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CONFERENCE

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5th Annual Monoclonal Antibodies

Advancing therapeutic antibody development and production

24th - 25th March 2009, London, UK

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Background Info
Day 1
Day 2
Partners
Past Papers

Platinum Sponsor

Associate Sponsors

Marketing Sponsors

Media Partners

Discussion Group

Background Info

Monoclonal antibodies have arrived as therapeutics and in some cases have become an integral part of standard treatment, as exemplified by Herceptin and Remicade. The global monoclonal antibodies market, worth $30bn in 2009, remains one of the most exciting and promising areas within the world pharmaceutical market today.

From inauspicious beginnings in the 1980s, monoclonal antibodies have become the most successful biotech drugs in history, with 22 FDA approved therapies and eight blockbusters currently in use. Technological advances have dramatically reduced their immunogenicity, and current third generation mAbs have clinical utility ranging across molecular diagnostics, oncology and infectious diseases.

The next 20 years promise to be equally exciting, with 200 products in the pipeline and a projected growth rate of 13%. Looking to this future, Visiongain focuses its 5th Monoclonal Antibodies conference on the main areas of growth in the coming years: solid and liquid tumours, autoimmune and inflammatory diseases and fully human mAbs. With an expert line-up of speakers from around the world, this two-day event is an ideal forum for investors and scientists alike, wishing to explore prospects for fourth generation mAbs.

By attending this conference, you will gain key insights into the hottest topics and main drivers in mAb research and development today, including:
• Moving towards fully human and tailor made antibody therapeutics
• The importance of isotyping in preclinical modelling
• New data from clinical trials for conjugated and unconjugated therapies
• Identifying and validating cell-surface antigens for antibody targeting
• Prospects for fragment monoclonal antibodies
• Overcoming immune reactions to improve clinical applications of antibody therapeutics
• Reducing inflammation and tissue damage in central nervous system diseases
• Market impact and post-marketing issues
• Prospects for inhibiting angiogenesis
• Perspectives on antibody process development including sharing IP, or implementing and licensing commercial process technologies
• Challenges facing implementation of anti-solid/liquid tumour therapies

Key Speakers:
• David Blakey, Chief Scientist, Oncology, AstraZeneca
• Simon Barry, Global Head, Vascular Modulation Group, AstraZeneca
• Giuseppe Ciaramella, Executive Director, Head of Biotherapeutics, Pfizer
• Pavel Bondarenko, Scientific Director, Amgen
• Andrew Popplewell, Director, V-Region Discovery & Engineering, UCB Celltech
• Lolke De Haan, Head of Toxicology, MedImmune
• Simon Russell, Head of Strategic Marketing, Biologics, Novartis
• Paulo Fontoura, Translational Medicine Leader, Neuroscience, F. Hoffmann-La Roche
• Zehra Kaymakcalan, Senior Principal Scientist, Abbott
• Bryan Edwards, Principal Scientist, Lead Generation, MedImmune
• Peter Kuebler, Lucentis Pharmacology Team Leader, Genentech
• Julian F. Burke, Chief Scientific Officer, Genetix
• Bo Kara, Director, Science and Technology, Avecia Biologics
• Jesús Zurdo, Head of Advanced Protein Technologies, Lonza Biologics
• Janice M. Reichert, Senior Research Fellow, Centre for the Study of Drug Development, Tufts University

Who will be there?
VPs, Directors, Heads and Managers of:
• Antibody development
• CNS autoimmune and inflammatory disease research
• Preclinical/clinical research and development
• Cell and molecular biology
• Recombinant DNA biotechnology
• Protein/biochemical antibody engineering
• Arthritis R&D
• Oncology R&D
• Age-related macular degeneration research/ophthalmology
• Immunobiology
• New product development
• Business development
• Clinical diagnostics
• Marketing
• Licensing
• Biologics/biosimilars
• Outsourcing/contract manufacturing
• Contract research organisations
• Pharmaceutical and patent law

Day 1

Day 1, Tuesday 24th March 2009

09:30 Registration and refreshments

10:00 Opening address from the chair

David Blakey
Chief Scientist, Oncology
AstraZeneca

10:10 Global trends in antibody development
• Global perspectives in antibody development
• Probabilities of approval success for human and humanized mAbs
• Future trends in antibody development

Janice M. Reichert
Senior Research Fellow
Tufts Centre for the Study of Drug Development
Editor-in-Chief, mAbs

10:50 Selection of cell lines for antibody expression and protein production
• In vitro antigen based selection
• Productivity and selection
• Selecting for stability

Julian F. Burke
Chief Scientific Officer
Genetix

11:25 Morning refreshments

11:40 Engineering antibodies – new modalities against invulnerable antigens
• Generating alternative diversity by homologous recombination
• A new approach to obtaining antibodies recognizing different epitopes effectively
• Antibody generation against the cell surfaced antigen

