Download or read book The Amgen Story written by Amgen Inc. (Thousand Oaks, Calif.) and published by . This book was released on 2005 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt: As the most successful biotech company in history and the eighth largest drug-producing company in the world, Amgen has improved the lives of millions of patients worldwide. In 2005, the company celebrates its twenty-fifth anniversary with the publication of "The Amgen Story. This stunning illustrated book contains hundreds of archival photos and compelling text from noted biotech writer David Ewing Duncan. It is testament and tribute to the staff, leaders, patients, and science that make each discovery possible.

Download or read book Science Lessons written by Gordon M. Binder and published by Harvard Business Review Press. This book was released on 2008 with total page 326 pages. Available in PDF, EPUB and Kindle. Book excerpt: Under Gordon Binder's leadership, Amgen became the world's largest and most successful biotech company in the world. This text describes what it really takes to manage risk, financing, creative employees, and intellectual property on the international stage.

Download or read book Amgen Inc V Kidney Center of Delaware County Ltd written by and published by . This book was released on 1995 with total page 58 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Accelerating the Development of Biomarkers for Drug Safety written by Institute of Medicine and published by National Academies Press. This book was released on 2009-07-20 with total page 101 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biomarkers can be defined as indicators of any biologic state, and they are central to the future of medicine. As the cost of developing drugs has risen in recent years, reducing the number of new drugs approved for use, biomarker development may be a way to cut costs, enhance safety, and provide a more focused and rational pathway to drug development. On October 24, 2008, the IOM's Forum on Drug Discovery, Development, and Translation held "Assessing and Accelerating Development of Biomarkers for Drug Safety," a one-day workshop, summarized in this volume, on the value of biomarkers in helping to determine drug safety during development.

Download or read book Blacks in Medicine written by Richard Allen Williams and published by Springer Nature. This book was released on 2020-04-24 with total page 219 pages. Available in PDF, EPUB and Kindle. Book excerpt: This socially conscious, culturally relevant book explores the little-known history and present climate of Black people in the medical field. It reveals the deficiencies in the American healthcare structure that have contributed to the mismanagement of healthcare in the Black population, and examines cross-currents that intersect with the major events in minority medical history. Illustrated across 10 expertly written chapters, this text features a longitudinal timeline with the presentation of evidence-based information drawn from historical, political, and clinical sources. The book begins with an analysis of diseases particularly prevalent in the Black community due to socioeconomic inequalities in available medical care. These diseases include sickle cell anemia, hypertension, heart failure, drug addiction, and HIV/AIDS. Bolstered by profiles of historically well-known Black physicians, stories of success in medical education, and the remarkable impact of Black medical organizations, subsequent chapters address the triumphs and tribulations of the Black medical professional in America. Concluding with an examination of the current health status of Black people in the United States, the book makes a case for future systemic improvements in healthcare delivery to minority communities. A unique, noteworthy reference, Blacks in Medicine: Clinical, Demographic, and Socioeconomic Correlations is written for a broad range of physicians and health providers, as well as professionals in the social sciences and public health.

Download or read book Biomarker Methods in Drug Discovery and Development written by Feng Wang and published by Springer Science & Business Media. This book was released on 2008-03-11 with total page 407 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this book, expert researchers provide a tool box for those who have a general interest in biomarker research and for those currently specializing in certain technologies but desiring an understanding of other available methodologies. Its chapters include validated, mature methods as well as new, incredibly promising protocols. This book is the perfect biomarker technical guideline and reference to stimulate more exciting biomarker research and technology development.

Download or read book Official Summary of Security Transactions and Holdings Reported to the Securities and Exchange Commission Under the Securities Exchange Act of 1934 and the Public Utility Holding Company Act of 1935 written by United States. Securities and Exchange Commission and published by . This book was released on 1997 with total page 476 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Biosimilars and Interchangeable Biologics written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2018-10-30 with total page 646 pages. Available in PDF, EPUB and Kindle. Book excerpt: What’s the Deal with Biosimilars? Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development. Part of a two-volume set that covers varying aspects of biosimilars, Biosimilars and Interchangeable Biologics: Strategic Elements explores the strategic planning side of biosimilar drugs and targets issues surrounding biosimilars that are linked to legal matters. This includes principal patents and intellectual property, regulatory pathways, and concerns about affordability on a global scale. It addresses the complexity of biosimilar products, and it discusses the utilization of biosimilars and related biological drugs in expanding world markets. Of specific interest to practitioners, researchers, and scientists in the biopharmaceutical industry, this volume examines the science, technology, finance, legality, ethics, and politics of biosimilar drugs. It considers strategic planning elements that include an overall understanding of the history and the current status of the art and science of biosimilars, and it provides detailed descriptions of the legal, regulatory, and commercial characteristics. The book also presents a global strategy on how to build, take to market, and manage the next generation of biosimilars throughout their life cycle.

Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.

