BioWorld International Correspondent

CHICAGO - The U.S. secretary of health and human services, Michael Leavitt, pledged to devote his last 1,000 days in office to delivering the vision of personalized medicine by working with the FDA and National Institutes of Health, among others, to reform drug discovery, development and regulation.

The change required to achieve the vision will be disruptive, Leavitt told delegates.

"Our regulatory structure is not yet prepared to deal with it. We have to re-engineer the regulatory processes to enable [personalized medicine], and we are going to," he said.

The "signal point" - showing medicine has been transformed from an intuitive art to a science of personalized medicine - will be reached when health care becomes predictive.

Leavitt presented a vision in which future customized treatments will be based on medical history, genetic variability and patient preferences.

"We are entering an era of patient-centered care," he said. That will see new technologies adopted at a faster pace, introduced by coalitions of companies working together to spread risk and underpinned by a 21st century regulatory system.

Leavitt proposed that in the future the true roots of diseases would be uncovered by running an individual's genetic profile against a "voluntary national genetic profile database."

In cases where healthy people were worried due to family history, the profiling might show the genetic cause for family illnesses.

Leavitt said that pre-emptive diagnosis "would be the focus of prevention."

Currently, there are diseases that affect so few that they have not attracted the attention of the pharmaceutical industry.

"Today very few have the financial capacity to survive clinical trials. Simple economics means a handful of pharmaceutical companies focus on blockbusters," said Leavitt, adding that, "the current system is frustratingly slow."

In contrast, bioentrepreneurs of the future will have access to information from health data firms "offering real-time data for 35 million people who have volunteered to be there." In a matter of days, it would be possible to identify diseases targets and download pre-competitive compounds that are known to work on the target. With more efficient preclinical testing, there would be lower attrition rates and drugs would get to the clinic faster.

Then, Leavitt promised, the days of the slow empirical trials that rarely give the right answer would be over. "Painstaking plodding will be transformed into a six-month sprint," based on the increased availability of information. That will include predicative toxicology, real-time feedback and monitoring any adverse effect.

Leavitt said the main barrier to achieving that vision is concern about data privacy. "There's serious sociology here," he said. "It will not be the technology or the science that limits us, it will be the sociology."

However, he said, the agenda for achieving personalized medicine is in place.

The FDA's Critical Path initiative to improve the regulatory process, and the NIH's Roadmap for updating drug discovery training staff with interdisciplinary skills and reengineering clinical trials procedures are two key components, integrating health information technology is another.

"All three elements have one thing in common: They require large-scale collaboration and a networked approach," he said. "I will use my department [of Health and Human Services] to serve as the rallying point."

He has set up a team to work on the project.

Leavitt concluded, "For the next 1,000 days, it will be my focus. Every day I will wake up thinking about patient-centered medicine."