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Extending The Spectrum Of Precompetitive Collaboration In Oncology Research


Extending The Spectrum Of Precompetitive Collaboration In Oncology Research
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Extending The Spectrum Of Precompetitive Collaboration In Oncology Research


Extending The Spectrum Of Precompetitive Collaboration In Oncology Research
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2010-10-15

Extending The Spectrum Of Precompetitive Collaboration In Oncology Research written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-10-15 with Medical categories.


Despite spending more time and money in developing novel therapeutics, the success rate for new pharmacologic treatments has been poor. Although the research and development expenditures have grown 13 percent each year since 1970 (a 50-fold increase), the number of new drugs approved annually is no greater now than it was 50 years ago. Over the past decade, skyrocketing costs and the complexity of the scientific knowledge upon which to develop new agents have provided incentives for alternative approaches to drug development, if we are to continue to improve clinical care and reduce mortality. These challenges create opportunities for improved collaboration between industry, academia, government, and philanthropic organizations at each stage in new drug development, marketing, and implementation. Perhaps the most appropriate initial step in addressing the need for collaboration is to consider more precompetitive relationships that allow sharing of scientific information to foster drug development. While these collaborative relationships in basic and preclinical research on drug targets and the early stages of clinical testing are acknowledged to be potentially important drivers for innovation and more rapid marketing of new agents, they also raise a number of concerns that must be addressed. For example, acknowledgment of academic productivity and independence and economic competitiveness must be considered and these challenges managed to foster a culture of collaboration. At the same time, regulatory issues, the need for standardization, and intellectual property concerns must be confronted if the current models for drug development are to be refined to encourage robust participation in precompetitive collaborations. Recognizing the growing importance of precompetitive collaborations in oncology drug development, as well as the challenges these innovative collaborations pose, the National Cancer Policy Forum of the Institute of Medicine held a workshop on February 9 and 10, 2010. This book is a summary of the workshop proceedings.



Establishing Precompetitive Collaborations To Stimulate Genomics Driven Product Development


Establishing Precompetitive Collaborations To Stimulate Genomics Driven Product Development
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2011-02-17

Establishing Precompetitive Collaborations To Stimulate Genomics Driven Product Development written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-02-17 with Medical categories.


Despite the many basic research discoveries in genetics, relatively few gene-based treatments, drugs, or preventative measures have been developed. One way to bridge this gap may be for industry, academia, and government to develop partnerships that share resources while distributing risk. However, intellectual property protections and other barriers can inhibit collaborative efforts. The Institute of Medicine held a workshop on July 22, 2010, to explore these issues and develop solutions.



Facilitating Collaborations To Develop Combination Investigational Cancer Therapies


Facilitating Collaborations To Develop Combination Investigational Cancer Therapies
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2012-02-06

Facilitating Collaborations To Develop Combination Investigational Cancer Therapies written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-02-06 with Medical categories.


Advances in biomedical research have increased our understanding of the complex nature of disease and the interaction of multiple molecular pathways involved in cancer. Combining investigational products early in their development is thought to be a promising strategy for identifying effective therapies. The IOM's National Cancer Policy Forum held a workshop to discuss challenges and identify potential solutions to improve collaboration and advance the development of combination investigational cancer therapies.



Principles And Practice Of Clinical Research


Principles And Practice Of Clinical Research
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Author : John I. Gallin
language : en
Publisher: Academic Press
Release Date : 2012-05-31

Principles And Practice Of Clinical Research written by John I. Gallin and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-05-31 with Medical categories.


This expanded third edition provides an introduction to the conduct of clinical research as well as more comprehensive and expansive content about the infrastructure necessary for a successful clinical research organization or enterprise. With authors who are experts in clinical research in both the public and private sectors, this publication provides essential information to clinical investigators who wish to develop and conduct well designed patient-based research protocols that comply with rigorous study design, ethical, and regulatory requirements.



The National Cancer Policy Summit


The National Cancer Policy Summit
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2011-05-25

The National Cancer Policy Summit written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-05-25 with Medical categories.


Many ongoing changes are likely to have an impact on cancer research and care. For example, technological advances are rapidly changing the way cancer research is conducted, and the recently passed healthcare reform legislation has many implications for cancer care. Technological advances are altering the way cancer research is conducted and cancer care is delivered, and the recently passed healthcare reform legislation has many implications for cancer care. There is a growing emphasis on molecularly targeted therapies, information technology (IT), and patient-centered care, and clinical cancer research has become a global endeavor. At the same time, there are concerns about shrinking research budgets and escalating costs of cancer care. Considering such changes, the National Cancer Policy Forum (NCPF) of the Institute of Medicine held a National Cancer Policy Summit on October 25, 2010. The Summit convened key leaders in the cancer community to identify and discuss the most pressing policy issues in cancer research and cancer care. The National Cancer Policy Summit: Opportunities and Challenges in Cancer Research and Care is a summary of the summit. The report explores policy issues related to cancer research, the implementation of healthcare reform, delivery of cancer care, and cancer control and public health needs. Expert participants suggested many potential actions to provide patient-centered cancer care, to foster more collaboration, and to achieve other goals to improve research and care.



