1st May 2007 Pre-congress briefing
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| Stem cells in drug discovery and development |
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| 08.00 | Registration and coffee
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| 08.50 | Chairman’s opening remarks Dr Paul Rounding, Managing Director, Business Development & Operations, Artemis Pharmaceuticals |
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| A stem cell landscape for drug discovery |
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| 09.00 | Keynote presentation: UK Stem Cell Initiative and current UK policy and regulations
- Public-private consortia developing medicines for patients using stem cell technology
- Pharmaceutical companies to explore the use of stem cells in drug development
Dr Mark Bale, Head of Genetics Branch, Scientific Development & Bioethics Division, Department of Health, UK |
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| 09.30 | Panel session: how stem cell technology is improving the drug discovery process
- How will the stem cells for pharmaceutical research sector develop?
- Examining the ongoing research strategy and potential requirements for big pharma
Moderator: Dr Paul Rounding, Managing Director, Business Development & Operations, Artemis Pharmaceuticals
Panellists: Dr Ruth McKernan, Vice President, and Head of Discovery Biology, Pfizer Global Research and Development Dr Jon Chesnut, Research and Development Manager, Invitrogen |
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| 10.10 | Defining industry compliant processes in the use of quality human stem cells
- Demonstration of automated procedures for the formatting of human stem cells
- Production of human stem cells for major applications maintaining high fidelity characteristics
Dr Tim Allsopp, Chief Scientific Officer, Stem Cell Sciences |
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| 10.40 | Morning coffee
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| Target identification and validation |
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| 11.00 | Exploiting neural progenitor cells; target discovery and validation
- Establishing a neural stem cell modulation strategy in a pharmaceutical
- Setting Identification of novel targets using such approaches
Dr Ignacio Munoz-Sanjuan, Senior Scientist, Amgen |
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| 11.30 | Pharmacological modulation of brain neurogenesis: application to neuroprotective compounds
- Hurdles in the pharmacology of brain neurogenesis; generating relevant cellular models
- Overcoming the elements responsible for the limited capabilities for myelin sheet repair
Dr Christophe Labie, Group Leader, CNS Department, sanofi-aventis |
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| 12.00 | Human pluripotent germ cell lines and their applications in drug discovery
- Human pluripotent germ cell lines that display all the usual characteristics of pluripotent stem cells
- Ability to form differentiated cell types of all three germ layers
Dr Helmuth van Es, Chief Scientific Officer, Stem Cell Innovations |
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| 12.30 | Panel session: modulation of endogenous neural progenitor cells
- Relevance of changes in resident adult progenitor / stem cell modulation to CNS indications
- Using stem / progenitor cells to better model disease paradigms – where are we?
Moderator: Dr Paul Rounding, Managing Director, Business Development & Operations, Artemis Pharmaceuticals
Panellists: Dr Ignacio Munoz-Sanjuan, Senior Scientist, Amgen Dr Christophe Labie, Group Leader, CNS Department, sanofi-aventis Dr Lilian Wikström, Head of Research, NeuroNova |
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| 13.00 | Networking lunch
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| 14.00 | Cancer stem cells - therapy yielding powerful new target discovery and development
- Normal and malignant cells in the haematopoietic stem cell lineage leads to novel drug targets
- Simultaneous identification of a novel target and a therapeutic antibody
Bruce Cohen, President and Chief Executive Officer, Cellerant Therapeutics |
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| Lead identification and optimisation |
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| 14.30 | 3D platforms for lead optimisation and harnessing target validation studies
- Advantages of 3D over 2D culture systems and methods for 3D culture and development
- Applications of 3D systems to CNS drug safety and efficacy studies
Professor Lars E Sundstrom, Chief Scientific Officer, Capsant Neurotechnologies |
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| High through-put drug screening |
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| 15.00 | High throughput in vivo screening using model organisms
- Small molecules that affect neuronal, gut and blood stem cell numbers and asymmetric division
- Generating start points for small molecule drug development in multiple areas
Dr Jon Tinsley, Head of Biology, VASTox |
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| 15.30 | Afternoon tea
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| Drug safety applications |
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| 16.00 | A novel high-throughput method for stem cell differentiation
- Efficient stem cell differentiation conventionally achieved by trial-and-error experimentation
- CombiCult™ as a high throughput method that multiplexes thousands of cell culture experiments
Dr Yen Choo, Founder and Chief Executive Officer, Plasticell |
