Download or read book Pharmaceutical Product Licensing written by Brian R. Matthews and published by CRC Press. This book was released on 1991-05-31 with total page 383 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides a systematic account of the major technical, administrative and legal requirements for registering a product in any of the national markets within the EEC, using the existing procedures, with guidance as to how these procedures are likely to change after 1992.
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 191 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 The Role of NIH in Drug Development Innovation and Its Impact on Patient Access written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-01-27 with total page 103 pages. Available in PDF, EPUB and Kindle. Book excerpt: To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.
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 Premerger Notification Practice Manual written by Bruce J. Prager and published by . This book was released on 1991 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 Regulatory Affairs in the Pharmaceutical Industry written by Javed Ali and published by Academic Press. This book was released on 2021-11-14 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance
Download or read book Making Medicines Affordable written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-03-01 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.
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 306 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 The Alliance Revolution written by Benjamin Gomes-Casseres and published by Harvard University Press. This book was released on 1996 with total page 330 pages. Available in PDF, EPUB and Kindle. Book excerpt: More than we ever anticipated, alliances among firms are changing the way business is conducted, particularly in the global, high-technology sector. The reasons are clear: companies must increasingly pool their capabilities to succeed in ever more complex and rapidly changing businesses. But the consequences for managers and for the economy have so far been underestimated. In this new book, Benjamin Gomes-Casseres presents the first in-depth account of the new world of business alliances and shows how collaboration has become part of the very fabric of modern competition. Alliances, he argues, create new units of competition that do battle with one another and with traditional single firms. The flexible capabilities of these multi-firm constellations give them advantages over single firms in certain contexts, offsetting the advantage of a single firm's unified control. When managed effectively, alliances can strengthen a firm's competitive advantage and narrow the gap between leading firms and second-tier players. This often results in intensified rivalry, and the competition within an industry is transformed. Alliances often spread swiftly through an industry as firms jockey for advantage. Yet the very spread of alliances increases their costs and poses new limits on their use. Gomes-Casseres concludes that firms need to manage their constellations to enhance collaboration within their groups, while raising what he calls "barriers to collaboration" for rivals. These ideas are developed and illustrated through original case studies of alliances among U.S., Japanese, and European firms in electronics and computers, including Xerox, IBM, and Fujitsu as well as other small and large companies. The book should be of interest to business academics, managers, and general readers concerned with contemporary capitalism.
Download or read book WHO guideline on country pharmaceutical pricing policies written by and published by World Health Organization. This book was released on 2020-09-29 with total page 70 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, high prices of pharmaceutical products have posed challenges in high- and low-income countries alike. In many instances, high prices of pharmaceutical products have led to significant financial hardship for individuals and negatively impacted on healthcare systems' ability to provide population-wide access to essential medicines. Pharmaceutical pricing policies need to be carefully planned, carried out, and regularly checked and revised according to changing conditions. Strong, well-thought-out policies can guide well-informed and balanced decisions to achieve affordable access to essential health products. This guideline replaces the 2015 WHO guideline on country pharmaceutical pricing policies, revised to reflect the growing body of literature since the last evidence review in 2010. This update also recognizes country experiences in managing the prices of pharmaceutical products.
