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Innovative Medicines Initiative

Innovative Medicines Initiative. Innovative Medicines Initiative: Joining forces in the healthcare sector . The European Union and the pharmaceutical industry have joined forces to make drug R&D processes in Europe more innovative and efficient, enhance Europe’s competitiveness

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Innovative Medicines Initiative

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  1. Innovative Medicines Initiative

  2. Innovative Medicines Initiative:Joining forces in the healthcare sector The European Union and the pharmaceutical industry have joined forces to make drug R&D processes in Europe more innovative andefficient, enhance Europe’s competitiveness &address key societal challenges by forming the biggest PPP in Life Science 2

  3. Public-Private Partnerships: Why ? • Pooling expertise, knowledge and resources • Developing incentives to address major • unmet medical needs • Providing a neutral trusted platform to align public and private interests

  4. IMI accelerates the development of new therapies for major yet unmet public health needs and diseases where treatments are lacking

  5. The Anti-Microbial Resistance Conundrum • - Anti-microbial resistance kills 25 000 European citizens every year • Annual costs are estimated at €1.5 billion • - Only 2 new antibiotic classes developed over the last 30 years • - Low level of industry investments in antibiotic innovation

  6. How IMI addresses infectious diseases • Invested €229 million in projects aiming at: • Solving scientific challenges • Fostering new models of industrial collaborations for antibiotics and diagnostics development • Developingnetworks for clinical trials • Revisiting regulatory environment • Providing necessary incentivesfor industry to reinvest in the area

  7. COMBACTE CLIN-Network 280 members and Candidate members

  8. Improved detection of infectious diseases 5EFPIA companies; 10 Public organizations; 4 SME Total Budget: 14.4 Mi € • RAPP-ID is developing Point-of-Care Tests (POCTs) for rapid (hospital <2h, primary care <30min) detection of bacteria, mycobacteria, fungi and viruses • Developed conceptual POCTs platforms for community-acquired pneumonia, influenza, tuberculosis • Designed conceptual POCs for the detection of antibiotic resistance for Ventilator-Associated Pneumonia and tuberculosis • Developed a diagnostic device and protocol related to breath-born aerosol sampling - patent application filed Concept RCA module chip

  9. The conundrum of brain disorders Developing new drugs to treat brain disorders takes longer, costs more than for other diseases Brain disorders affect 1 in 3 Europeans And cost the economy € 798 billion / year IMI projects are tackling these issues There are few effective treatments in this area

  10. How IMI addressesbraindisorders • Invested €148 million in projects aiming at: • Shedding new light on the underlying causes of autism (EU-AIMS) • Combining data to pave the way for new treatments for schizophrenia & depression (NEWMEDS) • Identifying new targets for drugs for chronic pain (Europain) • Developing models to predict the efficacy of drug candidates in Alzheimer’s patients (PHARMACOG) • Revisiting regulatory environment for drug development • Providing necessary incentivesfor industry to reinvest in brain disorders

  11. Advances in Autism 6 EFPIAcompanies; 15Public organizations; 3 SME 1 patient org; Total Budget: 35.9 Mi € • Identified brain functional abnormalities that can be reversed in ASD patients by modulating brain 5HT - outcome predictor for clinical trials • Identified significant differences in cortico-cortical anatomical connectivity in ASD patients - outcome predictor for clinical trials • Identified significant differences in brain functional response to emotional sounds in infants at risk for autism - risk predictor • Published first study of EU wide prescribing in ASD

  12. 2 Largest Clinical Trials for Early Detection and Monitoring of ASD Children Identification of biomarkers that precede ASD onset • Prospective study of 300 high-risk infants (3 and 7 months) with older siblings with ASD, and 100 low-risk • Infant cognition, behavior, neuroimaging, neurophysiology • Relation to symptoms/diagnosis of ASD at outcome Accelerated longitudinal study for validation of ASD biomarkers in children and adults • 450 ASD patients and 300 controls • magnetic resonance imaging, event-related potential, eye-tracking

