2013 Archived Content
 

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


Linking PK/PD with Immunogenicity 

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 GoletzTheresa 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



Day 1 | Day 2 | Download Brochure