This document summarizes an upcoming conference on immunogenicity assessment and clinical relevance for biopharmaceutical products. The conference will take place November 17-18, 2015 in Baltimore, MD and will include keynote speakers from the FDA and industry. It will feature sessions on regulatory expectations, preclinical studies and risk assessment, different assay formats and technologies, and challenges with immunogenicity assessment. Short courses on related topics will also be offered. The document provides an agenda with session topics, speaker names and affiliations, and descriptions of presentation topics.

1. Technologies and Strategies for Safe and Efficacious Products in the Clinic
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Keynote Speakers:
Plus! 4 Short Courses
ImmunogenicitySummit.com
Immunogenicity
Assessment &
Clinical Relevance
Immunogenicity
Prediction &
Mitigation
Optimizing
Bioassays for
Biologics
Conferences
NOVEMBER 17-19, 2015 • HILTON BALTIMORE • BALTIMORE, MD
Maura C. Kibbey, Ph.D.,
Senior Scientific Liaison,
Biologics Biotechnology,
United States Pharmacopeia
Valerie Quarmby, Ph.D.,
Staff Scientist, BioAnalytical
Sciences, Genentech, Inc.
Amy Rosenberg, Ph.D.,
Director, Therapeutic Proteins,
FDA/CDER
Xiaobin (Victor) Lu, Ph.D.,
Xiaobin (Victor) Lu, Ph.D.,
CMC Reviewer, Division of
Cellular Gene Therapies,
OCTGT, CBER, FDA
Register By August 21 Save up to $400!
“Provides access to opinion leaders in the field.”
- Director, PK, Oncomed

2. 2 | ImmunogenicitySummit.com
Sponsorship, Exhibit, and Lead Generation Opportunities:
CHI offers comprehensive packages that can be customized to your budget and objectives.
Sponsorship allows you to achieve your goals before, during, and long after the event. Packages
may include presentations, exhibit space and branding, as well as the use of delegate lists. Signing on early will
maximize your exposure to qualified decision-makers and drive traffic to your website in the coming months.
Podium Presentations — Available within Main Agenda!
Showcase your solutions to a guaranteed, targeted audience
through a 15- or 30-minute presentation during a specific
program, breakfast, lunch, or a pre-conference workshop.
Package includes exhibit space, on-site branding, and access
to cooperative marketing efforts by CHI. Lunches are delivered
to attendees who are already seated in the main session room.
Presentations will sell out quickly! Sign on early to secure
your talk.
Invitation-Only VIP Dinner/Hospitality Suite
Select specific delegates from the pre-registration list to attend
a private function at an upscale restaurant or a reception at the
hotel. From extending the invitations, to venue suggestions,
CHI will deliver your prospects and help you make the most of
this invaluable opportunity.
Focus Group
CHI will gladly provide you the opportunity of running a
focus group on-site. This exclusive gathering can be useful to
conduct market research, collect feedback on a new product
idea, and collect marketing intelligence from industry experts
on a specific topic.
User Group Meeting/Custom Event
Co-locate your user group meeting or custom event. CHI will
help market the event, manage logistical operations, develop
the agenda, and more. CHI can handle the entirety of the
meeting or select aspects.
Exhibit
Exhibitors will enjoy facilitated networking opportunities with
qualified delegates, making it the perfect platform to launch
a new product, collect feedback, and generate new leads.
Exhibit space sells out quickly, so reserve yours today!
Additional branding and promotional opportunities
are available, including:
• Conference Tote Bags
• Literature Distribution (Tote
Bag Insert or Chair Drop)
• Badge Lanyards
• Program Guide Ad
• Padfolios and More...
For additional information, please contact:
Carolyn Benton
Business Development Manager
781-972-5412 | cbenton@healthtech.com
Corporate Sponsors
10 Reasons to Choose CHI’s
Immunogenicity and Bioassay Summit 2015
1. 7 FDA experts on a range of topics: presentations,
breakout discussions and a short course
2. Addresses the real challenges in
immunogenicity assessment
3. Risk assessment strategies
4. Immunogenicity for biosimilars: from the FDA,
from Europe, and an industry case study
5. Models for immunogenicity prediction
6. Impact of impurities, aggregates and SVPs
7. Deimmunization and tolerance mechanisms:
including a clinical case study
8. Showcases advanced technologies for
bioassay development
9. Explores potency testing for gene and cell therapies
10. Provides solutions for bioassay development for
molecules with multiple modes of action
PLUS:
Choice of 12+ interactive breakout discussions: to help you iron out your immunogenicity and bioassay challenges
4 Short courses: assay development; risk assessment and regulatory strategy, and bioassay design and analysis

3. ImmunogenicitySummit.com | 3
Short Courses*
Monday, November 16
1:30 – 4:30 pm SC1: Basics of ImmunogenicityTesting
Instructors:
Jim McNally, Ph.D., Associate Director, PDM Immunogenicity Expert, EMD Serono
Amy Loercher, Ph.D., Manager, Clinical Immunology, GlaxoSmithKline
This interactive session will enable attendees to work out a basic immunogenicity preclinical and clinical testing strategy for various molecules
including bi-functional and other novel scaffolds. Areas of difficulty will be discussed with specific case studies. Attendees are encouraged to
contribute with their own experiences and to bring questions for discussion or submit to the meeting organizers in advance.
