Thinking about attending the Immunogenicity and Bioassay Summit, but have questions? I would be more than happy to walk you through the program agenda, pricing options and answer any questions you may have. In the meantime, don’t forget about the savings deadline coming up Friday, October 16th! Call David at 781-972-5472 if you would like to join us!

1. Technologies and Strategies for Safe and Efficacious Products in the Clinic
Join 250+ of Your Peers
Keynote Speakers:
Plus! 4 Short Courses
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
“Provides access to opinion leaders in the field.”
- Director, PK, Oncomed
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2. 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
Corporate Sponsors
Corporate Support Sponsors
Lead Sponsoring Publications Web Partners
Sponsoring Publications
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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
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4. 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 Biosimilar
Trails 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:
Challenges Associated with the Immunogenicity
Assessment of Pegylated Products
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.
Immunogenicity Assessment Clinical Relevance
Strategies, Overcoming Hurdles and Interpreting Results November 17-18, 2015
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Immunogenicity
Assessment Clinical
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Prediction Mitigation
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5. Immunogenicity Assessment Clinical Relevance
Strategies, Overcoming Hurdles and Interpreting Results November 17-18, 2015
2:50 Case Studies in Non-Clinical ImmunogenicityTesting with Fit
for Purpose Assays: Isotype Control Assays for OvercomingTarget
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
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.
Cover
Immunogenicity
Assessment Clinical
Relevance
Immunogenicity
Prediction Mitigation
Optimizing Bioassays
for Biologics
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6. Immunogenicity Assessment Clinical Relevance
Strategies, Overcoming Hurdles and Interpreting Results November 17-18, 2015
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 Presentation to be Announced
Sponsored by
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
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7. Immunogenicity Prediction Mitigation
Identification of Risk Factors and Tolerogenic Approaches November 18-19, 2015
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 inTherapeutic
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.
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Assessment Clinical
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Prediction Mitigation
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8. Immunogenicity Prediction Mitigation
Identification of Risk Factors and Tolerogenic Approaches November 18-19, 2015
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; ImmuneTolerance
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).
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.
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Immunogenicity
Assessment Clinical
Relevance
Immunogenicity
Prediction Mitigation
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9. Immunogenicity Prediction Mitigation
Identification of Risk Factors and Tolerogenic Approaches November 18-19, 2015
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
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10. Optimizing Bioassaysfor Biologics
Merging Biology and Statistics for Successful Biological Assay Development
November 18-19, 2015
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
Han Li, Ph.D., Principal Scientist, Lead Discovery and Optimization,
Bristol Myers 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 Presentation to be Announced
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.
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11. Optimizing Bioassaysfor Biologics
Merging Biology and Statistics for Successful Biological Assay Development
November 18-19, 2015
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.
9:35 Problem Solving Roundtable Discussions
Table 5: Incorporating NewTechnologies into Bioassay Development
Moderator: Han Li, Ph.D., Principal Scientist, Lead Discovery and Optimization,
Bristol Myers 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 FTiH Support of an ADC: Stability, Assay Development, and
Clinical Experiences
John F. Kellie, Ph.D., Investigator, Bioanalytical Sciences and Toxicokinetics,
GlaxoSmithKline
Characterization of circulating ADC species (conjugated antibody, total antibody, and
payload) is critical to understanding the safety and efficacy of ADC therapeutics.
Current methodology requires development and validation of immunoassays and
liquid chromatography-mass spectrometry assays. This presentation will share
experiences from assay validation through first time in human bioanalytical study
support along with an update and outlook for state-of-the-art technologies set to
drive ADC method development in the future.
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
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12. Optimizing Bioassaysfor Biologics
Merging Biology and Statistics for Successful Biological Assay Development
November 18-19, 2015
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
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13. 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
Conference Hotel:
Hilton Baltimore
401 West Pratt St.
Baltimore, MD 21201
Tel: 443-573-8700
Discounted Room Rate: $194 s/d
Discounted Room Rate Cut-off Date: October 20, 2015
Please visit www.ImmunogenicitySummit.com or you
may call the hotel directly to reserve your sleeping
accommodations. You will need to identify yourself as a
Cambridge Healthtech Institute conference attendee to
receive the discounted room rate with the host hotel.
