PEGS China 2015 Final Agenda

MARCH 31 - APRIL 2, 2015
SHANGHAI MARRIOTT HOTEL PUDONG EAST
SHANGHAI, CHINA
PEGSummitChina.com
2015 CONFERENCE PROGRAMS:
Protein & Antibody Engineering
Phage & Yeast Display
Antibody-Drug Conjugates
Characterization of Biotherapeutics
The Definitive Meeting Place for Protein &
Antibody Scientists from Around the World:
* Abbott * Abbvie * Agensys * Albert Einstein College
* Amgen * Chugai * City of Hope * Dartmouth College
* F-Star Biotechnology * Fudan University * Garvan Institute
* Genentech * Heidelberg Pharma * Henlius * IMCB Singapore
* Kadmon * Livzon MabPharm * Mabspace * MacroGenics
* MD Anderson Cancer Center * MedImmune * Merrimack
* NIABC * NIH * NewBio Therapeutics * Northwest A&F University
* Pfizer * PharmAbcine * Pieris * Rinat * Roche Diagnostics
* Sanofi * Shanghai C P Guojian * Sutro BIopharma
* University of Toronto * University of Queensland
* University of Zurich * USP China * Zova Biotherapeutics
FINAL AGENDA
PEGSCHINA
CAMBRIDGE HEALTHTECH INSTITUTE’S 2ND ANNUAL
Protein & Antibody Engineering and Development Summit
第二届中国
蛋白与抗体工程及研发峰会
REGISTER BY
JANUARY 16
& SAVE UP TO
$400
Organized by
Cambridge Healthtech Institute
Premier Sponsor
蛋白质与抗体工程
噬菌体和酵母展示
抗体及药物结合物
生物制药分析表征

PEGS China: the quintessential protein and antibody engineering
and development summit in China
Building on its inaugural success and back with new and expanded tracks, CHI’s 2nd Annual PEGS China selects and
presents key trends, latest case studies and leading players in the worldwide biopharmaceutical industry who are pushing
the envelope in protein and antibody engineering. The Summit will provide you with the scientific knowledge and technical
know-how that will help advance your biologics to the next phase of development, be they ADCs, bispecifics, novel
proteins, antibody constructs or biosimilars.
This 3-day event is THE meeting place for international and China scientists to come face-to-face and share case
studies and project updates, explore new techniques, hear innovative ideas, and form new collaborations or solidify
existing partnerships.
Meet and hear from our distinguished international Speaker Faculty including these Keynotes & Featured Speakers:
Track 1:
Protein & Antibody Engineering 蛋白质与抗体工程
Explore techniques to enhance antibody binding and specificity,
and delve into strategies for design and development of novel
scaffolds and next generation bispecific antibodies.
Track 3:
Antibody-Drug Conjugates 抗体及药物结合物
Examine novel payloads, linker technologies and conjugation
chemistries, while developing strategies for homogeneity
engineering and biophysical characterization of ADCs.
Track 2:
Phage & Yeast Display 噬菌体和酵母展示
Learn novel discovery and screening strategies to generate
antibodies against challenging targets and discover antibodies with
optimized efficacy and improved properties.
Track 4:
Characterization of Biotherapeutics 生物制药分析表征
Appraise different technologies and methods for characterizing
novel formats and improving the stability and solubility of biologics
and biosimilars.
2 | PEGSummitChina.com
PEGSCHINA
Cambridge Healthtech Institute’s 2nd Annual
Protein & Antibody Engineering and Development Summit
第二届中国
蛋白与抗体工程及研发峰会
Antibody Development Strategies in Today’s
China
Chengbin Wu, Ph.D., President of R&D and CSO,
Shanghai C P Guojian Pharmaceutical Co., Ltd.,
PR China
Designing and Engineering Novel Bispecific/
Bifunctional Antibodies and Fusion Proteins for
Enhanced Antitumor Activity
Zhenping Zhu, Ph.D., Executive Vice President,
Global Biopharmaceuticals, Kadmon Corporation
Whose Problem Is Post-Translational
Modifications? Discovery, Cell Culture,
Chromatography or Formulation?
Chandrashekar Ganesa, Ph.D., Senior Director,
Analytical Development, Global Biotherapeutics,
Sanofi
Kinetic and Thermodynamic Landscape of
Protein Aggregation
Bilikallahalli Muralidhara, Ph.D., Associate
Director, Vaccines & Biologics, Biopharmaceutical
Development, MedImmune, Inc.
ADCs: Is It Time to Rethink Some
Preconceptions?
Jaume Pons, Ph.D., Senior Vice President and
CSO, Rinat-Pfizer
Current Clinical Experience with Antibody-Drug
Conjugates: A View through the Therapeutic
Window
Robb Kahn, M.D., Senior Safety Science Leader,
Global Pediatric Oncology Drug Development,
Genentech, a member of the Roche Group

PEGSummitChina.com | 3
CONFERENCE AT A GLANCE
RESEARCH POSTER SUBMISSION
Cambridge Healthtech Institute encourages attendees to gain further
exposure by presenting their work in the poster sessions. To secure a
poster board and inclusion in the conference materials, your abstract
must be submitted, approved and your registration paid in full by
February 27, 2015.
Reasons you should present your research poster at this conference:
• Your poster will be showcased to our international delegation
• Receive $50/ ¥200 off your registration
• Your poster abstract will be published in our conference materials
• Your research will be seen by leaders from top pharmaceutical,
biotech, academic and government institutes
Group Discounts:
Register 3 and 4th is FREE.
Discount applies to attendees from the same organization registering for the same
event. All registrations must be submitted together to qualify for the discount.
Alumni Discount - 20% off
Cambridge Healthtech Institute (CHI) appreciates your participation at our events.
