UK Molecular Pathology Landscape

Transcription

1 UK Molecular Pathology Landscape Jonathan Pearce Medical Research Council, Translational Programme Manager Novel Markers and Technology: 12 October 2015

2 Stratified medicine has the potential to deliver improved diagnoses and therapies Input Affected population Genetic / Molecular Tools Clinical Presentation /Phenotype Therapeutic Response Outputs Disease Strata Value - Diagnostics to better predict disease state, prognosis, response - Mechanism of disease leading to new therapies Capturing this potential requires true partnership between basic and clinical researchers, industry (BioPharma and Diagnostics) and patients. No one group has all the necessary skills/resources 1

3 MRC Stratified Medicine Initiative Set up in 2010/11 and represented a new way of funding from the MRC Builds on the MRC/ABPI Inflammation and Immunology (I&I) Initiative 60m initiative to develop disease-specific research consortia, involving industry partners Consortia exploring predictors of response and mechanisms underpinning disease stratification, where there is evidence that therapeutically relevant strata exist 2

4 MRC Stratified Medicine Consortia RASP-UK PSORT MATURA-II MASTERPLANS S-CORT UKPBC RAMAP-II COPDMAP GAUCHERITE MATURA-I 13 internationally competitive stratified medicine discovery engines Build on NIHR and DA clinical research funding Total investment c. 57m 3 charity co-funders (CRUK, ARUK, BHF) 32 academic and 51 commercial partners Auto-Immune Mental Health MASTERMIND AIM HY Respiratory Cancer Cardiovascular Congenital STOP-HCV STRATA RAMAP-I Infections Diabetes

5 Molecular pathology review If the UK is to capture the stratified medicine opportunity, we need to be able to translate both its therapeutic and diagnostic outputs to patient and economic benefit While much consideration has been given to the challenges faced by those developing new therapies, less work has focused on the needs of diagnostics MRC has undertaken a review focused on these needs 4

6 Compared to therapies, the diagnostics path is complex & poorly linked Modality Developer Type Regulatory Approval Evaluation Adoption Drug All All Yes efficacy required NICE (TAP) Mandated Commercial All Yes but efficacy not required NICE (DAP) Not Mandated Diagnostic Hospital Rare Genetic No UKGTN Not Mandated Non-Rare/ Non-Genetic No - - The field would benefit from these gaps being addressed and from clear guidance on the path and required evidence for the discovery, development, regulatory approval and evaluation of molecular pathology tests 5

7 and the diagnostic development landscape is fragmented Research and Service base has become separated, to the detriment of both Clinical Research Pathology Service Industry UK IVD companies are not well placed to help bridge the divide There is a critical need to bring these various parties into closer proximity 6

8 Signatures are the future of diagnostic tests and will require close collaboration Time Test Biomarker(s) Assessed Current HercepTest Level of single biomarker, HER2, to predict response to Herceptin Emerging Oncotype DX Level of expression of 21 genes, to predict response to adjuvant chemotherapy Future Algorithmic signatures of multiple biomarkers from different classes (protein, metabolite, etc) to identify disease strata Managing the development challenges of future tests will require close collaboration between researchers, service providers and industry with access to multi platform, data integration and data analysis capabilities 7

9 The number of academic pathologists is in decline and there is a paucity of lectures Clinical academic pathology staffing levels since 2005 (FTE) Academic grades 2013 (% Total FTE) Professor Reader/ Senior Lecturer Lecturer Pathology All CAGR Pathology -4% All Specialities 1% 8

10 Review recommendations Path - Produce clear unified guidance setting out the critical path and required evidence for the discovery, development, approval and evaluation of tests. Address the gaps in the UK s regulatory, evaluation, adoption and delivery system Proximity - Establish joint research/clinical service nodes aligned with industry and complementing NIHR, TSB and other RC and partner investments People - Train next generation of research leaders in molecular pathology, potential merit of guaranteed follow through clinical lectureships Further development of UK capacity in statistics, bioinformatics and health economics Undergraduate medical curriculum to include molecular pathology, to aid adoption and interpretation 9

11 MRC and EPSRC molecular pathology nodes call In an initial response to recommendations, the MRC and EPSRC have launched a joint call to support up to eight molecular pathology nodes Up to 17.5m ( 15m from MRC and 2.5m from EPSRC) Each node will be a multidisciplinary centre of innovative molecular diagnostic test discovery and development bringing together: the research base pathology/genetic services and industry 10

12 Initial focus on development of novel molecular pathology approaches Discovery Early Development Late Development Regulatory Approval Evaluation Adoption We anticipate nodes will initially be positioned at discovery/early development boundary pulling discoveries forwarded by working on Validation of biomarkers associated with disease strata Development of novel sensing and analytical technologies for new diagnostic tools Application of mathematical and statistical methodologies for the extraction of information from complex datasets. Longer term, we expect nodes to traverse the path to adoption/delivery, as tests under development mature 11

13 MRC Stratified Medicine Consortia and MRC EPSRC Molecular Pathology Nodes Glasgow RASP-UK PSORT MATURA-II Manchester MASTERPLANS S-CORT MASTERMIND Edinburgh/ St Andrews Newcastle UKPBC RAMAP-II Nottingham COPDMAP Leicester/ Loughborough GAUCHERITE MATURA-I AIM HY 13 internationally competitive stratified medicine discovery engines Total c. 60m 3 charity co-funders (CRUK, ARUK, BHF) 32 academic and 51 commercial partners 6 centres of innovative molecular diagnostic test development Total c. 16m 8 academic and 21 commercial partners Auto-Immune Respiratory Cancer Infections Mental Health Cardiovascular Congenital Diabetes STOP-HCV STRATA RAMAP-I Node

14 The nodes will work as a network and complement partner investments Discovery Science/ Early TRL Mid TRL Late TRL MRC Stratified Medicine Consortia NIHR DECs Science base Nodes Catapult NHS EPSRC Analytical Sciences RC Centres MHRA NICE NIHR BRCs/BRUs NHS Innovation GEL Discovery Validation Regulation Evaluation Adoption