Executive Vice President
Pharmatech Associates
Berkeley, California
My career has afforded me opportunities to participate in the amazing decades of rapid growth and evolution of biological therapeutics. I started in R&D and quickly moved to pre-clinical drug development. I then expanded to QC for biologics. In my 20 yrs of experiences in US biotech and global biopharmaceuticals, I held positions of increasing responsibilities as heads of bio-analytical assays, QA, global QC and tech transfer, annual product quality review, CMC quality leader, and head of quality. Through it all, I remained a thought leader and advocate for new concepts and practices that allow the differentiating features of biologics products to be implemented in modernizing PQS, phase-appropriate GMP, QbD and control strategy, post-commercial process and product quality monitoring etc. When personal life took me to China 10 years ago, I founded the first biologics-only CMC consulting company in Asia, which later expanded to biologics QC testing with a strategic alliance with Charles River Laboratories; together, we trail-blazed the global standard biologics safety testing sub-sector in the region. After enabling numerous highly visible “China-first for global” product launches and out-licensing deals to the west, I am continuing to bring my passion, and global experience to global biologics industry.
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Monday, October 21, 2024
7:30 AM – 9:00 AM MT