19

th
21
st
September, Copenhagen, Denmark
THE INTERNATIONAL EXCHANGE OF KNOWLEDGE FOR AVOIDING &
MITIGATING IMMUNOGENICITY RISKS
Once a disease has entered the body, all parts which are healthy must fight it: not one
alone, but all. Because a disease might mean their common death. Nature knows this;
and Nature attacks the disease with whatever help she can muster.
Paracelsus (1493-1541)
Satish K. Singh
Ph.D, Research Fellow
Pfzer Corporation
Pharmaceutical R & D
Prof. Dr. Wim Jiskoot
Professor of drug
delivery, Biologics
Formulation Group
University of Leiden
Harald Petry
PhD. Director of Research
and Development
AMT Biopharma
Erwin L Roggen
Science Manager
Predictive Technology
Novozymes
Maureen Deehan
Head of Pharmacology
Novimmune SA
Daniela Verthelyi
M.D., Ph.D., Chief,
Laboratory of Immunology,
Division of Therapeutic
Proteins, OBP, CDER
FDA (US)
Robin Thorpe
Head, Biotherapeutics
Group
National Institute
for Biological Standards
and Control (NIBSC)
SPEAKER & PANELIST PANEL:
Igor Vostiar
Principal Scientist
Novartis
Organised by:
www.vivolifescience.com
Pharma Division
Birgit Reipert
PhD & Director
Department
of Immunology
Baxter BioScience
(Franchise Hemophilia/
Hematology)
Juliana Bessa
PhD, pRED Basel,
SMR-DT, F.
Hoffmann-La Roche Ltd
Dr. Andreas Seidl
Head of Bioanalytical
Testing Facility and Head
of Analytical Characterization,
Sandoz Biopharmaceuticals
Robin Marsden
Scientist, Bioanalytical Lead
Ambrx Inc.
Dr. Patrick Garidel
Head of Pharmaceutical
Basic Development/
Protein Science
Boehringer Ingelheim
Pharma GmbH & Co. KG
Christian Ross Pedersen
Novo Nordisk A/S
University of Geneva

CHAIRMAN
Tudor Arvinte
Ph.D., Professor
Department of
Pharmaceutics
University of Geneva
HIGHLIGHT TOPICS COVERED IN 2012
A Immunogenicity assessment: best practice to increase accuracy
and cost-effciency during pre-clinical and clinical trials
A FDA & EMEA Regulatory Approaches: FDA and EMEA Risk Balanced
guidance and regulatory matters to ensure continuous compliance.
A Assay development plan & methodology: all key issues to improve
bioassays effciency, such as detecting ATAs, validating Assays and
use of statistics
A Immunogenicity determination, testing and screening: strategies
to anticipate risks
A Mitigating risks: anticipating, neutralizing and tackling unwanted
immunogenicity risks
International Pharmaceutical Industry
Supporting the industry through communication
MEDIA PARTNER PLATINUM PARTNER PARTNER
2012 IMMUNOGENICITY
Dear Colleagues
The 2012 Immunogenicity will gather global biopharmaceutical, institutes, scientifc experts and regulators striving to tackle unwanted
immunogenicity which poses threats to patient safety and to scientifc development.
The comprehensive program is divided into 3 core areas. The frst focuses on Immunogenicity Awareness and Assessment of Clinical
Relevance. The second gives practical insights on Detecting, Determining and Mitigating Risks in connection with immunogenicity. These
two areas will be linked to assay and immunogenicity strategic questions to ensure you strengthen your risk-balance approach, gain an
in-depth understanding of regulatory requirements and, in turn, reach effcacy to your scientifc developments.
This is the platform for those active in the immunogenicity feld who know that the impact of immunogenicity can be quite severe. If
you are in search of expertise, practical know-how and innovative strategies to mitigate immunogenicity risks, join us in Copenhagen in
September 2012.
I look forward to welcoming you to the 2012 Immunogenicity.
