J&J exec prescribes adaptive approach to Alzheimer's drug development

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Drugmakers have misfired way more than hit their targets in developing new drugs for complex diseases such as Alzheimer's. Dr. Michael Krams, vice president and head of the neurology franchise at Johnson & Johnson ($JNJ), suggests that part of the problem lies in the way pharma companies have designed clinical trials, according to an article from Bio-IT World. As he has in past pharma stints at Pfizer ($PFE) and Wyeth, Krams endorses adaptive approaches to designing trials.

Adaptive clinical trials afford drugmakers flexibility not found in traditional drug studies. For instance, a drug trial could alter its original course to shut down one arm of the study in which a lack of efficacy is seen, or, conversely, expand an arm in which there's evidence that a drug is working. Computer modeling helps developers predict such turns in the course of studies and design them accordingly. Experts see this approach as a more efficient way to advance new therapies to patients, but change seldom comes quickly in the pharma world. And during his speech at an event in Bethesda, MD, last month, Krams gave some advice on how to move toward more adaptive trials.

As Bio-IT World reports, Krams suggests having a cooperatively developed blueprint for determining all support industry stakeholders need to adopt adaptive study designs, including university classes and workshops for pharma pros. He called for collaborations across therapeutic areas and companies to meet this challenge. To tackle the Alzheimer's problem, Krams has begun a dialogue with a key FDA official about adaptive approaches to studying new treatments against the common memory-stealing disease.

Traditional approaches to developing Alzheimer's drugs have proven disastrous. Johnson & Johnson and Pfizer's Phase III program for the Alzheimer's therapy bapineuzumab crashed and burned this year, and many experts had pointed out that patients already diagnosed with dementia were unlikely to respond to the drug and gave the program slim odds of success. This is only one of a long string of failures in the development of drugs against dementia in recent decades, leaving patients with few options to combat the disease.

Krams has big ideas for speeding the development of Alzheimer's therapies. But his solution involves early detection of the disease and large umbrella studies that test multiple drugs at the same time. The umbrella studies would further test only those treatments that seem to work. This adaptive approach is already catching on in cancer drug development, and neurological disorders such as Alzheimer's could be next.

Yet pharma pros are going to have to change their ways. "Billions of dollars are wasted because we don't talk enough," Krams said, as quoted by the magazine.

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