A Guide To Biotechnology Law And Business

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A Guide to Biotechnology Law and Business

Author : Robert A. Bohrer
Publisher :
ISBN 13 : 9781594600876
Total Pages : 0 pages
Book Rating : 4.6/5 (8 download)

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Book Synopsis A Guide to Biotechnology Law and Business by : Robert A. Bohrer

Download or read book A Guide to Biotechnology Law and Business written by Robert A. Bohrer and published by . This book was released on 2007 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a guide to the "big picture" of biotechnology law and business, presenting and analyzing the issues that arise throughout the life cycle of the biotechnology product. The book focuses primarily on the pharmaceutical field, from university research through the development process and into the marketplace. The aim of the book is to provide guidance to the biotechnology legal and business communities by providing a practical and integrated discussion of the many different topics that arise in developing biotechnology products. It is intended to be used by I.P. lawyers, FDA lawyers, business lawyers and biotech executives who want a concise introduction to the most fundamental issues in biotechnology law and business. "Understanding the molecular pathways in disease processes is critical to discovering new drugs. The equally important task is to understand the legal pathways that enable biotechnology commercialization. This book charts the course in a way that greatly improves the odds of success."--Drew Senyei, M.D., Managing Director, Enterprise Partners Venture Capital, La Jolla, CA "Bob Bohrer has provided a thorough and thoughtful guide to the biotech industry. His experience, which is based on years of examining the biotech sector, is shared in this book and provides a comprehensive and organized overview for the scientist, investor, service provider and anyone else associated with the biotech industry. This is a must-read for both the experienced biotech executives and those new to the industry."--Lisa A. Haile, J.D., Ph.D., Partner and Co-Chair, Life Sciences Group, DLA Piper US LLP "Professor Bohrer is well positioned to write this comprehensive volume. He was most likely the first legal academician to definitively determine what biotechnology incorporates, and has never stopped reflecting upon the scientific, legal, and social/ethical issues involved. Not only will person now interested in biotechnology benefit from this book, but future historians will thank him."--Douglas Dale Busch, Former General Counsel of The Salk Institute

Biotechnology and the Law

Author : Hugh B. Wellons
Publisher : American Bar Association
ISBN 13 : 9781590317617
Total Pages : 1016 pages
Book Rating : 4.3/5 (176 download)

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Book Synopsis Biotechnology and the Law by : Hugh B. Wellons

Download or read book Biotechnology and the Law written by Hugh B. Wellons and published by American Bar Association. This book was released on 2007 with total page 1016 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book is written to help lawyers faced with the challenge of identifying the legal issues and processes that must be faced by their clients in building, marketing, and protecting a biotech business. The contributors are experts in this specialized area and provide thorough, yet accessible, overviews of biotech subspecialties with an eye to practical application. A biotech legal practice involves specialized subject matter and regulatory schemes that, generally, are not part of the business lawyer's repertoire and which can present many hazards for the uninitiated. Because of the expansion in biotech practice beyond the traditional organizations and their representatives, this guide was written to help lawyers find their way through the biotech maze.

Handbook on Biotechnology Law, Business, and Policy

Author : Michael J. Malinowski
Publisher :
ISBN 13 : 9781634601535
Total Pages : 0 pages
Book Rating : 4.6/5 (15 download)

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Book Synopsis Handbook on Biotechnology Law, Business, and Policy by : Michael J. Malinowski

Download or read book Handbook on Biotechnology Law, Business, and Policy written by Michael J. Malinowski and published by . This book was released on 2016 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Softbound - New, softbound print book.

Biotechnology Entrepreneurship

Author : Craig Shimasaki
Publisher : Academic Press
ISBN 13 : 0124047475
Total Pages : 489 pages
Book Rating : 4.1/5 (24 download)

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Book Synopsis Biotechnology Entrepreneurship by : Craig Shimasaki