Beatriz Viellas
Senior Project Manager
Pharma Division
Actelion Pharmaceuticals Portugal, Lda, Medical Director; Alexion Pharma, General Manager, AMT, Chief Medical offcer, Apogenix,
Chief Medical Offcer, Astion Pharma A/S, Vice President Medical Affairs, Biomarin, Country Manager Benelux,Charit Universitts-
medizin Berlin, Prof. Dr, Infectious Diseases and Respiratory Medicine, Clavis Pharma, VP Clinical R&D, Defante Farmacutica,
S.A., CEO, Entomopharm, DVM PhD, EPC HealthCare GmbH, Managing Director; F.Hoffmann-La Roche Ltd, CNS Senior Disease
Area Director; Galapagos, SVP DRUP DISCOVERY; Genzyme A/S, Senior Medical Director; Genzyme Czech S.R.O, Vice President &
General Manager East Central Europe, GlaxoSmithKline, Pharmacovigilance Manager, Safety Evaluation & Risk Management; Institut
Jules Bordet, Head Molecular Biology/Oncogenetics, Pathology laboratory, MD PhD; Medicon Valley Alliance, CEO; Merck Serono
International S.A, Senior Medical Director; NeuroSearch A/S, Chief Medical Offcer; Novo A/S, Orphazyme ApS, CEO; Pfzer Inc.,
Senior Director-Therapy Area Lead; ProRetina Therapeutics, S.L., Director General; Sangart, chief sientifc offcer; SCM pharma,
Development Manager; Swedish Orphan Biovitrum, Vice President - Head of Research and Development; Swedish Orphan Biovitrum,
Medical Affairs Director; Swedish Orphan International AB, Chairman of the Board; Symphogen A/S, Director Clinical Development
and CEO; TopoTarget A/S, CEO and Chief Medical and Development Offcer; Zealand Pharma, Manager Clinical Operations, Principal
Scientist and CEO.
SAMPLE OF PREVIOUS SENIOR ATTENDANTS TO OUR BIO & PHARMA EVENTS:
Day 1
17.00 Check-in Registration
18.00 Networking Reception
Day 2
08.30 Registration
09.00 Conference starts
15.10 Round table discussions
17.50 Chairperson Closing Remarks
18.00 End of Conference & Evening
Networking Program
Day 3
08.30 Conference starts
12.30 End of Conference
CONFERENCE SCHEDULE
Immunogenicity Awareness and Assessment of Clinical Relevance
Many therapeutic developments are interrupted due to unwanted im-
munogenicity. Biotherapeutic candidates are oftentimes found to be im-
munotoxic and induce anti-drug antibody responses, being the core cause
of failure of development and, potentially, a major burden to safety.
Day 2:
8.30 Registration & Coffee
10.10 Coffee & Networking Break
12.10 Networking Lunch
10.40 Current analytical methods for the detection of protein
particles
What are protein particles?
The formation of protein particles and how to avoid it
Current analytical techniques for the detection of protein particles
Methods for single particle analysis
Dr. Patrick Garidel, Head of Pharmaceutical Basic Development/
Protein Science, Boehringer Ingelheim Pharma GmbH & Co. KG
11.10 Pre-Clinical Immunogenicity Assessment Of Protein
Therapeutics: assessment of T-cell epitopes case study
The case will cover the specifcation of CD4+ T cell epitopes of human
factor VIII using a humanized mouse model:
- Challenges for pre-clinical immunogenicity assessment
- Induction of antibody responses against factor VIII
- Specifcation of CD4+ T cell epitopes of human factor VIII using a
humanized mouse model
Birgit Reipert, PhD & Director Department of Immunology
(Franchise Hemophilia/Hematology), Baxter BioScience
9.40 Human-IgG transgenic mice for the study of immunoge-
nicity of therapeutic antibody preparations
The use of transgenic mice expressing a repertoire of human IgG1
antibodies in the assessment of immunogenic preparations of human
therapeutic antibodies will be presented:
The transgenic mice are universally tolerant to human IgG1
Different thresholds of immune tolerance are achieved
The transgenic mice can sense different forms of aggregates based
on differential ADA responses
Juliana Bessa, PhD, pRED Basel, SMR-DT,
F. Hoffmann-La Roche Ltd
9.10 Integrated analysis of in vivo, computational and in vitro
data for advancing BioTech product development and safety
This presentation will address various approaches for assessing safety
of BioTech Products for screening, early decision-making, risk assess-
ment and risk management. It will discuss the use of historical data
in read-across and data-waiving, and integrated analysis of new and
existing in vitro, in vivo and computational data to support a relative
immunogenicity assessment strategy. Assessment strategies allow-
ing for the identifcation of variants with reduced allergenic potential
(example 1) and variants with a reduced potential to elicit neutralizing
antibodies (example 2) will be presented.
