1. 7th Annual
Monoclonal Antibody
Examining new therapeutic applications, latest technological development and regulatory issues
18th – 20th May 2011, London, UK BOOK NOW!
Key Speakers
Ivan R Correia, MBA, Ph.D., Principal Research Scientist Protein Analytics, Abbott Bioresearch Center
Yulia Vugmeyster, Ph.D., Principal Research Scientist, Pfizer
Guodong Chen, Ph.D. Principal Scientist, Bristol-Myers Squibb
Thomas Jostock, Ph.D., FellowTechnology Platform Leader Process Sciences and Production, Novartis Pharma
Bailin X Tu, Ph.D., Principal Scientist, Abbott Diagnostic Division
Laura Andrews, Ph.D., Vice President of Pharmacology and Toxicology, Genzyme
Bernhard Helk Ph.D., Section Head, Novartis Pharma
Qingyu Cao Ph.D., MBA Licencing and Technology, Lonza Development Services
Justin A. Caravella, Ph.D., Senior Scientist, Biogen Idec
Hans J Johansson, Staff Scientist, GE Healthcare
Ralph Minter Ph.D., Head of Research - Technology, MedImmune
Paul W.H.I. Parren, Ph.D., Senior Vice President & Scientific Director, Genmab
Matthew Baker Ph.D., Chief Scientific Officer, Antitope
Alfred Luitjens, Senior Scientist New Technology, Crucell
Richard Stebbings, Ph.D., Transfusion Medicine & immunotoxicity section, Biotherapeutics Group,
National Institute for Biological Standards and Control -Health Protection Agency (HPA)
Pre-conference Workshop, Wednesday 18th May, 2011
Preclinical safety evaluation of mAbs
Led by: Laura Andrews, Ph.D., Vice President of Pharmacology and Toxicology, Genzyme
Driving the Industry Forward | www.futurepharmaus.com
Organised By
Media Partners
To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/mabs

2. Conference Introduction
7th Annual Monoclonal Antibody
18th – 20th May 2011, London, UK
Dear Colleague, Media Partners:
hile only 20% of the drugs on the market today are biologics, it is expected that with
W PharmiWeb.com is the leading industry-sponsored portal
650 biotechnology medicines in development in 2010 for more than 100 diseases, for the pharmaceutical sector. Supported by most of the
half the new drugs approved in 2015 will be biologics and most of them will be
monoclonal antibodies.1 leading pharmaceutical corporations, PharmiWeb.com provides dynamic
onoclonal antibodies (mAbs) currently generate global revenues of around $20
M real-time news, features, events listings and international jobs to industry
billion including blockbusters such as Avastin, Herceptin, Remicade, Rituxan, Humira professionals across Europe and the US.
and Erbitux and over the next five years it is expected to reach sales of $ 70 billion For further information please email: corporate@pharmiweb.com
with another 15 to 20 new mAbs to be approved by 2013.2
onoclonal antibodies are competing for targets in cancers, alzheimer, auto-immune
M
and various infectious diseases. With the rapid growth of mAbs-based products, BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY
new technologies have emerged for creating modified forms of antibodies, including
fragments, conjugates and multi-specific antibodies. WORLD. It is based and located in Warsaw, Poland.
ue to the complex nature of mAbs and their inherent heterogeneity careful attention
D Biotechnology World was founded in 2007 to provide the world’s biotech
is required for product design and manufacturing to assure a safe, effective and and pharma information and market to make it universally accessible and
consistent product.3 useful for scientific and business processes. Its first step to fulfilling that
isiongain’s 7th Annual Monoclonal Antibody conference will gather global antibody
V mission was building the BIOTECHNOLOGY EUROPE platform that will
leaders and experts for this 3 day event focusing on developing cost-effective antibody
products, advancements in manufacturing technologies, processes development allow a quick spread of information in different channels. BIOTECHNOLOGY
of monoclonal antibodies product from initial discovery through the filing of an EUROPE offers companies completed internet public relations, publication
investigational new drug application (IND). and marketing solutions. One of the mains goals of BIOTECHNOLOGY
By attending this conference you will: EUROPE is to integrate the Biotech and Pharma Sector in Europe to global
• ain insight on various therapeutic targets on oncology, multiple sclerosis,
G biotechnology, pharmaceutical and life science activities.
cardiovascular and autoimmune disorders For further information please visit: www.biotechnology-europe.com
• valuate advances in antibody technology such as fragments, conjugates and multi-
E
specific antibodies
• earn about future of monoclonal antibody technology
L Future Pharmaceuticals has forged powerful relationships
Driving the Industry Forward | www.futurepharmaus.com
• ear about new antibody engineering and modification technologies
H with key industry leaders to provide a platform for
• xamine platform approaches to monoclonal antibody purification
E successful brand recognition, and for senior decision-makers to have the
• ind out new techniques in cell engineering for monoclonal antibody production
F means to procure and plan implementation strategies based on the topics
• xplore antibody-based targeted therapy: taking advantage of the human innate
E covered. Positioned to be an authoritative resource within top pharma
immunity companies as well as small, specialty, and biotech, Future Pharmaceuticals
• ssess trends in capacity utilisation for therapeutic monoclonal antibody production
A magazine is geared to create a deep penetration into a highly targeted and
• mprove antibody production using directed evolution
I responsive audience, bridging the gap between the industries’ top issues and
• nvestigate immunogenicity issues with drug development
I
the solutions top-tier vendors can provide.
