CHI's 14th Annual PepTalk Protein Science Week

Cambridge Healthtech Institute’s 14th Annual JANUARY 19-23, 2015
Town and Country Resort &
Convention Center
SAN DIEGO, CA
Cambridge Healthtech Institute, 250 First Avenue, Suite 300 , Needham, Massachusetts 02494
Telephone: 781-972-5400 • Toll-free in the U.S. 888-999-6288 • Fax: 781-972-5425
PREMIER SPONSOR:
2015 Event Features:
• 1,200+ International Participants including Scientists,
Regulators and Solution Providers
• 20 Conferences on Antibodies, Formulation, Expression,
Analytics, Purification and more
• 13 Short Courses to Enhance Your Learning Experience
• 325+ Scientific Presentations from Industry Leaders
• 80+ Interactive BuzZ Session Roundtables
• 100+ Exhibitors Showcasing Novel Technologies and
Solutions
• 125+ Cutting-Edge Research Posters
PLENARY KEYNOTE
From Yeast to the Brain:
Advances in Proteomics
John R. Yates, Ph.D.,
Ernest W. Hahn Professor, Chemical Physiology
and Molecular and Cellular Neurobiology, The
Scripps Research Institute
Register by
September 12 for Early-Bird
Savings up to $600
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Short Courses
Training Seminars
PROTEIN ENGINEERING & DEVELOPMENT
Recombinanat Protein Therapeutics
Enhancing Antibody Binding & Specificity
Improving the Clinical Efficacy of Antibody
Therapeutics
ANTIBODY THERAPEUTICS
Cancer Targets for Antibody Therapeutics
Antibody-Drug Conjugates
Bispecific Antibody Therapeutics
FORMULATION & STABILITY
Optimizing Biologics Formulation Development
Lyophilization & Emerging Drying Technologies
Protein Aggregation & Emerging Analytical Tools
EXPRESSION & PRODUCTION
Engineering Genes, Vectors, Constructs & Clones
Recombinant Protein Expression & Production
Transient Protein Production
ANALYTICS & IMPURITIES
Characterization of ADCs, Bispecifics & New
Biotherapeutics
Detection and Characterization of Particulates
& Impurities
Extractables & Leachables
PROCESS TECHNOLOGIES & PURIFICATION
Single-Use Technologies & Continuous Processing
Protein Purification & Recovery
Higher-Throughput Protein Purification
ACCOMPANYING CONFERENCES:
• MEMBRANE PROTEINS
• CHO CELLS
Sponsorship & Exhibit Opportunities
Hotel & Travel / Additional Info
Registration & Pricing
Register online at CHI-PepTalk.com