Download or read book Biotechnology Entrepreneurship written by Craig Shimasaki and published by Academic Press. This book was released on 2014-04-08 with total page 489 pages. Available in PDF, EPUB and Kindle. Book excerpt: As an authoritative guide to biotechnology enterprise and entrepreneurship, Biotechnology Entrepreneurship and Management supports the international community in training the biotechnology leaders of tomorrow. Outlining fundamental concepts vital to graduate students and practitioners entering the biotech industry in management or in any entrepreneurial capacity, Biotechnology Entrepreneurship and Management provides tested strategies and hard-won lessons from a leading board of educators and practitioners. It provides a 'how-to' for individuals training at any level for the biotech industry, from macro to micro. Coverage ranges from the initial challenge of translating a technology idea into a working business case, through securing angel investment, and in managing all aspects of the result: business valuation, business development, partnering, biological manufacturing, FDA approvals and regulatory requirements. An engaging and user-friendly style is complemented by diverse diagrams, graphics and business flow charts with decision trees to support effective management and decision making. - Provides tested strategies and lessons in an engaging and user-friendly style supplemented by tailored pedagogy, training tips and overview sidebars - Case studies are interspersed throughout each chapter to support key concepts and best practices. - Enhanced by use of numerous detailed graphics, tables and flow charts

Biotechnology and the Law

Author :
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (31 download)

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Book Synopsis Biotechnology and the Law by :

Download or read book Biotechnology and the Law written by and published by . This book was released on with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Pharmaceutical and Biotech Patent Law

Author : Arnold & Porter Kaye Scholer Llp
Publisher :
ISBN 13 : 9781402431388
Total Pages : 1204 pages
Book Rating : 4.4/5 (313 download)

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Book Synopsis Pharmaceutical and Biotech Patent Law by : Arnold & Porter Kaye Scholer Llp

Download or read book Pharmaceutical and Biotech Patent Law written by Arnold & Porter Kaye Scholer Llp and published by . This book was released on 2019-06-07 with total page 1204 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical and Biotech Patent Law provides you with the legal, scientific, and technical information you need to help clients obtain, defend, and challenge patents in these important business areas. This practical guide shows you how to craft problem-free patent applications, including how to partner with the government to bring patented inventions quickly to the marketplace - invalidate competitors' patents by proving that they fail to meet key requirements - protect against various forms of patent infringement - and successfully rebut charges of infringement. It includes detailed checklists that help you resolve thorny patent problems in the complex pharmaceutical and biotech fields, and is regularly updated to reflect Federal Circuit rulings and other significant court decisions.

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"--

Career Opportunities in Biotechnology and Drug Development

Author : Toby Freedman
Publisher : CSHL Press
ISBN 13 : 0879697253
Total Pages : 408 pages
Book Rating : 4.8/5 (796 download)

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Book Synopsis Career Opportunities in Biotechnology and Drug Development by : Toby Freedman

Download or read book Career Opportunities in Biotechnology and Drug Development written by Toby Freedman and published by CSHL Press. This book was released on 2008 with total page 408 pages. Available in PDF, EPUB and Kindle. Book excerpt: An essential guide for students in the life sciences, established researchers, and career counselors, this resource features discussions of job security, future trends, and potential career paths. Even those already working in the industry will find helpful information on how to take advantage of opportunities within their own companies and elsewhere.

Biotechnology - The Science and the Business

Author : Derek G. Springham
Publisher : CRC Press
ISBN 13 : 9789057024061
Total Pages : 876 pages
Book Rating : 4.0/5 (24 download)

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Book Synopsis Biotechnology - The Science and the Business by : Derek G. Springham

Download or read book Biotechnology - The Science and the Business written by Derek G. Springham and published by CRC Press. This book was released on 1999-08-24 with total page 876 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biotechnology has not stood still since 1991 when the first edition of Biotechnology - The Science and the Business was published. It was the first book to treat the science and business of technology as an integrated subject and was well received by both students and business professionals. All chapters in this second edition have been updated and revised and some new chapters have been introduced, including one on the use of molecular genetic techniques in forensic science. Experts in the field discuss a range of biotechnologies, including pesticides, the flavor and fragrance industry, oil production, fermentation and protein engineering. On the business side, subjects include managing, financing, and regulation of biotechnology. Some knowledge of the science behind the technologies is assumed, as well as a layperson's view of buying and selling. As with the first edition, it is expected that this book will be of interest to biotechnology undergraduates, postgraduates and those working in the industry, along with students of business, economics, intellectual property law and communications.

