Agenda
DAY ONE - October 23rd, 2008
8.30-9.00 Registration and Morning Coffee
9.00-9.10 Chair’s Opening Remarks
Professor Dame Julia Polak, Department of Chemical Engineering, Tissue Engineering and Regenerative Medicine, Imperial College London, and Co-Founder & Director, NovaThera, UK
9.10-9.50 Keynote Address: Current Challenges to Translate Regenerative Medicine Research into Reliable Clinical Products
Presentation to cover:
- What is Regenerative Medicine?
- Translational challenges for research
- Creating reliable products for the NHS and other service providers
Professor Dame Julia Polak, Department of Chemical Engineering, Tissue Engineering and Regenerative Medicine, Imperial College London, and Co-Founder & Director, NovaThera, UK
9.50-10.30 Therapeutic Potential of PLX Placental Mesenchymal Stromal Cells
Presentation to cover:
- Pluristem’s unique 3-dimensional technology
- Proof-of-concept in several animal models
- The path to clinical trial
Dr Amir Toren, Director of Business Development, Pluristem Therapeutics Inc., Israel
10.30-11.00 Coffee
11.00-11.40 Integrated Solutions for Cell Therapy Product Development and Commercialization
Presentation to cover:
- Successful development approaches to achieve a risk-based balance of time and resources
- Validation of a manufacturing process with associated controls commensurate with envisioned clinical scale operations and an optimized COGs
- Implementation of a Quality Systems and facilities infrastructure required for cGMP and/or cGTP manufacturing operations and product distribution
- Comparability considerations for introducing changes to the manufacturing process, the product and/or the manufacturing facility
- Considerations for the integration of development strategies with regulatory strategy to accelerate products into the clinic
Dr Robert Preti, President and Chief Scientific Officer, Progenitor Cell Therapy, USA
11.40-12.20 Advancing a Pipeline of Cellular Medicines
Presentation to cover:
- Key elements required in building a robust clinical pipeline
- Clinical trial design and conduct
- Regulatory compliance
- Manufacturing scale-up for cellular medicines
Dr Ed Field, President & COO, Aldagen, Inc., USA
12.20-1.50 Lunch
2.00-2.40 Regenerative Products for Alzheimer’s and Parkinson’s Disease
Scope: Case Study for Regenerative Products in CNS
Speaker TBC
2:40-3:20 AMR-001 - An Autologous Bone Marrow Derived Cell Therapy for Cardiovascular Disease
Presentation to cover:
- cGMP - Production of a cell therapy for cardiovascular disease
- Preclinical development of a cell therapy to prevent/reduce adverse ventricular remodeling following a myocardial infarction
- Preliminary phase I clinical trial results
Dr Andrew Pecora, Chairman, Amorcyte, USA
3.20-3.40 Coffee
3.40-4.20 Which Intellectual Property will Control your Regenerative Medicine Products?
Presentation to cover:
- Territorial effects of patent rights
- Which types of patents protect regenerative medicine products
- Licensing and cross-licensing to achieve freedom to operate
- The importance of your own IP
Mr George Schlich, Partner, Schlich & Co., Chartered Patent Agents, UK
4.20-5.00 Stem Cell Neurogenesis: First-in-Human Trials
Presentation to cover:
- Scientific rationale for stem cell neurogenesis
- Considerations for the design of clinical trials
- Stem cell neurogenesis as a potential treatment for Parkinson’s Disease and Amyotrophic Lateral Sclerosis (ALS)
Dr Markus Jerling, Chief Medical Officer, NeuroNova AB, Sweden
5.00-5:15 Chair’s Closing Remarks
5.20-7.30 Wine Reception
DAY TWO - September 12th, 2008
8.30-9.00 Registration and Morning Coffee
9.00-9.10 Chair’s Opening Remarks
Dr Robert Deans, Senior Vice President of Regenerative Medicine, Athersys Inc., USA
9.10-9.50 Development of Injectable Scaffolds for Regenerative Medicine Applications
Presentation to cover:
- Clinical applications and benefits of injectable synthetic materials
- Tailoring the formulation
- Prototype development
Dr Robin Quirk, Co-Founder and Chief Operating Officer, RegenTec Ltd, UK
9.50-10.30 Stem Cell Technology: From Resource to Platforms
Presentation to cover:
- Production of stem cell lines for consistent performance
- Characteristics of stem cell lines of utility for the pharmaceutical industry
- Automated derivation and expansion of human stem cell lines
Dr Tim Allsopp, Chief Scientific Officer, Stem Cell Sciences Ltd, UK
10.30-11.00 Coffee
11.00-11.40 Regeneration of Articular Cartilage in Osteoarthritis Patients with Mixed Cell Therapy
Presentation to cover:
- Mixed cell therapy
- Cartilage regeneration in osteoarthritis
- Preclinical and Phase I clinical analysis
Dr Kwan Hee Lee, CEO, TissueGene Inc., USA
11.40-12.20 Realizing the Potential for Cell-based Therapeutics: Considerations for Reaching the ‘Plateau of Productivity’
Presentation to cover:
- Realisation of potential for cell-based therapeutic products for the treatment of human disease
- What are the future challenges?
- Considerations to forwardly integrate for commercial success
- Case study
Dr Stewart Craig, Principal, Broken Lance Biotechnology Consulting, USA
12.20-1.50 Lunch
2.00-2.40 Keynote Address: Adult Stem Cell Therapy for Acute Cardiovascular Ischaemic Injury
Presentation to cover:
- Isolation and clinical expansion of adult adherent bone marrow stem cells
- Preclinical safety and efficacy models for stem cell treatment of ischaemic heart, brain injury
- Trophic repair pathways and mechanistic understanding of recovery benefit
- Clinical approval and regulatory standards for phase I safety trials
Dr Robert Deans, Senior Vice President of Regenerative Medicine, Athersys Inc., USA
2.40-3.20 Contract Research and Regenerative Medicine
Presentation to cover:
- The Fraunhofer Institute as outsourced R&D for industry and academia
- Challenges in stem cell based therapies: regulatory issues, allogeneic vs autologous cells, sourcing storage and application
- Process development in regenerative medicine in bench to clinic applications: GLP, GMP, GCP
- Cell therapy development in stroke: a case study
Dr. Sonya Faber, Business Development Manager, Fraunhofer Institute for Cell Therapy and Immunology, Germany
3.20-3.40 Coffee
3.40-4.20 Big Pharma Investment in Cell Therapies
Presentation to cover:
- The hurdles and challenges for big pharma in terms of investing in cell therapies
- J&J’s perspective on the field in comparison to traditional drug development
- Funding options available to develop cell therapies into commercial products
Dr Brian Meltzer, Senior Director, Venture Program Management, Johnson & Johnson Corporate Development, USA
4.20-5.00 Human Embryonic Stem Cells and the Path to Regenerative Medicine
Presentation to cover:
- Quality requirements for hES cells
- Scale up of hES cell production and differentiation
- Application of hES cells in screening
- Better cells and better drugs
Dr Raimund Strehl, Head of Development, Cellartis AB, Sweden
5.00-5.15 Chair’s Closing Remarks
5.20-6.00 Wine Reception