Promising Solutions : Molecular Oncology and Personalized Medicine Simon B. Sutcliffe, MD, FRCP, FRCPC, FRCR President, BC Cancer Agency 8 th Princess Margaret Hospital Conference g p October 2008
Can molecular sciences inter Can molecular sciences inter Can molecular sciences interpret Can molecular sciences interpret t the t the the the biological basis of biolo biological basis of biolo g g g g ical basis of varia ical basis of varia variabilit variabilit ility of ility of y y y y of of outcome: outcome: outcome: outcome: 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 Can the tec Can the technolog hnology hnology y become y become become clinicall become clinicall linically linically relev relev re re l l l l evant? evant? t? t t? t t? t? YES YES Examples: next ‐ generation sequencing, combined mutational & expression analysis t ti l & i l i 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? • The ‘components’ of the transfer Th ‘ ’ f h f • The cost and the ‘business case’
Knowledge application – ‘preparedness’ Policy; Regulation Application li i Realization Clinical Population Discovery of potential validation application (%) Technology gap gap development (years) (years) Infrastructure Hardware Technology Infrastructure, Hardware, Technology Time (years)
Knowledge creation – ‘discovery/research’ Mature field Regulatory process ‐ > approval Technology transition I P I.P.; commercialization i li ti Applications pp Intensified Diagnostic & therapeutic development Realization research of potential (%) Grant supported research Technology development ‘Proof of principle’ Fundamental discovery Hypothesis generation Hypothesis generation Time (years)
Knowledge transfer – clinical application Routine clinical Approvals, funding policy practice Population application C.P.G. development; standards Clinical Clinical trials design & conduct Realization Validation of potential (%) Biosample acquisition & handling Issues: Consent, PHI access*, FIOPPA IT/IM (research/clinical integration) Application of Validation of technology Discovery Tech transfer; accreditation; training Time (years)
The Cost and the ‘Business Case’ B Breast Cancer : BC – 2007/08 t C 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 Cost of radiation therapy for breast cancer p.a 8M 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 Mature field Mature field R Routine clinical i li i l practice Practice to Research Practice to Research Intensified Intensified Clinical Clinical Activity research validation Research to Practice Fundamental discovery Application discovery Time
Or Or Organiza Organiza ganization Str ganization Str ion Structur ion Structur ucture : ucture : e : Inte e : Inte Integration of Integration of ion of ion of resear search and pr and practice actice Transfer 3 “Global Influence” Transfer 2 Transfer 1 “Adoption” Discovery “Innovation” Clinical Population Clinical Research Lab to Clinical Research Research Research to Research to Research Practice Discovery Validation Population Application
Ho How do w Ho How do w w do w e ‘close the ga w do w e close the ga ose the gap’? ose 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 knowledge transfer l d f • Strategic investment – intellectual, financial, resources, commercialization commercialization
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