Erwin L Roggen, Science Manager Predictive Technology,
Novozymes
14.10 Translating your immunogenicity risk assessment
program into action
The proper assessment of immunogenicity risk
Likelihood vs. consequences of immunogenicity
Preserving effcacy and patient safety
What obscures interpretation of immunogenicity?
Implementation of proper study design to provide context around
immunogenicity results
Leveraging your preclinical and clinical data to improve your post-
marketing plan and further improve patient safety
Robin Marsden, Scientist, Bioanalytical Lead, Ambrx Inc.
Robin has worked for over 3 years at Ambrx, where she has lead
the immunogenicity matrix team to predict and identify challenges
and risks in the development of potential protein therapeutics,
including developing program-specifc risk assessments. Her work also involves
presenting bioanalytical results in matrix environment, translating into impact on
resources and timelines.
13.10 The potential for optimising effcacy and safety, by
collecting ADA data from different technology formats
During this presentation, ADA assay data across different assay for-
mats and technologies will be presented, including ELISA, Gyros and
Mesoscale techniques. The focus of the presentation will be on:
- A comprehensive overview of ADA assay formats and equipment
currently commercially available
- In-house opinion on the advantages and disadvantages of each
format
- Case study data for a human monoclonal antibody
Dr. Maureen Deehan, Head of Pharmacology,
Experimental Science & Translational Medicine Department,
NovImmune
Maureen graduated from the Faculty of Medicine, University of Glasgow,
Scotland and pursued an academic career for 6 years in immune cell signaling
and then moved to industry where she has now achieved over 10 years experi-
ence in Pharma/Biotech. NovImmunes group supports preclinical and clinical
programs by developing assays for target validation, in vitro pharmacology,
pharmacokinetics, immunogenicity, safety, and biomark
13.40 Suppression of target interference in immunogenicity
assays. Case Study
Soluble drug targets can interfere with detection of ADA. The pre-
sented case study focuses on methodology applicable for improvement
of immunogenicity assays with target interference.
Methodologies applicable for elimination of target interference.
Technology comparison (MSD, Biacore)
Development and validation of immunogenicity assays with target
interference
Target interference and its implications for detection of ADA
(pre-clinical and clinical examples)
Igor Vostiar, Principal Scientist, Novartis
9.00 Chairmans Opening Address
CHAIRMAN: Tudor Arvinte, Ph.D., Professor,
Department of Pharmaceutics, University of Geneva
11.40 Novel assay technologies for immunogenicity testing and
ADA screening
Case study speaker to be announced, PerkinElmer
Detecting, Determining and Mitigating Risks in connection
with immunogenicity
More than 150 protein biopharmaceuticals have been approved for
clinical use, but hundreds more have failed to reach market. In order
to increase success rates of clinical trials and ensure clearance of
regulatory requirements and safety, it is essential to have a sound risk
assessment and mitigation strategy. This is the focus of this part of the
program.
