Funding  in  Health  +  Care  Stra2fied  Medicine  Innova2on  Pla:orm  

Alasdair  Gaw,  Sophie  Dale-­‐Black  Loic  Lhuillier,  Chris    Rowe,  Penny  Wilson      

Stratified Medicine Innovation Platform •  Launched  October    2010  •  Accelerate  Development  and  Uptake  of  Stra2fied  Medicine    

–  Improve  Pa2ent  Outcomes  – Provide  Cost  Benefit  to  the  NHS  and  The  Healthcare  Industry  – Deliver  wider  UK  economic  benefit  

•  Original  Partners  – Department  of  Health,  ScoPsh  Government  Health  Directorate  – NICE,  Medical  Research  Council,  Technology  Strategy  Board  – Arthri2s  Research  UK,  Cancer  Research  UK  

•  Consulta2on  and  Advice  – MHRA,  NIHR  

•  The  combined    5  year  Investment  amounts  to    £200  Million      

Aligning  investment  to  establish    Stra2fied  Medicine  for  improved  pa2ent  outcomes    

Clinical  need  

Fundamental  Science  

Sustainable  products  and  services  

 SMIP  UK  Roadmap  Key  Themes  •  Incen2vising  adop2on  •  Increasing  awareness  •  Pa2ent  recruitment  –  consents  and  ethics  

•  Clinical  trials  •  Data  –  collec2on,  management  and  use  

•  Regula2on  and  standards  •  Intellectual  property  •  Bio-­‐banks  and  biomarkers  

•  Increasing  the  impact  of  R&D  investment    hYps://ktn.innovateuk.org/web/stra2fied-­‐medicines-­‐innova2on-­‐

pla:orm      

Potential partners across Diagnostic test commercialisation pathway

Proof  of  principle  

Biomarker  discovery   Lab  validaGon   Clinical  

validaGon  Clinical  uGlity  

Market  approval  

Market  uptake  

Farr  InsGtute  CPRD  

care,data  Electronic  Health  Research  Centres  

Connected  Digital  Economy  Catapult   NHS  InnovaGon  

Monitor  Academic  Health  Science  

Networks  (AHSNs)  Regional/  local  NHS  

organisaGons  

Health  economic  companies  Product  engineering  companies  Biomarker  validaGon  companies  

Cell  Therapy  Catapult  Medical  Research  Council  

Genomics  England    Research  chariGes  

University  Tech  Transfer  Offices    

NICE  MHRA  EMEA  FDA  

NOCRI  DiagnosGc  Evidence  CooperaGves  

StraGfied  Medicines  Scotland  InnovaGon  Centre  

Clinical  Research  Networks  Contract  research  organisaGons  

NIHR  imaging  centres  Imanova  

Royal  Colleges  of  Medicine  High-­‐value  Manufacturing  Catapult  

UK  Biobank,    Charity  Biobanks,    

Precision  Medicine    Catapult  

Planning ahead to reduce time to commercialisation

Proof  of  principle  

Biomarker  discovery  Lab  validaGon  Clinical  

validaGon  Clinical  uGlity  

Market  approval  

Market  uptake  

Who  Pays?  Why?    

Whats  the  value?  

Who  Uses  it?    Where?  

What  is  the  evidence  required?  

NICE  ScienGfic  advice  Programme:    DAP  

MTEP  

MHRA  

AHSN  NHS  InnovaGons  

DiagnosGc  evidence  CooperaGves  

Precision  Medicine    Catapult  

•  Addressing  the  leading  healthcare  challenges  of  the  UK.    •  Aim  to  provide  exemplars  of  working  across  UK  landscape  to  reduce  2me  to  adop2on      

•  Linking  companies  with  NIHR  DECS,  MRC  Path  Nodes,    AHSN,  Devolved  government  structures  

•  Drive  adop2on  by  early  involvement  of  partners  and  Proof  of  u2lity  – Provision  of  economic  models  for  NICE  that  support  Stra2fied  Medicine  

StraGfied  Medicine  InnovaGon  PlaUorm    Round  6 StraGfied  Medicine:  Working  with  the  UK  Infrastructure    SBRI: 2 phase competition: £10m

Potential partners across Diagnostic test commercialisation pathway

Proof  of  principle  

Biomarker  discovery   Lab  validaGon   Clinical  

validaGon  Clinical  uGlity  

Market  approval  

Market  uptake  

Farr  InsGtute  CPRD  

NICE  MHRA  

Catpults  High-­‐value  Manufacturing  

UK  Biobank,    Charity  Biobanks,  

Biomarker  Research  uniGs  MRC  NIHR  etc    

Genomics  England  

DECS  (NIHR)  

