John Orloff is VP of development at Novartis. Like other keynote speakers at the recent Clinical Trials Congress, he’s not inclined to coat the industry’s predicament in sugar. “R&D expenditures are soaring at a time when new medical entity approvals are stagnating,” he said. “This is a paradigm that is not sustainable over the long term. We really need to do something to address this.”

In the case of Novartis, that turns out to be the Delphi project. It’s a ten-year road map. Orloff shared some of the big concepts at the conference.

He referred the audience to the FDA Critical Path opportunity list, and stressed the importance of the initiative as a public health question with many stakeholders. “It’s encouraging – the number of projects that have been launched,” Orloff says.

Explore & Confirm

It sounds like Novartis is working with companies assisting the Critical Path project, including BG Medicine, the C-Path Institute, Pharsight and Conformia, which has an FDA cooperative research and development agreement (CRADA) to understand the processes of drug development. “These technologies have the potential to transform the paradigm in R&D,” said Orloff.

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In the future, Orloff predicted, the drug delivery process may still be partitioned into four phases, but there will be just two overarching stages: one that is exploratory, another that is confirmatory. And once that transition has been completed, he speculates, late-phase trials may need fewer resources. It may be necessary to shift resources to earlier-phase trials to meet some new, as yet unspecified threshold for drug safety.

The issue of modeling and simulation is something that we’d previously discussed with Orloff before, and it was a theme he emphasized in Las Vegas. Using a variety of types of computer models (biological, physiological, statistical) of pathways and entire disease states is done across all therapeutic areas at Novartis.

Building Models

The company is deeply into trying to predict, in silico, if a drug is going to be safe and effective. But Orloff thinks even more can be accomplished with modeling. “Modeling and simulation will be systemtically integrated through the development process, from research to marketing and pricing,” he said.

There’s no escaping the notion that regulatory authorities (or even legislators) will have to explicitly endorse some of what Orloff was talking about. And part of that endorsement, Orloff suggested, may be forthcoming because of greater transparency. That transparency, in turn, is a function of technology. “We envision a much more transparent approach to regulatory agencies, with data available in real time and managed electronically,” he said.