17.30 Chairperson Closing Remarks
18.00 End of Conference & Evening Networking Program
15.10 ROUND TABLE DISCUSSIONS
Share experiences with the scientifc and academic community. These sessions are dedicated to both large and small questions, for those who
are in need of advice and take their initiatives further. You will have the possibility to participate in two 30-minute discussions, under the guid-
ance of a knowledgeable moderator. A smaller group of participants and speakers will discuss and pose their questions to each other regarding
the selected topic. These are a few suggestions:
Trends within immunogenicity risk strategy and
regulatory requirements
Challenges & tools to develop a clinically signifcant
immunogenicity testing
Protein aggregates & Immunogenicity
Immunogenicity clinical trial & testing protocols:
challenges within
Outlook and Challenges connected with Ligand
Binding Assays
Designing services which are the key considerations
and success advice in order to design successful
commercial service
A B C
D E F
16.20 Sub-protein aggregation & sub-visible particles (SVP)
and immunogenicity
Insights on publications, studies and experiences with the detection,
measurement and characterisation of sub-visible particles, including
aspects such as:
Potential immunogenicity of aggregates sub-visible particles
How they affect safety and effcacy of therapeutics and threat
available technology
Available improvements in sub visible particle testing
Mechanism of protein particulate formation
Diffculties with aggregates, leachables and other gaps that may
compromise product quality
Prof. Dr. Wim Jiskoot, Professor of drug delivery, Biologics
Formulation Group, University of Leiden
17.00 Tolerogenicity, tolerance induction and technologies to
reduce and avoid immunogenicity
The development of tools to predict propensity for aggregation, the
connection between aggregation and immunogenicity, as well as in the
study of large-scale cryoprocessing of biomolecules are focus areas
for Satish. He has also been involved in the implementation of QbD
principles in biologics product development. Listen more about:
Product related risk factors for immunogenicity
Coupling of Aggregation and immunogenicity a bioinformatics
approach
Experimental evidence for immunogenicity caused by aggregates
In silico tools to address aggregation propensity
Satish K. Singh, Ph.D, Research Fellow,
Pfzer Corporation Pharmaceutical R & D
Dr. Singh responsibilities include leading formulation, process and product
development activities for biologics, including vaccines. He has published more
than 40 articles with emphasis on the colloidal and physical chemistry of mac-
romolecules, and holds four issued patents. He has recently been involved in
leading a group of industry scientists to examine the concerns around protein-
based subvisible particulates and published a white-paper on this topic.
14.40 Coffee and Networking Break
Global and European Regulations
Estimates indicate that managing immunogenicity in trials and in the
approval process can add 18 months to development times and $75
million to costs for companies. More importantly, failure to monitor
immunogenicity can have devastating implications to patients. For
these reasons, EMEA, FDA and regulators globally have implemented
guidance for immunogenicity testing
Day 3:
Detecting, Determining and Mitigating Risks linked to
immunogenicity continuation
10.00 Coffee & Networking Break
12.30 End of Conference
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9.00 Generating tolerance, a way to improve clinical effcacy
of gene therapy
- To prevent host immune responses to the viral capsid proteins and
improve effcacy of vector delivery
- To circumvent host immune responses to the transgene and
facilitate long-term expression of transgenic therapeutic proteins
- To achieve a successful gene therapy with clinical beneft
Harald Petry, Director of Research and Development,
AMT Biopharma
Dr. Petry joined AMT in May 2007. He has worked in the area of gene therapy
for more than 15 years and has extensive experience in pharmaceutical re-
search. After his PhD he built up a career in academic research; for the last 10
years he has worked at Jenapharm GmbH (Germany), Berlex Biosciences (US)
and AMT (The Netherlands) in different functions with increasing managerial
and leadership responsibility.
9.30 Approaches to Appropriate Immunogenicity Risk
Assessment:
What holds back immunogenicity risk assessment: when patient
safety, effcacy and effciency are under threat
Engaging scientists and the organization to implement a holistic
risk assessment program
Establishing steps in each clinical end points support your analysis
plan and studies
Leveraging on the analysis of information: communicating with the
market and practicing physician post- clinical trials
Amongst other panelists:
Dr. Andreas Seidl, Head of Bioanalytical Testing Facility
and Head of Analytical Characterization,
Sandoz Biopharmaceuticals
11.30 European Perspective on Unwanted Immunogenicity
& Immunogenicity Assessment of Biologicals: Regulatory &
Practical Considerations
EU Guidelines on Unwanted Immunogenicity of Biologicals,
Biosimilars and monoclonal antibodies (mAbs)
Regulatory framework: key aspects to consider when developing
immunogenicity testing and assessment
EMAs post authorisation activities and potential for development of
Biologicals, Biosimilars and mAbs
Robin Thorpe, Head Biotherapeutics Group, National
Institute for Biological Standards and Control
Robin is an author with over 200 publications in scientifc journals and books
and highly involved with immunogenicity aspects at NIBSC and as a regular
attendant to the Biologicals Working Party & Biosimilars Working Party of the
CHMP at the EMEA.