• dentify suitable assays for evaluating the immunogenicity of mAbs
I
• eview contract production of mAbs for research and pre-clinical purposes
R
For further information please visit: www.futurepharmaus.com
• nderstand navigation strategies for intellectual property in the antibody world
U
• eview latest regulations, technologies, production methods and therapeutics
R InPharm is the online platform for exclusive
• e part of a major networking opportunity
B pharmaceutical news, comment, contracts, services, jobs
I look forward to meeting you at the conference and events and is home to InPharmjobs.com, Pharmafile and Pharmafocus.
Best regards
For further information please visit: www.In-Pharm.com
Sonia Tomar
Conference Producer
Sponsorship and exhibition opportunities
This event offers a unique opportunity to meet and do business with some
Who will be there?
VPs, Directors, Heads and Managers of: of the key players in the pharmaceutical and biotech industries. If you have a
• Antibody development
• CNS autoimmune and inflammatory disease research service or product to promote, you can do so at this event by:
• Preclinical/clinical research and development
• Cell and molecular biology • Hosting a networking drinks reception
• Recombinant DNA biotechnology
• Protein/biochemical antibody engineering • Taking an exhibition space at the conference
• Cardiovascular R&D
• Auto-immune disorders • Advertising in the delegate documentation pack
• Arthritis R&D
• Oncology R&D • Providing branded bags, pens, gifts, etc.
• Age-related macular degeneration research/ophthalmology
• Immunobiology If you would like more information on the range of sponsorship or exhibition
• New product development
• Business development possibilities for visiongain's 7th Annual Monoclonal Antibody Conference,
• Clinical diagnostics
• Marketing please contact us:
• Licensing
• Biologics/biosimilars Ronald Magali, +44 (0)20 7549 9934
• Outsourcing/contract manufacturing
• Contract research organisations ronald.magali@visiongainglobal.com
• Pharmaceutical and patent law
1
Engaging with the global antibody and biological markets presentation, presented at Visiongain’s 6th Annual Monoclonal antibodies conference. 2 Visiongain (2010) therapeutic monoclonal antibodies: world market report. 3 Wendy C. Weinberg, Michelle R.
Frazier-Jessen, Wen Jin Wu, Andrea Weir, Melanie Hartsough, Patricia Keegan and Chana Fuchs. (2005). Development and regulation of monoclonal antibody products: Challenges and opportunities. Special Issue: Therapeutic Antibodies and Their Use in Oncology. 24
(Number 4), 569-584

3. Pre-Conference Interactive Workshop
7th Annual Monoclonal Antibody
Wednesday 18th May 2011
Preclinical safety evaluation of mAbs
Led by: Laura Andrews, Ph.D. Timings: 9:30 - 10:00 Coffee & Registration
0
Vice President of Pharmacology and Toxicology 10:00 - 15:00 Workshop
Genzyme T
iming includes lunch and refreshment breaks
About the workshop: About your workshop leader:
Preclinical development programs that are designed to Laura Andrews, Ph.D
support the safe clinical use of biopharmaceuticals have Laura Andrews is Vice President of Pharmacology and Toxicology at
Genzyme where she directs the nonclinical development programs for
considerations that are very different from programs biotherapeutics. She is responsible for the nonclinical development
designed to support the development of small molecule programs for therapeutic biologics, gene therapy products, and cell
based therapies. Laura oversees the design, implementation and
drugs. In particular, with more and more targeted
interpretation of the in vivo GLP studies and the in vitro assays to
therapeutics being developed a traditional development support product development. Laura has authored the pharmacology
program is becoming more and more difficult. While the and toxicology section for several Genzyme INDs and marketing
applications in several different territories. Dr. Andrews received a BS
ICH S6 guidance continues to drive the program decisions
(1983) in Biology and Chemistry from Dickinson College, and a Ph.D.