Antibody Patenting

Author : Jürgen Meier
Publisher : Kluwer Law International B.V.
ISBN 13 : 9403510803
Total Pages : 516 pages
Book Rating : 4.4/5 (35 download)

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Book Synopsis Antibody Patenting by : Jürgen Meier

Download or read book Antibody Patenting written by Jürgen Meier and published by Kluwer Law International B.V.. This book was released on 2019-08-08 with total page 516 pages. Available in PDF, EPUB and Kindle. Book excerpt: Antibodies have revolutionized medicine and biotechnology, and have become indispensable tools in therapy, diagnostics, analytics, and research. Therapeutic antibodies, for example, have come to dominate the ranks of blockbuster drugs, currently accounting for 10 out of the top 15 best-selling medicines. At the same time, a body of case law dealing specifically with the patentability of antibody-related inventions and the enforcement of antibody patents has emerged in major jurisdictions. The, at times, significant divergences between different jurisdictions have been compounded by recent decisions in the United States, most notably Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017), which have severely curtailed the possibilities to obtain broad antibody patents. It is therefore essential to understand how antibody inventions are assessed in different jurisdictions in order to secure an optimal patent protection and to successfully enforce such patents. This book provides practitioners with a comprehensive resource elucidating all aspects of the patenting of antibodies from initial drafting and prosecution to enforcement, using a country-by-country format. It covers 23 of the most important IP jurisdictions worldwide – i.e., the European Patent Office, France, Germany, Italy, the Netherlands, Poland, Spain, Switzerland, the United Kingdom, Israel, the United States of America, Argentina, the Andean Community (Bolivia, Colombia, Ecuador, and Peru), Brazil, Canada, Chile, Mexico, China, India, Japan, Singapore, South Korea, and Australia. The 35 contributors to this book, all distinguished experts in this field, provide clear and practice-oriented advice on a range of topics including: – Which types of antibody inventions are patent-eligible? – Which types of functional and structural features are accepted for claiming antibodies? – What needs to be considered when defining antibodies in terms of their antigen, target affinity, binding specificity, epitope, competitive binding and other characteristics in relation to reference antibodies, as well as their effects on the target? – Which pitfalls must be avoided when defining amino acid sequences, chemical modifications or glycosylation patterns, and when relying on cell line deposits? – Which breadth of claims is accepted for antibody inventions, and what experimental support is required? – Which specific medical applications of antibodies can be claimed? – How is inventive step assessed in the specific case of antibody inventions? – What has to be considered when enforcing antibody patents, including in relation to biosimilars as well as the doctrine of equivalence? All chapters follow the same structure, which makes this book easily accessible and allows a direct comparison between different jurisdictions. Practitioners will find the much-needed tools and guidance to secure the best possible patent protection for antibody inventions in 23 of the most important jurisdictions worldwide. This book is the fifth volume in the AIPPI Law Series which has been established together with the International Association for the Protection of Intellectual Property (AIPPI), a non-affiliated, non-profit organization dedicated to improving and promoting the protection of intellectual property at both national and international levels.

Building Biotechnology

Author : Yali Friedman
Publisher : Thinkbiotech
ISBN 13 : 9780973467635
Total Pages : 306 pages
Book Rating : 4.4/5 (676 download)

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Book Synopsis Building Biotechnology by : Yali Friedman

Download or read book Building Biotechnology written by Yali Friedman and published by Thinkbiotech. This book was released on 2006 with total page 306 pages. Available in PDF, EPUB and Kindle. Book excerpt: Building Biotechnology helps readers start and manage biotechnology companies and understand the business of biotechnology. This acclaimed book describes the convergence of scientific, political, regulatory, and commercial factors that drive the biotechnology industry: * Cultivate a career in biotechnology, with or without an MBA or Ph.D. * Fund and assemble a company * Manage research and development, alliances, and funding * Understand the diverse factors defining the biotechnology industry * Invest intelligently in biotechnology This second edition significantly expands upon the foundation laid by the first, updating recent developments and adding significantly more case studies, informative figures and tables.

Preparing for Future Products of Biotechnology

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309452058
Total Pages : 231 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Preparing for Future Products of Biotechnology by : National Academies of Sciences, Engineering, and Medicine

Download or read book Preparing for Future Products of Biotechnology written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-07-28 with total page 231 pages. Available in PDF, EPUB and Kindle. Book excerpt: Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5â€"10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.