12.00 Product immunogenicity: from science to regulations
This talk will review risks and uncertainties surrounding critical
product attributes that impact on immunogenicity, concentrating on
aggregates, sub-visible particles, and describing recent studies on
the role of innate immune response modulating impurities in protein
immunogenicity.
Daniela Verthelyi, M.D., Ph.D., Chief, Laboratory of
Immunology, Division of Therapeutic Proteins, OBP, CDER,
FDA (US)
Daniela Verthelyis laboratory at the US FDA, studies innate immune response
modulators in several disease models. Currently their studies are focused on
the understanding the impact of TLR -stimulating impurities on product im-
munogenicity. Daniela has authored over 50 peer-reviewed articles in scientifc
journals, holds several patents, and received of the FDAs Excellence in Laboratory
Sciences Award, among other honors.
8.30 Lessons learned from previous studies on clinical
consequences
Challenging immunogenicity case study will be announced shortly,
which will give you hands-on strategies from Novo Nordisk A/S, a
representative Danish organisation.
Christian Ross Pedersen, Novo Nordisk A/S
Speakers
Satish K. Singh, Ph.D, Research Fellow Pfzer Corporation
Pharmaceutical R & D
Dr. Satish Singh is a Research Fellow, Pfzer Corporation,
Pharmaceutical R & D. His responsibilities include leading
formulation, process and product development activities for
biologics, including vaccines, in the organization. He has more
than 20 years experience in the industry in product development activities
ranging from oral dosage forms to ophthalmics and parenterals, encompassing
small molecules and biologics. His interests are in the use of physical chemistry
techniques for the understanding of formulation characteristics for biologics.He
has published more than 40 articles with emphasis on the colloidal and physical
chemistry of macromolecules, and holds four issued patents. He has recently
been involved in leading a group of industry scientists to examine the concerns
around protein-based subvisible particulates and published a white-paper on
this topic. His current research interests are in the development of tools to
predict propensity for aggregation, the connection between aggregation and
immunogenicity, as well as in the study of large-scale cryoprocessing of bio-
molecules. He has also been involved in the implementation of QbD principles
in biologics product development. Satish obtained his B.Tech from the Indian
Institute of Technology, New Delhi, and an MS and PhD in Chemical Engineering
from Kansas State University. He holds a position of Adjunct Professor at the
Dept. of Physical Pharmaceutical Chemistry at Uppsala University, Sweden.
Prof. Dr. Wim Jiskoot, Professor of drug delivery, Biologics
Formulation Group, University of Leiden
Wim Jiskoot graduated as a pharmacist in 1987 and received
his PhD degree in 1991 at Utrecht University on pharmaceutical
aspects of monoclonal antibodies. As a postdoctoral fellow at
the University of Utah (1991-1993) he studied protein-ligand
interactions using biophysical techniques. From 1994-1998 he was head of
the Department of Bacterial Vaccine Development at the National Institute of
Public Health and the Environment (RIVM), Bilthoven. In 1998 he became a
staff member at the Department of Pharmaceutics, Utrecht University, where
he focused his research on formulation and physicochemical characterization
of therapeutic proteins and vaccines. In March 2006 he was appointed as full
professor at the Division of Drug Delivery Technology, LACDR, and as the coor-
dinator of the Biologics Research Platform Leiden (BRPL). His current research
is concentrated on two themes: (1) formulation and unwanted immunogenicity
of therapeutic proteins and (2) vaccine delivery.
