Promising Solutions : Molecular Oncology and Personalized Medicine - - PowerPoint PPT Presentation

Promising Solutions : Molecular Oncology and Personalized Medicine

Simon B. Sutcliffe, MD, FRCP, FRCPC, FRCR President, BC Cancer Agency 8th Princess Margaret Hospital Conference g p October 2008

Can molecular sciences inter Can molecular sciences interpret t the the Can molecular sciences inter Can molecular sciences interpret t the the biolo biological basis of ical basis of varia variabilit ility of

• f

biolo biological basis of ical basis of varia variabilit ility of

• f

g y g y g y g y

• utcome:
• utcome:
• utcome:
• utcome:
• for an apparently homogeneous patient cohort?
• for an apparently homogeneous tumour type?
• for an apparently homogeneous tumour stage?

YES

• Examples: lung, prostate, lymphoma, breast, ovary
• Limitations

– Samples – size composition purity preservation Samples size, composition, purity, preservation – Technology – consistency, transferrability, cost, time – Science – level of evolution

Can the tec Can the technolog hnology y become become clinicall linically Can the tec Can the technolog hnology y become become clinicall linically l t l t? l t l t? re relev evant? t? re relev evant? t?

YES YES

Examples: next‐generation sequencing, combined t ti l & i l i mutational & expression analysis Implications: predictive prognostic & personalized Implications: predictive, prognostic, & personalized medicine Limitations: cost, timelines, utility, magnitude of benefit, transferability to clinical medicine, ‘readiness’ for adoption by clinical medicine adoption by clinical medicine

Can w Can w e ad addr dress the tr ess the transf ansfer of r of molecular science to the c molecular science to the clinic? linic?

Th ‘ ’ f h f

• The ‘components’ of the transfer
• The cost and the ‘business case’

Knowledge application – ‘preparedness’

Policy; Regulation li i Application Realization

• f potential

(%) Population application Clinical validation Discovery gap (years) gap (years) Technology development Infrastructure Hardware Technology Time (years) Infrastructure, Hardware, Technology

Knowledge creation – ‘discovery/research’

Mature field Technology transition I P i li ti Regulatory process ‐> approval Applications I.P.; commercialization Realization

• f potential

(%) Intensified research pp Diagnostic & therapeutic development Grant supported research Technology development Fundamental discovery Hypothesis generation ‘Proof of principle’ Time (years) Hypothesis generation

Knowledge transfer – clinical application

Routine clinical practice

Approvals, funding policy Population application C.P.G. development; standards

Realization

• f potential

(%) Clinical Validation

Clinical trials design & conduct

Biosample acquisition & handling Issues: Consent, PHI access*, FIOPPA IT/IM (research/clinical integration) Application of Discovery

Validation of technology

Time (years)

Tech transfer; accreditation; training

The Cost and the ‘Business Case’ B t C BC 2007/08 Breast Cancer : BC – 2007/08

New cases of breast cancer p.a 2700 Early stage, node negative (63%) pa 1701 Cost of systemic therapy for breast cancer p.a 33M Cost of radiation therapy for breast cancer p.a 8M Cost of radiation therapy for breast cancer p.a 8M Cost of treatment per case 15,185 1701 cases ‐> molecular signature @ $1000 1.7M 1701 cases > functional response analysis 1701 cases ‐> functional response analysis @ $1,200 2.04M 3.74M

incremental cost

Avoidance of non‐surgical therapies – 30% 510 Cost avoidance of ‘molecular’ triage 7.74M

cost avoided

Issue: How are the ‘avoided’ costs accrued and captured?

How do we ‘close the gap’?

• Anticipate & address ‘hurdles’/system ‘impediments’
• Organization structure – integration of research and practice
• Motivation – culture of knowledge translation

The Knowledge Translation Gap

R i li i l Mature field Routine clinical practice Mature field Practice to Research Intensified Clinical Practice to Research Activity Intensified research Clinical validation Research to Practice Fundamental discovery Application discovery

Time

Or Organiza ganization Str ion Structur ucture : e : Inte Integration of ion of Or Organiza ganization Str ion Structur ucture : e : Inte Integration of ion of resear search and pr and practice actice

Transfer 3 Clinical Research Discovery Research Population Research Transfer 1 “Innovation” Lab to Clinical Transfer 2 “Adoption” Clinical Research to “Global Influence” Research Research to Practice Discovery Population Application Validation

Ho How do w w do w e ‘close the ga

• se the gap’?

Ho How do w w do w e close the ga

• se the gap ?
• Anticipate & address ‘hurdles’/system ‘impediments’

p / y p

• Organization structure – integration of research and practice
• Motivation – culture of knowledge translation
• Incentives – reward ‘transfer’
• ‘Sharable’ infrastructure, expertise, technology, and

, p , gy, personnel

• The ‘business case’ is a key element of ‘preparedness’ for

k l d f knowledge transfer

• Strategic investment – intellectual, financial, resources,

commercialization commercialization