Participate in the Cell & Gene Therapy Forum to:

• Test the temperature of big pharma/big biotech’s interest in the cell, gene and tissue regeneration sector: Hear first hand how their interest is now manifesting itself and how they see the sector maturing
  
  
• Ask the cell and gene therapy pioneers for practical advice: They will all be represented at the highest of levels to offer mentoring support on all aspects of creating and driving value along the R&D and commercialization path
  
  
• Debate which disease areas are now considered most amenable to the application of cell, gene and tissue regeneration therapies – and gauge how well they will fare against the competition
  
  
• Make direct comparisons between regulatory pathways and interpretations in US, EU and Asia in order to fine tune your local, regional and global R&D and commercialization strategies
  
  
• Investigate untapped synergies between regenerative medicine, tissue engineering, devices, and cell and gene therapy
  
  
• Sharpen your skills in accessing and securing financing: Learn from those who have fought for and won a wide variety of funding types
  
  
• Gain step by step guidance via a series of case studies illustrating best practice characterization, and how comparability can be ensured as manufacturing scales up
  
  
• Add your requirements to the wish list of tailored enabling tools that cell and gene therapy companies most urgently need: The tools and service providers will be there to listen and act on your needs from pivotal trials right through to commercialization
  
  
• Take away lessons learned from the maturation cycle of other biologics - monoclonal antibodies, vaccines and RNAi - which elements will be the same, and which will be truly unique to cell and gene therapy?
  
  
• Examine the capabilities and benefits of different sources of stem cells to make better informed choices: How advanced is the experts’ understanding of mechanisms of action, specific toxicity and safety issues, regulatory pathways, likelihood of success in clinic, and manufacturing and scale-up issues?
  
  
• Make a thorough assessment of the advances being made in specificity and delivery of RNA therapies: How might their regulatory path differ from "standard" gene therapies, and how will this impact their development path and progress?
  
  
• Gather practical advice from case studies illustrating the realities of working within the EU regulatory framework for Advanced Therapy Medicinal Products: What peculiarities of its implementation do you need to be most aware of?
  
  
• Capitalize on different approaches to due diligence in the cell and gene therapy sector: Be better prepared by understanding what criteria investors are, and should be, evaluating when making their decisions
  
  
• Quantify the commercial potential of cell, gene and tissue therapies in combination with devices, with small molecules and with each other: Which combinations are most likely to improve delivery for cell and gene therapies? What product life extension opportunities are emerging as a result of these combinations?
  
  
• Plan well ahead for regional / global manufacturing and scale-up to be prepared for import/export considerations and their impact on cost of goods
  
  
• Monitor the latest results from cell and gene therapies in the CNS area, and discuss how the progress being made in preclinical and clinical development might be applied elsewhere
  
  
• Perfect the coordination of your clinical, manufacturing and commercial processes at each stage of clinical development by learning precisely where the key inflexion points are
  
  
• Optimize your manufacturing and testing strategies: Get answers to all your questions concerning whether or not to outsource, criteria for choosing a contractor, and how to manage the relationship successfully
  
• Judge whether or not automation is the next logical step for your company by hearing case studies and discussions illustrating its strengths, limitations and impact on cost of goods.
  

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