Masa Fujiwara
President & CEO
Chiome Bioscience

12:00 Engineering antibodies – structural insights
• Optimising antibody characteristics (affinity, species cross-reactivity) using phage and ribosome display
• Case studies from therapeutic programs
• Focus on structure-function relationships

Bryan Edwards
Principal Scientist, Lead Generation
MedImmune

12:35 Structure and function of disulfide isoforms of the human IgG2 subclass
• Potency difference against a cell-surface receptor was observed
• Analytical characterization, monitoring and enrichment of IgG2 isoforms
• Human IgG2 disulfide rearrangement in vitro and in vivo

Pavel Bondarenko
Scientific Director
Amgen

13:15 Networking lunch

14:15 Prospects for therapeutic antibody fragments
• Therapeutic potential of fragment mAbs
• Advantages/disadvantages compared to full-length IgG
• Challenges in clinical development

Andrew Popplewell
Director, V-Region Discovery and Engineering
UCB Celltech

14:55 Panel discussion: Isotyping for therapeutic antibodies- how much depends on preclinical models?
• Isotypes and ADCC/complement activation:
- implications for safety and/or efficacy
- technologies to enhance or decrease ADCC
• The effect of different isotypes on PK
• Implications for the detection of HAHA: IgG4 FAb arm exchange
• Different isotypes and glycosylation patterns: implications for manufacturing?

Chair: Giuseppe Ciaramella, Executive Director, Head of Biotherapeutics, Pfizer
Panellists: Lolke De Haan, Head of Toxicology, MedImmune
Zehra Kaymakcalan, Senior Principal Scientist, Biologics Research Centre, Abbott Laboratories
Kathryn Chapman, Program Manager, National Centre for the Replacement, Refinement and Reduction of Animals in Research

15:35 Afternoon refreshments

15:55 Characterising immunogenicity of antibody therapeutics
• Regulatory guidance on immunogenicity assessment
• Drivers of immunogenicity
• Strategies to measure and avoid immunogenicity
• Selected case studies

Philippe Stas
Chief Executive Officer
Algonomics

16:30 In silico methods to assess stability and aggregation risks in the development of therapeutic antibodies. Designing manufacturability and safety
• Overcoming protein mis-folding using in silico platform technologies
• Calculating solvent accessibility, structural preferences, aggregation propensity, and inter-molecular interactions to generate improved antibodies

Jesús Zurdo
Head of Advanced Protein Technologies
Lonza Biologics

16:50 Round-table discussions. Choose from:

Prospects for fully human monoclonal antibodies
• Genetic and biochemical strategies to reduce immunogenicity
• Improving chemical, proteolytic, thermodynamic and folding stability
• Clinically validated methods for human antibody engineering

Chair: Christian Rohlff, Chief Executive Officer, Oxford BioTherapeutics
Panellists: Robert J. Lutz, Executive Director, ImmunoGen
Pavel Bondarenko, Principal Scientist, Amgen

Perspectives on antibody manufacture and development
• The antibody development paradigm
• Population targeting strategies
• Accessing IP on the mAb, the target, and protein-target interactions
• Creating, developing, implementing, and licensing commercial process technologies
• CRO perspective on biologics analytical and biosafety assessment and non-clinical toxicity

Chair: Bo Kara, Director, Science and Technology, Avecia
Panellists: Jesús Zurdo, Head of Advanced Protein Technologies, Lonza Biologics
Richard Kennedy, Vice President of Research & Development, Almac
Janet McNicholas, Partner, Bell, Boyd and Lloyd LLP

17:30 Closing remarks from the chair

17:40 Networking Drinks Reception
Take your discussions further and build new relationships in a relaxed and informal setting

Day 2

Day 2, Wednesday 25th March 2009

09:30 Registration and refreshments

10:00 Opening address from the chair

David A. Palella
President
BioScience Ventures

10:10 Patenting antibodies
• Patentability issues in US and Europe - what can you protect now that many pioneering antibody technologies have become mainstream?
• Anticipating and addressing obviousness and sufficiency issues - what data do you need?
• Pro-active filing and prosecution strategies

Louise Holliday
Partner
D. Young & Co.

