EU s Innovative Medical Technology and EMA s Measures

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1 EU s Innovative Medical Technology and EMA s Measures 27 October 2017 Summit symposium October 2017, Kyoto, Japan Presented by Guido Rasi Executive Director, European Medicines Agency (EMA) An agency of the European Union

2 Innovation landscape: what we see A reflection at international level is needed to prioritise and recommend cooperation in innovative areas New development paradigms are progressing with unprecedented speed Complex and challenging products to develop, manufacture, evaluate and make available to patients CRISPR-Cas9 genome editing 1

3 Opportunistic Innovation Landscape Medical research and technological innovation are both advancing at an exponential pace, rapidly integrating each other Research and technology meet when there is a market opportunity, sometimes at unexpected moments and places This often brings radical systemic changes 2

4 Emerging business models Innovative industry is increasingly transforming itself into a service provider Industry needs also to train specialised medical staff for delivering innovative therapies to patients Allogeneic CAR T-Cells are a universal product candidate with multiple doses One Leukopack can yield 100s of doses Autologous CAR T-Cells are a personalized therapeutic procedure Product vs. Service 3

5 Why we need a new approach to innovation New competences for the regulatory and public health systems, both for the evaluation and for the delivery to patients To build expertise to evaluate increasingly complex products, Regulators need to reach out to many stakeholders and interact with new players outside the health arena Shift from treatment to potentially curative medicines require new approaches to value assessment, payment and financing Constraints driving strategic allocation of resources 4

6 Regulators an enabler between science and healthcare systems Regulators need to take a new role at the crossroad between science and national healthcare systems: in order to promote public health in the current environment, they can no longer be just a gateway between those two worlds; they need to become a catalyst/enabler for science to be translated into patientcentred healthcare and fits in the reality of healthcare systems. Regulators can be an enabler between science and healthcare systems by scanning the horizon, identifying the main gaps and connecting the various stakeholders together in order to bridge those gaps. 5

7 EMA Regulatory Science Observatory: a collaborative approach 6

8 Informing the Regulatory Science Strategy International liaison Scientific literature Health trends EU bodies collaboration Investors Horizon Scanning Outreach activities Detection trends in science, technology, and regulatory science tools Committees Expert groups Draft legislation Guidelines Products: datasets mining Media reports Meetings Conferences 7

9 Engaging with partners and stakeholders Leveraging collaboration at EU and International level with partners Stakeholder engagement to avoid selfreferential outcomes Identification of hotspots in the current regulatory science discussions Investors Research funding Research Infrastructures Academia Reg science EU bodies and agencies European Commission Academia R&D Patients representatives EU-IN EMA RSO matrix EMA Scientific Committees WPs Healthcare professionals EU National Competent Authorities International regulators Other (legal, ethical, policy) HTAs Payers General public Industry 8

10 Identifying the main gaps: EMA baseline report Trends in science and technology Trends in Regulatory Science tools 9 EMA Guido Rasi - Summit of ICMRA October 2017

11 Connecting stakeholders: crucial role of Regulators Yesterday Today Tomorrow Adaptive pathway Scientific concept for medicine development and data generation Parallel EMA-HTA scientific advice inclusion of additional stakeholders e.g. Patients, payers EUnetHTA Integrated public health players advice patient centred value centred access centred 10

12 Are we ready to embrace innovation in regulatory science? Yesterday Today Tomorrow Real World Evidence Integrating data e.g. from Registry in our assessment Big data Big Data landscape from a regulatory perspective Acceptability for Regulatory Decision Making (criteria) Change in regulatory paradigm Use of Artificial Intelligence in Regulatory Decision Making? 11

13 How are we impacting on science Yesterday Today Tomorrow PK-PD dose finding/extrapolati on Clinical trials Modelling Disease modelling (in-silico) 12

14 How we can impact on science Yesterday Today Tomorrow Stratification Biomarkers Integrated Omics Validation of surrogate endpoints Development of biomarker-driven Personalised Medicines 13

15 Leveraging collaborative research EU-NTC 14

16 Activity Bridging the gaps and setting priorities A model to set up priorities in the Regulatory Science Strategy HTAs Health threats Oncology AMR Big data Personalised medicine Disruptive innovation Extrapolation Disease Modelling Pregnancy Gene therapy Investment 15 EMA Guido Rasi - Summit of ICMRA October 2017

17 Innovation in the global regulatory science ecosystem 16

18 Thank you for your attention European Medicines Agency 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website Follow us

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