Tagged: productivity

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 »

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 »

Predicting the Future of Your Next Clinical Trial

A lot of people think the past predicts the future. I guess if you don’t have anything better, then there’s some truth to that. Recently I got a solicitation from Quintiles telling me just how valuable their database of past history is. You’ve probably heard the same promises – we know which sites produce, what… Read more »

Three Ways to Target Inefficiency in Clinical Development

Based on years of poor R&D productivity, the pharma industry is rethinking clinical development. Novartis CEO Joseph Jimenez is rethinking the traditional blockbuster.  Tomas Philipson and former FDA Commissioner Andrew von Eschenbach are rethinking  phase III trials. A third aspect of clinical development also requires rethinking but I’ll leave that for the end of this… Read more »

Why Hasn’t Technology Paid Off in Clinical Research?

There’s a telling figure at the end of an April 2012 discussion paper from The Institute of Medicine of the National Academies, “Transforming the Economics of Clinical Trials.” The authors, Judith M. Kramer and Kevin A. Schulman of Duke University, sum up the disappointing results to date of adopting new technologies in clinical research, with… Read more »

Surviving the Big Squeeze in Biopharma Development

The biopharma industry finds itself in a squeeze that rivals the drama of the garbage-compactor scene in Star Wars. On one side, operational inefficiency keeps closing in. Outlook 2013 from the Tufts Center for the Study of Drug Development reminds us that new business models haven’t solved the industry’s efficiency problems. Another recent Tufts CSDD… Read more »

Fighting the Efficiency War on Two Fronts

We welcome the news that FDA drug and biologic approvals soared to 39 in 2012. That’s the best year for approvals of new therapeutic agents since 1996, justifying all the champagne we drank on New Year’s Eve. Consistent with opinion at the recent Forbes healthcare summit, the increase in FDA approvals suggests the industry is… Read more »