'INNOVATIVE SOLUTIONS FOR RESEARCH IN HEALTHCARE' Developing a novel approach to deliver better precision medicine in Europe The EMA standpoint

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1 'INNOVATIVE SOLUTIONS FOR RESEARCH IN HEALTHCARE' Developing a novel approach to deliver better precision medicine in Europe The EMA standpoint STOA workshop - European Parliament, 10 January 2019 Presented by Prof. Guido Rasi Executive Director European Medicines Agency An agency of the European Union

2 Innovative medicines Opportunistic and disruptive Treatment for ADHD and digital endpoints Genome editing for rare diseases Multiple targeted treatments for cancer New development paradigms progress with unprecedented speed and bring radical changes 1

3 Precision medicines and emerging business models Complex and challenging products to develop, evaluate and make available to patients Highly innovative, potentially curative medicines requiring re-definition of value Emerging business models are driving need to improve cooperation between competent Authorities, at National and Regional level, on a key element of drugpricing decisions 2

4 A paradigm change: From treatment to potential cure From treatment to prevention From anatomical to molecular (and beyond?) drive diseases taxonomy From RCT to?ct From drug prescription to therapy deliver From risk/benefit to clinical added value From approval to access 3

5 Digital Revolution and Regulatory Environment are these compatible? The real issue is to get clarity on and enable secondary data use for health research, purposes, whether the data is from a clinical trial, health records, registries, biobanks or other sources i.e. Real World Data We need to ensure that we can all work together to achieve a Win-Win situation which both safeguards citizens rights to protection of their personal data and supports citizens legitimate expectations of excellent healthcare Delivering excellent health care relies on constant research to improve, and from a vibrant, innovative research environment that can make the EU a global leader in innovation of new medicines. Developing codes of conduct may be a way forward 4

6 A new concept Evidence by design Facilitating patient access through data that serves the entire decision-making chain Decision makers (regulators, HTAs and payers) answer different questions have different requirements in terms of evidence Alignment of the design of the evidence generation plan Planned studies (populations / comparators / design of trial / endpoints) Requirements for post-licensing evidence generation (e.g. registries) Expectation Optimised evidence generation plan Improve access for patients 5

7 EMA Regulatory Science to 2025 : Vision New role for regulators The way forward Regulators need to take a new role at the crossroads 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. EMA needs to become a catalyst, an enabler for science to be translated into patient-centred healthcare and fit in the reality of healthcare systems.

8 EMA Regulatory Science to 2025 Strategic goal 1 To catalyse the integration of science and technology in drug development. Strategic goal 2 To drive collaborative evidence generation to improve the scientific quality of evaluations. Strategic goal 3 To advance patient-centred access to medicines in partnership with healthcare systems. Strategic goal 4 To address emerging health threats and availability/therapeutic challenges. Strategic goal 5 To enable and leverage research and innovation in regulatory science. 7

9 Thank you!

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