Building Biotechnology

Author : Yali Friedman
Publisher :
ISBN 13 : 9781934899298
Total Pages : 367 pages
Book Rating : 4.8/5 (992 download)

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Book Synopsis Building Biotechnology by : Yali Friedman

Download or read book Building Biotechnology written by Yali Friedman and published by . This book was released on 2014 with total page 367 pages. Available in PDF, EPUB and Kindle. Book excerpt: Building Biotechnology helps readers start and manage biotechnology companies and understand the business of biotechnology. This acclaimed book describes the convergence of scientific, policy, regulatory, and commercial factors that drive the biotechnology industry and define its scope. In addition to its popularity among business professionals and scientists seeking to apply their skills to biotechnology, Building Biotechnology has also been adopted as a course text in dozens of advanced biotechnology programs. This fourth edition significantly expands upon the foundation laid by the first three, updating case law and business models in this dynamic industry and adding significantly more case studies, informative figures and tables. Most importantly, Building Biotechnology enables seasoned business professionals and entrepreneurial scientists alike to understand the drivers of biotechnology businesses and apply their established skills for commercial success.

A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition

Author : Stephen M. Kanovsky
Publisher :
ISBN 13 : 9781935065876
Total Pages : 672 pages
Book Rating : 4.0/5 (658 download)

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Book Synopsis A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition by : Stephen M. Kanovsky

Download or read book A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition written by Stephen M. Kanovsky and published by . This book was released on 2020-09 with total page 672 pages. Available in PDF, EPUB and Kindle. Book excerpt: FDLI's popular reference book, A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition, provides an introduction to the laws and regulations governing development, marketing, and sale of FDA-regulated products, including topics on food, drugs, medical devices, biologics, dietary supplements, cosmetics, new animal drugs, cannabis, and tobacco and nicotine products. Structured to serve as a reference and as a teaching tool, the book offers practical legal and regulatory fundamentals, and each chapter builds sequentially from the last to provide an accessible overview of the key topics relevant to practitioners of food and drug law and regulation. This book is a standard legal text in law schools and graduate regulatory programs and has been cited as a reference in judicial opinions (including the U.S. Supreme Court). This Seventh Edition includes new sections on controlled substances, compounded drugs, and cannabis and cannabis-derived compounds. It also incorporates the latest amendments to the Federal Food, Drug, and Cosmetic Act, as well as FDA regulations and guidances.

The Role of Intellectual Property Rights in Biotechnology Innovation

Author : David Castle
Publisher : Edward Elgar Publishing
ISBN 13 : 1849801932
Total Pages : 475 pages
Book Rating : 4.8/5 (498 download)

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Book Synopsis The Role of Intellectual Property Rights in Biotechnology Innovation by : David Castle

Download or read book The Role of Intellectual Property Rights in Biotechnology Innovation written by David Castle and published by Edward Elgar Publishing. This book was released on 2009 with total page 475 pages. Available in PDF, EPUB and Kindle. Book excerpt: . . . recommended to anyone interested in the thrilling subject of the relationship of IPRs and innovation. Ralf Uhrich, Journal of Intellectual Property This is an outstanding piece of scholarship. It will serve as a powerful stimulant for new research in the field and as a reliable guide for practitioners. Calestous Juma, Harvard University, US Intellectual property rights (IPRs), particularly patents, occupy a prominent position in innovation systems, but to what extent they support or hinder innovation is widely disputed. Through the lens of biotechnology, this book delves deeply into the main issues at the crossroads of innovation and IPRs to evaluate claims of the positive and negative impacts of IPRs on innovation. An international group of scholars from a range of disciplines economic geography, health law, business, philosophy, history, public health, management examine how IPRs actually operate in innovation systems, not just from the perspective of theory but grounded in their global, regional, national, current and historical contexts. In so doing, the contributors seek to uncover and move beyond deeply held assumptions about the role of IPRs in innovation systems. Scholars and students interested in innovation, science and technology policy, intellectual property rights and technology transfer will find this volume of great interest. The findings will also be of value to decision makers in science and technology policy and managers of intellectual property in biotechnology and venture capital firms.

