PWII-001 MODEL-BASED META-ANALYSIS (MBMA) OF OBJECTIVE RESPONSE RATE (ORR), PROGRESSION-FREE SURVIVAL (PFS), AND OVERALL SURVIVAL (OS) TO COMPARE PD-1 AND PD-L1 TREATMENT OUTCOMES IN METASTATIC (M) NON-SMALL-CELL LUNG CANCER (NSCLC) R. Franzese1, L. Qin2, S. Fu2, B. Rich3, M. Zierhut4, S. Visser5; 1GSK, Nashville, TN, USA, 2Certara, 3InnoMx, 4Certara, Princeton - NJ, USA, 5GSK.
PWII-002 EVALUATING THE UTILITY OF PROTEOMICS FOR IDENTIFICATION OF CIRCULATING PHARMACODYNAMIC BIOMARKERS FOR BIOSIMILARITY - USING PCSK-9 INHIBITOR BIOLOGICS AS A CASE STUDY L. Chekka1, D. Samarth1, E. Mohamed1, Y. Guo1, W. Wheeler2, S. Schrieber1, J. Florian1, Y. Wang3, D. Strauss1, P. Hyland1; 1U.S. Food and Drug Administration, 2IMS Inc, 3U.S. Food and Drug Administration, Silver Spring, United States.
PWII-003 MINIMAL SAMPLING TO ASSESS MECHANISMS LINKING IMMUNE CHECKPOINT INHIBITOR PHARMACOKINETICS AND OUTCOMES IN CANCER PATIENTS B. Remaily1, Y. Guo1, A. Adeluola2, G. Young1, T. Vu1, J. Thomas1, K. Kim1, Z. Xie1, G. Mulcahy1, C. Stanton1, M. Manna1, J. Na1, S. Kulp1, L. Ganesan1, C. Coss1, T. Mace1, D. Owen1, M. Phelps1; 1The Ohio State University, 2The Ohio State University, Columbus, OH.
PWII-004 DEVELOPMENT OF A QUANTITATIVE SYSTEMS PHARMACOLOGY (QSP) MODEL TO EVALUATE THE THERAPEUTIC POTENTIAL OF ANTI-CD19 CAR-T IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) H. Park1, G. Mugundu2, A. Singh2; 1Department of Pharmaceutical Sciences, College of Pharmacy, University of Tennessee Health Sciences Center, 2Takeda Pharmaceuticals.
PWII-005 PREDICTION OF OVERALL SURVIVAL IN MELANOMA PATIENTS: A TUMOR GROWTH INHIBITION OVERALL SURVIVAL MODELING FRAMEWORK E. Velasquez, S. Vadhavkar, N. Kassir, D. Kuruvilla; Genentech.
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