會前研討會短期課程

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Morning

Sunday, April 29 - 10:00 AM - 1:00 PM

SC1 - Phage and Yeast Display Libraries*

• Phage display and construction of phage-displayed scFv and Fab libraries
• Yeast display and construction of yeast-displayed scFv and Fab libraries
• Selection and screening technologies that are compatible with phage and yeast-display libraries

Instructors:

Andrew M. Bradbury, M.B., B.S., Ph.D., Staff Scientist, Biosciences, Los Alamos National Laboratory

James D. Marks, M.D., Ph.D., Professor, Anesthesia & Pharmaceutical Chemistry, University of California, San Francisco; Chief of Anesthesia and Vice Chairman, Anesthesia & Perioperative Care, San Francisco General Hospital

SC2 - Techniques for Antibody Selection & Screening*

• Integrated Single-Cell Analysis for Antibody Discovery
• Selection of anti-peptide monoclonal antibodies for use in immunoproteomics
• Comparing Tools for Antibody Screening

Instructors:
Moonsoo Jin, Ph.D., Assistant Professor, Biomedical Engineering, Cornell University
J. Christopher Love, Ph.D., Associate Professor, Chemical Engineering, Massachusetts Institute of Technology (MIT)

SC3 - Recommendations on Immunogenicity Evaluations–Anti-Drug Antibody and Neutralizing Antibody Assay Development, Validation and Sample Testing*

• Anti-drug antibody detection strategies based on risk assessment and neutralizing (NAB) assays
• Validation of assays
• Opportunities for automation of immunogenicity assay for high throughput sample testing in regulated environment

Instructors:

Darshana Jani, Scientific Manager, Clinical Science & Technology, Biogen Idec, Inc.

Hicham Alaoui, Director, Biology, Stryker Biotech

SC4 - Engineering Optimized Biotherapeutics*

Instructors to be Announced

SC5 - Translational Strategies for Development of Monoclonal Antibodies Part I: Focus on Early Discovery*

• Considerations for target selection, antibody screening and mAb preclinical development
• Antibody affinity and biophysical characterization: Biacore, Kinexa, and FACS
• Pre-Clinical Considerations-A Science Based Approach: Design Goal, MOA, Choice of Species, and Pre-Clinical Plans

Instructors:

Mohammad Tabrizi, Ph.D., Head, PK/PD & Senior Fellow, Merck
Gadi Bornstein, Ph.D., Principal Scientist, AstraZeneca R&D
Cherryl Funelas, Manager, Bioanalytical Development, Takeda San Francisco
Scott Klakamp, Ph.D., Research Fellow, Biophysical Chemistry and Research Informatics, Takeda San Francisco
Randall Brezski, Ph.D., Research Scientist, Biologics Research, Janssen R&D

Click here for a more detailed agenda

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Afternoon

Sunday, April 29 - 2:00 - 5:00 PM

SC 6 - Alternate Display Technologies*

• Development of new display systems to address shortcomings of phage and yeast display
• Constructing libraries and assessing library quality
• Screening and selection methods for generation of new affinity proteins as well as for epitope mapping purposes

Instructors:

John Löfblom, Ph.D., Assistant Professor, Molecular Biotechnology, AlbaNova University Center, Royal Institute of Technology (KTH)

Patrick S. Daugherty, Ph.D., Professor and Vice Chair, Department of Chemical Engineering, & Biomolecular Science & Engineering Program, University of California, Santa Barbara

Birgit Dreier, Ph.D., Senior Scientist, Laboratory of Prof. Dr. A. Plückthun, Department of Biochemistry, University of Zurich

SC 7 - Use of HT Sequencing for Antibody Library Generation and Selection*

• Improved library generation strategies including synthetic antibody library generation
• Sequencing antibody libraries
• High-throughput immune repertoire analysis

Instructors:

Jacob Glanville, Principal Scientist, Pfizer
François Rousseau, Ph.D., Head, Protein Engineering, Research, NovImmune SA
Zoltán Konthur, Ph.D., Group Leader, Max Planck Institute for Molecular Genetics

SC8 - Engineering of Bispecific Antibodies*

• Rationale for "resurgence" of these molecules
• Current state-of-the-art
• Breaking down engineering challenges

Instructor: Raffi Tonikian, Ph.D., Scientist I, Protein Engineering, Biogen Idec

SC9 - Biosimilars: Development, Regulation and Prospects*

• The approval pathway, strategies & defining 'similar'
• Tools for characterizing biologics
• Where are biosimilars headed, and how will they affect the biologics field?

