Wednesday, March 25, 2015

Study Identifies Best Practices for Lean Outsourcing of Clinical Development

By Marc Dresner, Senior Editor, IIR

We can now add clinical development to the list of functions at major corporations benefiting from the Lean movement pioneered by Toyota.

According to a study conducted by The Avoca Group on behalf of Purdue Pharma, Lean Models for outsourcing clinical development have by and large been achieving desired results at major pharmaceutical companies where they have been deployed.

“It was interesting to hear how well these models were working from so many different people at so many different companies,” said Dr. Denise Calaprice, Senior Consultant at the Avoca Group, in a recent interview with Inside Clinical.

Big pharmacos have been adopting Lean Models to accommodate greater demand for efficiency, reduced headcount and non-traditional, “nimble” product development strategies.

Denise Calaprice
Calaprice noted Lean and even “virtual” clinical outsourcing isn’t necessarily new; small pharmacos and biotechs have always done it out of necessity.

Dr. Mitch Katz
But in recent years, large pharmaceutical companies have been exploring and adopting Lean Models for outsourcing clinical development to accommodate greater demand for efficiency, reduced headcount and a drive toward non-traditional, “nimble” product development strategies.

Until now little was known about the extent or effectiveness of these implementations, which concerned Purdue’s Head of Medical Research and Drug Safety Operations Dr. Mitchell Katz when the company began considering a Lean strategy as part of a restructure last year.

“We had undergone a headcount reduction and our pipeline was lean…A model that would minimize the level of internal resources for CRO oversight made sense.”
– Dr. Mitch Katz, Purdue Pharma

“We [at Purdue] had undergone a headcount reduction and our pipeline was lean,” Katz told Inside Clinical. “For us, a model that would minimize the level of internal resources for CRO oversight—the Lean Model—made sense.”
(It’s worth noting that this wasn’t simply a belt-tightening measure; Katz said that while Purdue is shifting some focus from its pain franchise, the Lean Model will factor into plans to expand its CNS work.)
Purdue enlisted The Avoca Group to canvass companies—large and small—that had implemented or evaluated Lean Models in order to compile best practices and standards.


The study uncovered seven key areas companies should explore when considering adopting a Lean Model as part of its clinical development strategy.

The study uncovered seven key areas companies should explore when considering adopting a Lean Model as part of its clinical development strategy, spanning such things as which competencies to retain in-house (staff and/or process), the number and types/sizes of CROs to engage and even the types of trials to be outsourced (phase, TA, region).

“Companies had to ask themselves these questions in order to really make sure that they were behaving in a smart way with respect to these models,” Calaprice said.

“When they did go through that process of analysis and made the right decisions for their company—the decisions weren’t always the same—the model seemed to work really well for them,” she reported.

“It was interesting to see how certain contractual models—like risk-sharing—and metrics, CRO relationships and expectation manuals played such a significant and effective role,” Katz added.

In this episode of Inside Clinical—the Partnerships in Clinical Trials podcast interview series—Katz and Calaprice share findings from the study and discuss implications for sponsors and CROs.

Editor’s note: For more on this topic, Drs. Mitch Katz and Denise Calaprice will be speaking at the 24th Annual Partnerships in Clinical Trials Conference running April 22nd through the 24th in Boston.
For more information or to register, please visit www.clinicaltrialpartnerships.com
For more information about the study or The Avoca Group's customized research services, contact Danya.Burakoff@theavocagroup.com

ABOUT THE AUTHOR
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 publication for market researchers in the pharmaceutical industry. He may be reached at mdresner@iirusa.com. Follow him @mdrezz.




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