The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of topics including formulation platforms, AI, amorphous solid dispersions, and animal studies.
News|Videos|October 15, 2026
Rare Pediatric PRVs: Manufacturing Strategies for Expedited Approval, Part 1
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.
This webinar, “Rare Pediatric PRVs: Manufacturing Strategies for Expedited Approval,” is moderated by Nate Edwards, engagement manager with ARYA Consulting Partners, with guests Elisabeth Gardiner, CSO, Tevard Biosciences; and Donny Xu, a policy analyst at the RTW Institute. In part 1, the guests explain the history of the Rare Pediatric Disease Priority Review Voucher (PRV) Program and the benefits and challenges of going through the PRV process.
Related to this article
This week on PharmTech.com, experts discussed E&L suitability standards, rare disease treatment development, sourcing ingredient suppliers, the use of AI in quality control, and more.
Mitigating nitrosamine risk requires assessing each product individually and chasing zero nitrite in pharmaceutical excipients is often impractical and costly.
Continuous overall equipment effectiveness can be used to pinpoint hidden downtime and process bottlenecks in real time.
The agreement between CDER and OII with allow for coordinated marketing application assessments and inspections.
Aleksandra Zuraw, senior veterinary pathologist at Charles River, discusses how chain of custody, good laboratory practice, quality control, and validation are applied to digital pathology data used in drug development.
Vibha Jawa, PhD, chief scientific officer at EpiVax, explains why the need for animal studies varies by modality and what it takes for organ-on-chip and other human-relevant models to replace these studies in IND-enabling toxicology work.
Sanjay Konagurthu, PhD, senior director of Science and Innovation at Thermo Fisher Scientific, explains what teams need to do to ensure the usefulness of AI and what strides have been made with AI in regulatory submissions.