Supporting Innovation through Regulation and Science

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1 Supporting Innovation through Regulation and Science Larry O Dwyer, Scientific Affairs Manager PEARRL Regulatory Science Symposium 21 st June 2017, School of Pharmacy, UCC

2 Overview of Presentation Drivers for innovation Some HPRA activities to support innovation Education and Outreach Horizon-scanning Classification Innovation Office 15/06/2017 2

3 Drivers for Innovation

4 Population Demographics are Changing Source: Aging with Tech Support McKinsey and Company Sept /06/2017 4

5 Treatment Needs are Changing Cancer Ageing Population Long-Term Chronic Diseases Cardiovascular Disease Respiratory Disease Cancer Diabetes 15/06/2017 5

6 Treatment Needs are Changing Cancer Ageing Population Long-Term Chronic Diseases Cardiovascular Disease Respiratory Disease Cancer Diabetes 15/06/2017 6

7 Patients Knowledge and Expectations are Increasing Source: Future of Ireland III, Innovation Matters 15/06/2017 7

8 15/06/ The Life-Sciences Sector is Changing More collaboration between industry and academia and partnerships between companies Looking for newer R&D models New technologies providing opportunities

9 New Medicines in the EU Proportion of New Medicines (%) 28% 59% 21% 28% 27% 13% 17% Originator MAH 0 7% 0 Large Company Intermediate-sized Company SME Academia/public bodies / PPPs Private Collaborations Significant % of new medicines originated from SMEs and Academia Source: H. Lincker et al Nature Reviews Drug Discovery Vol 13 pp (2014) 15/06/2017 9

10 Sources of Innovation 15/06/

11 Percentage of Global R&D Spending in 2016, by industry Source: statistica.com 15/06/

12 Clinical Trials 15/06/

13 Clinical Trials Use of Selection Biomarkers Source: Clinical Development Success Rates , BIO, Biomedtracker, Amplion 15/06/

14 Examples of Novel Technologies / Product Types 3D Printing Robotics Drug-Device Combinations 15/06/

15 HPRA Activities to Support Innovation

16 Supporting Innovation A key Strategic objective 15/06/

17 15/06/ Examples of Some Recent Initiatives to Support Innovation National Scientific Advice Outreach Programme Involvement in Regulatory Science Ireland Horizon Scanning Involvement in PEARRL Supporting Innovation Innovation Office

18 Education and Outreach HPRA contributes to undergraduate courses and taught Masters in relevant disciplines Focus of outreach includes third level institutes, research and technology centres, SMEs Aim is to understand needs of researchers, agree engagement methods, increase awareness of the role and activities of HPRA 15/06/

19 15/06/ Horizon-Scanning Using internal and external sources of intelligence Aims are to inform need for: future regulatory changes, enhanced outreach, development of additional expertise, new ways of working

20 15/06/ Classification Important to identify the regulatory framework that will apply to an innovation at an early stage of development HPRA has a classification procedure for borderline products: medicines / medical devices / cosmetics / non-medicinal (e.g. foods) Details available on HPRA website Borderlines may be subject to change with the impact of legislation, e.g., new medical devices legislation, EU review of botanicals

21 15/06/ HPRA Innovation Office Launched in Nov 2016 An initial point of contact for innovators to submit queries in relation to innovative products and technologies within the HPRA s remit Queries can be submitted at any stage of development including initial research HPRA is also part of the EU Innovation Network

22 Submissions to the Innovation Office Query Submission via a dedicated online form or a dedicated address Request for general guidance on regulatory / scientific issues HPRA Review Response Queries will be reviewed by relevant HPRA experts Written response will generally be sent within 20 working days Response may recommend more detailed scientific advice May propose meeting or further interaction as development proceeds 15/06/

23 15/06/ Topics Addressed in Innovation Office Queries 5% 5% 5% 9% Medical Devices Medicines 43% Drug / Device Combinations 33% Diagnostics Cosmetics Other

24 15/06/ Origin of Innovation Office Queries 4% 9% 9% 14% SME 32% 32% Academia Life Sciences Industry Individuals Consortium Others / Unknown

25 15/06/

26 15/06/ Benefits from Supporting Innovation Support the dynamic innovative environment within Ireland Strengthen links between HPRA and Innovators Clarify regulatory requirements at an early stage and help to avoid issues at later stages of development Inform the future development of the HPRA Ensure that the HPRA is well positioned to take a lead role in relation to the regulation of innovative products and technologies at a European and international level Patients will benefit via the facilitation of more timely access to innovative health products

27 Thank you Contact the innovation office via our website: /06/

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