PRE-CONFERENCE SHORT COURSES*

Sunday, May 16

MORNING COURSES 10 AM - 1 PM

(SC1) PHAGE AND YEAST DISPLAY LIBRARIES AND THEIR SCREENING

This workshop is meant to bring the scientist up to speed on the display technologies covered by the main conference. The workshop will provide an overview of:

Phage display and construction of phage-displayed peptide, scFv and Fab libraries
Yeast display and construction of yeast-displayed scFv and Fab libraries
Screening technologies that are compatible with phage- vs. yeast-display libraries

Course Instructors:

Jamie Kathleen Scott, M.D., Ph.D., Professor and Canada Research Chair in Molecular Immunity, Department of Molecular Biology & Biochemistry and Faculty of Health Sciences, Simon Fraser University

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

(SC2) PRECLINICAL SAFETY ASSESSMENT OF BIOLOGICS – UNEXPECTED SAFETY FINDINGS

This short course provides an overview of the most common reasons for encountering unexpected preclinical safety issues during development of monoclonal antibodies in particular. These unexpected issues can arise from;

Binding to the intended target
Binding to unanticipated targets
Anti-drug antibody formation in preclinical species
Fc- and Fab-mediated interactions

Course instructors:

Thomas Monticello, DVM Ph.D., Diplomate ACVP, Executive Director, Toxicology, Amgen
Jeanine Bussiere, Ph.D., DABT, Executive Director, Toxicology, Amgen
Nancy Everds, DVM, Diplomate ACVP, Pathology Director, Clinical Pathology, Amgen

(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.

Strategic decision making
Operational planning
Oversight of resources
Program management models

Course Instructor:

Patricia Seymour Patricia Seymour, M.B.A., Senior Consultant, BioProcess Technology Consultants

Patricia Seymour has over 20 years of experience in the biotechnology industry. Her expertise spans the development and commercialization spectrum, including biologics and small molecule development and manufacturing, supply chain strategy and management and operations leadership. Her current activities include: developing overall CMC strategies for diverse product pipelines, developing and implementing outsourcing strategies, managing outsourced process development and manufacturing activities from drug substances through to distribution, steering clients through CMC regulatory requirements and overall CMC operations including project management and budgeting. Prior to joining BioProcess Technology Consultants, Ms. Seymour was Senior Director, Global Investigational Supply Operations at Millennium Pharmaceuticals, Inc., where she worked with other senior leaders to develop and implement CMC strategies including outsourcing. She was previously Director of Business Development at Covance Biotechnology Services (now Diosynth) where her responsibilities included negotiating contact manufacturing projects. As Senior Director, Corporate Development at Collaborative BioAlliance she was instrumental in launching the new contract manufacturing business unit. Before Collaborative, Ms. Seymour held research and development positions at ImmunoGen, Dana Farber and Sloan Kettering. Ms. Seymour received her B.S. from Villanova University and her M.B.A. from Boston University. Ms. Seymour is Certified Supply Chain Professional (APICS).

(SC4) ESSENTIAL CONSIDERATIONS FOR DEVELOPMENT OF ANTIBODY-BASED THERAPEUTICS FROM DISCOVERY TO THE CLINIC

This introductory course will evaluate critical considerations necessary for effective development of ABTs
Integration of relevant knowledge with respect to target antigen properties, antibody design criteria such as affinity, isotype selection, pharmacokinetic (PK)-pharmacodynamic (PD) properties, biophysical characterization and antibody cross-reactivity across species from the early stages of antibody development
Key learnings will include: Considerations for target selection, screening and preclinical development; Affinity and biophysical characterization; Translational Considerations

Course Instructors:

Mohammad Tabrizi, Ph.D., Vice President, Preclinical Development, AnaptysBio, Inc.

Gadi Bornstein, Ph.D., Principal Scientist, AstraZeneca R&D

Scott Klakamp, Ph.D., Research Fellow, Biophysical Chemistry and Bioinformatics, Takeda

AFTERNOON COURSES 2 PM - 5 PM

(SC5) ANTIBODY-DRUG CONJUGATES

Linker technology and drug characteristics
Site-specific antibody modifications
Use of alternative scaffolds for delivery
Recent clinical proof-of-concept data

Course Instructors:

Pamela A. Trail, Ph.D., Vice President, Oncology, MedImmune, Inc.

Changshou Gao, Ph.D., Principal Scientist, Antibody Discovery & Protein Engineering, MedImmune

Dario Neri, Ph.D., Professor, Chemistry & Applied Biosciences, Institute of Pharmaceutical Sciences, ETH Zürich
Kirsten Achilles Poon, Senior Toxicology Research Associate, Development Sciences Safety Assessment, Genentech, Inc.

