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Briefing day, Tuesday 12th May 2009
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| NON-THERAPEUTIC APPLICATION OF STEM CELL TECHNOLOGY |
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8am | Registration and coffee
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9am | Chairman’s opening remarks
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| | Dr Tim Allsopp, Head of Cell Improve Programme, Pfizer Regenerative Medicine
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| FUNDING AND PARTNERSHIP MODELS |
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9.10am | Update on Stem Cells 4 Safer Medicine (SC4SM): overview of working partnerships in toxicology research
• One year on – SC4SM overview and update
• Advantages derived from the SC4SM working partnerships – where are we and what’s next?
• Partnership representation and benefits
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9.40am | Case study: building and managing productive alliances in stem cell science
• Working with Harvard Stem Cell Institute to develop innovative stem cell initiatives
• Overview of collaborative projects, objectives and progress projections
• Opportunities for Big Pharma partnering: what we are looking for and where
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10.10am | Bridging the gap between Big Pharma, Biotech and Academic Institutions
• Case study examples of facilitating cooperative activity
• Strategic initiatives and engaging with drug discovery companies
• The development of improved tools for the discovery of better medicines
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| | Dr Lucie Bruijn, Science Director and Vice President of Research, ALS Foundation
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10.40am | Morning coffee
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| STEM CELLS AS TOOLS IN PREDICTING DRUG TOXICITY |
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11.10am | Non-therapeutic application of stem cells technology in the pharmaceutical industry
• Importance of stem cell platforms in clinical safety assessment
• Existing models for prediction of toxicity and their limitations
• Using stem cells in problem solving with regard to organ toxicity
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11.40am | Discovering novel approaches to predictive toxicology
• Role of cell models in compound safety assessment
• Appropriate cell models for the assessment of cellular therapies
• Applying human stem cell models as safety tools
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| TOOLS IN DRUG DISCOVERY – TARGET IDENTIFICATION AND VALIDATION |
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12.10pm | Considerations for using stem cells as tools in drug discovery
• Case studies: Utilizing stem cells as tools in drug discovery
• Developing novel stem cell tools for drug discovery
• Future non-therapeutic opportunities for stem cells
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12.40pm | Lunch
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1.40pm | Live image based screen on glioblastoma stem cells
• Novel adherent neural stem cells from normal and tumour samples as tools for pharmaceutical R&D
• Patient-specific cancer stem cells to understand biology and tailor therapy
• Live image based technology assessing self renewal and differentiation
• Making use of public libraries
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2.10pm | High throughput production of differentiated cell lines for drug discovery
• Use of Combinatorial Cell Culture to differentiate stem cells.
• Generating information on the biochemical mechanisms of differentiation
• Developing drugs that affect differentiation
• Differentiation of iPS cells using a high throughput technique |
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| ADVANCED TECHNOLOGY FOR STEM CELL PROPAGATION AND PURIFICATION |
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2.40pm | Automated stem cell propagation and purification
- Overview and limitations of existing methodology for derivation and propagation of stem cells lines
- LEAP™: a novel approach for efficient, standardized automated production of stem cell cultures
- Outlining LEAP™ technologies and capabilities
- What are the benefits of the LEAP™ system over current techniques?
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3.10pm | Afternoon tea
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| NOVEL STRATEGIES FOR STUDY OF DISEASE |
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3.40pm | Embryonic stem cell-derived neurons as a novel cellular model system to study neurodegenerative and neuroregenerative processes
• Isolation of embryonic stem cell-derived neurons
• Current cellular model systems for studying neurodegenerative and neuroregenerative processes and advantages of this model
• Recent findings, wider implications and promises of this technology
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| | Dr Miriam Bibel, Senior Researcher, Neurodegeneration Department, Novartis Institutes for Biomedical Reseaerch
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| EFFECTIVE UTLIZATION OF iPS CELLS |
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4.10pm | Toolbox utility of stem cells for target identification
• ES/iPS cell technology for drug discovery and development
• Commercialization of toxicity testing by using ESC-derived beating cardiomyoctyes
• Japanese efforts to coordinate drug discovery using human embryonic stem cells |
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4.40pm | Panel session: Impact of induced Pluripotent Stem (iPS) cells on the field of stem cells and regenerative medicine
• Assessing the impact of iPS cells, overcoming barriers and future development
• Perspectives on the realism of utility of iPS cells – what is the potential and how will their potential be realised?
