• New methods of deriving primate embryonic stem cells, in relation to the established derivation from embryos
• Political, business and regulatory considerations of stem cell development
• Translational stem cell science and the vision of CIRM

• How public policy directly affects stem cell research
• Establishing a positive legal framework to advance regenerative medicine
• Working with many bodies to ensure maximum development in the industry

• Pioneering regenerative medicine and the outlook for the future
• The scientific and impact of a methodological shift
• Possible timescales for change and potential for the advancement of regenerative medicine and tissue engineering

This is a revolutionary, exciting, quick and non-pressured way to meet fellow congress delegates and industry peers in one fifty minute session. These brief meetings are the starting point for conservation and networking throughout the conference. This is where long lasting and fruitful relationships begin. Please make sure you bring lots of business cards!

• Meet…move on… meet…move on…meet!
• Exchange business cards with fellow congress delegates, speakers and moderators
• The best networking session you’ve ever experienced

• Are big pharmaceutical companies ready to invest in stem cell businesses?
• Exploring the logistics of funding for small research bodies alongside big pharmaceutical companies
• Talent retention issues and the import of liberalised funding

• Reconciling business needs and investor expectations
• Funding sources and funding strategies
• The challenges of funding under the present regulatory system

• Recent developments in venture investment
• Comparison of EU and US funding allowance
• Biotech companies as investment potential under liberalised regulation

• Securing multifaceted funding options for biotech business
• Maximising valuation to a prime investment area
• Emergence of high net worth investment: The shape of things to come?

• Newly patented technologies for in house product lines
• Transferal of manufacturing capabilities with investment capital and changes in legislation
• Ensuring standardisation and safety protocol on a large scale

• Multiple uses of single cells: establishing cost effective automation
• Scale-up and automation of hESC cultures and cryo-conservable somatic stem cells
• Reversible engineering: post and mid-clinical models

• Exposition of trials and phasing
• Evaluating the safety and biological effect of using a bioresorbable scaffold-based, three-dimensional, human dermal fibroblast culture to treat diffuse small vessel disease in human hearts
• Clinical data, challenges and outcomes
• Next phase and regulatory approaches to development

• Common challenges in clinical trials for regenerative products
• Regulatory and developmental concerns

• Donor to shelf: creating a viable and useful product in the stem cell field
• Autologous and non-autologous cells
• The regulatory framework and development strategies

• Contract manufacturing logistics
• Post-clinical roll-out
• Marketing an emerging product

• Regulatory, manufacturing, and reimbursement hurdles faced by tissue engineered products
• Lessons learned from Advanced Tissue Sciences
• Redefining regenerative medicine products with a new business model for short and mid-term commercialization of human cell derived products

• Ensuring transparency in operations between biotech and big pharmaceutical companies
• The importance of initiating an early reimbursement dialogue
• Reimbursement strategies and safeguards
   

• Negotiating the new regulative guidelines
• The UK model: working with changing guidelines and exclusive criteria
• Working practically with the advanced therapies regulation and realistic timescales for application

• What is patentable? IP rights and problems within the challenging and saturated patent arena
• New patenting legislation for stem cell products and its implications for biotech and pharmaceutical co-operation
• Existing patents and the impact of their expiration

• What should I be thinking about in process development and manufacturing of my cell therapeutic?
• What process developing changes are needed prior to process validation?
• Will your raw materials and suppliers meet regulatory scrutiny?
• How will cost of goods goals be met?
• Is my production facility ready for inspection?

• Optimising manufacturing processes early in the product development cycle
• Leading edge technologies for cell separation, expansion and characterisation
• Inherent challenges of scale up and application of technical solutions

• Optimising manufacturing processes
• Manufacturing developments and creating a forward looking model for regenerative medicine scale-up
• Ensuring accurate and transparent operations for large scale productions

• The lack of historical precedent for stem cell biotech lobby groups
• Essential criteria for developing a regulative body
• How to ensure representative regulation in line with ATMP standards

• Benefit driven co-operation for stem cell businesses
• Open protocols and standardized systems in stem cell technology which enable consistent differentiation of stem cells into stable homogenous populations of particular cell types
• Physiologically relevant phenotypes suitable for toxicology testing in high throughput platforms

• Legislation that allows PP funding and development initiatives
• Why now? The PPP as a case study for immediate public investment
• Governmental involvement and public interest development for stem cell partnerships

• Developing consortia driven models for stem cell businesses based on their unique challenges
• Increasing the profile, impact and profitability of stem cell derived products
• Drug discovery and safety as a starting point for stem cell consortia: their potential in this field and in the wider therapeutic landscape

• Demonstrating the utility of embryonic stem cells as research tools for drug discovery
• Drug screening developments and progress
• Developing a clinically relevant biological system that offers an unprecedented level of transfer for effective drugs

• Rationale for neural stem cells as drug targets
• Assessing the areas where industry and academia can effectively work together
• Recent findings and promise of this technology

• Cellartis as a Swedish/British company, funding and external relations
• The biotech niche and potential for commercialisation
• The dependence of hESC-platform for industrialisation possibilities

• Focus: Derivation of hepatocytes and their industrial potential
• Derivation of cardiomyocytes and beta-cells
• Products and commercial possibilities with hESC-derived specialised cells

• Potential applications and benefits of predictive toxicology
• In vivo imaging for toxicology informatics
• Multidimensional modelling

• New research findings in throughput maximisation
• Harnessing small molecules for asymmetric division and target replication
• Accuracy benchmarks for efficient experimental procedures

• High throughput with ensured validity in muscle cells
• Cell washing and priming procedures for discovery and toxicology
• Demonstration of automated procedures for the formatting of human stem cells

• Generating information on the biochemical mechanisms of differentiation.
• Developing drugs that affect pathways, using proprietary technologies
• Modelling these products and developing a saleable product

• Developmental toxicity in humans and recent findings
• Animal models and interpretation
• Consortia for drug safety and working with research institutions