Antibody Therapeutics Short Courses Cancer Targets for Antibody
Formulation & Stability Short Courses Optimizing Biologics Formulation
Development Short Courses Lyophilization and Emerging Drying
Technologies
Expression & Production Short Courses Engineering Genes, Vectors,
PepTalk: The Protein Science Week is one of the largest gatherings of
protein science researchers in the United States, and when you bring
together some of the most influential people in the field - big things happen!
PepTalk offers an array of education, innovation and networking programs.
Over 300 high-caliber speakers share case studies, unpublished data,
breakthroughs and solutions that support and enhance your research.
Ample networking opportunities allow you to connect with colleagues and
peers from around the world and gain new perspectives on the evolution
of biologics. Choose between 20 Conferences, 13 Short Courses, 3 Training
Seminars, 80+ BuzZ Session Discussion Roundtables, and dedicated exhibit
hall and poster viewing hours to create a custom agenda that fits your
research and networking needs!
PLENARY KEYNOTE
Wednesday, Jan. 21, 4:25pm
From Yeast to the Brain: Advances in Proteomics
John R. Yates, Ph.D., Ernest W. Hahn Professor, Chemical Physiology and Molecular and Cellular Neurobiology, The Scripps Research Institute
ABOUT:
John R. Yates is the Ernest W. Hahn Professor in the Department of Chemical Physiology and Molecular and Cellular Neurobiology at The Scripps Research Institute. His research
interests include development of integrated methods for tandem mass spectrometry analysis of protein mixtures, bioinformatics using mass spectrometry data and biological
studies involving proteomics. He is the lead inventor of the SEQUEST software for correlating tandem mass spectrometry data to sequences in the database and developer of the
shotgun proteomics technique for the analysis of protein mixtures. His laboratory has developed the use of proteomic techniques to analyze protein complexes, posttranslational
modifications, organelles and quantitative analysis of protein expression for the discovery of new biology. Many proteomic approaches developed by Yates have become a national
and international resource to many investigators in the scientific community. He has received the American Society for Mass Spectrometry research award, the Pehr Edman Award
in Protein Chemistry, the American Society for Mass Spectrometry Biemann Medal, the HUPO Distinguished Achievement Award in Proteomics, Herbert Sober Award from the
ASBMB and the Christian Anfinsen Award from The Protein Society. He was ranked by Citation Impact, Science Watch as one of the Top 100 Chemists for the decade, 2000-2010.
He was #1 on a List of Most Influential in Analytical Chemistry compiled by The Analytical Scientist 10/30/2013 and is on the List of Most Highly Influential Biomedical Researchers,
1996-2011, European J. Clinical Investigation 2013, 43, 1339-1365.He has published 751 scientific articles with ~57,000 citations, and an H index 119.
ALL REGISTERED CONFERENCE PARTICIPANTS ARE WELCOME!
Get Connected!
PRE-CONFERENCE DINNER
SHORT COURSES*
Sunday, Jan. 18
Monday-Tuesday,
Jan. 19-20
DINNER SHORT COURSES*
Tuesday, Jan. 20
Wednesday-Thursday (am),
Jan. 21-22
Thursday (pm)-Friday,
Jan. 22-23
PIPELINE 1
Protein Engineering &
Development
Short Courses Recombinant Protein Therapeutics Short Courses Enhancing Antibody Binding and
Specificity
Improving the Clinical Efficacy of
Antibody Therapeutics
PIPELINE 2
Therapeutics Short Courses Antibody-Drug Conjugates Bispecific Antibody Therapeutics
PIPELINE 3
Protein Aggregation and Emerging
Analytical Tools
PIPELINE 4
Constructs and Clones Short Courses Recombinant Protein Expression
and Production Transient Protein Production
PIPELINE 5
Analytics & Impurities Short Courses
Characterization of ADCs,
Bispecifics and New
Biotherapeutics
Short Courses Detection and Characterization of
Particulates and Impurities Extractables and Leachables
PIPELINE 6
Process Technologies &
Purification
Short Courses Single-Use Technologies and
Continuous Processing Short Courses Protein Purification and Recovery Higher-Throughput Protein
Purification
NEW Accompanying Conferences Short Courses Short Courses Membrane Proteins / CHO Cells
Training Seminars Short Courses Intro to Bioprocessing Short Courses
Intro to Formulation
Intro to Analytical Method
Development and Validation
for Therapeutic Proteins
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PREMIER SPONSOR
CORPORATE SPONSORS
CORPORATE SUPPORT SPONSORS
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PRE-CONFERENCE DINNER SHORT COURSES*
SC1: Production Challenges for Complex Biologics: ADCs,
Bispecifics and Fusion Proteins
This course addresses the typical production issues encountered with
complex biologics, namely fusion proteins, antibody-drug conjugates and
bispecific antibodies. Experts elucidate the structure and nature of these
biologics in order to understand and master their properties. Along with
exploring manufacturing challenges, the course also reveals how to overcome
these challenges with practical insights and advice.
Instructors: Stefan Schmidt, Ph.D., Vice President, DSP, Rentschler
Biotechnology
Christopher D. Thanos, Ph.D., Director, New Molecular Entities, Halozyme
Therapeutics, Inc.
SC2: The S-Score System: A Tool for Identifying New Cancer
Targets for Antibody-Drug Therapy
The course discusses a new method that aids identification and prioritization
of predicted cancer genes for future analysis. It generates a gene-specific
“S-score” by incorporating data from different analysis types. I present results
where this method was applied to Cancer Genome Atlas data for identification
of oncogenes and tumor suppressors, a web server allowing users to query
the system with clinically relevant issues and case studies where the S-score
has helped identify targets for antibody-based therapy.
Instructor: Sandro J. de Souza, Ph.D., Laboratory of Computational Biology,
Ludwig Institute for Cancer Research
SC3: A Rational Approach to Formulation Development of
Biologic Therapeutics
The course offers a forum discussing how to develop formulation for biologic
drugs. Case studies demonstrate how to incorporate Quality-by-Design (QbD)
concepts to design multivariate experiments, how to obtain representative
data and how to analyze data in order to propose sound formulation of drug
substance or drug product in the context of designated container closure
systems. The course will combine how-to suggestions and real-world
examples in an interactive discussion.
Instructor: Kevin Zen, Ph.D., Manager, Biologics Development, Allergan
SC4: Genome Editing Using CRISPR
Mammalian cells are the workhorses for biopharmaceutical production. Thus,
genome engineering/editing of these hosts to improve product quality and
yields are of great interest. CRISPR, the newest gene editing tool, is gaining
popularity among protein engineers and cell line developers. This course
provides an introduction to CRISPR technology and insights on implementation
for your protein expression and production pipeline.
Instructors: Helene Faustrup Kildegaard, Ph.D., Co-Principal Investigator,
Novo Nordisk Foundation Center for Biosustainability, Technical University of
Denmark
Norman Garceau, Ph.D., CSO, Blue Sky Biotech, Inc.
Additional Instructors to be Announced
SUNDAY, JANUARY 18 | 5:00-8:00 PM
SC5: Accelerated Stability Testing of Biologics
This short course guides the researcher in designing studies for accelerated
stability testing of biologics. The course begins with basic underlying concepts
governing protein drug product stability, and focuses on design principles for
measuring stress and accelerated stability testing of not only the protein of
interest, but also excipients and primary packaging components. Strategies to
handle complexities arising from their interactions will also be discussed.
Instructor: Vishal C. Nashine, Ph.D., Senior Research Investigator, Drug Product
Science & Technology, Bristol-Myers Squibb Co.
SC6: Establishing the Business Case for Single-Use and
Continuous Processing
This short course introduces attendees to the paradigm shift and a new way
of economic and manufacturing considerations for implementing single-use
systems and continuous processing. Based on case studies, projects and
available data, we establish a platform for drug manufacturing that is robust,
streamlined, sustainable and energy saving, and at the same time reduces
COGS and carbon print, culminating towards a more streamlined operation for
either batch or continuous processing.
Instructor: Robert Dream, PE, CPIP, CPMP, Ph.D., Principal, HDR Company Ltd.
BuzZ Sessions are facilitated, small-group discussions.
Interactive participation leads to problem-solving
solutions and future collaborations around focused
topics.
If you have a topic idea or would like to moderate a table, please
contact: Ann Nguyen at anguyen@healthtech.com
Please visit our website for more details.
* Please visit our website for more details.
Separate registration required.
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DINNER SHORT COURSES* TUESDAY, JANUARY 20 | 5:00-8:00 PM
SC7: Targeting of GPCRs with Monoclonal Antibodies
While GPCRs (G protein-coupled receptors) are important therapeutic targets,
it has been challenging to discover therapeutically relevant antibodies against
them. This course examines different steps along the anti-GPCR antibody
discovery pathway and highlights various approaches to accomplishing each
step. Topics include: 1) Antibody discovery, 2) Assays to measure antibody
binding, 3) In vitro assays to measure functional activity of the antibody, and 4)
Review of promising GPCR targets and antibodies in the clinic.
Instructor: Barbara Swanson, Ph.D., Director, Research, Sorrento Therapeutics, Inc.
SC8: Affecting Effector Function: Engineering the Fc Region
There are a growing number of antibodies and Fc fusion proteins in
development that contain a modified Fc region, either via changes in amino
acid sequence or in glycoforms. Engineering antibodies and Fc fusion
proteins has become more sophisticated at generating molecules that are
better suited to the pharmacological activity required. This course focuses
on characterizing and engineering effector functions in order to create more
effective therapeutics.
Instructors: Tomoyuki Igawa, Ph.D., Manager, Antibody Engineering Group,
Discovery Research, Chugai Pharmaceutical Co., Ltd.
Futa Mimoto, Ph.D., Researcher, R&D, Chugai Pharmaceutical Co., Ltd.
SC9: Protein Aggregation: Mechanism, Characterization and
Consequences
Protein aggregation is recognized by regulatory agencies and the
biopharmaceutical industry as a key quality attribute of biotherapeutic
products. Various aggregates hold the potential for adversely impacting
production and patients in a variety of ways. This in-depth workshop
reviews the origins and consequences of aggregation in biotherapeutics,
and then examines strategies for predicting and quantifying aggregation in
biopharmaceuticals. It benefits scientists engaged in development, production,
analytical characterization and approval of biotherapeutics and who require a
good working knowledge of protein aggregation.
Instructor: Thomas Laue, Ph.D., Professor, Biochemistry and Molecular
Biology; Director, Biomolecular Interaction Technologies Center (BITC),
University of New Hampshire
SC10: Transient Protein Production in Mammalian Cells
This short course introduces both the fundamental concepts and technologies
needed to establish transient protein production in mammalian cells. This
allows for the rapid generation, purification and characterization of milligram-to-
gram quantities of secreted or intracellular recombinant proteins for
therapeutic, functional and structural studies. The course combines instruction
and case studies in an interactive environment.
Instructors: Richard Altman, MS, Research Scientist, Molecular Sciences,
Alexion Pharmaceuticals
Henry C. Chiou, Ph.D., Associate Director, Cell Biology, Life Science Solutions,
Thermo Fisher Scientific
Dominic Esposito, Ph.D., Director, Protein Expression Laboratory, Frederick
National Laboratory for Cancer Research, Leidos Biomedical Research, Inc.
Krista Johnson, MSc, Research Scientist, Protein Sciences, Alexion
Pharmaceuticals
SC11: Materials in Contact with Biologics: Understanding Risk to
Quality and Safety
Materials that contact biologics during manufacturing, storage and final
packaging can pose risks to biopharmaceutical quality. This in-depth
course reviews the regulatory requirements, types of materials used and
material chemistry, and then examines the strategies for prediction and
risk assessment of potential threats to quality and safety of biologics drug
products. The course reviews development of a successful analytical strategy
for single-use components, container closure components and risk posed
by leachables.
Instructor: Diane Paskiet, Ph.D., Director, Scientific Affairs, West
Pharmaceutical
SC12: Protein Purification Strategies: Dealing with Proteins that
Are Prone to Aggregate
This course provides a comprehensive and detailed outline of hands-on
issues for purifying proteins. We first address general considerations about
the protein we want to produce, including issues of activity, solubility,
homogeneity, purity and proper oligomeric conformation. Aggregation is one
of the main obstacles in protein production, so we look at how to monitor
for aggregation and comprehend its mechanism. We also discuss how to
check for the optimal solubility conditions at the expression level, and our
comprehensive approach for optimizing solubility during purification. We also
discuss expression screening methodology, environmental factors to consider
during purification, families of additives and screening for additives. Lastly, we
address ways to avoid aggregation, as well as setting up protein concentration
and storage.
Instructor: Mario Lebendiker, Ph.D., Head, Protein Purification Facility, Wolfson
Centre for Applied Structural Biology, Hebrew University of Jerusalem
SC13: Continuous Processing of Therapeutic Proteins in
Single-Use: Technology and Production Concept
The course demonstrates how each unit operation in a typical mAb process
can be run continuously and also shows how these unit operations are
integrated into a truly continuous process. We also demonstrate how the
combination of continuous processing and single-use technology can be
implemented in a production facility. GMP-compliant production aspects such
as process control, automation, PAT, process robustness, quality assurance
and facility will also be discussed.
Instructor: Jørgen Magnus, Ph.D., Manager, R&D, Bayer Technology Services
GmbH
* Please visit our website for more details.
Separate registration required.
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TS1: INTRODUCTION TO BIOPROCESSING
Instructors:
Susan Dana Jones, Ph.D., Vice President and
Senior Consultant, BioProcess Technology
Consultants, Inc.
Sheila G. Magil, Ph.D., Senior Consultant,
BioProcess Technology Consultants, Inc.
CHI’s Introduction to Bioprocessing training seminar offers a
comprehensive survey of the steps needed to produce today’s
complex biopharmaceuticals from early development through
commercial. The seminar begins with a brief introduction to
biologic drugs and the aspects of protein science that drive
the intricate progression of analytical and process steps that
follows. We then step through the stages of bioprocessing,
beginning with the development of cell lines and ending at
the packaging of a finished drug product. The seminar also
will explore emerging process technologies, facility design
considerations and the regulatory and quality standards that
govern our industry throughout development. The important
roles played by the analytical and formulation steps in
developing and gaining approval for a biopharmaceutical are
also examined.
This 1.5-day class is directed to attendees working in any
aspect of industry, including scientific, technical, business,
marketing or support functions, who would benefit from
receiving a detailed overview of this field.
About the Instructors:
Susan Dana Jones is a seasoned biotechnology entrepreneur
with experience in product development, outsourcing and
strategic planning. Dr. Jones is a subject matter expert in
cell line development and characterization for biosimilar, new
biopharmaceutical, and vaccine development programs.
She has broad knowledge of regulatory requirements for
manufacturing products for human use and has prepared CMC
sections of multiple regulatory submissions. She currently
serves on the Board of Directors of Gene Solutions, the
Scientific Advisory Board of Symphogen, and is a member
of the Editorial Advisory Board of BioProcess International.
She received her Ph.D. in Genetics from the University of
California, San Francisco.
Sheila Magil has over 20 years of experience in quality and
analytical method development for biologics, peptides and
small molecules. Her expertise includes quality assurance,
protein and peptide biochemistry, and analytical development.
She was formerly Senior Manager of Analytical Development
and Quality Control at Biomeasure, Inc., and previously held
positions at WaratahPharma, Alkermes, Bion, and HHMI at
Massachusetts General Hospital. Dr. Magil has implemented
quality systems and has managed external analytical and
QC activities for multiple biopharmaceutical products. Dr.
Magil holds a Ph.D. in Biochemistry from the University of
Minnesota.
TS2: INTRODUCTION TO BIOLOGICS
FORMULATION AND DELIVERY
Instructor:
Timothy Kelly, Ph.D., Vice President,
Biopharmaceutical Development,
KBI Biopharma, Inc.
The course focuses on strategies to plan and execute
preformulation and formulation development studies for biologics,
which require co-optimization of multiple physical, chemical
and conformational stability attributes while operating under
accelerated timelines to deliver the drug to the clinic. The course
begins with an overview of biophysical and biochemical properties
of proteins. A typical development workflow (including statistical
analysis and DOE elements) will be outlined to demonstrate
the core elements employed during protein formulation. The
course concludes with real-world examples from formulation
development projects for liquid and lyophilized products.
• Basics of protein biochemistry, with focus on folding
mechanism, stability and structural hierarchy
• Degradation pathways relevant to biologics shelf life
• Biophysical and analytical characterization tools
• Typical workflow for biologics formulation
development projects
• Introduction to common delivery devices
About the Instructor:
Tim Kelly has over 20 years of experience in protein and
nucleic acid characterization. In his role at KBI Biopharma,
Tim is responsible for analytical development, formulation
development, and quality control. Prior to joining KBI Biopharma,
Tim held the position of Director of Quality Control for Diosynth
Biotechnology, where he was responsible for method validation,
in-process control, release and stability of clinical and commercial
biopharmaceutical products. Tim’s experience also includes the
analytical development, formulation development, characterization
and/or production of more than 200 clinical and commercial
protein therapeutics, including monoclonal antibodies, enzymes,
cytokines, fusion proteins, PEGylated proteins, protein vaccines
and peptides. Tim has led the successful formulation development
of over 95 clinical and commercial biopharmaceutical products,
including liquid and lyophilized dosage forms for intravenous and
subcutaneous administration, at protein concentrations ranging
from 10μg/mL to 200mg/mL. Tim earned his Ph.D. in Molecular
Genetics & Biochemistry from Georgia State University.
TS3: INTRODUCTION TO ANALYTICAL
METHOD DEVELOPMENT AND VALIDATION
FOR THERAPEUTIC PROTEINS
Instructor:
Jichao (Jay) Kang, Ph.D., RAC, Director,
Analytical and Formulation Development,
Gallus Biopharmaceuticals NJ, LLC
This course is a panoramic review of analytical method
development and validation for therapeutic proteins, including
antibodies and enzymes. It is intended for scientists working
on therapeutic proteins in Analytical Development, Quality
Control, Product Development or related functional areas. It
starts with basic knowledge of work on therapeutic proteins:
manufacturing of proteins drugs, regulatory affair knowledge
and protein chemistry. It then discusses fundamentals and
practical aspects of commonly used analytical methods
for proteins, including methods for structure elucidation,
glycan characterization, biophysical characterization, potency
measurement, purity and impurity analysis. The course
concludes with the strategy and common practice in
method validation and method transfer, including regulatory
compliance at different stages of product development,
application of DOE and QbD. The course emphasizes practical
applications, real-world examples and useful tips.
Benefits
• Gain a complete picture of analytical method
development and validation process
• Gain a basic understanding of commonly used analytical
methods for proteins
Who Should Attend
• Analytical development scientists, process development
scientists, QC analysts, regulatory affair managers,
project managers and quality assurance managers
About the Instructor:
Dr. Jichao Kang holds a Ph.D. in Pharmaceutics and has
been working on characterization, method development
and validation and formulation for protein therapeutics since
1995. He is an accomplished researcher with over 15 peer-reviewed
journal articles and book chapters, several patents
and numerous conference presentations. The proteins he
has worked on extensively include cytokines, antibodies,
enzymes and protein conjugates. He is a key contributor in
dozens of IND/IMPD and BLA/MAA filings. He is currently
the Director of Analytical and Formulation Development
at Gallus BioPharmaceuticals NJ, LLC, one of the leading
CMOs for biologics, and held the same position at Laureate
BioPharma before it was acquired by Gallus. Prior to Laureate,
he was the department head of Analytical Development at
Auxilium Pharmaceuticals, Inc., and was a key contributor
in Auxilium’s successful marketing application of Xiaflex in
both U.S. and EU. He also worked in MedImmune, PDL, and
Neose Technologies.
JANUARY 19-20, 2015
DAY 1 8:30 AM - 5:30 PM | DAY 2 8:30 AM - 12:30 PM
JANUARY 21-22, 2015
DAY 1 8:30 AM - 4:25 PM | DAY 2 8:30 AM - 12:30 PM
Please visit our website for more details.
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PIPELINE 1: PROTEIN ENGINEERING & DEVELOPMENT
11th Annual Recombinant Protein Therapeutics
Fusion Proteins and Beyond
JANUARY 19-20
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The customizable functionality of fusion protein therapeutics creates advantages over antibody-based therapies by combining modular building blocks that can
reach targets not accessible to antibodies. Additional advantages include lower patient dosing, reduced production costs and improved product homogeneity. The
Recombinant Protein Therapeutics meeting explores the varying constructs and “designs” of fusion protein molecules, and discloses how they are being engineered
to form more efficacious therapeutics that offer specificity with enhanced stability and longer half life. Experts present case studies from R&D through clinical data
and share the results they have achieved.
SUNDAY, JANUARY 18
4:00-5:00 pm Short Course Registration
5:00-8:00 Pre-Conference Dinner Short Courses
See pages 4-5 for details
4:00-8:00 Main Conference Registration
MONDAY, JANUARY 19
7:30 am Conference Registration and Morning Coffee
NEXT-GENERATION BIOLOGICS
9:00 Chairperson’s Opening Remarks
Stefan Schmidt, Ph.D., Vice President, DSP, Rentschler Biotechnology
»»KEYNOTE PRESENTATION
9:10 Roche’s Strategies to Discover, Design, Develop, and Deliver
New Innovative Therapeutic Biologics
Ralf Schumacher, Ph.D., Site Head, Large Molecule Research Penzberg, and
pRED Center Manager, Roche Diagnostics GmbH
Biologics have become a key component in the treatment of various life-threatening
diseases. The majority of these drugs are classical monoclonal
antibodies. In order to discover and develop differentiated monoclonal
antibodies, Roche’s strategy is based on engineering technologies.
ADCC-enhancement, multi-pathway-inhibition, specific tumor-targeting
of pharmacophores and blood-brain-barrier crossing are examples for
successfully engineered mAbs and fusion proteins. In this presentation, I will
describe Roche’s strategies to design such molecules, give examples but will
also address challenges for technical development.
»»FEATURED PRESENTATION
9:50 Monomeric Fc Fusion Clotting Factors for the Treatment of
Hemophilia
Jennifer Dumont, Ph.D., Director, Medical Affairs, Biogen Idec, Inc.
10:20 Coffee Break
ENGINEERING BREAKTHROUGHS
10:45 A Small Biologic Alternative to PCSK9 Antibodies:
Pharmacologic Profile and Demonstration of Robust LDL Lowering
with an Anti-PCSK9 Adnectin
Tracy Mitchell, Ph.D., Principal Scientist, Bristol Myers-Squibb Co.
PCSK9 is perhaps the most promising drug target for treating cardiovascular
disease since the discovery of statins. Compared with therapeutic IgG antibodies
currently in clinical trials, targeting circulating PCSK9 with a smaller molecular
scaffold could offer reduced dose burdens and different pharmacologic profiles.
We present the pharmacological profile of BMS-962476, a potent Adnectin
inhibitor of PCSK9 that has demonstrated robust target engagement and LDL
lowering in mice, cynos and humans.
11:15 Development of an Intein-Based Conjugation Platform for the
Synthesis of Fc-Fusion Proteins
Oliver Thiel, Ph.D., Principal Scientist, Chemical Process Research &
Development, Amgen, Inc.
Identification of an ideal platform technology for conjugation of small molecules
and peptides to biomolecules for improved pharmacokinetics has been a recent
focus within academic and industrial laboratories. This contribution will focus
on the development of an intein-based platform for conjugation of peptides at
the C-terminus of the Fc domain of immunoglobulins. In the course of platform
development, selection of intein, cleavage residue, and linker between Fc and
intein were examined.
11:45 A Bi-Functional Antibody-Receptor Domain Fusion Protein
Simultaneously Targeting IGF-IR and VEGF for Degradation
Yang Shen, Ph.D., Director, Antibody Technology, and Research Advisor, Antibody
Engineering, ImClone Systems, a wholly-owned subsidiary of Eli Lilly and
Company
A fully human Bi-functional Antibody-receptor domain (VEGFR1 domain 2) fusion
molecule with ligand Capture (BiAbCap) targeting IGF-IR and VEGF was designed
and developed, that displays excellent thermal and physical stability. Taking
advantage of natural receptor-ligand interaction, bi-AbCap represents a novel and
developable format of bi-functional antibodies with potent neutralizing activities
against both targets. The unique “capture-for-degradation” mechanism translates
to potent anti-tumor activity superior to the combination in vivo.
12:15 pm Sponsored Presentation (Opportunity Available)

