Ms. Segar has 20+ years of experience in regulatory strategy and project management and guiding clients through all stages of development, including early stage development through to post-marketing. Her experience includes strategic preparation and participation in FDA meetings (pre-IND, End of Phase, Pre-NDA/BLA, and Type C/D meetings), as well as writing and managing 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 Master’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.