Strategies for Monoclonal Antibody Therapy 2004

[Lorraine Lescure]

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 Strategies for Monoclonal Antibody Therapy 2004
      A Visiongain b2b Conferences Event
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1st & 2nd July, Hilton Kensington Hotel, London

Event Summary;
"Therapeutic applications, products in clinical trials and future outlook" 
* Comprehensive case studies; MAb treatments on the market and in trials
* An analysis of the market; current and future growth areas
**By attending Monoclonal Antibody Therapy 2004, you will arm yourself with the 
knowledge required for you and your company to succeed in this rapidly growing 
sector;

NB - Monoclonal Antibodies Sales are forecast to grow by over 400% by 2009 - 
Don't get left behind, attend Monoclonal Antibody Therapy 2004 and stay 
informed!

A text agenda is featured below; please email 
mailto:lorraine.lescure@visiongain.com for a PDF brochure.

Themes will include:
* Handling cost issues of MAb treatment
* Overcoming problems of antibody production
* The future of MAb's: transgenic proteins
* Case studies: analysis of major drugs in the market 
* Case studies: potential of products in clinical trials 
* Case studies: innovative delivery systems

Industry Leading speakers confirmed at this event:
* Dr. Andrea Feyereislova, Clinical Science Leader for Herceptin, Roche
* Bob Ward, Senior Director, Commercial Development Biologics and Small 
Molecules, Schering-Plough
* Rene Imwinkelreid, Head of Lonza Biologics, Lonza Biologics
* Dr. Joachim Kalmus, Clinical Development Oncology, Schering
* Ralph Minter, Senior Research Scientist, Cambridge Antibody Technology
* Dr. David Humphreys, Celltech R&D, Celltech
* Stephen Squinto, Executive VP and Head of Research, Alexion Pharmaceuticals
* Dr. Zhenping Zhu, Assistant Vice President Head, Antibody Technology, ImClone 
Systems
* Dr. Herren Wu, Senior Director, Antibody Discovery & Protein Engineering, 
MedImmune
* Dr. Lorin Roskos, Senior Director, Pharmacokinetics and Toxicology, Abgenix

Who Should Attend? (job titles)
* Senior Director, Antibody Discovery
* Senior Scientist, Protein Technology Biosciences
* Director, Antibody Technologies / Engineering
* Director, Protein Engineering & Structure
* Senior Director, Immunology
* Head, Expression and Cell Science
* Biologics Manufacturing Development Manager
* Chief Technical Officer
* Director, Preclinical R&D
* Director, Product Development
* Vice President, Research and Development
- plus all senior representatives involved in monoclonal antibody 
production/research.

Places at this event are limited, please call or email me now to secure your 
place

- PRICING -
Attend the:
** Conf. + pre conf. workshop GBP 1600.00 Plus VAT 
** Conference only Fee: GBP1299.00 Plus VAT
** Pre conference workshop only Fee: GBP 650.00 Plus VAT 

- BOOKINGS -
Booking is easy, simply contact Lorraine Lescure on:
Telephone: +44 (0)20 8767 6711
Fax: +44 (0)20 8767 5001
Email: mailto:lorraine.lescure@visiongain.com
Terms and conditions apply - see below.

I look forward to hearing from you soon.

Regards,
Lorraine Lescure
Account Manager 
Visiongain b2b Conferences 
Tel: +44 (0) 20 8767 6711 
http://www.b2b-conferences.com
mailto:lorraine.lescure@visiongain.com 




Sponsorship Opportunities
This event will provide unrivalled opportunities to promote your brand to an 
audience of senior level delegates. 
Options include:
* Full Conference Sponsorship 
* Exhibition Stand/Booth 
* Promotional Inserts 
* Delegate Bag Sponsor
* Cocktail Reception Sponsor 
Whatever your budget, whatever your requirements we can find you a way to place 
your brand at Monoclonal Antibody Therapy 2004.- 
mailto:lorraine.lescure@visiongain.com for more info.



