Download or read book The Licensing Agreement in Pharmaceutical Business Development 3rd edition written by and published by Pharmalicensing. This book was released on with total page 61 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 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 Cobert s Manual Of Drug Safety And Pharmacovigilance Third Edition written by Cobert Barton and published by World Scientific. This book was released on 2019-04-10 with total page 524 pages. Available in PDF, EPUB and Kindle. Book excerpt: Completely revised and updated, Cobert's Manual of Drug Safety and Pharmacovigilance, Third Edition, is a how-to manual for those working in the fields of drug safety, clinical research, pharmacology, regulatory affairs, risk management, quality/compliance, and in government and legal professions.This comprehensive and practical guide discusses the theory and the practicalities of drug safety (also known as pharmacovigilance), and provides essential information on drug safety and regulations in the United States, Europe Union, and more, including: recognizing, monitoring, reporting, and cataloging serious adverse drug reactions.Cobert's Manual of Drug Safety and Pharmacovigilance, Third Edition, teaches the daily practice of drug safety in industry, hospitals, the FDA and other health agencies — both in the United States and around the world — and provides critical information about what to do when confronted with a drug safety problem.
Download or read book Risk sharing in the Pharmaceutical Industry written by Gerrit Reepmeyer and published by Springer Science & Business Media. This book was released on 2006-02-25 with total page 297 pages. Available in PDF, EPUB and Kindle. Book excerpt: The productivity in pharmaceutical research and development faces intense pres sure. R&D expenditures of the major US and European companies have topped US$ 33 billion in 2003 compared to around US$ 13 billion just a decade ago. At the same time, the number of new drug approvals has dropped from 53 in 1996 to only 35 in 2003. Moreover, the protraction of clinical trials has significantly reduced the effective time of patent protection. The consequences are devastating. Monopoly profits have started to decline and the average costs per new drug have reached a re cord level of close to US$ 1 billion today. As a result, any failure of a new sub stance in the R&D process can lead to considerable losses, and the risks of introduc ing a new drug to the market have grown tremendously. Particularly if a company is highly dependent on just a handful of mega-selling blockbuster drugs, the risks can be even greater. For example, Pfizer generated about 90% of its worldwide revenues in 2002 with just 8 products. Any shortfall of a promising late-stage drug candidate would have left Pfizer with a gaping hole in its product portfolio. In order to deal with these risks, many pharmaceutical companies have started to organize their R&D in partnership. In fact, more than 600 alliances in pharmaceutical R&D are signed every year.
Download or read book Drug Discovery and Development Third Edition written by James J. O'Donnell and published by CRC Press. This book was released on 2019-11-21 with total page 697 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Discovery and Development, Third Edition presents up-to-date scientific information for maximizing the ability of a multidisciplinary research team to discover and bring new drugs to the marketplace. It explores many scientific advances in new drug discovery and development for areas such as screening technologies, biotechnology approaches, and evaluation of efficacy and safety of drug candidates through preclinical testing. This book also greatly expands the focus on the clinical pharmacology, regulatory, and business aspects of bringing new drugs to the market and offers coverage of essential topics for companies involved in drug development. Historical perspectives and predicted trends are also provided. Features: Highlights emerging scientific fields relevant to drug discovery such as the microbiome, nanotechnology, and cancer immunotherapy; and novel research tools such as CRISPR and DNA-encoded libraries Case study detailing the discovery of the anti-cancer drug, lorlatinib Venture capitalist commentary on trends and best practices in drug discovery and development Comprehensive review of regulations and their impact on drug development, highlighting special populations, orphan drugs, and pharmaceutical compounding Multidiscipline functioning of an Academic Research Enterprise, plus a chapter on Ethical Concerns in Research Contributions by 70+ experts from industry and academia specialists who developed and are practitioners of the science and business
