ECONOMIC FOOTPRINT OF CTs IN BELGIUM STRATEGIC PLAN TO PROMOTE CTs

Transcription

1 ECONOMIC FOOTPRINT OF CTs IN BELGIUM STRATEGIC PLAN TO PROMOTE CTs Ingrid Maes Director Pharma, Healthcare and Life Sciences PwC on behalf of: PwC on behalf of: PwC on behalf of: PwC PwC on behalf of: PwC on behalf of: For: Sponsored by:

2 Thank you! PwC PwCon behalf of: PwC on behalf of: PwC on behalf of: w.theinitiative.be www. 2

3 Content 1. Actual situation on clinical trials in Belgium 2. Future evolutions in clinical research 3. Conclusions and recommendations 3

4 Content 1. Actual situation on clinical trials in Belgium 2. Future evolutions in clinical research 3. Conclusions and recommendations 4

5 Actual CT situation in Belgium Past trends: Past Now Future Our research is based on: Investigation of trends based on the FAGG database on CTs Survey held in Jan-Feb 2012 with 53 representatives of various stakeholders Comparison study of other countries (benchmarking) Group Nr. of respondents Health Authority 2 Research based pharma 17 CROs 8 Hospital Direction 9 Ethical Committees 9 HC practicioners/ Investigators Patient Organisations 3 5 5

6 # OF CLINICAL TRIALS number of CTs EVOLUTION OF NUMBER OF CTS (TOTAL) EVOLUTION OF NUMBER OF CTS (PER PHASE) -6% -4% -20% +17% -22% +8% Source: CTA FAGG database YEAR Source: CTA FAGG database Since 2008 continuous decline in industry-driven CTs. Exploratory studies (I+II) stable. 6

7 Potential consequences of declining number of CTs in Belgium In your opinion, what would be the impact of a decline in CTs in Belgium? Job losses Loss of expertise in R&D Loss of qualified staff Loss of innovation Closing down of CT and research units Less access to innovative drugs 7

8 Shift in in- and outsourcing CTs are increasingly in- and outsourced for full development or part thereof (functional aspects) Key drivers for this trend: Efficiencies, mainly in terms of resource and portfolio management, flexibility and cost savings More standardised study approach Specialty expertise of the provider and the resulting faster speed of enrolment Easy access to in/outsourcing providers For complex or innovative CTs however (e.g. FIH, phase II) more local expertise & resources are needed. Sponsors mostly outsource specific functional aspects of their CTs 100% 80% 60% 40% 20% 0% EXPLORATORY CONFIRMATORY Full Development Single CT Operational Functional Aspects Most sponsors prefer to work on a preferred provider basis in order to build a relationship of trust and expertise and to ensure efficiency Sponsor CRO 20% 80% Do you work on a preferred supplier basis with your clients? No Yes Sponsor IOP 10% 90% No Yes 8

9 Actual status of CT processes: Time to CA approval EVOLUTION OF NUMBER OF DAYS FROM REQUEST FOR APPROVAL TO FINAL APPROVAL Ph II, III and IV Ph 0 and I 28 days 15 days These averages remain well below the legal delays of 15 days for exploratory and 28 days for confirmatory studies. The ambitious Belgian timelines are therefore well respected. Source: CTA FAGG database *"clock-stop period was excluded from this calculation. 9

10 Actual status of CT processes: EC Approval process % SINGLE OPINIONS OF TOP 5 ETHIC COMMITTEES ON TOTAL SINGLE OPINIONS Source: CTA FAGG database YEAR 70% of CTs are evaluated by 5 leading ECs 10

11 General drivers for location choice vs. drivers for choosing Belgium* What are the most important factors when choosing the CT location (global)? Approval Time What are the key drivers for choosing Belgium as a CT location? Approval Time Market Potential Expertise Market Potential Expertise Cost** Quality Cost** Quality Processes Access to Patient Populations Processes Access to Patient Populations Access to CT sites Access to CT sites Drivers location-choice (General) PwC Global Study Drivers for Belgium * Chart depicts relative values, not absolutes ** PwC global study shows cost to be a highly critical factor 11

12 Stakeholders recommendations a Network Build collaborative expertise centres; Public/Private coordination hub b Processes Standardise & Centralise g f Incentives Provide incentives Resources Improve access to patients; Pathology orientation; Target groups of patients stakeholder recommendations towards attracting more CTs in Belgium d c Data & Technology Build CT & patient registry; through an IT portal Training & Education Share best practices; Standardise & uniformisation; Stronger Branding; Raise ethical know-how e Legal/Regulatory Framework Facilitate access to innovative drugs; Cap costs Demand a CT environment that better facilitates the execution of CTs 12

13 Content 1. Actual situation on clinical trials in Belgium 2. Future evolutions in clinical research 3. Conclusions and recommendations 13