Diagnos2cs  company  

AHSN  Innova2on  leaders  

Catapults  Precision  Medicine    Catapult  

•  Phase  1    – Up  to  9  months  dura2on:  – Objec2ve  to  provide  health  economic  assessment  of  product  and  any  early  work  to  demonstrate  feasibility  of  product/service  technology  • Amount  available  up  to    £150,000  per  project    Aim  to  provide  exemplars  of  working  across  UK  landscape  to  reduce  2me  to  adop2on  

• At  9  months    a  report  of  the  results  and  proposed  value  must  be  submiYed  • Successful  applicants  may  then  apply  for  Phase  2  funding  • Provisional  dates  

StraGfied  Medicine  InnovaGon  PlaUorm    Round  6 StraGfied  Medicine:  ConnecGng  the  UK  Infrastructure    SBRI: 2 phase competition: £10m

Competition opens 7 September 2015Briefing event 15 September 2015Registration deadline 28 October 2015 noonDeadline for applications 4 November 2015 noonContracts awarded 08 January 2016

•  Phase  2  of  the  compe22on:  £8  million  – For  projects  up  to  3  years  dura2on:  – Opens  September  2016  – Successful  applicants  from  Phase  1  only  –   Applicants  will  submit    a  full  development  plan  up  to  commercialisa2on  – Aher  submission  applicants  will  pitch  to  a  board  of  assessors    – Expecta2on  of  up  to  4  projects  being  funded.      

StraGfied  Medicine  InnovaGon  PlaUorm    Round  6 StraGfied  Medicine:  ConnecGng  the  UK  Infrastructure    SBRI: 2 phase competition: £10m

•  Partnering  Workshops  – 4  workshops  across  the  UK  – Representa2ves  of  each  na2ons  organisa2ons  will  be  present  – Workshops  dates  are:  

• Scotland:          22nd  June,  DoubleTree  Hilton  Edinburgh  • Northern  Ireland:  24th  June,  Titanic,  Belfast  • England:          30th  June,  ETC  Farringdon  London  • Wales:            2nd  July  Life  Sciences  Hub  Cardiff  

StraGfied  Medicine  InnovaGon  PlaUorm    Round  6 StraGfied  Medicine:  ConnecGng  the  UK  Infrastructure  SBRI: 2 phase competition: £10m

For more information...

Innovate  UK  Web  Page:    www.innovateuk.org    

Contact  Alasdair  Gaw:      alasdair.gaw@innovateuk.gov.uk  

christopher.rowe@innovateuk.gov.uk  

 

   

 hYps://www.eventbrite.co.uk/e/stra2fied-­‐medicines-­‐diagnos2c-­‐biomarker-­‐approaches-­‐opportuni2es-­‐edinburgh-­‐2ckets-­‐17041945919  hYps://www.eventbrite.co.uk/e/stra2fied-­‐medicines-­‐diagnos2c-­‐biomarker-­‐approaches-­‐opportuni2es-­‐belfast-­‐2ckets-­‐17042016129  hYps://www.eventbrite.co.uk/e/stra2fied-­‐medicines-­‐diagnos2c-­‐biomarker-­‐approaches-­‐opportuni2es-­‐cardiff-­‐2ckets-­‐17042054243  hYps://www.eventbrite.co.uk/e/stra2fied-­‐medicines-­‐diagnos2c-­‐biomarker-­‐approaches-­‐opportuni2es-­‐london-­‐2ckets-­‐17042004093  

WORKSHOP  REGISTRATION  LINKS  

•  Proposals  that  bring  forward  new  modelling  systems  that:  •  Integrate  healthcare  and  science  data  to  predict  the  likelihood  

– of  a  product  demonstra2ng  the  intended  effect  in  a  clinical  sePng  – of  demonstra2ng  clinical  u2lity.    

• This  will    include    systems  biology  and  bioinforma2cs  applica2ons  

•  Provide  innova2ve  mul2-­‐parameter  algorithms  that  enhance  the  predic2ve  strength  of  a  diagnos2c  to  allow  regulatory  acceptance  and  commercialisa2on  

•  Provide  innova2ve  Health  economic  models  for  products  that  will  allow  new  clinical  care  pathways  to  be  established      

Knowledge  Transfer  Partnership Modelling  for  StraGfied  Medicine £1m, project length 6months to 3 yrs