The Pharmagellan Guide to Analyzing Biotech Clinical Trials PDF Download

Author: Frank David
Publisher:
ISBN: 9780998407524
Category :
Languages : en
Pages :

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Book Description
A comprehensive primer to help non-experts evaluate clinical studies of new therapies. If you work in or around biotech, you're supposed to understand clinical trial results. But what if you're not an expert in study design or biostatistics? You may feel out of your comfort zone when faced with a journal article, press release, or investor presentation. Inside this book: -- Structured roadmap for assessing the main components of a planned orcompleted biotech trial.-- Clear explanations of the most common concepts and terms in biotechclinical studies, illustrated with over 100 real-world examples.-- Deep dives on essential topics like p values, sample size calculations, andKaplan-Meier curves, written in plain English for non-statisticians.-- Pointers for interpreting positive and negative study results, understandingcommon figures and tables, and identifying red flags in press releases.If you're a biotech executive, investor, advisor, or entrepreneur--or aspire to be one--this handbook will give you the foundation you need to analyze planned and completed clinical trials with more confidence."Hugely helpful. I wish I'd had a book like this earlier in my career." - SIR MENEPANGALOS, Executive VP, Biopharmaceuticals R&D, AstraZeneca"A terrific primer for non-experts looking to better evaluate new therapies." -DAPHNE ZOHAR, Founder and CEO, PureTech Health"Crisp and clear. Wise advice on when to rely on clinical data and when to beskeptical." - MICHAEL ROSENBLATT, Senior Partner, Flagship Pioneering"A source of much-needed illumination." - DAN LEPANTO, Senior ManagingDirector, M&A, SVB Leerink

Author: Frank S. David
Publisher: Pharmagellan, LLC
ISBN: 9780998407500
Category : Business & Economics
Languages : en
Pages : 138

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Book Description
If you're a biotech executive, investor, deal maker, entrepreneur, or adviser-or aspire to be one-then you need to know how to build and analyze forecasts and valuation models of R&D-stage drugs. The Pharmagellan Guide is a comprehensive, thoroughly referenced handbook for early-stage biopharma assets and companies.

Author: Chi-Jen Lee
Publisher: CRC Press
ISBN: 1420039148
Category : Medical
Languages : en
Pages : 520

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Book Description
The pharmaceutical industry is on the verge of an exciting and challenging century. Advances in pharmaceutical sciences have dramatically changed the processes of discovery and development of new therapeutic drugs and, in turn, resulted in an extraordinary increase in the potential prophylactic and therapeutic interventions. In this atmosphere, an

Author: Karl Keegan
Publisher: John Wiley & Sons
ISBN: 0470741341
Category : Business & Economics
Languages : en
Pages : 216

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Book Description
The first book to provide a simple and practical means of valuing biotech companies The book begins with a short history of the biotechnology industry; this is important as although it is about 30 years old, the first company went public only in 1996, so it is possible to plot the course of investment waves and dips It examines the European industry and its evolvement, and draws parallels between the similarities and differences between that and the US Looks at the various companies which make up the biotech industry (therapeutic; life sciences; and the medical technology company) and gives tools for the investor to properly evaluate them Praise for Biotechnology Valuation "Keegan states that the valuation of Biotech companies is as much an art as a science. This brief but comprehensive review of the skills and knowledge required, not of just the financial market and sentiment, but also of the technical attributes of a company and the drug development and regulatory hurdles that must be overcome, highlights the importance of the breadth of understanding required. Biotech investing is not for the timid, but it can bring substantial returns. Keegan's book, punctuated with his personal experience and opinions, is a good place to start." —Chris Blackwell, Chief Executive, Vectura Group plc "A user-friendly, yet thorough discussion of a notoriously difficult topic. Dr Keegan's book is a fine resource for both business types and academicians." —Steve Winokur, Managing Director, CanaccordAdams "A highly readable and comprehensive explanation of the technical and commercial parameters that influence biotechnology companies at all stages of development, providing clear context for selection from the toolkit of valuation methodologies the author recommends to assess company and product performance, or ascribe value." —Dr L.M. Allan, Director, Bioscience Enterprise Programme, University of Cambridge "A fabulous approach to a difficult topic." —Deirdre Y. Gillespie, MD, President & CEO, La Jolla Pharmaceutical Company

Author: Tom Brody
Publisher: Academic Press
ISBN: 0128042583
Category : Medical
Languages : en
Pages : 897

