Dr. Peng has 18 years of experience in clinical pharmacology and pharmacometrics and has worked with multiple modalities (e.g., small molecules, peptides, monoclonal antibodies, and antibody-drug conjugates). Her broad experience also extends to several therapeutic areas, including autoimmune diseases, cancers, diabetes, cardiovascular diseases and HIV. As the Clinical Pharmacology Lead for 12 programs, she was instrumental in the design, analysis, and interpretation of several types of clinical pharmacology studies, including renal, hepatic, pediatric, QT, DDI, BE/BA, SAD, and MAD, but her experience also extends to Phase 2 through Phase 4. She has conducted many PK/PD analyses to support a more rapid and efficient development path for several programs. Joanna is able to produce key drug development reports under tight timelines, including CSRs, PK reports, PK/PD modeling reports and regulatory documents, including INDs, sBLAs, briefing books, Scientific Advice Requests (SARs), and Investigator Brochures. She has also attended regulatory meetings with the FDA, EMEA and MPA. Dr. Peng’s notable achievements includes sBLA approvals for Humira early rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis and psoriasis indications when working as the Clinical Pharmacology Lead and her population PK/PD analysis resulted in a novel dosing regimen that was approved for labeling for Humira. Additionally, during the last 3+ years of being a consultant, Dr. Peng’s contribution to conducting PK analyses, modeling and simulation, writing NDA sections (2.7.1, 2.7.2 and 2.5.3), and advising on strategy has led to 4 IND submissions, 3 NDA and 2 sNDA approvals.