Topic: Industry Commentary

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 »

Debunking the Instant Myth of FDA as Rubber Stamp

FDA’s high approval rate for New Drug Applications (NDAs) is much in the news, with headlines like the one on a Matthew Herper post at Forbes: The FDA Is Basically Approving Everything. Here’s the Data to Prove It. The data comes from an analysis that Forbes commissioned at BioMedTracker. When FDA approves 23 out of… Read more »

Independent Pre-FDA Draft Guidances from Stakeholders

The introduction to an FDA draft guidance for industry published in June 2015, “Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment,” makes an unusual statement: Development of this guidance was preceded by the submission to FDA of a proposed draft guidance independently prepared by a consortium of stakeholders including patients, parents and caregivers, clinicians,… Read more »

Mitigating Risk in Neurosciences Studies with e-Source Assessments

The case for electronic data capture in neurosciences studies is strong. The high failure rate in CNS development, headlined by a series of failed Alzheimer’s studies, is one reason to seek better methods. According to a Scientific American article by Kenneth Kaitin and Christopher Milne of the Tufts Center for the Study of Drug Development,… Read more »

Recognition of Health Decisions as Best CRO – an Honor and a Springboard

The Triangle area of North Carolina represents the intersection of three cities – Raleigh, Durham and Chapel Hill – and three major research universities – the University of North Carolina at Chapel Hill, Duke University and North Carolina State University. Research Triangle Park is at the center of the Triangle area, which is home to… Read more »

In Praise of Clinical Trials Professionals on Clinical Trials Day

May 20 is International Clinical Trials Day, an occasion for honoring clinical trials professionals. The limits of sample size prevent clinical trials from answering all questions about the effects of new medical products in broad populations. However, clinical research professionals ensure that we learn as much as possible while also limiting patient exposure to investigational… Read more »

Meeting the Challenges of Phase 2 Clinical Development

Some investigational products successfully make the transition from phase 2 to phase 3 while most fall by the wayside. Disregarding products that fail because they simply lack efficacy or safety, what makes the difference between phase 2 success for a relative few products and failure for most? In our view, the key to maximizing chances… Read more »

Fighting Infectious Disease on Multiple Fronts

Medical researchers and clinical developers are working on a variety of novel vaccines, therapeutics and diagnostics to address a host of challenges in infectious disease. Many of these challenges have made recent news. The Ebola outbreak in West Africa, the first locally acquired case of Chikungunya in the United States and the appearance of Middle… Read more »