Tagged: FDA

Biopharma’s R&D Productivity Problem Resurfaces as We Enter 2014

While FDA approvals of truly new drugs and biologics soared to 39 in 2012, the story as we enter 2014 shows a striking reversion to lower productivity levels that have long plagued the industry. The number of FDA approvals dropped to 27 in 2013. Big Pharma can take credit for only 14 of the approved… Read more »

Clinical Research Now: One Foot in the 21st Century, the Other in Ancient Greece

We do 21st century biology in our laboratories and then do clinical trials that Hippocrates would have been quite comfortable with.  – Roger Perlmutter, executive vice president of Merck and president of Merck Research Laboratories, in a panel discussion at the Forbes Healthcare Summit in October. Perlmutter’s characterization of current clinical trials rings true.  Much… Read more »

Risk-Based Monitoring: Where are the Benefits?

I got a call this morning from a frustrated colleague who runs the oncology franchise in Europe for a big pharma company. Despite a substantial investment in software that promised increased focus and efficiency through risk-based monitoring, my colleague is seeing neither. Did I have any suggestions? Questions about why technology is not producing expected… Read more »

Looking Ahead: Reducing Risk in Biologics Trials

Despite their complexity, biologics are going mainstream. According to a report by Evaluate Pharma, biologics represent 40% of development pipelines for companies they surveyed. You might even say biologics programs involve lower risks than small-molecule programs – a higher percentage of biologics progress from preclinical to approval. But going mainstream hasn’t made biologics more predictable…. Read more »

CNS Development Makes a Comeback

Only yesterday, we were reading about the death of CNS drug development.  The reasons were simple: first, several Big Pharma companies were abandoning or cutting their CNS programs; and second, there seemed to be a consensus that odds were against translating CNS-related innovations in basic science into successful clinical programs. That was in December 2011…. Read more »

The FDA’s Final Risk-Based Monitoring Guidance and Beyond

The FDA has issued the final version of its risk-based monitoring guidance. In my view, this represents a milestone in industry and regulatory understanding of the extent to which electronic systems can increase the efficiency of clinical trials while maintaining data quality and patient safety. The guidance does not dismiss the value of site visits,… Read more »

Are Your Clinical Operations Adaptive-Ready?

The Adoption and Impact of Adaptive Trial Designs, a new report from the Tufts Center for the Study of Drug Development, confirms something that I’ve been saying for years – you can’t use adaptive designs without highly efficient operations: Operating concerns – specifically delays and disruptions in trial execution, patient participation and distribution of clinical… Read more »

A Peek at Real-World Performance in Clinical Trials

If you outsource clinical trials, you have no doubt noticed that all CROs claim to increase efficiency and reduce timelines, cost and risk. Since everybody has solved these problems, it’s something of a mystery how clinical research continues to experience so many delays, such high costs and so many failed programs. Opportunities for third-party validation… Read more »