Translational Regenerative Medicine
Scaling-up from lab to clinic
To be held on 30th - 31st March 2010, BSG House, London, UK

Background Info
Key Speakers
• Stephen Minger, Senior Lecturer in Stem Cell Biology, King’s College London
• Jan Lundberg, Executive Vice President - Discovery Research, AstraZeneca
• John Connolly, Head of Cell & Gene Therapies, Department of Health
• Alan Lamont, Director of Science and Technology Alliances, AstraZeneca
• Robert Pinnock Director, Scientific & Academic Liaison United Kingdom and Ireland, Merck Sharp & Dohme
• Paulo Fontoura, Translational Medicine Leader, F. Hoffmann-La Roche
• James Lawford Davies, Senior Partner, Clifford Chance
• Alexander Denoon, Senior Associate, Clifford Chance
• Jane Lebkowski, Chief Scientific Officer Regenerative medicine, Geron
• Rosemary Drake, Chief Scientific Officer, The Automation Partnership
• Lars Wahlberg, Executive Vice President & Chief Operating Officer, NsGene
• Anthony Hollander, Chief Scientific Officer, Azellon
• Robert Lechler, Vice Principal (Health), King’s College London
• Anthony Mathur, Senior Lecturer and Consultant Cardiologist, Barts and the London
• Robert Gaspar, Professor of Paediatrics and Immunology, Great Ormond Street Hospital
Set to more than quadruple from $48 to $208bn over the next 15 years, the global regenerative medicine market is set for stellar growth as therapies begin entering the clinic.

Regenerative medicine is set to revolutionize healthcare as stem cell, tissue engineering, gene therapy and materials science come together to transform patient treatment. Bringing you the latest in translational applications from leading experts, don’t miss this exceptional showcase of medical innovations in this fast-moving field.

By attending this conference you will gain the latest insights into:

• The economic future of the global regenerative medicine market and acquiring venture capital
• The use of stem cell therapies in type 1 diabetes
• Small molecule drugs to stimulate neurogenesis and neuroprotection in Parkinson’s disease
• The use of direct stem cell therapies in cardiovascular diseases
• The use of direct stem cell therapies in wound healing
• The use of direct stem cell therapies in bone remodelling
• Gene therapy for retinal degeneration
• Scaling-up in the lab
• Scaling up in manufacturing
• Clinical trials for novel therapies
• How to commercialise your product
• Overcoming patent, legal and regulatory hurdles

Who will be there?

Presidents, Chief Executive Officers, VPs, Chief Scientific Officers, Directors, Business Development Managers, and Principal Scientists of:

• Adult Stem Cell Research
• Embryonic Stem Cell Research
• Tissue Engineering
• Translational Medicine
• Gene Therapy
• Bioengineering and Bioprocessing
• Biotechnology
• Cell Therapy
• Biomaterials
• Neuroscience
• Diabetes
• Cardiovascular Medicine
• Pharmacology
• Pharmacogenomics
• Proteomics
• Personalised Medicine
• Business Development
• Strategic Alliances
• New Product Development
• Pharmacovigilance
• Process Development
• Manufacturing
• Clinical Trials
• Licensing and External Research

Day 1
Day One, Tuesday 30th March 2010
09:00 Registration and refreshments

09:30 Opening address from the co-chairs

Stephen Minger
Senior Lecturer in Stem Cell Biology
King’s College London

Ruth McKernan
Chief Scientific Officer
Pfizer Regenerative Medicine*

09:40 Prospects for the global regenerative medicine market

• Dynamics of the regenerative medicine market
• Why academic collaborations are increasingly important
• What does industry want?

Alain Vertes
Global Alliance Director
Roche*

10:20 Mapping regulations for regenerative medicine in the UK

• Regulations for regenerative medicine
• The regulatory landscape in the UK
• How to make a regulatory route map

John Connolly
Head of Cell & Gene Therapies
Department of Health

11:00 Morning refreshments

11:20 Bioprocessing of regenerative medicines

• Routes to faster production methods
• Standardisation
• Ensuring cGMP

12:00 Scaling-up in the lab with hESCs

• Purifying and maintaining stem cells under cGMP conditions
• Evidence for reliable production and quality control of product manufacturing
• Rigorous safety testing in preclinical models

Jane Lebkowski
Chief Scientific Officer
Geron

12:40 Networking lunch

14:00 Automation- the route to successful scale-up and manufacture for cell-based therapies?