more often than not a different approach is warranted due (1987) in Pathology and Cell Biology from Thomas Jefferson University
to species specificity and paucity of relevant animal models. and Medical College in Philadelphia, PA. She was Board Certified in
General Toxicology in1998. She holds memberships in the Society of
To design a predictive non clinical program that will
Toxicology (SOT), Society for Toxicologic Pathology (STP) and the
support not only first in human dosing but also eventual American College for Toxicology (ACT). She is on the nomination
approval of the therapeutic is becoming more complex. committee of ACT and recently was appointed as a member of
SACATM (Scientific Advisory Committee on Alternative Toxicological
Assuring safety in humans is the first and foremost task of a Methods). She is currently on the Board of Directors for the American
well designed program but assuring safety and application Board of Toxicology and a Fellow of the Academy of Toxicologic
Sciences.
to specific patient populations is also essential to the
targeted therapeutic products. Topics to be addressed About the company
in this workshop will include general issues related to Genzyme is one of the world’s leading biotechnology companies. Its
differences between species that might contribute to approximately 10,000 employees work in countries throughout the
world and are united by a common goal: to make a major positive
species selection/interpretation, utility of tissue cross impact on the lives of people with debilitating diseases.
reactivity to determine relevant species, considerations into Since its founding in 1981, Genzyme has grown from a small start-up
the development of a homologous protein (from bench to a diversified enterprise with 2009 revenues of $4.5 billion. Over the
past three decades Genzyme has introduced a number of breakthrough
to beast), development and characterisation of animal
treatments in several areas of medicine, which have provided hope to
models as relevant species (including KO animals and patients who previously had no viable treatment options. Genzyme
models of disease), and additionally what to do if nothing products are helping patients in 100 countries.
is ‘relevant’. Included will be specific case examples. Today, Genzyme continues to be driven by its commitment to patients.
The company is working to develop new medicines, improve its existing
The workshop attendee will learn key concepts in the
therapies, secure approvals for its products around the world, and
considerations for designing a predictive program for a ensure that patients have access to these treatments.
biotherapeutic product. www.genzyme.com

4. Day 1
7th Annual Monoclonal Antibody
Thursday 19th May 2011
09:00 Registration and refreshments 12:40 Networking lunch
09:30 Opening address from the chair
13:40 Case study: Enhancing a CHO cell line development
09:40 Evaluating primary structure and post translational platform: new technologies to increase speed,
modification of mAbs in serum; implications for throughput and yield
drug development • hallenges in cell line development
C
• Developing a high throughput method to evaluate mAbs in serum • ew technologies for enhanced selection and screening
N
• Monitoring clearance of fragments and molecules with different pI’s • mplications on platform performance
I
• valuating change in glycoform profile and its impact on clearance
E • ase studies
C
in serum
Thomas Jostock, Ph.D.
• Evaluating deamidation and oxidation of mAbs in serum
Fellow, Technology Platform Leader, Process Sciences and Production
• Evaluating aggregates of mAbs in serum Novartis Pharma
Ivan R Correia, MBA, Ph.D.
Principal Research Scientist, Protein Analytics
Abbott Bioresearch Center
14:20 Antibody engineering for diagnostics: anti-HCV
chimeric antibodies
10:20 Harnessing the power of biologics mass spectrometry • enerated 4 anti-HCV mouse-human chimeric antibodies to replace
G
in the characterisation of therapeutic antibodies: the use of human donor sera/plasma for HCV immunoassays
recent developments and future prospects • table CHO cell lines were established to manufacture each
S
• Analytical challenges in the characterisation of therapeutic antibodies chimeric antibody
• Mass spectrometric approaches to characterisation of PTMs • east display technology was used to map the epitope for each
Y
• Higher order structure characterisation of therapeutic antibodies chimeric antibody
• Quantitative analysis of therapeutic antibodies including PTMs Bailin X Tu, Ph.D.
Principal Scientist
Guodong Chen, Ph.D.
Abbott Diagnostic Division
Principal Scientist, Bioanalytical and Discovery Analytical Sciences
Bristol-Myers Squibb
15:00 Afternoon Refreshments
11:00 Morning refreshments
15:20 Prediction of aggregation propensities
11:20 Early engineering of antibodies for improved
Bernhard Helk Ph.D.
