Regulatory Concerns In mRNA Therapeutic Development
If you think many of the mRNA therapeutic development challenges you face are being seen for the first time, you’re not alone. Regulators are learning in lockstep, creating both opportunities and disadvantages for biopharmas developing a regulatory strategy for mRNA-based therapies. In this segment of the BioProcess Online Live event CMC, SCALE UP, & THE ROAD TO mRNA REGULATORY APPROVAL, panelists Akhilesh Bhambhani, Sr. Director, Biologics Drug Product Development at Ultragenyx Pharmaceuticals and Roberta Duncan, VP and mRNA Program Lead at Seqirus share early learnings on the regulatory path.
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