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| | Moderator: Dr Tim Allsopp, Head of Cell Improve Programme, Pfizer Regenerative Medicine Confirmed: Dr Mahendra Rao, Vice President of R&D, Primary and Stem Cell Systems, Invitrogen Corporation
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5.30pm | Close of day one followed by networking drinks reception
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Conference Day One, Wednesday 13th May 2009
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| TRANSLATING RESEARCH INTO COMMERCIALLY SUCCESSFUL THERAPEUTICS
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8am | Registration and coffee
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9am | Chairman’s opening remarks
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| | Dr Chris Mason, Director, Regenerative Medicine Bioprocessing Unit, University College London
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9.10am | Keynote address: driving translational stem cell science towards the clinic: insights and requirements
• The role of stakeholders (including big pharma) in translating research into commercial success
• Where are the blockages and what can biotech do to get the pipeline flowing?
• Translating stem cell science and the vision of CIRM
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| FUNDING AND SECURING INVESTMENT |
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9.40am | Commercialization of regenerative medicine: translating great science into successful business
• Current state of commercial activity: where are we and how did we get here?
• Access to capital: funding sources (public, private, government), venture capital metrics and typical VC terms
• Major commercialization challenges: technical, business models, reimbursement
• Commercialization best practices: regulatory and IP
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10.15am | Panel session: is there a correct business model for regenerative medicine?
• Business strategies for commercialization – what do you need to demonstrate and when?
• Maximising financial efficiency and minimising failure rate
• Wider funding implications and impact of failure on the stem cells and regenerative medicine community
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| | Moderator: Dr Chris Mason, Director, Regenerative Medicine Bioprocessing Unit, University College London
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10.45am | Speed Networking
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11.45am | Morning coffee
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12pm | Baxter, stem cells and regenerative medicine
• Summary of the Baxter approach to stem cell therapy and regenerative medicine
• Overcoming commercialization challenges; regulatory hurdles and others
• Summary of stem cell therapy clinical trial results at Baxter
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| | Dr David Amrani, Senior Director and Head, Regenerative Medicine and Stem Cells R&D, Baxter
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12.30pm | Successfully pushing stem cell therapeutics into the clinic
• Commercializing products from adult bone marrow
• Current and ongoing clinical programs and progress
• Ongoing challenges associated with commercializing stem cell therapeutics
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1pm | Lunch
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| OVERCOMING REGULATORY HURDLES |
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2pm | Cells as pills: developing saleable stem cell products and an industry perspective on the current regulatory landscape for regenerative medicine
• Donor to shelf: creating a viable and useful product in the stem cell field
• Autologous and non-autologous cells
• The current global regulatory landscape for commercialisation of stem cell therapeutics
• Working with the regulators and some suggestions for improving the process
• Establishing a positive legal framework to advance regenerative medicine
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| ACHIEVING REIMBURSEMENT AND INTELLECTUAL PROPERTY ISSUES |
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2.40pm | Generating a reimbursement model for stem cell therapies
• Reimbursement strategies, safeguards and early dialogue between stakeholders
• Demonstration model for reimbursement – what needs to be done and how
• Translating this information into a practical guideline for generating a reimbursement model |
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3pm | Navigating the intellectual property landscape for stem cells
• Overview of the intellectual property landscape for stem cell products and problems/solutions
• Implications for biotech and pharmaceutical co-operation
• The impact of patent expiration and how to navigate it |
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| REGENERATIVE MEDICINE IN ASIA |
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3.30pm | Developments in stem cells and regenerative medicine in Asia
• A brief history, success stories, barriers and current developments in regenerative medicine in Asia
• Who are the main players and what is being done
• Formation and progress of the Stem Cell Network of the Asia Pacific Region
• What does the future hold for the stem cells and regenerative medicine industry in Asia? |
| | Mr Doug Sipp, Manager, Scientific Communication and International Affairs, Riken Center for Developmental Biology
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4pm | Afternoon tea
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| ENHANCED PRODUCTION AND MANUFACTURING SYSTEMS |
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4.30pm | Tools and technologies for the development of defined cell culture environments
• Cell characterization and cell analysis
• Maintenance, expansion and differentiation media formulations
• Defined culture environments for cell therapy
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5pm | Preparing for commercialization
• When to start thinking about a CMO
• Manufacturing challenges and solutions
• What to expect from your CMO
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| FINDING AN INDUSTRY VOICE FOR STEM CELLS AND REGENERATIVE MEDICINE |
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5.30pm | Panel session: does the stem cell industry need a dedicated international industry association?
