REMEDiE Kick-off meeting

May 22 2008Kings Manor

University of York

Regenerative Medicine in Europe: emerging needs and challenges in a global context

Objectives of the meeting

To discuss:

• establishing a common vision of the project amongst all partners

• developing working partnerships

• clarifying the objectives of each work package

• discussing the work of the first few months of the project

• clarifying expectation of the Commission from partners regarding deliverables, reporting, recording work, etc

Principal goals of REMEDiE• A detailed examination of the political economy of

globalised regenerative medicine, applying this to highly significant policy and public issues within Europe

• An integrated series of projects organised around three inter-related streams of research

• An integrated quantitative relational database on the geo-economic pattern of activity within the field of regenerative medicine derived from a) ongoing review of secondary data sources and b) primary data derived from partner projects

• The use of new techniques to interrogate data using macro-econometric modelling and geometric mapping of data items secured by different projects in the three areas

Overview of the Workpackages and their relationship is described as follows:

REMEDiEWP. 8 Coordination of analysis/ WP 10 Management of the Consortium

WP1:global market: investment

WP2: global market trading

WP3: global politics: transnational science

WP4: global politics: states, strategies

WP5: global bioethics:culture, bioethics and cultural conflict

WP6: global bioethics:IP and cultural difference

WP 9: Policy engagement and Communication of results

WP 7: Regenerative medicine database

WP7 will seek to secure comprehensive data on the range of areas encompassed by the definition of RM noted on p.4; other substantive WPs will focus on some, not all of these areas, reflecting the different empirical domains that they cover and the principal developments in each: for example, in WP3, the focus is primarily on regulation with respect to tissue banks and stem cells, whereas WP2 focuses on the place of oocytes in the RM universe. WP7 provides the broader reference source for the more specific WPs, and provides them with spatial analyses of some of their core data.

Political economy of regen med

Global markets, politics and bioethics (governance) depends on the meaning of the ‘bio-object’ being mobilised in the RM universe.

Bio-objects: coping with indeterminacy

• Interspecies embryos/human admixed embryos (animal human hybrid)

• Tissue-engineered products• Stem cell lines• Artificial gametes/synthetic biology• Transgenics/clones• Embryonic-like IPS• Genomic databasesThis true elsewhere: eg ‘nanosilver particles: US EPA unsure whether to define as ‘device’ or a ‘pesticide’

Regulation of Healthcare Products in the EURegulation of Healthcare Products in the EU

Dir2001/83/EC

Reg (EC)726/2004

Tissue Tissue EngineeringEngineering

CellCellTherapyTherapy

GeneGeneTherapyTherapy

MedicalDevices

Biotech(e.g. insulin)

ChemicalMedicines

(e.g. aspirin)

RegReg (EC) (EC) 1394/20071394/2007

ScienceScience

Dir93/42/EEC

DirDir2003/63/EC2003/63/EC

EU LegislationEU Legislation

Advanced Therapy Medicinal ProductsAdvanced Therapy Medicinal Products

From indeterminacy to Zones of determinacy?

Some key issues to inform our discussion of work ahead: boundaries and data collection

Summary of WPs and their substantive focus within the RM field

WP5Chimeras

WP1Cord blood

WP6WP5EmbryosWP6WP4WP3WP1Stem cells

WP6WP2Oöcytes

WP1Gene therapy

WP4WP1Tissue engineering

WP4WP3WP1Tissue /biobanks

WorkpackageRM field area

IPS

CoordinatorOverall coordination

• Progress monitoring of thetechnical activities of the project according to the pre-defined time-table

• Managing the resources

• Managing the grant agreement with the EC

• Managing the consortiumagreement with all participants

• Coordinating the organisationof meetings

Overall financial monitoring

• Distributing the funds to participants in line with contractand consortium agreement

• Gathering, monitoring andintegrating financial andadministrative data from partners

• Preparing annual and finalreports to the EC

• Communication

• Communication with theEuropean Commission on behalfof the consortium

Steering Group Members• Andrew Webster (Co-ordinator)• Itziar Alkorta (WP5)• Kathrin Braun (WP2)• Herbert Gottweis (WP3)• Judit Sandor (WP6)• Brian Salter (WP4)

IAG Members:• Donna Dickenson• Linda Hogle• Cathy Waldby

IAG• Professor Donna Dickenson, Centre for Ethics in Medicine,

University of Bristol• Professor Simone Bateman, CNRS-Université Paris Descartes• Dr Andreas Reis Department of Ethics, Equity, Trade and Human

Rights, World Health Organization• Professor Ka Lin Professor of Sociology and Economics, Nanjing

University• Professor Linda Hogle Director of the Holtz Center for Science and

Technology, University of Wisconsin• Professor Catherine Waldby Department of Sociology, University

of Sydney• Professor Francoise Baylis, Medicine and Philosophy, Dalhousie

University, Canada• Dr Helge Rynning, Senior adviser, Economic Policy, The Research

Council of Norway• Dr GiuseppeTesta, European Institute of Oncology, Milan• Professor Josef Kure, Head of Department of Medical Ethics,

Masaryk University , Brno, Czech Republic

Month 6 (October 08)UoYFirst 6 monthly policy brief to EC

OngoingAll partnersInitial research activity on WPs

Month 4UoY – with input from all partners

Establish structure of relational database

May 31UoYReport on meeting to all members of steering and international advisory group

May 22 at YorkAll partnersKick off meetingMay 10 2008UoYPapers for kick-off meeting

Month 4 (end July 2008)All partnersDisseminate news of project to:National policy, commercial and patient groups

Month 4 (end July 2008)UoY – with input from all other partners

New web site

Target datePartner(s) reponsibleTask

REMEDiE: Tasks for first six months (up to October 2008)

The REMEDiE Consortium