DAY 1 | Monday, January 26th 2009

Morning plenary session

Maturing the cell, tissue and gene therapy sector
- Creating and driving value along the R&D and commercialization

Followed by your choice of:

Focus session 1

OR | Focus session 2

OR | Workshop *

Manufacturing strategy: What roles are outsourcing, new platform technologies and process automation playing in achieving profitability?

Followed by afternoon plenary session

Designing cell and gene therapy clinical trials
- Taking a close look at each phase of development to identify the key inflexion points, assess risk:benefit, and plan for commercialization and reimbursement

Followed by afternoon plenary session

Latest results from the CNS area: how are cell and gene therapies progressing in preclinical and clinical development?

Followed by afternoon plenary session

Afternoon plenary session

What’s missing from the tool box?
- Understanding which tailored enabling technologies cell and gene therapy companies need to help get into humans and progress to market?

DAY 2 | Tuesday, January 27th 2009

Morning plenary session

Analyzing the latest interpretation of the US, EU and Asian regulatory environments for cell, gene and tissue therapies
- How are they impacting global R&D and commercialization strategies?

Followed by your choice of:

Focus session 1

OR | Focus session 2

OR | Workshop *

Rigorous characterization of cell therapy products through the phases: Ensuring comparability

Followed by afternoon plenary session

Preparing for combination therapies: Putting in place the regulatory, development and commercial pathways necessary to realise the potential of cell + gene + device + small molecule + biologic products

Followed by afternoon plenary session

The EU regulatory framework for Advanced Therapy Medicinal Products: Practical advice illustrating the realities of its implementation and the differences between member states’ interpretation

Followed by afternoon plenary session

Afternoon plenary session

Ongoing opportunities for - and barriers to - cell, gene and tissue therapy
Which diseases are now considered most amenable to their application?
How will they fare against the competition?

DAY 3 | Wednesday, January 28th 2009

Morning plenary session

Gaining an insight into big pharma and big biotech’s current and future plans for cell, gene and tissue regeneration therapies
- Analyzing internal and external investment, and collaborative moves

Followed by your choice of:

Focus session 1

OR | Focus session 2

OR | Workshop *

Viral and non-viral vectors for the targeted delivery of gene-based therapies: Advances in safety, regulation, manufacturing and scale-up

Assessing the therapeutic performance of stem cells from different sources
- How is a better understanding of mechanism of action impacting their application to particular disease environments?

Financing global growth in the cell, gene and tissue therapy sector
What sources of funding are now being exploited?
Are investors evaluating these opportunities appropriately?