Q andAQ: What information from the metrics program will FDA be likely to consider using and how will the pilot influence the FDA going forward with their metrics program?

A: (Russ Wesdyk, FDA) Keep in mind that the information that FDA collects is limited to information that an investigator would already be asking for, something you have to have anyway. We want to minimize the burden, keep the definitions as simple as possible, and keep the footprint as minimal as possible. We’re interested in getting the most “bang for the buck” without increasing the burden. With regard to question of which metrics the FDA might use, based on where we are that’s something I can’t speak to specifically.  Will the ISPE metrics program influence the FDA? Yes. Will it directly impact the FDA? No. ISPE is not the only stakeholder.

Q: How will the metrics pilot program benefit companies that were not involved in Wave l?

A: (Diane Hagerty, Genentech) First, you are here! That’s great! The report is going to be available to everyone, including regulators. Many things were learned in the case studies and what we learned will be considered in Wave ll.

Q: Given the estimate that it took an average of 90 hours for participants to collect data, will there be a report addressing the ranges of how long it took for companies to collect the data?

A: (Vanya Telpis, McKinsey) We will work to provide information on the ranges.

Q: Please comment on the report data that says “Total Complaints” were difficult to provide.

A: (Russ Wesdyk, FDA) We would be interested in hearing from companies on why they were difficult to provide.  I’d welcome any feedback on it.  Feedback from the floor suggested that while Total Complaints are routinely collected, they may not be collected for “all sites” for the company, but may have been in the past collected for specific sites, a simpler task. Asking for the metrics with a new, specific definition may have required a different process for collection for some companies.

Q:  (Rick Friedman, FDA) – Across the supply chain there is no standard platform for the exchange of data, and that is a challenge to a robust quality system. This issue of IT structure might be the “elephant” in the room.

A: (Diane Hagerty, Genentech) A point well taken. The issue of different platforms is getting the attention of senior management.  It’s not going to be easy moving forward, considering multinational companies, for example.

A: (Russ Wesdyk, FDA) I’d like to comment on data systems and where data resides.  An annual product review is a requirement. (Russ Wesdyk conducted an informal, on-the-spot survey and asked the audience to self- identify if their company did not do an annual review across all sites and found that only 30 percent (estimated) of the audience did do an APR across all sites.)  Everyone in your family takes drugs that you make, yet 60 percent do not aggregate an annual product review to understand at the corporate level what is happening with your product across the supply chain.  Think about that.