Topic: Precision Medicine

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… Read more »

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,… Read more »

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… Read more »

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… Read more »

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… Read more »

Status Check on Precision Medicine at AMP in Austin

The Health Decisions team is excited about exhibiting at the 2015 Annual Meeting of the Association for Molecular Pathology in Austin, Texas November 5-7. This conference always provides an important status check on progress in precision medicine, as emphasized by this year’s AMP theme: “Realizing the Dream of Precision Medicine.” We are excited about the… Read more »

Precision Medicine, Molecular Diagnostics and Clinical Utility

A funny thing happened in the race to realize the substantial benefits of precision medicine: healthcare payer reluctance to reimburse for testing with molecular diagnostics until there is evidence connecting test results with improved patient outcomes. On the one hand, we are witnessing rapid progress in identification of biomarkers and development of related assays. On… Read more »

Rising to the Challenges of Precision Medicine: Onward!

As we enter 2015, Health Decisions’ mission – continuous innovation to reduce risk and time to market, fail unsuccessful products faster, enable cost-effective development of precision medicines and provide earlier and more affordable access to novel therapeutics and medical devices – is more important than ever. The biopharma and medical-device industries face numerous challenges. Foremost… Read more »