FRIDAY, October 12
8:30 am Chairperson’s Remarks
Dimiter S. Dimitrov, Head, Protein Interaction Group & Senior Investigator, Membrane Structure & Function, NIH NCI
8:35 Strategies to Extend the Half-Life of Small Recombinant Antibody Therapeutics
Roland E. Kontermann, Ph.D., Professor, Biomedical Engineering, Institute of Cell Biology & Immunology, University of Stuttgart
With a growing number of small antibody therapeutics being developed, including bispecific and bifunctional antibodies, half-live extension strategies have become increasingly important to improve their pharmacokinetic and pharmacodynamic properties. An overview of the various strategies to extend the half-life of recombinant antibodies as well as results from a comparative study including novel strategies utilizing binding to serum albumin and serum immunoglobulins are presented and discussed.
9:05 Pharmacokinetics of Engineered Antibody Domains
Dimiter S. Dimitrov, Head, Protein Interaction Group & Senior Investigator, Membrane Structure & Function, NIH NCI
Antibody fragments and antibody-like scaffolds have improved penetration into tissues due to their small size but exhibit relatively short serum half-life. We measured the pharmacokinetics of wild-type monomeric CH2D, a short stabilized CH2D variant and a dimeric CH2D in normal B6 mice, human FcRn transgenic mice and cynomolgus macaques. The data demonstrate that engineered CH2D-based variants have relatively long serum half-lives (on the order of 10 hours), making them a unique scaffold suitable for development of targeted therapeutics.
9:35 The Unique PK/PD Characteristics of Antibody Fragments
Lu Xu, Ph.D., Pharmacokinetics and Pharmacometrics, OncoMed Pharmaceutical
Antibody fragments such as Fab (fragment antigen-binding) and (Fab)’2 (Fab with hinge region, both arms) have been developed into therapeutic agents, taking advantage of their unique pharmacokinetic (PK) and pharmacodynamic (PD) characteristics. The mechanism and implications of the unique PK and PD characteristics of antibody fragments are reviewed in this presentation, with a case study of the preclinical and clinical development of ranibizumab.
10:05 Sponsored Presentation (Opportunity Available)
10:35 Coffee Break in the Exhibit Hall with Poster Viewing (Sponsorship Opportunity Available)
11:10 Poster Presentation: A Mechanism-Based PK/PD Model to Characterize Antibody-Antigen Interactions for a Bispecific Antibody
Yan Ji, Ph.D., Research Scientist, Drug Disposition Development, Eli Lilly & Co.
11:30 Poster Presentation: Preliminary Physiologically Based Pharmacokinetic (PBPK) Model of Squalene in Vaccines
Million A. Tegenge, Ph.D., Postdoctoral Fellow, FDA
11:50 Poster Presentation: Pharmacokinetics of Engineered Multivalent scFv Constructs Against TEM1
Chunsheng Li, Ph.D., Research Associate, Ovarian Cancer Research Center, University of Pennsylvania
12:10 pm End of Conference
1:00-4:00 pm Post-Conference Short Course*
PK/PD Bioanalysis: Streamlining Method Development to Measure Novel Constructs
Moderator: Robert Durham, Ph.D., Manager, Field Application Scientists, Gyros, Inc.
Instructors:
Tracey Clark, Ph.D., Senior Scientist, Drug Metabolism, PDM Biotherapeutics, PGRD Pfizer
Alexander Kozhich, Ph.D., Senior Research Investigator, Bristol-Meyers Squibb
Raj Nagaraja, Ph.D., Senior Research Fellow, NBE-PK, Biotherapeutics, Boehringer-Ingelheim Pharma, Inc.
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*Separate Registration Required
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