The pursuit of personalized medicine and companion diagnostics by pharmaceutical companies is of critical importance to lab professionals. Personalized medicine consists of selecting the right drug for the right patient at the right time. The idea goes hand-in-glove with companion diagnostics, which involves the use of a lab tests, usually molecular biomarkers, to choose those patients who will receive a particular drug. Roche, in my opinion, is developing a business model based, in large measure, on companion diagnostics (see: The UnitedHealthcare Business Model; Comparison with Roche and Siemens). Companion lab tests are now often developed early in the development phase of new drugs and may even be used to select research subjects for the clinical trials relating to that drug. I have previously had the impression that these terms were being bandied around by some drug companies mainly for marketing purposes but were not being taken seriously. A recent blog note provides evidence that the pharmaceutical companies are now adopting these ideas with more rigor (see: Drug Companies Pursue Personalized Medicine Approach). Below is an excerpt from the note

Personalized medicine...has long been considered an ideal. But it is also a threat to some pharmaceutical companies wedded to the idea of blockbuster drugs that could be taken by potentially all patients with a given disease. But pharmaceutical companies are now actively pursuing personalized medicine, according to a new report from the Tufts Center for the Study of Drug Development at Tufts University....[A Tufts spokesperson] said from 12 to 50 percent of the drugs companies are developing, depending on the company, involved a personalized medicine approach....Personalized medicine often involves developing genetic or other tests that can be used to determine which patients are most likely to benefit from a drug or which are most likely to suffer serious side effects. Relatively few drugs are now accompanied by such so-called companion diagnostic tests. They are most common in oncology. The breast cancer drug Herceptin, for instance, is given only to women whose tumors have an abundance of a protein called Her2. That is not likely to change immediately. The Tufts study says only 10 percent of the drugs now being tested in late-stage clinical trials have a companion diagnostic. But that should change with drugs that are not as far along in development. The survey found that 50 percent of trials now collect DNA from participants to help find “biomarkers’’ that correlate with a drug’s effectiveness or safety issues. Some 30 percent of the companies said they now require all compounds in development to have a biomarker....And while some companies are interested in using biomarkers to help understand how a drug is working in the body, they are less enthusiastic about the establishment of required tests before a drug can be used.

An interesting question here is why a pharmaceutical company would not actively embrace personalized medicine and companion diagnostics. It seems like such a good idea even to the casual observer. A clue is provided in the last sentence above -- some companies "are less enthusiastic about the establishment of required tests before a drug can be used." Drug companies earn their profits by selling drugs. If sales of a particular product are huge, the product is call is blockbuster. It's a well known fact that some patients don't take the drugs that are prescribed for them because the side effects are not tolerable. Also, that a large proportion of the chemotherapeutic agents administered to patients have little or no therapeutic effect on the tumor. Any lab test that can be used a priori to determine whether or not to prescribe a drug will reduce the sales of that drug by rejecting some potential recipients. Hence the lukewarm response by some drug companies to personalized medicine. It appears that some of these companies are now embracing the inevitable and changing their approach to drug development and patient selection.

Drug Companies Pursue Personalized Medicine Approach

By ANDREW POLLACK

Personalized medicine – often described as providing the right drug to the right patient at the right time – has long been considered an ideal. But it is also a threat to some pharmaceutical companies wedded to the idea of blockbuster drugs that could be taken by potentially all patients with a given disease.

But pharmaceutical companies are now actively pursuing personalized medicine, according to a new report from the Tufts Center for the Study of Drug Development at Tufts University.

“They are really going at this whole hog,’’ said Christopher-Paul Milne, associate director at the Tufts Center, which receives some funding from the pharmaceutical industry. “They are basically transitioning the way they do development into a personalized medicine approach.’’

Mr. Milne said from 12 to 50 percent of the drugs companies are developing, depending on the company, involved a personalized medicine approach.

The Tufts report is based on a survey of 25 companies, large and small, to which 16 companies responded, as well as interviews with representatives of 13 companies.

Personalized medicine often involves developing genetic or other tests that can be used to determine which patients are most likely to benefit from a drug or which are most likely to suffer serious side effects.

Relatively few drugs are now accompanied by such so-called companion diagnostic tests. They are most common in oncology. The breast cancer drug Herceptin, for instance, is given only to women whose tumors have an abundance of a protein called Her2.

That is not likely to change immediately. The Tufts study says only 10 percent of the drugs now being tested in late-stage clinical trials have a companion diagnostic.

But that should change with drugs that are not as far along in development. The survey found that 50 percent of trials now collect DNA from participants to help find “biomarkers’’ that correlate with a drug’s effectiveness or safety issues. Some 30 percent of the companies said they now require all compounds in development to have a biomarker.

The report notes that personalized medicine might be making drug development more complicated, not less. And while some companies are interested in using biomarkers to help understand how a drug is working in the body, they are less enthusiastic about the establishment of required tests before a drug can be used.

Still, growing cost pressures on health care could make it inevitable that drugs will be used only for the patients most likely to benefit from them.

“I think they are at the point where they don’t have much choice,’’ Mr. Milne said of the drug companies. “I think that’s why we are seeing them make the transition.’’

Correction: Mr. Milne is presenting the results Thursday at a personalized medicine conference at Harvard Medical School. The report is also posted on the university’s Web site.