Business Development for the Biotechnology and Pharmaceutical Industry


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.







Intellectual Property Law and Access to Medicines


Book Description

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.




Doing Business in Colombia - Second Edition


Book Description

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.




Foreign Operation Methods


Book Description

The choice of foreign operation methods, whether they are used singly or in combination, is a critical question for internationalising companies. This thoroughly updated edition of a successful text provides comprehensive coverage of the main tools companies use in seeking to penetrate foreign markets – covering investment, exporting and contractual arrangements such as franchising and management contracts. An important feature of this book is its thorough overview of theoretical and strategic perspectives such as mode packaging, mode switching and mode flexibility and will be invaluable for final year undergraduate and postgraduate students.




Exchanging Value


Book Description




Successful Technology Licensing


Book Description

This Manual focuses on issues essential for understanding licensing, including: the context in which licensing may occur; key terms of a licensing agreement and negotiation methods; and how to prepare for and negotiate a win-win licensing contract.







Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition)


Book Description

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.Related Link(s)