Wouldn’t it be great if all drugs worked for every person who took them? Some do perform their functions successfully in most people, but others work only for a subset of the population. But if that subset is easily identified by particular biochemical or genetic characteristics, that’s a drug that will be hugely successful within a defined group of people.

This effort to deliver what has been called personalized medicine involves bringing together a potential drug and a companion diagnostic test that can identify those most likely to benefit from the drug. Ron Mazumder, a product development leader at Janssen Pharmaceutica in Hopewell, explains that if data from a clinical trial suggests that a drug works best for, say, people who share the same mutation in their DNA, that information can be used to create a diagnostic test to identify people in the subpopulation. “It’s a way to match the right drug to the right patient,” he says.

Mazumder will be a speaker in the “Diagnostics and Personalized Medicine” webinar by BioNJ that will examine opportunities, barriers, and efforts to bridge the gap between diagnostics and therapeutics on Thursday, May 5, at noon. Other speakers are John Beeler, director of theranostics and business development at bioMerieux, and Steve Carchedi, chief marketing officer at GE Healthcare Medical Diagnostics. This webinar is free. For more information or to register, contact BioNJ at 609-890-3185 or visit www.BioNJ.org.

This new approach moves away from what has been more of a “one size fits all” model. The pharmaceutical industry has come to realize that, particularly in disease areas like oncology and neuroscience, patients are heterogeneous. “There are differences among patients, and response rates can be low in the general population,” says Mazumder. “But if you can target a drug to a particular subset, you can get significantly increased response rates and a very dramatic clinical benefit.”

Personalized medicine, he adds, is likely to lower costs to patients because it will exclude patients likely to have no or limited benefit from a drug — even if it may mean a slight increase in a drug’s price.

One insurance company, Medco, has been interested enough in personalized medicine to explore the potential for predicting whether specific patient populations will respond better to generics versus branded medicines.

Also falling under the general personalized medicine umbrella is the effort to develop targeted therapeutics for a specific mechanism, either a protein or a drug pathway. The goal is to develop therapeutics with higher efficacy and fewer side effects. Some of those targeted therapies will also benefit from diagnostics that can pair a targeted therapeutic with a specific patient population.

Creating partnerships between the diagnostics and pharmaceutical industries is already beginning to happen, with pharmaceutical development teams reaching out to diagnostic partners. They then work together to make sure that the launch of the diagnostic test and the launch of the drug are synchronized.

The data from trials will indicate whether there is a specific patient population that may benefit from the drug. Such a subpopulation, says Mazumder, will typically have a biomarker, an objective measure. Although a pharmaceutical company may discover this biomarker at different points in the development process, it is best for the companies to actually position that discovery in the middle stages of clinical development.

To do so, they have tasked teams with understanding the mechanism of action, be it genetic or protein based. These teams collect patient samples and do exploratory work on them to find shared genetic components or protein levels that might correlate with the success of a drug in a particular population. The next step is to develop a prototype of a diagnostic test, which is a fairly routine process, and make sure it is effective.

Because this area is so new, commercial sectors of pharmaceutical companies and potential buyers must be convinced of the approach’s value. Right now much still remains to be learned: How do you value the drug and diagnostic combination? How should it be priced? How do you show health economic benefits? How do you differentiate the drug-diagnostic combination from other drugs on the market that may or may not use a personal medicine approach?

#b#Changing the model#/b#. “Perhaps only a few pharma companies have really embraced an end-to-end coordinated diagnostic and pharma development paradigm. It is something that is gaining traction, but it is still early,” says Mazumder.

Personalized medicine is likely to affect a growing number of drugs in pipelines, but will not change the paradigm 100 percent. “Some drugs have a high enough benefit in large enough populations that personalized medicine doesn’t really make sense,” he says. “It makes sense in certain therapeutic areas that are likely to grow more as we understand more of the science.”

Mazumder grew up in Baltimore, where his father was a professor of chemistry at Morgan State University and his mother an administrator for state government.

After graduating from Johns Hopkins University in 1986 with a bachelor’s in natural sciences, Mazumder completed a doctorate in biochemistry at the University of Maryland. Two years ago he received an MBA from Lehigh University.

He started out at Gen-Probe, a diagnostics company in San Diego, then moved to AXYS Pharmaceuticals, a biotech in La Jolla. He then went to Motorola Life Sciences, a biotech in Illinois. In 2003 he joined Johnson & Johnson, leaving in 2008 for a two-year stay at Merck. He came back to Johnson & Johnson to take his current position as head of product development in a newly formed department to execute the company’s personalized medicine strategy.

Mazumder is optimistic about the potential success of personalized medicine. “Although we are seeing a lot of focus in the oncology therapeutic area, I think this is something that can affect drugs in a number of therapeutic areas, neurology, immunology, cardiovascular, and also infectious disease,” he says. “It has the potential to benefit all therapeutic areas.”

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