Content by Keyword: Science

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Privacy, Confidentiality, Security

Privacy and Health Research. Privacy, Confidentiality, Security

Privacy is a deeply felt but elusive concept. Everyone is sensitive to having his privacy violated. The concepts of "personal matters" and "intimate knowledge" are familiar, as is the notion that individuals live in a "private sphere" over which they are to be granted autonomy. The right to private life was proclaimed in the Universal Declaration
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Major Current Issue Clusters

Privacy and Health Research. Major Current Issue Clusters

The Report identifies many problem areas. The following are four large groups of issues that, while not entirely new, are growing rapidly in scale and complexity, and must urgently be attended to: Secondary uses of data, and data linking Research on private-sector health data Cybersecurity Genetic privacy. Issue cluster: Secondary res
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Data from Research, Research on Data

Privacy and Health Research. Data from Research, Research on Data

Contemporary health research is generating a multitude of benefits for humankind, and the future benefits look at least as promising. As the above heading indicates, health research generates new data by observation and experiment, but also—in part because its questions are of such an "applied," practical nature—it often proceeds by analyzing
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Government Funding of New Drug Development

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Government Funding of New Drug Development

In general, the investment to produce a new drug for a small market is no different than producing a new drug for a large market, but a company is less likely to recoup its investment in a small market. Government funding of new drug development can raise the science base and move any promising drug closer to launch. Improving the science base can
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Industry Perception of Science Base Readiness

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Industry Perception of Science Base Readiness

There was a divergence of opinion among the pharmaceutical company interviewees about the readiness of the science base for cocaine pharmacotherapies. Representatives of two companies expressed skepticism about the readiness of the science base. One representative indicated that current limitations stem from a lack of understanding regarding the b
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Industry Perception of Science Base Readiness

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Industry Perception of Science Base Readiness

There was a divergence of opinion among the pharmaceutical company interviewees about the readiness of the science base for cocaine pharmacotherapies. Representatives of two companies expressed skepticism about the readiness of the science base. One representative indicated that current limitations stem from a lack of understanding regarding the b
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Social Stigma

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Social Stigma

Social stigma of drug abusers was cited as a market barrier by representatives of two of the pharmaceutical companies, though it is regarded as surmountable if the commercial and scientific viability of the product is favorable. The pharmaceutical companies that identified social stigma as a barrier were familiar and sympathetic to the case experi
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Regulatory Issues for Approval: File IND/Clinical

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Regulatory Issues for Approval: File IND/Clinical Studies, File NDA, and Other Approval

Several points within the drug approval process were seen by industry as potential market barriers to product development in this field. However, as a group, none were viewed as major barriers that could not be surmounted, especially if the market barriers cited as critical ones above were lowered or eliminated.
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Industry Perception of Market Barriers

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Industry Perception of Market Barriers

Some of the market barriers identified in the 1995 IOM report were confirmed through the interviews with private firms and case studies conducted for this effort. Figure 36 summarizes the market barriers that were confirmed (in full or in part) and not confirmed during this study. (As noted above, the number of interviews and case studies was limi
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Case Study 2: Naltrexone

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Case Study 2: Naltrexone

Introduction Drug Overview
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Existing Government Strategies to Lower Market

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Existing Government Strategies to Lower Market Barriers

The government was involved in aspects of development and marketing for each of the four case study drugs. These phases, adapted from the 1995 IOM report, include discovery, clinical studies, NDA phase, and marketing. Figure 23: Overview of Past Government Strategies to Lower Market Barriers   Strategy
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Internal Rate of Return and Reducing the Time to

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Internal Rate of Return and Reducing the Time to Market

Another important investment criterion used by some companies is the internal rate of return (IRR). The IRR is the rate of interest at which the present value of all net cash flows into and out of a project over a specified time interval equals zero. A higher IRR makes an investment opportunity more favorable.
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Objective 6.4 - Accelerate Private-Sector

HHS Strategic Goals and Objectives - FY 2001 . Objective 6.4 - Accelerate Private-Sector Development of New Drugs, Biologic Therapies, and Medical Technology

How We Will Accomplish Our Objective We will accelerate development by: applying state-of-the-art science knowledge to ensure timely review of important new medical products. streamlining the review processes for approval of new drugs, therapies, and technology.
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Objective 6.2 - Improve Our Understanding of How

HHS Strategic Goals and Objectives - FY 2001 . Objective 6.2 - Improve Our Understanding of How to Prevent, Diagnose, and Treat Disease and Disability

How We Will Accomplish Our Objective We will improve our understanding of how to prevent, diagnose and treat disease and disability by:
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Goal 6 - Strengthen the Nation's Health

HHS Strategic Goals and Objectives - FY 2001 . Goal 6 - Strengthen the Nation's Health Science Research Enterprise and Enhance its Productivity

The "health research" goal recognizes the prominence of health research in HHS and its importance in furthering the overall mission of improving the nation's health. Many strategies under other goals and objectives are also research based, so there is overlap among the goals and objectives. The objectives under Goal 6 deal with creating knowledge
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Objective 5.2 - Improve the Safety of Food,

HHS Strategic Goals and Objectives - FY 2001 . Objective 5.2 - Improve the Safety of Food, Drugs, Medical Devices, and Biological Products

How We Will Accomplish Our Objective We will access state-of-the-art science necessary for timely and credible regulatory decisions by: recruiting top scientists. engaging in continuous training of the professional work force.
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Goal 5 - Improve the Nation's Public Health

HHS Strategic Goals and Objectives - FY 2001 . Goal 5 - Improve the Nation's Public Health Systems

In addition to behavior, access, and quality, the vitality of the public health system in the United States is essential to ensuring and improving the health of Americans. Therefore, Goal 5 is concerned with making sure the infrastructure of the public health system is sound.
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Goal 4 - Improve the Quality of Health Care and

HHS Strategic Goals and Objectives - FY 2001 . Goal 4 - Improve the Quality of Health Care and Human Services

Improving quality of life and health in the United States also involves improving the quality of human services and health care that persons receive. The focus of this goal and supporting objectives is on the implementation of a variety of strategies to improve service quality. In this respect, several of the objectives parallel the goals in the D
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Objective 2.5 - Increase the Proportion of Older

HHS Strategic Goals and Objectives - FY 2001 . Objective 2.5 - Increase the Proportion of Older Americans Who Stay Active and Healthy

How We Will Accomplish Our Objective We will support an initiative to prevent falls--a leading cause of functional decline in the elderly. Our strategy will focus on:
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Objective 1.5 - Reduce the Abuse and Illicit Use

HHS Strategic Goals and Objectives - FY 2001 . Objective 1.5 - Reduce the Abuse and Illicit Use of Drugs

How We Will Accomplish Our Objective We will provide science-based information on the effects of drug use and on effective prevention and treatment strategies to health professionals, states, communities, and the public.

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Form Approved OMB# 0990-0379 Exp. Date 9/30/2020