Review/Inspection Control Strategy Communications Key in Advancing Biotech Regulation, FDA Biotech Official Stresses

Biotech product and process knowledge has created the foundation for regulatory changes, but close communication and coordination between manufacturers and regulatory agencies will be necessary to realize those changes while ensuring and advancing product quality, FDA Center for Drug Evaluation and Research (CDER) Office of Biotechnology Products (OBP) Review Chief Sarah Kennett emphasized at the 2016 CASSS CMC Strategy Forum Europe.

Kennett took the opportunity in her presentation at the opening international regulator panel session of the Paris forum in May to offer a nuanced view of the regulatory opportunities, on the one side, and the challenges that have to be addressed in realizing them, on the other.

“I think we are in a time period now where we really have a potential to see a lot of change,” she affirmed – “thanks in part to a lot of the advancements that have been made by industry over the last few years. At the same time, I think that we have to have some good communications and coordination between manufacturers and the regulatory agencies to get some of these changes implemented.”

This central theme of Kennett’s talk reverberated also through the presentations at the opening plenary session by Ireland Health Products Regulatory Authority (HPRA) Pharmaceutical Assessor Sean Barry (IPQ September 28, 2016), and Japan Pharmaceuticals and Medical Devices Agency (PMDA) Office of Cellular and Tissue-based Products Principal Reviewer Yasuhiro Kishioka.

The three presenters addressed a similar range of front-burner CMC issues for biotech products, including problems in recent applications, their respective agency’s accelerated development programs, and the shifting approaches and expectations for lifecycle management.

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