The following topics will be covered:
• Current common industry practices
• Basic issues regarding screening, confirmatory and titer assays
• Assay methodologies and various technologies
• Current approaches to data analysis and cutpoints
• Preclinical and clinical considerations
• Common problems
5:30 – 8:30 pm Dinner SC2: Challenges of Immunogenicity Assessment
Instructors:
Jim McNally, Ph.D., Associate Director, PDM Immunogenicity Expert, EMD Serono
Amy Loercher, Ph.D., Manager, Clinical Immunology, GlaxoSmithKline
This interactive session of intermediate level will focus on the potential challenges of immunogenicity testing in preclinical and clinical
development and present case studies demonstrating how they can be handled. Attendees are encouraged to contribute with their own
experiences and to bring questions for discussion or submit to the meeting organizers in advance.
The following topics will be covered:
• Challenges and approaches to resolve commonly encountered issues
• Multi-domain binding proteins
• Pre-existing ADAs
• Emerging trends in the development of neutralizing antibody assays
• Cross reactivity to endogenous proteins
• Clinical implications of ADAs
Wednesday, November 18
6:30 – 9:30 pm Dinner SC3: Immunogenicity Risk Assessment and Regulatory Strategy
Instructors:
Joao Pedras-Vasconcelos, Ph.D., Biotech Quality and Immunogenicity Reviewer, Office of Biotechnology Products, CDER-FDA
Paul Chamberlain, NDA Advisory Board
The objective of this short-course is to illustrate the rationale for, and application of, the regulatory approach to identifying, evaluating and
mitigating immunogenicity-related risks for different product types. The agenda is designed to encourage interaction between the presenters and
the participants in sharing experience of application of a multi-disciplinary, integrated approach.
The following topics will be covered:
• Regulator’s perspective
• Overview of multi-disciplinary, integrated approach to identifying,
evaluating and mitigating immunogenicity-related risks
• Examples that illustrate the “why” and “how to” for different
product types / risk levels:
• Bacterial-derived proteins
• Enzyme replacement therapies
• Bone morphogenic proteins
• Allogeneic cell-based therapies
• Yeast-derived glycoproteins
• PEGylated uricase
• Novel antibody constructs
6:30 – 9:30 pm Dinner SC4: Strategic Bioassay Design and Analysis
Instructor:
Liming Shi, MS, MA, Senior Research Scientist, Bioassay Development, Eli Lilly and Company
This course will focus on the fundamentals of statistics and simple methodology that are routinely applied in bioassay laboratories.
Covered topics will include review of statistical concepts and calculations, study design, assessing bioassay measurement quality and
comparative studies.
The following topics will be covered:
• Uniqueness of bioassay, especially cell-based potency assay
• Considerations in bioassay development and validation
• Bioassay measurements and calculations
• Quality control of bioassay performance
• Comparative studies for bioassay development and transfer
*Separate registration is required.
“ This is a great meeting to get up to date information and
hear regulatory feedback and industry experiences.”
- Senior Director, Ultragenyx

4. 4 | ImmunogenicitySummit.com
Immunogenicity Assessment Clinical Relevance
Strategies, Overcoming Hurdles and Interpreting Results
TUESDAY, NOVEMBER 17
7:30 am Registration and Morning Coffee
8:30 Chairperson’s Opening Remarks
Lakshmi Amaravadi, Ph.D., Senior Director,Translational Medicine, Biogen Idec, inc.
KEYNOTE PRESENTATION:
8:35 A Harmonized Approach to Interpretation and Reporting
of Clinical Immunogenicity Data
Valerie Quarmby, Ph.D., Staff Scientist, BioAnalytical Sciences,
Genentech, Inc.
A recent “White Paper” (Shankar et al 2014 AAPSJ) has
provided a common set of terms and definitions to describe
clinical immunogenicity data. The paper also provides a
harmonized approach to the interpretation of immunogenicity results
in the context of pharmacokinetics, efficacy, and safety. Industry-wide
use of these recommendations will enable the clinical relevance of
immunogenicity to be assessed consistently.
REGULATORY EXPECTATIONS REGARDING
IMMUNOGENICITY ASSESSMENT FOR
INNOVATORS AND BIOSIMILARS
9:05 How Product Quality Attributes of Biotherapeutics Affect
Immunogenicity: A Regulatory Perspective
William Hallett, Ph.D., Product Quality Immunogenicity Reviewer,
CDER/OPQ/OBP FDA
Several quality attributes of biopharmaceuticals can significantly impact its
immunogenic potential. Critical quality attributes of biopharmaceuticals that
affect immunogenicity include molecular structure, glycosylation, aggregates,
subvisible particulates, mechanism of action, etc. Manufacturing changes
made during product life cycle, e.g. scale up, fermentation, raw materials,
formulation, dosage form, etc. may affect a product’s immunogenic potential.
This presentation discusses the regulatory perspective on product quality
management and its effect on immunogenicity.
9:35 Regulatory Perspectives on Setting up the Clinical
Immunogenicity Study for a Biosimilar
Susan Kirshner, Ph.D., Associate Chief, Laboratory of Immunology, Therapeutic
Proteins, Biotechnology, CDER/FDA
10:05 Multiplexing Immunogenicity Assays
with the MSD U-PLEX® Platform
Laure Moller, Ph.D., Director, Scientific Support North America,
Meso Scale Discovery
Sponsored by
10:35 Coffee Break in the Exhibit Hall with Poster Viewing
11:15 Lessons Learnt from the European Experience Regarding
Biosimilars and Immunogenicity
Paul Chamberlain, NDA Advisory Board
The experience gained during the 10-year period following the implementation
of the EU biosimilars pathway indicates that a suitably cautious approach
was applied, insofar as no immunogenicity-related issues have emerged for
the approved applications of the different biosimilar products. In some cases,
product quality-related issues were identified in the pre-authorization setting
as being potential relevant for heightened risk of immunogenicity and were
duly taken into account for the biosimilarity decision.