- Agenda -

**Pre-Conference Interactive Workshop:**
Wednesday 30th June 2004
Workshop Leader: Hanne Kristensen, Diatec
***Monoclonal Antibodies:
Pointers for Pre-Clinical Studies***

09:40 Coffee and Registration

10:00 Introduction from workshop leader
* Overview of different technologies used by Diatec for
production
* Practical examples
* Purification and downstream processing
* Quality control
* Benefits of using a small, ISO 9001 certified company for
research
* speed of production
* flexibility
* process development knowledge




****DAY 1 THURS 1st JULY 2004***

Conference Chairman
Bob Ward, Senior Director ,Commercial Development, Biologics and Small 
Molecules, Schering-Plough

9:00 Registration and coffee

9:30 Opening remarks from the Chair

INTRODUCTION

9:40 How to Overcome Obstacles for Successful MAb Treatment
* Selecting the best MAb for a given target: a rational approach to
MAb design goals
* Justifying first-in-human studies: preclinical efficacy, safety, and
pharmacokinetics
* Bad target or wrong dose? Selection of the optimum clinical dose
* Managing the risk of immunogenicity
Dr. Lorin Roskos
Senior Director, Pharmacokinetics and Toxicology
Abgenix

10:20 Contract Manufacturers: A Strategic Asset for your Company
* Contract manufacturers: filling the needs of biotech companies
* How has this niche industry grown?
* Reasons for success- full process development and regulatory
support
* Stages: vector construction, cell line development to full scale
manufacture
Rene Imwinkelreid
Head of Lonza Biologics
Lonza Biologics

11:00 Morning Coffee

ANTIBODY PRODUCTION

11:20 Process Development Requirements for Antibody
Therapeutics
* Approach for antibody therapeutic products
* Generic process applications- cycle time reduction?
* Overcoming problems posed by production capacity
* Improving purification steps in the production process
* Regulatory considerations
Cristina Glad
Executive Vice President
BioInvent

12:00 Strategies to Overcoming Immune Reactivity
* Problems of immune response and impact on therapeutic
antibodies
* Strategies for chimeric and humanised antibodies
* Molecular imprinted polymer (MIP) for engineering synthetic
antibodies
* Antibody engineering with target-activated enzymes
Dr. Dee Athwal
Senior Principal Scientist
Celltech

12:40 Lunch

14:00 CAT-354: An IL13 Neutralising Antibody Optimised by
Ribosome Display
* Ribosome display - a versatile technology for protein engineering
* Optimisation strategies - the combination of targeted and
evolutionary approaches
* The results of antibody engineering - production of antibody CAT-354
* The next stages of pre-clinical development for CAT-354
Ralph Minter
Senior Research Scientist
Cambridge Antibody Technology

14:40 CASE STUDY: Simplifying the Purification of Periplasmic Fab',
the Creation and use of New E. coli Strains
* What are the benefits of Fab' production in the E. coli periplasm?
* Study of host protein mutation and co-purification with Fab
* The creation and use of new E. coli strains: chromosomal gene
replacement
* What are the benefits of simplified purification regimes?
* The future: supplying large market indications with high quality
drug
Dr. David Humphreys
Celltech R&D
Celltech

15:20 Afternoon Tea

THERAPEUTIC APPLICATIONS

Over two-thirds of monoclonal antibody products are for transplant rejection,
cancer, autoimmune diseases and infectious diseases

15:40 CASE STUDY: The Success of Remicade in treating
Inflammatory Conditions
* The role of inflammatory cytokines in patients with crohn's disease
- the cytokine tumour necrosis factor-alpha (TNF-alpha)
* How does this chimeric human: mouse antibody neutralise TNF-alpha?
* Role of remicade as an anti-TNF-blocking therapy for rheumatoid
arthritis
* Clinical efficacy of infliximab
- short and long term benefits
- treatment of refractory Behcet syndrome
* The success of remicade- marketing approvals and global sales
Bob Ward
Senior Director ,Commercial Development
Biologics and Small Molecules
Schering-Plough

16:20 CASE STUDY: Zevalin, a Novel Treatment Regime
Zevalin is the first product with a monoclonal antibody that is
combined with a radioactive chemical for the treatment of non-Hodgkin
lymphoma
* Two part administration of Zevalin: screening and treatment
* Results from safety and efficacy studies
* Toxicity of treatment- limiting use
* How effective is it in patients who are refractory to antibody
treatment?
Dr. Joachim Kalmus
Clinical Development Oncology
Schering

