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EuroBioForum 2013 2nd Annual Conference 27-28 May 2013 - Hilton Munich City, Munich, Germany http://www.eurobioforum.eu/2013 ======================================= # NATIONAL PERSPECTIVES # Scotland: 2b or not 2b – delivering Smart Clinical Trails Graeme Boyle Interim Director Stratified Medicine Scotland & Senior Programme Manager at Health Science Scotland ======================================= http://www.eurobioforum.eu
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2B or not 2B
The case for Smart Clinical Trials
Graeme Boyle, Stratified Medicine Scotland
EuroBioForum, Munich, May 27, 2013
Lost in Translation?
Basic research
Prototype discovery
PreclinDev.
Early trials
Late trials HTA, HRS
Use in NHS
TMRC
Health Science Scotland
1st gap in translation 2nd gap in translation
HTA: health technology assessment HSR: health services research Adapted from Cooksey report Chart 7.1, page 105
SMC/SHTG/MHRA SULSA/SINAPSE
NRS/PCC
Scotland - World Class
Therapeutic Areas – e.g.
• CV – Metabolic
• Oncology
• Inflammatory/Immune
• Stem Cell/Regenerative Medicine
Infrastructure – e.g.
• NRS/CRF
• BioBanks
• Health Informatics
• Stratified Medicine
Issue 1 – Collaborative Research
Adapted from Tufts Center Report
Stratified Medicine Scotland - Innovation Centre
“The right treatment, to the right patient,
at the right cost………”
Stratified Medicine = better outcomes
It will allow us to offer
• The right drug
• To the right patient
• For the right disease
• At the right time
• With the right dose
• Targeted treatment based on genetic profile
• Develop diagnostic markers for disease
• Reduce the costs of clinical trials through better cohort selection
Reduction in drug toxicity
Faster and cheaper to bring drugs to market
Targeted drug design
Earlier illness detection & prevention
Determine disease variants
Scotland’s USP
Genetics
Provider Informatics
Exemplar Programme 2: Heart disease & diabetes
Exemplar Programme 3: RhA & respiratory
Exemplar Programme 1: Oncology
Company
A
Tissue/Bio-repositories/Datasets
Biomedical Informatics/e Health
Imaging
Genomic/”omic’ medicine
Innovation Centre Business Platform
The Model
Company
B
Co mpany C
Stratify patients
Patient sample sent to CRO for genotyping
Drug Trials Get Smarter
Mutation A Enrolled
Rejected (Treatment Delayed)
Clinical Trial agent targets mutation A
NGS Panel
Trial B
Trial A
Trial D
Trial C
Mutation B Mutation A Mutation D Mutation C
No Mutation
Enrollment through centralized testing (old)
Enrollment through care-embedded testing (future)
Patients with disease
OLD
NEW
Modified from
Long Term Vision
To transform management of chronic disease globally by accelerating biomedical research, high quality health care
provision and economic growth.
12 GE Title or job number
7/13/2011
Key Segment: Molecular Diagnostics
Precise therapy
requires precise
diagnostics
The way we look at disease is changing Assembling the necessary technologies
to lead
Responders
Patient populations
Mammography Molecular Biopsy Tools
Tumor
+
IHC Stain
Gene sequencing Molecular pathology
Imaging Molecular Diagnostics
Alzheimer’s Disease Age matched control
[18F]AH110690 PET Imaging
90 –120 min summation
Alzheimer’s Disease Age matched control
[18F]AH110690 PET Imaging
90 –120 min summation
Operations &
commercialization
Molecular imaging
agents & equipment
Technology &
content
Enabling
workflow
in vivo
diagnostics
GRC
Molecular
Pathology
Digital
Pathology
Clarient
Molecular profiling segment for cancer expected to
grow from $15B in 2010 to $47B in 2015
... to be a leader in the next diagnostic
frontier
Toxic
impact
No
impact
A
B A
B
Genomic profile of tumour Actionable mutations
KRAS
(G12D)
p16/CDKN2A
(loss)
TP53
(V274F )
Modified from
Issue 2 – Creating Economic Value
SME
New and existing
Research Partner
End User of IP arising
New Entrants Supply Chain
Partner
Technology Solution Provider
Characteristics of Scotland
• Population 5M
• Rural and inner city
• Stable population
• Collaboration – Aberdeen, Edinburgh, Dundee, Glasgow, St Andrews
• Single coherent health care provider
• Unique patient identifier
Collecting data from cradle to grave …
Maternity
BIRTH
DEATH
Neonatal Record SMR11
Child health surveillance
Immunisation
GP consultations
Dental SMR13
Out patients SMR00 Hospital Admissions SMR01
Mental Health SMR04
Prescribing Screening
Community care SMR50
Cancer registrations SMR06
Cancer registry
NRS W
NRS NE
NRS SE
NRS E
Biorepository Network
Strategic national collections • Rheumatoid arthritis • Renal cancer • Type 1 diabetes • Generation Scotland/ SHHS
National/ local planned collections • Generic consent • Strategy driven • Future focus
Bespoke collections • Specific consent • Project based • Investigator ‘owned’
Infrastructure development • Inventory management system • Patient record linkage • Enhanced storage capacity • Facilitated rapid access
Pathology archive
Issue 2: European Biorepository Network
Imaging phenotype (PACS)
laboratory phenotype (SCI store)
Storage Area Network
Mortality (GROS)
Hospital episodes (SMR: ISD)
Identification (CHI)
Prescribing
NHS Data stores
Primary Care? Dumb terminals
SAFE HAVEN
Secure storage power protection camera surveillance
NHS staff
Integrated datasets
Accredited access
Health Informatics Centres
Issue 3: Connecting Health Informatics
Issue 4 – Information Commons
The Opportunity – Window
Actively Working but 1-2 years off Matured capability
Potential but no plans to develop Unlikely to provide access due to policy or technical Unknown
Readiness to implement electronic Health Records – Stratified Medicine
GSK recognises Scotland’s current leadership in electronic Public Health Records … this IC will provide the opportunity to secure that position
through its application to Clinical Trials to stratify patient groups..
Patrick Vallance, President Pharmaceutical R&D, GSK
European Markets for Stratified Medicine
Source:Advancing Access to Personalized Medicine: A Comparative Assessment of European
Reimbursement Systems – Personalised Medicine Coalition
Issue 5: Developing skills
• Modern apprenticeship • Further education level
The Stratified Medicine Scotland consortium has identified the key training needs required to support the exploitation of stratified medicine by Scottish industry.
• Graduate level (Health science/informatics)
• Post Graduate (Health science/informatics)
• Entrepreneurship • Senior level/industry exchange (GSK, P Vallance)
• Industry/Academia mentoring
Issue 6: Ethics and Public Engagement
Challenges & Opportunities
• Collaborative Research
• Economic Impact
• Biorepository linkages
• Informatics
• Skills Development
• Public Engagement & Ethics
Modified from ESF: Personalised Medicine for the European Citizen
Danke schön
Thank You Merci takk
Dank u mulțumesc Спасибо
Grazie & Tapadh Leibh