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So far healthdec_rljyp3 has created 34 blog entries.

ASRM-NICHD Workshop Focuses on Expanding Access to ART

The 2016 Scientific Congress of the American Society for Reproductive Medicine (ASRM) is in full swing in Salt Lake City. Among the events of greatest interest to the Health Decisions contingent at the congress is "Advancing Science and Practice to Improve Access in Reproductive Care," a workshop jointly sponsored by ASRM and the Eunice Kennedy [...]

ASRM-NICHD Workshop Focuses on Expanding Access to ART 2018-08-14T21:11:24+00:00

Lessons from Women’s Health Studies to Benefit Many Areas

The new NIH policy on consideration of sex as a biological variable in NIH-funded research and the 2014 FDA Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data are ushering in an era in which the biology of sex requires consideration at all stages of medical research. This is a welcome development [...]

Lessons from Women’s Health Studies to Benefit Many Areas 2018-08-14T21:12:06+00:00

Prospective IVD Trials: When Are They Necessary?

IVD developers sometimes find it surprising that it is not enough to demonstrate the analytic validity of a test - the ability of the test to determine whether what it is designed to detect is present or absent. IVD developers may expect existing scientific knowledge and a series of informed inferences to connect the dots [...]

Prospective IVD Trials: When Are They Necessary? 2018-08-14T21:12:52+00:00

Health Decisions to Exhibit and Present at DIA 2016

On the eve of the 2016 Drug Industry Association 52nd Annual Meeting in Philadephia June 26-30, the Health Decisions event team is looking forward to lively discussions of clinical development issues in booth #1143, a busy calendar of meetings with current and prospective clients and leading a forum on one of the hottest issues in [...]

Health Decisions to Exhibit and Present at DIA 2016 2018-08-14T21:13:43+00:00

Marking International Clinical Trials Day 2016

International Clinical Trials Day takes place each year on May 20, commemorating the day in 1747 on which James Lind started his controlled trial of scurvy treatments. Health Decisions marked the day internally by celebrating our own project managers, clinical trial leads, clinical research associates, in-house clinical research associates, clinical trial assistants, biostatisticians and other [...]

Marking International Clinical Trials Day 2016 2018-08-14T21:14:31+00:00

Women’s Health Week: Highlighting Unmet Medical Needs

Significant unmet medical needs profoundly affect the lives of hundreds of millions of women worldwide. Women have more than their fair share of healthcare needs for a variety of reasons, including: Women’s healthcare needs vary substantially over the life cycle, from childhood and adolescence through the childbearing years and menopause; this increases the challenge for [...]

Women’s Health Week: Highlighting Unmet Medical Needs 2018-08-14T21:15:13+00:00

Key Issues in Coordinating Drug and CDx Development

Companion diagnostics (CDx) are IVDs developed for the purpose of identifying a characteristic that increases the likelihood of patient responsiveness to a specific treatment. Companion diagnostics will take on increasing importance with the growth of precision medicine. Some aspects of the future of dedicated companion diagnostics are unclear as understanding of complex disease mechanisms increases, [...]

Key Issues in Coordinating Drug and CDx Development 2018-08-14T21:15:54+00:00

Precision Medicine White Paper Goes Live in Busy Week for the Precision Medicine Initiative

With the White House hosting a Precision Medicine Initiative Summit and National Institutes of Health Director Francis Collins announcing plans to enroll 79,000 volunteers this year in the PMI Cohort Program, there can be little doubt that precision medicine is gaining momentum on the national and global scene. Health Decisions has been increasingly active in [...]

Precision Medicine White Paper Goes Live in Busy Week for the Precision Medicine Initiative 2016-02-26T16:58:29+00:00

2015 Approvals Herald Rapid Progress, Growing Diversity in Precision Medicine

The Personalized Medicine Coalition (PMC) reports that 13 of 45 new molecular entities or therapeutic biologics approved by FDA in 2015, or 28%, were personalized medicines. The number of approved personalized (precision) medicines increased from 9 in 2014. While completing the transition to precision medicine will take years and require addressing major challenges, the momentum [...]

2015 Approvals Herald Rapid Progress, Growing Diversity in Precision Medicine 2017-09-05T21:37:05+00:00

Picking Up the Pace in Precision Medicine

Early successes in precision medicine have inspired widespread support for accelerating the transition from traditional one-size-fits-all therapeutics. In some areas, such as age-related macular degeneration, gene sequencing has identified previously unrecognized disease mechanisms and inspired development activity around new targets. In oncology, it has become commonplace to make treatment decisions informed by comparison of germ-line [...]

Picking Up the Pace in Precision Medicine 2015-12-01T16:07:56+00:00
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