The eye’s anatomy is highly resistant to penetration of therapeutic agents, and successfully bypassing its protective barriers requires in-depth knowledge of ocular delivery, as well as specialized formulation and development expertise. In this guide, we will discuss how new and existing technologies can be employed to optimize ophthalmic formulations. We will then review the top considerations for an ocular drug delivery project to maximize the probability of success.
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.
The FDA’s Rare Disease Framework Initiative brings risk-based CMC review and pre-approval inspections into scope for sponsors, CDMOs, and quality teams.
Boyang Wang, Immortal Dragons, explains how FDA’s Expedited IND Pilot and research partners could speed serial steps to first-in-human trials compared to China’s 818 Decree.
This article examines how modern automation platforms create the digital foundation required for Pharma 4.0 by integrating manufacturing systems, centralized data management, Industrial Internet of Things connectivity, electronic batch production records, and AI-driven analytics.
