Download or read book FTO freedom to Operate in the Pharmaceutical Industry written by Hirotaka Nonaka and published by Nomos Verlagsgesellschaft. This book was released on 2018 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Key features of innovation in the pharmaceutical industry -- How to achieve freedom to operate (FTO) -- Dealing with adverse patents -- Structure and operation of FTO-licensing markets in the parmaceutical industry -- FTO-licensing between a venture business company for innovative drug development and a pharmaceutical company.
Download or read book Drug Repurposing written by David Cavalla and published by Royal Society of Chemistry. This book was released on 2022-01-31 with total page 351 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug repurposing is the development of existing drugs for new uses: given that 9 in 10 drugs that enter drug development are never marketed and therefore represent wasted effort, it is an attractive as well as inherently more efficient process. Three repurposed drugs can be brought to market for the same cost as one new chemical entity; and they can also be identified more quickly, an important benefit for patients whose diseases are progressing faster than therapeutic innovation. But repurposing also requires a fresh look at configuring pharmaceutical R&D, considering clinical, regulatory and patent issues much earlier than would otherwise be the case; a holistic gedanken experiment almost needs to be undertaken at the very start of any repurposing development. In addition to new ways of thinking, the discovery of repurposing opportunities can take advantage of artificial intelligence techniques to match the perfect new use for an existing drug. And while repurposing of medicines has been in the mind of every doctor since Hypocrates, modern clinical practice will simply have to adapt to new repurposing techniques in an age where the number of known diseases is increasing much faster than the healthcare dollars available.
Download or read book Promoting Access to Medical Technologies and Innovation Intersections between Public Health Intellectual Property and Trade written by World Intellectual Property Organization and published by WIPO. This book was released on 2013 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt: This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.
Download or read book Guidelines for Preparing Patent Landscape Reports written by World Intellectual Property Organization and published by WIPO. This book was released on 2015-08-24 with total page 131 pages. Available in PDF, EPUB and Kindle. Book excerpt: These Guidelines are designed both for general users of patent information, as well as for those involved in producing Patent Landscape Reports (PLRs). They provide step-by-step instructions on how to prepare a PLR, as well as background information such as objectives, patent analytics, concepts and frameworks.
Download or read book Industry Immersion Learning written by Lisbeth Borbye and published by John Wiley & Sons. This book was released on 2011-09-19 with total page 223 pages. Available in PDF, EPUB and Kindle. Book excerpt: How to Create and Conduct Real-Life Reusable Case Studies with Industry Employer Alliances and Projects Written and Endorsed by Science and Business Professionals in the Research Triangle Park in North Carolina, USA. Many students and university teachers are unfamiliar with the industry environment. Case studies developed in collaboration with working professionals can help students and professors bridge the gap between universities and industry. This book provides guidance on how to approach industry professionals and create educational alliances. The strategy of establishing contact with industry employers and the process of developing and teaching case-studies are described. Among the case-studies are examples of how to identify biomarkers and new drugs simultaneously, prioritize and develop products in compliance with rules and regulations, commercialize products and protect and manage the intellectual property, optimize processes and technologies for manufacturing, and minimize human errors in production.
Download or read book Burger s Medicinal Chemistry Drug Discovery and Development 8 Volume Set written by and published by John Wiley & Sons. This book was released on 2021-04-20 with total page 6057 pages. Available in PDF, EPUB and Kindle. Book excerpt: Burger’s Medicinal Chemistry, Drug Discovery and Development Explore the freshly updated flagship reference for medicinal chemists and pharmaceutical professionals The newly revised eighth edition of the eight-volume Burger’s Medicinal Chemistry, Drug Discovery and Development is the latest installment in this celebrated series covering the entirety of the drug development and discovery process. With the addition of expert editors in each subject area, this eight-volume set adds 35 chapters to the extensive existing chapters. New additions include analyses of opioid addiction treatments, antibody and gene therapy for cancer, blood-brain barrier, HIV treatments, and industrial-academic collaboration structures. Along with the incorporation of practical material on drug hunting, the set features sections on drug discovery, drug development, cardiovascular diseases, metabolic diseases, immunology, cancer, anti-Infectives, and CNS disorders. The text continues the legacy of previous volumes in the series by providing recognized, renowned, authoritative, and comprehensive information in the area of drug discovery and development while adding cutting-edge new material on issues like the use of artificial intelligence in medicinal chemistry. Included: Volume 1: Methods in Drug Discovery, edited by Kent D. Stewart Volume 2: Discovering Lead Molecules, edited by Kent D. Stewart Volume 3: Drug Development, edited by Ramnarayan S. Randad and Michael Myers Volume 4: Cardiovascular, Endocrine, and Metabolic Diseases, edited by Scott D. Edmondson Volume 5: Pulmonary, Bone, Immunology, Vitamins, and Autocoid Therapeutic Agents, edited by Bryan H. Norman Volume 6: Cancer, edited by Barry Gold and Donna M. Huryn Volume 7: Anti-Infectives, edited by Roland E. Dolle Volume 8: CNS Disorders, edited by Richard A. Glennon Perfect for research departments in the pharmaceutical and biotechnology industries, Burger’s Medicinal Chemistry, Drug Discovery and Development can be used by graduate students seeking a one-stop reference for drug development and discovery and deserves its place in the libraries of biomedical research institutes, medical, pharmaceutical, and veterinary schools.