Download or read book Basic Principles of Drug Discovery and Development written by Benjamin E. Blass and published by Academic Press. This book was released on 2021-03-30 with total page 738 pages. Available in PDF, EPUB and Kindle. Book excerpt: Basic Principles of Drug Discovery and Development presents the multifaceted process of identifying a new drug in the modern era, which requires a multidisciplinary team approach with input from medicinal chemists, biologists, pharmacologists, drug metabolism experts, toxicologists, clinicians, and a host of experts from numerous additional fields. Enabling technologies such as high throughput screening, structure-based drug design, molecular modeling, pharmaceutical profiling, and translational medicine are critical to the successful development of marketable therapeutics. Given the wide range of disciplines and techniques that are required for cutting edge drug discovery and development, a scientist must master their own fields as well as have a fundamental understanding of their collaborator's fields. This book bridges the knowledge gaps that invariably lead to communication issues in a new scientist's early career, providing a fundamental understanding of the various techniques and disciplines required for the multifaceted endeavor of drug research and development. It provides students, new industrial scientists, and academics with a basic understanding of the drug discovery and development process. The fully updated text provides an excellent overview of the process and includes chapters on important drug targets by class, in vitro screening methods, medicinal chemistry strategies in drug design, principles of in vivo pharmacokinetics and pharmacodynamics, animal models of disease states, clinical trial basics, and selected business aspects of the drug discovery process. - Provides a clear explanation of how the pharmaceutical industry works, as well as the complete drug discovery and development process, from obtaining a lead, to testing the bioactivity, to producing the drug, and protecting the intellectual property - Includes a new chapter on the discovery and development of biologics (antibodies proteins, antibody/receptor complexes, antibody drug conjugates), a growing and important area of the pharmaceutical industry landscape - Features a new section on formulations, including a discussion of IV formulations suitable for human clinical trials, as well as the application of nanotechnology and the use of transdermal patch technology for drug delivery - Updated chapter with new case studies includes additional modern examples of drug discovery through high through-put screening, fragment-based drug design, and computational chemistry
Download or read book Development and Validation of Analytical Methods written by Christopher M. Riley and published by Elsevier. This book was released on 1996-05-29 with total page 363 pages. Available in PDF, EPUB and Kindle. Book excerpt: The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted industry practice for assay validation. This book is intended to serve as a guide to the analyst in terms of the issues and parameters that must be considered in the development and validation of analytical methods. In addition to the critical issues surrounding method validation, this book also deals with other related factors such as method development, data acquisition, automation, cleaning validation and regulatory considerations. The book is divided into three parts. Part One, comprising two chapters, looks at some of the basic concepts of method validation. Chapter 1 discusses the general concept of validation and its role in the process of transferring methods from laboratory to laboratory. Chapter 2 looks at some of the critical parameters included in a validation program and the various statistical treatments given to these parameters.Part Two (Chapters 3, 4 and 5) of the book focuses on the regulatory perspective of analytical validation. Chapter 3 discusses in some detail how validation is treated by various regulatory agencies around the world, including the United States, Canada, the European Community, Australia and Japan. This chapter also discusses the International Conference on Harmonization (ICH) treatment of assay validation. Chapters 4 and 5 cover the issues and various perspectives of the recent United States vs. Barr Laboratories Inc. case involving the retesting of samples. Part Three (Chapters 6 - 12) covers the development and validation of various analytical components of the pharmaceutical product development process. This part of the book contains specific chapters dedicated to bulk drug substances and finished products, dissolution studies, robotics and automated workstations, biotechnology products, biological samples, analytical methods for cleaning procedures and computer systems and computer-aided validation. Each chapter goes into some detail describing the critical development and related validation considerations for each topic.This book is not intended to be a practical description of the analytical validation process, but more of a guide to the critical parameters and considerations that must be attended to in a pharmaceutical development program. Despite the existence of numerous guidelines including the recent attempts by the ICH to be implemented in 1998, the practical part of assay validation will always remain, to a certain extent, a matter of the personal preference of the analyst or company. Nevertheless, this book brings together the perspectives of several experts having extensive experience in different capacities in the pharmaceutical industry in an attempt to bring some consistency to analytical method development and validation.
Download or read book Confidential Prospectus written by China-America Banking and Mercantile Co and published by . This book was released on 1901 with total page 108 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Successful Technology Licensing written by World Intellectual Property Organization and published by WIPO. This book was released on 2014-07-17 with total page 68 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Download or read book Modern Methods of Clinical Investigation written by Institute of Medicine and published by National Academies Press. This book was released on 1990-02-01 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.
