Topic: Diagnostics

Women’s Health Week 2017: Spotlight on Infectious Conditions

For National Women’s Health Week last year, this blog focused on the need for progress in a variety of areas in which women have unmet medical needs. Last year’s post mentioned the need for progress in noninvasive diagnostics and therapeutics for osteoporosis, female sexual dysfunction, endometriosis, bacterial vaginosis and uterine fibroids. This year we want… Read more »

Differences Between Drug and Medical Device Trials: CSRs

While drugs and medical devices are both essential in modern medical care, there are times when standard clinical development processes seem to treat medical devices as an afterthought. For example, medical writers for a CRO conducting studies of both drugs and devices must learn to interpret a drug-centric guidance document to author an appropriate Clinical… 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Update: The FDA post-election statement on delaying implementation of the agency’s draft guidance on LDTs affirms the status quo – for now.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 »

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… 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 »

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 »