Industry Testing New Models for Developing Biomarkers

DNA microarray analysis depicts lymphoma cell gene expression patterns.

As personalized medicine occupies a growing role in the pharmaceutical pipeline, major companies are changing their research and development paradigms, according to the Tufts Center for the Study of Drug Development (CSDD).

“Early indications show that development of personalized medicines is commanding more resources,” said Christopher-Paul Milne, DVM, MPH, JD, associate director at the center in Boston, Massachusetts, and author of the November/December Tufts CSDD Impact Report last year.¹

The study, based on a survey of nearly 2 dozen companies, found that 50% of clinical trials now collect DNA from participants to help find biomarkers that correlate with a drug’s effectiveness or safety issues. Some 30% of the companies said they now require all compounds in development to have a biomarker.

Milne said significant scientific, regulatory, commercial, and practical challenges confront companies, resulting in a variety of approaches. Many drug developers are working with academic medical centers to better understand disease mechanisms and identify strata of target populations, and with diagnostics developers to augment in-house capabilities.

The study found that although biomarkers increasingly are used to better understand patient response, companies still cannot use biomarker data to support approval until regulators’ capacity to evaluate it catches up to the science.

The report also noted that personalized medicine might be making drug development more complicated. 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.

A lack of evidence linking diagnostic tests to health outcomes, however, has led US healthcare payers to be skeptical about the clinical usefulness of those tests and is hindering the growth of personalized medicines, according to the July/August Tufts CSDD Impact Report.²

Some payers are denying or restricting reimbursement for testing, with a minority of payers requiring documentation that a diagnostic test has been conducted prior to prescribing personalized drugs, even when the diagnostic is included on the label.

“Scientifically, the process of biomarker discovery and validation in general, and parallel development of drugs and companion diagnostics in particular, has been slow,” Joshua P. Cohen, PhD, senior research fellow at Tufts CSDD and author of the study, said in a press release.

References

1. Tufts Center for the Study of Drug Development. Personalized Medicine Is Playing a Growing Role in Development Pipelines. Boston, MA: Tufts University. 2010;12(6). Impact Report.
2. Tufts Center for the Study of Drug Development. Lack of Clinically Useful Diagnostics Hinder Growth in Personalized Medicines. Boston, MA: Tufts University. 2011;13(4). Impact Report.