JANUARY 19-20
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12:45 Session Break
1:00 Luncheon Presentation (Sponsorship Opportunity Available) or
Enjoy Lunch on Your Own
ENHANCING PROPERTIES
2:00 Chairperson’s Remarks
Manfred Schuster, Ph.D., COO, Apeiron Biologics AG
2:05 Unravelling the Molecular Basis of Host Cell-Specific
Glycosylation and Species-Specific Pharmacokinetics
Catherine Huntington, Ph.D., Research Scientist II, Antibody Discovery and
Protein Engineering (ADPE), MedImmune, LLC
Glycosylation plays a significant role in the half-life of recombinant proteins in vivo,
with the production cell lines affecting PK. Here, we expand on observations that
HEK-293 expressed proteins are rapidly cleared in mouse models and our efforts
to characterise the glycan forms responsible. Additionally, we will present our work
to develop methods to profile glycan forms on recombinant proteins with the aim
to predict impact on half-life of different species.
2:35 Enhancing Stability of the Therapeutic Enzyme L-Asparaginase
by Biocompatible Nanoparticles
Manfred Konrad, Ph.D., Research Director, Enzyme Biochemistry, Max Planck
Institute for Biophysical Chemistry
The enzyme L-asparaginase is a protein drug of high value in antileukemic therapy.
Clinically approved L-asparaginases are of bacterial origin, though they elicit
severe side effects, in particular immunogenicity. We present a novel approach
for encapsulation of the enzyme using calcium carbonate particles surrounded
by layers of biocompatible polymers, thus forming nanocontainers as carriers to
enhance serum stability and suppress recognition by the immune system.
3:05 Manufacturing of Half-Life Extended Fusion Proteins: Current
Trends and Challenges
Stefan Schmidt, Ph.D., Vice President, DSP, Rentschler Biotechnology
Second and third generation therapeutic proteins often contain a half-life
extension moiety. These additional modules of fusion proteins often complicate
the manufacturing process as they require specific adaptations of both up- and
downstream processes. First, we give a comprehensive overview on the current
state-of-the-art regarding half-life extension technologies, and second, we
illustrate manufacturing challenges and solutions presented through selected
case studies, additionally giving practical advice on optimization potential.
3:35 Sponsored Presentation (Opportunity Available)
3:50 Refreshment Break
CONQUERING DISEASE
4:15 A Neuroprotective Brain-Penetrating Endopeptidase Fusion
Protein Ameliorates Alzheimer Disease Pathology and Restores
Neurogenesis
Eliezer Masliah, M.D., Professor, Neuroscience and Pathology, University of
California at San Diego
Alzheimer’s (AD) and Parkinson’s Disease (PD) are the most common
neurodegenerative disorders. We developed recombinant endopeptidases and
antibodies with a unique brain targeting sequence derived from ApoB and have
shown in animal models of AD and PD that these hybrid proteins ameliorate
the pathology and recover the functional deficits. These results suggest that the
recombinant brain-targeted proteins might be of use in the treatment of AD and PD.
4:45 Novel Human Resistant Mutant that Acts as Antagonist
Reduced Body Weight Gain and Restored Insulin Responsiveness in
Mice Fed High Fat Diet
Arieh Gertler, Ph.D., CEO, Protein Laboratories Rehovot; Professor-Emeritus and
Head of Research Team, Biochemistry, The Hebrew University of Jerusalem
Resistin promotes both inflammation and insulin resistance associated with
energy homeostasis impairment. To block resistin action, we developed a
recombinant human resistin mutant (C6A) that acts as a resistin antagonist
(RA). We clearly show that RA leads to a significant decrease in body weight of
HFD mice. Importantly, RA treatment completely restored glucose tolerance as
evidenced by glucose tolerance test and also restored insulin-responsiveness as
estimated by insulin tolerance test.
5:15 Local Inhibition of Cytokine Signaling to Treat Anterior and
Posterior Ocular Disorders
Eric Furfine, Ph.D., CSO, Eleven Biotherapeutics
Cytokines, chemokines, and growth factors mediate anterior and posterior eye
diseases. Our lead product, the IL-1 receptor inhibitor EBI-005, was designed
and engineered for the topical treatment of dry eye disease and was biologically
active in subjects with dry eye disease. In addition, we engineered an IL-6
inhibitor with potential for local treatment diabetic macular edema. Finally, a
novel soluble receptor inhibitor of cytokines IL-17A and IL-17F was engineered for
the local treatment of uveitis. Both IL-6- and IL-17-targeted drugs were designed
and engineered for intravitreal administration.
5:45-7:00 Welcome Reception in the Exhibit Hall with Poster
Viewing