11:45 Experiences with Immunogenicity Assessment in
BiosimilarTrails with a Monoclonal Antibody
Niklas Czeloth, Ph.D., Head, Biosciences, Biosimilars, Boehringer Ingelheim
Immunogenicity assessment of biosimilar products is an important aspect
of the overall development process while the experience with monoclonal
antibody biosimilars still remains limited. The presentation will share
experiences in setting up immunogenicity assays for a biosimilar product and
will discuss on relevance of differences observed for the same product in two
independent trials using healthy volunteers.
12:15 pm Sponsored Presentations (Opportunities Available)
12:45 LUNCHEON PRESENTATION:
Immunogenicity of Oligonucleotides
Sponsored by
Marie-Soleil Christin-Piché, Ph.D., Scientific Director, Immunology,
Charles River Montreal
End User to be Announced
1:45 Session Break
PRECLINICAL STUDIES AND RISK ASSESSMENT
2:15 Chairperson’s Remarks
Theo Rispens, Ph.D., Senior Scientist, Immunopathology, Sanquin
2:20 Strategies for Immunogenicity Risk Assessment
Bonita Rup, Ph.D., Biotechnology Consultant, Bonnie Rup Consulting LLC
Immunogenicity risk assessments typically consider an established set of
risk factors relating to the product and recipient population, and treatment
regimens. As the number of biopharmaceuticals under development increase,
competitive and regulatory risk should also be considered. To assure the
value of these assessments, it is important to continuously re-examine the
“generally accepted” risk factors, particularly to better understand how they
interact and determine how to improve their reliability. This presentation will
overview the current practices of risk assessment and mitigation and discuss
potential options for continuous improvement.
2:50 Case Studies in Non-Clinical ImmunogenicityTesting with
Fit for Purpose Assays: Isotype Control Assays for Overcoming
Target Interference
Michael Partridge, Ph.D., Staff Scientist, Bioanalytical Sciences, Regeneron, Inc.
The industry standard for ADA detection, the bridging immunoassay, requires the
production of specific reagents and may be susceptible to target interference.
We evaluated fit for purpose assays in non-clinical studies as alternatives for ADA
detection.These methods included bridging assays that detect ADA generated to
the constant regions of mAb drugs as well as ELISAs.This presentation will discuss
the advantages and limitations of these approaches in several non-clinical studies.
3:20 Refreshment Break in the Exhibit Hall with Poster Viewing
4:00 Choosing an Appropriate ADA Assay for Preclinical Studies:
Comparison of Different ADA Assays in NHP Case Studies
Jianyong (Jerry) Wang, Ph.D., Scientist, Biochemical and Cellular
Pharmacology, Genentech, Inc.
Sensitive and fast ADA testing methods play important roles in preclinical
studies. Different plate-based ADA assays were compared in multiple NHP
studies involving bispecific antibodies, IgG1 and IgG4 mAbs. The attractive
features and limitations of each method, and critical factors on assay
development will be discussed to provide a general guidance for selecting an
appropriate ADA assay for preclinical studies.
4:30 Problem Solving Roundtable Discussions
Table1: Meeting Regulatory Expectations
Moderator: William Hallett, Ph.D., Product Quality Immunogenicity
Reviewer, CDER/OPQ/OBP FDA
Table 2: Challenges in Developing NeutralizingAntibody (Nab)Assays
Moderator:YulingWu, Ph.D., Principal Scientist,Translational Sciences, MedImmune
Table 3: OvercomingTarget Interference in ADA assays
Moderator: Jim McNally, Ph.D., Associate Director, PDM Immunogenicity
Expert, EMD Serono
Table 4: Dealing with Pre-Existing Positive ADA Activity
November 17-18, 2015

5. ImmunogenicitySummit.com | 5
Immunogenicity Assessment Clinical Relevance
Strategies, Overcoming Hurdles and Interpreting Results
Moderator: Lakshmi Amaravadi, Ph.D., Senior Director, Translational Medicine,
Biogen Idec, Inc.
Table 5: Critical Issues in ADA Assay Validation
Moderator: Amy Loercher, Ph.D., Manager, Clinical Immunology, GSK
5:30 Welcome Reception in the Exhibit Hall with Poster Viewing
6:30 End of Day One of Immunogenicity Assessment Clinical
Relevance
WEDNESDAY, NOVEMBER 18
7:30 am Registration and Morning Coffee
8:00 am Chairperson’s Remarks
Jim McNally, Ph.D., Associate Director, PDM Immunogenicity Expert, EMD Serono
DIFFERENT ASSAY FORMATS ANDTECHNOLOGIES
FOR IMMUNOGENICITY ASSESSMENT
8:05 Replacing Legacy ADA Assays with New and Better
Methods to Support Routine Patient Care
Yongchang Qiu, Ph.D., Senior Director, Head, Bioanalytical and Biomarker
Development, Research Nonclinical Development, Shire
Legacy ADA testing used to support early clinical trials are often limited by
technologies and guidance available at that time and can be very complex with
many methods. As a result, these assays have presented many challenges,
such as slow turn-around time and high cost, for ADA testing to support
routine patient care. Here we present our effort on development of new and
better assays to replace legacy methods and address “data continuity” issues
before and after method switch.
CHALLENGES WITH
IMMUNOGENICITY ASSESSMENT
8:35 A Neutralizing Antibody Assay Based on a Reporter of
Antibody Dependent Cell-Mediated Cytotoxicity
Yuling Wu, Ph.D., Principal Scientist, Translational Sciences, MedImmune
Immunogenicity assessment is an essential component of safety evaluation in
biopharmaceutical clinical development. Benralizumab (MEDI-563, anti-IL5Rα
mAb) is a humanized afucosylated mAb against IL5Rα with enhanced effector
function. It potently induces ADCC (antibody-dependent cell-mediated cytotoxicity)
of eosinophils and basophils.To support benrulizumab clinical development, we
developed an ADCC cell-based neutralizing antibody (NAb) assay to detect NAbs
against benrulizumab in human serum.This study presents the development,
optimization and characterization of an ADCC cell-based NAb assay.