Download or read book Biopharmaceutical Drug Design and Development written by Susanna Wu-Pong and published by Springer Science & Business Media. This book was released on 1999-04-01 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: New discoveries in biology are occurring at an incredible rate, and with these discoveries arise nearly unimaginable opportunities in every area of human existence. Imagine the excitement surround ing the "penicillin project" and the subsequent rapid development of anti-infective agents that took place in the 1940s and 1950s. Fast for ward to the world today and our ability to treat life-threatening infec tions. This is but one small piece in the present kaleidoscope of new therapeutic agents. In fact, the world of science, biology, and medi cine is changing so quickly that it is difficult for scientists and medi cal practitioners to stay abreast of their fields and confidently anticipate that their education and training will sustain them over a three- to four-decade career without considerable continuing educa tion and training. For the pharmaceutical scientist responsible for the discovery and development of therapeutic agents based on advances in biotechnology, it is imperative to quickly come up to speed and stay at the forefront of developments, which is no easy task for those not specifically trained in this area. Biopharmaceutical Drug Design and Development, edited by Susanna Wu-Pong and Yongyut Rojanasakul, cuts a potentially wide swath in terms of its intended audience. It clearly is a primer for those not trained in the area, or for those who wish to be brought into the mainstream of drug discovery and development in the world of bio technology.

Download or read book Directory of Corporate Counsel Spring 2024 Edition written by and published by Wolters Kluwer Law & Business. This book was released on with total page 4772 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Aspen Treatise for Patent Law written by Janice M. Mueller and published by Aspen Publishing. This book was released on 2024-07-19 with total page 1266 pages. Available in PDF, EPUB and Kindle. Book excerpt: Succinct and timely, the 7th Edition of the best-selling PATENT LAW continues to demystify its subject as it explores and explains important cases, statutes, and policy. Approachably written for law students, attorneys, inventors, and laypersons alike, this acclaimed text stands on its own or may be used alongside any patent or IP casebook to support more in-depth study of patent law. New to the 7th Edition: Supreme Court review of bedrock patentability requirements: o Amgen (the Court’s first examination of enablement in nearly 100 years) Supreme Court clarification of long-standing equitable doctrines in patent litigation: o Minerva (assignor estoppel is valid but limited to instances when assignor’s claim of invalidity contradicts representations made in assigning patent) Ongoing, intensive Supreme Court scrutiny of the America Invents Act (AIA), the most significant change to U.S. patent law in 70 years, including: Thryv (Federal Circuit lacks jurisdiction to review PTAB’s § 315(b) time-bar decisions) Arthrex (PTO Director review of PTAB final decisions remedies Constitutional violation in appointment of PTAB judges. The problematic landscape of patent-eligibility jurisprudence under § 101, including Federal Circuit decisions in: American Axle (methods of manufacturing) CareDx (diagnostic methods) Trinity Info Media, Adasa, Killian, Free Stream Media, Uniloc, Rudy (abstract ideas) The challenging application of the cornerstone non obviousness requirement to the burgeoning field of design patents, including the Federal Circuit’s first en banc consideration of a patent case in 5 years: LKQ ​Confronting new questions of novelty, priority, and prior art under the AIA, including Federal Circuit and PTAB decisions in: SNIPR Techs. (enumerating patentability and priority requirements for “pure pre-AIA,” “pure AIA,” and “mixed” patents and applications) Penumbra (when is a patent relied on as § 102(a)(2) prior art entitled to the earlier filing date of its related parent or provisional application) Fine-tuning the scope of AIA IPR estoppel to prevent petitioners from relitigating the same validity issues in federal court, including Federal Circuit decisions in: Cal. Inst. (interpreting “during the IPR”) Ironburg (“skilled searcher” standard) The limited role of extrinsic evidence in patent claim interpretation: Genuine Enabling (rejecting accused infringer’s expert testimony seeking to narrow claim scope via prosecution disclaimer) Allowing assertions of the equitable defense of prosecution history laches against unreasonable and inexcusable prosecution delays, despite compliance with statutory and regulatory requirements: Hyatt, Personalized Media How the European Union’s new Unitary Patent and Unified Patent Court (2023) are revolutionizing international patenting Professors and students will benefit from: Thorough coverage and clear writing that clarifies principal legal doctrines, key judicial authorities, governing statutes, and policy considerations for obtaining, enforcing, and challenging a U.S. patent In-depth treatment and comparison of pre- and post-America Invents Act regimes for novelty and prior art with numerous hypotheticals Timely statistics on patent trends Succinct analysis of multi-national patent protection regimes Helpful visual aids, such as figures, tables, and timelines A sample patent and breakdown of a prosecution history Boldfaced key terms and a convenient Glossary