(SC6) ANALYTICAL TOOLS AND METHODS USED IN BIOPHARMACEUTICAL CHARACTERIZATION TO DRIVE THERAPEUTIC DRUG DESIGN

2:00 pm - 6:00 pm

Overview of the common analytical techniques used for performing a structural assessment of biopharmaceuticals, with real-life examples highlighting how they are applied
Speakers are leaders in structural characterization for biopharmaceutical drug development, and bring a wide breath of experience to the forum
Discussion will span a range of topics from protein profiling for isoform detection and percent population to peptide mapping for detecting low-level changes to drug product and the identification of post-translational modifications
Additionally, methods for looking at solvent accessibility and epitope mapping will be presented

Course Instructors:

Jennifer F. Nemeth, Ph.D., Head, Discovery Mass Spectrometry, Centocor R&D, Inc.

Steve Pomerantz, Ph.D., Senior Research Scientist, Centocor R&D, Inc.

Jason C. Rouse, Ph.D., Director, Mass Spectrometry, Analytical Research and Development, Pfizer, Inc.

Sharon Gao, Ph.D., Principle Scientist, Analytical Biochemistry, Biogen Idec

Paul Schnier, Ph.D., Molecular Structure & Design, Amgen, Inc.

(SC7) PHAGE DISPLAY IN VACCINE DEVELOPMENT

Peptide Mimotopes: Discovery of small peptides that can mimic vaccine antigens
Vaccine Antigen Epitope Mapping: Use of phage display to discover dominant antigen epitopes
Phage Based Vaccines: Use of peptides on phage vs. peptides alone for vaccination

Course Instructors:

Aaron K. Sato, Ph.D., Senior Director, OncoMed Pharmaceuticals, Inc.

Danuta Kozbor, Ph.D., Associate Professor of Immunology and Microbiology, Department of Immunology, Roswell Park Cancer Institute

Dimiter S. Dimitrov, Ph.D., Senior Investigator, Protein Interaction Group, National Cancer Institute, NIH

Beka Solomon, Ph.D., Department of Molecular Microbiology & Biotechnology, George S. Wise Faculty of Life Sciences, Tel-Aviv University

(SC8) MEMBRANE PROTEINS - An important protein class

Overview of Membrane Proteins
Structure & Assembly
Function & Interactions
Drug Targets
Transporters

Course Instructors:

William A. Cramer, Ph.D., Henry Koffler Professor, Biological Science, Purdue University

Ernst ter Haar, Ph.D., Research Fellow I, Structural Biology, Vertex Pharmaceuticals, Inc.

Robert K. Nakamoto, Ph.D., Professor and Vice Chair, Department of Molecular Physiology & Biological Physics, University of Virginia

Dinner Short Courses

Tuesday, May 18

5:30 PM - 8:30 PM

(SC9) DINNER, PRESENTATIONS AND INTERACTIVE PANEL DISCUSSION - SATISFYING FDA RECOMMENDATIONS IN THE AREA OF PROTEIN AGGREGATE QUANTIFICATION IN PROTEIN THERAPEUTICS

At the close of the day an optional Dinner and Short Course will be hosted at the conference venue. Attendees must register in advance, as seating is limited. This event will feature both presentations and an interactive panel discussion where the audience can bring up specific issues or questions important to their work.

Overview of immunogenicity studies & conclusions
FDA recommendations in the area of aggregate quantification
Common techniques used to characterize protein aggregates & basic principles
Advantages, disadvantages, and complementarities of each of these techniques

Chair: Kevin Mattison, Ph.D., Senior Bioanalytical Scientist, Product Development, Malvern

Course Instructors:

Thomas M. Laue, Ph.D., Professor, Biochemistry and Molecular Biology; Director, Biomolecular Interaction Technologies Center (BITC), University of New Hampshire

Henryk Mach, Ph.D., Senior Investigator, Bioprocess Analytical and Formulation Sciences, Merck Research Laboratories

Devendra (Davy) S. Kalonia, Ph.D., Professor of Pharmaceutics, University of Connecticut

Mark Pollo, Associate Senior Biophysical Chemist, Bioproduct Research and Development, Eli Lilly

Thursday, May 20

5:30 PM - 8:30 PM

(SC10) AFFINITY TAGS FOR PROTEIN PURIFICATION DINNER, PRESENTATIONS & INTERACTIVE DISCUSSION