9:05 Evaluation of Pre-Existing Antibodies: How Meaningful is
the Investigation?
Lakshmi Amaravadi, Ph.D., Senior Director, Translational Medicine, Biogen
Idec, Inc.
Pre-existing antibodies have been detected in many clinical programs and
have been receiving increased attention in the last decade. It is important
to appropriately characterize the pre-existing antibody reactivity in the
immunogenicity program in order to identify treatment emergent anti-drug
antibodies appropriately, to quantify the titer response, and more importantly
to understand if there is any clinical risk associated with such pre-existing
antibodies. In order to further our understanding of this key aspect of
immunogenicity evaluation an AAPS sub-committee has been assembled. The
presentation will discuss some key findings from this committee. Some case
studies will also be discussed.
9:35 Experiences with Confirmatory Assays, False Positives and
Negatives, and Cutpoint Determination
Amy Loercher, Ph.D., Manager, Clinical Immunology, GlaxoSmithKline
This presentation will focus on difficulties that may be encountered with
confirmatory assays, false positive and false negative assay signals and
various approaches to cutpoint determinations. Case studies will be
presented that examine strategies for immunogenicity assessments of
biopharmaceuticals for both soluble and membrane-bound cellular targets.
10:05 Sponsored Presentations (Opportunities Available)
10:35 Coffee Break in the Exhibit Hall with Poster Viewing
CLINICAL CASE STUDIES ON
SPECIFIC BIOTHERAPEUTICS
FEATURED PRESENTATION:
11:10 ImmunogenicityTesting in PatientsTreated with Anti-TNF:
What is the Best Measure of Clinical Response?
Theo Rispens, Ph.D., Senior Scientist, Immunopathology, Sanquin
Anti-drug antibody (ADA) formation to therapeutic monoclonal
antibodies such as adalimumab and infliximab (anti-TNF) is
associated with lower drug levels and clinical non-response.
Controversy exists about the clinical consequences of ADA
formation, which partly arises from the use of different assays and testing
strategies. This presentation will focus on the relationship between
concentrations of the drug (PK), anti-drug antibodies and clinical response, as
well as the characteristics of ADA responses to these drugs.
11:40 Immunogenicity and Clinical Relevance Assessment Enabling
the Approval of a Subcutaneous Formulation of Herceptin
Rebecca Elliott, MSc, Manager, BioAnalytical Sciences, Genentech, Inc.
The assessment of immunogenicity (antibodies against Herceptin® or
recombinant human hyaluronidase) was one of the secondary objectives of
a randomized, multi-center, open-label Phase III study. This demonstrated
non-inferiority of a fixed-dose subcutaneous formulation of Herceptin® when
compared with an intravenous formulation based on pharmacokinetics and
efficacy in patients with HER2-positive early breast cancer. Exploratory
analyses were performed to investigate any potential correlation of
immunogenicity to pharmacokinetics, efficacy, and safety.
12:10 pm Rapid ADA Response against a C5a Receptor
Antagonist Impacting PK and PD
Per Holse Mygind, Ph.D., Senior Scientist, Immunogenicity Assessment,
Novo Nordisk
A first generation antibody therapeutic against the C5a receptor was
developed to treat patients with chronic autoimmune diseases. A rapid and
significant ADA response was detected in a large number of patients. These
discoveries contributed to the development of a second generation antibody
against the C5aR receptor. The presentation will provide details on the
analytical strategies, assays applied and ADA characterizations, as well as the
impact on clinical measures of pharmacokinetics and pharmacodynamics.
12:40 End of Immunogenicity Assessment Clinical Relevance
November 17-18, 2015
Lead Sponsoring Publications Web Partners
Sponsoring Publications

6. 6 | ImmunogenicitySummit.com
Immunogenicity Prediction Mitigation
Identification of Risk Factors and Tolerogenic Approaches
WEDNESDAY, NOVEMBER 18
1:00 pm Conference Registration
2:00 Chairperson’s Opening Remarks
Stephan Kontos, Ph.D., Co-Founder, Director, Research, Anokion
RISK ASSESSMENT
2:05 Evaluating Relative Risk of Immunogenicity of
Biotherapeutics with Chemical Modifications and Impurities
Marisa Joubert, Ph.D., Senior Scientist, Process Development, Amgen, Inc.
We have investigated the potential biological impact of different product
quality attributes, including oxidation of amino acid residues and the level of
host cell impurities, in an in vitro comparative immunogenicity assessment
(IVCIA) assay. The results highlight the relative risk of immunogenicity of
product specific factors and point to a dependency on multiple parameters
including the type of attribute, amount of attribute, the presence of multiple
attributes, and the immune status and medication regimen of the individual.
FEATURED PRESENTATION
2:35 Development of Mechanistic Models for the Prediction of
Immunogenicity Outcomes in the Clinic
Tim Hickling, Ph.D., Associate Research Fellow,
Pharmacokinetics, Dynamics and Metabolism, Pfizer, Inc.
This presentation will describe a mathematical approach to
quantitatively forecasting the outcome of immunogenicity in
clinical trials. A generic model will be described that incorporates
immunogenicity risk assessment data, e.g. Epitopes, patient HLA-type,
ADA assay characteristics (Sensitivity/Drug-tolerance). A case study will
be presented with fitted clinical data to demonstrate predictive capability.
Application of this approach in the context of inflammatory disease and to
other therapeutic areas will be discussed.