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. Just
check off the box marked Alumni Discount on the registration form to receive the
discount. Please note: Our records must indicate you were an attendee at a past
CHI event in order to qualify.
JOIN THE PEGS COMMUNITY ONLINE
Premier Sponsor
Corporate Sponsors
TUESDAY, MARCH 31 Track 1:
Track 2:
Plenary Keynotes
WEDNESDAY, APRIL 1
(morning)
Track 1:
Track 2:
WEDNESDAY, APRIL 1
(afternoon)
Track 3:
Track 4:
Plenary Keynotes
THURSDAY, APRIL 2 Track 3:
Track 4:
Joint Closing Session

PEGS CHINA | TUESDAY, MARCH 31
TRACK 1:
PROTEIN & ANTIBODY ENGINEERING
Innovative Engineering * Novel Scaffolds * Bispecific Antibodies
TRACK 2:
PHAGE & YEAST DISPLAY
Novel Screening * Improved Properties * Challenging Targets
7:30 am Registration and Morning Coffee
8:50 Chairperson’s Opening Remarks
Dimiter Dimitrov, Ph.D., Senior Investigator, NCI, National Institutes of Health
ENHANCING ANTIBODY BINDING, SPECIFICITY AND
DRUG-LIKE PROPERTIES
Unpublished
Data
Case Study
9:00 Antibody Engineering for Better in vivo Efficacy
Weidong Jiang, Ph.D., CSO, Henlius Biopharmaceuticals, Inc.
Antibody engineering is a great tool for improving antibody
functions in vivo. We have routinely engineered therapeutic
antibodies for better in vivo efficacies via affinity maturation,
specifically by improving on-rate of the antibody binding affinities.
One particular case will be reported here for better functions in vivo
as well as other functions such as immunogenicity improvement.
Unpublished
Data
9:30 In vitro and in vivo Study of pH-Dependent Antigen
Binding Antibody with Increased FcgammaRIIB Binding
Yuji Hori, Ph.D., Research Scientist, Chugai Pharmaceutical, Japan
Sweeping antibody with enhanced FcR mediated cellular uptake of
antibody-antigen complex and pH-dependent endosomal antigen dissociation
enables antigen elimination from plasma, providing enhanced efficacy and
novel mode of action for antibody therapeutics. This talk will present an in
vivo profile of sweeping antibody and its in vitro confocal microscopic study
to address the intracellular trafficking of the soluble antigen.
10:00 Design and Develop Next-Generation Bispecific Antibodies with
Good Drug Like Properties (DLP)
Jinming Gu, Ph.D., Senior Scientist, Global Biologics, Abbvie, Inc.
Bispecific antibodies have emerged as the next generation of antibody-based
therapeutics. So far, there have been more than 50 different bispecific
antibody platforms published in the literature. However, it continues to be a
major challenge to identify bispecific antibodies with good drug like properties
which functions preclinically. This presentation will discuss different
approaches we are utilizing to design and develop bispecific antibodies with
good drug like properties.
10:30 Coffee Break
NOVEL PROTEINS AND ALTERNATIVE SCAFFOLDS
Unpublished
Data
11:00 Anticalins: Versatile Binding Proteins based on a Flexible
Natural Scaffold
Arne Skerra, Ph.D., Professor, Technische Universität München;
Founder, Pieris AG, Germany
Anticalins are derived from human lipocalins, whose four structurally
hypervariable loops form a binding site that can be tailored against medically
relevant targets. However, anticalins are much smaller and comprise a single
polypeptide chain, offering facile production in microbial hosts and flexible
formatting: multiple specificities, attachment of payloads and extended
plasma half-life via PEGylation or PASylation. Two anticalins have reached
clinical stage for therapeutic applications.
11:30 ADAPT - A Novel Scaffold Protein for Radionuclide Molecular
Imaging
Johan Nilvebrant, Ph.D., Postdoctoral Researcher, The Donnelly Centre,
Center for Cellular and Biomolecular Research, University of Toronto, Canada
ADAPTs (ABD-derived affinity proteins) are a novel class of scaffold-based
affinity proteins, which are derived from the albumin-binding domain (ABD)
of streptococcal protein G. They have been generated in a bispecific format
to target various antigens. These radiolabeled ADAPTs were recently used to
provide high contrast PET-images of HER2 positive tumor xenografts shortly
after injection and show promise as a new class of imaging agents.
12:00 pm Sponsored Presentation (Opportunity Available)
12:30 Networking Luncheon
Jonas V. Schaefer, Ph.D., Head, High-Throughput Laboratory, Department of
Biochemistry, University of Zurich, Switzerland
NOVEL DISCOVERY AND SCREENING STRATEGIES
9:00 Awaiting a New Era of Cancer Immunotherapy
Qi Zeng, Ph.D., Associate Professor, Institute of Molecular and Cell Biology
(IMCB), Singapore
Traditionally, therapeutic antibodies have been limited to target extracellular or
secreted cancer proteins. In this talk, we demonstrated that PRL-3 humanized
antibody can be used to target tumor specific PRL-3 Intracellular proteins.
The PRL-3 humanized antibody could block PRL-3 positive (but not negative)
tumors in orthotopic animal models. Our findings will vastly expand a large
pool of “untargetable” intracellular cancer proteins to become targetable
with immunotherapies.
Case Study
9:30 Drug Discovery Using a Modular Antibody Platform™
Haijun Sun, Ph.D., Vice President, Tumor Biology and Protein
Sciences, F-Star Biotechnology, United Kingdom
In this presentation, we will discuss our Modular Antibody Platform and
highlight some of the key steps during the discovery phase to select the best
monospecific or bispecific therapeutic candidates. Several case studies from
preclinical programs will be discussed.
