The Pharmagellan Guide To Analyzing Biotech Clinical Trials

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The Pharmagellan Guide to Analyzing Biotech Clinical Trials

Author : Frank David
Publisher :
ISBN 13 : 9780998407524
Total Pages : pages
Book Rating : 4.4/5 (75 download)

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Book Synopsis The Pharmagellan Guide to Analyzing Biotech Clinical Trials by : Frank David

Download or read book The Pharmagellan Guide to Analyzing Biotech Clinical Trials written by Frank David and published by . This book was released on 2022-01-10 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

The Pharmagellan Guide to Biotech Forecasting and Valuation

Author : Frank S. David
Publisher : Pharmagellan, LLC
ISBN 13 : 9780998407500
Total Pages : 138 pages
Book Rating : 4.4/5 (75 download)

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Book Synopsis The Pharmagellan Guide to Biotech Forecasting and Valuation by : Frank S. David

Download or read book The Pharmagellan Guide to Biotech Forecasting and Valuation written by Frank S. David and published by Pharmagellan, LLC. This book was released on 2017-01-06 with total page 138 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Clinical Trials

Author : Tom Brody
Publisher : Academic Press
ISBN 13 : 0128042583
Total Pages : 897 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Clinical Trials by : Tom Brody

Download or read book Clinical Trials written by Tom Brody and published by Academic Press. This book was released on 2016-02-19 with total page 897 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

From Breakthrough to Blockbuster

Author : Donald L. Drakeman
Publisher : Oxford University Press
ISBN 13 : 0195084004
Total Pages : 241 pages
Book Rating : 4.1/5 (95 download)

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Book Synopsis From Breakthrough to Blockbuster by : Donald L. Drakeman

Download or read book From Breakthrough to Blockbuster written by Donald L. Drakeman and published by Oxford University Press. This book was released on 2022 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Beginning in the 1970s, several scientific breakthroughs promised to transform the creation of new medicines. As investors sought to capitalize on these Nobel Prize-winning discoveries, the biotech industry grew to thousands of small companies around the world. Each sought to emulate what the major pharmaceutical companies had been doing for a century or more, but without the advantages of scale, scope, experience, and massive resources. How could a large collection of small companies, most with fewer than 50 employees, compete in one of the world's most breathtakingly expensive and highly regulated industries? This book shows how biotech companies have met the challenge by creating nearly 40% more of the most important treatments for unmet medical needs. Moreover, they have done so with much lower overall costs. The book focuses on both the companies themselves and the broader biotech ecosystem that supports them. Its portrait of the crucial roles played by academic research, venture capital, contract research organizations, the capital markets, and pharmaceutical companies shows how a supportive environment enabled the entrepreneurial biotech industry to create novel medicines with unprecedented efficiency. In doing so, it also offers insights for any industry seeking to innovate in uncertain and ambiguous conditions. Looking to the future, it concludes that biomedical research will continue to be most effective in the hands of a large group of small companies as long as national healthcare policies allow the rest of the ecosystem to continue to thrive"--

Medicine, Science and Merck

Author : P. Roy Vagelos
Publisher : Cambridge University Press
ISBN 13 : 9780521662956
Total Pages : 326 pages
Book Rating : 4.6/5 (629 download)

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Book Synopsis Medicine, Science and Merck by : P. Roy Vagelos

Download or read book Medicine, Science and Merck written by P. Roy Vagelos and published by Cambridge University Press. This book was released on 2004-01-05 with total page 326 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book traces the careers of Roy Vagelos, who eventually became the CEO of Merck and Co., Inc.

