Описание: This book critically investigates the patent protection of medication in light of the threats posed by HIV/AIDS, malaria and tuberculosis epidemics to the citizens of countries in Sub-Saharan Africa (hereinafter "SSA" or "Africa").
Автор: Harold C. Wegner Название: Patent Law in Biotechnology, Chemicals & Pharmaceuticals ISBN: 1349219606 ISBN-13(EAN): 9781349219605 Издательство: Springer Рейтинг: Цена: 16070.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: A practical guide to patent prosecution and strategy in the US with particular reference to invention in chemicals and biotechnology. The presentation is focused on case law in the US and deals with specific cases. A section is devoted to international patent protection.
Автор: Susan A. Griffiths; C. Lumley Название: Safety Evaluation of Biotechnologically-derived Pharmaceuticals ISBN: 9401060436 ISBN-13(EAN): 9789401060431 Издательство: Springer Рейтинг: Цена: 13974.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Considerable investment has been made by both pharmaceutical and biotechnology companies in pharmaceutical products of biotechnology. However, because relatively few of these products have been marketed, lack of relevant experience means that uncertainty still surrounds the most appropriate strategy for their safety evaluation. The 13th CMR International Workshop, held in February 1997, provided the opportunity for regulatory authority and industry experts from Europe, Japan and the USA to share their experiences of designing safety evaluation programmes for specific product classes: colony stimulating factors, growth factors, hormones, interferons, interleukins, monoclonal antibodies for therapeutic use, and gene therapy products. Participants worked together to recommend those studies that should be considered for such safety evaluation, and those that may be unnecessary. These recommendations subsequently made a valuable contribution to the ICH guideline Safety Studies for Biotechnological Products', which was finalised at ICH 4 in Brussels in July 1997. The Workshop proceedings not only describe the recommendations but also provide the reader with an appreciation of the science behind safety evaluation strategies used by experts, the influence of different regulatory systems on these strategies, and the type of data required by both toxicologists and clinicians before they have sufficient confidence to administer pharmaceutical products of biotechnology to humans.
Описание: This book is all about the definition and finding ways to prioritize and accelerate translation research in biomedical sciences and rapidly turning new knowledge into first-in-human studies. It represents an effort to bring together scientists active in various areas of translational research to share science and, hopefully, generate new ideas and potential collaborations. The book provides a comprehensive overview of translational work that includes significant discoveries and pioneering contributions, e.g., in immunology, gene therapy, stem cells and population sciences. It may be used as an advanced textbook by graduate students and even ambitious undergraduates in biomedical sciences. It is also suitable for non-experts, i.e. medical doctors, who wish to have an overview of some of the fundamental models in translational research.Managing the translational enterprise remains a work in progress. The world is changing rapidly, and the scientific world needs to seek new ways to ensure that discoveries get translated for patients efficiently and as quickly as possible. In addition, everyone expects the investment in biomedical research should pay dividends through effective therapeutic solutions. This unique project provides a broad collaborative approach of the international scientific team to present its view and opinion how to cross barriers to incentives for translational research in medical sciences.Contributing to the book is an international team of prominent co-authors. The book consists of unique and widely treated topics, and includes new hypotheses, data and analyses.
From Nobel Prize-winning economist Michael Kremer and fellow leading development economist Rachel Glennerster, an innovative solution for providing vaccines in poor countries
Millions of people in the third world die from diseases that are rare in the first world--diseases like malaria, tuberculosis, and schistosomiasis. AIDS, which is now usually treated in rich countries, still ravages the world's poor. Vaccines offer the best hope for controlling these diseases and could dramatically improve health in poor countries. But developers have little incentive to undertake the costly and risky research needed to develop vaccines. This is partly because the potential consumers are poor, but also because governments drive down prices.
In Strong Medicine, Michael Kremer and Rachel Glennerster offer an innovative yet simple solution to this worldwide problem: "Pull" programs to stimulate research. Here's how such programs would work. Funding agencies would commit to purchase viable vaccines if and when they were developed. This would create the incentives for vaccine developers to produce usable products for these neglected diseases. Private firms, rather than funding agencies, would pick which research strategies to pursue. After purchasing the vaccine, funders could distribute it at little or no cost to the afflicted countries.
Strong Medicine details just how these legally binding commitments would work. Ultimately, if no vaccines were developed, such a commitment would cost nothing. But if vaccines were developed, the program would save millions of lives and would be among the world's most cost-effective health interventions.
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