Stem Cell Research And The Collaborative Regulation Of Innovation

Hopes are high that stem cell (SC) research will lead to treatments and cures for some of the most serious diseases affecting humankind today. SC science has been used in a treatment setting in the replacement of patients’ windpipes and in restoring sight to patients who were blind in one eye and in future it is hoped that when the body is injured it will be able to be stimulated to produce those types of SCs necessary to repair the particular damage caused. In the meantime, research into specific treatments for a wide range of serious conditions is being undertaken including Alzheimer’s disease, cancer, and diabetes. The book considers the regulatory governance of stem cell research, setting out a readily understandable account of the science and the challenges it poses for regulators as the research is increasingly being clinically applied. It provides a critical account of those elements of a regulatory system which will be required for any jurisdiction aiming to facilitate innovative and productive SC research while maintaining appropriate ethical and legal controls. The book addresses the specific failings in the current regulatory approach to SC research in the UK and goes on to look at the regulatory approaches in the US. The book systematically analyses the roles and responsibilities of the three key participants who collaborate in this process: regulators, scientists and tissue providers, arguing that a regulatory system which fails to recognise and facilitate the vital role which each of these three groups plays runs the risk of impairing the chances of the hopes for SC research being realised. The book places a particular emphasis on ensuring that those who contribute their bodily tissues to this endeavour are treated fairly, involving a recognition that their tissues are their property.

Stem Cells: Therapeutic Innovations under Control traces the discovery of stem cells and induced pluripotent cells. It establishes the link between knowledge about cell development and tissue engineering, and presents perspectives in regenerative medicine. Cell proliferation and tissue architecture open up unexpected applications in tissue engineering, with the development of tissues or organs. In this context emerges the need to address the issue of bioethics and regulatory considerations. Because stem cells can multiply and differentiate into cells specific to a particular tissue or organ, they represent vast potential in the health field. Traces the discovery of stem cells to link knowledge of cell development with tissue engineering Presents prospects in regenerative medicine Establishes the link between knowledge about cell development and tissue engineering

The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.

Since 1998, the volume of research being conducted using human embryonic stem (hES) cells has expanded primarily using private funds because of restrictions on the use of federal funds for such research. Given limited federal involvement, privately funded hES cell research has thus far been carried out under a patchwork of existing regulations, many of which were not designed with this research specifically in mind. In addition, hES cell research touches on many ethical, legal, scientific, and policy issues that are of concern to the public. This report provides guidelines for the conduct of hES cell research to address both ethical and scientific concerns. The guidelines are intended to enhance the integrity of privately funded hES cell research by encouraging responsible practices in the conduct of that research.

The SAGE Encyclopedia of Stem Cell Research, Second Edition is filled with new procedures and exciting medical breakthroughs, including executive orders from the Obama administration reversing barriers to research imposed under the Bush administration, court rulings impacting NIH funding of research based on human embryonic stem cells, edicts by the Papacy and other religious leaders, and the first success in cloning human stem cells. Stem cell biology is clearly fueling excitement and potential in traditional areas of developmental biology and in the field of regenerative medicine, where they are believed to hold much promise in addressing any number of intractable medical conditions. This updated second edition encyclopedia will expand on information that was given in the first edition and present more than 270 new and updated articles that explore major topics in ways accessible to nonscientists, thus bringing readers up-to-date with where stem cell biology stands today, including new and evolving ethical, religious, legal, social, and political perspectives. This second edition reference work will serve as a universal resource for all public and academic libraries. It is an excellent foundation for anyone who is interested in the subject area of stem cell biology. Key Features: Reader’s Guide, Further Readings, Cross References, Chronology, Resource Guide, Index A Glossary will elucidate stem cell terminology for the nonscientist Statistics and selected reprints of major journal articles that pertain to milestones achieved in stem cell research Documents from Congressional Hearings on stem cells and cloning Reports to the President’s Council on Bioethics, and more

This book is a unique guide to emerging stem cell technologies and the opportunities for their commercialisation. It provides in-depth analyses of the science, business, legal, and financing fundamentals of stem cell technologies, offering a holistic assessment of this emerging and dynamic segment of the field of regenerative medicine. • Reviews the very latest advances in the technology and business of stem cells used for therapy, research, and diagnostics • Identifies key challenges to the commercialisation of stem cell technology and avenues to overcome problems in the pipeline • Written by an expert team with extensive experience in the business, basic and applied science of stem cell research This comprehensive volume is essential reading for researchers in cell biology, biotechnology, regenerative medicine, and tissue engineering, including scientists and professionals, looking to enter commercial biotechnology fields.

How should the law deal with the challenges of advancing biotechnology? This book is a philosophical and legal re-analysis.