Download or read book Licensing Selling and Finance in the Pharmaceutical and Healthcare Industries written by Martin Austin and published by Routledge. This book was released on 2016-05-06 with total page 192 pages. Available in PDF, EPUB and Kindle. Book excerpt: Licensing, Selling and Finance in the Pharmaceutical and Healthcare Industries is an assessment of the turbulent state of pharmaceutical and biotechnology markets as we enter the second decade of the 21st Century. At the same time, the book offers a cautionary evaluation of the future financing of innovation in terms of what's gone wrong and how to succeed in the future. Martin Austin explores the challenge that the pharmaceutical (and related) industries face in terms of balancing short term, cost containment and expenditure control in areas such as internal research and development; whilst embracing in-licensing and the acquisition of innovative therapies to counteract their impending portfolio weaknesses in the mid to longer term. The first part of the book provides an engaging and convincing perspective on the context in which the industry currently finds itself; the second part is a pragmatic guide to commercialising your intellectual property; including how to recognise and value what you have as well as the new ways of working that you will need to adopt when negotiating, collaborating and contracting in partnership and alliance with others. Commentators have described in great detail the cocktail of commercial, clinical and social issues that threaten to overwhelm the pharmaceutical industry; Martin Austin's book offers a very distinctive perspective on these issues and their solution.
Download or read book A Practical Guide to Drug Development in Academia written by Daria Mochly-Rosen and published by Springer Science & Business Media. This book was released on 2014-07-08 with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt: "A lot of hard-won knowledge is laid out here in a brief but informative way. Every topic is well referenced, with citations from both the primary literature and relevant resources from the internet." Review from Nature Chemical Biology Written by the founders of the SPARK program at Stanford University, this book is a practical guide designed for professors, students and clinicians at academic research institutions who are interested in learning more about the drug development process and how to help their discoveries become the novel drugs of the future. Often many potentially transformative basic science discoveries are not pursued because they are deemed ‘too early’ to attract industry interest. There are simple, relatively cost-effective things that academic researchers can do to advance their findings to the point that they can be tested in the clinic or attract more industry interest. Each chapter broadly discusses an important topic in drug development, from preclinical work in assay design through clinical trial design, regulatory issues and marketing assessments. After the practical overview provided here, the reader is encouraged to consult more detailed texts on specific topics of interest. "I would actually welcome it if this book’s intended audience were broadened even more. Younger scientists starting out in the drug industry would benefit from reading it and getting some early exposure to parts of the process that they’ll eventually have to understand. Journalists covering the industry (especially the small startup companies) will find this book a good reality check for many an over-hopeful press release. Even advanced investors who might want to know what really happens in the labs will find information here that might otherwise be difficult to track down in such a concentrated form."