14 Trends in clinical trials Future evolutions Past Now Future

15 Opportunities based on future environment to boost clinical research activities in Belgium Future Trends Evidence Based Medicine evolves to a continuous process of data gathering in clinical practice Opportunity Increased demand for post approval continous data gathering, reimbursment renewals (live-licensing) More collaborative models Create a network of expertise centres More evidence required for and from early development New EU regulatory environment Translational research will drive additional data gathering and CTs Upgrade local expertise, ameliorate legal framework for biobanks, maintain timelines. 15

16 Stakeholder needs in order to allocate more CTs in Belgium What changes are needed for your organisation to allocate more CTs to Belgium? Percentage of respondents that want... Standardization Networking (specialised research networks) Transparency in CT costs Tools for recruitment (patient recruitment) More efficient CT process Better Ethical Committee approval process 16

17 Initiatives taken by EU countries to attract CTs LEAD: MINISTRY OF HEALTH Healthy Growth Plan Improving conditions for private-public partnerships in health research & innovation PUBLIC- PRIVATE DRIVEN LEAD: ABPI & MHRA Improving legal framework (IPO, clarity,...) Access to information for industry (toolkits, web, routemaps,...) LEAD: LEEM & CeNGEPS (public-private) Development of national network of CT centres Patient recruitment (CT registry, website, awareness,...) LEAD: NEFARMA Standardization/one-stop shop concept (forms, contracts,...) Professionalization (performance monitoring, training,...) Patient participation (volunteer registry,...) SECTOR DRIVEN LEAD: INFARMA Advocacy activities (gov t, industry,...) & public education Transparency (self-regulation doc, CT registry websites) 17 LEAD: Pharma.be Standardization of documents ( IC, contracts...) Professionalization (website, working groups with agencies)

18 Relevance of other country best practices for Belgium One-Stop-Shop IT portal for: submitting CT applications Informing on CTs transparent data sharing Stronger branding of country as a R&D/Health/Innovation centre (e.g. enhance visibility of academic potential, etc.) Standardisation of study related documents, processes Voluntary patient registry Specialised research networks Public/private initiative to support clinical research activities (e.g. CeNGEPS) 18

19 Content 1. Actual situation on clinical trials in Belgium 2. Future evolutions in clinical research 3. Conclusions and recommendations 19

20 3 key Strategic Initiatives can help attract more CTs to Belgium RECOMMENDATIONS STRATEGIC INITIATIVES Public/Private coordination hub Standardise & Centralise Stronger branding Improve access to patients Standardisation One stop shop 2 1 Network of Specialised Centres (CoE) with specific patient populations Build expertise networks Share best practices & ethical know-how Improve access to patients, target groups of patients, pathology orientation 3 Supportive Governmental Framework Build CT & Patient Registry through IT portal Standardisation & uniformisation Facilitate access to innovative drugs & cap costs Provide supportive incentives 20

21 Actions proposed to each of the different stakeholders 1 Standardization Strategic Initiatives Sponsors Enhance communication CROs, In-& Outsourcing Providers Enhance communication National Competent Authorities Create Portal Hospital Directions Standardise processes Investigators Standardise Fees Ethical Committees Centralise processes Patient Organisations Involve Patients 21

22 Actions proposed to each of the different stakeholders Standardization 1 2 Strategic Initiatives Network of Specialised Centres Sponsors Enhance communication Improve collaborations CROs, In-& Outsourcing Providers Enhance communication Collaborate & Communicate National Competent Authorities Create Portal Coordination & Accreditation Hospital Directions Standardise processes Collaborate & Specialise Investigators Standardise Fees Specialise Ethical Committees Centralise processes Collaborate Patient Organisations Involve Patients Partner with centres 22

23 Actions proposed to each of the different stakeholders Strategic Initiatives Standardization Network of Specialised Centres Supportive Governmental Framework Sponsors Enhance communication Improve collaborations Liaise to shape Policy CROs, In-& Outsourcing Providers Enhance communication Collaborate & Communicate Liaise to shape Policy National Competent Authorities Create Portal Coordination & Accreditation Control costs & Enable access to innovative drugs Hospital Directions Standardise processes Collaborate & Specialise Collaborate on best practice guidelines Investigators Standardise Fees Specialise Input on CT registry Ethical Committees Centralise processes Collaborate Collaborate on best practice guidelines Patient Organisations Involve Patients Partner with centres Liaise to shape Policy 23

24 Conclusions CTs are core for the pharma sector. For Belgium this research is strategically and economically important. To take maximum advantage of this opportunity, stakeholders should work towards: Standardisation (One stop shop) Network of Specialised Centres Supportive Governmental Framework 24

25 Thank you! PwC for: PwC on behalf of: PwC on behalf of: PwC on behalf of: PwC on behalf of: PwC on behalf of: Sponsored by: Contact Ingrid Maes