Michael Ibara, head of pharmacovigilance information management at Pfizer, discusses the intricacies of how to manage drug safety data in an increasingly electronic age. But the context of his remarks is much larger, and involves how both industry and government may be able to convince the public that all reasonable measures are being made to keep medicines as safe as possible.

To manage adverse event reports and make scientific decisions as quickly as possible, Ibara believes that a new organization with an intermediary role will be necessary. He believes that electronic health record systems could help the industry learn about problems early—and let regulators have better data about the severity and extent of any issues. Over time, that could avoid some litigation and damaging news coverage.

Ibara is not a political theorist or an attorney. He’s just trying to solve a problem. In our 15-page transcript, Ibara makes the usual disclaimers that some of his statements are his own personal views, not those of his employer. But he still thinks that with the right participants, a public-private organization could handle large quantities of electronic data and make better decisions about that information.

One of the most interesting aspects of the Aster project is the fact that few of the physicians had ever sent any AE data to the FDA when the project began. But after it had been under way, their participation typically rose to 5 reports over a three-month interval. How Ibara and his collaborators at Harvard accomplished that is addressed in the podcast. Ibara will be speaking at the Post Approval Summit later this month.

Podcast Topics

Safety Data Tsunami

Designing the Interface

Why The Status Quo Doesn’t Work

Improving the Signal-to-Noise ratio in drug safety

Time Savings for Physicians

FDA Participation

Safety Standards: ICH and HL7

European Experiences