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 [...]
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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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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, [...]
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 [...]
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 [...]
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 [...]