Phytotherapies


Phytotherapies
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Author : Iqbal Ramzan
language : en
Publisher: John Wiley & Sons
Release Date : 2015-04-17

Phytotherapies written by Iqbal Ramzan and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-04-17 with Medical categories.


Covering fundamentals and new developments in phytotherapy, this book combines pharmaceutical sciences and chemistry with clinical issues. • Helps readers better understand phytotherapy and learn the fundamentals of and how to analyze phytotherapeutic agents • Discusses phytotherapy in modern medicine, chemoprevention of disease, and alternatives to western medicines for specific diseases • Chapters summarizes the uses and applications of phytomedicines, by type like Chinese, Greco-Arab, Indian, European, and Ayurvedic • Includes international regulatory perspectives and discusses emerging regulations for various established and emerging markets



Informing The Future


Informing The Future
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2011-10-12

Informing The Future written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-10-12 with Medical categories.


This report illustrates the work of IOM committees in selected, major areas in recent years, followed by a description of IOM's convening and collaborative activities and fellowship programs. The last section provides a comprehensive bibliography of IOM reports published since 2007.



Rare Diseases And Orphan Products


Rare Diseases And Orphan Products
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2011-04-03

Rare Diseases And Orphan Products written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-04-03 with Medical categories.


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.



Improving The Utility And Translation Of Animal Models For Nervous System Disorders


Improving The Utility And Translation Of Animal Models For Nervous System Disorders
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2013-03-25

Improving The Utility And Translation Of Animal Models For Nervous System Disorders written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-03-25 with Medical categories.


Nervous system diseases and disorders are highly prevalent and substantially contribute to the overall disease burden. Despite significant information provided by the use of animal models in the understanding of the biology of nervous system disorders and the development of therapeutics; limitations have also been identified. Treatment options that are high in efficacy and low in side effects are still lacking for many diseases and, in some cases are nonexistent. A particular problem in drug development is the high rate of attrition in Phase II and III clinical trials. Why do many therapeutics show promise in preclinical animal models but then fail to elicit predicted effects when tested in humans? On March 28 and 29, 2012, the Institute of Medicine Forum on Neuroscience and Nervous System Disorders convened the workshop "Improving Translation of Animal Models for Nervous System Disorders" to discuss potential opportunities for maximizing the translation of new therapies from animal models to clinical practice. The primary focus of the workshop was to examine mechanisms for increasing the efficiency of translational neuroscience research through discussions about how and when to use animal models most effectively and then best approaches for the interpretation of the data collected. Specifically, the workshop objectives were to: discuss key issues that contribute to poor translation of animal models in nervous system disorders, examine case studies that highlight successes and failures in the development and application of animal models, consider strategies to increase the scientific rigor of preclinical efficacy testing, explore the benefits and challenges to developing standardized animal and behavioral models. Improving the Utility and Translation of Animal Models for Nervous System Disorders: Workshop Summary also identifies methods to facilitate development of corresponding animal and clinical endpoints, indentifies methods that would maximize bidirectional translation between basic and clinical research and determines the next steps that will be critical for improvement of the development and testing of animal models of disorders of the nervous system.



Toward Precision Medicine


Toward Precision Medicine
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Author : National Research Council
language : en
Publisher: National Academies Press
Release Date : 2012-01-16

Toward Precision Medicine written by National Research Council and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-01-16 with Medical categories.


Motivated by the explosion of molecular data on humans-particularly data associated with individual patients-and the sense that there are large, as-yet-untapped opportunities to use this data to improve health outcomes, Toward Precision Medicine explores the feasibility and need for "a new taxonomy of human disease based on molecular biology" and develops a potential framework for creating one. The book says that a new data network that integrates emerging research on the molecular makeup of diseases with clinical data on individual patients could drive the development of a more accurate classification of diseases and ultimately enhance diagnosis and treatment. The "new taxonomy" that emerges would define diseases by their underlying molecular causes and other factors in addition to their traditional physical signs and symptoms. The book adds that the new data network could also improve biomedical research by enabling scientists to access patients' information during treatment while still protecting their rights. This would allow the marriage of molecular research and clinical data at the point of care, as opposed to research information continuing to reside primarily in academia. Toward Precision Medicine notes that moving toward individualized medicine requires that researchers and health care providers have access to very large sets of health- and disease-related data linked to individual patients. These data are also critical for developing the information commons, the knowledge network of disease, and ultimately the new taxonomy.