Drugmakers collaborate to facilitate drug tests

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Associated Press

Posted on November 15, 2012 at 10:00 AM

Updated Thursday, Nov 15 at 12:01 PM

TRENTON, N.J. (AP) — Johnson & Johnson and two other major drugmakers say they are collaborating in a global project aimed at getting patient tests of experimental drugs up and running more quickly and efficiently.

They are each contributing to a database of doctors, hospitals and clinics vetted to participate in the complex tests needed to determine whether an experimental medicine is effective and safe.

The effort could eventually mean new medicines will get approved and reach patients sooner.

Merck & Co., based in Whitehouse Station, N.J., and Indianapolis-based Eli Lilly and Co., will be the first partners in the venture with J&J, based in New Brunswick, N.J.

They're inviting other pharmaceutical and biotech companies to add their own information to their databank that J&J's Janssen Research & Development unit set up.

It's an unusual partnership in an industry where drugmakers compete vigorously for patients and billions of dollars in medicine sales — and a sign that companies are willing to work together more amid a tidal wave of generic competition to top-selling drugs that's wiping out billions of dollars in annual revenue.

"The current clinical trial environment is inefficient, costly and unsustainable," Dr. Andreas Koester, Janssen's head of clinical trial innovation and external alliances, said in a statement. "We are enthusiastic about working with other industry leaders to collectively apply our expertise, capabilities and shared passion for advancing science and improving lives."

The goal is to eliminate duplicative, time-wasting steps that increase drugmakers' costs and stretch out the time it takes to get a new medicine approved. Currently, that costs roughly $1 billion and takes about a decade, from laboratory and animal testing through usually three rounds of studies on increasing numbers of patients.

Every time a drugmaker wants to start patient testing, it must find dozens, sometimes hundreds, of doctors and university scientists to run the studies and recruit participants from among patients at their hospitals and clinics. Those conducting the tests must be trained on how to select appropriate patients and explain risks to them, keep detailed records and oversee nurses and others making sure each patient gets an experimental drug or a placebo as scheduled, along with follow-up tests for months or even years.

The database will give those working on experimental drugs a one-time approval process and drugmakers a big pool of ready, qualified scientists with known expertise.

Over the last decade or so, drugmakers have been teaming up more to develop new drugs, sharing the costs and risks along with the profits when a drug pans out.

The new collaboration builds on another partnership announced two months ago, called TransCelerate BioPharma, that includes 10 top U.S. and European drugmakers. They aim to reduce costs and speed up drug testing, and identified the new database as one way to do that.

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Linda A. Johnson can be followed at http://twitter.com/LindaJ_onPharma

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