3:05 Relevance of Animal Models for Immunogenicity Prediction
Jack Ragheb, Ph.D., Principal Investigator, Therapeutic Proteins, CDER/FDA
The immunogenicity of therapeutic proteins in humans cannot be assessed by
testing these drug products in non-human species as the immune system can
distinguish orthologous proteins as foreign and will mount an immune response.
The recent advent of humanized mice may represent a relevant preclinical model
for in vivo testing of the human immunogenicity of a therapeutic protein.The
qualification of such a model should lead to identification of critical attributes
responsible for immunogenicity, permitting the design of suitable control
strategies that ensure product quality and mitigate risk.
3:35 Sponsored Presentation (Opportunity Available)
3:50 Refreshment Break in the Exhibit Hall with Poster Viewing
FACTORS CONTRIBUTINGTO IMMUNOGENICITY
4:30 Innate Immune Response Modulating Impurities in
Therapeutic Proteins
Daniela Verthelyi, M.D., Ph.D., Chief, Immunology Lab, CDER/OBP/FDA
Therapeutic proteins can contain impurities derived from the cell substrate and
the manufacturing process that have the potential to activate innate immune
cells fostering product immunogenicity. This talk will describe different
approaches for the detection of innate immune response modifying impurities
in therapeutic proteins and discuss how that may inform immunogenicity risk
assessments, particularly in the context of comparability exercises.
5:00 Immunogenicity ofTherapeutic Proteins: Impact of
Aggregates, Glycosylation and Other Post-Translational
Modifications.
Naren Chirmule, Ph.D., Vice President, Scientific Research, Biocon
During the manufacturing of protein therapeutics several post translational
modifications occur, the majority of which have been attributed to
immunogenicity risk potential. A systematic analysis of various critical
quality attributes such as aggregation, glycosylation etc. has been studied.
This presentation will focus on comparing the impact of different types
of aggregates on immune activation. These observations may inform the
monitoring approaches of these aggregates during process development.
5:30 Immunogenicity of Sub-Visible Particles:
Are We Barking Up the WrongTree?
Atanas Koulov, Ph.D., Group Head, Pharma Technical Development Europe
(Biologics), Analytics, F. Hoffmann-La Roche Ltd.
This presentation will discuss our recent findings using an IgG1 transgenic
mouse model and newly developed methods for particle fractionation and
selective particle modification. Using chemically characterized and well-defined
size-fractions of subvisible particles afforded interrogation of the factors
governing potential break of immune tolerance. Our findings demonstrate
that only particles that are heavily modified chemically (oxidized) can break
immune tolerance in this transgenic mouse model, whereas unmodified
particles cannot.
6:00 End of Day One of Immunogenicity Prediction Mitigation
6:00 Dinner Short Course Registration
6:30 – 9:30 Dinner Short Courses*
SC3: Immunogenicity Risk Assessment and Regulatory
Strategy
SC4: Strategic Bioassay Design and Analysis
*Separate registration required. See page 3 for details.
THURSDAY, NOVEMBER 19
TOLERANCE INDUCTION
7:30 am Registration and Morning Coffee
8:00 am Chairperson’s Remarks
Marisa Joubert, Ph.D., Senior Scientist, Process Development, Amgen, Inc.
8:05 Anti-Drug Antibody – A Challenge in the Field ofTherapeutic
Proteins, Lessons Learned from Pompe Disease; Immune
Tolerance Induction in ERT
Zoheb Kazi, MBBS, Postdoctoral Research Associate, Pediatrics/Medical
Genetics, Duke University Medical Center
Cross-Reactive Immunological Material (CRIM) -negative (CN) and a subset of
CRIM-positive (CP) Infantile Pompe disease (IPD) mount an immune response
against enzyme replacement therapy (ERT) resulting in clinical decline.
Prophylactic immune tolerance induction (ITI) protocol has prevented immune
responses in CN patients treated with ERT. We will present data on the safety
and efficacy of ITI approaches for CP and CN IPD receiving ERT.
KEYNOTE PRESENTATION:
8:35 Addressing Immunologic Sabotage of Dystrophin
ReplacementTherapies in Duchenne Muscular Dystrophy
Amy S. Rosenberg, M.D., Division Director, Office of
Biotechnology Products, FDA
Clinical investigation for more definitive treatment of
Duchenne Muscular Dystrophy (DMD), will only meet with
success by addressing key immunologic features of the
disease: the profound inflammatory response in DMD muscle mediated
by innate immune system elements and the preexisting or potential
cellular immune response to dystrophin, mediated by CD8+ and CD4+ T
cells. Thus, taming inflammation is essential not only to reducing muscle
cell loss and fibrosis per se, but as well to facilitate induction of immune
tolerance to dystrophin by facilitating the conversion to, recruitment of, and
function of regulatory T cells (Tregs).
November 18-19, 2015

7. ImmunogenicitySummit.com | 7
Immunogenicity Prediction Mitigation
Identification of Risk Factors and Tolerogenic Approaches
9:05 Tools andTechnologies for Comprehensive Sponsored by
Immunogenicity Risk Management
Emilee Knowlton, D.Phil., Immunology Sales Specialist, ProImmune
Immunogenicity is a very complex issue to address in drug design and
development. An overview of the best tools for immunogenicity risk mitigation
will be provided, including Mass Spectrometry antigen presentation assays, DC-T
cell assays to measure responses to fully formulated biologics, HLA-peptide
Binding Assays, and naïveT cell Proliferation Assays to characterize individual
epitopes. How the potential risk of first infusion reactions can be mitigated using
whole-blood cytokine release assays will also be described.
9:35 Problem Solving Roundtable Discussions
Table 1: Potential Immunogenic Risk of Drug Product Formulations
Moderator: Marisa Joubert, Ph.D., Senior Scientist, Process Development,
Amgen, Inc.