• Addressing the needs – what are the issues?
• Essential criteria for developing a regulatory body
• What needs to happen: establishing future milestones
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| | Confirmed: Mr Bernard Siegel, Founder and Executive Director, Genetics Policy Institute
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6pm | Close of day one followed by networking drinks reception
Sponsored by:
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Conference Day Two, Thursday 14th May 2009
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| FUTURE SCENARIOS FOR MEDICINE – HOW REGENERATIVE MEDICINE WILL MEET UNMET MEDICAL NEED |
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9am | Chairman’s opening remarks
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| ADDRESSING THE CHALLENGE OF COMMERCIALIZATION |
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9.05am | Is there a viable future for stem cells in diabetes therapy?
• Overview of stem cell research at Novo Nordisk
• Overcoming therapeutic hurdles to stem cell use
• Stem cells and diabetes: overview and update on Novo Nordisk activities |
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9.30am | Embryonic stem cell therapies for diabetes
• Immunoisolation technologies for diabetes stem cell therapies
• Manufacturing and safety challenges and answers
• Are stem cell therapies for diabetes possible in the near future? |
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9.55am | Adult stem cells on the way to market
- Introduction to Cellerix: Developing a pipeline of advanced products in under 5 years
- Ontaril: A phase III product well positioned to gain market approval in 2011
- Cx501: A chimeric skin for the treatment of a severe genetic disease
- Allogeneic products: The future of cell therapy
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10.20am | Morning coffee
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10.50am | Lessons learned in the UK clinical approval of ReN001, a stem cell therapy for stroke
- An outline of ReN001: A stem cell therapy to improve stable disability after stroke
- How we got here: Steps taken and lessons learned in achieving clinical approval in the UK for ReN001
- Clinical trials and beyond: what does the future hold for ReN001?
- Some wider perspectives on the clinical and market approval process for stem cell therapies
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| CARDIOVASCULAR STEM CELL THERAPEUTICS
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11.15am | Towards the initiation of human clinical trials for heart muscle regeneration
• Validating safety and effectiveness of myoblast injections into damaged heart muscle
• Increasing cell count and viability of human myoblasts cultured from skeletal biopsy
• Routine delivery of myoblasts for chronic post-infarction left ventricular dysfunction during bypass surgery |
| | Dr Philippe Menasche, Director , Cell Therapy in Cardiovascular Diseases Research Unit, Hopital Europeen Georges Pompidou
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11.40am | Implanting a completely biological tissue engineered blood vessel
• Clinically relevant vascular grafts
• Development on new tissue engineering approaches
• Clinical results and future work
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12.05pm | Case study: Heart muscle regenerative therapy clinical trial results
• Exposition of trials and phasing
• Evaluating the safety and biological effect of using a human dermal fibroblast culture to treat diffuse small blood vessel disease in human hearts
• Clinical data and regulatory challenges
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12.30pm | Lunch
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| A BIG PHARMA PERSPECTIVE ON FUTURE COMMERCIALIZATION OF STEM CELL THERAPEUTICS |
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1.30pm | Panel session: Big pharma perspectives on addressing areas of unmet medical need through regenerative medicine
• The key questions for regenerative medicine
o Why have big pharma not invested heavily in this space?
o What does biotech need to demonstrate to make this happen?
