Dr. Yang

Dr. Yang is a former US Food and Drug Administration (FDA) Pharm/Tox reviewer and a board-certified toxicologist (DABT), provides and guides regulatory support, strategy, and submissions for client’s drug development projects (small molecules, biologics, vaccines, and drug-device combination products). With over 10 years of FDA experience, Dr. Yang has expertise in evaluating nonclinical data submitted to Investigational New Drug (IND) Applications and New Drug Applications (NDA/BLA) in cardiology and nephrology. Dr. Yang has participated in more than 80 regulatory meetings at the FDA, including pre-IND, End-of-Phase II (EOP2), and pre-NDA meetings. Dr. Yang designs, contracts, and monitors nonclinical programs that support IND submission and provides resolution of toxicology and regulatory issues during nonclinical development of pharmaceutical candidates. Dr. Yang has led nonclinical development of novel drug candidates through the successful filing of an IND, and into clinical studies.
Within FDA, she has held leadership positions, including Toxicology Working Group/ Cardiotoxicity Interest Group. She has served in international committees and co-chaired multiple continuing education courses, symposia, and workshops within the FDA and at annual Society of Toxicology meetings. Dr. Yang has published over 45 peer-reviewed research articles and book chapters and has experience reviewing multiple grant proposals.

Technical and Regulatory Expertise:

  • Nonclinical Strategy
    • Assist with candidate selection and optimization
    • Assess adequacy of nonclinical data for IND and NDA/BLA
    • Protocol input for IND-enabling studies
    • Dose selection for FIH
    • Extrapolation of nonclinical data to humans
    • Special protocol assessment (SPA)
    • Impurity justification and qualification
    • Answering regulatory questions
  • Nonclinical Operations
    • CRO selection and bidding
    • Nonclinical protocol development
    • Study monitoring
    • In-vivo potency
    • ADME/PK
    • Safety Pharmacology
    • Genotoxicity
    • General toxicology
    • Development and reproductive toxicology
    • Carcinogenicity
    • In-vivo drug interactions
    • Surrogate biomarkers
    • Animal models for efficacy and toxicology
    • Dosage formulation/ regimen
    • Analytical validation
    • GLP compliance

 

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