Day Two

Thursday 26th July, 2012

08.00 Registration, Coffee and Networking

08.55 Chair’s Opening Remarks

David Buckler, Associate Director, Therapeutic Proteins, Regeneron Pharmaceuticals

09.00 Development of Therapeutic Monoclonal Antibodies and Their Alternatives: An FDA Perspective

• Ensuring the safety, efficaciously, and high quality of monoclonal antibody and related products available to diagnose, prevent and treat illnesses in patients in America

• Understanding antibody formats and characteristics most favoured by CDER

Rashmi Rawat, Product Quality Reviewer, Division of Monoclonal Antibodies, CDER, FDA

Advanced Antibody Engineering Strategies

09.30 Enhanced Biological Activity of Biparatopic Antibodies

• An extensive overview of the Strand Exchange Engineered Domain (SEED) platform

• Exploring the ability to permit the heterodimerization of antibody heavy chains to create bispecific antibodies

• Realizing enhanced activity with combinations of conventional antibodies with SEED-based bispecific antibodies binding distinct epitopes on a single antigen

Sean McKenna, U.S. Head of Protein Engineering & Antibody Technologies, EMD Serono

10.00 Morning Refreshments

10.30 Alternative Routes To High Affinity Recognition of Challenging Epitopes

• Alternative immune models for conserved and posttranslationally modified targets

• Insights into novel immune models via repertoire analysis

• Accelerating discovery of an optimal epitope early in a program for maximal impact

William Finlay, Associate Director, Discovery Research, Pfizer

11.00 Case Study: An Update on the Scaffold Biotherapeutic Anti-CD20 SMIP

• Turning antibody-derived scaffolds into druggable biologics

• Distinct in vitro binding properties of the anti-CD20

• Overcoming the major challenges of alternative scaffolds

Lioudmila Tchistiakova, Director, Engineered Immune Proteins, Pfizer

11.30 What Makes a Good Therapeutic Antibody?

• Discussing the “essential” biophysical and chemical properties

• Looking at the most effective mechanisms of action

• Comparing criteria for selection of an antibody candidate

Randall Brezski, Janssen; Tristan Vaughan, MedImmune; William Strohl, Johnson & Johnson; Brian Miller, Pfizer

12.00 Lunch

1.00 Monoclonal Antibody Discovery, Engineering and Production in Glycoengineered Yeast

• Understanding the important role of glycosylation in monoclonal antibody pharmacokinetics and pharmacodynamics

• Alternative monoclonal antibody production platform using glycol-engineered Pichia

Dongxing Zha, Group Leader, Antibody Development, Merck

An Insight Into Novel Molecules And Alternative Antibody Formats

1.30 An Efficient Route to Generate Bispecific Antibodies from Distinct Half-Antibodies

• Technology to generate bispecific antibodies with noncommon light chains

• Eliminating the need of linkers to prevent light chain mispairing.

• The advantages of creating individual half-antibodies which are purified, combined and then re- purified

Christoph Spiess, Scientist, Antibody Engineering, Genentech

2.00 Engineering of a Bispecific Domain Antibody with Exquisite Epitope Specificity

• Guided selections for generation of epitope specific domain antibodies

• Bispecific formatting for in vivo half-life extension

• Improving specific molecular key quality attributes through selection and screening

Allart Stoop, Project Leader, Targeted Biopharm Discovery Unit, GSK

2.30 Afternoon Refreshments

3.00 Engineered Soluble Monomeric Fc – Monomeric Fusion Proteins and Scaffolds

• Looking at the successful generation of engineered monomeric Fc of high solubility and minimal number of mutations

• Improving antibody characterization by binding to FcRn

• An overview of monomeric fusion proteins and scaffolds

Dimiter Dimitrov, Head, Protein Interaction Group, NCI

3.30 Case Study: Identifying “Best in Class” Candidates: From Screening to IND Filing

• Identifying the best possible standard mAb lead using phage display

• When structure follows function, mAbs and novel formats.

Seth Ettenberg, Oncology Biotherapeutics, Head Cambridge Site, Novartis