10:00 Establishment of an Innovative High-Throughput Platform for
Next-Generation Binder Discovery
To optimize the efficiency and capacity of next-generation binder selections
and discovery, our laboratory established a streamlined process, consisting
of parallel Ribosome Display selections and various semi-automated high-throughput
screenings. We now can perform simultaneous selections against
94 targets and subsequently screen and validate several thousand binders
in parallel for their binding and biophysical characteristics. This results in
the need of testing fewer candidates to eventually find the most promising
lead candidates.
10:30 Coffee Break
ANTIBODIES AGAINST COMPLEX & CHALLENGING
TARGETS
11:00 Strategy for Identifying Allosteric Antibody that Modulates
Membrane Receptor
Michelle Yuqing Shen, Ph.D., Senior Scientist, Amgen China R&D
We developed a screening strategy using in vitro cell-based assays to identify
antibodies that enhanced endogenous ligand signaling. Furthermore, we
applied binding assays to reveal those antibodies that do not compete with
endogenous ligand binding to receptors. This mechanism of action leverages
on enhancement of endogenous ligand signaling while offers greater receptor
selectivity and better safety profile owing to allosteric binding to receptors
and modulators’ ceiling effect.
11:30 Generation and Optimization of Nanoparticle Targeting Antibodies
Lihui Xu, Antibody Technology, Merrimack Pharmaceuticals
12:30 Networking Luncheon

TUESDAY, MARCH 31 | AGENDA
TRACK 1:
TRACK 2:
1:45 Chairperson’s Remarks
ANTIBODIES AGAINST INFECTIOUS DISEASES
1:50 Synthetic Antibodies for Ebola Virus Immunotherapy and Research
Jonathan R. Lai, Ph.D., Associate Professor, Biochemistry, Albert Einstein
College of Medicine
Synthetic antibody engineering is an emerging technology for the
identification of highly specific antibodies from large molecular display
libraries. Here, we will show the application of this method to discover
potential immunotherapies and research reagents for Ebola virus. We
have identified novel synthetic antibodies against the glycoproteins of the
Zaire (EBOV) and Sudan (SUDV) Ebolavirus species. These antibodies have
neutralization potential and, in the case of SUDV, afford post-exposure
protection of mice.
2:20 Novel Strategies for Isolation of Antibodies Against Infectious
Disease Targets
Stephen Mahler, Ph.D., Professor, Australian Institute for Bioengineering and
Nanotechnology, University of Queensland, Australia
Using either immunised or naïve libraries and phage display technology,
we demonstrate novel strategies for isolation of antibodies that bind
immunodominant and non-immunodominant epitopes of viral antigens. The
strategies include biopanning against recombinant viral antigens, peptides,
antigens expressed on host cell surface and also the use of molecular
scaffolds to display viral protein domains. Strategies for isolation of novel
antibodies that bind Dengue and Malaria antigens are presented.
2:50 The Development of Antibody-Based Therapeutics for the Treatment
of Emerging Infectious Diseases
Tianlei Ying, Ph.D., Head, Antibody Engineering and Drug Discovery Group,
School of Basic Medical Science, Fudan University
Emerging infectious diseases are currently the major threat to public health.
By using human antibody libraries and in vitro display technologies we have
identified potent neutralizing antibodies against some new viruses including
MERS-CoV and avian influenza viruses. We also have been working on
the engineering of novel antibody fragments with small size and long in
vivo half-lives.
3:20 Sponsored Presentation (Opportunity Available)
3:50 Refreshment Break
5:40 Welcome Reception in the Exhibit Hall with Poster Viewing
6:40 Close of Day
NOVEL PROTEINS AND ALTERNATIVE SCAFFOLDS (cont’d)
1:50 Exceptionally Potent and Broad Inhibitors of HIV-1 based on
Antibody Domains and One Domain Soluble CD4 Multivalent Fusion
Proteins
We generated bispecific multivalent fusion proteins of an engineered
cavity-altered single-domain CD4 with another potent HIV-1 inhibitor - an
antibody domain targeting the coreceptor-binding site on gp120. The fusion
proteins neutralized all HIV-1 isolates tested with potency about 10-, 50-, and
200-fold higher than that of VRC01, T20, and sCD4-Fc fusion protein CD4-
Ig, respectively. These fusion proteins could be potentially useful for HIV-1
therapy including eradication of the virus.
2:20 Cross-Neutralizing Single-Domain Antibodies to Pandemic Influenza
Simon E. Hufton, Ph.D., Principal Scientist, Biotherapeutics, National Institute
for Biological Standards and Control (NIBSC)
The response to the 2009 A(H1N1) influenza pandemic has highlighted
the need for additional strategies for intervention which preclude the prior
availability of the influenza strain. We have isolated single domain antibodies
with broad neutralisation activity from immunised alpaca’s and used yeast
display technology to investigate antibody/antigen interactions to assist
in the understanding of their mechanism of action. These single domain
antibodies are attractive candidates for diagnostics and immunotherapy of
pandemic influenza.
Unpublished
Data
2:50 Meditopes: Development of Noncovalent Peptide-Fab
Interaction to Rapidly and Specifically Add Functionality to
mAbs
John C. Williams, Ph.D., Associate Professor, Molecular Medicine,
Beckman Research Institute at City of Hope
MAbs require chemical conjugation and/or extensive re-engineering to deliver
toxins, imaging agents and other functionalities to diseased tissues. Herein,
we present the discovery of a novel cyclic peptide (aka a meditope) that binds
to the cavity of cetuximab Fab. While this binding site is unique to cetuximab,
it can be grafted on to mAbs. Studies will be presented highlighting the rapid
and efficient functionalization of mAbs.
5:40 Welcome Reception in the Exhibit Hall with Poster Viewing
6:40 Close of Day
4:35 Keynote Introductions
Weidong Jiang, Ph.D., CSO, Henlius Biopharmaceuticals, Inc.
