Ms. Segar has 14 years of experience in medical writing and consulting, specifically related to project management, orphan drug regulatory and nonclinical expertise. Her experience includes regulatory strategy and participating in FDA meetings and writing of numerous INDs/NDAs/BLAs, FDA meeting requests and briefing packages, orphan drug designations (US and EU), fast track designations, breakthrough therapy designations, and pediatric rare disease designations. Prior to joining DRA, Ms. Segar was an Associate Director of Regulatory Affairs at IQVIA and Cote Orphan, LLC, as well as a Senior Project Manager at Aclairo Pharmaceutical Development Group, LLC. She has a Masters’s Degree in Biotechnology with a concentration in Biodefence at Johns Hopkins University, a BA in Biology from Elon University and holds a Regulatory Affairs Certification.