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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