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.

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

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

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"--

Download or read book Business Development for the Biotechnology and Pharmaceutical Industry written by Martin Austin and published by CRC Press. This book was released on 2016-04-08 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Single Use Technology in Biopharmaceutical Manufacture written by Regine Eibl and published by John Wiley & Sons. This book was released on 2019-07-18 with total page 367 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

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.

Download or read book Handbook of Radiopharmaceuticals written by Michael J. Welch and published by John Wiley & Sons. This book was released on 2003-01-17 with total page 872 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Valuation in Life Sciences written by Boris Bogdan and published by Springer Science & Business Media. This book was released on 2007-03-23 with total page 257 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is the first complete guide to valuation in life sciences for industry professionals, investors, and academics. It introduces the characteristics of drug and medical device development, explains how to translate these into the valuation, and provides valuable industry data. Special emphasis is put on the practicability of the proposed methods by including many hands-on examples, without compromising on realistic results.

Download or read book Value Creation in the Pharmaceutical Industry written by Alexander Schuhmacher and published by John Wiley & Sons. This book was released on 2016-04-11 with total page 511 pages. Available in PDF, EPUB and Kindle. Book excerpt: This practical guide for advanced students and decision-makers in the pharma and biotech industry presents key success factors in R&D along with value creators in pharmaceutical innovation. A team of editors and authors with extensive experience in academia and industry and at some of the most prestigious business schools in Europe discusses in detail the innovation process in pharma as well as common and new research and innovation strategies. In doing so, they cover collaboration and partnerships, open innovation, biopharmaceuticals, translational medicine, good manufacturing practice, regulatory affairs, and portfolio management. Each chapter covers controversial aspects of recent developments in the pharmaceutical industry, with the aim of stimulating productive debates on the most effective and efficient innovation processes. A must-have for young professionals and MBA students preparing to enter R&D in pharma or biotech as well as for students on a combined BA/biomedical and natural sciences program.

Download or read book Healthcare Investing Profiting from the New World of Pharma Biotech and Health Care Services written by Les Funtleyder and published by McGraw Hill Professional. This book was released on 2008-12-31 with total page 289 pages. Available in PDF, EPUB and Kindle. Book excerpt: Is your portfolio in peak health? Ranking among the world's largest markets, the $2.5 trillion health care industry is growing at an unprecedented rate. According to Miller Tabak + Co.'s health care strategist Les Funtleyder, major structural renovations to the system are imminent. “Health care is entering an era of reform,” Funtleyder writes, “and with reform comes change and the opportunity for investment gain.” Health-Care Investing provides a thorough explanation of how the industry's mammoth size and complexity can be worked to your advantage and why health care is more resistant to changes in economic cycles than other markets. Funtleyder gives you a comprehensive overview of the industry, from both macro and micro points of view, so you can make informed decisions regarding your investments. You'll find critical information concerning The natural inelasticity of health care and how to profit from it How to take advantage of the market's complexities and inefficiencies Issues and policy changes you need to know The social responsibility aspect of investing in health care Why this market is essential for diversified portfolios In Health-Care Investing, Funtleyder provides the tools you need to dig up the richest opportunities possible and build them into your investment strategy. You'll get a detailed look at traditional market patterns and the events that have shaped--and will continue to shape--the industry. Then you'll find specific strategies you can use to maximize your profits, whether you invest in pharma, biotech, managed services, or a combination of them. This informative and practical guide also includes a list of questions you can use as an investment “template,” which will help guide your decision-making process. With Health Care Investing, you'll be armed with the know-how to make the right decisions today in order to fully capitalize on events of the future.

Download or read book Biotechnology Valuation Investing written by Jason Hsu and published by Independently Published. This book was released on 2019-03-16 with total page 166 pages. Available in PDF, EPUB and Kindle. Book excerpt: The selection of biotech stocks for investment is more difficult compared with the selection of other stocks and industries that possess historical data, since biotechnology is a recently new science. In the first edition of this book, we described the crucial parameters for the valuation of an early stage biotech company without a drug in the market. In this edition, we analyze novel financial models that can value stocks of biotech companies with products in the market or products under development (in pre-clinical and clinical studies). All of these parameters should be helpful to potential new investors when creating a stock portfolio that includes highly promising biotech companies. Our strategy of selecting highly promising stocks based on all parameters described in this book and of performing a basic financial modeling analysis with DFC and/or real options valuation models has proven very successful, as this strategy provides returns higher than 100% in most cases. In the first edition of this book, based on our strategy, we suggested that Juno Therapeutics and Kite Pharma were "hot" stocks. At that time, Kite's stock was $50.19, while Juno's stock was $54.21. Since then, Kite's stock reached $179.79, with the company acquired by Gilead for $11.9 billion, while Juno's stock reached $86.96, with the company acquired by Celgene for $9 billion. Furthermore, Moderna Therapeutics, a private company that we valued at $5.5 billion in 2016 based on our real options financial model, today has a $7.5 billion valuation. This newly revised and expanded version was written to help investors in the selection of biotech stocks based on different scientific and financial criteria.

