An Song

Provide expert advice to biotech companies and venture capital firms in several areas including IND and BLA filing strategy; biotherapeutic preclinical development and translational research; PKPD, biomarker and immunogenicity assessment in preclinical and clinical studies; therapeutic proposal evaluation; US-Asia cross-boarder healthcare investment and collaboration.

- Developed and executed company strategy as a member of the executive team and the R&D leader. - Built and led research, nonclinical and clinical scientific development functions including AAV vector discovery and characterization, product design and engineering, in vitro and in vivo pharmacology, toxicology, immunology, biomarker and bioanalytical development, with a total of ~30 FTEs. Hired and mentored talents, and managed budgets. - Point of contact for the Science & Technology Committee of the Board of Directors. - Core member of a company-wide multi-functional scientific review body; Chair of Early Development Leadership Forum. - Led and managed interactions with internal and external collaborators; sponsored government grant applications. - External presentations on behalf of the company; core member of 4DMT’s Scientific Communication Review Committee. Significant Accomplishments: ▪ Revitalized the Scientific Advisory Board by re-establishing its structure and membership, leading to successful setup and publication of new framework on company website, enhancing visibility and strategic direction. ▪ Established and mentored the biomarker & immunology team to support the entire portfolio, significantly enhancing research capabilities and operational efficiency across all projects. ▪ Revolutionized the AAV capsid discovery platform by AI/ML technology, shortening discovery cycle and increasing success rate.

- Developed and executed company strategy as a founding member of the executive team. - Built research, preclinical, and CMC functions (>10 FTE); Hired and mentored talents; led and managed interactions with academic collaborators. - Oversaw CMC activities outsourced at CDMOs; oversaw a group of consultants spanning spectrum of expertise (CMC, Quality, toxicology/pathology, PK/clinical pharmacology, biomarkers/CDx, etc.). - Represented the company in partnership and investor interactions and fundraising; led/co-led successful government and non-profit organization grant applications; presented at scientific conferences. - Project Team Leader of Immune-Onc’s lead program. Significant Accomplishments: ▪ Established high-performing R&D team from scratch in early-stage startup, leading to filing of 2 Investigational New Drug (IND) applications in oncology within 3 years.

- Led a department (~80 staff members) responsible for developing state-of-the-art methods for the assessment of pharmacokinetics, pharmacodynamics, immunogenicity, diagnostic biomarkers, and in vitro pharmacology activity of Genentech pipeline biotherapeutics from Early Development (ED) to post-marketing - Extensive drug development experience through leading multi-functional global teams and serving on various review committees - American Association of Pharmaceutical Scientists (AAPS) Biotechnology Executive Committee Member and Chair of the Therapeutic Product Immunogenicity Focus Group/Community - US Pharmacopeia Convention Immunogenicity Testing Expert Panel and reviewer for multiple scientific journals

- Led a global team accountable for nonclinical pharmacology, PK, toxicology, bioanalysis, immunogenicity, clinical pharmacology, and biomarkers for the Ocrevus multiple sclerosis program. - Core member of the Global Development Team, Life Cycle Team, and Global Filing and Response Teams: authored BLA/MAA filing dossier, interacted (F2F and TC) with global Health Authorities (FDA, EMA, Health Canada, etc.) for product labeling and approval