  13. Preclinical Alzheimer’s disease 9 EFPIAcompanies; 36Public organizations; 7 SME 3 patient org.; Total Budget*: 53.4 Mi € • Findings in preclinical Alzheimer’s disease: • common in cognitively normal elderly people • can be diagnosed by cerebrospinal fluid markers • associated with future cognitive decline and mortality – therapeutic target * Total budget for the EMIF program that included EMIF AD, EMIF metabolomics and EMIF platform

  14. Novel Disease Markers for Alzheimer’s Disease 12 EFPIAcompanies; 13Public organizations; 5 SME Total Budget: 27.7 Mi € • Platelets: APP metabolites, 55 kD and 25 kD fragments - AlzProtect • Lymphocytes: ~ 150 RNA transcripts related to Abeta pathway, inflammatory pathway and to immune mechanism - Exonhit(now Diaxonhit) • Red blood cells: binding of Abeta1-42 on cellular membrane and change in PKC conformation in red blood cells- Innovative Health Diagnostics (IHD) • Red blood cells: panel of inflammatory markers- Innovative Concept in Drug Development (ICDD) • COMPLETED RECRUITMENT OF 150 MILD COGNITIVE IMPAIRED PATIENTS FOR BIOMARKER MATRIX CLINICAL TRIAL

  15. Advances in schizophrenia and depression research 10EFPIA companies; 7Public organizations; 3 SME Total Budget: 23.2 Mi € • Gained novel insights into the biology of schizophrenia • Standardised the cognitive models across several industrial partners • Developed novel tools for drug discovery - animal models, human imaging • Developed new web tools - image analysis, biomarker significance • Provided information for the design of more efficient clinical trials

  16. Achievements in chronic pain 8EFPIA companies; 12Public organizations; 1 SME Total Budget: 18.2 Mi € • Initiated international consensus meetings on conducting preclinical trials • Conducting clinical trials to improve patient stratification • Developing tools to predict which patients will respond to treatments • Studying the placebo effect to reduce clinical trial failures • Initiated EMA interactions to frame regulatory landscape

  17. DIABETES: Fighting the epidemic through Public-Private Partnership Hurdles to drug development Distrust in past-research Major Public Health Need Diabetes will affect 43 million Europeans in 2030 €89 million spent on 2011 on treating diabetes and its complications Patients’ heterogeneity Lack of reliable markers for disease activity and complications Cardiovascular complications of rosiglitazone and benfluorex

  18. How IMI facilitates the development of new diabetes therapies • Invested €125 million in 3 projects aiming at: • Solving scientific challenges • Developing reliable measures of diabetes activity and complications • Developing treatments tailored to the different needs of individual patients

  19. Biomarkers of Diabetic Complications 6 EFPIAcompanies; 18Public organizations; 1 SME Total Budget: 32.6 Mi € • Generated the largest ever made database of GWASsamples in diabetic nephropathy (DN) from patients with T1D & T2D - discovery of potential biomarkers • Identified multiple biomarker candidates for diabetic related kidney damage, retina damage and coronary vascular disease • Developed an ultrasound/radiofrequency-based virtual histology for non-invasive assessment of plaque structure • 3 patents in preparation

  20. Advances in Diabetes 8EFPIAcompanies; 12Public organizations; 1 SME Total Budget: 25.9 Mi € • Discovered a lipid signature in the serum of mice fed with high fat diet that correlates with physiological readouts – potential biomarker for diabetes • Generated the 1st human ß-cell line (EndoCBeta H1) and its beta cell phenotype maintenance has been confirmed by 3 pharma partners • Working on the 2nd generation human ß-cell lines with excisable immortality genes - more suitable for drug discovery purposes • Generated the world largest bio repository of human islets for diabetes research, with a bioinformaticalanalysis of the genome, transcriptome, lipidomeand morphological and physiological characteristics- 138 islets

  21. IMI DIABETES PLATFORM Memorandum of Understanding between IMIDIA, SUMMIT and DIRECT for exchange of data and confidential information

  22. IMI develops better tools to ensure the safety of existing and future medicines

  23. Safer and Faster Evidence Based Translation 11 EFPIAcompanies; 5Public organizations; 4 SME Total Budget: 35.9 Mi € • Evaluated153 potential biomarker candidates for drug-induced injury of the kidney, liver and vascular system • 17 exploratory clinical studies started or completed > 6500 retrospective samples collected • 64 biomarker assays developed • Dialogue with Regulatory Agencies established