Instructor: Kathleen Madden Williams, Ph.D., Partner, Edwards Wildman Palmer LLP

SC10 - Translational Strategies for Development of Monoclonal Antibodies Part II: Focus on Nonclinical Development to Clinic*

• Considerations for Immunoassay Development in Support of Pharmacokinetic, Immunogenicity & Biomarker Evaluation
• Antibody Safety, Species Selection, Introduction to surrogate approaches in development of monoclonal antibodies
• Translation of exposure-response data from discovery into the clinic in support of FIH dosing

Instructors:

Mohammad Tabrizi, Ph.D., Head, PK/PD & Senior Fellow, Merck
Gadi Bornstein, Ph.D., Principal Scientist, AstraZeneca R&D
Cherryl Funelas, Manager, Bioanalytical Development, Takeda San Francisco
Scott Klakamp, Ph.D., Research Fellow, Biophysical Chemistry and Research Informatics, Takeda San Francisco
Randall Brezski, Ph.D., Research Scientist, Biologics Research, Janssen R&D

Click here for a more detailed agenda

SC11 - Molecular Imaging on Tissues Using Mass Spec*

• Learn about the technology and how it is applying to the pharmaceutical industry
• Learn about the techniques and "tricks-of-the-trade" for MALDI-TOF tissue imaging process
• Learn how others are applying the technology to answer questions and drive science

Instructors:

Jennifer Nemeth, Ph.D., Principal Research Scientist & Head, Discovery Mass Spectrometry, Janssen R&D

Pierre Chaurand, Ph.D., Associate Professor, Chemistry, Université de Montréal

Michelle Reyzer, Ph.D., MSRC Mass Spectrometry Research and Development, Vanderbilt University Medical Center

Click here for a more detailed agenda

* Separate Registration Required

DINNER SHORT COURSES

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Tuesday, May 1 - 6:00 - 9:00 PM

SC12 - Asia-U.S. Biotech Alliances: Opening Up New Opportunities for Pre-Clinical Development of Biologics*

• Exchange and transfer of IP, materials, know-how
• Understanding export-import laws
• Review of currency laws and cultural divide

Instructors:

Kathleen Madden Williams, Ph.D., Partner, Edwards Wildman Palmer LLP

Jim Weissman, Vice President, Business Development, MannKind Corporation
Jun Ouyang, Ph.D. , Senior Product Manager, Pharma Technical Regulatory, Genentech, a Member of the Roche Group

SC13 - Light Scattering – Theory, Do's & Don'ts, and Data Interpretation*

• How is the mass distribution determined in DLS & what is the accuracy?
• Can light scattering be used for particle counting?
• How do I convert zeta potential to surface charge?

Instructors:

Kevin Mattison, Ph.D., Principal Scientist – Bioanalytics, Malvern Instruments
Ulf Nobbmann, Ph.D., SEC & Light Scattering Specialist, Malvern Instruments
Jean-Luc Brousseau, Ph.D., SEC & Light Scattering Specialist, Malvern Instruments

Click here for a more detailed agenda

Thursday, May 3 - 5:30 - 8:30 PM

SC14 - Antibody Conjugate Therapeutics Challenges*

• Antibody-drug conjugates
• Antibody-radionuclide conjugates
• Antibody-protein toxin (or antibody fragment-protein toxin fusion) conjugates
• Antibody-enzyme conjugates with small-molecule prodrugs
• Antibody to drug-containing liposomes or nanoparticles
• Regulatory approval

Instructors:

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

Robert J. Kreitman, M.D., Principal Investigator, Clinical Immunotherapy, NIH, NCI

Gregory P. Adams, Ph.D., Co-Leader, Developmental Therapeutics Program Fox Chase Cancer Center

Mahendra Deonarain, Ph.D., Honorary Reader in Antibody Technology, Imperial College London; CSO, PhotoBiotics Ltd.
Gokhan Yahioglu, Ph.D., Director, Chemistry, PhotoBiotics Ltd
Saurabh Sharma, Ph.D., Assistant Professor, Neurosurgery, Children's Memorial Hospital at the Northwestern University

SC15 - Advances in Immunogenicity Assays*

• Understanding Pre-Existing Anti-Drug Antibodies
• Coping with Seemingly Insurmountable Interference: Back to the Basics
• Case Study on Development and Validation of Assays for the Detection of Anti-drug Neutralizing Antibodies
• Case Study on Development of an Immunogenicity Testing Program
• Different Technology Platforms that Address Challenges Faced for the Development of Fit for Purpose Immunogenicity Assays

Instructors:

Stephen Keller, Ph.D., Associate Director II, Preclinical and Clinical Development Sciences, Abbott Biotherapeutics

Michele Fiscella, Ph.D., Director, Clinical Immunoassays, Human Genome Sciences

Boris Gorovits, Ph.D., Director, Pharmacokinetics Pharmacodynamics & Metabolism, Pfizer, Inc.

Jaya Goyal, Ph.D., Senior Scientist, Clinical Science and Technology, Biogen Idec, Inc.
Maureen Deehan, Ph.D., Head, Pharmacology, Experimental Science & Translational Medicine, NovImmune SA

Click here for a more detailed agenda

* Separate Registration Required