Thursday, December 19, 2013

Ex Pfizer R&D Boss: Drug Efficacy and Safety Not Enough

The Cost of Proving Value and What It Means for Clinical Research

By Marc Dresner, IIR
John LaMattina
Ask John LaMatinna what’s on his mind lately and, among other things, he’ll mention the cost of outcomes studies.  Pfizer’s former Global R&D President—now an author, Forbes blogger and senior partner with biotech ventures firm PureTech—warns the price of admission for new drugs is going up, in cases, significantly. “In the old days it was about safety and efficacy and getting FDA approval,” said LaMatinna. “[Now] most clinical trials will need to have a comparator arm in them to show that your drug is better than existing drugs.” And 'better', he says, can be especially burdensome as outcomes studies increasingly come into play.

“These studies can cost hundreds of millions of dollars…
and if it doesn’t work, you’re cooked”

- John LaMattina

“These studies can cost hundreds of millions of dollars…and if it doesn’t work, you’re cooked, right? Nobody is going to care about your new drug,” LaMatinna told Inside Clinical.

LaMatinna expects that CROs are already gearing up to accommodate proof of value, but the pressure will definitely be on to scale and do so cost effectively...

In this interview with Inside Clinical:
• What clinical research organizations and their partners need to consider to support demand for proof of value
• How the outsourcing of R&D is creating huge opportunities
• Why the death of the blockbuster is a myth

Listen to the Podcast!
Download the Transcript!

Editor’s note: Join John LaMatinna at the 23rd Annual Partnerships in Clinical Trials March 30-April 2 in Las Vegas.  As a reader of this blog, when you register to join us and mention code XP1900BLOG, you can save up to $100 off the current rate when you register to join us!

ABOUT THE INTERVIEWER
Marc Dresner is IIR USA's senior editor and special communication projects lead. He is the former executive editor of Pharma Market Research Report, a confidential newsletter for marketing researchers in the pharmaceutical industry. He may be reached at mdresner@iirusa.com. Follow him @mdrezz.




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