Safety Stream
Inaugural
PK/PD of Antibody-Derived Molecules
Improving Pre-Clinical Results for Clinical Success
May 2-3, 2013
Cambridge Healthtech Institute’s Inaugural PK/PD of Antibody-Derived Molecules will review tools for understanding and predicting effects in humans as well as engineering for optimal efficacy and safety. Experts will address issues surrounding identification of disease-specific biomarkers as well as the most appropriate models to implement in PK/PD studies. Derivation of antibody candidates, challenges associated with preclinical PK/PD analysis, effective computational modeling, and successful translation to clinic will also be addressed.
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Thursday, MAY 2
12:30 pm Conference Registration
1:30 Chairperson’s Remarks
1:40 An Integrated Analytical Strategy for Biologics
Peter Lloyd, Head, PK/PD, Biologics, Novartis
PK, PD and potential immunogenicity (IG) of therapeutic proteins cannot be investigated in isolation. An integrated approach is needed which takes into account the interdependency of PK/PD/IG assays. This presentation will focus on the use of an integrated bioanalytical strategy to effectively interpret the behaviour of protein therapeutics.
2:10 Immunogenicity of Therapeutic Proteins: Strategies for Assessing Antidrug Antibodies and Their Impact
Theresa J. Goletz, Ph.D., Director, Clinical Immunology, Amgen, Inc.
The presentation will provide an overview of the interactions of therapeutic proteins with anti-therapeutic antibodies. Examples will illustrate challenges encountered during various stages of drug.
2:40 Case Studies on Interdependency between PK, PD, and Immunogenicity Profiles of Therapeutic Proteins for Autoimmune Indications
Yulia Vugmeyster, Ph.D., Principal Research Scientist, Pharmacokinetics, Dynamics, and Metabolism, Pfizer Research Labs
3:10 Refreshment Break in the Exhibit Hall with Poster Viewing
4:00 Problem Solving Breakout Discussions
Concurrent problem solving breakout discussions, open to all attendees, speakers, sponsors, and exhibitors, provide a forum for discussing key issues and meeting potential collaborators. Plan to take part and explore these topics in-depth. Please pick a topic of your choice, find your table and join in.
TABLE: Optimizing PK Stability of Protein Therapeutics
Moderator: Josh Pearson, Ph.D., Senior Scientist, Biochemistry & Biophysics Group, Department of Pharmacokinetics & Drug Metabolism, Amgen, Inc.
• Rational design of therapeutic fusion proteins; thinking beyond half-life extension to biodistribution and PK/PD
• Balancing the engineering of fusion proteins for enhanced in vivo stability versus potential immunogenicity risks to endogenous proteins
• Enhancing in vivo stability of a protein therapeutic by altering molecular properties through post-translational modification or chemical ligation
• Prolonging in vivo molecular integrity of fusion proteins and antibody-drug conjugates by altering linker properties
TABLE: Integrating Your Biologics Safety Strategy
Moderator: Peter Lloyd, Head, PK/PD, Biologics, Novartis
TABLE: Human Clinical Trial Predictions with Systems Pharmacology
John Burke, Ph.D., Senior Principal Scientists, Head, Systems Biology, Boehringer Ingelheim Pharmaceuticals, Inc.
5:00 End of Day
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