The Role of NIH in Drug Development Innovation and Its Impact on Patient Access

The Role of NIH in Drug Development Innovation and Its Impact on Patient Access
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Total Pages: 103
Release: 2020-01-27
Genre: Medical
ISBN: 0309498511

To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.

SBIR and the Phase III Challenge of Commercialization

SBIR and the Phase III Challenge of Commercialization
Author: National Research Council
Publisher: National Academies Press
Total Pages: 200
Release: 2007-03-15
Genre: Political Science
ISBN: 0309179106

In response to a Congressional mandate, the National Research Council conducted a review of the Small Business Innovation Research Program (SBIR) at the five federal agencies with SBIR programs with budgets in excess of $100 million (DOD, NIH, NASA, DOE, and NSF). The project was designed to answer questions of program operation and effectiveness, including the quality of the research projects being conducted under the SBIR program, the commercialization of the research, and the program's contribution to accomplishing agency missions. This report summarizes the presentations at a symposium exploring the effectiveness of Phase III of the SBIR program (the commercialization phase), during which innovations funded by Phase II awards move from the laboratory into the marketplace. No SBIR funds support Phase III; instead, to commercialize their products, small businesses are expected to garner additional funds from private investors, the capital markets, or from the agency that made the initial award.

NCI Fact Book

NCI Fact Book
Author: National Cancer Institute (U.S.)
Publisher:
Total Pages: 82
Release: 1979
Genre: Cancer
ISBN:

An Assessment of the SBIR Program at the National Science Foundation

An Assessment of the SBIR Program at the National Science Foundation
Author: National Research Council
Publisher: National Academies Press
Total Pages: 366
Release: 2008-07-26
Genre: Technology & Engineering
ISBN: 0309104874

The Small Business Innovation Research (SBIR) program is one of the largest examples of U.S. public-private partnerships. Founded in 1982, SBIR was designed to encourage small business to develop new processes and products and to provide quality research in support of the many missions of the U.S. government, including health, energy, the environment, and national defense. In response to a request from the U.S. Congress, the National Research Council assessed SBIR as administered by the five federal agencies that together make up 96 percent of program expenditures. This book, one of six in the series, reports on the SBIR program at the National Science Foundation. The study finds that the SBIR program is sound in concept and effective in practice, but that it can also be improved. Currently, the program is delivering results that meet most of the congressional objectives, including stimulating technological innovation, increasing private-sector commercialization of innovations, using small businesses to meet federal research and development needs, and fostering participation by minority and disadvantaged persons. The book suggests ways in which the program can improve operations, continue to increase private-sector commercialization, and improve participation by women and minorities.

Conflict of Interest in Medical Research, Education, and Practice

Conflict of Interest in Medical Research, Education, and Practice
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 436
Release: 2009-09-16
Genre: Medical
ISBN: 0309145449

Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.

Biotechnology Entrepreneurship

Biotechnology Entrepreneurship
Author: Craig Shimasaki
Publisher: Academic Press
Total Pages: 489
Release: 2014-04-08
Genre: Medical
ISBN: 0124047475

As an authoritative guide to biotechnology enterprise and entrepreneurship, Biotechnology Entrepreneurship and Management supports the international community in training the biotechnology leaders of tomorrow. Outlining fundamental concepts vital to graduate students and practitioners entering the biotech industry in management or in any entrepreneurial capacity, Biotechnology Entrepreneurship and Management provides tested strategies and hard-won lessons from a leading board of educators and practitioners. It provides a 'how-to' for individuals training at any level for the biotech industry, from macro to micro. Coverage ranges from the initial challenge of translating a technology idea into a working business case, through securing angel investment, and in managing all aspects of the result: business valuation, business development, partnering, biological manufacturing, FDA approvals and regulatory requirements. An engaging and user-friendly style is complemented by diverse diagrams, graphics and business flow charts with decision trees to support effective management and decision making. - Provides tested strategies and lessons in an engaging and user-friendly style supplemented by tailored pedagogy, training tips and overview sidebars - Case studies are interspersed throughout each chapter to support key concepts and best practices. - Enhanced by use of numerous detailed graphics, tables and flow charts

Catalog of Federal Domestic Assistance

Catalog of Federal Domestic Assistance
Author:
Publisher:
Total Pages: 1730
Release: 2000
Genre: Economic assistance, Domestic
ISBN:

Identifies and describes specific government assistance opportunities such as loans, grants, counseling, and procurement contracts available under many agencies and programs.

Catalog of Federal Domestic Assistance

Catalog of Federal Domestic Assistance
Author: United States. Office of Management and Budget
Publisher:
Total Pages: 1708
Release: 1999
Genre: Economic assistance, Domestic
ISBN:

Identifies and describes specific government assistance opportunities such as loans, grants, counseling, and procurement contracts available under many agencies and programs.