JANUARY 19-20
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TUESDAY, JANUARY 20
8:00 am Morning Coffee
CONQUERING CANCER
Manfred Konrad, Ph.D., Research Director, Enzyme Biochemistry, Max Planck
Institute for Biophysical Chemistry
8:35 Late Stage Development of a Chimeric Antibody
Manfred Schuster, Ph.D., COO, Apeiron Biologics AG
This case study will focus on how our APN311 chimeric antibody targeting high-risk
neuroblastoma was able to overcome clinical, technical and financial hurdles
towards our application for market approval planned for mid-2014 in the US
and Europe. This talk will also give insights into clinical analytics and our CMC
strategy, and highlight a novel immune-therapy administration scheme to reduce
side effects and to maintain or even improve clinical response.
9:05 A Recombinant Immunotoxin for Cancer Treatment with Low
Immunogenicity by Identification and Silencing of Human T Cell
Epitopes
Ronit Mazor, Ph.D., Research Fellow, Lab for Molecular Biology (LMB), NCI/NIH
Recombinant immunotoxins are less active in patients with solid tumors
because their immune system makes anti-drug antibodies which inactive
the immunotoxin. To suppress the immune response, we have identified and
largely silenced the T cell epitopes responsible for the immune response
with a redesigned immunotoxin containing T cell epitope mutations that are
highly cytotoxic to cells isolated from cancer patients and produces complete
remissions in mice with human cancer xenografts.
9:50 Coffee Break in the Exhibit Hall with Poster Viewing
ENGINEERING FLEXIBILITY
11:00 Engineered Affibody Molecules in Multiple Formats for
Targeted Therapy
Fredrik Frejd, Ph.D., Vice President and CSO, Affibody AB
The half-life of biotherapeutics can be extended up to several weeks by applying
Affibody’s albumin binding domain (ABD) as a fusion partner. In addition,
Antibodies are functionalized using Affibody molecules to create bispecific
AffiMabs. Results from oral administration of a half-life extended peptide
for treatment of metabolic disease will be shown, along with new data to
complement C5-specific and IL-17-specific Affibody-ABD fusion molecules and
AffiMabs simultaneously targeting the IL-6 and TNF.
11:30 DeBouganin Fusion Proteins: A “Fit for Purpose” ADC Drug Design
Glen C. MacDonald, Ph.D., CSO, Viventia Bio, Inc.
Immunotoxins are comprised of a cell targeting domain linked to a cytotoxic toxin
payload. DeBouganin, a de-immunized variant of the type I ribosome-inactivating
protein (RIP) bouganin, is highly potent and represents an alternative to conventional
cytotoxic anti-cancer agents. This presentation will illustrate deBouganin’s distinct
mechanisms of action in the context of recombinant fusion proteins and highlight its
potency against cancer stem cells and cell lines overexpressing MDR.
12:30 Session Break
2:00 BuzZ Session A
3:00 Refreshment Break in the
Exhibit Hall with Poster Awards
3:45 BuzZ Session B
(Please visit our website for details)
4:45 Close of Conference
4:30-5:00 Short Course Registration
5:00-8:00 Dinner Short Courses See pages 4-5 for details