Download or read book Antibody Patenting written by Jürgen Meier and published by Kluwer Law International B.V.. This book was released on 2023-08-22 with total page 707 pages. Available in PDF, EPUB and Kindle. Book excerpt: Antibodies have revolutionized medicine and biotechnology, and have become indispensable tools in therapy, diagnostics, analytics, and research. Therapeutic antibodies, for example, have become firmly established in the ranks of blockbuster drugs, currently accounting for about half of the top 10 best-selling medicines. At the same time, a body of case law dealing specifically with the patentability of antibody-related inventions and the enforcement of antibody patents has emerged in major jurisdictions. The, at times, significant divergences between different jurisdictions have been compounded by recent decisions in the United States, which have severely curtailed the possibilities to obtain broad antibody patents. It is therefore essential to understand how antibody inventions are assessed in different jurisdictions in order to secure an optimal patent protection and to successfully enforce such patents. This book provides practitioners with a comprehensive resource elucidating all aspects of the patenting of antibodies from initial drafting and prosecution to enforcement, using a country-by-country format. The updated and expanded Second Edition covers more than 30 of the most important IP jurisdictions worldwide – i.e., the European Patent Office, Belgium, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, the Netherlands, Poland, Spain, Sweden, Switzerland, the United Kingdom, the United States of America, Canada, Mexico, the Andean Community (Bolivia, Colombia, Ecuador, and Peru), Argentina, Brazil, Chile, China, India, Israel, Japan, Singapore, South Korea, Taiwan, Australia, and New Zealand. The 49 contributors to this book, all distinguished experts in this field, provide clear and practice-oriented advice on a range of topics including: • Which types of antibody inventions are patent-eligible? • Which types of functional and structural features are accepted for claiming antibodies? • What needs to be considered when defining antibodies in terms of their antigen, target affinity, binding specificity, epitope, competitive binding and other characteristics in relation to reference antibodies, as well as their effects on the target? • Which pitfalls must be avoided when defining amino acid sequences, chemical modifications or glycosylation patterns, and when relying on cell line deposits? • Which breadth of claims is accepted for antibody inventions, and what experimental support is required? • Which specific medical applications of antibodies can be claimed? • How is inventive step assessed in the specific case of antibody inventions? • What has to be considered when enforcing antibody patents, including in relation to biosimilars as well as the doctrine of equivalence? All chapters follow the same structure, which makes this book easily accessible and allows a direct comparison between different jurisdictions. Practitioners will find the much-needed tools and guidance to secure the best possible patent protection for antibody inventions in more than 30 of the most important jurisdictions worldwide. This book is the fifth volume in the AIPPI Law Series which has been established together with the International Association for the Protection of Intellectual Property (AIPPI), a non-affiliated, non-profit organization dedicated to improving and promoting the protection of intellectual property at both national and international levels.

Download or read book Financial Disclosure Reports of Members of the U S House of Representatives for the Period Between January 1 2004 to December 31 2004 written by United States. Congress House and published by . This book was released on 2005 with total page 1422 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Biotechnology Annual Review written by M.R. El-Gewely and published by Elsevier. This book was released on 2003-10-09 with total page 435 pages. Available in PDF, EPUB and Kindle. Book excerpt: It is an exciting time to follow the new developments in the field of biotechnology and its wider applications in the different areas. The whole genomes of over 1000 viruses and over 100 microbes can now be found in Entrez Genome. The genomes represent both completely sequenced organisms and those for which sequencing is still in progress. The three main domains of life - bacteria, archaea, and eukaryota - are represented, as well as many viruses and organelles. The exponential increase of the sequence data lead to the development of the new "Bioinformatics" field in order to attempt making sense, at least biological sense, out of all the new and fast data.It will take also other techniques such as "functional genomics" to link the gap between a specific phenotype or a treatment and a gene sequence. Functional genomics tools are therefore important for the accurate molecular diagnosis/prognosis, target discovery validation needed for drug development and novel targets for antibiotics development. Functional genomics are also important for the confirmation of therapy in pharmacogenomics studies. Biotechnology is in many respects shaping our life and affecting our means of production and the creation of jobs. Progress in the applications of biotechnology depends on a wide base of basic as well as applied sciences. The output of biotechnology has already proved itself in many diverse fields from health tobiomining and from agriculture to enzyme "breeding". It is therefore difficult to follow all of the current as well as the potential applications of biotechnology.The objective of the Biotechnology Annual Review series is to attempt to provide readers with the needed indepth knowledge, by reviewing specific topics in biotechnology in each issue. The philosophy behind this series is to encourage good reviews to make it easier for readers to keep in touch with progress and applications of biotechnology. Reviews on topics related to regulatory affairs, social impact of biotechnology, biodiversity, biosafety, public acceptance and patent issues are also encouraged.

Download or read book Patent Case Management Judicial Guide written by and published by . This book was released on 2009 with total page 656 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Handbook of Preformulation written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2006-09-18 with total page 470 pages. Available in PDF, EPUB and Kindle. Book excerpt: Preformulation studies are the physical, chemical, and biological studies needed to characterize a drug substance for enabling the proper design of a drug product, whereas the effectiveness of a drug product is determined during the formulation studies phase. Though the two disciplines overlap in practice, each is a significantly distinct phase of