International Panel of Regulators Spotlights Current Biotech CMC Regulatory Problems and Convergence Pathways

The limitations, constraints and disconnects in the current CMC regulatory processes around the world are emerging into high relief as the biopharmaceutical community wrestles with how to get new medicines that fill critical healthcare gaps more rapidly to patients and how to facilitate manufacturing adjustments that better assure the quality of marketed products.

The opening plenary session of the CASSS/FDA Well-Characterized Biotechnology Products (WCBP) Symposium in late January in Washington, D.C. brought together a panel of regulators from various agencies to review the regulatory obstacles that need to be addressed to achieve these public health goals, including the lack of international harmonization.

On the panel were: ● CDER Director Janet Woodcock ● ANVISA Research and Clinical Trial Manager Laura Gomes Castanheira ● EMA Quality of Biological Medicines Head Veronika Jekerle ● CBER Director Karen Midthun ● Health Canada Senior Regulatory Scientist Anthony Ridgway, and ● Japan Pharmaceuticals and Medical Devices Agency (PMDA) Division of Biological Chemistry and Biologicals Head Teruhide Yamaguchi.  Genentech CMC Regulatory Director Kathleen Francissen served as the moderator for the session and was instrumental in guiding the discussions.

The panel’s focus encompassed the emerging expedited clearance strategies, such as FDA’s “breakthrough therapy” pathway, and the challenges they pose to the traditional CMC development and regulatory paradigm.

Also in focus was global regulatory convergence, and the need for furthering the alliances and collaborations among regulatory agencies – particularly in addressing the growing complexity and globalization of biologics and the availability and integrity of their supply worldwide.

Woodcock, who played a central role in the dialogue at the session, repeated her clarion call for evolving the quality regulatory paradigm to better accommodate process improvements and patient needs, and to do so in a larger global context (IPQ June 25, 2013).

“I think it is important to match the resources to the problem,” she stressed. “It is important that we understand the need of the public, the people who are dying of these diseases, for speedy action on the part of the agency.”  If trading off some CMC regulatory control up-front is needed, “so be it,” she said.  “I think this is the right thing to do.”

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