2nd Annual Enhancing Antibody Binding and Specificity
Emerging Science and New Technologies to Fine-Tune
Antibody-Antigen Binding and Target Specificity
JANUARY 21-22
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As the industry expands its repertoire of antibody drug products into new therapeutic areas, product formats and protein constructs, the control of antibody/antigen
targeting, binding and specificity will take on a new level of importance for researchers in this field. The second component of the PepTalk Protein Engineering &
Development pipeline, the Enhancing Antibody Binding and Specificity conference, presents innovative approaches to the modulation of binding activity, mechanism
of action and difficult target challenges such as transmembrane proteins.
TUESDAY, JANUARY 20
1:30 pm Conference Registration
WEDNESDAY, JANUARY 21
SPECIFICITY ENGINEERING
Jonas V. Schaefer, Ph.D., Head, High-Throughput Laboratory, Department of
Biochemistry, University of Zurich
8:20 The Impact of Anti-IgG Hinge Antibodies in Protease-
Enriched Diseases
Robert E. Jordan, Ph.D., Senior Director and Senior Research Fellow (retired),
Janssen Pharmaceuticals
Anti-IgG hinge antibodies display fine specificity for proteolytically-cleaved
IgGs but are not cross-reactive with the intact IgG counterpart. Engagement
of anti-hinge antibodies with cell-bound cleaved IgGs restores antibody
effector function in vitro and in vivo either when elicited by vaccination or
as a mAb. The findings presented here suggest a novel mechanism for
enhancing antibody-mediated cell-killing effector functions with application in
pathological settings where protease activity is abundant.
9:00 Engineering of High-Affinity Two-in-One Antibodies Using
Phage Display Coupled to Deep Sequencing
Sarah Sanowar, Ph.D. Senior Research Associate, Antibody Engineering,
Genentech, Inc. – A Member of the Roche Group
To improve antibody affinity, we sought to develop a robust strategy to identify
improved affinity variants beyond traditional phage-based screening. We turned
to an approach, which combines affinity-based selection on phage with deep
sequencing. Phage libraries with various diversity designs were combined to
maximize the searched sequence space. This strategy gave us a comprehensive
set of information on the effect of mutations in the antigen-binding site for a two-in-
one antibody with dual action Fab for both of its antigens.
STRATEGIES FOR SCREENING LARGE
ANTIBODY LIBRARIES
9:30 The Antibiome: Toward Renewable Antibodies to the Proteome
Michael Hornsby, Ph.D. Researcher, Pharmaceutical Chemistry, University of
California, San Francisco
We have developed a robust high-throughput robotic pipeline for the generation
and validation of renewable recombinant antibodies utilizing antibody phage-display.
In order to match the capacity of the antibody generation to the
availability of input antigens, we have developed several robust antigen
production pipelines. Both pipelines working together in concert will allow the
Recombinant Antibody Network (RAN) to develop quality renewable antibody
reagents to the proteome.
10:50 Pipeline 2.0: Integrating All Aspects from Target Acquisition
through Binder Validation for Optimized Binder Generation
Jonas V. Schaefer, Ph.D., Head, High-Throughput Laboratory, Department of
Biochemistry, University of Zurich
A robust pipeline for the high-throughput generation of affinity reagents enables
many scientific projects and novel applications. To optimize the pipeline’s
throughput, our laboratory developed a streamlined process, consisting
of parallel Ribosome Display selections and various semi-automated high-throughput
screenings. Also including aspects of target acquisition to binder
validation while decreasing its time and cost requirements, we perform
simultaneous selections against 94 targets and screen and validate several
thousand binders in parallel for their characteristics.
2:00 BuzZ Session A
3:45 BuzZ Session B

JANUARY 21-22
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SCREENING FOR RARE ANTIBODIES
11:20 An in vivo Human-Plasmablast Enrichment Technique Allows
Rapid Identification of Therapeutic Influenza A Antibodies
Gerald Nakamura, Ph.D., Scientific Manager, Antibody Engineering, Genentech,
Inc. – A Member of the Roche Group
Recent advances enabling the cloning of human immunoglobulin-G genes
have proven effective for discovering monoclonal antibodies with therapeutic
potential. However, these antibody-discovery methods are often arduous
and identify only a few candidates from numerous antibody-secreting cells.
We describe an in vivo enrichment technique that identified broadly influenza
neutralizing human antibodies with high frequency. Using this technology, we
identified four broadly neutralizing influenza A antibodies by screening only 840
human antibodies.
11:50 Towards a Quantum Leap in the Utility of Combinatorial
Libraries for Drug Hunters by Placing New Functional Screening
Options Up Front
Ronald M. Lindsay, Ph.D., CEO, Zebra Biologics
Whereas the relative merits of deriving therapeutic antibody candidates
via humanized mouse or phage display approaches are still debated, both
approaches yield an over abundance of initial ‘hits’ as defined by binding to
a desired target. Selecting “winners” from these initial hit binders remains
a bottleneck. I will discuss new screening approaches that allow more direct
high throughput selection of functional antibodies for known targets and the
discovery of new targets.
12:50 Session Break
RATIONAL APPROACHES TO ANTIBODY ENGINEERING
2:05 Antibody Modeling and Computational Design of Optimized
Molecules
Stanley Krystek, Ph.D., Senior Principal Scientist, Molecular Structure and
Design Bristol-Myers Squibb
Antibody structure-based modeling has been aimed at optimization of
pharmaceutical properties and has also been used for humanization, structure-guided
affinity maturation, antibody library design and modulation of effector
function. Examples of antibody modeling will be presented that describe
enabling applications of protein engineering of therapeutic molecules whose
stability, homogeneity, immunogenicity, aggregation and chemical liabilities
have been optimized leading to safer, more efficacious and developable
therapeutic molecules.
2:35 Extracting Life’s Operating Manual – Comprehensive Ruleset
Discovery and Bioengineering Applications
Jacob Glanville, Ph.D., CSO, Distributed Bio
Without comprehensive rulesets to guide rational design, most antibody
bioengineering efforts are iterative process of applying and testing small changes.
The combination of high-throughput sequencing, combinatorial gene synthesis
and selection pressures provides a unique opportunity to enumerate the ruleset
space that governs a molecule or entire repertoire. We’ll review the last 6 years of
theory and practical application, then transition to highlight some of the startling
novel technological applications such rule-based design can enable.
3:05 Precise and Efficient Antibody Epitope Determination Through
Library Design, Yeast Surface Display and Next- Generation Sequencing
Thomas Van Blarcom, Ph.D., Principal Scientist, Protein Engineering, Pfizer, Inc.
Here we describe a method to precisely and efficiently map the epitopes of small
panels of antibodies in parallel over the course of several weeks. This method
relies on the nexus of rational library design, quantitative yeast surface display and
next generation DNA sequencing and was demonstrated by mapping the epitopes
of several antibodies that neutralize the alpha toxin from Staphylococcus aureus.
»»4:25 PLENARY KEYNOTE SESSION See page 2 for details
5:45-7:00 Reception in the Exhibit Hall with Poster Viewing
THURSDAY, JANUARY 22
DISCOVERY AND DEVELOPMENT OF ANTIBODIES
FOR MEMBRANE PROTEIN TARGETS
Trevor Wilkinson, Ph.D., Associate Director, Protein Sciences, Antibody
Discovery and Protein Engineering, MedImmune
8:35 GPCR Expression by Individual Cell Types: Novel Membrane
Targets for Therapeutic Antibodies
Paul Insel, Ph.D., Professor, Pharmacology & Medicine, University of California,
San Diego
GPCRs, the largest family of membrane receptors, also represent the largest
class of targets of FDA-approved drugs. However, little is known regarding
GPCR expression by individual cell types. Using a GPCRomic strategy, we have
identified the full range of non-chemosensory GPCRs, including numerous
orphan GPCRs, expressed by many such cell types. Our other findings suggest
the possibility of using antibody therapeutics directed at such receptors.