Table 2: Current and EmergingTools: Selecting Candidates and
Predicting Clinical Outcome
Moderator: Tim Hickling, Ph.D., Associate Research Fellow, Pharmacokinetics,
Dynamics and Metabolism, Pfizer, Inc.
Table 3: Protein DesignTools for Biotherapeutic Deimmunization
Moderator: Karl Griswold, Ph.D., Associate Professor, Thayer School of
Engineering, Dartmouth
Table 4: Progress towards Inducing ImmunologicalTolerance to
Biotherapeutics
Moderator: Stephan Kontos, Ph.D., Co-Founder, Director, Research, Anokion
10:35 Coffee Break in the Exhibit Hall with Poster Viewing
ROLE OF B ANDT CELL EPITOPES
11:15 Decreasing Immunogenicity of Recombinant Immunotoxins
by Identifying and Modifying B andT Cell Epitopes
Ira Pastan, M.D., Co-Chief, Molecular Biology, National Cancer Institute,
National Institutes of Health
Recombinant Immunotoxins are chimeric proteins designed to kill cancer
cells. They consist of an Fv or Fab that binds to the cancer cell and a portion
of pseudomonas exotoxin A that kills the cell. RITs have shown anti-tumor
activity in some leukemias and in mesothelioma, but antibody formation limits
the amount that can be given. We have developed experimental approaches
to identify and remove T and B cells while maintaining high cytotoxic activity.
Clinical trials with one of these have recently opened.
11:45 Design and Development of Deimmunized Lysostaphin for
Treatment of Drug-Resistant Staphylococcus aureus Infections
Karl Griswold, Ph.D., Associate Professor,Thayer School of Engineering, Dartmouth
Using advanced protein design algorithms, predicted T cell epitopes were
depleted from lysostaphin, a potent antibacterial drug candidate that
exhibits undesirable immunogenicity. Aggressively deimmunized variants
rescued humanized mice from recurrent infection by methicillin-resistant
Staphylococcus aureus, whereas wild type lysostaphin failed due to high
anti-drug antibody titers. These controlled experiments in a clinically relevant,
immunocompetent disease model demonstrate for the first time that T cell
epitope depletion enhances therapeutic efficacy.
12:15 pm DesigningTherapeutic Drugs with Reduced
Immunogenicity
Mark Fogg, Ph.D., Group Leader, Immunology, Abzena
The importance of T cell help has been widely accepted as a significant risk
factor in the development of anti-drug antibodies (immunogenicity). Case
study data will be presented on the deimmunisation of naturally immunogenic
non-human protein therapeutics.
12:45 Luncheon Presentation (Sponsorship Opportunity Available)
or Lunch onYour Own
1:15 Cupcakes and Coffee in the Exhibit Hall with Poster Viewing
DEIMMUNIZATION ANDTOLERANCE MECHANISMS
2:00 Chairperson’s Remarks
Tim Hickling, Ph.D., Associate Research Fellow, Pharmacokinetics, Dynamics
and Metabolism, Pfizer, Inc.
2:05 Controlling Antibody Responses by Engaging CD22
Matthew Macauley, Ph.D., Assistant Professor, Chemical Physiology, Scripps
Research Institute
CD22 is an inhibitory B-cell co-receptor that recognizes glycans. We have
shown that co-engaging it with the B-cell receptor (BCR) induces antigen-
specific B-cell tolerance. This was first demonstrated using liposomes that co-
present a high affinity CD22 and antigen. More recently, we have developed a
cell-based platform that takes advantage of these same principles.
2:35 Creating Biologics Drugs with Improved Efficacy and Safety
Profiles by Preventing Anti-Drug Antibodies withTolerogenic
Nanoparticles
Kei Kishimoto, Ph.D., CSO, Selecta Biosciences
Anti-drug antibodies (ADAs) can adversely affect the safety and efficacy
of biologic drugs. We will describe the development of Synthetic Vaccine
Particles (SVPs) for the induction of antigen-specific tolerance to prevent
ADAs, using coagulation Factor VIII for the treatment of haemophilia A and
pegylated uricase for the treatment of refractory gout as case examples.
3:05 Induction ofTolerance Using Engineered RegulatoryT and
CytotoxicT Cells with Chimeric Antigen Receptors
David W. Scott, Ph.D., Professor and Vice Chair for Research, Department of
Medicine (MED), Uniformed Services University of Health Sciences
Human T cells engineered to express chimeric antigen receptors (CARs)
have been utilized to successfully target cancer cells. We have adapted
this approach to create specific T regulatory cells using both CARs and
chimeric T-cell receptors from patients in two disease models. Application
of engineered T cells to modulate adverse antibody responses in hemophilia
and pathogenic responses to CNS proteins will be presented. Prospects with
engineered cytotoxic cells will be discussed.
3:35 Inducing ImmuneTolerance to Highly ForeignTherapeutics
by Engineering for Erythrocyte Binding
Stephan Kontos, Ph.D., Co-Founder, Director, Research, Anokion
We sought to develop a recombinant, translational approach that exploits
the tolerogenic potential of apoptotic cells without the need to manipulate
cells themselves, with the goal of inducing antigen-specific tolerance to
immunogenic therapeutics. In engineering erythrocyte-binding domains into
the chemotherapeutic E. coli enzyme asparaginase, we show that in addition
to greatly enhancing PK and PD profiles, erythrocyte-binding drives potent,
long-lived antigen-specific humoral immune tolerance towards the therapeutic.
4:05 Close of Conference
November 18-19, 2015
High level presentations and well
organized: a perfect combination
to bring people together.
