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.
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 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
A one-stop source for investing in biotech-with detailed coverage of the science, the business, the players, and the strategies for one of today's most promising (and volatile) industries To invest in biotech is to invest in the future, and as such, investors need to learn the nuances of the science they're putting their money on. The core asset of biotech companies is knowledge, and sound investment decisions are impossible without an understanding of this complex science. That's where The Biotech Investor's Bible fits in. This much-needed, one-of-a-kind resource simplifies the complex science surrounding the business of biotech and clarifies subtle distinctions within the context of their financial repercussions. The book explains the basics of genetics, patents, and therapies; and teaches investors how to value biotech companies and their state-of-the art products and technology. The Biotech Investor's Bible offers an informative summary of the relatively short history of the industry and provides a comprehensive review of various industry sectors.
"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"--
Business Development in the biotechnology and pharmaceutical industries accounts for over $5 billion in licensing deal value per year and much more than that in the value of mergers and acquisitions. Transactions range from licences to patented academic research, to product developments as licences, joint ventures and acquisition of intellectual property rights, and on to collaborations in development and marketing, locally or across the globe. Asset sales, mergers and corporate takeovers are also a part of the business development remit. The scope of the job can be immense, spanning the life-cycle of products from the earliest levels of research to the disposal of residual marketing rights, involving legal regulatory manufacturing, clinical development, sales and marketing and financial aspects. The knowledge and skills required of practitioners must be similarly broad, yet the availability of information for developing a career in business development is sparse. Martin Austin's highly practical guide spans the complete process and is based on his 30 years of experience in the industry and the well-established training programme that he has developed and delivers to pharmaceutical executives from across the world.
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.
Authoritative guide to the principles, characteristics, engineering aspects, economics, and applications of disposables in the manufacture of biopharmaceuticals The revised and updated second edition of Single-Use Technology in Biopharmaceutical Manufacture offers a comprehensive examination of the most-commonly used disposables in the manufacture of biopharmaceuticals. The authors—noted experts on the topic—provide the essential information on the principles, characteristics, engineering aspects, economics, and applications. This authoritative guide contains the basic knowledge and information about disposable equipment. The author also discusses biopharmaceuticals’ applications through the lens of case studies that clearly illustrate the role of manufacturing, quality assurance, and environmental influences. This updated second edition revises existing information with recent developments that have taken place since the first edition was published. The book also presents the latest advances in the field of single-use technology and explores topics including applying single-use devices for microorganisms, human mesenchymal stem cells, and T-cells. This important book: • Contains an updated and end-to-end view of the development and manufacturing of single-use biologics • Helps in the identification of appropriate disposables and relevant vendors • Offers illustrative case studies that examine manufacturing, quality assurance, and environmental influences • Includes updated coverage on cross-functional/transversal dependencies, significant improvements made by suppliers, and the successful application of the single-use technologies Written for biopharmaceutical manufacturers, process developers, and biological and chemical engineers, Single-Use Technology in Biopharmaceutical Manufacture, 2nd Edition provides the information needed for professionals to come to an easier decision for or against disposable alternatives and to choose the appropriate system.
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.
A comprehensive, authoritative and up-to-date reference for the newcomer to radiopharmaceuticals and those already in the field. Radiopharmaceuticals are used to detect and characterise disease processes, or normal biological function, in living cells, animals or humans. Used as tracer molecules, they map the distribution, uptake and metabolism of the molecule in clinical studies, basic research or applied research. The area of radiopharmaceuticals is expanding rapidly. The number of PET centers in the world is increasing at 20% per year, and many drug companies are utilising PET and other forms of radiopharmaceutical imaging to evaluate products. * Readers will find coverage on a number of important topics such as radionuclide production, PET and drug development, and regulations * Explains how to use radiopharmaceuticals for the diagnosis and therapy of cancer and other diseases * The editors and a majority of the contributors are from the United States
