International Policy Discussion on Stem Cells January 2003 THE UK STEM CELL INITIATIVE Professor Sir George Radda Professor Sir George Radda Chief Executive

International Policy Discussion on Stem Cells January 2003

THE UK STEM CELL INITIATIVETHE UK STEM CELL INITIATIVE

Professor Sir George RaddaProfessor Sir George Radda Chief Executive MRCChief Executive MRC

Pioneering research by Martin Evans (1981)Pioneering research by Martin Evans (1981) Cord blood banking of haemopoietic stem Cord blood banking of haemopoietic stem

cells by the UK NBS (from 1996) cells by the UK NBS (from 1996) Development of “Dolly” at Roslin (1997)Development of “Dolly” at Roslin (1997) UK legislation (HFE Act 1990;2001) UK legislation (HFE Act 1990;2001) Public consultation by HFEA/HGAC (1998)Public consultation by HFEA/HGAC (1998) CMO’s Report (2000) and HoL Review (2002)CMO’s Report (2000) and HoL Review (2002) Window of opportunityWindow of opportunity


UK NICHEUK NICHE

International

ResearchCouncils

MRC BBSRC ESRC

Government

STEM CELLS

Donors

DRIVERS

• Serious diseases

• UK legislation

• Scientific advances

• Opportunity

Consumers Patients

Government

Regulatory

AgenciesHFEA MCA MDA DH

Industry

STAKEHOLDERSSTAKEHOLDERS

Charities

PDS WTAS BHFDUK JDRFCRUK


CO-ORDINATIONCO-ORDINATION

PARTNERSHIPSPARTNERSHIPS

COLLABORATIONCOLLABORATION

COMMUNICATIONCOMMUNICATION


CO-ORDINATION - information & activitiesCO-ORDINATION - information & activities

UK Funders UK Funders Co-ordinating Co-ordinating Committee for Committee for Stem Cell Stem Cell ResearchResearch

portfolio sharingportfolio sharing

meetings

funding opportunities

communications coalition

Research Councils, Charities, HFEA, DH, MCA


CO-ORDINATION - guidance documentsCO-ORDINATION - guidance documents

Committee Committee charged with charged with developing developing Ethical, Ethical, Legal and Legal and Regulatory Regulatory PrinciplesPrinciples

standard donor information

standard consent forms

banking route maps

MRC, HFEA, DH, MCA


CO-ORDINATION - stem cell bankCO-ORDINATION - stem cell bank

Research Councils, Charities, HFEA, DH, MCA, experts including: social science, ethics, religion, law, genetics, banking, consumers

UK Stem UK Stem Cell Bank Cell Bank Advisory Advisory CommitteeCommittee

targeted call

commend bid for funding

peer review/interviews

options appraisal


PARTNERSHIPS - joint funding opportunitiesPARTNERSHIPS - joint funding opportunities

Stem Cell Conference(MRC, BBSRC, ESRC)

Stem Cell Fellowships(Alz Soc, BBSRC, Diab UK, JDRF, MRC, PDS)

UK Stem Cell Bank(MRC, BBSRC)


Stem Cell Centres(BBSRC, JDRF)

High Level Steering Committee • develop codes of practice for bank and cell line use• review applications to use embryonic cell lines• report to MRC Council and brief Ministers on request

Local Management Committee

• report to Steering Committee

User & Clinical Liaison Committees• highlight issues to Steering Cmtee


PARTNERSHIPS: stem cell bank governancePARTNERSHIPS: stem cell bank governance

PARTNERSHIPS - stem cell bank principlesPARTNERSHIPS - stem cell bank principles Supply ethically sourced, quality controlled adult, fetal, ES cell linesSupply ethically sourced, quality controlled adult, fetal, ES cell lines

Provide separate non-GMP and GMP facilitiesProvide separate non-GMP and GMP facilities

Accessible to academia and industry in the UK and overseasAccessible to academia and industry in the UK and overseas

Conditional that ES cell line samples must be bankedConditional that ES cell line samples must be banked

Lines may not be passed to third parties other than via the bankLines may not be passed to third parties other than via the bank

IPR must be negotiated before accessing the bank IPR must be negotiated before accessing the bank

Overseas users must show equivalent licenses and accreditationsOverseas users must show equivalent licenses and accreditations

Negotiations conducted with heads of overseas institutesNegotiations conducted with heads of overseas institutes

Dip stick compliance testing by fundersDip stick compliance testing by funders


COLLABORATION - 2002 COLLABORATION - 2002 spending reviewspending review Strengthen existing centres/establish new onesStrengthen existing centres/establish new ones

Multidisciplinary programme of researchMultidisciplinary programme of research

Provision of national facilitiesProvision of national facilities Attract expertise from other disciplines Attract expertise from other disciplines

Training/career development opportunitiesTraining/career development opportunities

Foster international and commercial Foster international and commercial developmentsdevelopments


develop consortia with research teams

practical course on working with cell lines

review and pilot donor info and consent forms


IVF IVF ClinicsClinics


IndustryIndustry

model IPR forms

develop and market human therapies

provision of scale up

collaborate with the best scientists



ResearchResearchLeadersLeaders

proactive co-ordination

Disease-targeted plusinvestigator-led research

mouse/human systems key

basic/clinical mix from outset



UK niche: ES cellsUK strength: adult/fetal cells

Public Public interest and interest and transparencytransparency

media

opinion formers

consultation

plain language

COMMUNICATIONCOMMUNICATION


consumers



Sharing stem cell linesSharing stem cell lines Banking stem cell linesBanking stem cell lines ExpertiseExpertise Training and career developmentTraining and career development IPRIPR International collaborationsInternational collaborations

DISCUSSION TOPICSDISCUSSION TOPICS


Portfolio sharing and gap analysis Portfolio sharing and gap analysis Co-ordinated research strategiesCo-ordinated research strategies Shared reagents, technologies, dataShared reagents, technologies, data Co-ordinated banking strategiesCo-ordinated banking strategies Networked research teamsNetworked research teams Joint funding opportunitiesJoint funding opportunities Linked web portals Linked web portals

INTERNATIONAL COLLABORATIONSINTERNATIONAL COLLABORATIONS


Documents

International Policy Discussion on Stem Cells January 2003 THE UK STEM CELL INITIATIVE Professor Sir George Radda Professor Sir George Radda Chief Executive