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
Download or read book Patent It Yourself written by and published by NOLO. This book was released on 2025-07-29 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Practical Methods for Biocatalysis and Biotransformations 2 written by John Whittall and published by John Wiley & Sons. This book was released on 2012-04-16 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biocatalysts are increasingly used by chemists engaged in fine chemical synthesis within both industry and academia. Today, there exists a huge choice of high-tech enzymes and whole cell biocatalysts, which add enormously to the repertoire of synthetic possibilities. Practical Methods for Biocatalysis and Biotransformations 2 is a "how-to" guide that focuses on the practical applications of enzymes and strains of microorganisms that are readily obtained or derived from culture collections. The sources of starting materials and reagents, hints, tips and safety advice (where appropriate) are given to ensure, as far as possible, that the procedures are reproducible. Comparisons to alternative methodology are given and relevant references to the primary literature are cited. This second volume – which can be used on its own or in combination with the first volume - concentrates on new applications and new enzyme families reported since the first volume. Contents include: introduction to recent developments and future needs in biocatalysts and synthetic biology in industry reductive amination enoate reductases for reduction of electron deficient alkenes industrial carbonyl reduction regio- and stereo- selective hydroxylation oxidation of alcohols selective oxidation industrial hydrolases and related enzymes transferases for alkylation, glycosylation and phosphorylation C-C bond formation and decarboxylation halogenation/dehalogenation/heteroatom oxidation tandem and sequential multi-enzymatic syntheses Practical Methods for Biocatalysis and Biotransformations 2 is an essential collection of biocatalytic methods for chemical synthesis which will find a place on the bookshelves of synthetic organic chemists, pharmaceutical chemists, and process R&D chemists in industry and academia.
Download or read book Early Drug Development written by Fabrizio Giordanetto and published by John Wiley & Sons. This book was released on 2018-06-11 with total page 816 pages. Available in PDF, EPUB and Kindle. Book excerpt: This one-stop reference systematically covers key aspects in early drug development that are directly relevant to the discovery phase and are required for first-in-human studies. Its broad scope brings together critical knowledge from many disciplines, ranging from process technology to pharmacology to intellectual property issues. After introducing the overall early development workflow, the critical steps of early drug development are described in a sequential and enabling order: the availability of the drug substance and that of the drug product, the prediction of pharmacokinetics and -dynamics, as well as that of drug safety. The final section focuses on intellectual property aspects during early clinical development. The emphasis throughout is on recent case studies to exemplify salient points, resulting in an abundance of practice-oriented information that is usually not available from other sources. Aimed at medicinal chemists in industry as well as academia, this invaluable reference enables readers to understand and navigate the challenges in developing clinical candidate molecules that can be successfully used in phase one clinical trials.
Download or read book Intellectual Property Management for Start ups written by Martin A. Bader and published by Springer Nature. This book was released on 2023-02-16 with total page 522 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines intellectual property (IP) as an important value driver for start-ups. Businesses of all sizes are inevitably confronted with intellectual property issues at some point, but start-ups and their collaborators face unique challenges and opportunities in IP management. Identifying, generating, and exploiting intellectual property can lead to sustainable competitive advantages and avoidance of risks. Many start-ups sense the complexity of IP management and therefore place their energy elsewhere. However, the clear conclusion to be drawn from this unique collection of contributions is that putting an IP management strategy in place is critical to the successful development of a business. Prof. Dr. Martin A. Bader and Prof. Dr. Sevim Süzeroğlu-Melchiors have years of experience as consultants, entrepreneurs, business owners, and researchers where they saw firsthand the need for a comprehensive yet practical resource for start-ups and their key stakeholders. This book explores different perspectives in dealing with IP from six different angles: the start-up’s view, the investor’s view, the corporation’s view, the university’s view, the global IP office’s view, and the advisor’s view. Each section consists of chapters written by leading experts from around the globe including Silicon Valley, Canada, Israel, Switzerland, Germany, Finland, France, Australia, Brazil, India, Japan, Singapore, and South Africa. Contributors bring practical experience from a wide range of sectors, such as information and communication technology, software, artificial intelligence, machine learning, cybersecurity, industrial automation, internet of things, life sciences, pharma, crop science, biotech, medtech, mining, sustainability, climate tech, and even quantum technologies. This timely publication serves as a guidebook for entrepreneurs and other key stakeholders in the start-up ecosystem. It empowers founders to develop their own IP management strategy to mitigate risk, create and capture value, and lay the groundwork for sustainable growth. An essential reference for start-ups to achieve business excellence. “This edited book volume offers valuable insights, bringing together perspectives of key stakeholder groups from a wide variety of innovation ecosystems – an invaluable resource.” —Carsten Fink, Chief Economist, World Intellectual Property Organization, Geneva “A timely book for those wanting a clear overview of the issues the different players encounter in the start-up ecosystem. A useful resource indeed. Congratulations to the editors and team.”