White Coats & Suit Jackets: A Coming-of-Age Story

Apr 01, 2011
By Pharmaceutical Executive Editors

Theoretically, the confluence of early-stage academic research with for-profit biotech and pharmaceutical product developers makes a lot of sense. Without a strict profit motive driving laboratory activities, academics and their respective institutions are free to experiment with compounds in a way that industry can't, to a certain degree.

Many of those experiments will not deliver immediate and actionable results from a product commercialization perspective, but it stands to reason that more freedom in the lab can lead to breakthrough treatments for patients. Like any relationship, however, academia and industry bring different perspectives to the table, and while improving the lives of patients is a common thread they share, the various steps and protocols needed to reach that goal can differ significantly.

Despite the occasional pratfall and miscommunication, mixing lab coats with pinstripe suits has led to innovative new therapies in the past, and with the National Institutes of Health's (NIH) freshly conceived National Center for Advancing Translational Sciences headed by director Francis Collins (see Pharm Exec's February cover story) the Obama Administration hopes to create new incentives for collaboration, at a time when industry is scaling back R&D budgets.

"There have always been partnerships between academia and industry, and many drugs have resulted from these arrangements. But now there's an imperative in the academy to nurture these partnerships. They have limited resources, rising costs, and less NIH money," says Kenneth I. Kaitin, Director of the Tufts Center for the Study of Drug Development in Boston. "At the same time, companies desperately need organizations to take over some of the very expensive early stage research. Academic institutions are perfect for that."

Unfortunately, imperatives and desperation are like cats in a bath: they rarely get along. Add in a hefty dose of culture clash, disparate expectations, and conflicting goals, and the odds of success look even dimmer—without, that is, some kind of framework for constructive engagement.

"There needs to be more discussion about synchronizing the reward systems for the two groups, and figuring out effective mechanisms for establishing partnerships. Very few people have really taken the time to critically evaluate what works—and what doesn't."

Here, then, are seven rules for researchers and industry to live by when considering getting hitched.

1. Organized Labor

Lack of organization in the form of missing documentation—from the proper treatment of lab animals to the collection of human data—can mean the difference between FDA approval and future profits and a rejected application
When it comes to tidiness, even husbands with the best intentions will almost certainly fail to meet the expectations of their spouses some of the time. Researchers hoping to work with industry can expect the same level of scrutiny, says Tom Marriott, vice president of regulatory and clinical research for Zars Pharma, in Salt Lake City. One of Marriott's main roles is to evaluate laboratories that apply to conduct trials for his company.

"The primary thing that I look for is whether the group or the school is well organized; that they recognize the importance of good documentation," Marriott says. A habit of keeping thorough notebooks of work is imperative. "One would prefer that they are writing brief summary reports for the various experiments that they are doing, especially those that lead to a conclusion that the work is valuable."

That fastidiousness isn't neurosis. Lack of organization in the form of missing documentation—from the proper treatment of lab animals to the collection of human data—can mean the difference between an FDA approval and future profits and a rejected application.

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