Unpublished
Data
Case Study
4:40 Antibody Development Strategies in Today’s China
Chengbin Wu, Ph.D., President, R&D and CSO, Shanghai C.P. Guojian Pharamceutical Co. Ltd., PR China
In the past 10 years, commercial manufacturing of antibodies at GMP standard has become possible in China, leading to
successful commercialization of several antibody-based therapeutics, with many more in various stages of development.
This talk will provide a brief overview of antibody development in China, with a case study discussing key aspects of developing an
anti-Her2 antibody that has completed Phase III clinical trials in China.
5:10 Designing and Engineering Novel Bispecific/Bifunctional Antibodies and Fusion Proteins for Enhanced Antitumor
Activity
Zhenping Zhu, Ph.D., Executive Vice President, Global Biopharmaceuticals, Kadmon Corporation
Major obstacles in the successful development of BsAb (bispecific antibodies) have been the difficulties of designing and
constructing a druggable molecule and producing sufficient materials for development and commercialization. The technological
challenge is to construct a recombinant molecule with good pharmaceutical properties. Developing highly effective BsAb and bifunctional
proteins will require clear elucidation and understanding of the molecular details in the aberrant signaling pathways that lead to various
diseases to guide the selection of the target pairs for co-targeting.
PLENARY KEYNOTE SESSION

TRACK 4:
CHARACTERIZATION OF BIOTHERAPEUTICS
Biophysical Characterization * Aggregate Prevention * Enhancing Developability
PEGS CHINA | WEDNESDAY, APRIL 1
TRACK 1:
TRACK 2:
Daniel Christ, Ph.D., Associate Professor & Head, Antibody Therapeutics,
Immunology Program, Garvan institute of Medical Research, Australia
GENERATING ANTIBODIES AND COMPLEX PROTEINS
WITH IMPROVED PROPERTIES
9:00 Stable Human Antibody Therapeutics and Biobetters through
Engineering of Complementarity Determining Regions
Daniel Christ, Ph.D., Associate Professor & Head, Antibody Therapeutics,
Immunology Program, Garvan institute of Medical Research, Australia
We have recently identified aggregation hotspots in the CDR regions of
antibody variable domains, and have developed generally applicable phage
display strategies to overcome these limitations. Here we outline the
application of the technology to human IgG antibody therapeutics, and
present examples of how the approach can be utilised for the ‘retrofitting’ of
preclinical and clinical candidate molecules, as well as biobetters.
9:30 Identification of Myeloid-Derived Suppressor Cell-Specific Targets
by Phage Display
Hong Qin, M.D., Ph.D., Assistant Professor, Lymphoma & Myeloma, MD
Anderson Cancer Center
We identified two novel, mouse MDSC-specific peptides using phage
display technology. The engineered peptides (peptibodies) efficiently
depleted systemic and intratumoral MDSC in tumor-bearing mice, but
did not affect other proinflammatory cell types. Proteomic analysis of cell
surface membrane proteins precipitated by the peptibodies suggests that
the lead candidate target on the surface of MDSC is S100 family proteins
(S100A9/A8). Hence, we developed a technical platform of cell-specific
marker discovery.
10:30 Coffee Break in the Exhibit Hall with Poster Viewing
Case Study
11:10 Affinity Matured Anti-Tacrolimus Antibody for Improved
Immunoassay Performance
Bailin Tu, Ph.D., Principal Scientist, Biologics Discovery and Design,
Abbott Laboratories
We screened and isolated scFv clones from diverse libraries with mutagenic
complementarity regions (CDRs) from anti-tacrolimus hybridoma cell
line using yeast display. Various combinatorial pairings constructed from
these individual mutations contained >10-fold improvements in both the
dissociation rate and overall equilibrium affinity constants. Selected clones
produced as IgG have increased functional sensitivity, with a 3- to 6-fold
better performance relative to the parental tacrolimus monoclonal antibody.
Unpublished
Data
Case Study
11:40 Employing Immune Tolerance Technology to Obtain
Antibodies with Improved PK/PD Properties
Xueming Qian, Ph.D., Chairman and CEO, Mabspace Biosciences,
Co. Ltd., PR China
Generating antibodies with improved PK/PD properties is an
important goal for developing a differentiated and competitive
antibody product. We employ immune tolerance breaking
technology to obtain antibodies targeting diverse epitope space, enabling
the selection of antibodies with improved biological activities, improved
manufacturability or pH-dependent binding to enable recycling. Case studies
will be presented for fast follow-on antibody programs targeting PDL-1 and
VEGFR2, two important proteins regulating tumor microenvironment.
Unpublished
Data
12:10 pm Igy Antibody Engineering, More Than Antibody
Extraction from Egg Yolk
XiaoYing Zhang, Ph.D., Professor, Veterinary Pharmacology, College
of Veterinary Medicine, Northwest A&F University
Avian IgY antibodies have been generated against conserved mammalian
antigens with high titer and specificity, and also successfully developed to
detect small molecules in nano-molar range/mL. mIgY antibodies can be
effectively used in certain applications like immunological detection and
diagnosis, screening and validating biomarkers, and drug targets. mIgY
antibodies are developed by phage display technology. And these can be
developed into Ab fragments, chimeric Abs and humanized Abs.
12:40 Networking Luncheon in the Exhibit Hall with Poster Viewing and
Close of Phage & Yeast Display Conference
Nanotechnology, University of Queensland
NOVEL APPLICATIONS FOR BISPECIFIC ANTIBODIES
9:00 Therapeutic Applications of DART Proteins – What’s Next?
Syd Johnson, Ph.D., Vice President, Antibody Engineering, MacroGenics, Inc.
Bispecific antibodies that recruit effector cells to tumors represent a
highly potent class of immunotherapeutic agents that may outperform
or complement traditional chemotherapy, naked antibodies and ADCs.