Download or read book Early Stage and Discovery Deals Strategy Structure and Payment Terms 2nd Edition written by and published by Pharmalicensing. This book was released on with total page 143 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Biotechnology Fundamentals Third Edition written by Firdos Alam Khan and published by CRC Press. This book was released on 2020-03-04 with total page 497 pages. Available in PDF, EPUB and Kindle. Book excerpt: After successful launching of first and second editions of Biotechnology Fundamentals, we thought let us find out the feedbacks from our esteemed readers, faculty members, and students about their experiences and after receiving their suggestions and recommendation we thought it would be great idea to write 3rd edition of the book. Being a teacher of biotechnology, I always wanted a book which covers all aspects of biotechnology, right from basics to applied and industrial levels. In our previous editions, we have included all topics of biotechnology which are important and fundamentals for students learning. One of the important highlights of the book that it has dedicated chapter for the career aspects of biotechnology and you may agree that many students eager to know what are career prospects they have in biotechnology. There are a great number of textbooks available that deal with molecular biotechnology, microbial biotechnology, industrial biotechnology, agricultural biotechnology, medical biotechnology, or animal biotechnology independently; however, there is not a single book available that deals with all aspects of biotechnology in one book. Today the field of biotechnology is moving with lightening speed. It becomes very important to keep track of all those new information which affect the biotechnology field directly or indirectly. In this book, I have tried to include all the topics which are directly or indirectly related to fields of biotechnology. The book discusses both conventional and modern aspects of biotechnology with suitable examples and gives the impression that the field of biotechnology is there for ages with different names; you may call them plant breeding, cheese making, in vitro fertilization, alcohol fermentation is all the fruits of biotechnology. The primary aim of this book is to help the students to learn biotechnology with classical and modern approaches and take them from basic information to complex topics. There is a total of 21 chapters in this textbook covering topics ranging from an introduction to biotechnology, genes to genomics, protein to proteomics, recombinant DNA technology, microbial biotechnology, agricultural biotechnology, animal biotechnology, environmental biotechnology, medical biotechnology, nanobiotechnology, product development in biotechnology, industrial biotechnology, forensic science, regenerative medicine, biosimialars, synthetic biology, biomedical engineering, computational biology, ethics in biotechnology, careers in biotechnology, and laboratory tutorials. All chapters begin with a brief summary followed by text with suitable examples. Each chapter illustrated by simple line diagrams, pictures, and tables. Each chapter concludes with a question session, assignment, and field trip information. I have included laboratory tutorials as a separate chapter to expose the students to various laboratory techniques and laboratory protocols. This practical information would be an added advantage to the students while they learn the theoretical aspects of biotechnology.
Download or read book The Price of Global Health written by Ed Schoonveld and published by Routledge. This book was released on 2016-02-24 with total page 494 pages. Available in PDF, EPUB and Kindle. Book excerpt: Public debate on the rising cost of new biotechnology drug treatments has intensified over the last few years as healthcare budget pressures have mounted under a strained economy. Meanwhile, the demand for new, effective medical and drug treatments continues to rise as unhealthy lifestyles cause further increases in diabetes and cardiovascular disease. Global drug pricing is one of the most hotly debated yet least understood aspects of the pharmaceutical industry. How should drug prices be set and what does it mean for patients? Why do governments increasingly get involved, and what is its impact on the global competitive environment? How can a life-saving industry have a poorer image than gun and tobacco industries, whose products are associated with death? Ed Schoonveld explains how pharmaceutical prices are determined in a complex global payer environment and what factors influence the process. His insights will help a wide range of audiences, from healthcare industry professionals to policy makers and the broader public, to gain a better understanding of this highly complex and emotionally charged field. The Price of Global Health is recognized as a valued and unique reference book that covers a complete array of topics related to global pharmaceutical pricing. It contains an in-depth but straightforward exploration of the pharmaceutical pricing strategy process, its underlying market access, general business and ethical considerations, and its implications for payers, physicians and patients. It is a much-needed and invaluable resource for anybody interested or involved in, or affected by, the development, funding and use of prescription drugs. In particular, it is of critical importance to pharmaceutical company executives and other leaders and professionals in commercialization and drug development, including marketing, business development, market access and pricing, clinical development, drug discovery, regulatory affairs, health outcomes, market research and public affairs. The second edition includes new chapters on payer value story development, oncology, orphan drugs and payer negotiations. Furthermore, many country chapters have been substantially updated to reflect changes in the healthcare systems, including the Affordable Care Act in the US, AMNOG in Germany, medico-economic requirements in France and many other country-specific changes. Lastly, almost every chapter has been updated with new examples and illustrations.