HPLC Methods for Recently Approved Pharmaceuticals

Author : George Lunn
Publisher : John Wiley & Sons
ISBN 13 : 0471711675
Total Pages : 743 pages
Book Rating : 4.4/5 (717 download)

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Book Synopsis HPLC Methods for Recently Approved Pharmaceuticals by : George Lunn

Download or read book HPLC Methods for Recently Approved Pharmaceuticals written by George Lunn and published by John Wiley & Sons. This book was released on 2005-05-06 with total page 743 pages. Available in PDF, EPUB and Kindle. Book excerpt: An indispensable resource for busy researchers Your time is valuable-too valuable to spend hunting through the technical literature in search of the right HPLC assay techniques for your projects. With HPLC Methods for Recently Approved Pharmaceuticals, you'll quickly identify and replicate the ideal procedures for your project needs, without having to refer to original source publications. More of your time can then be spent in the lab, not the library. Covering the relevant world literature through 2003, this book picks up where Dr. Lunn's acclaimed HPLC Methods for Pharmaceutical Analysis left off. It arms you with established HPLC assay techniques for hundreds of newly approved drugs, as well as drugs for which assay methods were only recently developed. Combining detailed descriptions of procedures with specially annotated references, this practical handbook gives you: * HPLC methods for 390 commonly prescribed pharmaceutical compounds * Various procedures for each drug listed together-making it easy to mix and match for customized approaches * Methods for drugs in biological fluids and for bulk and formulated drugs * Chemical structures, molecular weights and formulas, and CAS Registry Numbers * Cross-references to The Merck Index * Retention times of other drugs that can be assayed using the same methods

Emerging Protein Biotherapeutics

Author : Iqbal S. Grewal
Publisher : CRC Press
ISBN 13 : 1420063219
Total Pages : 372 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Emerging Protein Biotherapeutics by : Iqbal S. Grewal

Download or read book Emerging Protein Biotherapeutics written by Iqbal S. Grewal and published by CRC Press. This book was released on 2009-06-26 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Methods for Structural Analysis of Protein Pharmaceuticals

Author : Wim Jiskoot
Publisher : Springer Science & Business Media
ISBN 13 : 9780971176720
Total Pages : 694 pages
Book Rating : 4.1/5 (767 download)

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Book Synopsis Methods for Structural Analysis of Protein Pharmaceuticals by : Wim Jiskoot

Download or read book Methods for Structural Analysis of Protein Pharmaceuticals written by Wim Jiskoot and published by Springer Science & Business Media. This book was released on 2005-12-05 with total page 694 pages. Available in PDF, EPUB and Kindle. Book excerpt: Protein pharmaceuticals form a fast-growing category in the arsenal of drugs. This book explores the nature of different analytical techniques and the way in which they are related to pharmaceutical proteins. In addition to serving the analytical chemist, this book is needed by the formulation scientist who is responsible for design and formulation of a pharmaceutical protein that can be monitored during production and over time.

Developability of Biotherapeutics

Author : Sandeep Kumar
Publisher : CRC Press
ISBN 13 : 1482246155
Total Pages : 312 pages
Book Rating : 4.4/5 (822 download)

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Book Synopsis Developability of Biotherapeutics by : Sandeep Kumar

Download or read book Developability of Biotherapeutics written by Sandeep Kumar and published by CRC Press. This book was released on 2015-11-18 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biopharmaceuticals are emerging as frontline medicines to combat several life-threatening and chronic diseases. However, such medicines are expensive to develop and produce on a commercial scale, contributing to rising healthcare costs. Developability of Biotherapeutics: Computational Approaches describes applications of computational and molecular

Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems

Author : Ashok Katdare
Publisher : CRC Press
ISBN 13 : 1420004131
Total Pages : 474 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems by : Ashok Katdare

Download or read book Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems written by Ashok Katdare and published by CRC Press. This book was released on 2006-07-28 with total page 474 pages. Available in PDF, EPUB and Kindle. Book excerpt: To facilitate the development of novel drug delivery systems and biotechnology-oriented drugs, the need for new, yet to be developed, and approved excipients continues to increase. Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems serves as a comprehensive source to improve understanding of excipients and forge potential new avenues for regulatory approval. This book presents detailed, up-to-date information on various aspects of excipient development, testing, and technological considerations for their use. It addresses specific details such as historical perspective, preclinical testing, safety, and toxicology evaluation, as well as regulatory, quality, and utility aspects. The text also describes best practices for use of various functional excipients and extensive literature references for all topics.