- Chloe A, ImmunXperts

8. 8 | ImmunogenicitySummit.com
Optimizing Bioassaysfor Biologics
Merging Biology and Statistics for Successful Biological Assay Development
WEDNESDAY, NOVEMBER 18
ADVANCES IN BIOASSAYTECHNOLOGIES
2:00 pm Chairperson’s Opening Remarks
Max L. Tejada, Ph.D., Senior Research Scientist II, Analytical Operations,
Gilead Sciences
2:05 Back to the Future, Envisioning the Next Generation
Bioassay Development
Ray Zhang, Ph.D., Research Investigator, Bristol-Meyers Squibb
Bioassay development requires a unique combination of techniques, from cell
line selection and generation, to assay design, validation and final testing. An
ideal bioassay needs to reflect true MOA, robust, sensitive and reproducible.
Our thoughts on a bioassay development incorporating advance technologies
from in house and vendors will be presented. Our ultimate goal is to develop a
system that will have broad and long lasting applications.
2:35 Development of Luminex as a Platform for the Detection of
Anti-Drug Antibody IgE Isotypes in Human Serum
LiNa Loo, Ph.D., Senior Scientist, Bioanalytical Development, Merck
Since biotherapeutic drugs such as monoclonal antibodies (mAbs) have the
potential to induce immunogenicity, it is critical to perform an immunogenicity
assessment to ensure drug efficacy and patient safety. Here, Luminex and
Mesoscale were evaluated as platforms for detection of anti-drug antibody
IgE isotype in human serum. By using a mouse-human chimeric drug-specific
monoclonal IgE antibody as the positive control, the assay characteristics
were compared for the two platforms.
3:05 Reporter Assays to Assess Effector Function
Shihua Lin, Ph.D., Analytical Biotechnology Development, MedImmune LLC
3:35 Sponsored Presentation (Opportunity Available)
3:50 Refreshment Break with Exhibit and Poster Viewing
POTENCYTESTING FOR GENE AND CELLTHERAPIES
4:30 Challenges in Potency Assay Development for a Non-
Replicating Lentiviral Vector
Brenna Kelley-Clarke, Ph.D., Scientist II, Assay Development, Immune Design
Immune Design has developed an HIV-1-based integration-deficient lentiviral
vector currently being evaluated in cancer immunotherapy (LV305). LV305 is
designed to transduce human dendritic cells, triggering presentation of an
encoded antigen via the MHC Class I pathway; this is proposed to elicit an
effective CD8-T lymphocyte response towards malignancies that over-express
that antigen. The biological complexity of LV305 and its proposed MOA pose
unique challenges in developing a potency assay matrix.
KEYNOTE PRESENTATION
5:00 A Regulatory Perspective for Development of Potency
Assay for Cellular and GeneTherapy Products: A Product
Lifecycle Approach
Xiaobin (Victor) Lu, Ph.D., CMC Reviewer, Division of Cellular
Gene Therapies, OCTGT, CBER, FDA
The challenges of developing a potency assay for a CGT are
multi-factorial including complexity of assay procedures,
inherent variability due to use of living cells, tissues or live
organisms, and variable reagents. Furthermore, a bioassay based potency
assay can be impacted by changes made in the product manufacturing
processes. This presentation will outline a product life-cycle approach
for developing potency assays for a CGT product from preclinical studies
to the Biological License Application. It will conclude with general
recommendations for addressing some of the challenges in potency assay
development and implementation for CGT during product and clinical
development programs.
ASSAY ACCEPTANCE CRITERIA
5:30 Assay Acceptance Criteria for Multiwell-Plate–Based
Biological Potency Assays
C. Jane Robinson, Scientific Liaison, Biopharmaceutical Emerging Best
Practices Association (BEBPA)
Following preliminary consultation, a draft white paper “Assay Acceptance
Criteria for Multiwell-Plate–Based Biological Potency Assays” was published
in 2014. In the subsequent extensive consultation process, a variety of issues
were raised and discussed, including a range of current practices. Some of
these issues and the recommendations of the white paper, including the two-
level sequential assessment of acceptance criteria and use of an assay control
sample, will be presented.
6:00 End of Day One of Optimizing Bioassays for Biologics
6:00 Dinner Short Course Registration*
6:30-9:30 SHORT COURSE:
Strategic Bioassay Development and Design
Instructor: Liming Shi, MS, MA, Senior Research Scientist, Bioassay
Development, Eli Lilly and Company
*Separate registration required. See page 3 for details.
THURSDAY, NOVEMBER 19
DEVELOPING ASSAYS FOR MULTIPLE
MODES OF ACTION
7:30 am Registration and Morning Coffee
8:00 am Chairperson’s Remarks
Liming Shi, MS, MA, Senior Research Scientist, Bioassay Development, Eli
Lilly and Company
8:05 Bioassay Development for Bispecific Antibodies: A Different
Ball Game
Piyush M. Vyas, Ph.D., Research Scientist, Bioassay Development, Eli Lilly and
Company
Bispecific Antibodies are evolving rapidly and are already in stages for
clinical trials. Some of these Bispecific Antibodies have shown synergy in
their biological activity as compared to the combination of their individual
counterparts. Bioassay development and Data analyses for such Bispecific
Antibodies to show the synergy, is a complex process. Traditional data
analyses approaches might not be suitable enough in order to analyze such
data. Data analyses of such Bispecific Antibodies need to be approached in a
different way.
8:35 Regulated ADC Bioanalysis Using Ligand Binding Assays:
Challenges and Strategies
Seema Kumar, Ph.D., Principal Scientist, Pfizer, Inc.
