European Antibody Congress

08.30 Registration

09.00 Chair’s opening remarks
• Antibodies – an inescapable reality for big pharma?
• Moving out of the fringes and into the limelight – the future of antibodies
Dr Gabriele Schaeffner
Head, Section Monoclonal and Polyclonal Antibodies
Paul-Ehrlich-Institut, Germany

WHERE ARE WE NOW? ANTIBODIES AND THE MARKETPLACE

09.20 Opening address: the European antibody industry
• Antibodies – leading the re-emergence of the European biotech industry
• Political challenges facing the antibody sector
• The European regulatory climate – promoting excellence or stifling research?
• Update on EU research programmes
Dr Achilleas Mitsos
Director-General DG Research
European Commission

09.50 Coffee break

METHODS TO IDENTIFY NEW ANTIBODIES

10.50 Case study: ribosome display – the end for phage?
• How much potential does ribosome display have?
• Update on refinements to the ribosome display platform
• Will ribosome display replace phage?
Dr Lutz Jermutus
Director of Protein Engineering
Cambridge Antibody Technology

11.20 Case study: IV methods to display and screen recombinant antibody libraries
• Overview of the approach to create multiple sub-libraries
• Handling diversity - benefits of microarray displays
• Automating the screening process
• Applications of this platform
Dr Dana Ault-Riche
Chief Executive Officer
Pointilliste

11.50 Panel discussion - a critique of the display methods available
• Commonly used libraries - the pros and cons
- Yeast and fungi
- Phage Display
- Ribosome Display
• Novel antibody IgG display systems – how well do they work?
• Protein arrays – how to identify and screen out your antibody
Moderator:
Prof. Mats Ohlin
Department of Immunotechnology
Lund University, Sweden

Panellists:
Dr Ricarda Finnern
Director of Research and Discovery
Dyax s.a.

Dr Michael Braunagel
Co-founder and Director
Affitech

12.40 Networking lunch

THE NEXT GENERATION – ADVANCES IN ANTIBODY PRODUCTION

14.10 Panel discussion: antibody engineering – exploring the latest developments
• Antibody enhancement – forming conjugates with drug compounds and enzymes
• Examining tumour activated pro drugs (TAPS) in the fight against cancer
• Single chain antibodies and their derivatives for complimentary activation in inflammatory diseases
• Maximising the benefits of domain isolation
• Nanobodies, synthetic antibodies and fluorbodies – how relevant are they?
Moderator:
Paul Chamberlain
Director, Biopharmaceuticals Drug Development Programs
MDS Pharma Services

Panellists:
Dr Hans de Haard
Director of Technology Development
Ablynx

Dr Robert J. Lutz
Senior Director Preclinical Development
Immunogen

Dr Bassil Dahiyat
President and Chief Executive Officer
Xencor

15.00 SPEED NETWORKING
• Meet…move on…meet…move on…meet!
• Exchange business cards with fellow conference delegates and industry peers
• The best 50 minute networking session you’ve ever experienced

15.50 Coffee break

16.15 Case study: BiTEs – leveraging the benefits of both Abs and T cells
• Introducing the structure and science of BiTE
• Advantages of BiTE over traditional mAb therapeutics
• Production and manufacturing challenges to date
• Update on clinical status
Dr Patrick Baeuerle
Professor for Immunology & Chief Scientific Officer
Micromet

16.45 Case study: functional anti-cancer antibodies: a new age now begins
• The state of the art - clinical results and approved drugs
• Discovering antibodies and antigens through FunctionFIRST
• Examples of novel antigens and antibodies: pre-clinical validation
• Challenges ahead - each development pathway is unique
Dr David Young
Chief Scientific Officer
Arius

17.15 Chair’s closing remarks followed by Networking Reception

Day Two Wednesday 2nd November 2005 www.terrapinn.com/2005/antibody
Attack.

