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 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 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 Pharmaceutical Product Licensing written by A. C. Cartwright and published by CRC Press. This book was released on 1991-05-31 with total page 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 Determinants of Licensing Decisions written by Binu Thomas and published by . This book was released on 2019 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: There are several determinants that could have an effect on in-licensing decisions by a pharmaceutical or biotech firm. This work studies over 200 licensing deals involving big pharma companies in the period (2011 - 2015) and identifies different factors that could play a role in licensing deals, and classifies these determinants into direct determinants and indirect determinants. The direct determinants are defined as determinants that are directly attributable to the molecule. The direct determinants could be related to the indications, type of molecule, effectiveness, safety dose, presentation, shelf-life, treatment cost, target clinicians, availability, owner, stage of development, patent life, product differentiation, number of competitors offering similar product, or the probability of regulatory and technical success. The indirect determinants include the management, type of organization, size of organization, location of the company, quality of scientific publications, scientific advisory board, and current reputation in a certain therapeutic area, stage of deal, and type of license sought, valuation approach, or up-fronts sought. While direct determinants are widely believed to be directly related to the licensing decisions, we find the indirect determinants also play a significant role in these decisions. This paper studies the recent licensing deals and finds that both internal and indirect determinants need to be focused in licensing efforts.

Download or read book Determinants of Licensing Deals in Pharmaceutical Industry written by Binu Thomas and published by . This book was released on 2020 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The drug discovery and development are very expensive, risky and time consuming. It requires several years and billions of dollars for developing a drug to the marketplace. Hence, smaller biotech companies seek to out-license or develop their drugs in collaboration with large pharmaceutical companies. On the other hand large pharmaceutical companies are constantly seeking new candidates to fill their product pipelines. From the perspective of a biotech company it is important to choose the licensing partner carefully as it takes several years of commitment and large investments to bring a new drug to the marketplace. However, recent analysis has shown that owing to the buoyant capital environment biotech companies have been able to raise capital and develop drugs to the marketplace. A sample of 101 pharmaceutical companies and 381 licensing deals that were announced in the period 2011-2015 were collected for quantitative analysis using Multilayer Perceptron technique and regression analysis. This study evaluated the five determinants including size of the company, pharmaceutical sales, number of employees, age of the company and pharmaceutical research and development expenditure that would have an effect on the licensing deal. The analysis of the data reveals that while seeking an out-licensing partner, a licensor preferred companies with R & D budget for expenditure and number of employees.

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 Licensing Strategies and Performance written by Kathleen R. Whitney and published by . This book was released on 1991 with total page 532 pages. Available in PDF, EPUB and Kindle. Book excerpt:

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 Premerger Notification Practice Manual written by and published by American Bar Association. This book was released on 2003 with total page 560 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides summaries and discussions of informal interpretations given by the Premerger Notification Office of the Federal Trade Comission and enforcement actions brought by the antitrust agencies regarding the premerger notification requirements if the Hart-Scott-Rodino Antirust Improvements Act of 1976 and the Commision's implementing regulations.

Download or read book Licensing of Drug product for European Union written by Sandeep Narayan Patil, PMP and published by Notion Press. This book was released on 2021-05-25 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the second book in the series of three. These three books will be based upon the idea to tailor PMI’s Project Management methodologies to the typical pharmaceutical projects. This book mainly discusses launch of drug products in EU market which are manufactured in countries like India or china by supplier manufacturer. It is specially designed for Project Managers, team members and pharmacy students. Format of book is purposely kept simple. This book includes various useful flow charts and templates that can be used during the project life cycle. Information provided in this book is obtained from highly authentic sources, and links of data sources is provided for reference. Surely this is the kind of book every pharmaceutical personnel will want to be on their shelf.

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 A Practical Guide to Licensing Herbal Medicinal Products written by Thomas Brendler and published by . This book was released on 2009 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This publication seeks to Answer all questions most frequently asked by manufacturers and provides full guidance on license applications. The procedure for licensing herbal products in the UK and European Union is changing. The Traditional Herbal Medicinal Product Directive (THMPD) was implemented in the UK in 2005 and allows herbal products to be registered under medicines law. By 2011, every pharmaceutical company manufacturing herbal medicines that are sold in the UK and European Union must have obtained a market authorization. As a manufacturer of such products, you need to ask the following: what type of herbal products are you manufacturing?; would your product comply with the regulations?; are you required to register your herbal products?; what type of registration or license do you need?; what evidence and manufacturing data do you need to provide?; what are the packaging and leaflet requirements for your product?; and, most importantly: how do you apply for a license? It also provides full guidance on product registration, including step-by-step guidance on completing the application forms, information on to whom the forms should be submitted and what costs are involved. All the official legal guidelines and forms are included within the guide. This text is easy and practical to use, guiding you and your company through the initial decision-making process to registering your herbal products.

Download or read book Compulsory Licensing of Pharmaceutical Products Access to Essential Medicines in Developing Countries written by Anna Niesporek and published by . This book was released on 2005 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

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 Intellectual Property in Molecular Medicine written by Salim Mamajiwalla and published by . This book was released on 2015 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Patents are an important way of protecting inventions in the pharmaceutical and biotechnology industries. However, intellectual property law reforms have not kept pace with the rapid advances in genomics, synthetic biology, and stem cell research. Meanwhile, universities are increasingly spinning off companies that use these technologies, requiring the academic scientists involved to gain an understanding of intellectual property law and the patent system as it applies to biomedical innovations. This collection from Cold Spring Harbor Perspectives in Medicine aims to provide a clear, current, and comprehensive understanding of biomedical intellectual property and the laws that protect it. The contributors describe patent laws and practices in the United States, Canada, Australia, and the European Union. They explain the roles of regulatory agencies in intellectual property, various opinions on the patentability of biological materials (e.g., DNA and stem cells), and the implications of recent court decisions (e.g., the Myriad case). Practical issues related to licensing agreements and patent applications are also discussed. The authors offer guidance on the criteria for patent eligibility (e.g., utility, nonobviousness, and novelty), issues related to timing and possession, and rules for determining inventorship. Other topics include trade secrets, research exemptions, and the protection of traditional knowledge related to biological resources. This volume will serve as an essential reference for all scientists, physicians, and technology transfer professionals seeking to navigate the complex rules, regulations, and procedures concerning intellectual property in biotech and pharma.

Download or read book Medical Product Regulatory Affairs written by John J. Tobin and published by John Wiley & Sons. This book was released on 2011-08-24 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. Everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.