The complex multi-component structure in combination with heterogeneous
and dynamically evolving behavior presents unique challenges in ADC
bioanalysis. The challenges may vary depending on the objective of ADC
bioanalysis. The case studies showcasing various bioanalytical strategies that
could be employed in developing and validating successful ligand binding
assays for ADC characterization will be presented.
9:05 Critical Success Factors for Cell-Based
Assay Development andTransfer
Sponsored by
John Kamerud, Ph.D., Scientific Director, Eurofins
Method development or transfer must occur before a CRO validates an assay.
The development / transfer of complex methods that involve the use of cell
lines require specific criteria to be evaluated to ensure the success of the assay.
In particular, the growth characteristics of the cell line, culture conditions, cell
banking requirements, assay format, readout, reagents and data interpretation
should be evaluated and controlled to ensure a robust path to validation.
November 18-19, 2015

9. ImmunogenicitySummit.com | 9
Optimizing Bioassaysfor Biologics
Merging Biology and Statistics for Successful Biological Assay Development
9:35 Problem Solving Roundtable Discussions
Table 5: Incorporating NewTechnologies into Bioassay
Development
Moderator: Ray Zhang, Ph.D., Research Investigator, Bristol-Meyers Squibb
Table 6: Challenges in Assay Bridging
Moderator: Maura C. Kibbey, Ph.D., Senior Scientific Liaison, Biologics
Biotechnology, United States Pharmacopeia
Table 7: MethodTransfers
Moderator: Max L. Tejada, Ph.D., Senior Research Scientist II, Analytical
Operations, Gilead Sciences
10:35 Coffee Break with Poster Viewing
PROCESS COMPARABILITY AND CHARACTERIZATION
11:15 Use of aTiered Approach to Develop Robust Potency
Assays in Support of Monoclonal Antibody Product Development
Laura Geagan, Principal Research Associate, Bioanalytical Development, Genzyme
Cell-based assays are often used for evaluating the potency of biological
therapeutics during product development. The development of cell-based methods
frequently coincides with the stage of development of the product they support.
Early stage assays are often required to provide meaningful data to support
process, purification and formulation development at a time when optimization of
the method is not complete. As the drug progresses through the development
paradigm, the performance of the cell-based potency assay improves as well. In
this presentation we describe a tiered approach to develop a robust cell-based
potency assay to support pre-clinical product development. The analysis paradigm
was updated as the drug progressed into Phase I for consistency with guidance
provided in USP chapters 1032-1034.The use of the assay to support process
development will be discussed.
11:45 Late Breaking Presentation
12:15 pm Sponsored Presentations (Opportunities Available)
12:45 Luncheon Presentation (Sponsorship Opportunity Available)
or Lunch onYour Own
1:15 Cupcakes and Coffee in the Exhibit Hall with Poster Viewing
BRIDGING STUDIES AND ASSAYTRANSFER
2:00 Chairperson’s Remarks
2:05Transfer and Validation of a Cell-Based Neutralizing Antibody
(NAb) Assay to a CRO
Florence Guilhot, Ph.D., Head,Translational Pharmacology Lab, NovImmune SA
Biotherapeutics can lead to the production of anti-drug antibodies (ADA) in treated
subjects which may result in loss of efficacy or elicit adverse events. Standard
immunoassays can detect ADA, but cannot differentiate between neutralizing and
non-neutralizing ADA. Development of a neutralizing antibody (NAb) assay is a key
step to support clinical trials.This presentation will provide an overview of (i) assay
characteristics of the functional reporter NAb cell-based assay (ii) challenges for
the transfer and validation of a NAb assay to support the clinical trial.
2:35 Leveraging Automated Liquid Handlers, High-Density Plates,
and Multi-Dimensional Assay Optimization to Accelerate the
Delivery of Neutralizing Antibody Bioassay
John M. Lehrach, Research Scientist II, Bristol-Meyers Squibb
BMS Core BioAssay Group (CBG) leveraged the cellular assay repertoire,
cell inventory, and the detection technology platforms in Leads Discovery
and Optimization (LDO) Department to perform automation assisted multi-
dimentional optimization for the development of a Nab Bioassay. BMS
informatics tools enabled automated data analysis. The technology platform
selected was a homogenous cAMP HTRF assay. CBG delivered a 96-well
format Nab assay with excellent Nab sensitivity, assay reproducibility, and
serum tolerance utilizing assay-ready cryo cells.
KEYNOTE PRESENTATION
3:05 Compendial Potency Assays and Associated Biological
Reference Materials – Challenges in Assay Bridging
Maura C. Kibbey, Ph.D., Senior Scientific Liaison, Biologics
Biotechnology, United States Pharmacopeia
USP, regulators, and manufacturers share a common goal
of reducing in vivo testing, yet replacing animal assays with
suitable in vitro assays may be challenging. This presentation
will highlight USP’s current efforts to include modern bioassays in the USP-
NF as well as bridging expectations for revision sponsors who would like to
propose a modern assay for the compendium.
3:35 Global BioassayTransfers
Camille Dycke, Ph.D., F. Hoffmann-La Roche Ltd. / Genentech; Associate
Director, Method Management andTechnologies, Bioassay, Global Biologics QC
To support global product release, the bioassay used in the commercial
control system of the product is transferred to multiple QC testing laboratories
around the globe. In order to facilitate these global method transfers, the
implementation of global processes, a global training plan and a solid method
life cycle management program, are key elements to ensure success. A few
case studies will be presented, illustrating product globalization.
4:05 Close of Conference
November 18-19, 2015
Conference Hotel:
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Hotel Travel

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C1: Immunogenicity Assessment Clinical Relevance C2: Immunogenicity Prediction Mitigation
C3: Optimizing Bioassays for Biologics
SHORT COURSES
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Pre-Conference Short Courses: Dinner Short Courses:
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and Regulatory Strategy
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