Friday, April 10, 2015

What Small Biopharma Can Teach Big Pharma About Nimble

PLUS: Why Pharma Must Stop Commoditizing Clinical Sites and What Needs to Happen to Develop Rational Combination Therapies

By Marc Dresner, IIR

A couple of weeks ago, the Inside Clinical series reported on new research into the Lean outsourcing trend that has captured so much attention at large pharmaceutical companies.

As the name suggests, Lean is about efficiency, but the companies adopting the model also see it as a means to drive “nimble” product development—a faster, more flexible and adaptive way of doing things.

What remains to be seen, however, is whether or not large companies will actually take full advantage of the insight and expertise their CRO partners bring to the table to effect a truly nimble strategy.

Sponsors pay quite a bit of lip service to collaboration; anecdotally, we know that CROs are still often underutilized, especially for planning upfront.

But just as Lean outsourcing models were inspired by the small biopharmas and startups that have always used them out of necessity, it may be that large pharmaceutical companies can fashion nimble approaches by borrowing a page or two from how these small companies actually partner with CROs.
Dr. Nick Kenny

According to Dr. Nick Kenny, EVP and General Manager of Global Oncology and Hematology at INC Research, large companies can learn a great deal from the innovative startups in the oncology space.

“Small biotechs have become very nimble about applying other people’s knowledge together with their own and making rapid decisions.”

“Traditionally the thinking has been: What can Big Pharma teach biotechs?” said Kenny. “The paradigm has shifted; now it’s the innovative, small companies that are actually making good partnerships.”

“A lot of these biotechs have become very nimble about applying other people’s knowledge together with their own and making rapid decisions based upon looking at data and really being adaptive partners, as opposed to some Big Pharma companies with traditional approaches that see their external vendors more as arms and legs to do the work versus contributing some intellectual capital,” Kenny told Inside Clinical.

“There is not a huge incentive for investigators to struggle through the administrative burden to participate in trials.”

Kenny also expressed concern about what he sees as the excessive administrative burden for study sites and clinical investigators, which he says at least partially accounts for chronic low participation rates in trials.

“There is not a huge incentive for investigators to struggle through the administrative burden and actually participate in trials,” Kenny said.

In this episode of Inside Clinical—the Partnerships in Clinical Trials podcast interview series—Dr. Kenny discusses how small companies partner differently, why the industry needs to stop treating sites and investigators like commodities and what urgently needs to happen to enable development of rational combination therapies.

Editor’s note: Dr. Nick Kenny will be presenting with Dr. Pablo Lapuerta from Lexicon on patient-centric study design at the 24th Annual Partnerships in Clinical Trials Conference running April 22-24 in Boston.

For more information or to register, please visit www.clinicaltrialpartnerships.com  


ABOUT THE AUTHOR / 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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