Download or read book The Generic Challenge written by Martin A. Voet and published by Brown Walker Press. This book was released on 2011 with total page 174 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Generic Challenge is a must-read for pharmaceutical executives and managers, and regulatory, legal, business development, R&D and strategic marketing professionals and anyone who has an interest in the future of the leading American pharmaceutical and biotechnology industries and the high value jobs they provide. It explains clearly and understandably the role of patents, FDA regulation of generic drugs and the Hatch Waxman Act on drug development today and how improvements in innovative drug products provide enhanced benefits to patients while extending the commercial lives of the drugs.There is simply no other book of its kind available on this important subject. REVIEWS "I read The Generic Challenge in one evening. It is easy to read, anecdotal and short. It is hard to believe that so much information and seasoned advice is packed into this little book. Patents and FDA Exclusivity form the bedrock foundation of today's pharmaceutical and biotechnology industries. I would recommend this book to virtually everyone working in those industries -- from the CEO down to the drug reps and lab techs -- regardless of whether they will deal directly with patents." Dennis Crouch, Associate Professor of Law, University of Missouri, Editor of Patently-O.com "An extraordinary book full of practical, strategic information on the interaction of drug creation, law and regulatory approval. Provides a perceptive and insightful analysis of patent and regulatory laws affecting drug development. A must-read for anyone associated with a pharmaceutical company, from mangers and CEOs to CFOs and regulatory professionals, The Generic Challenge will guide readers through the many legal and business pitfalls that arise at every stage of their business." Stephen R. Albainy-Jenei, Attorney at Law, Editor of PatentBaristas.com
Download or read book Conflict of Interest Protection of Public Ownership in Drug Development Deals Between Tax exempt Federally Supported Labs and the Pharmaceutical Industry written by United States. Congress. House. Committee on Small Business. Subcommittee on Regulation, Business Opportunities, and Technology and published by . This book was released on 1993 with total page 260 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Intellectual Property Law and Access to Medicines written by Srividhya Ragavan and published by Taylor & Francis. This book was released on 2021-07-28 with total page 428 pages. Available in PDF, EPUB and Kindle. Book excerpt: The history of patent harmonization is a story of dynamic actors, whose interactions with established structures shaped the patent regime. From the inception of the trade regime to include intellectual property (IP) rights to the present, this book documents the role of different sets of actors – states, transnational business corporations, or civil society groups – and their influence on the structures – such as national and international agreements, organizations, and private entities – that have caused changes to healthcare and access to medication. Presenting the debates over patents, trade, and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), as it galvanized non-state and nonbusiness actors, the book highlights how an alternative framing and understanding of pharmaceutical patent rights emerged: as a public issue, instead of a trade or IP issue. The book thus offers an important analysis of the legal and political dynamics through which the contest for access to lifesaving medication has been, and will continue to be, fought. In addition to academics working in the areas of international law, development, and public health, this book will also be of interest to policy makers, state actors, and others with relevant concerns working in nongovernmental and international organizations.
Download or read book Drug Delivery Systems Third Edition written by Vasant V. Ranade and published by CRC Press. This book was released on 2011-04-25 with total page 610 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug delivery technologies represent a vast, vital area of research and development in pharmaceuticals. The demand for innovative drug delivery systems continues to grow, driving a variety of new developments. Drug Delivery Systems, Third Edition provides a comprehensive review of the latest research and development on drug delivery systems. Coverage includes liposomal, transmucosal, transdermal, oral, polymeric, and monoclonal antibody directed delivery. Each chapter provides a table of marketed and investigational products with numerous practical examples. The book also provides readers with a multitude of possible drug delivery systems that can be used to improve therapeutics, along with global and regulatory perspectives. This third edition contains a chapter on nanoscience and technology for drug delivery along with cutting-edge business intelligence and strategies. Written in a straightforward manner, the authors provide a global perspective on current and future advances and market opportunities. Supplying a cogent overview of the field and extensive guidance on where to get more information, it is an essential resource for anyone venturing into this area of drug development.
Download or read book Exchanging Value written by World Intellectual Property Organization and published by WIPO. This book was released on 2005 with total page 7 pages. Available in PDF, EPUB and Kindle. Book excerpt: Focuses on "the identification and acquisition, or transfer, through licensing, of technology that is owned by another by virtue of an intellectual property right." - page 5.
Download or read book Doing Business in Colombia Second Edition written by Cavelier Abogados and published by Juris Publishing, Inc.. This book was released on 2011-10-01 with total page 486 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cavelier Abogados is proud to present again the latest edition of Doing Business in Colombia. The country has experienced significant changes since the First Edition was published in 2000. This volume includes a general overview of the Colombian legal system, regulations relating to business incorporation, labor, immigration and some specific samples of the main civil and commercial contracts used in the country. It also includes the latest developments in environmental law, intellectual property law, unfair competition, zoning law, taxes, international treaties, state contracts and regulations regarding foreign investment. The authors have prepared special chapters to provide in-depth coverage of certain matters that have gained importance such as asset laundering prevention, economic insolvency and corporate governance that will provide readers with an accurate idea of the legal situation of a country that is quickly becoming very attractive for foreign investment. Given the number of free trade agreements Colombia is party to and the growth of its national economy, Doing Business in Colombia is an important and timely work.
Download or read book Guide to Valuation of Pharmaceutical Licensing Deals written by Murat Karabiyikoglu and published by Young Writers. This book was released on 2009-03 with total page 99 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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