10:30 Panel discussion: Market impact and post-marketing issues
• Challenges for new entrants in crowded markets
• Options to reducing cost of goods and, ultimately, price of mAb therapeutics
• Challenges to reimbursement in major markets of US and EU
• Commercial considerations for protein design & TPP development

Chair: Keith Rodgers, Chief Executive Officer, Bodiam Consulting
Panellists: Simon Russell, Head of Strategic Marketing, Biologics, Novartis
Julian F. Burke, Chief Scientific Officer, Genetix
Tim van Hauwermeiren, Chief Executive Officer, Argen-x
Christian Rohlff, Chief Executive Officer, Oxford BioTherapeutics
Janice M. Reichert, Senior Research Fellow, Tufts Centre for the Study of Drug Development, and Editor-in-Chief, mAbs

11:00 Targeting cell death: novel opportunities for antibody-based therapeutics
• Novel Dead-Cert^™ antibody reagents for accurate measurement of cell viability, apoptosis and necrosis in vitro and in vivo
• Innate host responses to dying cells in vivo
• Improving cell culture establishment and productivity through dead-cell removal in vitro
• Switching immune responses to cell death in vivo: novel anti-cancer antibody therapeutics

Chris Gregory
Chief Scientific Officer
Immunosolv

11:20 Morning refreshments

11:40 Panel discussion: Angiogenesis inhibitors- where are we and what are the prospects for the future?
• Therapeutic needs and commercial opportunities
• Difficulties in angiogenesis inhibition discovery
• mAbs and personalised medicine
• PlGF, VEGF inhibition + vascular damaging agents: prospects for the future

Chair: David Blakey,Chief Scientist, Oncology Discovery, AstraZeneca
Panellists: Simon Barry, Global Head, Vascular Modulation Group, AstraZeneca
Mats Hellström, Senior Principal Scientist, BioInvent

12:20 ESBA105, a TNF-inhibitory single-chain antibody tailored for local therapies
• Osteoarthritis
• Anterior uveitis
• Tissue penetration
• Drug-like properties

David Urech
Head of Research & Development
ESBA Tech

12:50 Networking lunch

13:50 Development of a Fab for ophthalmology: a case study
• Contributions of in vitro and in vivo studies
• Roles and limitations of in vivo animal models
• Overcoming challenges for clinical pharmacology

Peter Kuebler
Lucentis Pharmacology Team Leader
Genentech

14:30 Human therapeutic antibody discovery in oncology and inflammation
• Use of phage display for discovery of panels of high affinity antibodies
• Application of SPR based methods to identify antibodies of interest
• Characterization of selected antibodies using appropriate assays and models

Andrew Nixon
Vice President, Lead Discovery and Biochemistry
Dyax

15:10 Reducing inflammation and tissue damage in multiple sclerosis
• Calor dolor et rubor: a common theme in neurodegeneration
• Targeting cytokines in the brain
• Targeting membrane-proximal epitopes to inhibit autoimmune inflammation in the CNS

Paulo Fontoura
Translational Medicine Leader, Neuroscience
F. Hoffmann-La Roche

15:50 Afternoon refreshments

16:10 Novel antibodies for breast and prostate cancer

Matthew Baker
Chief Scientific Officer
Antitope

16:50 Conjugated mAbs for myeloma treatment
• Improved cytotoxic treatments
• Anti-tumour activity through target cell activation
• Evidence from in vivo trials

Robert J. Lutz
Executive Director
ImmunoGen

17:30 Chair’s closing remarks

17:40 End of conference

Partners

Platinum Sponsor:

IMS Health
Operating in more than 100 countries, IMS Health is the world’s leading provider of market intelligence to the pharmaceutical and healthcare industries. With $2.2 billion in 2007 revenue and more than 50 years of industry experience, IMS offers leading-edge market intelligence products and services that are integral to clients’ day-to-day operations, including portfolio optimization capabilities; launch and brand management solutions; sales force effectiveness innovations; managed care and consumer health offerings; and consulting and services solutions that improve ROI and the delivery of quality healthcare worldwide. For further information please visit: www.imshealth.com

Associate Sponsors:

D Young & Co
D Young & Co, which is one of the oldest and best-established UK firms of patent and trademark attorneys, is now a dynamic modern partnership. The Firm is renowned for its professionalism, business sensitivity, creativity and flexibility.
The biotech group in D Young & Co has considerable expertise in a wide variety of biological subject-matter, including immunology and antibody technology, molecular biology, drug delivery, diagnostics and therapeutics, genomics, bioinformatics and stem cells. The team acts for a diverse range of clients, including multinational corporations, small and medium-sized enterprises, successful start-up companies, and prestige academic institutions. For further information, please visit www.dyoung.co.uk

ESBATech
ESBATech AG is a Zurich, Switzerland-based, privately held, clinical stage biotech company concentrating in research, development and commercialization of its antibody fragments for therapeutic applications via local and topical administration.
ESBATech applies its proprietary, fully human single-chain antibody framework platform to generate product candidates against targets of clinical relevance. The company is dedicated to maximizing drug efficacy by directed local and topical delivery of the product to the site where the disease is manifested while minimizing the systemic and unwanted exposure of the drug. For further information, please visit www.esbatech.com

