News|Videos|October 23, 2026

Rare Pediatric PRVs: Manufacturing Strategies for Expedited Approval, Part 2: CMC and Regulations

Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about the regulatory and manufacturing hurdles facing rare disease drug developers.

Elisabeth Gardiner, chief scientific officer at Tevard Biosciences, and Donny Xu, a policy analyst with the RTW Institute, talk with Nate Edwards of Arya Consulting about how chemistry, manufacturing, and controls (CMC) is the biggest late-stage risk in the development of treatments for rare diseases.

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