Jiyoon Lee

1. mRNA Japanese Encephalitis Vaccine Project (CEPI Funding)

• Review and draft clinical trial documents for Phase 1/2 study in Australia (Protocol, Investigator's Brochure, and Case Report Forms..etc,).
• Provided response to HREC queries and liaise with the principle investigators, ensuring smooth regulatory communication.
• Contributed to the creation of the Clinical Development Plan (CDP) for the project.

2. Pan-Sarbeco Virus Vaccine Project (CEPI Funding)

• Supported the preparation of a briefing document for the FDA pre-IND meeting
• Developed the Phase 1/2 clinical trial protocol and continuously monitor development trends
• Coordinated clinical working group meetings with CEPI, facilitating strategic collaboration and project advancement

3. Inactivated Hepatitis A Virus Vaccine Project

• Led IND submission for Phase 1/2 trials and managed communications with the Ministry of Food and Drug Safety (MFDS), driving regulatory approval.

4. Live-attenuated Zoster Vaccine Project

• Provided clinical support for Managing marketing authorization submissions and maintenance for multinational NRAs (e.g., clinical responses, bridging study waiver request, documenting company core data sheet)

5. New Vaccine Pipeline Feasibility Study

• Conducted in-depth clinical review and setup for new pipeline projects, providing strategic due diligence assessments.
• Evaluated clinical viability and regulatory landscape to support the introduction of new vaccines into development.

1. COVID-19 vaccine Project

• Led the submission of conditional marketing authorizations to MHRA, EMA, and WHO, directly drafting and meticulously reviewing CTD modules M1–3
• Authored comprehensive responses to list of questions during the regulatory approval process, ensuring adherence to global standards
• Prepared briefing documents for consultations with global NRAs and streamlined strategic regulatory communications
• Managed global CRO partnerships for European regulatory submissions, overseeing contracting, budgeting, and coordination.

2. Rotavirus Vaccine Project

• Developed robust WHO justifications for and export authorizations communicated with MFDS, supporting strategic project development.
• Delivered critical regulatory insights on CMC issues for phase III clinical trial materials and commercial production, enhancing change management processes

3. New Vaccine Development Project Support

• Crafted innovative regulatory strategies and composed successful proposals to secure CEPI funding.
• Led regulatory guideline trend analysis and facilitated CRO/CEPI meetings, driving forward new project initiatives.