• Perspectives for translating stem cell science into commercial success – requirements for taking regenerative medicine forward |
| | Confirmed: Dr Ruth McKernan, Chief Scientific Officer, Regenerative Medicine, Pfizer
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| SKIN, BONE AND HAIR THERAPEUTICS |
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2.10pm | Preparation of living cell therapies for wound healing and other soft tissue applications
• Delivering living, cell-based products to activate inherent ability to repair and regenerate
• Developing a business strategy based on excellence in research and development, through manufacturing to successful commercialization
• New clinical data
• Lessons learned in the growth and recent commercial success of Organogenesis
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2.35pm | The development of second generation cell-based, tissue engineered products for wound care
• Generating human tissue substitutes using NIKS® keratinocytes and derived cells
• Application of platform technology for therapeutic development
• Evaluating the therapeutic value of the keratinocyte progenitor cell line
Dr Lynn Allen-Hoffman, Chief Executive Officer and Chief Scientific Officer, Stratatech Corporation
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3pm | One Size Fits All - Off the Shelf Adult Stem Cell Orthopaedic Therapies
• Allogenic mesenchymal precursor cells (MPCs), understanding the business model
• The road to FDA approval
• Pre-clinical results
• Human experience to date
• Additional therapeutic applications for MPCs |
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3.50pm | Development of innovative cell therapy technology to restore skin and hair
• The importance of developing human cell-based products at commercially viable scale for attractive markets
• Derivation of regeneration products from unmodified human cells
• Clinical overview of products and lessons learned in bringing products to market |
| | Mr Nick Higgins, Chief Executive Officer and Executive Director, Intercytex
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| IMMUNOLOGICAL TOLERANCE AND AGING |
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4.15pm | Transplantation of embryon progenitor cells, immunological tolerance and aging
- Allogeneic transplantation of stem cells is almost always complicated by the reaction of rejection of the transplant
- Transplantation of large doses of fetal hematopoietic progenitor cells capable to induce central immunological tolerance
- Clinical trials at the Institute of Cell therapy had shown a real rejuvenation of the human body after the transplantation of large doses of fetal hematopoietic progenitor cells
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| | Professor Olexandr Kukharchuk, Director of the Coordinating Center for Organ Transplantation, cells and tissues of the Ministry of Health Care of Ukraine, Institute of Cell Therapy
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| FURTHER THERAPEUTIC DEVELOPMENT |
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4.40pm | Proprietary technologies for hematopoietic stem cell expansion with increased in vivo functionality
• Expanded cells display improved migration, homing and engraftment
• Enhancing tissue regeneration following ischemia
• Phase II/II clinical study of StemEx® for bone marrow transplantation
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5.05pm | A Cellerant perspective on developing and commercializing cell-based therapies
• Challenges around developing novel hematopoietic stem cell-based cellular and antibody therapies
• Overview of therapeutic pipeline at Cellerant: proof of concept studies, clinical applications and beyond
• A Cellerant perspective on clinical and regulatory hurdles
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| | Dr Ram Mandalam, President and Chief Executive Officer, Cellerant Therapeutics
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5.30pm | Opportunities and challenges of commercializing stem cell research
• Realising the immediate potential of regenerative medicine and stem cells: perspectives on near term commercialization
• Product development at BioTime and pipeline overview
• Outline of medical applications and future opportunities for stem cell commercialization
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5.55pm | Close of congress
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