MacroGenics’ Dual-Affinity Re-Targeting (DART) proteins are among the most
stable and potent biologics in this therapeutic class. This talk will highlight
several DART proteins currently in clinical studies and those entering clinical
studies, as well as new formats and specificities that are under development
for future drug candidates.
Unpublished
Data
9:30 Antibody Engineering Strategies for the Production of
Bispecific Heterodimeric IgG in Mammalian Cells
Wei Yan, Ph.D., Director, Research, Therapeutic Discovery,
Amgen, Inc.
11:10 Clinical Development of Tanibirumab and Its Bispecific Antibody,
DIG-KT
Jin-San Yoo, Ph.D., President & CEO, PharmAbcine, Inc., Korea
Tanibirumab has completed a Phase I study. In contrast to other KDR pathway
antagonists, Tanibirumab did not cause hypertension and hemorrhage side
effects, and due to its cross-species cross reactivity, it has been possible to
assess in in vivo efficacy studies. I’ll discuss Tanibirumab’s Phase I&II GBM
trials, and development of bispecific next-generation products to enable
Tanibirumab to reach its full potential.
11:40 Bispecific Antibody Formats Tailored for Specific Applications
Jochen Kruip, Ph.D., Department Head, BioInnovation Novel Therapeutic
Protein Formats, Sanofi
Besides a bispecific antibody targeting Il13- and IL4 (currently in phase II) we
have further developed our original format to allow specific applications such
as T cell engagement.
12:10 pm Targeted Delivery of Nanomedicines Using Bispecific
Antibodies
Nanotechnology, University of Queensland
Although there are around 8 nanomedicines approved for cancer therapy,
none of these are actively targeted to cancer receptors. Active targeting can
increase the proportion of drug payload that reaches the tumour site(s). The
utility of targeting nanoparticles to tumour cells with bispecific antibodies
(BsAbs) is demonstrated, whereby one arm binds the nanoparticle, and the
other the target. The use of BsAbs has several advantages over chemical
conjugation of antibody fragments to nanoparticles.
12:40 Networking Luncheon in the Exhibit Hall with Poster Viewing and
Close of Protein & Antibody Engineering Conference

THURSDAY, APRIL 2 | AGENDA
TRACK 4:
TRACK 3:
ANTIBODY-DRUG CONJUGATES
Clinical Experience * Payloads & Linkers * Engineering Homogeneity
3:05 Refreshment Break in the Exhibit Hall with Poster Viewing
Wei Wang, Ph.D., Associate Research Fellow, Pharmaceutical R&D,
Pfizer, Inc.
BIOPHYSICAL AND BIOCHEMICAL CHARACTERIZATION
Unpublished
Data
Case Study
3:50 Characterization Study of an Antibody with Two
Light Chains
A. Scott Muerhoff, Ph.D., Director, Biologics Discovery and
Design, Abbott Diagnostics
We have characterized an antibody against Prothrombin Induced by
Vitamin K Absence (PIVKA-II). Initial testing of the purified antibody
by various biochemical methods contrasted with the results of
the IEC. Biacore analysis demonstrated 3 populations of antibodies with
varying reactivity to the antigen. Finally antibody gene sequencing showed
myeloma’s endogenous light chain was present in the hybridoma and paired
with the functional heavy chain.
4:20 Presentation To Be Announced Sponsored by
Unpublished
Data
4:50 Microchip Electrophoresis (MCE) for Traditional and
Novel Formats of Antibody-Based Biotherapeutics
Harald Wegele, Ph.D., Head, Analytical Development and Quality
Control, Pharma Technical Development Biologics Europe, Roche
Diagnostics GmbH, Germany
Antibody analytics require the identification and assessment of specific
antibody fragments and modifications. Microchip capillary electrophoresis
(MCE) provides an automated high-throughput platform to monitor antibody
quality. Here, we demonstrate the characterization of classical and novel
formats of antibody-based biotherapeutics. The MCE assay shows a good
linear range, high sensitivity and provides a resolution superior to CE-SDS for
many aspects.
5:20 Analytical Characterization in Support of Protein Therapeutics
Development: Linking Structure to Function
Jia-Ming Yang, Ph.D., Senior Scientist, Analytical Development, Livzon
MabPharm Inc., PR China
Characterization of product heterogeneities needs to combine
physicochemical and biological analysis to identify the critical quality
attribute. This presentation will show several case studies of applying our
analytical platform in structure and function characterization during different
developmental stages. Consideration on significance and quality control of
the attributes for process development is also discussed.
5:50 Close of Day
3:05 Refreshment Break in the Exhibit Hall with Poster Viewing
Robb Kahn, M.D., Senior Safety Science Leader, Global Pediatric Oncology
Drug Development, Genentech, a member of the Roche Group
ADCs IN PRECLINICAL AND CLINICAL DEVELOPMENT
»»FEATURED PRESENTATION
3:50 Current Clinical Experience with Antibody-Drug Conjugates:
A View through the Therapeutic Window
Robb Kahn, M.D., Senior Safety Science Leader, Global Pediatric Oncology
Drug Development, Genentech, a member of the Roche Group
Numerous antibody-drug conjugates (ADCs) are in clinical development and
several have entered the therapeutic market. The concept of an ADC is to
improve the “therapeutic window” of cancer chemotherapy. This presentation
will examine the therapeutic windows for representative ADCs in clinical
development, allowing us to peer into the therapeutic window of specific
ADCs through a discussion of their risk-benefit profiles.
Unpublished
Data
4:50 Superior Anti-Tumor Activity Compared to T-DM1 in
Preclinical Studies of Targeted Therapies for Her2-positive
Cancers by a Novel Her2-ADC
Sheldon Cao, Ph.D., CEO, Zova Biotherapeutics, Inc.