JANUARY 21-22
SUBMIT A POSTER
Cambridge Healthtech Institute encourages
attendees to gain further exposure by presenting
their work in the poster sessions.
Reasons you should present your research poster at this
conference:
• Your poster will be exposed to our international delegation
• Receive $50 off your registration
• Your poster abstract will be published in our conference
materials
• You will automatically be entered into the poster competition
• Your research will be seen by leaders from top
pharmaceutical, biotech, academic and government institutes
To secure a poster board and inclusion in the conference materials,
your abstract must be submitted, approved and your registration
paid in full by November 21, 2014.
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9:05 Targeting T Cells with an Anti-Ion Channel Antibody with
Ultralong CDR H3s
Vaughn Smider, M.D., Ph.D., Assistant Professor, Molecular Biology, The Scripps
Research Institute
The relatively flat binding surface of a typical antibody paratope may not allow
optimal interactions with certain epitopes. Cow antibodies contain ultralong
CDR H3’s consisting of a b-ribbon stalk and disulfide-bonded knob. The knob
structures are reminiscent of ion channel bioactive peptides known to interact
with high specificity and affinity with ion channels. We have engineered a
cow antibody to bind and inhibit an ion channel critical for T cell activation in
autoimmune disease and inflammation.
9:50 Coffee Break in the Exhibit Hall with Poster Awards
10:50 Molecular Snapshot of GPCR Regulation and Signaling by
Arrestins: Emerging Avenues for Novel Drug Discovery
Arun Shukla, Ph.D., Professor, Medicine, Duke University Medical Center
GPCRs represent a primary drug targets for a number of human diseases.
The concept of beta arrestin mediated GPCR signaling (also known as biased
signaling) is changing the landscape of drug discovery targeting GPCRs. We
present unprecedented insights into arrestin mediated regulation and signaling
of GPCRs through a high resolution snapshot obtained by a combinatorial
approach. These insights open new avenues of novel drug discovery with
reduced side effects for a number of human disorders.
11:20 Discovery and Optimization of Novel Anti G-Protein Coupled
Receptor Monoclonal Antibodies
Trevor Wilkinson, Ph.D., Associate Director, Protein Sciences, Antibody
Discovery and Protein Engineering, MedImmune
G-protein coupled receptors represent a challenging target class for the isolation
and optimization of therapeutic biologics. We have used a combination of
immunization and phage display to isolate functional antagonistic antibodies
targeting a chemokine receptor and a formyl peptide receptor that will be
presented as case studies. We also describe how combinatorial mutagenesis
approaches have been used to make significant improvements to both affinity and
species cross-reactivity of a lead molecule and demonstrate that the optimised
antibodies show significantly increased potency in cellular disease assays.
11:50 High-Throughput Strategies to Obtain High Affinity, Specific,
and Conformationally Selective Recombinant Antibodies to
Membrane Proteins by Phage Display
Marcin Paduch, Ph.D., Technical Director, Synthetic Antibody & Crystallography
Core Facility, The University of Chicago
State of the art methods for generating recombinant antibodies to membrane
proteins require the use of detergents that do not necessarily mimic the native
lipid environment. We have developed a suite of next-generation high-throughput
technologies to generate high affinity, specific, and conformationally selective
reagents by exploiting liposomes, nanodiscs and cell surface display for antigen
presentation. These native-like environments create the possibility of trapping
physiological states otherwise not accessible by current methods.
12:20 pm Session Break

JANUARY 22-23
2nd Annual Improving the Clinical Efficacy of Antibody Therapeutics
Cutting-Edge Protein Engineering for the Next Generation of Safe and
Effective Biotherapeutics
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When the more than 350 therapeutic monoclonal antibodies in development advance into the clinic and to commercial launch, the quality of therapeutic response
will become increasingly important to regulatory agencies and frugal payors. Regulators are demanding better data to support claims of safety and potency – and
payors are seeking meaningful therapeutic benefits relative to existing standards of care before adding higher-cost biotherapeutics to formularies. The Improving the
Clinical Efficacy of Antibody Therapeutics conference showcases state-of-the-art discovery and development-stage engineering strategies for improving the safety
and effectiveness of this important class of biologic drugs.
THURSDAY, JANUARY 22
11:30 am Conference Registration
12:30 pm Luncheon Presentation (Sponsorship Opportunity Available)
or Enjoy Lunch on Your Own
1:30 Ice Cream Break in the Exhibit Hall with Poster Viewing
GLYCOENGINEERING AND ENHANCING
EFFECTOR FUNCTION
Janine Schuurman, Ph.D., Vice President, Research, Genmab
2:05 A Palette of Engineered Fc Domains for Optimal Antibody-
Mediated Target Cell Clearing and Immunomodulation
George Georgiou, Ph.D., Professor, Cockrell Family Regent’s Chair in Engineering,
Department of Biomedical Engineering, The University of Texas at Austin
We have engineered a variety of aglycosylated Fc domains displaying:
(i) very high binding affinity and selectivity for each individual human Fcγ
receptor; (ii) Fc domains that bind only to C1q; (iii) to Fcγ receptors as well
the FcγRI receptor that binds to IgA. These Fc domains were shown to elicit
unique profiles of immune cell activation and the clearance of target cells.
2:45 Improving the Therapeutic Efficacy of pH and Calcium-
Dependent Antigen Binding Antibodies
Tomoyuki Igawa, Ph.D., Group Manager, Discovery Research, Chugai
Pharmaceutical Company
pH or calcium-dependent antigen binding antibody enhances antigen elimination by
dissociating the antigen in the endosome. Here we report that Fc receptors such
as FcRn and inhibitory FcgRIIB can be exploited to further accelerate the antigen
elimination by pH or calcium-dependent antigen binding antibody. Enhancing binding
to Fc receptors, either by Fc engineering or by formation of multimeric antibody-antigen
complex, significantly accelerated antigen elimination from plasma in vivo.
3:15 Glycoengineering Enhanced ADCC in a FGFR2b-Specific
Antibody Treating Patients with Gastric Cancers
Kristen Pierce, Ph.D., Associate Director, Oncology, Five Prime Therapeutics
4:15 Refreshment Break in the Exhibit Hall with Poster Viewing
5:00 Complement Is Activated by IgG Hexamers Assembled at the
Cell Surface
Janine Schuurman, Ph.D., Vice President, Research, Genmab
Complement activation by antibodies is an important mechanism in immune
defense and immunotherapy. Using X-ray crystallography, mutagenesis studies
and cryo-EM tomography, we revealed that IgG antibodies form hexamers on
the cell surface following antigen binding. Enhancing hexamerisation on the
cell surface by using the HexaBodyTM platform potentiated the intrinsic killing
capability of antibodies in in vitro, in vivo and ex vivo models.
5:30 Cytotoxic Mechanisms of Immunotherapy: Harnessing
Complement in the Action of Anti-Tumor Monoclonal Antibodies
Ronald P. Taylor, Ph.D., Professor of Biochemistry, University of Virginia
We followed CDC mediated by CD20 mAbs engineered to enhance Fc-
Fc contacts, thus promoting strong C1q binding and rapid CDC. Confocal
microscopy movies revealed that during CDC, Ca2+ rapidly enters cells
and is soon localized to mitochondria. Ca2+ poisoning likely is the most
proximate mediator of cytotoxicity. These observations should allow for deeper
understanding of CDC mechanisms, and will play a critical role in development
of more effective immunotherapeutic mAbs.
6:00-7:00 Reception at the Tiki Pavilion
FRIDAY, JANUARY 23
COMBINATION STRATEGIES FOR ENHANCING THE
EFFICACY OF ANTIBODY THERAPY
Yasmina Abdiche, Ph.D., Research Fellow, Rinat-Pfizer
8:35 Multi-Targeting Antibody Mixtures to Address Tumor
Heterogeneity and Plasticity
Michael Kragh, Ph.D., Director, Preclinical Pharmacology & Toxicology, Symphogen A/S
9:05 Using an Oligoclonal Approach to Target HER3/ErbB3
Matthew Robinson, Ph.D., Assistant Professor, Fox Chase Cancer Center
HER3/ERBB3 is recognized as an important therapeutic target in a variety of
cancers and clinical validation of antibody-based therapies targeting this receptor
is currently underway. We have taken an oligoclonal approach to develop an
optimized anti-HER3/ERBB3 agent capable of inhibiting signaling through this
critical receptor and its heterodimeric partners. Work detailing the isolation and
characterization of an anti-HER3/ERBB3 oligoclonal will be discussed.

