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Clinical Data Disclosure, Transparency and Plain Language Summaries
February 25-26, 2025
The Bellevue Hotel, Philadelphia, PAHybrid Event I Attend Live In-Person or Online

Sailaja Pullela
Director, Clinical Trial Transparency at Moderna
Speaker

Profile

Sailaja is the Director & Head of Clinical Trial Transparency and Disclosures at Moderna, where she leads efforts in registry and results disclosure, redaction operations, plain language summaries, and data sharing. She spearheads the implementation of the EU Clinical Trials Regulation (EU CTR) at the company level, ensuring operational readiness by establishing governance frameworks and regulatory procedures for CTIS submissions. Sailaja ensures compliance with global regulations, including Health Canada PRCI and EMA Policy 0070, while championing plain language summaries and initiatives rooted in Health Literacy principles to enhance patient and public communications.

With over 24 years of experience spanning academia and industry, Sailaja possesses cross-functional expertise in clinical research, pharmacovigilance, regulatory processes, project management, and clinical trial transparency. She is deeply passionate about driving innovations in life sciences, with a focus on improving clinical trial disclosure and fostering trust through transparency.

Agenda Sessions

  • Examination of risk-based clinical document anonymization techniques and related processes to support PRCI and Policy 0070 submissions across a subsection of commercial sponsors and practical use cases.

    1:30pm