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Guest: Michael Ibara, Pfizer

Between A Rock And The FDA

April 22, 2010
LENGTH: 40:01

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



January 18, 2019

Guest: Michael Ibara, Pfizer

Between A Rock And The FDA

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. 

Guest: Roy Vagelos, Merck

Merck’s Finest Hour

Roy Vagelos may be retired, but he remains a legend all the same. The former Merck leader spoke at this year’s Clinical Trials Congress. 

Guest: Landen Bain, CDISC

Eclinical, Health Record Integration

In 2009, it is easier and more feasible to connect two vast data cosmos that have long existed separately. The electronic data capture (EDC) systems for clinical research are slowly being connected to larger, more general-purpose electronic health record (EHR) systems for physicians. 

Guest: Paul Clarkson, Genentech

Podcast: Making Smart Protocols

As a trustee of the Society for Clinical Data Management (SCDM), Paul Clarkson is the archetype of the data manager who understands the largest issues affecting clinical development. As director of data management at Genentech, he’s been thinking about how data managers can help their organizations develop better protocols. 

Guest: Anthony Costello

Clinical Data in 2017

The burden of day-to-day responsibilities does not always allow for appropriate reflection on the future. The Society for Clinical Data Management is trying to address that next month in its annual Leadership Forum. 

Guest: Carol Rozwell

The Case For Standards Now

Gartner’s Carol Rozwell is one of the industry’s leading authorities on technology adoption and clinical data standards. In this illuminating interview with ClinPage editor Mark Uehling, she discusses why some organizations hesitate to use CDISC standards and how some contract research organizations (CRO) have recently begun to see data standards differently. 


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