The Licensing Agreement in Pharmaceutical Business Development: 3rd edition PDF Download

Author:
Publisher: Pharmalicensing
ISBN: 1905310250
Category :
Languages : en
Pages : 61

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Author: Martin Austin
Publisher: CRC Press
ISBN: 1317170598
Category : Business & Economics
Languages : en
Pages : 202

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Book Description
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
ISBN: 1317105311
Category : Business & Economics
Languages : en
Pages : 192

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Book Description
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: Cobert Barton
Publisher: World Scientific
ISBN: 9813279168
Category : Medical
Languages : en
Pages : 524

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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: Gerrit Reepmeyer
Publisher: Springer Science & Business Media
ISBN: 379081668X
Category : Business & Economics
Languages : en
Pages : 297

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Book Description
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: James J. O'Donnell
Publisher: CRC Press
ISBN: 1351625144
Category : Medical
Languages : en
Pages : 697

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Book Description
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:
Publisher: Pharmalicensing
ISBN: 1905310234
Category :
Languages : en
Pages : 143

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Author: Firdos Alam Khan
Publisher: CRC Press
ISBN: 1000041484
Category : Medical
Languages : en
Pages : 497

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Book Description
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
Publisher: Springer
ISBN: 3319668331
Category : Business & Economics
Languages : en
Pages : 179

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Book Description
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: Oliver Gassmann
Publisher: Springer Science & Business Media
ISBN: 3540776362
Category : Business & Economics
Languages : en
Pages : 186

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Book Description
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.