WINTHER TRIAL: AN SME DRIVEN EUFP7 PROGRAM TO CREATE AN INDUSTRY STANDARD TOOL TO OPTIMIZE THERAPEUTIC DECISION MAKING

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1 WINTHER TRIAL: AN SME DRIVEN EUFP7 PROGRAM TO CREATE AN INDUSTRY STANDARD TOOL TO OPTIMIZE THERAPEUTIC DECISION MAKING Mohammad Afshar, MD, PhD Ariana Pharma WIN Symposium June Paris

2 Disclosure Mohammad Afshar is the CEO and co-founder of Ariana Project partly funded by EU FP7 2

3 Ariana Pharma: transforming Big Data into Clinical Decision SME: Headquarters in Paris, offices in Boston Spin off of the Institut Pasteur, VC Backed KEM data mining technology developed in collaboration with leading pharmas and FDA pharmacogenomics Focused on patient stratification in clinical trials and therapeutic decision support Data mining KEM Software Patient stratification Multi-marker diagnostics Diagnostic products 3

4 Acknowledgements Ariana Dr Mariana Kuras Dr Dave Morley Dr Sébastien Vaucouleur Ariane Odjo Marine Le Morvan (X 10 Mines) Fanny Perraudeau (X 10 Mines) BGU Eitan Rubin Gustave Roussy Vladimir Lazar JC Soria KNIME 4

5 WINTHER Data web portal to support weekly Clinical Management Committee of all PIs in 5 different countries JC Soria 5

6 Objective Transform a successful academic prototype into an industrial product: onco KEM Global system for ranking of treatments Modular knowledge base Modular prediction algorithm (WINTHER, SIMS, SIMS2, etc) 6

7 Onco KEM : system overview Patient Physician Healthcare information system 1. Request treatment selection report 4. Notify clinician of pending report Web application Authentication Analytics Engine Report Engine Knowledge Base Localization DB Onco KEM Core Hospital 2. Ship tissue samples for profiling 3. Upload patient profiling data Billing Data management Onco KEM DNA profiling Hosted HIPAA-compliant data center RNA profiling mirna profiling Lab Lab user Payer Reimbursement Ariana Pharma 7

8 Onco KEM: on-demand treatment report generation Upload WINTHER patient data file (FEF) 30 seconds later 8

9 Onco KEM : drill-down to more detailed information Score explanations References Drug approvals 9 Link to ClinicalTrials.gov

10 Onco KEM : benefits and features (June 2015) Benefits Access Improved outcomes Cost User Features Visual dashboard Add/edit/search patients High-performance WINTHER algo Printable PDF reports Recording of treatment decisions FDA, EMA drug approvals 10 Design Features Secure, scalable, hosted web appl. Generic support for algos, patient data files and reports Version control

11 Preliminary data showing ranking of TT entering the trial vs ranking of TT chosen by clinicians 15 first ARM-B and treated patients The average ranking of therapies used by patients before entering the clincal trial is shown in blue. The average ranking of the selected treatments is significantly improved (smaller numbers) after using the algorithm (Red) 11

12 Personalized medicine Products OncoKEM fits perfectly Ariana s pipeline of stratification products for personalized cancer therapy Cancer Treatment Selection Software (SAAS) Onco KEM Xenografts Vivo Models Combination Therapy Winther trial IMODI: Sanofi, Ipsen, Pierre Fabre, Servier, Biofortis SPRING ETC Trials Before After Real Time, Brain Cancer Dx Algorithm- Validation Production BRUKER KEM Inside Gastric cancer Dx Gastro Glycosylation SBI Remote home monitoring Sympad CEA 12

13 Regulatory Environment 13

14 Making onco KEM available to WIN: a unique cancer network with worldwide reach 4 Continents 15 Countries 22 Hospitals >1,5 Million cancer patients per year IMODI network 7 Hospitals & an additional 200K patients 14

15 Perspective Fully learn from data collected in WINTHER Trial Improve and validate predictive algorithms using advanced data mining (KEM) Provide onco KEM to the whole network Actively contribute to the next trials Reference platform for predictive algorithms Demonstrate impact on clinical endpoints 15