• Different manufacturing approaches using standard cell culture vessels
• Developing cost-effective methods for scaling up in manufacture
• Automating production of cells and tissues for clinical trials

Rosemary Drake
Chief Scientific Officer
The Automation Partnership

14:40 The immune response to stem cell-derived tissues

• Direct and indirect pathways of MHC allorecognition
• Distinction between antigenicity and immunogenicity
• Possible approaches to promote immune tolerance to allogeneic tissues

Robert Lechler
Vice Principal
King’s College London

15:20 Afternoon refreshments

15:40 Regenerative medicine clinical trials- challenges associated with translation into man

• Preliminary box-ticking
• Clinical trial registration
• When things go wrong: ensuring the cash keeps flowing

Anthony Mathur
Consultant Cardiologist
Barts and the London Hospital

16:20 Successful bone marrow gene therapy for SCID

Robert Gaspar
Professor of Paediatrics and Immunology
Great Ormond Street Hospital

17:00 Round table discussions. Choose from:

Is there such a thing as personalised medicine in cell therapy?

Panellists: Stephen Minger, Senior Lecturer in Stem Cell Biology, King’s College London
Rosemary Drake, Chief Scientific Officer, The Automation Partnership
Julie Daniels, Director, Cells for Sight Tissue Bank , Moorfields Eye Hospital
David Newble, Chief Executive Officer, The Automation Partnership*

OR

Engaging with the global regenerative medicine market

Topics will include: obtaining venture capital, engaging with partners in industry & acadaemia, and investment opportunities in the post credit crunch era. Commercialising your product, and keeping abreast of regulatory requirements will also be discussed. If you would like to submit a question to the panel, please email: raju@bharatbook.com.

Panellists: Brian Meltzer, Senior Director, Venture Program Management, Johnson & Johnson Corporate Development*
Robert Pinnock, Director, Scientific & Academic Liaison, Merck Sharp & Dohme
Alan Lamont, Director of Science and Technology Alliances, AstraZeneca
Jan Lundberg, Executive Vice President, Discovery Research, AstraZeneca
Iphigenie Charatsi, Business Manager, UK Stem Cell Bank*

17:40 Closing remarks from the chair

17:50 Networking drinks

Day 2
Day Two, Wednesday 31st March 2010
09:00 Registration and refreshments

09:30 Opening address from the Chair

Paulo Fontoura
Translational Medicine Leader, Neuroscience
F. Hoffmann-La Roche

09:40 Negotiating IP and regulatory hurdles
• Legal issues for clinical development
• Applying for patent protection
• UK, US and European regulatory perspectives

James Lawford Davies
Senior Partner
Clifford Chance

Alexander Denoon
Senior Associate
Clifford Chance

10:20 Heart muscle regenerative therapy
• Manufacturing technology
• Preclinical studies with myocytes
• Clinical development

Michael Siani-Rose
President & Founder
Theregen*

11:00 Morning refreshments

11:20 Vascular regenerative medicine
• Seeding patient stem cells
• Constructing blood vessels
• Results from clinical trials

Keith Murphy
Chief Executive Officer
Organovo*

12:00 Claudia's trachea: lessons learned for future tissue engineering strategies

Anthony Hollander
ARC Professor of Rheumatology & Tissue Engineering
University of Bristol*

12:40 Networking lunch

14:00 Case study: creating skin for wound healing

• Apligraf: a living, cell-based therapy
• Kick-starting the natural healing process
• Applications to diabetic and venous leg ulcers

Geoff MacKay
Chief Executive Officer
Organogenesis*

14:40 Reversing blindness with cellular and gene therapies
• Overview of Leber’s congenital amaurosis and wet AMD
• Developing viral vectors and cell lines
• Follow-up studies

Julie Daniels
Director, Cells for Sight Tissue Bank
Moorfields Eye Hospital

Robin Ali
Professor of Human Molecular Genetics,
Institute of Ophthalmology, University College London*

15:20 Encapsulated cell therapy for neurological disease

Lars Wahlberg
Executive Vice President & Chief Operating Officer
NsGene

16:00 Afternoon refreshments

16:20 Exploring neurogenesis mechanisms for novel CNS therapeutics
• Opportunities for neurogenesis therapy in CNS diseases
• Regulation of proliferation & differentiation of neural stem cells
• Autocrine versus paracrine regulation of neural stem cells

Aaron Chuang
Scientific Manager, Stem Cell Research
GlaxoSmithKline*

17:00 Neurogenesis and neuroprotection in Parkinson’s disease and amyotrophic lateral sclerosis

• The impact of altered stem/progenitor cell activity in neurodegenerative disease
• sNN0031/PDGFBB - in the clinic to promote neurogenesis and dopamine system restoration
• sNN0029/VEGF165 - towards the clinic to protect motor neurons
• Direct application of protein drugs to the CNS- pros and cons

17:40 Chair’s closing remarks

17:50 End of conference

Related Reports:

World Outlook for Regenerative Medicine
Report on Regenerative Medicine World Market Segmentation by City
Outlook for Regenerative Medicine in Japan
Report on 2009 2014 Outlook for Regenerative Medicine in Greater China