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| 16.30 | A novel approach to hESC application for predictive toxicology
- Toxicity testing: traditional approaches versus predictive toxicology
- Potential applications and benefits of predictive toxicology
Professor Ian Cotgreave, Director of Molecular Toxicology, Safety Assessment, AstraZeneca |
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| 17.00 | Discovery of candidate biomarkers of toxic response in human embryonic stem cells
- Developmental toxicity in humans leading to serious consequences after chemical exposure
- Developmental toxicity testing conducted on animal models as a means to predict adverse effects
Dr Gabriela Gebrin Cezar, Assistant Professor, Department of Animal Science, University of Wisconsin-Madison |
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| 17.30 | Close of pre-congress briefing followed by welcome drinks reception
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Day one Wednesday 2nd May 2007
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| 08.00 | Registration and coffee
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| 08.50 | Chairman’s opening remarks
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| | Mary Archer, Chair,and Chairman Cambridge University Hospitals NHS Foundation Trust, East of England Stem Cell Network
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| Laying the foundation of stem cell funding |
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| 09.00 | Opening presentation: funding translational stem cell research
- The current funding climate and the importance of translational stem cell research
- Encouraging new approaches to funding
David Macauley, Chief Executive, UK Stem Cell Foundation |
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| 09.30 | Keynote panel session: new paradigms for funding and supervising investment of stem cell research
- Forging better links between basic, translational and applied research
- Stem cell research funding most effectively used to provide the appropriate infrastructure
Moderator:
Dr Mary Archer, Chair, East of England Stem Cell Network and Chairman, Cambridge University Hospitals NHS Foundation Trust
Panellists: Dr Octavi Quintana Trias, Director “Health”, Research DG, European Commission Dr Frances Rawle, Programme Manager, Molecular and Cellular Medicine Board, Medical Research Council Dr Colin Miles, Head, Molecular & Cell Biology Branch, Science & Technology Group, BBSRC Dr Mark Walport, Director, The Wellcome Trust |
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| 10.15 | Morning coffee
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| Translational stem cell science – a roadmap to the clinic |
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| 10.45 | Tailoring human ES cells (hESC) for biomedical applications
Professor Oliver Brüstle, Director, Institute of Reconstructive Neurobiology, University of Bonn and Scientific Director, LIFE & BRAIN
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| 11.05 | Stem cells of stratified epithelia
- Stratified epithelia containing adult stem cells that are instrumental for renewal, regeneration and repair
- The renewal of stratified epithelia: a functional analysis
Professor Yann Barrandon, Joint Chair of Stem Cell Dynamics, Centre Hospitalier Universitaire Vaudois (CHUV) and Ecole Polytechnique Fédérale de Lausanne (EPFL |
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| 11.25 | Preclinical studies and translational medicine; preparing for IND human trials of cellular therapies
- FDA views of cellular therapeutics as ‘drugs’ and approaching clinical trials using preclinical data
- Successful animal model and toxicology examples for FIH studies and early planning for studies governed by GLP
Dr Lauren E Black, Senior Scientific Advisor, Navigators, Preclinical Services, Charles River Laboratories |
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| 11.55 | Suitable pre-clinical animal models for stem cell therapies
- Mouse to mouse and human to mouse cell transplantation models
- Stem cell differentiation in autologous and allogeneic transplantations
Dr Jan Matthias Braun, Coordinator, Regenerative Medicine Network, Leipzig-Halle Max Buerger Research Centre, University of Leipzig |
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| 12.15 | Speed networking
- Meet…move on… meet…move on…meet!
- Exchange over 100 business cards with fellow congress delegates, speakers and moderators
- The best networking session you’ve ever experienced!
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| 13.00 | Networking lunch
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| Stem cell commercialisation - turning science into business |
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| 14.00 | Chairman’s opening remarks
Dr Paul Rodgers, Founder and Managing Director, Ithaka LifeSciences |
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| 14.10 | New age business models; high stake issues when building a stem cell business
Hugh Ilyine, Vice President and Chief Operating Officer, Stem Cell Sciences
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| 14.40 | Case study: partnering for commercial success; Olympus-Cytori
Christopher J Calhoun, Chief Executive Officer, Cytori Therapeutics |
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| 15.10 | Panel session: commercialisation and investment opportunities
- Outlining the resurgence of interest in and fund for early-stage companies
- What do young stem cell biotech companies need to have in place to maximise valuation?
