Dynamic Target-Mediated Drug Disposition (TMDD)
Abstract Methods: We have developed a novel pharmacokinetic model, termed dynamic TMDD, to mechanistically describe the…
Renee Fisher2024年9月16日
Semi-mechanistic Model of ATG-101, a PD-L1/4-1BB Bispecific Antibody, for Treatment of Solid Tumors
Abstract Trimer formation is key to the pharmacology of the bispecific ATG-101 but is difficult…
Renee Fisher2024年9月16日
Blinatumomab Trimer Formation
Insights from a Mechanistic PKPD Model on the Implications for Switching from Infusion to Subcutaneous…
Renee Fisher2024年9月16日
Dose Selection for DuoBody®-PD-L1x4-1BB (GEN1046)
Abstract DuoBody®-PD-L1x4-1BB (GEN1046) is an investigational, first-in-class, bispecific antibody designed to elicit an antitumor immune…
Renee Fisher2024年9月9日
Optimizing Avidity of Bispecific Drugs
Abstract Bispecific drugs have great potential to improve tissue selectivity through avid binding interactions but…
Renee Fisher2024年9月9日
Effects of Tissue Targeting Bispecifics on Therapeutic Window
Abstract Objectives: The presence of target receptors in non-target tissues can reduce the therapeutic window…
Renee Fisher2024年9月9日
FDA Trends for Accelerated Drug Approvals in Oncology Indications
The FDA has modified and increased expectations around data needed to support accelerated approvals in…
Danielle Pillsbury2023年9月20日
Adoption of PROs in Early Clinical Trials for Oncology Drugs: Challenges and Opportunities
Despite changes in regulatory expectations, adoption of PROs in early-phase oncology trials remains very low…
Danielle Pillsbury2023年9月20日
