Topic: Industry Commentary

Addressing High Failure Rates in Drug Development

FDA has published an excellent report on 22 instances in which phase 2 and phase 3 trials had divergent results. Appendix A of the report provides justifications for essential elements of modern clinical trials, including a control group, randomization and blinding. In addition, Appendix A highlights risks of techniques for improving efficiency in early development,… Read more »

2017 – Time for a Bold R&D Initiative in Women’s Health

Despite NIH and FDA women’s health policy initiatives previously described in this blog, the list of novel drugs approved by FDA in 2016 includes only one product for a woman-specific health indication. FDA granted accelerated approval in December 2016 for rucaparib (Rubraca™), a Clovis Oncology PARP inhibitor for ovarian cancer. Rubraca is indicated for patients… Read more »

Settling on a Framework for LDT Regulation: Update

Update: The FDA post-election statement on delaying implementation of the agency’s draft guidance on LDTs affirms the status quo – for now. The delay allays the concerns of some stakeholders about potential effects of greater FDA involvement in LDT regulation, such as slowing innovation in diagnostics and patient access to the most advanced diagnostics and,… Read more »

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… 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 »