pharmaceutical properties
Section Head
• harmaceutical properties of antibodies can have a profound effect on
P Novartis Pharma
the development, methods of therapeutic use, and efficacy profile of a
drug candidate
• ocused engineering approaches have been used to eliminate potential
F 16:00 Current advances in monoclonal antibody purification
liabilities in several therapeutic antibodies • Designing the next platform for antibody purification
• ntibody solubility has been improved by engineering approaches in two
A • A novel high capacity Protein A resin
cases, but prediction of solubility remains a challenging problem • he next generation polishing resins, including multi-modal
T
• echniques can be incorporated into an antibody discovery workflow to
T resin technologies
increase the quality and diversity of candidate molecules at an early stage
Hans J Johansson
Justin A. Caravella, Ph.D. Staff Scientist
Senior Scientist GE Healthcare
Biogen Idec
12:00 Monoclonal antibody conjugation via 16:40 Closing remarks from the chair
chemical modification
• Fusion of a recombinant antibody fragment
• hemical conjugation of small recombinant proteins with
C 16:50 Networking drinks
polyethylene glycol
Take your discussions further and build new relationships
Yulia Vugmeyster, Ph.D. (tentative) in a relaxed and informal setting
Principal Research Scientist
Pfizer
Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2011

5. Day 2
7th Annual Monoclonal Antibody
Friday 20th May 2011
09:00 Registration and refreshments 12:40 Networking lunch
09:30 Opening address from the chair 13:40 Flexible Facilities with single-use systems for
mAb production
09:40 Immunogenicity of protein therapeutics can give rise • Introduction of FlexFactory concept in GMP manufacturing
to partial or complete loss of drug efficacy, altered
• Main advantages of the FlexFactory are:
pharmacokinetics, or cross-reaction with a patient’s
- Increased flexibility
endogenous proteins
- Ease of segregation
• Overview of the immunogenicity causes and drivers
- Lower building costs
• pplying the novel EMEA guidance and industry whitepapers to
A
antibody therapeutics - Efficient use of floor space
• linical and non-clinical strategies to assess/control immunogenicity of
C • he FlexFactory is introduced with unit operations having fully
T
therapeutic antibodies disposable flow paths
• rediction and assessment of T-cell epitope driven immunogenicity at
P • oals and challenges of GMP manufacturing run of a Monoclonal
G
early stage of product development using in silico and in vitro tools. antibody with the flexfactory
• ntibody deimmunisation to further mitigate immunogenicity risk
A Alfred Luitjens
• Selected case studies Senior Scientist New Technology
Crucell
Qingyu Cao Ph.D., MBA
Licencing and Technology
Lonza Development Services
14:20 Panel discussion: improving monoclonal antibody
10:20 Reducing immunogenicity in therapeutic antibodies manufacturing technology
• Processes of complementarity-determining region grafting, resurfacing P
anlist will discuss about manufacturing issues in product development,
• Hyperchimerisation diminish mAb product failure, product testing, effective and new ways to reduce
production cost. for any questions or participation please contact
• immunogenicity by reducing the number of foreign residues
sonia.tomar@visiongainglobal.com
Matthew Baker Ph.D.
Chief Scientific Officer
Antitope
15:00 Afternoon refreshments
11:00 Morning refreshments
15:20 Cytokine storm after TGN1412: better understanding
11:20 Antibodies as tools to identify and validate novel and prediction
targets in multiple disease areas • Is TGN1412 cytokine release similar to that caused by other therapeutic mAbs?
• he need for novel antibody targets and challenges faced by
T • What are the key in vitro biomarkers of TGN1412 cytokine release?
conventional target discovery approaches
• What is the cellular source of TGN1412 cytokine release?
• Using antibodies as tools to find and validate new targets
• Why did pre-clinical safety testing in macaques fail?
• Challenges of performing phage display selections on diverse cell types
• What lessons have we learnt from TGN1412?
• Target deconvolution and in vivo target validation
Richard Stebbings, Ph.D.
Ralph Minter, Ph.D.
Transfusion Medicine & Immunotoxicology Section, Biotherapeutics Group
Head of Research - Technology
National Institute for Biological Standards and
MedImmune
Control -Health Protection Agency (HPA)
12:00 Case study: Daratumumab, a novel therapeutic 16:00 Navigation strategies for intellectual property in
human CD38 antibody for the treatment of the antibody world
multiple myeloma • Legal and regulatory update
• Daratumumab, a novel therapeutic human IgG1 antibody • Regulatory challenges for approval of antibody
• Mechanisms of action • Patents and intellectual property right
• Potent anti-cancer activity in animal models
• Synergisms with conventional drugs 16:40 Chair’s closing remarks
• Clinical development in multiple myeloma
Paul W.H.I. Parren, Ph.D. 16:50 End of Conference
Senior Vice President & Scientific Director
Genmab

6. Registration Form
7th Annual Monoclonal Antibody
18th - 20th May 2011, London, UK
Conf. code VG
Standard Prices
Conference and workshop
Conference only
Fee: £1699
Fee: £1299
VAT: £339.80
VAT: £259.80
Total: £2038.80
Total: £1558.80
7th Annual Monoclonal Antibody
Workshop only Fee: £599 VAT: £119.80 Total: £718.80 18th – 20th May 2011
Number of bookings: Total cost:
London, UK
Promotional Literature Distribution
Distribution of your company’s promotional literature to all conference attendees
Fee: £999 VAT: £199.80 Total: £1198.80
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Main Switchboard Number: Fax: +44(0) 20 7549 9932
Visiongain Ltd
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UK
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