Dr. Li is the Founder of BLA Regulatory and an expert of Clinical and Regulatory Affairs. Dr. Li has been working in the Biopharmaceutical industry for more than 15 years such as in AstraZeneca, MedImmune, AZ BioVenture, Ascentage Pharma, and SNBL. Dr. Li contributed significantly as the Regulatory Lead to the development of FASENRA (Benralizumab, an anti-IL5R antibody for Asthma) from Ph-2 to Worldwide Marketing applications and approvals including US, EU, Switzerland, Canada, Australia, Japan, and Brazil.

Dr. Li obtained his PhD degree in Molecular Medicine from Kyoto University, School of Medicine, Japan. Dr. Li did medical residency in surgical departments followed by clinical research training for his master’s degree in China-Japan Friendship Hospital and Peking Union Medical College in Beijing, China. Dr. Li studied/contributed to clinical studies of Adoptive Immunotherapy using T lymphocytes and Dendritic cells for treatment of Breast cancer and Melanoma patients. Dr. Li also conducted cytokine signal transduction researches as a post-doctoral fellow in the US. Dr. Li obtained his Regulatory Affairs Certificate (RAC) from Regulatory Affairs Professionals Society (RAPS) in 2005.

Technical and Regulatory Expertise

  • General Regulatory Affairs Strategy
    • Standard Regulatory pathways
      • Pre-IND development and indication targeting
      • First-time in Human
      • Original IND/CTA
      • FDA meeting strategy
      • Phase-1-3 Regulatory Strategy
      • Worldwide pre-BLA risk assessment and mitigation strategy
      • Worldwide BLA submission Strategy
      • Worldwide Drug Naming Strategy
      • Labeling for Innovative drugs and Biosimilars
    • Innovative and Accelerated Regulatory Pathways
      • Orphan Drug Designation
      • Priority Review
      • Fast Track
      • Breakthrough Therapy
      • Accelerated Approval
    • Regulatory and Project Management
      • US agent for your medicinal products needs in the US
      • FDA meeting management and representation
        • For Innovative Drugs
          • Pre-IND
          • End of Phase-I and II
          • Pre-BLA
          • Mid- and Late-cycle BLA review meeting
          • Advisory Committee Meeting
        • For Biosimilars Biologics Products Development Meetings (BPD)
          • BPD1
          • BPD2
          • BPD3
          • BPD4
          • Post-IND/CTA and BLA management
        • IND Maintenance
          • IND amendments
          • DSUR
        • Post-BLA management
          • Regulatory Defense strategy including pre-Approval Advisory Committee Meeting
          • Labeling negotiation strategy
          • Launch coordination
          • Brand name strategy and coordination
        • Electronic Regulatory submissions
          • Medical writing coordinate
          • Formatting
          • Publishing
          • E-Submission