  24. Development of reliable toxicity predictive systems 13 EFPIAcompanies; 8Public organizations; 4 SME Total Budget: 13.9 Mi € • 5th release of the Vitic NexuseTOXdatabase • 537 substances (165 confidential) linked to 1,703 study designs • (Bayer, Boehringer, Esteve, GlaxoSmithKline, Lundbeck, Novartis, Pfizer, Roche, Sanofi, Servier and UCB) • 3rd release of the ChOXdatabase • 411 toxicology-linked targets; 162,287 distinct compounds and 701,181 activities • Version 1 of the integration system, eTOXsys, was released to all partners • 7 out of 10 companies have already a running system. • 90 predictive models developed

  25. New Methodologies in Pharmacovigilance &Pharmacoepidemiology 12 EFPIAcompanies; 16 Public organizations; 2 SME Total Budget: 29.8 Mi € • Aims to strengthen the monitoring of benefit-risk of medicinesin Europe by developing innovative methods • Works to enhance early detection and assessment of adverse drug reactionsfrom different data sources (clinical trials, spontaneous reporting and observational studies) • Is developing methods to enable the integration and visual presentation of data on benefits and risks • Delivered PROTECT ADRdatabase of adverse drug reactions (ADRs) – 45298 ADRs for 654 medicines • Delivered the inventory of Drug Consumption Databasesin Europe – 17 countries

  26. IMI provides a unique neutral platform for a continuous dialogue with patients, regulators, academia and industry

  27. Since 2009, 40 projects launched - total budget €1.2 billion * *: Estimate

  28. Creation of unprecedented collective intelligence networks Collaborative publications among IMI researchers -Call 1-3 Data & analysis: Thomson Reuters (Custom Analytics & IP Solutions)

  29. Delivering high quality research • Citation Impact by research area Data & analysis: Thomson Reuters (Custom Analytics & IP Solutions)

  30. Securing regulatory relevance of projects outputs via regulators’ involvement • Regulators represented in IMI projects as: Coordinator: EMA (1); • Participants: EMA (1) and other EU national Agencies (5); • Advisory Board: EMA (>10) and FDA (5) • Informal interactions already established for a number of projects • EMA Qualification Advice procedures ongoing for 2 projects • IMI referred to the EMA Road Map to 2015 and more specifically highlighted in workprograms of some EMA Working Parties Safety, Pharmacogenomics, Patients’ and Consumers’ Organisations • IMI/EFPIA held an information session for projects with EMA/FDA on the processes for Drug Development Tools advice and qualification (May 2013)

  31. IMI actively involves patients

  32. Development of tools to measure physical activity status in COPD 8EFPIAcompanies; 7Public organizations; 1 SME 3 patient org; Total Budget: 16.7 Mi € • Aim: development of Patient Reported Outcomes that • measure aspects of physical activity relevant to patients and • are sensitive to changes due to treatment. re-assessment 6+12 months for seasonal effects initial validation (6 wks) reductionintegration 230 patients literature 2 questionnaires patients final validation:clinical & behavioural studies 6 activity meters 2 meters 2009-2011 2011-2012 2013-2014

  33. Biomarkers for Predicting Severe Asthma Outcome 9 EFPIAcompanies; 21Public organizations; 3 SME 5 patient org; Total Budget: 20.1 Mi € • Established diagnostic criteria on severe asthma • Developed various “omics” platforms based on genetic, proteomic, metabolomic, breathomic biomarkers • Generated a preliminary phenotype ‘handprint’ by combining molecular, histological, clinical and patient-reported data • Patient cohort - 14 centres across Europe targeting 1025 subjects, to validate the handprints for their predictive efficacy in gold standard and experimental therapeutic intervention Diagnosis and definition of severe asthma: an international consensus; Belet al., 2011 An integrative system biology approach to understanding pulmonary diseases; Auffrayet al., 2010