Download or read book Valuation in Life Sciences written by Boris Bogdan and published by Springer Science & Business Media. This book was released on 2010-04-19 with total page 378 pages. Available in PDF, EPUB and Kindle. Book excerpt: Valuation is a hot topic among life sciences professionals. There is no clear understanding on how to use the different valuation approaches and how to determine input parameters. Some do not value at all, arguing that it is not possible to get realistic and objective numbers out of it. Some claim it to be an art. In the following chapters we will provide the user with a concise val- tion manual, providing transparency and practical insight for all dealing with valuation in life sciences: project and portfolio managers, licensing executives, business developers, technology transfer managers, entrep- neurs, investors, and analysts. The purpose of the book is to explain how to apply discounted cash flow and real options valuation to life sciences p- jects, i.e. to license contracts, patents, and firms. We explain the fun- mentals and the pitfalls with case studies so that the reader is capable of performing the valuations on his own and repeat the theory in the exercises and case studies. The book is structured in five parts: In the first part, the introduction, we discuss the role of the players in the life sciences industry and their p- ticular interests. We describe why valuation is important to them, where they need it, and the current problems to it. The second part deals with the input parameters required for valuation in life sciences, i.e. success rates, costs, peak sales, and timelines.

Download or read book The Biotech Investor written by Tom Abate and published by Times Books. This book was released on 2013-08-13 with total page 308 pages. Available in PDF, EPUB and Kindle. Book excerpt: A sophisticated investor's practical tool kit for analyzing the science, business, opportunities, and risks in the century's most promising industry The world is entering a biotechnology boom-but only informed investors will prosper in the incredibly complex biotech business. Separating the bioengineered wheat from the chaff, San Francisco Chronicle science and technology columnist Tom Abate, one of the top objective authorities on biotech, gives investors the analytical foundation to understand the science, finances, time horizon, and technological and commercial potential of this burgeoning industry. In The Biotech Investor, Abate provides sophisticated business analysis, guidelines for assessing company leadership, easy-to-digest reports from the labs, and indispensable investor tools and metrics. He explains how breaking news, medical conferences, U.S. Food and Drug Administration approvals, and the patent process affect investing strategies. Finally, he looks beyond medicine to review the financial opportunities presented by biotechnology advances in everything from agriculture to jean manufacturing, and shows investors how to identify "coattail" industries such as instrumentation and software development that will benefit from biotech successes. The Biotech Investor is the comprehensive, expert source for successful and intelligent investing in one of the twenty-first century's most promising industries.

Download or read book The Biotech Investor s Bible written by George Wolff and published by John Wiley & Sons. This book was released on 2001-06-13 with total page 374 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Science Lessons written by Gordon M. Binder and published by Harvard Business Review Press. This book was released on 2008 with total page 326 pages. Available in PDF, EPUB and Kindle. Book excerpt: Under Gordon Binder's leadership, Amgen became the world's largest and most successful biotech company in the world. This text describes what it really takes to manage risk, financing, creative employees, and intellectual property on the international stage.

Download or read book Scientific Due Diligence written by Nathan Martinsberg and published by Createspace Independent Publishing Platform. This book was released on 2018-05-03 with total page 182 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many a blockbuster drug began in the mind of a single entrepreneur. From start-ups to spin-offs, there are no lack of options for a company or venture capitalist to license or invest into. But how can you know that this is the correct investment? The correct option to choose? The one which will lead to financial success and a nice end-of-year bonus? This is where scientific due diligence comes in, the independent, realistic and critical review of a potential technology. From early development data through to clinical study results, patents to competitor analysis, the due diligence process is essential for any investment decision. We have developed this handbook to guide investors and due diligence investigators through the minefield of scientific due diligence in the pharmaceutical world. It covers best-practice approaches, traps to avoid, and the most important areas to focus your limited time on. Investing in pharma? Then this is the book for you. --- Book contents --- The book has been divided into sections which cover the entire due diligence process. The first section covers the basics of due diligence: - Chapter 1 introduces due diligence investigations, including the attributes of good due diligence investigators, the basic rules to follow, and commonly-seen licensing approaches. - Chapter 2 covers the initial steps of assessment, including the preliminary screening for potential licenses and the secondary screen to identify true opportunities. - Chapter 3 shows the preparation for the on-site scientific due diligence investigation, including typical organisational tasks and team set-up. Next, the specific requirements for each area of expertise are covered in more depth: - Chapter 4 covers the investigation from the regulatory affairs perspective, including factors such as approval risk, regulatory planning, and useful special pathways. - Chapter 5 deals with quality, the assurance that the technology has been developed and manufactured to the required quality levels. The chapter covers typical GMP documents and important GxP requirements which will need to be verified. - Chapter 6 covers chemistry, manufacturing and control, the details of the product and the production process. This includes manufacturing-site specific documents and the process development and validation requirements. - Chapter 7 describes preclinical trials, the preliminary work prior to human testing. This includes approaches for evaluating preclinical studies as well as more specific information for toxicology and pharmacology work. - Chapter 8 involves clinical trials, the most important test of any new drug. This section covers both general trial requirements as well as those specific to individual clinical phases. - Chapter 9 deals with marketing, the ability to sell the new product. This includes determining market position, analysing potential competitors, and determining reimbursement options. - Chapter 10 describes the intellectual property factors which may be involved, covering both patenting and data exclusivity approaches to IP protection. - Chapter 11 finishes the scientific due diligence process by providing the final set of questions to ask prior to making the final recommendation. Finally the five appendices provide reference information which will help when conducting a due diligence investigation, from example checklists to work from through to advice for when you are being audited.