Oncology Clinical Trials

Author : Susan Halabi, PhD
Publisher : Demos Medical Publishing
ISBN 13 : 1935281763
Total Pages : 396 pages
Book Rating : 4.9/5 (352 download)

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Book Synopsis Oncology Clinical Trials by : Susan Halabi, PhD

Download or read book Oncology Clinical Trials written by Susan Halabi, PhD and published by Demos Medical Publishing. This book was released on 2009-12-22 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Forecasting for the Pharmaceutical Industry

Author : Arthur G. Cook
Publisher : CRC Press
ISBN 13 : 1317134109
Total Pages : 323 pages
Book Rating : 4.3/5 (171 download)

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Book Synopsis Forecasting for the Pharmaceutical Industry by : Arthur G. Cook

Download or read book Forecasting for the Pharmaceutical Industry written by Arthur G. Cook and published by CRC Press. This book was released on 2016-03-03 with total page 323 pages. Available in PDF, EPUB and Kindle. Book excerpt: Forecasting for the Pharmaceutical Industry is a definitive guide for forecasters as well as the multitude of decision makers and executives who rely on forecasts in their decision making. In virtually every decision, a pharmaceutical executive considers some type of forecast. This process of predicting the future is crucial to many aspects of the company - from next month's production schedule, to market estimates for drugs in the next decade. The pharmaceutical forecaster needs to strike a delicate balance between over-engineering the forecast - including rafts of data and complex ’black box’ equations that few stakeholders understand and even fewer buy into - and an overly simplistic approach that relies too heavily on anecdotal information and opinion. Arthur G. Cook's highly pragmatic guide explains the basis of a successful balanced forecast for products in development as well as currently marketed products. The author explores the pharmaceutical forecasting process; the varied tools and methods for new product and in-market forecasting; how they can be used to communicate market dynamics to the various stakeholders; and the strengths and weaknesses of different forecast approaches. The text is liberally illustrated with tables, diagrams and examples. The final extended case study provides the reader with an opportunity to test out their knowledge. The second edition has been updated throughout and includes a brand new chapter focusing on specialized topics such as forecasting for orphan drugs and biosimilars.

Enterprise Project Portfolio Management

Author : Dr. Richard Bayney
Publisher : J. Ross Publishing
ISBN 13 : 1604270608
Total Pages : 305 pages
Book Rating : 4.6/5 (42 download)

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Book Synopsis Enterprise Project Portfolio Management by : Dr. Richard Bayney

Download or read book Enterprise Project Portfolio Management written by Dr. Richard Bayney and published by J. Ross Publishing. This book was released on 2012-08-11 with total page 305 pages. Available in PDF, EPUB and Kindle. Book excerpt: This unique guide and professional reference presents a structured framework for practitioners and students of project, program, and portfolio management to enhance their strategic and analytic capabilities in the evolving discipline of project portfolio management (PPM). It provides a practical, step-by-step approach to building competencies in categorizing, evaluating, optimizing, prioritizing, and managing an IT, pharmaceutical, biotech or other complex R&D-oriented portfolio of investments.

Biochemical Modulation of Skin Reactions

Author : Agis F. Kydonieus
Publisher : CRC Press
ISBN 13 : 9780849321177
Total Pages : 352 pages
Book Rating : 4.3/5 (211 download)

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Book Synopsis Biochemical Modulation of Skin Reactions by : Agis F. Kydonieus