ZV02-1016 is a Her2-targeting ADC based on newly developed K-LockTM
technology. Anti-Her2 Ab was conjugated with highly cytotoxic auristatin
analogue through a non-cleavable linker to form ZV02-1016. ZV02-1016 is
shown to be more potent than T-DM1 in vitro in Her2 expressing cancer
cell lines and in vivo in Her2-positive cancer cell line xenografts. ZV02-1016
is currently under further evaluation as a candidate for clinical treatment of
Her2-positive cancers in future.
5:20 Application of Translational PKPD in ADC Development
Kedan Lin, Ph.D., Senior Scientist, Therapeutic Area Lead for Oncology Large
Molecules, Pharmacokinetics & Pharmacodynamics, Genentech, Inc.
5:50 Close of Day
2:00 pm Chairperson’s Opening Remarks
Robb Kahn, M.D., Senior Safety Science Leader, Global Pediatric Oncology Drug Development, Genentech, a member of the Roche Group
2:05 ADCs: Is It Time to Rethink Some Preconceptions?
Jaume Pons, Ph.D., Senior Vice President and CSO, Rinat-Pfizer
In this presentation, we will discuss how site-specific conjugation technologies have allowed a deeper understanding of ADC
properties.
2:35 Whose Problem is Post-Translational Modifications? Discovery, Cell Culture, Chromatography or Formulation?
Chandrashekar Ganesa, Ph.D., Senior Director, Analytical Development, Global Biotherapeutics, Sanofi
Recombinant protein post-translational modifications (PTMs) are important to monitor and control during the manufacture of
biologics. However, the diversity, identification and understanding the relevance of PTMs during the product development cycle
can be challenging. This presentation will examine current analytical technologies and discuss how to effectively use them in
characterizing the different types of PTMs. It will also discuss various strategies to manage PTMs during various stages of therapeutic
protein development.
PLENARY KEYNOTE SESSION
WEDNESDAY, 1

PEGS CHINA | THURSDAY, APRIL 2
TRACK 4:
TRACK 3:
8:30 am Morning Coffee
Thomas Pillow, Ph.D., Scientist, Discovery Chemistry, Genentech, Inc.
NOVEL PAYLOADS, LINKERS AND SITES
Unpublished
Data
9:00 ADCs based on RNA Polymerase II Inhibiting Toxins
Andreas Pahl, Ph.D., CSO, Heidelberg Pharma GmbH
Payloads of today’s ADCs are exclusively based on compounds
acting on microtubules or DNA and seem to suffer from various
limitations. New generations of payloads enter the field including Heidelberg
Pharma’s amanitin, a highly effective inhibitor of the eukaryotic RNA
Polymerase II. Due to its unique mode of action and its hydrophilic properties,
this toxin differs from well-known payloads. This presentation will summarize
the current status of this new toxin.
Unpublished
Data
9:30 Cancer Stem Cell Targeting with Antibody-Drug Conjugate
Payloads and Linker Technologies
Riley Ennis, MSc, Thiel Fellow, Cell and Molecular Biology,
Dartmouth College
A challenge with current antibody-drug conjugates (ADCs) is to improve
patient outcomes by circumventing drug resistance, disease recurrence, and
cancer stem cells. We explore a novel cytotoxic payload, Azonafides, that can
be integrated into ADC platforms. This cytotoxin is more stable in circulation,
has unique mechanisms of action, and is derived from natural products.
Azonafides create an exciting clinical opportunity to improve the therapeutic
window, efficacy, and safety of ADCs.
10:00 New Linker Chemistries for Expanding the Utility of ADCs
This presentation will describe the use of potent anthracycline and PBD
payloads for second generation HER2-targeted ADCs, and how different
linkers to these payloads can be used to tune the therapeutic activity. A new
linker that takes advantage of the site-specificity of THIOMABTM technology
will be described. Additionally, the presentation will describe the application
of ADCs to non-oncology indications.
Unpublished
Data
11:10 Engineering Homogeneous ADCs with Single or
Combination Warheads
Aaron Sato, Ph.D., Vice President, Research, Sutro Biopharma, Inc.
Using Xpress CF+, hundreds of non-natural amino acid antibody
variants are made within a day. Using fast, quantitative conjugation
chemistries, antibodies are conjugated within hours with low molar excess of
linker warhead. The best sites are selected based on expression, cell binding,
conjugation efficiency (DAR), and cell killing. In vivo efficacy, PK/PD, and
stability studies further winnow to our best ADC candidates. Multiple ADC
examples will be provided.
Unpublished
Data
11:40 Bidentate Linkers for Site-Specific Conjugation and
Improvement of Homogeneity and Other Druggabilities in ADC
Bruce Nianhe Han, Ph.D., CSO, Research & Development, NewBio
Therapeutics, PR China
We have discovered new linkers, bis(maleimde)derivatives which can
conjugate small molecule toxins to antibodies in site-specific manner. With
this technology, no antibody engineering is required and we only need to use
the interchain disulfide bonds of IgG to perform conjugation. The resulting
final products have high percentage of ADC with defined antibody-drug ratios.
These homogeneous ADCs have also shown improved in vitro and in vivo
stability, and other related druggabilities.
12:40 Networking Luncheon in the Exhibit Hall with Poster Viewing
8:30 am Morning Coffee
Bilikallahalli Muralidhara, Ph.D., Associate Director, Vaccines & Biologics,
Biopharmaceutical Development, MedImmune, Inc.
»»CHARACTERIZING AGGREGATES AND IMPURITIES FEATURED PRESENTATION
9:00 Kinetic and Thermodynamic Landscape of Protein Aggregation
Protein folding and aggregation are kinetically controlled processes, however
understanding and drawing correlation between the two phenomenon
for large and cofactor binding proteins is fairly complex. Thermodynamics
stability parameters derived from kinetic and equilibrium studies predict
the propensity of protein molecules to aggregation and sub-visible/visible
particle formation. Case studies of co-factor modulated protein stability and
correlations to aggregation/particle formation will be presented.