—Audrey Yap, Managing Partner YUSARN AUDREY LLC, Past President LESI, Chairman Singapore Innovation & Productivity Institute, Singapore “A ‘must read’ for all innovators in the start-up world. It is truly a fantastic book and one I would recommend being bought and read (in full)!”—Laurence Freeman, Professor (Adjunct), CU Denver Business School, Jake Jabs Center for Entrepreneurship, Denver, Colorado, United States/div
Download or read book Biotechnology Law written by Alan J. Morrison and published by Columbia University Press. This book was released on 2020-02-04 with total page 466 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biotechnology and law are inextricable. Patent, regulatory, and contract law profoundly shape the biotech industry, and each of these practice areas is deeply intertwined with the science it governs. Yet many in this industry lack even a basic grasp of these laws, jeopardizing their business success as a result. This book is an essential introduction to biotechnology law for scientists, startup founders, regulatory specialists, patent liaisons, investors, academics, students, and other nonattorneys with biotech backgrounds. It covers core topics such as patentability, patent prosecution and infringement, patent opinions, the development and FDA approval of small-molecule and biologic drugs, regulatory exclusivity, generic drugs and ANDA litigation, biosimilars and the patent dance, patent licenses, and collaboration agreements. Written with scientists in mind, Biotechnology Law is a clear, concise, and entirely practical primer on the topic, replete with straightforward, real-world examples to illustrate each key concept. Understanding the legal machinery through which science becomes business is not a luxury—it is a crucial part of a scientist’s training. Alan J. Morrison’s expert treatment embraces this new reality.
Download or read book Concepts in Biotechnology written by Klaus Buchholz and published by John Wiley & Sons. This book was released on 2014-07-22 with total page 453 pages. Available in PDF, EPUB and Kindle. Book excerpt: Adopting a unique approach, this novel textbook integrates science and business for an inside view on the biotech industry. Peering behind the scenes, it provides a thorough analysis of the foundations of the present day industry for students and professionals alike: its history, its tools and processes, its markets and products. The authors, themselves close witnesses of the emergence of modern biotechnology from its very beginnings in the 1980s, clearly separate facts from fiction, looking behind the exaggerated claims made by start-up companies trying to attract investors. Essential reading for every student and junior researcher looking for a career in the biotech sector.
Download or read book Pharmaceutical Product Development written by Vandana B. Patravale and published by CRC Press. This book was released on 2016-05-25 with total page 433 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products. Pharmaceutical Product Development equips the pharmaceutical formulation scientist with extensive and up-to-date knowledge of drug product development and covers all steps from the beginning of product conception to the final packaged form that enters the market and lifecycle management thereof. Applications of core scientific principles for product development are also thoroughly discussed in conjunction with the latest approaches involving design of experiment and quality by design with comprehensive illustrations based on practical case studies of several dosage forms. The book presents pharmaceutical product development information in an easy-to-read mode with simplified theories, case studies and guidelines for students, academicians and professionals in the pharmaceutical industry. It is an invaluable resource and hands-on guide covering managerial, regulatory and practical aspects of pharmaceutical product lifecycle management.
Download or read book TEXTBOOK ON PHARMACEUTICAL INTELLECTUAL PROPERTY RIGHTS written by Dr. Anasuya Patil, Dr. Nayyar Parvez, Dr. Sachinkumar Dnyaneshwar Gunjal, Prof. Madhusmruti Khandai, Dr. Rajni Arora, Nagam Santhi Priya and published by Shashwat Publication. This book was released on 2023-08-04 with total page 454 pages. Available in PDF, EPUB and Kindle. Book excerpt: The laws and regulations governing the pharmaceutical industry were adopted to protect the consuming public by attempting to provide drugs of constituent quality, purity, and efficacy. The Food, Drug and Cosmetic Act (the Act) is a living document in that it is amended frequently and interpreted constantly. The act may be imperfect, but careful attention to its provisions plus an effort of good faith by all persons concerned with drug manufacturing can produce the type of product for which the Act and its regulations strives. Even though the applicable laws and regulations may change with regard to specifics, there are, nonetheless, many constant applicable generally. This book serves an overview of the more significant laws, regulations and Acts. This text book describes the Food, Drug and Cosmetic Act, treats briefly regulations bearing on pharmaceutical manufacturing, looks at the structure, powers, and duties of the Food and Drug administration (FDA), describes state and local laws and regulations, and finally, covers the protection of industrial property and product liability.
