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The California Institute for Regenerative Medicine
The California Institute for Regenerative Medicine (CIRM) was created in 2005 by The California Stem Cell Research and Cures Act (Proposition 71) to distribute $3 billion in state funds for stem cell research. The passage of Proposition 71 by the voters of California occurred at a time when federal funding for research involving human embryonic stem cells was uncertain, given the ethical questions raised by such research. During its initial period of operations, CIRM has successfully and thoughtfully provided more than $1.3 billion in awards to 59 California institutions, consistent with its stated mission. As it transitions to a broadened portfolio of grants to stimulate progress toward its...
The California Institute for Regenerative Medicine
The California Institute for Regenerative Medicine (CIRM) was created in 2005 by The California Stem Cell Research and Cures Act (Proposition 71) to distribute $3 billion in state funds for stem cell research. The passage of Proposition 71 by the voters of California occurred at a time when federal funding for research involving human embryonic stem cells was uncertain, given the ethical questions raised by such research. During its initial period of operations, CIRM has successfully and thoughtfully provided more than $1.3 billion in awards to 59 California institutions, consistent with its stated mission. As it transitions to a broadened portfolio of grants to stimulate progress toward its...
The Delivery of Regenerative Medicines and Their Impact on Healthcare
Now that prohibitions against stem cell research are relaxing, it is time for the field to move forward with the advances that promise to eliminate so much human suffering. However, it would be naive to ignore the fact that regenerative medicines pose a whole new set of challenges to an industry sector that for decades has geared itself to the deve
Framing Opioid Prescribing Guidelines for Acute Pain
The opioid overdose epidemic combined with the need to reduce the burden of acute pain poses a public health challenge. To address how evidence-based clinical practice guidelines for prescribing opioids for acute pain might help meet this challenge, Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence develops a framework to evaluate existing clinical practice guidelines for prescribing opioids for acute pain indications, recommends indications for which new evidence-based guidelines should be developed, and recommends a future research agenda to inform and enable specialty organizations to develop and disseminate evidence-based clinical practice guidelines for prescribing opioids to treat acute pain indications. The recommendations of this study will assist professional societies, health care organizations, and local, state, and national agencies to develop clinical practice guidelines for opioid prescribing for acute pain. Such a framework could inform the development of opioid prescribing guidelines and ensure systematic and standardized methods for evaluating evidence, translating knowledge, and formulating recommendations for practice.
Building on Canada's Strengths in Regenerative Medicine
K2P 2K3 Notice: The project that is the subject of this report was undertaken with the approval of the Board of Governors of the Council of Canadian Academies (CCA). [...] Any opinions, findings, or conclusions expressed in this publication are those of the authors, the Steering Committee of the Workshop on the Opportunities and Challenges for Regenerative Medicine in Canada and do not necessarily represent the views of their organizations of affiliation or employment, or the sponsoring organization, Innovation, Science and Economic Development Canada. [...] The Council of Canadian Academies iii the Council of Canadian academies Science Advice in the Public Interest The Council of Canadian A...
The Ethical Challenges of the Stem Cell Revolution
Stem cells, particularly pluripotent stem cells, hold significant promise for developing therapies for diseases and disorders for which there are no current treatments and for regenerating human cells, tissues, and possibly even organs. However, to be able to translate stem cell research into therapies, researchers must first address many scientific, ethical, and regulatory hurdles. The need for researchers and sponsors to demonstrate progress and the hopes of patient groups for new therapies have pressured researchers to move quickly into clinical trials and encouraged the opening of clinics offering unproven and unapproved stem cell treatments. This book tells the story of the development of the field, and identifies the ethical issues and challenges stem cell translation raises. It will be of interest to ethicists, scientists, and regulators working in the stem cell field, as well as the general reader following scientific developments.
Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies
On June 26, 2017, the Forum on Regenerative Medicine hosted a public workshop in Washington, DC, titled Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies in order to examine and discuss the challenges, opportunities, and best practices associated with defining and measuring the quality of cell and tissue products and raw materials in the research and manufacturing of regenerative medicine therapies. The goal of the workshop was to learn from existing examples of the manufacturing of early-generation regenerative medicine products and to address how progress could be made in identifying and measuring critical quality attributes. The workshop also addressed the challenges of designing and adhering to standards as a way of helping those who are working to scale up processes and techniques from a research laboratory to the manufacturing environment. This publication summarizes the presentations and discussions from the workshop.