Erwin L Roggen, Science Manager Predictive Technology,
Novozymes
Dr. Erwin L. Roggen is Manager for In Vitro Toxicology at
Novozymes. He received his doctorate in Biochemistry from
the University of Antwerp (1984). Four postdoctoral fellow-
ships allowed him to expand his expertise into the areas
of protein chemistry, molecular biology, immunology, cell biology and
management. He also works as a project manager at 3RsMC. Dr. Roggen
joined Novozymes AS where he developed and implemented tools for in
vitro toxicity testing and integrated strategies for safety assessment. He
served as coordinator of a European Framework (FP) 6 funded projects
and as board member of 4 FP funded projects addressing issues related to
in vitro toxicology. He is author/co-author of 45 peer reviewed articles and
15 book chapters. Dr. Roggen is currently president of IVTIP, member of
EPAAs Steering Committee, ECVAMs Scientific Advisory Board, the Board
of Ecopa and the Dutch Center for Toxicogenomics, the editorial board of
Toxicology In Vitro and Frontiers, and invited reviewer for Toxicological
Sciences, among others. He is expert for the European Commission funded
industry-academia partnership Biotech projects. Dr. Roggen has been
member of the SOT since 2004.
Maureen Deehan, Head of Pharmacology Novimmune SA
Dr. Maureen Deehan is Head of Pharmacology, in the Experimental
Science & Translational Medicine Department at NovImmune,
in Geneva, Switzerland. The group supports preclinical and
clinical programs by developing assays for target validation, in
vitro pharmacology, pharmacokinetics, immunogenicity, safety,
and biomarkers. Following graduation from the Faculty of Medicine, University
of Glasgow, Scotland she pursued an academic career for 6 years in immune
cell signaling and then moved to industry where she has now achieved over 10
years experience in Pharma/Biotech. Dr Deehan is currently a member of the
European Immunogenicity Platform.
Robin Thorpe, Head, Biotherapeutics Group National
Institute for Biological Standards and Control (NIBSC)
Robin Thorpe PhD, FRCPath, is Head of the Biotherapeutics
Group at the National Institute for Biological Standards and
Control (NIBSC). Recent interests include the unwanted immuno-
genicity of biologicals, development of improved bioassays for
cytokines, the immunology of monoclonal antibodies and cytokine contamination
of biological products. He attends meetings of the Biologicals Working Party &
Biosimilars Working Party of the CHMP at the EMEA. He is a member of the British
Pharmacopoeia Commission (MHRA) Expert Advisory Group NOM, the British
Pharmacopoeia Panel of Experts on Biological and Biotechnological Products and
the Working Group on Monoclonal Antibodies of the European Pharmacopoeia. Dr
Thorpe is a member of the Biologicals & Vaccines Expert Advisory Group of the
CHM. He is the Chairman of the IUIS nomenclature subcommittee for chemok-
ines and the standardisation and nomenclature committee of the International
Cytokine Society. Dr Thorpe is an author on over 200 publications in scientifc
journals and books. He is an associate editor for the journal Cytokine,
Biotherapeutics section editor for Biologicals and editorial board member of the
Journal of Immunological Methods & Current Analytical Chemistry.
Tudor Arvinte, Ph.D., Professor, Department of
Pharmaceutics, University of Geneva
Tudor Arvinte was born in Romania in 1956, received his
Ph.D. in biophysics from the University of Dsseldorf,
Germany. He held research positions in Europe (Max-
Planck-Institute, C.N.R.S.) and in U.S.A. (Cornell University
and Texas A&M University). He joined Ciba-Geigy in England, and then
Ciba-Geigy and Novartis in Basel where he was Head of Exploratory
Formulation for biotech products. T. Arvinte worked on the formulation of
more than 80 proteins and peptides, has 70 publications and 12 patents.
He is Invited Professor at the School of Pharmacy, University of Geneva. In
2003 T. Arvinte co-founded Therapeomic, Inc., a biotech company focused
on developing formulations for biopharmaceuticals in collaborations with
pharmaceutical companies.
Dr. Andreas Seidl, Head of Bioanalytical Testing Facility
and Head of Analytical Characterization, Sandoz
Biopharmaceuticals
Andreas Seidl is heading the Bioanalytical Test Facility and the
Analytical Characterization departments of Sandoz Biophar-
maceutical development Oberhaching/Germany. At Sandoz he
developed concepts for demonstration of physicochemical and biological com-
parability of biosimilars in comparison with their originator reference products
as well as after process changes. During his career at Sandoz he hold different
positions in analytical and pharmaceutical development, quality control and
characterization of biopharmaceuticals. He was involved in the analytical and
pharmaceutical development of the frst complex biosimilars such as Binocrit
(INN: epoetin alfa) which gained market approval in the European Union by the
EMA/EC in 2007. Andreas Seidl is a chemist by training and holds a PhD from
the University of Constance/Germany in the area of protein chemistry/analytics
and analytical biochemistry.
