Complementing the perspectives offered by regulators from Canada, Japan and Chile at the CASSS Summer CMC Strategy Forum on bioconjugates and multispecifics (see IPQ’s August 1&8 and August 15&22 Weekly Supplements) were presentations by former FDA reviewers Marjorie Shapiro and Katherine Duncan, who drew on their extensive regulatory experience and learnings in discussing the CMC challenges that these products present and the pathway forward in addressing them.
Before retiring from the agency in March 2025, Shapiro headed the Laboratory of Molecular and Development Immunology at the Center for Drug Evaluation and Research’s Office of Biotechnology Products.
Duncan served as a CDER Office of Pharmaceutical Quality (OPQ) Senior Pharmaceutical Quality Assessor before joining GSK as CMC Policy and Advocacy Director in December 2024. (Editor’s Note: See IPQ’s October 2024 story on Duncan’s presentation on FDA’s CMC regulatory experiences with and expectations for peptides at the 2024 USP Peptide and Oligonucleotide Therapeutics Workshop.)
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