08.30 Registration

09.00 Chairman’s opening remarks
Paul Chamberlain
Director, Biopharmaceuticals Drug Development Programs
MDS Pharma Services

OUTSIDE THE LAB – THE BUSINESS OF ANTIBODIES

09.10 Keynote address: regulation - what you need to do to get approval
• Strategies to get your antibody to market as quickly as possible
• Interpreting current guidelines
• Pre-clinical and clinical regulatory requirements
• How the five recent FDA initiatives impact on production of monoclonal antibodies:
- Process Analytical Technology (PAT)
- Part 11
- CDISC
- New vaccine regulation
- The molecular libraries (NIH) Initiative
• Update on EU Clinical Trial directives
• Regulatory issues affecting business strategy
Dr Lincoln Tsang
Partner, Arnold and Porter LLP (UK)
Chairman,Regulatory Affairs Advisory Committee, BioIndustry Association
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09.40 IP and antibodies – how far should you be allowed to go?
• Challenges surrounding IP in the antibody world
• Strategies for obtaining and/or enforcing your patents
• Bringing clarity to the IP surrounding antibody phage display
• Strategies for licensing and/or contesting the patents of others
Dr Philip Webber
European Patent Attorney
Frank B Dehn & Co (UK)

10.10 Coffee break

11.10 Panel discussion: collaboration – how to build a successful partnership
• Why partner and when?
• Strengthening strategic research directions
• Securing non-exclusive internalisation of partner technology platforms
• Technology licence transfers – finance and practicalities
• Overcoming fears and anxieties – maintaining influence and control
Moderator:
Dr Sam Fazeli
Biotechnology Analyst
Nomura

Panellists:
Dr Simon Moroney
Chief Executive Officer
MorphoSys AG

Nicholas Adams
Director Business Development
Antisoma

Jane Dancer
Senior Manager, Business Development
Cambridge Antibody Technology

Frank Landolt
IP and Legal Counsel
Ablynx N.V.

12.00 Networking lunch

THERAPEUTIC CASE STUDIES – PRODUCTS APPROACHING THE MARKET

In a special session, hear about some of the most exciting therapeutic antibodies to have recently appeared or approaching the market. Each case study will include:
- Overview of the product and applications
- Latest findings
- Implications of approval

13.30 Case study: update on anti-IL-12p40 antibody ABT-874
Dr Trudi Veldman
Director Biologics Generation
Abbott Bioresearch Centre

13.50 Case study: TIE-1 targeted inhibitor of tumour growth
Dr Clive R. Wood
Chief Scientific Officer and SVP, Discovery Research
Dyax

14.10 Case study: novel human antibody therapeutics for the treatment of lymphoid cancers
Prof. Jan van de Winkel
Chief Scientific Officer
Genmab A/S

14.30 Question and answer session with the first three case study speakers

14.50 Coffee break

15.50 Case study: MYLOTARG – treatment of CD33-positive acute myeloid leukaemia
Dr Nitin Damle
Department of Oncology
Wyeth Pharmaceuticals

16.10 Case study: Erbitux – an oncological growth factor blocker
Dr Philip Frost
Chief Scientific Officer
ImClone

16.30 Case study: LymphoStat-B antibodies inhibiting the biological activity of B-lymphocyte simulators
Dr Vivian R. Albert
Vice President, Development Sciences and Research
Human Genome Sciences Inc.

16.50 A hidden CD4 monoclonal antibody with unique characteristics
Dr John Wijdenes
General Director
Diaclone SAS

16.50 Question and answer session with the three case-study presenters

17.10 Chairman’s closing remarks

Manufacturing and scale-up day www.terrapinn.com/2005/antibody_eur
Separately bookable: Thursday 3rd November 2005

[left hand column]

08.30 Registration

08.50 Chairman’s opening remarks
Dr Bernard Chan
Director of Biologicals Manufacturing
UCB-Celltech

MANUFACTURING MANAGEMENT

09.00 Keynote address: the challenge of large scale antibody manufacture
• From the past to the future - trends in manufacturing practice
• Planning and building new manufacturing facilities
• Strategies to mitigate risk and economic impact
John Dingerdissen
Vice President, Worldwide Manufacturing, Global Biologics Supply Chain LLC
Johnson & Johnson

