Innovative Medicines Initiative:

Transcription

1 Innovative Medicines Initiative: Opportunities for local players to become important parts of multicountry pharma innovation Nathalie Serigneuret 4 March 2015 Clinical Trials Conference 2015, Budapest

2 IMI Europe s partnership for health > 5 bn 2.5 bn Partnership bn

3 IMI key concepts Non-competitive collaborative research Competitive Calls for proposals Open collaboration in public-private consortia o Data sharing, dissemination of results Industry contribution in kind Pool expertise, knowledge and resources, favour cross-fertilization between public & private patners Support competitiveness of European biopharmaceutical industry Neutral trusted platform to align public & private interests

4 IMI calls two stage procedure Topic definition phase Stage 1 Stage 2 Granting phase Industry consortium Academic research teams Mid-size enterprises Hospitals Regulators Applicant consortium SMEs Patients organisations industry consortium Identification of topics and willingness to collaborate by EFPIA companies and associated partners Submission of short proposals by applicant consortia & evaluation by independent experts Preparation of full proposal & evaluation by independent experts/ethical panel Signature of Consortium Agreement and Grant Agreement Call launch Invitation to selected team to merge with industry team Start of the Granting phase Project launch!

5 IMI1 portfolio

6 IMI1 a cross-sector community 799 academic teams 59 projects 17 regulators 26 patient orgs 480 EFPIA teams 169 SMEs Over researchers working in consortia for: collective intelligence networks improved R&D productivity innovative approaches to unmet medical needs

7 IMI1 projects delivering excellent science Citation impact Percentage of highly cited papers World average TI Pharma Wellcome Trust FNIH IMI % 10% 20% 30% Data & analysis: Thomson Reuters (Custom Analytics & Engineered Solutions)

8 Measures of success SUCCESS New model developed & published Setting new standards In house implementatio n by industry Impact on regulatory practice Translation of scientific outputs into outcomes Better drugs and impact on medical practice BETTER SCIENCE = BETTER DECISION MAKING

9 From IMI1 to IM2

10 Evolution of IMI from bottlenecks in industry to bottlenecks in industry and society Make Drug R&D processes in Europe more efficient and effective and enhance Europe s competitiveness in the Pharma sector Idea generation Basic research and non-clinical testing Human testing Regulatory Approval HTA and Pharmacovigilance Daily Medical practice Primary focus of early IMI calls 2007 SRA Shift to also addressing challenges in in society and healthcare 2011 SRA IMI 2 includes real life medical practice 2013 SRA

11 IMI2 Strategic Research Agenda Based on healthcare priorities identified by the WHO 2013 report on priority medicines for Europe and the world Aims at progressing the vision of personalised/stratified medicines Comprehensive framework for a 10-year programme Project ideas from industry and third parties will be screened against it

12 IMI2 building on successes of IMI1 European Commission From H M EFPIA & Partners in Research 1425 M Associated Partners 213 M IMI M Vision of stratified medicines: prevention, treatment and health management End-to-end approach; product lifecycle from discovery, through development to healthcare delivery and patient access to innovative medicines Collaboration across sectors to harness all knowledge and technologies which can contribute to IMI2 vision - diagnostics, imaging, IT, medical devices, and with non industrial associated partners

13 IMI 2 goals of the programme Increase the success rate of clinical trials of new medicines & vaccines Speed up the earlier stages of drug development Develop new treatments for areas of unmet need Develop new biological markers to diagnose diseases and assess treatments Improve the drug development process by creating tools to assess the efficacy, safety and quality of medicines

14 IMI2 Strategic Research Agenda Priority Themes Enablers 1. Neuro-degeneration 2. Immuno-inflammation 3. Metabolic disorders 4. Infection control 5. Translational Safety Support Technologies 1. Imaging 2. ICT 3. Medical devices. Patient access to innovative solutions (MAPPs): Target validation Stratified medicine, precision medicine Innovative trials Data generation and interpretation Prevention, disease interception Patient adherence Health disease management Regulatory framework Reimbursement/patient access

15 IMI2 Call for proposals Call 1 (Stage 2 step) Translational approaches to disease modifying therapy of type 1 diabetes mellitus (T1DM) Discovery and validation of novel endpoints in dry age-related macular degeneration and diabetic retinopathy Call 2 Ebola + programme (Projects launched) Call 3 Research and innovation topics Submission deadline: 24 March 2015 Remote assessment of disease & relapse (RADAR): CNS Assessing risk & progression of prediabetes & type 2 diabetes Linking clinical neuropsychiatry & quantitative neurobiology Quality control in vaccine manufacture Pertussis vaccination research Knowledge repository for patient focused medicine development Call 4 Coordination and Support Action (Stage 1 finalised) Enabling platform on medicines adaptive pathway to patients

16 IMI2 Call2 Ebola+ programme overview Single stage fast track process

17 IMI rules and procedures

18 A single set of rules etc. EU Financial Regulation Specific rules for participation Covering all H2020 research and innovation actions Adaptability where needed: Entities eligible for funding IP

