Immunogenicity Summit
Immunogenicity and Bioassay Summit
2013 Archived Content

PK/PD of Novel Constructs 

Scientific Advisory Board

Balaji Agoram, Ph.D., Director, Clinical Pharmacology, MedImmune

Dhavalkumar K. Shah, Ph.D., Senior Scientist, Modeling & Simulation, Pfizer

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Tuesday, November 12

8:30 am Chairperson’s Remarks 

Benno Rattel, Ph.D., Executive Director, Nonclinical Development ARM, AMGEN Research (Munich) GmbH 


Nonclinical PK/PD of Multi-Specific Modalities 

8:35 Discovery Phase Support for Large Molecule Therapeutics with Multiple Specificities: New Challenges in Bioanalytical and Pharmacokinetic Assessment

Chris MacaraegChris Macaraeg, Senior Associate Scientist, PKDM, Amgen

The future of large molecule therapeutics includes increasingly complex biologics with multiple target specificities.  While there is an urgency to shorten discovery time, the complexity of these molecules creates additional bioanalytical challenges.  Multiple ligand binding assays are necessary to fully assess their pharmacokinetic properties, determine their functional activities and identify potential biotransformation.  The presentation will focus on the bioanalytical challenges associated with these multi-specific molecules and present case studies where different approaches were used to overcome these challenges.

9:05 PK Optimization of Bispecific DART Proteins for Clinical Use

Syd JohnsonSyd Johnson, Ph.D., Vice President, Antibody Engineering, MacroGenics, Inc.

Manufacturability, stability and pharmacokinetics have been challenges to effective development of bispecific antibodies for clinical use. We have developed and optimized several formats of our highly stable Dual-Affinity Retargeting (DART®) proteins that address these issues. Multiple examples will be presented of DART proteins approaching the clinic for oncology, autoimmunity or infectious disease applications. Challenges of nonclinical toxicology for these highly potent molecules in relevant species will also be discussed.

9:35 Testing Strategies for the Assessment of Bispecific T cell-engaging BiTE® Antibodies and Their Transition into the Clinic

Benno RattelBenno Rattel, Ph.D., Executive Director, Nonclinical Development ARM, AMGEN Research (Munich) GmbH

Bispecific T-cell engagers, commonly referred to as BiTE® antibodies, are comprised of two different flexibly linked single-chain antibodies, one directed against a tumor antigen and one targeting CD3. BITE® antibodies can transiently link tumor cells with resting polyclonal T-cells for induction of a surface target antigen-dependent re-directed lysis of tumor cells, closely mimicking a natural cytotoxic T-cell response. Strategies for nonclinical assessment and for defining a safe clinical starting dose, and lessons learnt in the clinic will be presented.

10:05 Sponsored Presentation (Opportunity Available)

10:35 Coffee Break in the Exhibit Hall with Poster Viewing

pH-Dependent Binding Antibodies 

11:10 Engineering of pH-Dependent Binding Antibodies for Improved Pharmacokinetics

Changshou Gao, Ph.D., Fellow, Antibody Discovery & Antibody Engineering, MedImmune

Antibody-mediated serum half-life extension of soluble antigens (antibody buffering) and receptor antigen-mediated antibody clearance can negatively impact antibody efficacy and increase the need for high dosing. Antibodies with pH-dependent binding can address both of these issues by offering decreased antibody buffering allowing better clearance of soluble antigens and reducing target-mediated clearance of receptor binding antibodies. We’ll discuss different approaches to engineer pH-dependent mAbs for enhanced potency through improved pharmacokinetics.

11:40 PK Modeling of Sweeping Antibody; Antigen Sweeping Effect of Antibody with pH-Dependent Antigen Binding and Increased FcR Binding

Yuki IwayanagiYuki Iwayanagi, Ph.D., Research Scientist, Preclinical Research, Chugai Pharmaceutical Co. Ltd.

Sweeping antibody with enhanced FcR-mediated cellular uptake of the antigen-antibody complex and pH-dependent endosomal antigen dissociation enables elimination of the antigen from plasma. Sweeping antibody provides novel approach to target antigens which was difficult to be targeted by conventional antibody. Using PK model analysis, we describe the antigen sweeping effect of sweeping antibody in comparison to conventional high affinity antibody.

12:10 pm End of PK/PD of Novel Constructs

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