Reservations made after the cut-off date or after the group
room block has been filled (whichever comes first) will be
accepted on a space- and rate-availability basis. Rooms are
limited, so please book early.
Car Rental Discounts are Available:
For details, visit www.ImmunogenicitySummit.com
and click on the hotel travel button.
Hotel Travel
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14. ADDITIONAL REGISTRATION DETAILS
Each registration includes all conference
sessions, posters and exhibits, food
functions, and access to the conference
proceedings link.
Handicapped Equal Access: In accordance
with the ADA, Cambridge Healthtech
Institute is pleased to arrange special
accommodations for attendees with
special needs. All requests for such
assistance must be submitted in writing
to CHI at least 30 days prior to the start
of the meeting.
To view our Substitutions/
Cancellations Policy, go to
http://www.healthtech.com/regdetails
Video and or audio recording of any kind
is prohibited onsite at all CHI events.
A series of diverse reports designed to
keep life science professionals informed
of the salient trends in pharmaceutical
technology, business, clinical development,
and therapeutic disease markets.
For a detailed list of reports, visit
InsightPharmaReports.com, or contact
Adriana Randall, arandall@healthtech.com,
+1-781-972-5402.
Pricing and Registration Information
CONFERENCE PRICING
Commercial Academic, Government,
Hospital-Affiliated
SUMMIT PRICING BEST VALUE! (Includes access to all conference days, Tuesday-Thursday, excludes short courses)
Early registration discount until August 21, 2015 $2,549 $1,149
Advance registration discount until October 16, 2015 $2,749 $1,249
Registrations after October 16, 2015 and on-site $2,949 $1,349
SINGLE CONFERENCE PRICING (Includes access to Tues. – Wed. am conference or Wed. pm – Thurs. concurrent conferences, excludes short
courses)
Early registration discount until August 21, 2015 $1,699 $879
Advance registration discount until October 16, 2015 $1,849 $899
Registrations after October 16, 2015 and on-site $2,049 $1,029
Tues. – Wed. am, November 17-18 Wed. pm – Thurs., November 18-19
C1: Immunogenicity Assessment Clinical Relevance C2: Immunogenicity Prediction Mitigation
C3: Optimizing Bioassays for Biologics
SHORT COURSES
One short course $699 $399
Two short courses $999 $699
Three short courses $1,299 $899
Pre-Conference Short Courses: Dinner Short Courses:
Monday, November 16 Wednesday, November 18
1:30-4:30 pm SC1: Basics of Immunogenicity Testing
6:30-9:30 pm SC3: Immunogenicity Risk Assessment
and Regulatory Strategy
5:30-8:30 pm (Dinner Course)
SC2: Challenges of Immunogenicity Assessment
6:30-9:30 pm SC4: Strategic Bioassay Design and Analysis
CONFERENCE DISCOUNTS
Poster Discount ($50 Off): Poster abstracts are due by October 16, 2015. Once your registration has been fully processed, we will send an email
containing a unique link allowing you to submit your poster abstract. If you do not receive your link within 5 business days, please contact jring@
healthtech.com. * CHI reserves the right to publish your poster title and abstract in various marketing materials and products.
REGISTER 3 ­- 4th IS FREE: Individuals must register for the same conference or conference combination and submit completed registration form together for
discount to apply.
Alumni Discount: Cambridge Healthtech Institute (CHI) appreciates your past participation at the Immunogenicity and Bioassay Summit. As a result of the great
loyalty you have shown us, we are pleased to extend to you the exclusive opportunity to save an additional 20% off the registration rate.
Group Discounts: Discounts are available for multiple attendees from the same organization. For more information on group rates contact
Uma Patel at 781-972-5447.
If you are unable to attend but would like to purchase the Immunogenicity Bioassay Summit 2015 CD for $495 (plus shipping), please visit
ImmunogenicitySummit.com. Massachusetts delivery will include sales tax.
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