Bridging Non-clinical Studies to Clinical Design Using a Quantitative Systems Pharmacology Model of T Cell Engaging Bispecifics
Fei Hua, Lin Lin, David Hagen, Emily Pace, Alison Betts, Lucia Wille, John M. Burke, Joshua F. Apgar
Semi-mechanistic PK and target-occupancy modeling to support dose justification for anti-PD-L1 clinical candidate CK-301 (cosibelimab) in oncology patients
Lin Lin, James Hilbert, Leonid Gorelik, Jian-Ping Tang, James Oliviero, John M. Burke, Joshua F. Apgar, Lore Gruenbaum
Inferring target occupancy from fitting nonlinear-PK data with mechanistic PK-RO model for Pembrolizumab
Fei Hua, PhD, Lin Lin, PhD, Lore Gruenbaum, PhD, Bjorn L. Millard, PhD, Carissa Young, PhD, John M. Burke, PhD, Joshua F. Apgar, PhD (2018).
A quantitative systems pharmacology model of colonic motility with applications in drug development
Raibatak Das, Lucia Wille, Liming Zhang, Chunlin Chen, Wendy Winchester, Jangir Selimkhanov, Jill Wykosky, Joshua F. Apgar, John M. Burke, Mark Rogge, Fei Hua, Majid Vakilynejad (2019).
Quantitative Systems Pharmacology Model of a Masked, Tumor-Activated Antibody
Stroh M, Sagert J, Burke JM, Apgar JF, Lin L, Millard BL, Kavanaugh WM (2019).
Model Firsts
How Quantitative Systems Pharmacology Can Pick the Right Dose for First-in-Human Trials
By Karen Tkach Tuzman, Associate Editor, BioCentury (2018).
Mechanistic PKPD Models of Protein Therapeutics for Early Clinical Development
Fei Hua, Ph.D.; Daniel Kirouac, Ph.D.; Lore Gruenbaum, Ph.D.; John Burke, Ph.D.; Joshua Apgar, Ph.D. AAPS News Magazine (2018).
Quantitative Systems Pharmacology Model of hUGT1A1-modRNA Encoding for the UGT1A1 Enzyme to Treat Crigler-Najjar Syndrome Type 1
Joshua F. Apgar , Jian-Ping Tang, Pratap Singh, Nanda Balasubramanian, John Burke, Michael R. Hodges, Melissa A. Lasaro, Lin Lin, Bjorn L. Miliard, Kristi Moore, Lucy S. Jun, Susan Sobolov, Anna Katharina Wilkins and Xiang Gao (2018).