19 Who is eligible for funding? Academic institutions Small & medium-sized enterprises (SMEs) Mid-sized enterprises ( 500m) Non-profit organisations e.g. research organisations, patient organisations, NGOs, public bodies, intergovernmental organisations etc. Other countries: Established in: No funding unless EU Member State - participation deemed Associated Country essential by IMI for carrying out the action - foreseen in the Annual Work Plan

20 Simplified conditions for participation Minimum conditions for standard collaborative actions Research and Innovation Actions: At least three legal entities Coordination and Support Actions: At least one legal entity each established in a different Member State or an associated country Additional conditions In the annual work plan (and Call documents)

21 One single funding rate per project One project = One rate For all beneficiaries and all activities Defined in the annual work plan/call documents: Up to 100% of the eligible costs Limited to a maximum of 70% for innovation projects (exception for non-profit organisations - maximum of 100%) One single indirect cost model: 25 % Flat Rate

22 Innovative clinical trial paradigms

23 Pre-Clinical Research Closed & Open Innovation Filing Approval HTA Assessment Price/Reimbursement Challenges in development pathway Drug Discovery Pre Clinical Testing Clinical Trials Regulatory Review Patients access to innovative medicines Phase 1 Phase 2 Phase 3 5,000 10,000 Compounds 250 Compounds 5 Therapies 1 Therapy PhV Monitoring Real world evidence Number of Patients/Subjects Years 6 7 Years 2 5 Years Innovative clinical trial paradigms needed to move towards more personalised medicines

24 IMI2 SRA major Axes of research Reclassification of disease by molecular means Target Identification and validation(human biology) Determinants of drug /vaccine Safety and efficacy Innovative drug delivery methodologies Biomarker identification/validation (precision medicine) Target & Biomarker Identification (safety & efficacy) Innovative Medicines European Health Priorities Innovative clinical trial paradigms Patient tailored adherence programmes Innovative methodologies to evaluate treatment effect Adoption of innovative clinical trial designs Benefit/Risk Assessment Healthcare delivery: focus on the treatment programmes not just the medicine Manufacturing for personalised medicines Discovery and Development of novel preventative and therapeutic agents Innovative adherence programmes Drive change in delivery of medical practice

25 New approaches for clinical trials Innovative methodologies Novel clinical endpoint/ PRO Innovative/ adaptive designs Modelling/ simulation Benefit/risk assessment New approaches Better definition of the disease Novel Biomarkers Operationality of CTs Use of ICT EHRs Cohorts Registries Clinical networks of excellence

26 New approaches for clinical trials example of ongoing IMI projects Innovative methodologies Modelling/ simulation Benefit/risk assessment Operationality of CTs Novel clinical endpoint/ PRO New approaches Use of ICT Innovative/ adaptive designs EHRs Cohorts Registries Better definition of the disease Novel Biomarkers Clinical networks of excellence

27 DupCheck NewMeds tool Helps identify duplicate patients globally within & across sponsors and therapeutic indications who are participating in a concurrent clinical trial or patients who participated in previous trials of the investigational compound. Data entered at time of screening either at or can be integrated into Electronic Data Capture (EDC), ECRF, or IXRS/IVRS. EMA Qualification advice and FDA supportive. Currently available at no cost to Pharma companies, qualified academic investigators and providers of EDC, ECRF, IXRS/IVRS services.

28 Participation of Hungary in IMI projects

29 Participation of Hungary in IMI1 projects Projects MIP-DILI Compact EUC²LID AETIONOMY Projects PharmaTrain U-BIOPRED* SMEs SOLVO BIOTECHNOLOGY ZRT PHARMACOIDEA Development and Service Ltd. ChemAxon Kutató-Fejlesztő Korlátolt Felelősségű Társaság Pharmacoidea Development and Service Ltd. Academia Semmelweis University Semmelweis University PRECISESADS* University of Szeged 0 SME Academia other Project EMTRAIN Ministry of Human Resources, Medical Research Council * activities related to clinical data from cohorts

30 IMI COMBACTE project Participation of Hungary in CLIN-NET Building an Europe-wide network of hospitals prepared for and experienced in performing highquality clinical studies with new antimicrobials against multiresistant bacterial pathogens. > 300 hospital sites in 37 countries In Hungary 23 clinical sites identified through the participation of a national network hospitals (HSCMID)

31 COMBACTE Clinical trials SAATELLITE Phase II trial with MEDI4893 against S aureus among mechanically ventilated intubated ICU subjects for prevention pneumonia; > 80 sites across EU selected from CLIN-NET Experience so far with contracts Heterogeneity in local legal requirements between different European countries In majority of EU countries, payments typically made to institutions who then transfer funds to the investigators, while providing infrastructure support In certain countries, institutions prefer part of the clinical study funds to be paid directly to investigators and laboratories, using individual bank accounts, in addition to separate payments to the institution

32 Some considerations Move towards novel clinical trials approaches that will optimise the development path and access pathways that balance early patient access, public health and societal benefits (MAPPs) Focus in IMI2 on innovative clinical trial paradigm Value of collaboration/sharing data/knowledge Real opportunities for local players to be part of IMI collaboration as well as to become important parts of multicountry pharma innovation

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34 Thank you Nathalie Seigneuret Senior Scientific Project Manager