  34. IMI contributes to the competitiveness of the European pharmaceutical sector

  35. IMI improves pharmaceutical R&D productivity • Establishment of robust validated models for drug development • Identification of new drug targets • Tools for predictive toxicology • Advances in precision medicine • Novel, clinically relevant biomarkers • New patient reported outcomes (with regulatory guidance) • New tools for ‘big data’ management, effective data interpretation, and clinical decision support • Streamlining of clinical trial design and regulatory frameworks • Access and creation of clinical investigator networks • Resources for a successful translation - genes to animal models to patients • Investment in reclassification of complex diseases

  36. Novel in vitro methods for cancer drug discovery 7 EFPIAcompanies; 7Public organizations; 4 SME Total Budget: 30.7 Mi € • Developed cancer organoid cultures - 3D cultures that preserve cancer heterogeneity • Completed cancer drug screening 10 drugs on 5 patient derived cell lines each • Developed patient derived xenograft cancer models • Discoveredpotential biomarkers able to predict tumor sensitivity to Afatinib (105 BM)and to Regorafenib (69 BM) treatment

  37. Targeting Rheumatoid Arthritis 9EFPIAcompanies; 24 Public organizations; 1 SME Total Budget: 38.1 Mi € • Identification and characteristics of cohorts and biobanksfor different stages of RA (33 cohorts, more than 10.000 biosamples) • Identification of biomarkersfor response to therapy • Standardization of existing and development of new animal models • Production of monoclonal human antibodies to autoantigenic targets in RA • Identification ofnew targets for therapy, including six potential miR targets that are translatable between mice and RA Stittrich AB et al. Ann RheumDisdoi: 2011 70: A43 10.1136/ard.2010.148981.3, presentedatthe EWRR 2011

  38. Modeling and Simulation Clinical Trial Simulator - Prototype v.2 10 EFPIAcompanies; 10 Public organizations; 5 SME Total Budget: 21.2 Mi € • Flexible study designs for PII clinical drug development: • parallel group studies • crossover studies • complex treatments • Simulation of patients sampled • Simulating the exposure to the investigational drug • Simulatingtypes of drug effects related to drug exposure: • Continuous effects • Time-to-event effects • Categorical effects • Count data as effects • Methods of evaluating the simulated trials • Optimal sampling times • Individual probabilities or risks • Trial success • Automatic reporting

  39. Efforts to Automate clinical research 10 EFPIAcompanies; 21 Public organizations; 2 SME Total Budget: 16 Mi € 2 1 3 EXECUTION Data Collection DESIGN Feasibility Study EXECUTION Patient Recruitment FDA-EMEA SUBMISSION Regulators Protocol (CDISC PRM – SDM) Case Report Form (CDISC ODM) XML XML XML XML Trial Registry Clinical Data Management System (CDMS) Document Management System Clinical Trial Management System (CTMS)

  40. IMI trains a new generation of industrial scientists and regulators, and reduces the cost of continuous professional development for companies • €38.5 million invested in Education and Training programs • More than 1000 scientists have been trained so far • Many more scientists take advantage of industrial internships • Enhanced learning experience

  41. IMI Education and Training programs > 1000 trainees so far Catalogued >5000masters, PhD, CPD and short courses taught in 21 languages, from 39 countries, covering over 60 scientific, therapeutic and biomedical areas from about 1000 universities. More than 320 students participated in various courses (50% from EFPIA companies) in 2012. Provided 20 new courses in drug safety sciences. 58 students are following the flexible and fully e-learning programme covering medicines risk identification and quantification, medicines and public health, medicine risk communication, assessing the benefits of medicines, and regulatory processes. 24 universities network + 16 universities affiliates. 685 students have been following various courses (28% from EFPIA companies). Europe’s first Patients’ Academy on Therapeutic Innovation aiming to provide scientifically reliable information on medicines and R&D, as well as an online public library that will empower patients to engage more effectively in the development and approval of new treatments and become true partners in pharmaceutical R&D.

  42. Strategic Research Agenda for IMI2: The right prevention and treatment for the right patient at the right time Draft available at http://bit.ly/1axI076 Comments and suggestions are welcome: SRAconsultation@efpia.eu

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