VP Pediatric Development Americas
Lynne is responsible for providing professional leadership to the organization to ensure compliance with all applicable Food and Drug Administration (FDA), European Medicines Agency (EMA) and International Conference on Harmonization (ICH) regulations from a pediatric perspective, as well as the creation and execution of preclinical, clinical and regulatory strategies to support the pediatric product pipeline of our clients. Lynne is an innovative, results-oriented, entrepreneurial-spirited biopharmaceutical executive with 28 years of experience in clinical operations/development, regulatory affairs, project management, and quality assurance with extensive R&D experience with both small molecules and protein therapeutics from IND to NDA/BLA, and has developed/contributed to the pediatric strategy for over 30 Pediatric Investigation Plans (PIPs)/initial Pediatric Study Plans (iPSPs), across multiple therapeutic areas.. Prior to the integration with Synteract, Lynne was a strong contributor to the leadership and team building of KinderPharm as Sr. VP of Clinical Development and Regulatory Affairs. She managed the Clinical and Regulatory departments of KinderPharm as well as cross-functional groups, both internally and externally to meet aggressive development timelines. Lynne has held positions of increasing responsibility during her career in both clinical development and regulatory affairs, most recently as Sr. VP Clinical Development at PhaseBio Pharmaceuticals, and VP Clinical Operations and Regulatory Affairs at TetraLogic Pharmaceuticals. Lynne received a Master of Science in Health Sciences (MSHS) in Regulatory Affairs from The George Washington University and is regulatory affairs certified through the Regulatory Affairs Professional Society. Lynne has published on pediatric development both through the Regulatory Affairs Professional Society as well as TOPRA, the organization for regulatory professionals in Europe.
Monday, September 23
1:00 PM – 1:55 PM