Robin Marsden, Scientist, Bioanalytical Lead, Ambrx Inc.
Robins areas of expertise are expert bioanalytical method
development, troubleshooting, and validation for PK, PD, and
immunogenicity assays (ADA and cell-based NAb) in the con-
text of stage-appropriate needs. She has worked at Ambrx, Inc
since 2008, where she has lead the development, optimization,
troubleshooting, and phase-appropriate validation of PK, PD and immunoge-
nicity assays (ELISA and ECL platforms). She also leads the immunogenicity
matrix team to predict and identify challenges and risks in the development
of potential protein therapeutics, including developing program-specifc risk
assessments, where she has presented bioanalytical results in matrix environ-
ment, translating into impact on resources and timelines. She also oversees
functional NAb assay transfer, development, and validation. Previously, Robin
worked as a Research Associate at Amylin Pharmaceuticals (2005-2008), as an
Associate Scientist at Dendreon, Inc (Formerly Corvas, Inc.) (2001 2004) and
as a Project Manager at Alta Analytical Laboratory 1999-2001). Robin has also
experiences as a staff research associate III at the University of California, San
Diego, research associate at Dynavax, Inc. and Intern Cancer Immunothera-
peutics at Viagene.
Harald Petry, PhD. Director of Research and Development,
AMT Biopharma
Dr. Petry joined AMT in May 2007 as Director of the Research
and Development. He has worked in the area of gene therapy
for more than 15 years and has extensive experience in
pharmaceutical research. After his PhD he built up a career in
academic research; for the last 10 years he has worked at Jenapharm GmbH
(Germany), Berlex Biosciences (US) and AMT (The Netherlands) in different
functions with increasing managerial and leadership responsibility.
Daniela Verthelyi, M.D., Ph.D., Chief, Laboratory of
Immunology, Division of Therapeutic Proteins, OBP,
CDER FDA (US)
Dr. Verthelyi received her MD from the University of Buenos
Aires and a PhD from the Virginia Tech in USA, and then
completed a fellowship training in Immunology at the Section
in Retroviral Immunology of the Center for Biologics Evaluation and Research of
the FDA before joining the Laboratory of Immunology of Division of Therapeutic
Proteins and eventually becoming its Chief. Dr Verthelyis laboratory, established
in 2002, studies innate immune response modulators in several disease models.
She has authored over 50 peer reviewed articles, chairs the NIH/FDA Cytokine
interest Group, and received of the FDAs Excellence in Laboratory Sciences
Award, among other honors.
Igor Vostiar, Principal Scientist, Novartis
Igor has been working at Novartis since july 2008. Before
that, he worked as a scientist at Xencor in the fields of PK/
PD assay development, flow cytometry, cell-based assay
development and surface plasmon resonance (biacore)
(2006-2008). He was a postdoctoral researcher at PNNL
for one year, working with ELISA development and multiplex bead-based
assays and a research scientist at the Linkpings Universitet, in the fields
of bioprocess monitoring, surface plasmon resonance and immunosensors.
He has got an academic background as PhD, Biochemistry and Biotechnology
and as a MSc, Biotechnology from Slovensk technick univerzita v Bratis-
lave Slovensk technick univerzita v Bratislave.
Birgit Reipert, PhD & Director Department of Immunology,
Baxter BioScience (Franchise Hemophilia/Hematology)
Birgit Reipert, PhD, is Director of the Department of Immunology
within the Franchise Hemophilia/Hematology at Baxter BioScience.
