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Author : Anonim
Publisher : Pharmalicensing
Page : 61 pages
File Size : 49,5 Mb
Release : 2024-06-05
Category : Electronic
ISBN : 9781905310258
Author : Martin Austin
Publisher : CRC Press
Page : 202 pages
File Size : 53,5 Mb
Release : 2016-04-08
Category : Business & Economics
ISBN : 9781317170594
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.
Author : Martin Austin
Publisher : Routledge
Page : 192 pages
File Size : 55,6 Mb
Release : 2016-05-06
Category : Business & Economics
ISBN : 9781317105312
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.
Author : Gerrit Reepmeyer
Publisher : Springer Science & Business Media
Page : 297 pages
File Size : 42,8 Mb
Release : 2006-02-25
Category : Business & Economics
ISBN : 9783790816686
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.
Author : Cobert Barton,Gregory William,Thomas Jean-loup
Publisher : World Scientific
Page : 524 pages
File Size : 55,8 Mb
Release : 2019-04-10
Category : Medical
ISBN : 9789813279162
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.
Author : James J. O'Donnell,John Somberg,Vincent Idemyor,James T. O'Donnell
Publisher : CRC Press
Page : 697 pages
File Size : 41,9 Mb
Release : 2019-11-21
Category : Medical
ISBN : 9781351625142
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
Author : Firdos Alam Khan
Publisher : CRC Press
Page : 497 pages
File Size : 47,9 Mb
Release : 2020-03-04
Category : Medical
ISBN : 9781000041484
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.
Author : Oliver Gassmann,Gerrit Reepmeyer,Maximilian von Zedtwitz
Publisher : Springer Science & Business Media
Page : 186 pages
File Size : 43,9 Mb
Release : 2008-02-19
Category : Business & Economics
ISBN : 9783540776369
Pharmaceutical giants have been doubling their investments in drug development, only to see new drug approvals to remain constant for the past decade. This book investigates and highlights a set of proactive strategies, aimed at generating sustainable competitive advantage for its protagonists based on value-generating business practices. We focus on three sources of pharmaceutical innovation: new management methods in the drug development pipeline, new technologies as enablers for cutting-edge R&D, and new forms of internationalisation, such as outside-in innovation in the early phases of R&D.
Author : Anonim
Publisher : Pharmalicensing
Page : 143 pages
File Size : 43,6 Mb
Release : 2024-06-05
Category : Electronic
ISBN : 9781905310234
Author : Ed Schoonveld
Publisher : Routledge
Page : 496 pages
File Size : 51,6 Mb
Release : 2016-02-24
Category : Business & Economics
ISBN : 9781317019299
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.
Author : Cavelier Abogados,Natalia Tobón-Franco,Eduardo Varela-Pezzano
Publisher : Juris Publishing, Inc.
Page : 486 pages
File Size : 43,8 Mb
Release : 2011-10-01
Category : Business enterprises, Foreign
ISBN : 9781578233106
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.
Author : Srividhya Ragavan,Amaka Vanni
Publisher : Taylor & Francis
Page : 428 pages
File Size : 43,7 Mb
Release : 2021-07-28
Category : Law
ISBN : 9781000398731
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.
Author : Murat Karabiyikoglu
Publisher : Young Writers
Page : 99 pages
File Size : 51,5 Mb
Release : 2009-03
Category : Drugs
ISBN : 0955882176
Author : United States. Congress. House. Committee on Small Business. Subcommittee on Regulation, Business Opportunities, and Technology
Publisher : Unknown
Page : 260 pages
File Size : 52,7 Mb
Release : 1993
Category : Conflict of interests
ISBN : PSU:000021245381
Author : Anonim
Publisher : Unknown
Page : 404 pages
File Size : 44,5 Mb
Release : 2004
Category : Biotechnology industries
ISBN : STANFORD:36105063249697