Conference on 4th Annual Recombinant Antibodies

With over 25 products approved for human use and 26 candidates in Phase III trials1,2,mAbs remain arguably the most exciting proteins today. Pharmaceutical companies have become more interested, especially in antibody fragments

Online PR News – 10-November-2010 – – Conference on 4th Annual Recombinant Antibodies
To be held at 19th – 21st January 2011, BSG Conference Centre, London, UK
Improving design, engineering and immunoclinical outcomes

Key Speakers for Conference on 4th Annual Recombinant Antibodies

Sylke Poehling, Senior Director Biologics Discovery, Pharma Research and Early Development, Roche
Frank Brennan, Principal Safety Assessment Expert, Novartis
Rolf Werner, Corporate Senior Vice President, Biopharmaceuticals, Boehringer Ingelheim
Leopold Bertea, Vice President, Biologics Center, Sanofi -Aventis, R&D
Christian Blot, Associate Director, Global Regulatory Affairs - Drug Safety & Animal Research Interface, Sanofi -Aventis
Ulrich Haupts, Director, Protein Optimisation, Bayer Schering Pharma
Jill Carton, Associate Director, Biologics Research, Centocor
Matthew Sleeman, Director of Biology, MedImmune
Lolke De Haan, Head of Toxicology, MedImmune
Andrew Nesbitt, Director of the Cimzia Mode of Action Group, UCB Celltech
Alain Pralong, Vice President, Process Development, Crucell
Kerry Chester, Professor of Molecular Medicine, University College London

Conference on 4th Annual Recombinant Antibodies Introduction

As shown by Rituxan and Herceptin, antibodies have blockbuster potential and now number eight of today’s 20 top-selling biotech drugs1. With ongoing growth rates pushing 15%, the global market will reach $70bn by 2013 as new approvals and a growing world population drive patient demand2,3.

With over 25 products approved for human use and 26 candidates in Phase III trials1,2,mAbs remain arguably the most exciting proteins today. Pharmaceutical companies have become more interested, especially in antibody fragments, as these progress through development for new indications including respiratory, cardiovascular and viral diseases1,3.

With competition intensifying, improving engineering, development and production has become ever more important in today’s economic climate. This includes testing in vivo efficacy and effectiveness for humanised / fully human therapies and enhancing the half-life of small proteins4. Decreasing immunogenicity, improving cell line productivity and decreasing manufacturing costs remain ongoing challenges, as do more effective biodistribution, targeting, tissue penetration and uptake 4, 5.

Addressing these issues, Fourth Annual Recombinant Antibodies conference showcases how such goals are being met by leading experts. Whether your interests lie in basic, pre-clinical, translational or clinical research, business diversification, licensing or partnering, attending this meeting will empower you to:
• Improve product valency, affinity and avidity for receptors or ligands
• Counteract proteolytic degradation, renal removal and immunocomplex formation
• Better utilise, deploy and evaluate in silico tools during early-phase research
• Overcome protein aggregation in clinical development
• Enhance physicochemical and pharmacokinetic properties to prolong or decrease circulating antibody half-life and exposure
• Engineer decreased immunogenicity, cross-reactivity and in vivo toxicity
• Optimise the potency of IgG molecules for ADCC, ADCP or CDC applications
• Examine prospects for second and third generation therapeutics including Fab, scFv, bispecific, and alternative scaffold technologies
• Maximise site-specific drug loading for chemical conjugates
• Obtain new data on applications for infl ammatory diseases, and solid and haematological tumours
• Employ improved HTS tools and choose the right species for in vivo trials
• Decrease production and processing costs and boost antibody expression, yield, delivery and safety

Who should attend Conference on 4th Annual Recombinant Antibodies ?
Presidents, Chief Executive Officers, Chief Scientific Officers, Vice Presidents, Professors, Heads, Directors, Principal/Senior Scientists and Managers/Team Leaders of:
• Antibody design, production and development
• Recombinant DNA/molecular biotechnology
• Protein/biochemical engineering
• Biotherapeutics
• Assay and cell display technologies
• Bio-analytical and protein-analytical R&D, and analytical chemistry
• Process development • Preclinical/clinical research and development
• Oncology
• CNS, autoimmune and inflammatory disease research
• Arthritis, colorectal/breast/lymphoma/prostate/lung cancer R&D
• Immunobiology and immunogenicity testing
• Pharmacovigilance
• Business and alliance development
• Marketing and licensing
• Biosimilars
• Contract manufacturing and research organisations
• Regulatory affairs, pharmaceutical and patent law
• Pharmaceutical and patent law

Pre-Conference Interactive Workshop
Wednesday 19th January 2011

From stainless steel to disposable technology - a leap in the manufacturing of biopharmaceuticals

What will be learnt:

Traditional chemical engineering technology based on stainless steel has been applied as standard in the manufacturing of biopharmaceuticals over the past 30 years. Increasing requirements for quality and process control, combined with relatively low product titers, have resulted in highly complex and expensive equipment and facility layouts. The construction and commissioning of a new facility can take five to seven years and cost more than €350 million.

Over the past 15 years, significant efforts have been made to increase process productivity and develop new manufacturing technologies that permit a reduction in CAPEX and OPEX costs. Major developments in disposable technology since 2000 have resulted in the possibility of replacing traditional stainless steel equipment. This combination of process productivity and new technologies has had a significant impact on strategies for developing and manufacturing biopharmaceuticals, and reducing associated costs.