17:00 Questions and Discussion

17:10 Summation of day one from conference chair

17:20 Close of Day One




****DAY 2 FRI 2ND JULY 2004***

9:00 Registration and Coffee

9:30 Opening remarks from the chair

9:40 A Potent New Generation Anti-Tumour MUC1 Antibody
* How the antibody recognises the novel tumour-specific epitope TA-MUC1
* Results after 3 days of injection in the tumour of skin xenografted
nude mice
* Tumour efficacy studies in mice
* Advantages over Pemtumomab: higher affinity, higher tumour
specificity, lower binding to serum MUC1, and lower binding to
PBMC
* Primary indication: GI cancers; secondary indications: other
carcinomas, e.g. breast, ovarian, kidney cancer
Dr. Steffen Goletz
Chief Scientific Office
Leiter Forschung & Entwicklung
NEMOD Biotherapeutics GmbH & Co.KG

10:20 CASE STUDY: Herceptin, First FDA Approved Treatment for
Breast Cancer
* Anti-cancer benefits of Herceptin
- binding to HER2 and blocking growth factors
- killing of cancer cells by the stimulation of the immune system
* Phase III trials: Herceptin in women with HER2 positive early stage
breast cancer as adjuvant therapy
* Results of safety and efficacy studies
Dr. Andrea Feyereislova
Clinical Science Leader for Herceptin
Roche

11:00 Morning Coffee

11:20 CASE STUDY: Synagis, only Monoclonal Antibody Approved
to prevent Respiratory Syncytial Virus (RSV)
* First MAb successfully developed to combat infectious disease:
mode of action
* Safety and efficacy studies
* Advantages over previous treatments
* Development of Numax
- second generation of Synagis
Dr. Herren Wu
Senior Director
Antibody Discovery & Protein Engineering
MedImmune

R&D: PRODUCTS IN CLINICAL TRIALS

12:00 CASE STUDY: The Potential of Erbitux
* Target: epidermal growth factor receptor
* Results of clinical studies
- biological activity in a number of tumours
* Results from monotherapy
- patients with colorectal cancer
- metastatic colorectal cancer
* Efficacy and safety of Erbitux
- patients with advanced solid tumours
Dr. Zhenping Zhu
Assistant Vice President Head
Antibody Technology
ImClone Systems

12:40 Lunch

14:00 CASE STUDY: Eculizumab, Humanised MAb in a New Class of
Drugs
* Complement-5 inhibitors: activation methods
* Phase I/II results for rheumatoid arthritis, nephritis, systemic lupus,
psoriasis, dermatomyositis and pemphigoid
* Predicted worldwide sales for different indications
* Orphan Drug Status: treating paroxysmal nocturnal hemoglobinuria
Stephen Squinto
Executive VP and Head of Research
Alexion Pharmaceuticals

FUTURE OUTLOOK: TRANSGENIC PROTEINS

14:40 Transgenic Plants: A New Model to meet Production Needs
* Potential of this segment
- is it really a viable alternative?
* Large scale genetically engineered proteins an option for less
complex proteins?
* Overcoming technical issues
* Challenges
Dominique Mison
Bio-industrial Director
Meristem Therapeutics

15:20 Afternoon Tea

INNOVATIVE DELIVERY SYSTEMS

15:40 CASE STUDY: Crystalline MAb Formulations for
Subcutaneous Delivery
* MAb's: limitations of current administration and use
* Altus Crystalomics TM protein crystallisation technology for
subcutaneous delivery
* Pharmacokinetic profile and pharmacodynamic efficacy in vivo
* Advantages of delivery method: higher concentrations, low dose
volume, low viscosity, high stability
* New opportunities for biopharmaceutical applications
Dr. Sujit Basu
Group Leader
Parenteral Formulation and Delivery
Altus Biologics

16:20 Questions and Discussion

16:40 Chairman Summation

16:50 Close of Conference




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