9:30 Subvisible Particles in Biotherapeutics: Evolving Regulatory
Landscape and Product Development
Satish K. Singh, Ph.D., Research Fellow, Biotherapeutics Pharmaceutical
Sciences, Pfizer, Inc.
Proteinaceous particles arise from growth of aggregates and are thus
an early indicator for product stability, as well as product and process
consistency. These particles are also considered a risk factor for
immunogenicity. Regulatory requirements on the monitoring and reporting
of these particles have been enhanced. This talk will examine this evolving
technical and regulatory landscape, and their incorporation into product
development strategy.
Unpublished
Data
10:00 New Approaches to Determine and Characterize CHO
Host Cell Proteins
Harald Wegele, Ph.D., Head, Analytical Development and Quality
Control, Pharma Technical Development Biologics Europe, Roche
Diagnostics GmbH, Germany
As HCPs may act immunogenic, their characterization during manufacturing
processes is of major interest. We apply electrochemiluminescent assays
combined with 2D-chromatographic fractionation to monitor HCP removal.
Their profiles and coverage by anti-HCP antibodies is analyzed using 2-D
Fluorescence Difference Gel Electrophoresis (2-D DIGE) and Western
blot techniques.
STABILITY AND SOLUBILITY FOR ENGINEERED
PROTEINS AND ANTIBODIES
Unpublished
Data
11:10 Estimation of Shelf Life based on Accelerated
Stability Studies
Wei Wang, Ph.D., Associate Research Fellow, Pharmaceutical
R&D, Pfizer, Inc.
Estimation of the product shelf life is often based on accelerated stability
studies during the early stage of product development. These short-term
studies allow rapid evaluation and optimization of product stability. Such
data, however, may not always predict accurately the real-time shelf life for
biologics. This presentation discusses the general principles, challenges, and
options in shelf life estimation.
11:40 Large Impact of Single Amino Acid Mutation on
the Stability,
Unpublished
Data
Solubility and Viscosity of Engineered
Monoclonal Antibodies
Masaru Muraoka, Ph.D., Research Scientist, Discovery Research
Department, Chugai Pharmaceutical Co., Ltd., Japan
In protein engineering of monoclonal antibodies, conferring pH-dependent
antigen binding property is a common technique for improving therapeutic
potential. However, in some cases, such protein engineering, even with
single amino acid mutation, has an adverse effect on the stability, solubility
and viscosity of monoclonal antibody. This talk will present case studies
covering these issues and discuss the strategies for protein engineering.
12:40 Networking Luncheon in the Exhibit Hall with Poster Viewing

TRACK 4:
TRACK 3:
THURSDAY, APRIL 2 | AGENDA
SITE-SPECIFIC CONJUGATIONS FOR PRODUCTION OF
HOMOGENEOUS ADCs
2:05 Site-Specific Conjugations for Well-Defined and Stable ADCs
Changshou Gao, Ph.D., Fellow, R&D, Department of Antibody Discovery &
Protein Engineering, MedImmune, LLC.
Significant effort has been devoted recently to developing site-specific
conjugations for producing homogenous ADCs with well-defined drug to
antibody ratios. This presentation will discuss our approaches to generate
ADCs with different conjugation chemistries that allow precise control of
conjugation site and stoichiometry. Upon conjugation to a drug, the site-specific
ADCs showed enhanced stability, increased in vivo anti-tumor
efficacy, and decreased off-target toxicity.
2:35 Overcoming Challenges and Enhancing Production of Antibody for
Site-Specific Antibody-Drug Conjugates
Marie Zhu, Ph.D., Director, Process Sciences, Agensys, Inc./Astellas, Inc.
ADCs have been emerging as a new class of anticancer therapeutics,
in which monoclonal antibodies are designed to deliver a cytotoxic drug
selectively to antigen expressing cells. The site-specific ADC technology
we are using results in ADCs with a homogenous drug-antibody ratio. In
this study, we investigate how the cell line development process impacts
on antibody expression, and how feed media components and cell culture
processes affect cell growth and antibody production.
5:35 Close of Conference 5:35 Close of Conference
STANDARDS & CHALLENGES IN BIOPHARM
DEVELOPMENT AND COMMERCIALIZATION
2:05 Development of Biological Standards – USP Approach
Jun Liu, Ph.D., Director, Therapeutic Proteins, Biologics & Biotechnology
Department, USP China
The U.S. Pharmacopeia Convention (USP) is a standard-setting organization
recognized for its compendia and reference standards adopted in over 140
countries worldwide. USP currently offers more than 150 documentary
standards in addition to 76 reference substances of biologics. USP has been
playing a growing role in helping the biopharmaceutical world to accelerate
the development and approval of safe and effective biological medicines.
2:35 The Challenges and Strategies of Development and
Commercialization of High Quality Biopharmaceutical Product
Jun Liu, Ph.D., Senior Group Leader and Senior Scientist, Late Stage
Pharmaceutical Development, Genentech, Inc.
Successful development and manufacturing of a high quality product require
having a closely controlled and robust manufacturing process, a well-designed
formulation, and sensitive and reliable analytical methods. In this presentation,
we will discuss our overall strategy and highlight some of the key steps during
the product development and manufacturing to ensure our product quality.
Several case studies, including mAbs and ADCs will be discussed.
Darshana Jani, Ph.D., Senior Manager, Clinical Assay Group, Global Innovation Pharma, Pfizer, Inc.
4:05 Analytical Strategies and Characterization of Antibody-Drug Conjugates
Gayathri Ratnaswamy, Ph.D., Director, Analytical & Formulation, Agensys, Inc.
