J&J's Stoffels: "Modeling Change in Personalized Medicine"

Personalized medicine represents a paradigm shift from the “blockbuster” model in drug development that focuses on understanding and crafting treatments for specific diseases, not specific patients.

It’s the aspiration that we can provide the right treatment for the right patient at the right time and the right dose.

The blockbuster model, in its day, was not without value. Gains of the last two decades in reducing deaths from diseases such as heart disease and cancer are testament to its power.

But recent advances in science, genomics technologies, biomarkers, and drug development provide an opportunity to take an approach that is more personalized to specific patients.

When I first entered the field of HIV drug development, being diagnosed with HIV meant a death sentence. Now HIV/AIDS is a manageable, albeit chronic, condition. Focused scientific research, innovative drug development, and extraordinary collaboration and commitment —among scientists, physicians, industry, patients, advocates, and regulators — changed the disease.

The combination of two factors accelerated drug development in the area. The first was the use of “viral load” as a surrogate biomarker – defined as a laboratory substitute for a clinically meaningful result - for HIV disease progression. The second was the sequencing of the HIV genome, which provided us the tools to understand HIV drug resistance.

J&J company Virco’s diagnostic expertise led to the development of a resistance diagnostic test to better predict how any patient’s virus will respond to any drug. And that information in turn helped Tibotec, another J&J company, develop new drugs to help outwit HIV.

Their combination approach meant that development was faster, approval was faster, and reimbursement happened more quickly.

That’s a model that’s good for pharmaceutical companies, good for regulators, good for payers and good for patients. And today’s information-empowered flat world makes for a ripe landscape for us to use this approach to continue developing more personalized treatments.

To bring personalized medicine forward, scientists, regulators, policy makers, and pharmaceutical company leadership will need to find ways to more successfully work together, adopt a new mindset, and take a networked approach to innovation—one in which we can successfully share pre-competitive information and common platforms such as biomarkers, genomic data, predictive toxicology, and serious adverse events information.

By working across companies, universities and research institutes, we can tap a wider range of expertise, capabilities and resources.

Together we can share in both the benefits and costs of innovation that will yield more useful technologies and solutions. These in turn will contribute to new advances in healthcare and the realization of individualized patient care.

Paul Stoffels, M.D., is Company Group Chairman, Global Research and Development, Pharmaceuticals, Johnson & Johnson, focused on leading global teams to discover and develop new and innovative treatments for unmet medical needs in the areas of CNS, pain, infectious disease, metabolism, cardiovascular, primary care and virology.