Loksidh "Chaaya" Ganorkar, MBA, PhD - Senior Director, Regulatory & Scientific Affairs.
Chaaya comes to CTI with a strong background in regulatory affairs. Prior to joining the CTI team, Chaaya worked at Seqirus (formerly Novartis) where she held the role of Head of Regulatory CMC & Compliance. In this role she acted as an FDA agent for all products including leading discussions and negotiations with the FDA along with overseeing the development and execution of global regulatory CMC strategy for the division's vaccine products. Chaaya's background also includes experience in various roles at Merck, including Associate Director, Biologics Regulatory CMC where she was responsible for driving global regulatory strategy and direct interaction with the FDA in CMC biologic issues for investigational and marketed biologics and biosimilars.
Chaaya earned her PhD in pharmaceutics and pharm/chemistry from the University of Utah, a Masters of Business Administration from Western Michigan University, and her Bachelors of Pharmacy from the University of Indore.
Carie Masoner - Director, Regulatory & Scientific Affairs
Carie comes to CTI with an abundance of experience in both clinical trial management and regulatory affairs. Carie began her career with Medpace as a Clinical Research Associate and Clinical Trials Manager before moving to Xanodyne Pharmaceuticals where she held progressive roles of Senior Clinical Trial Manager, Regulatory Affairs Manager, and Associate Director of Regulatory Affairs. She has worked in the Regulatory Affairs space with CSC Strategic Regulatory Services, Virtual Regulatory Solutions, Cardinal Health, and most recently at Firma Clinical Research where she held the role of Senior Director, Regulatory Affairs and Medical Writing.
Throughout her career Carie has gained strong experience in the development of regulatory documents and applications including INDs, NDAs, MAAs, Orphan Drug Designation Requests, and Pediatric Study Plans across a variety of therapeutic areas. She routinely acts as the U.S. Agent and primary point of contact on behalf of clients with the FDA and has participated in Pre-IND, Pre-NDA, End of Phase 2, and Type C meetings for various drug candidates.
Carie earned a Bachelor of Science degree in Human and Consumer Sciences at Ohio University