Download or read book Biochemical Modulation of Skin Reactions written by Agis F. Kydonieus and published by CRC Press. This book was released on 1999-12-15 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: Like almost every major scientific or medical breakthrough in history, the transdermal delivery of drugs started as only an idea - slowly moving its way from the drawing board to actual testing and eventually approval. Today, there are more than 20 companies involved in transdermal drug delivery. In addition, almost every large pharmaceutical firm has ongoing transdermal delivery programs. But in spite of this effort and after 15 years from the introduction of the Nitroglycerin patch, only six transdermal drugs exist in the marketplace. The practice has been hampered by the fact that most drugs, as well as many excipients used in the manufacture of transdermal patches, cause skin irritation or skin sensitization. Similar problems exist with the application of dermatologicals and cosmetics to skin, which in many cases are equally as severe as those encountered in transdermal delivery. Biochemical Modulation of Skin Reactions: Transdermals, Topicals, Cosmetics presents a series of chapters describing technologies and the practical application of biochemicals which might lead to the reduction or abrogation of these skin reaction. In addition, it addresses those areas of skin immunology and skin sciences that account for the processes that control irritant and allergic contact dermatitis and outlines the numerous cellular and molecular factors involved in the development of irritation and sensitization. Indeed, Biochemical Modulation of Skin Reactions helps serve as a catalyst for further research in the field, allowing for more drugs and cosmetics to be applied to the skin without adverse effects. Features

Bio- and MedTech Entrepreneurship

Author : Heidrun Flaadt Cervini
Publisher : Stämpfli Verlag
ISBN 13 : 372721693X
Total Pages : 308 pages
Book Rating : 4.7/5 (272 download)

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Book Synopsis Bio- and MedTech Entrepreneurship by : Heidrun Flaadt Cervini

Download or read book Bio- and MedTech Entrepreneurship written by Heidrun Flaadt Cervini and published by Stämpfli Verlag. This book was released on 2020-07-21 with total page 308 pages. Available in PDF, EPUB and Kindle. Book excerpt: The process of innovation in life science is capital intensive, associated with a high risk as well as highly regulated and is therefore distinct from other types of innovation. This book closes the educational gap in life science entrepreneurship and fills a market niche. It allows you to understand, manage and successfully lead the innovation process in life science. Learn how to develop and successful market biomedical technology Increase the return of your investments in biomedical innovation Get ready for a new career in a life science start-up Discover how to transfer a bio- or medtech project from academia to industry Obtain a comprehensive overview of the innovation process in life science

Advances in Macrofungi

Author : Kandikere R. Sridhar
Publisher : CRC Press
ISBN 13 : 1000454150
Total Pages : 434 pages
Book Rating : 4.0/5 (4 download)

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Book Synopsis Advances in Macrofungi by : Kandikere R. Sridhar

Download or read book Advances in Macrofungi written by Kandikere R. Sridhar and published by CRC Press. This book was released on 2021-09-17 with total page 434 pages. Available in PDF, EPUB and Kindle. Book excerpt: Large scale cultivation of macrofungi is possible with fermentation, using easily accessible lignocellulosic agricultural residues utilising economical methods to generate substantial biomass, food and biofuels. Bioconversion of lignocellulosic wastes by macrofungi generates value-added fungal nutritional biomass for humans and livestock. Besides commercial cultivation techniques, other topics covered include healing potential of mushrooms, industrial opportunities, mycelium-based products, forest wild mushrooms and industrial applications of white rot fungi. This book addresses the various applications of macrofungi. It encourages readers to explore non-conventional sources of nutrition as well as bioactive metabolites to serve as nutraceuticals. The volume emphasizes the significance of macrofungi as source of bioactive compounds to remedy human lifestyle diseases especially cancers and cardiovascular ailments along with immunostimulation potential by Cordyceps. This book also emphasises on the role of mushrooms as a source of cosmeceuticals, source of flavors, essence, scents and perfumes.

Biotechnology Valuation

Author : Karl Keegan
Publisher : John Wiley & Sons
ISBN 13 : 0470741341
Total Pages : 216 pages
Book Rating : 4.4/5 (77 download)

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Book Synopsis Biotechnology Valuation by : Karl Keegan

Download or read book Biotechnology Valuation written by Karl Keegan and published by John Wiley & Sons. This book was released on 2009-01-15 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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