09.30 Preparing for commercial introduction - pipeline and production flow management
• Efficient management of multi-product manufacturing facilities
• Management of variations in manufacturing scale
• Manufacturing strategies for “non-blockbuster” antibodies
• Accommodating changes in processes and systems during scale-up and scale-down
• Maintaining comparability with multi-site manufacturing
Dr Andreas Werner
Head of Biopharmaceutical Production Management
Boehringer Ingelheim

10.00 Establishing a new European manufacturing facility
• European site-selection issues faced by global biotechnology organisations
• Securing licences for activity, manufacturing and export
• Update on the Genentech Espana venture
Tim Hughes
Managing Director
Genentech Espana

10.30 Coffee break

11.30 Recent changes to the regulatory environment and impacts on antibody manufacture and development
• The impact of post-approval regulation on manufacturing development planning
• Balancing regulatory risks with expenses
• Strategies to postpone manufacturing development activities until post approval
Dr Philip Hess
President and Founder
Philip Hess Associates

12.00 Microbial v Mammalian cell production – striking the balance
• At what stage do you need to make a decision?
• How effectively can you operate a facility incorporating both?
• Testing for microbial contaminants in mammalian production
• Maximising titres and economic considerations
Dr S. Robert Adamson
Vice President
Wyeth Biopharma Development Network

12.30 Networking lunch

[right hand column]

YIELD IMPROVEMENT – ADAPTING THE OLD OR ADOPTING THE NEW?

14.00 Case study: the importance of developing a high yield of product
• Update on the GS gene expression technology
• Selecting cell lines that are compatible with production requirements
• Adhering to regulatory guidelines with respect to cell line development
Dr John Birch
Chief Scientific Officer
Lonza Group

14.30 Case study: PER.C6 – a cell line for high quality, high yield and improved expression
• Background to the cell line
• The current demands on cell lines
• Evaluation of the effectiveness of PER.C6 in both fed-batch and continuous perfusion systems
• How does PER.C6 compare with other alternative cell lines?
Dr Bram Bout
Vice President Protein Production
Crucell Holland, N.V

15.00 Coffee break

RECOVERY AND PURIFICATION

16.00 Creating conditions for maximised recovery
• Removal of process contaminants by membrane chromatography
• Use of protein A media for chromatography
• Application of mixed-mode ligands for capture of antibodies and other proteins
• Strategies to prevent yield loss
Philip Nelson
Senior Manager, Recovery Technology Support
Abgenix Inc.

16.30 Case study: development of a new 10% liquid triple virally reduced intravenous immune globulin from human plasma
• Goals of the development
• Manufacturing pathways and purification
• Biochemical and pre-clinical characterisation
• Product consistency and comparison between different manufacturing facilities
Dr Wolfgang Teschner
Senior Manager, Plasma Product Development
Baxter AG

MANUFACTURING ON A GLOBAL SCALE

17.00 Clinical manufacturing in a global network
• Process development and clinical manufacturing in a network organisation
• Definition of responsibilities
• Contractual issues
• Strategy for global supply chain management in a network organisation
Dr Torben Lund-Hansen
Vice President, Manufacturing
Genmab A/S

17.30 Chairman’s closing remarks
Dr Bernard Chan
Director of Biologicals Manufacturing
UCB-Celltech

Pre-congress workshop www.terrapinn.com/2005/antibody
Monday 31st October 2005

Optimising alliances for antibody products and technologies
A one-day workshop hosted by PharmaVentures Ltd

As a consequence of the continued growth in antibody products and technologies, collaborative, licensing and M&A deals between large pharmaceutical and biotechnology companies will increase. It is essential that these alliances are carefully structured and managed to ensure success.

PharmaVentures will address the key issues facing executives going into and managing the collaboration moving forward. By drawing on our extensive consultancy knowledge and our experience of providing training, we can provide the right level of insight to ensure improved outcomes.

The pre-conference workshop day will provide an interactive format in which views can be exchanged and the key issues discussed.

Workshop agenda

09.00 - Registration and coffee

09.30 - Introductory discussion

10.00 - Trends in antibody production and technology deals

11.00 - Coffee break

11.30 - Valuing antibody transactions

12.30 - Lunch break

14.00 - Pricing and reimbursement considerations

15.00 - Managing antibody alliances successfully

16.00 - Concluding discussion