JANUARY 22-23
2nd Annual Improving the Clinical Efficacy of Antibody Therapeutics
Cutting-Edge Protein Engineering for the Next Generation of Safe and
Effective Biotherapeutics
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9:35 Development of an Antibody Combination Therapeutic (ACT)
for the Treatment of Ventilator Associated Pneumonia
Elizabeth Reczek, Ph.D., President and CSO, Excelimmune, Inc.
Antibody Combination Therapeutics (ACTs) are a novel class of polyvalent
biopharmaceuticals, uniquely suited for the treatment of complex diseases.
Excelimmune has developed a fully human antibody discovery platform and
AAV-based, virus-free recombinant protein expression technology capable of
rapid and consistent production of complex antibody mixtures in a single batch
format. We are leveraging this technology to develop an ACT therapeutic for the
treatment of Ventilator Associated Pneumonia (VAP).
10:05 Coffee Break in the Exhibit Hall with Poster Awards
CHARACTERIZATION OF PROPERTIES
IMPACTING EFFICACY
11:00 Analytical Methods to Characterize the Binding Kinetics,
Affinity, and Epitope of Therapeutic Antibodies
Yasmina Abdiche, Ph.D., Research Fellow, Rinat-Pfizer
11:30 Impact of Effector Cells on in vitro ADCC Activity of
Therapeutic Antibodies
Shan Chung, Ph.D., Senior Scientist, Bioanalytical Sciences, Genentech, Inc. – A
Member of the Roche Group
In this study we evaluated the impact of different type of effector cells on
the in vitro antibody-dependent cell-mediated cytotoxicity (ADCC) activity of
two glycoforms of a humanized IgG1 antibody. The results of this study show
differential effects on both the efficacy and potency of the antibodies by different
effector cells and that both the allotype and the expression level of CD16a affect
the potency of effector cells in ADCC assays.
12:00 pm Analytical Fc Receptor Affinity Chromatography for
Functional Characterization of Monoclonal Antibodies
Tilman Schlothauer, Ph.D., Senior Scientist, Protein Analytics,
Roche Diagnostics GmbH
Fc receptor-based affinity chromatography is a new emerging field of Fc
functionality analytics. Until now different human FcγReceptors (FcγRIIIa & IIa)
and the Fc Receptor neonatal (FcRn) from three species have been utilized
for coupling onto Sepharose-based matrices. FcRn affinity columns separate
antibody species (analytical and preparative) that differ in their affinity to FcRn
receptors, using conditions that closely resemble the physiological mechanism
of interaction between IgG and FcRn.
1:00 Session Break
STRATEGIES FOR IMPROVING THE EFFICACY OF
Jon Wojciak, Ph.D., Scientist, Lpath
2:05 Monoclonal Antibody Therapy for Multiple Myeloma
Frits van Rhee, M.D., Ph.D., Professor, Medicine; Director, Developmental and
Translational Medicine, Myeloma Institute for Research and Therapy, University
of Arkansas
2:35 Observations Regarding Antibody Pharmacokinetics and a
Case Study; Engineering a mAb for Prolonged Half-Life to Better
Assess an Animal Model Species
Tom Nesspor, Research Scientist, Biologics, Janssen
Epitope, affinity, immune effector function, and pharmacokinetics determine the
efficacy of therapeutic mAbs. This talk will review recent findings in our group
relating to antibody pharmacokinetics such as non-FcRn influences on clearance,
strategies for prolongation and reduction of half-life, and correlations between
human FcRn transgenic mice and human pharmacokinetics. It will conclude with
a case study describing the engineering of mAbs for prolonged half-life to better
assess an important animal model species.
3:05 Antibodies that Target Bioactive Lipids
Jon Wojciak, Ph.D., Scientist, Lpath
Developing therapeutic antibodies with favorable biophysical properties (e.g.
antigen affinity and specificity, solubility, aggregation, etc.) is a formidable
challenge, and engineering these antibodies can lead to molecules that undergo
rapid-reversible, self-association. Using molecular modeling and site-directed
mutagenesis, the reversible self-association of a humanized, monoclonal anti-lipid
antibody was minimized while the antigen affinity and specificity was retained.
3:35 Computational and Experimental Mapping of Deimmunized
Biotherapeutic Design Space
Karl E. Griswold, Ph.D., Associate Professor, Bioengineering, Thayer School of
Engineering, Dartmouth College
Biotherapeutics are powerful drugs, but the risk of protein immunogenicity represents
a barrier to their broader development and use. While methods for T cell epitope
identification are maturing rapidly, facile selection of deimmunizing yet function-preserving
mutations remains a challenge for protein engineers. Here we describe
experimental validation of integrated deimmunization algorithms that simultaneously
optimize both protein function and immunogenic potential. We demonstrate the
capacity to tune a protein’s sequence-structure-function-immunogenicity relationships.

PIPELINE 2: ANTIBODY THERAPEUTICS
Inaugural Cancer Targets for Antibody Therapeutics
Discovery, Engineering and Optimization of Next-Generation Oncology Targets
JANUARY 19-20
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The science and technology of antibody engineering have brought forth a new era of therapeutic antibodies in oncology, with new product formats and an intense
interest in immune system modulation now at the forefront of many company development efforts. PepTalk’s new Cancer Targets for Antibody Therapeutics
conference explores new directions in the discovery of emerging and challenging targets in this space – and the steps that will be required in developing these into
next-generation therapeutics for patients.
SUNDAY, JANUARY 18
4:00-5:00 pm Short Course Registration
5:00-8:00 Pre-Conference Dinner Short Courses
See pages 4-5 for details
4:00-8:00 Main Conference Registration
MONDAY, JANUARY 19
NEW APPROACHES TO TARGETING THE TUMOR
MICROENVIRONMENT
Gregory P. Adams, Ph.D., Co-Leader, Developmental Therapeutics Program, Fox
Chase Cancer Center
9:10 Multifunctional Angiogenesis Inhibitors Designed from
Non-Antibody Scaffolds
Jennifer R. Cochran, Ph.D., Associate Professor, Bioengineering and
Chemical Engineering, Stanford University
We engineer protein therapeutics, based on growth factor ligands and
receptors with altered biochemical and biophysical properties, as alternatives
to antibodies. I will present recent work where we used a growth factor as a
scaffold to create ligand-based antagonists that bind to multiple cell surface
receptors, and demonstrated that these proteins more effectively inhibit
angiogenic processes compared to mono-specific receptor targeting agents.
9:50 Manipulating the Tumor Microenvironment to Enhance
Effector Function for Improved Antibody Efficacy in Patients
Stephen Beers, Ph.D., Senior Research Fellow, Faculty of Medicine, University of
Southampton
Successful antibody therapy appears to rely predominantly on Fcγ receptor
expressing effector cells such as macrophages. Unfortunately, a number of
cancers have proven resistant to antibody therapy potentially due to the adverse
effects of the tumor microenvironment on these cells. Here, the potential of
harnessing tumor associated macrophages as effectors will be discussed as well
as means presented by which they may be re-programmed to enhance their
antibody effector capacity.
10:20 Coffee Break
ENGINEERING ANTIBODIES FOR IMPROVED TUMOR
PENETRATION
10:45 A Cell-Penetrating Antibody Technology Platform: Making the
Undruggable Druggable
Hua Eleanor Yu, Ph.D., Billy and Audrey L. Wilder Endowed Professor of Tumor
Immunology, Co-Leader of Cancer Immunotherapeutics Program, City of Hope
Comprehensive Cancer Center
We have developed a novel technology platform to allow efficient cell-penetration
of proteins/antibodies in vitro and in vivo. Using flow cytometry, confocal imaging
and Western blotting, we demonstrate the self-penetrating ability of the modified
antibodies. Both local and systemic administrations of the modified antibodies
effectively inhibit their intracellular targets in tumors, resulting in tumor cell
apoptosis and tumor regression in multiple models. Our discoveries enable the
development of a new class of research tools and novel therapeutics.
11:15 The Effect of Molecular Weight, PK, and Valency on Tumor
Biodistribution and Efficacy of Antibody-Based Drugs
Ruth Muchekehu, Ph.D. Research Scientist, Vertex Pharmaceuticals
To explore the role of pharmacokinetics, valency, and size on tumor targeting,
the biodistribution of an FGFR4 targeting CovX-body (an FGFR4-binding peptide
linked to a non-targeting IgG scaffold; 150 kDa), F(ab)2 (100 kDa) and Fab (50
kDa) fragments was measured. The highest percent of injected drug was
achieved with the IgG, and increasing the valency of the IgG by conjugating a
homodimeric peptide to the scaffold, translated into superior efficacy.
11:45 How to Leverage Oncogene Addiction: Targeted Biological
Therapy Inducing Growth Factor Receptor Internalization and
Degradation
John Haurum, M.D., D.Phil., CEO, F-star GmbH & F-star Biotechnology Ltd.
FS102 is a HER2-specific Fcab™ (Fc with antigen binding). In HER2-
overexpressing tumour cells, FS102 induce profound HER2 degradation and
apoptosis, and FS102 eliminates HER2-overexpressing tumours in patient-derived
mouse xenograft models. We present this as an example of a general
class of oncogene-targeted biological therapies, which induce tumour killing via
internalization and degradation of the addictive growth factor receptor.
12:45 Session Break