Moderator: Dr Paul Rodgers, Founder and Managing Director, Ithaka LifeSciences
Panellists: Greg A Bonfiglio, Managing Director, Partner, Proteus Venture Partners Linda Powers, Managing Director and Co-Founder, Toucan Capital Dr Werner Wolf, Venture Partner, TVM Capital Michael D Goldberg, General Partner, Mohr, Davidow Ventures |
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| 15.55 | Afternoon tea
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| 16.25 | Case study: building a sustainable UK stem cell therapy business
Matching the science and the business model; generating a viable stem cell-derived product The challenges of funding and corporate communications: a UK perspective
Michael Hunt, Chief Executive Officer, ReNeuron |
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| 16.55 | Panel session: negotiating the regulatory and IP landscape
· Working with regulation that currently applies during product development and market approval
· Regulatory and intellectual property landscape affecting research and commercialisation
Moderator:
Dr Paul Rodgers, Founder and Managing Director, Ithaka LifeSciences
Panellists:
Ivor Elrifi, Co-chair of the Intellectual Property Section, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo
Julian Crump, Member, Intellectual Property Section and Head, Chemistry and Life Sciences Group, London, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo
Julian Hitchcock, Senior Solicitor, Mills & Reeves
James Lawford Davies, Solicitor, Bevan-Brittan
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| 17.40 | Close of day one followed by networking drinks reception
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Day two Thursday 3rd May 2007
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| 08.00 | Registration and morning coffee
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| 08.50 | Chairman’s opening remarks Dr Chris Mason, Director, Regenerative Medicine Bioprocessing Unit, University College London |
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| Developing the therapeutic landscape |
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| 09.00 | Keynote presentation: moving from bench to bedside
- Challenges faced by academia to take stem cell populations into the clinic
- Strategies for making therapeutically relevant cell populations
Dr Stephen L Minger, Director, Stem Cell Biology Laboratory, Wolfson Centre for Age-RelatedDiseases, King’s College London |
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| 09.30 | Human embryonic stem cell therapies; progress towards the clinic
- In vitro and in vivo proof of concept for hESC-derived cells; glial, cardiomyocyte and islet
- Scope of IND-enabling data for spinal cord injury clinical trials
Dr Thomas B Okarma, President and Chief Executive Officer, Geron |
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| 10.00 | Strategies for the accelerated development of therapeutics from hES cells
- Continued efforts to develop technologies in the emerging area of regenerative medicine
- Generating embryonic stem cells that maintains the developmental potential of an embryo
Dr Michael West, President and Chief Scientific Officer, Advanced Cell Technology |
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| 10.30 | Morning coffee
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| 11.00 | Developing a stem cell therapy for stroke disability
- c-mycERTAM technology for stem cell scale-up and clinical development
- ReN001 for stroke; taking a novel stem cell line through the regulatory process
Dr John Sinden, Chief Scientific Officer, ReNeuron |
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| 11.30 | Case study: commercialising cell therapy for wound care and aesthetic medicine
- Regulatory landscape and challenges of maintaining supply chain logistics
- Manufacturing considerations in moving from clinic to market
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| | Paul Kemp, Chief Scientific Officer and FOunder, Intercytex
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| Negotiating the obstacles to clinical trial |
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| 12.00 | Case study: potentiating the therapeutic effect of stem cell product
- In vitro & in vivo proof-of-concept demonstrating superior potency and therapeutic effect with engineered stem cells and update on ongoing human clinical trial
- Manufacture of engineered stem cell products utilizing robust, scalable, closed system, cGMP compliant technology platform in compliance with regulatory Master File submission
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| 12.30 | A retrospective look at challenges commercialising living cell-based products
- Mass production; balancing quality, reliability and cost efficiency to make a scalable process
- Health policy, marketing and sales and corporate learning’s
Dr Geoff MacKay, President and Chief Executive Officer, Organogenesis |
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| 13.00 | Networking lunch
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| Assessing therapeutic potential for regenerative medicine |
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| 14.00 | Panel session: utilising knowledge and experience in negotiating the obstacles to clinical trial
- Identifying the unique challenges to progress towards stem cell therapies and clinical trials
- Important biological insights emerging from clinical studies
Moderator: Dr Chris Mason, Director, Regenerative Medicine Bioprocessing Unit, University College London
Panellists: Michael Siani-Rose, President and Founder, Theregen Corporation Dr Geoff MacKay, President and Chief Executive Officer, Organogenesis Dr Michael West, Chief Executive Officer, Advanced Cell Technology |
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| 14.30 | Case study: treatments for currently incurable neurodegenerative diseases
Professor Eldad Melamed, Chief Medical Advisor, Brainstorm Cell Therapeutics
Dr Holly Atkinson, Director of Business Development, Brainstorm Cell Therapeutics |
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| 15.00 | Case study: diabetes – from bench to bedside
- Current limitations of a lack of supply of islet cells and a means to deliver these cells
- Proprietary encapsulation technology offering transformational cell replacement products
Dr Alan Lewis, President and Chief Executive Officer, Novocell |
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| 15.30 | Afternoon tea
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| 16.00 | Case study: autologous stem cells as regenerative medicine
Dr Elmar Burchardt, Vice President, Medical Affairs, Aastrom Biosciences |
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| Core development and manufacturing expertise |
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| 16.30 | Case study: presenting positive stem cell trial results with VesCell
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| 17.00 | cGMP of cell-based therapeutics for clinical trials and commercialisation
- Challenges of converting a laboratory cell culture procedure to production
- Key regulatory and cGMP considerations
Dr Alan K Smith, President and Chief Operating Officer, Cognate BioServices |
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| 17.30 | Chairman’s closing remarks and close of congress |
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