Kelly Austin

PhD, PPM and her team are regulatory strategists specializing in Orphan Drug Designations (ODD) and Pediatric Rare Disease Vouchers (PRD)

After 4 years of interacting full-time with the FDA Office of Orphan Products Development, I know what they’re looking for. I look at this from a different point of view than a clinical expert. I can tell you exactly what the agency wants.

I specialize in navigating regulatory affairs pathways to achieve FDA Orphan Drug Designation (ODD), European Medicines Agency (EMA) ODD, as well as Fast Track, Breakthrough, and RMAT. Offering feasibility studies and strategic reviews, my focus is on guiding start-ups with therapies in pre-clinical or clinical development to capture designations and enhance their attractiveness to investors. I facilitate meetings with the FDA, prepare briefing packages, and provide the same high-quality submissions for start-ups that larger consulting firms do, at an affordable rate.

  • 300+ FDA and EMA Submissions
  • 200+ FDA Orphan Drug Submissions
  • 30+ Fast Track, Breakthrough, RMAT
  • 25+ FDA and EMA meetings
  • 20+ FDA Pediatric Rare Disease Submissions
  • 15+ EMA Orphan Drug Submissions

I’m happy to confer with you regarding your data, and the indication you’re looking to gain designation for. I can usually tell you within a free one hour scoping call whether or not you are likely to receive ODD with your current data, and what is the best strategy to achieve your goals.

Kelly Austin

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