a result, the survival of patients with cancer has steadily improved and, in most cases, patients who are not cured may receive multiple lines of treatment, often with financial consequences for the patients, insurers and healthcare systems. Although many books exist that address economic evaluation, Economic Evaluation of Cancer Drugs using Clinical Trial and Real World Data is the first unified text that specifically addresses the economic evaluation of cancer drugs. The authors discuss how to perform cost-effectiveness analyses while emphasising the strategic importance of designing cost-effectiveness into cancer trials and building robust economic evaluation models that have a higher chance of reimbursement if truly cost-effective. They cover the use of real-world data using cancer registries and discuss how such data can support or complement clinical trials with limited follow up. Lessons learned from failed reimbursement attempts, factors predictive of successful reimbursement and the different payer requirements across major countries including US, Australia, Canada, UK, Germany, France and Italy are also discussed. The book includes many detailed practical examples, case studies and thought-provoking exercises for use in classroom and seminar discussions. Iftekhar Khan is a medical statistician and health economist and a lead statistician at Oxford Unviersity’s Center for Statistics in Medicine. Professor Khan is also a Senior Research Fellow in Health Economics at University of Warwick and is a Senior Statistical Assessor within the Licensing Division of the UK Medicine and Health Regulation Agency. Ralph Crott is a former professor in Pharmacoeconomics at the University of Montreal in Quebec, Canada and former head of the EORTC Health Economics Unit and former senior health economist at the Belgian HTA organization. Zahid Bashir has over twelve years experience working in the pharmaceutical industry in medical affairs and oncology drug development where he is involved in the design and execution of oncology clinical trials and development of reimbursement dossiers for HTA submission.

Artificial Intelligence in Oncology Drug Discovery and Development

John Cassidy,Belle Taylor
Artificial Intelligence in Oncology Drug Discovery and Development Book PDF

Author : John Cassidy,Belle Taylor
Publisher : BoD – Books on Demand
Page : 194 pages
File Size : 48,9 Mb
Release : 2020-09-09
Category : Medical
ISBN : 9781789846898

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Artificial Intelligence in Oncology Drug Discovery and Development by John Cassidy,Belle Taylor Pdf

There exists a profound conflict at the heart of oncology drug development. The efficiency of the drug development process is falling, leading to higher costs per approved drug, at the same time personalised medicine is limiting the target market of each new medicine. Even as the global economic burden of cancer increases, the current paradigm in drug development is unsustainable. In this book, we discuss the development of techniques in machine learning for improving the efficiency of oncology drug development and delivering cost-effective precision treatment. We consider how to structure data for drug repurposing and target identification, how to improve clinical trials and how patients may view artificial intelligence.

Pharmacokinetics in Drug Development

Peter L. Bonate,Danny R. Howard
Pharmacokinetics in Drug Development Book PDF

Author : Peter L. Bonate,Danny R. Howard
Publisher : Springer
Page : 330 pages
File Size : 55,7 Mb
Release : 2016-10-06
Category : Medical
ISBN : 9783319390536

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Pharmacokinetics in Drug Development by Peter L. Bonate,Danny R. Howard Pdf

In this volume, the specific challenges and problems facing the evaluation of new oncology agents are explored with regards to pharmacokinetic, pharmacodynamic modeling and clinical pharmacology development strategies. This book delivers, with an emphasis on the oncology therapeutic area, the goals set in the first three volumes: namely – to provide clinical pharmacologists practical insights for the application of pharmacology, pharmacokinetics and pharmacodynamics for new drug development strategies. Pharmacokinetic-pharmacodynamic concepts for tyrosine kinases, the evaluation of cardiac repolarization prolongation through QTc interval effects, efficacy- and safety-response analyses to support new drug approvals, clinical and preclinical tumor growth modeling, and flat- vs weight-based dose selection are showcased from an oncology clinical pharmacologist’s point-of-view. Oncology development strategies are surveyed for new FDA-approvals to identify patterns in expectations at time of first approval. The special considerations necessary to address combination drug development, metronomics, biosimilars and breakthrough therapies are also presented.

Clinical Trials in Oncology, Third Edition

Stephanie Green,Jacqueline Benedetti,Angela Smith,John Crowley
Clinical Trials in Oncology Third Edition Book PDF

Author : Stephanie Green,Jacqueline Benedetti,Angela Smith,John Crowley
Publisher : CRC Press
Page : 266 pages
File Size : 43,5 Mb
Release : 2012-05-09
Category : Mathematics
ISBN : 9781439814482

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Clinical Trials in Oncology, Third Edition by Stephanie Green,Jacqueline Benedetti,Angela Smith,John Crowley Pdf

The third edition of the bestselling Clinical Trials in Oncology provides a concise, nontechnical, and thoroughly up-to-date review of methods and issues related to cancer clinical trials. The authors emphasize the importance of proper study design, analysis, and data management and identify the pitfalls inherent in these processes. In addition, the book has been restructured to have separate chapters and expanded discussions on general clinical trials issues, and issues specific to Phases I, II, and III. New sections cover innovations in Phase I designs, randomized Phase II designs, and overcoming the challenges of array data. Although this book focuses on cancer trials, the same issues and concepts are important in any clinical setting. As always, the authors use clear, lucid prose and a multitude of real-world examples to convey the principles of successful trials without the need for a strong statistics or mathematics background. Armed with Clinical Trials in Oncology, Third Edition, clinicians and statisticians can avoid the many hazards that can jeopardize the success of a trial.

Anticancer Drug Development Guide

Beverly A. Teicher,Paul A. Andrews
Anticancer Drug Development Guide Book PDF

Author : Beverly A. Teicher,Paul A. Andrews
Publisher : Springer Science & Business Media
Page : 684 pages
File Size : 45,5 Mb
Release : 2004-02-01
Category : Medical
ISBN : 9781592597390

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Anticancer Drug Development Guide by Beverly A. Teicher,Paul A. Andrews Pdf

This unique volume traces the critically important pathway by which a "molecule" becomes an "anticancer agent. " The recognition following World War I that the administration of toxic chemicals such as nitrogen mustards in a controlled manner could shrink malignant tumor masses for relatively substantial periods of time gave great impetus to the search for molecules that would be lethal to specific cancer cells. Weare still actively engaged in that search today. The question is how to discover these "anticancer" molecules. Anticancer Drug Development Guide: Preclinical Screening, Clinical Trials, and Approval, Second Edition describes the evolution to the present of preclinical screening methods. The National Cancer Institute's high-throughput, in vitro disease-specific screen with 60 or more human tumor cell lines is used to search for molecules with novel mechanisms of action or activity against specific phenotypes. The Human Tumor Colony-Forming Assay (HTCA) uses fresh tumor biopsies as sources of cells that more nearly resemble the human disease. There is no doubt that the greatest successes of traditional chemotherapy have been in the leukemias and lymphomas. Since the earliest widely used in vivo drug screening models were the murine L 1210 and P388 leukemias, the community came to assume that these murine tumor models were appropriate to the discovery of "antileukemia" agents, but that other tumor models would be needed to discover drugs active against solid tumors.