Chiome Bioscience Inc.
Chiome Bioscience Inc. was established in 2005 after receiving official authorization as a RIKEN Venture Enterprise. Chiome is a solution provider to unmet medical needs by generating antibodies against tough antigens. Chiome has a very unique platform technology the "ADLib^® System" by accelerating gene conversion in Ig loci. The "ADLib^® System" can provide unparalleled speed for novel antibody generation and adaptability to diverse antigens. Chiome successfully developed the cell-cell interaction method to overcome cell surfaced antigens including GPCRs. Chiome announced the multi-year alliance with Chugai Pharmaceutical Co. Ltd. in 2008. Chiome is seeking alliance partners all over the world. For further information, please visit www.chiome.jp

Marketing Sponsors:

UCB
UCB is a leading global biopharmaceutical company, employing around 10,000 people in over 40 countries. UCB NewMedicines is UCB's discovery research through to clinical proof of concept organization established to secure the future pipeline of UCB. With a therapeutic focus on central nervous system (CNS) and autoimmune and inflammatory (AIID) disorders, UCB NewMedicines places emphasis on external research and collaboration to sustain pipeline innovation. UCB's Celltech Antibody Centre of Excellence, located at the company’s UK site in Slough, Berkshire, specialises in the development of antibody-based drugs, with strong technology platforms underpinning new products. For further information, please visit www.ucb.com

Immunosolv
ImmunoSolv is an R&D biotechnology spin-out from the University of Edinburgh that specialises in antibody-based strategies for detection and manipulation of non-viable cells. If they persist, such cells are detrimental to their viable neighbours and are rapidly removed from tissues in the body by efficient clearance mechanisms. Immunosolv has developed novel clearance technology that recapitulates this process in the laboratory, thus allowing improved viability and quality of cells for research, biomanufacturing and therapy. Immunosolv is also applying its core antibody technology to target cells undergoing programmed cell death (apoptosis) and the products of apoptotic cells in order to develop novel anti-cancer therapeutics. For further information, please visit www.immunosolv.com

Media Partners:

PharmiWeb.com
PharmiWeb.com is the leading industry-sponsored portal for the pharmaceutical sector. Supported by most of the leading pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news, features, events listings and international jobs to industry professionals across Europe and the US. For further information please email: corporate@pharmiweb.com

BIOTECHNOLOGY EUROPE
BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD. It is based and located in Warsaw, Poland. Biotechnology World was founded in 2007 to provide the world’s biotech and pharma information and market to make it universally accessible and useful for scientific and business processes. Its first step to fulfilling that mission was building the BIOTECHNOLOGY EUROPE platform that will allow a quick spread of information in different channels. BIOTECHNOLOGY EUROPE offers companies completed internet public relations, publication and marketing solutions. One of the main goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector in Europe to global biotechnology, pharmaceutical and life science activities. For further information please visit www.biotechnology-europe.com

Future Pharmaceuticals
Future Pharmaceuticals has forged powerful relationships with key industry leaders to provide a platform for successful brand recognition, and for senior decision-makers to have the means to procure and plan implementation strategies based on the topics covered. Positioned to be an authoritative resource within top pharma companies as well as small, specialty, and biotech, Future Pharmaceuticals magazine is geared to create a deep penetration into a highly targeted and responsive audience, bridging the gap between the industries' top issues and the solutions top-tier vendors can provide. For further information, please visit www.futurepharmaus.com

InPharm
InPharm is the online platform for exclusive pharmaceutical news, comment, contracts, services, jobs and events and is home to InPharmjobs.com, Pharmafile and Pharmafocus. For further information please visit: www.In-Pharm.com

Landes Bioscience
In January of 2009 Landes Bioscience will begin publishing mAbs, the first international peer-reviewed journal to focus exclusively on monoclonal antibodies. mAbs will be a multi-disciplinary journal dedicated to the art and science of mAb research and development. mAbs will publish original research, reviews and commentaries on topics including antibody engineering (e.g., immunoconjugates, antibody fragments), therapeutic targets, preclinical and clinical studies, manufacturing, regulatory review, patents, and emerging markets. The Editor-in-Chief of mAbs is Janice M. Reichert of Tufts Center for the Study of Drug Development. For further information please visit: www.landesbioscience.com/journals/mabs/

If you would like more information on the range of sponsorship or exhibition possibilities for this event, please contact:
Patricia Gallegos, +44 (0)20 7549 9952
patricia.gallegos@visiongainglobal.com

Past Papers

Past papers are free to delegates. If you are unable to attend the event, Past Papers are published two weeks after the event and are available to purchase.

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