• Antibodies – an inescapable reality for big pharma?
• Moving out of the fringes and into the limelight – the future of antibodies
  

• Update on European research programmes
• EU support for antibody research
• Introducing the Seventh Framework Programme
  

• How much potential does ribosome display have?
• Update on refinements to the ribosome display platform
• Will ribosome display replace phage?
  

• Overview of the approach to create multiple sub-libraries
• Handling diversity - benefits of microarray displays
• Automating the screening process
• Applications of this platform
  

• 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
  
  

• 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
  

• Computational fluid dynamics as a tool to obtain valuable information on operating conditions
• Scale down to scale up!
• Mixing, mass transfer and shear.....show stoppers for large scale cell culture

• 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
  

• Introducing the structure and science of BiTE
• Advantages of BiTE over traditional mAb therapeutics
• Production and manufacturing challenges to date
• Update on clinical status
  

• 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
  

• The GPEX technology -allowing screening as part of the cell line generation process
• Titrating heavy and light genes to the correct gene ration
• Milligram to gram production from an initial pooled cell line
• Clonal selection from the initial pooled cell line

• 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
  

• 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
  

• 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
  
  
  

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
  

• From the past to the future - trends in manufacturing practice
• Planning and building new manufacturing facilities
• Strategies to mitigate risk and economic impact
  

• From the past to the future - trends in manufacturing practice
• Planning and building new manufacturing facilities
• Strategies to mitigate risk and economic impact

• 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
  

• European site-selection issues faced by global biotechnology organisations
• Securing licences for activity, manufacturing and export
• Update on the Genentech Espana venture
  

• The impact of post-approval regulation on manufacturing development planning
• Balancing regulatory risks with expenses
• Strategies to postpone manufacturing development activities until post approval
  

• 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
  

• The trend towards disposable processing systems
• The economic and operational advantages
• The Hyclone – Baxter single-use stirred-tank bioreactor system
• How does this technology compare with conventional systems?
  

• 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
  

• 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?
  

• 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
  

• Optimisation of antibody purification conditions 
• Examples of antibody purification using mixed-mode ligands 
• Profiling of process impurities
  

• Goals of the development
• Manufacturing pathways and purification
• Biochemical and pre-clinical characterisation
• Product consistency and comparison between different manufacturing facilities
  

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.