Intellectual Property and Biotechnology

Author : Matthew Rimmer
Publisher : Edward Elgar Publishing
ISBN 13 : 1848440189
Total Pages : 393 pages
Book Rating : 4.8/5 (484 download)

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Book Synopsis Intellectual Property and Biotechnology by : Matthew Rimmer

Download or read book Intellectual Property and Biotechnology written by Matthew Rimmer and published by Edward Elgar Publishing. This book was released on 2008-01-01 with total page 393 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dr Rimmer s book is a marvellous introduction to a crucial topic of our time. He writes engagingly, provocatively and always with good humour. A highly technical and complex area of law has been reduced to clear descriptions and searching analysis. Truly, this is an important book on an essential topic that will help define the ethics of a future that includes nothing less than the future of our species. From the foreword by the Hon Justice Michael Kirby AC CMG, the High Court of Australia . . . the author has done an excellent job by explaining the subject in an open and accessible manner. This book is a timely and very thought-provoking analysis of patent law and biotechnology. . . The book is a unique theoretical contribution to the controversial public debate over commercialization of biological inventions. . . there is an extensive bibliography. . . a valuable resource for further reading. The book will be of prime interest to lawyers and patent attorneys, scientists and researchers, business managers and technology transfer specialists. Journal of Intellectual Property Rights Rimmer s book is highly recommended for anyone interested in the issues and debate related to biological inventions, regardless of which side the reader is on. Stefan M. Miller, Journal of Commercial Biotechnology . . . this book gives an excellent account of the most celebrated biotechnology cases from three continents, and for this alone is to be thoroughly recommended. David Rogers, European Intellectual Property Review Rimmer has put a great deal of thought and effort into this series of chapters. For those looking at how to reform, direct and develop laws in relation to biotechnology, this book is brimming with ideas, suggestions and recommendations of what to do next. Rebecca Halford-Harrison, Chartered Institute of Patent Attorneys . . . an excellent introduction to a wide range of legal thinking in an increasingly controversial and relevant area to humankind. Sharon Givoni, Australian Intellectual Property Law Bulletin Rimmer s new book is a timely and very thought-provoking analysis of patent law and biotechnology and asks a very serious question: can a 19th century patent system adequately deal with a 21st century industry? Kate McDonald, Australian Life Scientist This book documents and evaluates the dramatic expansion of intellectual property law to accommodate various forms of biotechnology from micro-organisms, plants, and animals to human genes and stem cells. It makes a unique theoretical contribution to the controversial public debate over the commercialization of biological inventions. The author also considers the contradictions between the Supreme Court of Canada rulings in respect of the Harvard oncomouse, and genetically modified canola. He explores law, policy, and practice in both Australia and New Zealand in respect to gene patents and non-coding DNA. This study charts the rebellion against the European Union Biotechnology Directive particularly in respect of Myriad Genetics BRCA1 and BRCA2 patents, and stem cell patent applications. The book also considers whether patent law will accommodate frontier technologies such as bioinformatics, haplotype mapping, proteomics, pharmacogenomics, and nanotechnology. Intellectual Property and Biotechnology will be of prime interest to lawyers and patent attorneys, scientists and researchers, business managers and technology transfer specialists.

The Business of Bioscience

Author : Craig D. Shimasaki
Publisher : Springer Science & Business Media
ISBN 13 : 1441900640
Total Pages : 282 pages
Book Rating : 4.4/5 (419 download)

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Book Synopsis The Business of Bioscience by : Craig D. Shimasaki

Download or read book The Business of Bioscience written by Craig D. Shimasaki and published by Springer Science & Business Media. This book was released on 2009-09-18 with total page 282 pages. Available in PDF, EPUB and Kindle. Book excerpt: My journey into this fascinating field of biotechnology started about 26 years ago at a small biotechnology company in South San Francisco called Genentech. I was very fortunate to work for the company that begat the biotech industry during its formative years. This experience established a solid foundation from which I could grow in both the science and business of biotechnology. After my fourth year of working on Oyster Point Boulevard, a close friend and colleague left Genentech to join a start-up biotechnology company. Later, he approached me to leave and join him in of all places – Oklahoma. He persisted for at least a year before I seriously considered his proposal. After listening to their plans, the opportunity suddenly became more and more intriguing. Finally, I took the plunge and joined this ent- preneurial team in cofounding and growing a start-up biotechnology company. Making that fateful decision to leave the security of a larger company was extremely difficult, but it turned out to be the beginning of an entrepreneurial career that forever changed how I viewed the biotechnology industry. Since that time, I have been fortunate to have cofounded two other biotechnology com- nies and even participated in taking one of them public. During my career in these start-ups, I held a variety of positions, from directing the science, operations, regulatory, and marketing components, to subsequently becoming CEO.