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Book Description
Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. - Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more - Extensively covers the "study schema" and related features of study design - Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials - Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers

Author: Joy A. Cavagnaro
Publisher: John Wiley & Sons
ISBN: 1118679385
Category : Medical
Languages : en
Pages : 1012

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Book Description
"The goal is to provide a comprehensive reference book for the preclinicaldiscovery and development scientist whose responsibilities span target identification, lead candidate selection, pharmacokinetics, pharmacology, and toxicology, and for regulatory scientists whose responsibilities include the evaluation of novel therapies." —From the Afterword by Anthony D. Dayan Proper preclinical safety evaluation can improve the predictive value, lessen the time and cost of launching new biopharmaceuticals, and speed potentially lifesaving drugs to market. This guide covers topics ranging from lead candidate selection to establishing proof of concept and toxicity testing to the selection of the first human doses. With chapters contributed by experts in their specific areas, Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials: Includes an overview of biopharmaceuticals with information on regulation and methods of production Discusses the principles of ICH S6 and their implementation in the U.S., Europe, and Japan Covers current practices in preclinical development and includes a comparison of safety assessments for small molecules with those for biopharmaceuticals Addresses all aspects of the preclinical evaluation process, including: the selection of relevant species; safety/toxicity endpoints; specific considerations based upon class; and practical considerations in the design, implementation, and analysis of biopharmaceuticals Covers transitioning from preclinical development to clinical trials This is a hands-on, straightforward reference for professionals involved in preclinical drug development, including scientists, toxicologists, project managers, consultants, and regulatory personnel.

Author: Larry L. Augsburger
Publisher: CRC Press
ISBN: 1841849774
Category : Medical
Languages : en
Pages : 436

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Book Description
Pharmaceutical Dosage Forms: Capsules covers the development, composition, and manufacture of capsules. Despite the important role that capsules play in drug delivery and product development, few comprehensive texts on the science and technology of capsules have been available for the research and academic environments. This text addresses this gap, discussing how capsules provide unique capabilities and options for dosage form design and formulation.

Author: Susan Halabi, PhD
Publisher: Demos Medical Publishing
ISBN: 1935281763
Category : Medical
Languages : en
Pages : 396

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Book Description
Clinical trials are the engine of progress in the development of new drugs and devices for the detection, monitoring, prevention and treatment of cancer. A well conceived, carefully designed and efficiently conducted clinical trial can produce results that change clinical practice overnight, deliver new oncology drugs and diagnostics to the marketplace, and expand the horizon of contemporary thinking about cancer biology. A poorly done trial does little to advance the field or guide clinical practice, consumes precious clinical and financial resources and challenges the validity of the ethical contract between investigators and the volunteers who willingly give their time and effort to benefit future patients. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, Oncology Clinical Trials, provides a comprehensive guide for both early-career and senior oncology investigators into the successful design, conduct and analysis of an oncology clinical trial. Oncology Clinical Trials covers how to formulate a study question, selecting a study population, study design of Phase I, II, and III trials, toxicity monitoring, data analysis and reporting, use of genomics, cost-effectiveness analysis, systemic review and meta-analysis, and many other issues. Many examples of real-life flaws in clinical trials that have been reported in the literature are included throughout. The book discusses clinical trials from start to finish focusing on real-life examples in the development, design and analysis of clinical trials. Oncology Clinical Trials features: A systematic guide to all aspects of the design, conduct, analysis, and reporting of clinical trials in oncology Contributions from oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives Hot topics in oncology trials including multi-arm trials, meta-analysis and adaptive design, use of genomics, and cost-effectiveness analysis Real-life examples from reported clinical trials included throughout

Author: Iqbal S. Grewal
Publisher: CRC Press
ISBN: 1420063219
Category : Medical
Languages : en
Pages : 372

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Book Description
Given the speed at which antibody therapy is becoming readily accepted, a comprehensive industry guide is sorely needed. Written by leading international authorities, this book maintains an overall emphasis on various therapeutic approaches and applications and provides critical discussions on the most significant areas of research in biologics. It focuses on the applications of protein biologics in autoimmunity and inflammation, hematological malignancies, and solid tumors. Each chapter clearly presents the most informative and contemporary account of its subject available, making this an unrivaled reference source beneficial to those in both academia and biotechnology industries.

Author: John J. Campbell
Publisher: Pharmaceutical Press
ISBN: 9780976309635
Category : Pharmaceutical industry
Languages : en
Pages : 311

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Book Description