Short Courses *

Sunday, January 10 • 2:00pm - 5:00pm

(SC1) Immunogenicity Assessment: Preclinical, Clinical and Post-Marketing

Accurate immunogenicity assessment is essential for the successful development of therapeutic proteins. This workshop will review basic aspects of immune responses and discuss methodologies and advances in immunogenicity detection. Experts and also the ones new to this field will benefit from presentations by the workshop leaders and interactive sections .

What you will Learn in this Course

• Overview of immunogenicity, screening assays and Nab assays
• Assay Selection, design and validation
• Addressing challenges associated with immunogenicity detection and interpretation
• Recent trends and advances in immunogenicity detection assays

Instructors:

Maria Barbosa, Ph.D., Principal, CA Consultants

Eric Wakshull, Ph.D., Senior Scientist/Group Leader, Bioanalytical Research & Development, Genentech, Inc.
Shalini Gupta, Ph.D., Director, Clinical Immunology, Amgen

(SC2) Controlling the Impact of Manufacturing Change Implementation for Biologics

For people from process development, analytical methods and regulatory affairs. A course that stresses the importance of knowing the critical process parameters for the product and the impact of change on critical quality attributes. Physical and biological characterization to ensure product consistency will be presented.

What you will Learn in this Course

• Potential impact of process change on the product and Quality by design
• Physicochemical characterization and bioassays for comparability studies
• Regulatory issues regarding change implementation
  

Instructors:
Chris Gee, B.Sc. (Hons), Senior Research Scientist, Product Characterization, MedImmune Ltd
John Henstrand, Ph.D., Senior Scientist II, Manufacturing Sciences Group, BioMarin Pharmaceutical, Inc.
Vesselin E. Mitaksov, Ph.D., Senior Scientist, Global Biologics, Pfi zer Global R&D
Dieter Schmalzing, Ph.D., Director, MMTech / CQPS, Genentech, Inc.
Ronald Taticek, Ph.D., Director, Regulatory CMC, Genentech, Inc.

(SC3) Program Management for Scientists

Congratulations! You have been promoted to Program Manager. Now what? Can your bench-top scientific experience in proteins - expression, characterization, development of protein-based therapeutics, bioprocessing, etc. - lead to success in people/business management? Most scientists train for years in their prospective fields but must learn business management “on-the-fly.” This course is designed for scientists who have recently been promoted to program/product manager or are planning ahead.

What you will Learn in this Course

• Strategic decision making
• Operational planning
• Oversight of resources
• Program management models

Instructor:
Patti Seymour, M.B.A., Senior Consultant, BioProcess Technology Consultants

(SC4) Specialized Protein Expression Systems – An Overview

What is the best host platform for a particular cell line? What is the best system to use to express a particular protein? Learn what non-mammalian expression systems have to offer and the benefits of various ‘specialized’ systems.

What you will Learn in this Course

• An overview of non-mammalian expression systems
• An in-depth exploration of some of the leading host platforms
• Why an alternative system may be the best choice for expressing your protein

Instructors:

John R. Gasdaska, Ph.D., Director, Protein Sciences, Biolex Therapeutics

Peter Heifetz, Ph.D., President & Chief Executive Officer, OrPro Therapeutics, Inc.

C. Peter Romaine, Ph.D., Professor and J.B. Swayne Chair in Spawn Science, Department of Plant Pathology, The Pennsylvania State University; and Co-Founder & Chief Scientific Officer, Agarigen

Tuesday, January 12 • 4:30pm - 7:30pm

(SC5) Characterization and Analysis of Particulates: Methods and Tools                

Particulate analysis in Protein Therapeutics has recently received an increasing focus due to the correlation of aggregates and particles in the therapeutic with immunogenicity. New techniques suitable for testing and characterizing protein particles continue to emerge. This workshop addresses technologies currently available for characterizing sub-visible particulates in therapeutic formulations.

What you will Learn in this Course

• What are the methods available for analysis of subvisible particles in protein therapeutics?
• Comparison of size ranges, sensitivity limits and capabilities of the various methods
• Equipment available for performing these tests
• Characterization of sub-micron particulates using light scattering techniques

Instructors:

Nanda Subbarao, Ph.D., Senior Consultant, Analytical-CMC, Biologics Consulting Group
Kevin Mattison Ph.D., Senior Bioanalytical Scientist, Malvern Instruments

(SC6) Tech Transfer: ENTREPRENEURIAL SCIENCE – The Handoff from Academia to Industry 

Industry yearns for the entrepreneurial science being spawned in academic settings, while academics often feel a short shrift of appreciation for their innovation and hard work. This course will bring together representatives from all sides of this divide to discuss the issues involved, and how to build infrastructure for successful tech transfer.

What you will Learn in this Course

• What the issues are that hinder tech transfer
• The different perspectives of all sides
• Ideas and suggestions for enabling successful tech transfer between academia and industry

Instructors:

John P. Hennessey, Jr., Ph.D., Vice President, Research & Development, NovaDigm Therapeutics, Inc.

William W. Ward, Ph.D., Associate Professor, Director, CREBB, Rutgers University
Thomas Kowalski, J.D., Partner, Biotechnology Group, Frommer Lawrence and Haug LLP
Jane C. Moores, Ph.D., Assistant Vice Chancellor, Technology Transfer, University of California, San Diego
C. Peter Romaine, Ph.D., Professor and J.B. Swayne Chair in Spawn Science, Department of Plant Pathology, The Pennsylvania State University; and Co-Founder & Chief Scientific Officer, Agarigen

(SC7) From Protein and Peptide Characterization to Quantitation: Advancing Mass Spec Beyond Protein Discovery

Mass spectrometry has emerged as the preferred method for the characterization and quantitation of peptides and proteins. However, the acronyms are as endless as the applications. Learn from seasoned experts as they share their insights and strategies to obtain results for your research applications. This short course is specifically designed to help you optimize your time and get information that is most relevant to your particular area of research.

What you will Learn in this Course

As related to your research for protein expression, scale-up, therapeutics, or formulation:

• Protein and peptide fractionation
• Protein identification and characterization
• Protein quantitation

Instructor:
Christie L. Hunter, Ph.D., Director of Applications, Mass Spectrometry Systems, Applied Biosystems

(SC8) Phage Display for Antibody & Peptide – Technical Tips & Guidelines 
Click here for more details on this short course

Phage display has proven to be a robust and convenient technology for the selection of high-quality antibodies and peptides. Alternative display systems such as yeast have become more popular and this course will highlight progress with such alternative systems.

What you will Learn in this Course

• How to construct protein or peptide libraries
• How to express on the surface of phage
• How to select from a library
• Compare with alternative display systems

Instructors:
Gregg Silverman, M.D., Professor of Medicine, Director, Laboratory of B cell Immunobiology, University of California San Diego School of Medicine
Robert Mabry, Ph.D., Senior Scientist, ZymoGenetics, Inc.
Kristin Rookey, Principal Scientist, Selection, Screening & Molecular Biology Group Head, Discovery Research, Dyax Corp.

*Separate Registration Required