Development of Novel Biotherapeutics

Developability, Enhanced Product Properties and Therapeutic Application

7-8 November 2013

Preliminary Agenda

This 1 ½ day conference with additional plenary session late morning before the conference opens focuses on measures to enhance product properties such as avoidance of aggregation, optimization of stability, PK, affinity and targeting, and improved manufacturability. It provides an opportunity to hear the experiences of the pioneers that have products in pre-clinical and clinical development. It will focus on the challenges of designing and interpreting pre-clinical toxicology and safety studies, and on decision points for moving into the clinic. Don’t miss the dinner short course on Troubleshooting and Engineering of Antibody Constructs.


PLENARY SESSION

Overview of Trastuzumab

Martine Piccart, Head, Medical Oncology, Jules Bordet Institute, Chair, ESMO (European Society for Medical Oncology)

Antibody-Drug Conjugates: From Bench to Bedside and Back

Robert Lutz, Ph.D., Vice President, Translational Research & Development, ImmunoGen, Inc.


MEASURES TO AVOID DEGRADATION AND AGGREGATION 

In silico Prediction of Degradation Hotspots in Antibody Variable Regions

Hubert Kettenberger, Ph.D., Principal Scientist, Large Molecule Research, Roche Pharma Research and Early Development (pRED)

Unique in silico Tools for Prediction of Propensity to Aggregate and for Viscosity for Monoclonal Antibodies and Therapeutic Proteins

Bernhard Helk, Ph.D., Head, Physico-Chemical Analysis, Novartis Pharma AG

Engineering Aggregation Resistance in IgGs based on Lessons Learned from Comparative Expression

Jonas V. Schaefer, Ph.D., High-Throughput Laboratory, Biochemistry, University of Zurich


ENHANCEMENT OF PRODUCT PROPERTIES BEFORE ENTERING THE CLINIC 

Rapid Design of Optimized Site-Specific ADCs and Manufacture by Cell-Free Protein Synthesis

Trevor J. Hallam, Ph.D., CSO, Research & Development, Sutro Biopharma, Inc.

Optimization of Bispecific DART Proteins for Clinical Use

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

CTLA4 – Fc Fusion: Engineering for Increased Affinity to CD80 and CD86 for the Treatment of Inflammatory Diseases

David Lowe, Ph.D. Fellow, Research & Development, Antibody Discovery and Protein Engineering, MedImmune LLC


PRECLINICAL DEVELOPMENT 

Development of Leptin and Interleukin 22 Antagonists and Potential Use in Therapy of Cachexia and Autoimmune Diseases: A Novel Approach for Development of High-Affinity Cytokine Antagonists

Arieh Gertler, Ph.D., Professor, Institute of Biochemistry, Food Science and Nutrition, Hebrew University in Jerusalem

RG7116, A Novel Therapeutic Antibody that Locks HER3 in the Closed Conformation, Potently Blocks HER3 Signaling, and is Optimized for Immune Effector Activation

Birgit Bossenmaier, Ph.D., Principle Scientist, Discovery Oncology, Roche

Targeted Fas-Mediated Treatment of B-Cell Lymphoma by Hexameric CTLA4-FasL

Noam Shani, KAHR Medical, Hadassah Medical Center, Jerusalem

Pro-Apoptotic and Anti-Angiogenic Tumor Therapy Approaches with Novel DARPin Formats

Ignacio Dolado, Ph.D., Program Leader, Research Oncology, Molecular Partners AG


NOVEL PRODUCTS IN THE CLINIC 

Selecting Lead DVD-Ig Candidates for Clinical Development

Tariq Ghayur, Ph.D., Senior Research Fellow, Abbvie

Exploring Antibody Domains as Effective Candidate Therapeutics

Steven Grant, Ph.D., Manager, Biopharm Discovery, Biopharm Research & Development, GSK (Domantis)

Plant-Derived Pharmaceuticals; A New Era for Medicine

Kathleen Hefferon, Ph.D., Scientist, Cell and Systems Biology, University of Toronto