In addition, she has got a lectureship at the Medical University
of Vienna (Austria). She received her PhD from the Ernst-Moritz
Arndt University, Greifswald (Germany), and postdoctoral training at the Institute
for Medical Immunology at the Charit, Berlin (Germany), at the Department of
Immunology of the Institute for Cancer Research, Berlin, and at the Paterson
Institute for Cancer Research, Manchester (UK). Birgit Reipert joined Immuno AG
in 1994 and Baxter AG in 1997. Birgit Reipert has a long standing interest in the
immunogenicity of therapeutic proteins and in the search for new approaches to
prevent unwanted immune responses to these proteins.
Juliana Bessa, PhD, pRED Basel, SMR-DT,
F. Hoffmann-La Roche Ltd
Juliana Bessa has being working as a Postdoc in the characteriza-
tion of the human IgG transgenic animals as a tool to predict
immunogenicity of human therapeutic antibodies. Juliana is
Brazilian and frst came to to Switzerland in 2000 for 6 months,
when she undertook a diploma work at the Institute of Pharmaceutical Technology
in Basel. In 2001, she did a traineeship at Novartis (enrolled in the IAESTE exchange
programme) for an year. By 2002, she started a Master in Immunology programme
at the Heart Institute, Faculty of Medicine of University of So Paulo in the group of
Prof. Dr. Jorge Kalil and, after two years, she started a immunology PhD programme,
at the Manfred Kopfs group, working in collaboration with Dr. Martin Bachmann,
studying the immunological aspects of intranasal delivery of virus-like particles (VLPs)
and its implications for protective vaccine design.
Speakers
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Lisa Bergstrm, Marketing Director, 2012 Immunogenicity
Phone: +46 8 676 01 40
E-mail: mailto:lisa.bergstrom@midfeldmedia.com
A Microsoft
A Oracle
A IBM
A SAS
A Gartner
A Acando
19
th
21
st
September, Copenhagen, Denmark
DELEGATES PROFILE:
Senior Scientists, Directors and Vice Presidents involved with Immunotoxicity,
Immunogenicity and Product Safety will join us, including those working with:
A Drug Bioanalytical
A Drug Biotherapeutic and
Bioanalysis
A Metabolism & PK/PD
A Immunoassay & Immunology
A Preclinical & Translational Science
A Clinical Development
A R&D
A Molecular and Cell Biology and
Antibody Engineering
Dr. Patrick Garidel, Head of Pharmaceutical Basic
Development/Protein Science, Boehringer Ingelheim
Pharma GmbH & Co. KG
His activities are focused on the development biologics from
the downstream process to drug product (liquid and solid
formulations). His expertise covers: protein purifcation,
development of drug delivery systems (e.g. controlled release, liposomes) and
formulations, primary packaging and devices, process development and transfer
of biopharmaceuticals, bio-analytic and structural biochemistry, and particle
characterisation. Additionally, he is responsible for the establishment of innovative
platform technologies for e.g. powder inhalation and gene therapy. PG studied
chemistry and biotechnology at the University of Kaiserslautern, where he
received his PhD in physical chemistry / biophysics. During his academic career,
he took over various post doc positions at the Institute for Pharmaceutical
Technology and Biopharmacy, and at the Institute of Physical Chemistry at the
Martin Luther University Halle/Wittenberg (Halle/Saale, Germany), DESY (Hamburg,
Germany), Rutgers University (Newark, USA) and Hospital for Special Surgery
(New York, USA).
REGISTRATION:
Hotline: +46 8 - 650 02 70
E-mail: registration@midfeldmedia.com
Fax: + 46 8 441 07 93
I would like to register a group of delegates. Please contact me regarding Special Group Rates.
Phone number:
INVESTMENT DETAILS
I would like to register
Organised by:
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Conference: Investment 1290 Euro (excl. tax)
Academia*: Investment 790 Euro (excl. tax)
Dinner: Investment 150 Euro (excl. tax)
Postal address: IMMUNOGENICITY 2012
C/O Midfeld Media, Apelbergsgatan 60
S-111 37 Stockholm, Sweden
**Disclaimer: Discounted rates are only valid for full-time employees
at Academia or non-proft organizations. Discounts may be denied at
any time by the organizer if the above given term is not met or can
be proven by the applicant/delegate.
Please use Registration CODE: APOMM
19
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21
st
September, Copenhagen, Denmark
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