OpenAI acquired Orchestra Bio to pair AI agents that track drug development timelines with its Rosalind life sciences tools, raising oversight questions for pharma teams.
News|Videos|October 22, 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, CSO, 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. Donny notes that several companies have received complete response letters from the FDA because of unmet CMC requirements rather than weak safety or efficacy data. Gardiner explains that processes validated for small early trials often scale poorly. Supply chain disruptions and manufacturing partners going out of business add to the risk, and smaller companies with tight margins have little money to plan for these problems early.
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Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about rare disease treatment development and navigating the FDA’s Rare Pediatric Disease Priority Review Voucher Program.
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