This presentation will focus on the challenges of analytical method development and characterization for ADCs in comparison with that of
mAbs using case studies. Strategies for the analytical development for early stage versus late stage will be presented.
4:35 Bioanalytical Support for the Clinical Development of Antibody-Drug Conjugate Program
Darshana Jani, Ph.D., Senior Manager, Clinical Assay Group, Global Innovation Pharma, Pfizer, Inc.
Antibody-Drug Conjugates (ADC) are a novel class of biotherapeutics, combining the targeted delivery capability of a monoclonal antibody
with the potent cytotoxic activity of a small molecule. Due to the complex and heterogeneous nature of ADCs, a more robust bioanalytical
testing strategy is required to assess the ADC pharmacokinetics (PK) and immunogenicity (anti-drug antibody (ADA) and neutralizing ADA).
Challenges and solutions to ADC bioanalysis will be discussed.
5:05 ADCs: Biophysical Characteristics and Impact on Product and Process
Satish K. Singh, Ph.D., Research Fellow, Biotherapeutics Pharmaceutical Sciences, Pfizer, Inc.
The biophysical characteristics of ADCs are strongly impacted by the chemistry and associated linker-payload. A strong understanding of
these characteristics is therefore important for robust product and process development. This talk will cover some examples illustrating these
aspects for ADCs.
JOINT CLOSING SESSION: Characterizing ADCs for Better Developability

PODIUM PRESENTATIONS
– Available Within the Main Agenda!
Showcase your solutions to a guaranteed, targeted audience. Package includes
a 15- or 30-minute podium presentation within the scientific agenda, exhibit
space, on-site branding, access to cooperative marketing efforts by CHI, and
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INVITATION-ONLY VIP
DINNER/HOSPITALITY SUITE
Sponsors will select their top prospects from the conference pre-registration
list for an evening of networking at the hotel or at a choice local venue. CHI will
extend invitations and deliver prospects, helping you to make the most out of
this invaluable opportunity. Evening will be customized according to sponsor’s
objectives i.e.:
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EXHIBIT
Exhibitors will enjoy facilitated networking opportunities with qualified
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Additional branding and networking opportunities are available, including:
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WAYS TO DRIVE LEADS TO
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We will mine our database of 800,000+ life science
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Opportunities include:
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CHI offers comprehensive sponsorship
packages which include presentation
opportunities, exhibit space, branding
and networking with specific prospects.
Sponsorship allows you to achieve your
objectives before, during, and long after the
event. Any sponsorship can be customized
to meet your company’s needs and budget.
Signing on early will allow you to maximize
exposure to qualified decision-makers.
For sponsorship and exhibit information,
please contact:
Companies A-K:
Jason Gerardi
Manager, Business
Development
T: 781-972-5452
E: jgerardi@healthtech.com
Companies L-Z:
Carol Dinerstein
Director, Business
Development
T: 781-972-5471
E: dinerstein@healthtech.com
Sponsoring Organizations Lead Sponsoring Publications Sponsoring Publications Web Partners
PEGS CHINA 2015 MEDIA SPONSORS

DISCOUNTED ROOM RATE:
CNY 1,050/ $170 Single; CNY 1,150/ $186 Double – Includes Breakfast
DISCOUNTED ROOM RATE CUT-OFF DATE:
February 20, 2015
Please call the hotel directly to reserve your sleeping accommodations,
or visit our website PEGSummitChina.com to make your reservations on
line. 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.
VISA REQUIREMENTS:
International attendees requiring a letter of invitation for visa application
to China, should first be registered and paid in-full for the conference
and have reserved a room at the host hotel prior to being issued an
invitation letter. Please visit the event site to complete the details required
to process the invitation letter. You will receive the invitation letter
via email within 7 - 10 business days.
Visa processing times may vary between countries/cities. We highly
recommend that you apply for your visa 3 months in advance to avoid
possible delays at certain consulates/embassies.
ABOUT SHANGHAI:
Get tips and travel guide to Shanghai China, including events,
attractions, hotel etc. at the official Shanghai travel website:
www.meet-in-shanghai.net
WHY STAY AT THE SHANGHAI
MARRIOTT?
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at the hotel
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guest room
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HOTEL & TRAVEL

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STANDARD PACKAGE (INCLUDES ACCESS TO TWO CONFERENCES) BEST VALUE!
Early Registration Rates until January 16 $2049 $1029
Advance Registration Rates until February 27 $2199 $1099
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BASIC PACKAGE (INCLUDES ACCESS TO ONE CONFERENCE)
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Advance Registration Rates until February 27 $1699 $829
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* All credit card payments will be charged in USD. The invoice for your registration will list the USD equivalent of the listed registration fees, based on the exchange rate of the day.
** A 6% VAT will be added to all payments received in CNY.
CONFERENCE SCHEDULE
Tuesday-Wednesday (March 31- April 1, 2015) Wednesday-Thursday (April 1-2, 2015) T1: Protein & Antibody Engineering T3: Antibody-Drug Conjugates T2: Phage & Yeast Display T4: Characterization of Biotherapeutics
CONFERENCE DISCOUNTS
Poster Submission - Discount ($50 off): Poster abstracts are due by February 27, 2015. Once your registration has been fully processed, we will send an email containing a unique link allowing you to submit your poster abstract. *CHI reserves the right to publish your poster title and abstract in various marketing materials and products.
Antibody Society Members: (20% off) CHI is pleased to offer all Antibody Society Members a 20% discount to attend. Records must indicate you are a member at time of registration.
Protein Society Members: (20% off) CHI is pleased to offer all Protein Society Members a 20% discount to attend. Records must indicate you are a member at time of registration.
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.
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Each registration includes all sessions in the registered conference, 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
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