JANUARY 19-20
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& Impurities
• CHO CELLS
16
EMERGING TARGETS
John Haurum, M.D., D.Phil., CEO, F-star GmbH & F-star Biotechnology Ltd.
2:05 Targets for Antibodies in Neuro-Oncology: Getting Past the
Blood-Brain Barrier
Lois Lampson, Ph.D., Associate Professor of Surgery, Brigham and Women’s
Hospital
Antibody-mediated therapy for brain tumors is thought to face two hurdles: The
blood-brain barrier (BBB) and, for some effector mechanisms, the presumed
“immune privilege” of the brain. Here we ask, for different kinds of brain tumor
targets: Are the BBB or “privilege” really the key problems? How different is
the brain, really, from other sites?
2:35 Alternative Immune Models for Generating Novel Antibodies
to Highly Conserved Oncology Targets
William “Jonny” Finlay, Ph.D., Director, Pfizer
Many novel oncology targets are highly conserved between humans and
rodents, making it slow and laborious to generate high potency, highly specific
antibodies that cross-react with multiple orthologs. Alternative immune models
can therefore be a very valuable resource to rapidly generate exemplary
antibodies against unique epitopes. These antibodies allow investigators to
validate and de-risk novel targets and mechanisms of action, in a variety of in
vivo models, at pace.
3:05 SAR650984, A CD38 Monoclonal Antibody for Selected CD38+
Hematological Malignancies
Francisco Adrian, Ph.D., Section Head, Sanofi Oncology
CD38 is a type II transmembrane glycoprotein highly expressed at the surface
of malignant multiple myeloma plasma cells. SAR650984 is a humanized IgG1
antibody targeting CD38 in PhII clinical trials. The preclinical characterization
of SAR650984 will be presented, including epitope mapping, impact on CD38
enzymatic activity, pro-apoptotic activity in MM cellular models and patient
samples, and in vivo activity in combination with bortezomib.
4:15 A Novel T Cell Bispecific Antibody Targeting EGFRvIII to
Specifically and Potently Kill Tumor Cells in vitro and in vivo
Eugene Zhukovsky, Ph.D., CSO, Research, Affimed Therapeutics AG
4:45 Drugging the Undruggable: Using Knowledge-Based Design
to Develop Antibodies against Difficult Targets
Gregory P. Adams, Ph.D., Co-Leader, Developmental Therapeutics Program, Fox
Chase Cancer Center
The development of new clinically relevant antibodies has historically depended
upon the immunization of animals or the selection of clones with desired
specificity from large antibody libraries. While this works for many targets there
are numerous important target epitopes that are difficult or even “undruggable”.
Working with collaborators we have pursued a rational design approach
employing structure prediction, loop grafting and computational combinatorial
CDR display to develop antibodies specific for difficult targets.
5:15 Selection of Antibodies for T Cell Redirected Killing
Diego Ellerman, Senior Research Associate, Protein Chemistry, Genentech, Inc.
– A Member of the Roche Group
T cell recruitment and redirected killing is a growing clinical strategy that is
currently being explored for different oncological targets. This approach requires
the use of bispecific antibodies targeting both the T cell receptor and a tumor-specific
antigen. Different antibodies’ properties could play a role in determining
the efficacy of the molecule, such as affinity, epitope location, binding
geometry. We present case studies showing the influence of these factors.
5:45-7:00 Welcome Reception in the Exhibit Hall with Poster
Viewing
TUESDAY, JANUARY 20
DISCOVERY AND ENGINEERING OF
IMMUNOMODULATORY ANTIBODIES
David King, Ph.D., CSO, AnaptysBio, Inc.
»»FEATURED PRESENTATION
8:35 Monoclonal Antibodies as the Foundation of the
Immunotherapy Revolution
David Meininger, Ph.D., MBA, Executive Director, Business Development &
Licensing, Merck & Co., Inc.
Antibody-mediated inhibition of the PD-1 checkpoint pathway embodies a
paradigm shift in cancer therapy. However, nearly half of melanoma patients
and a majority in other indications with clinical data published to date have
failed to respond to therapy. The highest priorities in cancer research today are
arguably understanding PD-1 therapy non-responsiveness and developing new
PD-1 alternatives and combinations with antibodies anticipated to represent
foundational components of associated emerging treatment regimens.

JANUARY 19-20
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9:05 Engineering a Novel, Multivalent Fusion Protein that Potently
Agonizes a TNFSF Receptor
Melissa Damschroder, Ph.D., Associate Director, Research & Development,
Antibody Discovery and Protein Engineering, MedImmune
11:00 Control of Regulatory T (Treg) Cell Function by Protein
Kinase C-eta (PKCη): A Novel Target for Cancer Immunotherapy
Amnon Altman, Ph.D. Director, Scientific Affairs, Division of Cellular Biology, La
Jolla Institute for Allergy and Immunology
Antibody-mediated blockade of the checkpoint inhibitory receptor, CTLA-4, is
currently used for treating patients suffering from melanoma and other cancers.
Treg cells represent an important immune escape mechanism that facilitates
tumor growth. I will report on a novel Treg cell-intrinsic signaling pathway
mediated by recruitment of PKCη to the CTLA-4 cytoplasmic tail (Nat. Immunol.
15:465, 2014). In the absence of this pathway, Treg cells are unable to suppress
anti-tumor immunity.
11:30 Discovery and Engineering of Novel Antibodies to Immune
Checkpoints
David J. King, Ph.D., CSO, AnaptysBio, Inc.
Among the most promising approaches to cancer therapy is the activation of
anti-tumor immunity by blockade of immune checkpoints such as CTLA-4 and
PD-1. A number of other immune checkpoints are of interest, and functional
antibodies to PD-1, TIM-3 and LAG-3 have been generated. Inhibition of each
pathway demonstrates activity, and combinations can increase T cell activation
and have the potential to lead to increased clinical efficacy.
12:30 Session Break
2:00 BuzZ Session A
3:45 BuzZ Session B

2nd Annual Antibody-Drug Conjugates
Engineering Targeted Therapeutics
JANUARY 21-22
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18
The therapeutic potential of antibodies is enhanced by conjugating them to small molecule drugs. This combination merges the benefits of highly potent drugs with
selective binders of specific tumor antigens. Antibody-drug conjugates offer the promise of delivering more powerful tumor-killing activity while resulting in diminished
side effects for cancer patients. This important Antibody-Drug Conjugates conference brings together leaders in the world of ADCs who share their R&D case studies,
along with their preclinical and clinical data, to illustrate how this form of empowered antibody is transforming next-generation antibody therapeutics.
TUESDAY, JANUARY 20
1:30 pm Conference Registration
2:00 BuzZ Session A
3:45 BuzZ Session B
WEDNESDAY, JANUARY 21
MOVING ADCs SAFELY INTO THE CLINIC
Trevor Hallam, Ph.D., CSO, Sutro Biopharma, Inc.
8:20 Examination of ADC Safety Challenges in the Clinical Setting
Flavia Brunstein, M.D., Ph.D., Safety Science Leader, Safety Risk
Management, Genentech, Inc. – A Member of the Roche Group
The concept of an ADC is to improve the therapeutic window of cancer
chemotherapy, through targeted delivery of highly potent cytotoxic
molecules directly to tumor cells expressing unique antigens that
are specific to the monoclonal antibody. Preliminary clinical data are
encouraging, but toxicity still occurs.
9:00 In vitro-in vivo Molecular Integrity of Antibody-Drug
Conjugates: Applying Learning to Clinical Measurements for ADCs
Dan Rock, Ph.D., Scientific Director, Pharmacokinetics and Drug Metabolism,
Amgen, Inc.
Characterizing the mechanisms of ADC instability and release of free cytotoxin are
germane in the design of the next generation of ADCs. The methods and analytical
tools useful in characterizing the ADME and stability of ADCs will be reviewed.
9:30 Engineering Antibodies and ADCs for Successful
Development
Lars Linden, Ph.D., Group Leader and Head, Protein Biochemistry, Bayer
HealthCare
Developability analysis of antibodies and ADCs determines, together with
cell line productivity and cost-of-goods analysis, the manufacturing feasibility
of a drug candidate. A thorough biochemical & biophysical characterization
is performed to analyze the intrinsic stability and technical robustness of
clinical candidates. Standardization is ensured by a check of antibody platform
compatibility (DSP and analytics). Early buffer screening is performed for
accelerated formulation development.
MODELING AND ENGINEERING BREAKTHROUGHS
10:50 Mechanistic Models for Designing Efficacious ADCs
Arijit Chakravarty, Ph.D., Senior Scientist II, Modeling and Simulation, DMPK,
Takeda Pharmaceuticals
11:20 Translational Modeling and Simulation Approach for
Optimizing Discovery and Development of Antibody-Drug
Conjugates for the Treatment of Cancer
Nahor Haddish-Berhane, Ph.D., Senior Principal Scientist, Pfizer, Inc.
Antibody-Drug Conjugates (ADCs) are considered a promising approach to
targeted chemotherapy. In this presentation, we showcase a mechanistic
modeling and simulation approach that integrates preclinical PK and PD data
along with key in vitro biomeasures to predict clinical outcome of ADCs.
Additional applications of the model in antibody optimization and feasibility,
precision medicine, resistance development to ADCs and cancer indication
selection will be discussed.

CHI's 14th Annual PepTalk Protein Science Week

CHI's 14th Annual PepTalk Protein Science Week

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