The Day of Precision Medicine is Dawning, FDA Official Tells the SOP

Future pharmacies will offer patients more testing kits for gene-related disease risks and counseling for personalized prescriptions

By Steve Berberich
March 10, 2009

The pharmaceutical industry and regulators are each adjusting well to the dawning of personalized medicine, said Lawrence Lesko, PhD, FCP, director of clinical pharmacology and biotherapeutics, U.S. Food and Drug Administration (FDA), recently at the University of Maryland School of Pharmacy.

By 2019, a typical pharmacy, he said, will display extensive racks of self-testing kits for the risks of gene-associated diseases and a counseling center along side the prescription counter, where the pharmacist will help patients manage drugs designed for their personal genetic makeup.

Such changes will be the inevitable fruits of personalized medicine now taking root, Lesko said, adding that “precision medicine” may have been a better popular name for personalized medicine.

Lesko delivered the annual Andrew G. DuMez Memorial Lecture in honor of the former and pioneering dean of the School, who served the University from 1926-1948, and was a recipient of the highest national pharmacy award, the Remington Medal.

Lesko “is one of the leading thinkers in the area of pharmacology,” says Natalie D. Eddington, PhD, the current dean of the School.

“For precision medicine, the disease must be diagnosed to the gene,” said Lesko, who emphasized that vast amounts of data generated by human genome research in recent years creates an opportunity for drug makers to better target medicines to smaller populations of patients.

But at the same time, the challenge for drug makers is like turning a large field of long-range radar antennae inward into the body, he said. “Who is going to interpret the data? Who will explain that information to the patients? Pharmacists are the logical answer. Precision medicine will need a professional, non-physician go between.”

Except for lacking a strong business economy for personalized medicine right now, the leading factor holding it back is lack of education, he said.

“We have a public health crisis in this country. Drugs are intended to treat symptoms not diseases.” Instead, “new [personalized] drugs will now be developed by pathways, by going after the biochemical actions set off by genes. Cancer gets it,” added Lesko, referring to new drug discovery and development trends in cancer research that work to find genetic keys for fighting different kinds of cancers.

To ease the pharmaceutical industry into personalized medicine, “centers of pharmacy practice in precision medicine will evolve just like the pharmacy industry has done for all such major changes,” he said.

From the government’s standpoint, Lesko said, “It didn’t take a lot of pushing to get the pharmaceutical industry interested in personalized medicine. New drugs cost drug makers more than an average of $1 billion to market.”

Lesko said pharmacists will not likely be very challenged by the emergence of personalized medicine. But they must first overcome three limiting factors: time constraints of current pharmacy practices; the cost of continuing education; and the evaluation of current interest in taking personalized medicine forward.

For the drug makers, “We need to integrate genomic biomarkers into all phases of drug development,” he said. And for the FDA, “First, we need to set up public–private partnerships to qualify predictive biomarkers” in human cells for disease-fighting drugs.”

Lesko said a current example of a gene-specific drug is Warfarin. The effectiveness of the widely prescribed anticoagulant is variable depending on whether patients have a couple of key genes. The FDA has labeled at least 10 precision medical drugs so far that can be considered personalized medicines, he said.

The FDA has advanced three ideas for the emergence of personalized medicine, said Lesko. It created a “safe harbor” for industry to submit exploratory genomic data. It has a genomic consulting service. And the agency has a center to re-label previously approved drugs with new pharmacological information.