In this workshop, we review the development of disposable technology, its implementation and opportunities that remain unfulfilled. This is presented with Crucell’s view on the future manufacturing of biopharmaceuticals.

Day 1
Thursday 20th January 2011

09:00 Registration and refreshments

09:30 Opening address from the Chairs

Sylke Poehling
Senior Director Biologics Discovery, Pharma Research and Early Development Roche

Alain Vertes
Sloan Fellowship, London Business School

09:40 Strategies and challenges for the next generation of monoclonal therapies
• Strategies to select the best targets
• Strategies to optimise structures
• Strategies to provide affordable treatments

Leopold Bertea
Vice President, Biologics Center, Sanofi-Aventis, R&D

10:20 High-throughput methods for protein optimisation
• A robust and generic platform for multiparameter protein optimisation
• Antibody maturation and sequence optimisation
• Enzyme engineering

Ulrich Haupts
Director, Protein Optimisation, Bayer Schering Pharma

11:00 Morning refreshments

11:20 Antibody engineering by design
• PK and receptor occupancy models to future-proof antibody design
• Harnessing the power of phage display to meet specific design criteria
• Combining biology, pharmacology and PD to translate preclinical observations into the clinic
• Phase I clinical results and their relation to the theoretical model

Matthew Sleeman
Director of Biology, MedImmune

12:00 Modulating pharmacokinetics to improve in vivo efficacy
• Increasing or decreasing circulation time as required
• Conjugation with peptides, proteins and other molecules
• Fab engineering, albumin-binding strategies and other fusion approaches

Mahrendra Deonarain
Head, Recombinant Antibody Therapeutics Laboratory, Imperial College London

12:40 Networking lunch

14:00 Case Study: Certolizumab pegol: the only PEGylated Fab’ anti-TNF
• Certolizumab pegol differs from other anti-TNFs because it is univalent, does not have an Fc and is PEGylated
• This alternative structure leads to different experimental characteristics which can be shown in vitro and in animal models
• All the anti-TNFs signal differently through membrane TNF

Andrew Nesbitt
Director of the Cimzia Mode of Action Group, UCB Celltech

14:40 Affibody molecules for medical imaging and biotherapy
• Manufacturing and therapeutic advantages of affinity ligands
• Rapid biodistribution and tissue penetration
• Applications to PET, MRI and optical imaging, and payload delivery

Stefan Stahl
Professor of Molecular Biotechnology, Swedish Royal Institute of Technology

15:20 Afternoon refreshments

15:40 Discovery and optimisation of monoclonal antibodies for therapeutic development
• Fit-for-purpose features for therapeutic optimisation
• Enabling technologies for successful mAb discovery
• Screening for developable therapeutics

Jill Carton
Associate Director, Biologics Research Centocor

16:20 Panel discussion: Improving performance, efficacy and manufacturing - where are we and what are the prospects for the future?

Bo Kara
Director of Science & Technology, Merck Sharp & Dohme

16:50 Closing remarks from the chair

17:00 Networking drinks
Take your discussions further and build new relationships in a relaxed and informal setting

Day 2
Friday 21st January 2011

09:00 Registration and refreshments

09:30 Opening address from the Chairs

Rolf Werner
Corporate Senior Vice President, Biopharmaceuticals, Boehringer Ingelheim

Kerry Chester
Professor of Molecular Medicine, University College London

09:40 Safety and immunotoxicity assessment of therapeutic monoclonal antibodies
• Rational design of mAbs to reduce risk of immunotoxicity
• Assessing the risk of immunotoxicity of mAbs (in silico, in vitro and in vivo studies)
• Dose selection for FIM studies with immunomodulatory mAbs (MABEL and MRSD).

Frank Brennan
Principal Safety Assessment Expert, Novartis

10:20 Case study: Bispecific molecules: translational challenges for safety and efficacy testing
• The bispecific T cell engager (BiTE) concept
• Pathways for progression into the clinic without a relevant preclinical safety species
• Translational safety and early clinical data for a bispecific molecule

Lolke de Haan
Head of Toxicology, MedImmune

11:00 Morning refreshments

11:20 Alternative strategies for toxicity testing of species-specific biopharmaceuticals
• A method combining sequence optimisation and affinity maturation
• Comprehensive site directed saturation mutagenesis and HTS
• Insight into a stable and universally applicable process

12:00 Immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use
• How to assess immunogenicity
• Limiting hypersensitivity reactions
• Overcoming regulatory pressures

Matthew Baker
Chief Scientific Officer, Antitope

12:40 Networking lunch

13:40 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?

14:20 A collaborative industry approach to the challenges of non-human primate (NHP) usein mAb development
• The changing environment of mAb development and its impact on NHP use
• Identification of the opportunities to minimise NHP use
• Data-sharing to provide an evidence base for regulatory change
• Development of a framework to translate opportunities into practice

Kathryn Chapman
Programme Manager, Pharmaceutical Industry,
National Centre for the Replacement, Refinement and Reduction of Animals in Research

15:00 Afternoon refreshments

15:20 Panel discussion: Challenges associated with translating preclinical studies from animals to humans

Topics to be addressed include: the implications of human immunoglobulin allotypes for antibody immunogenicity and identifying the most appropriate model for preclinical use. Practical program development, implementing safety assessment studies and the role of cross-company collaboration in interpreting ICH S6 will also be covered.

16:00 Presentation to be announced

Christian Blot
Associate Director, Global Regulatory Affairs - Drug Safety & Animal Research Interface, Sanofi-Aventis

16:40 Chair’s closing remarks

16:50 End of conference

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