Sailaja Pullela

Associate Director, Clinical Trial Transparency & Disclosure at Moderna

Speaker

Sailaja is the Associate Director of Clinical Trial Transparency and Disclosures at Moderna. She is responsible for registry and results disclosure, redaction operations, plain language summaries and data sharing. She is also the lead in the implementation of the EU CTR at company level, a role that required her to identify business needs to ensure operational readiness which involved establishing the governance of regulatory and cross-functional procedures for preparing submissions to CTIS. She is responsible for ensuring compliance with regulations such as Health Canada PRCI, EMA Policy 0070. She also leads plain language summary deliverables as well as other initiatives focused on incorporating Health Literacy principles and best practices into patient and public communications. Sailaja has 22+ years of experience both is academic and industry with cross functional experience in clinical research, pharmacovigilance, regulatory, project management and passionate about specializing in applications for life sciences with a focus on clinical trial transparency and disclosure.