Post on 31-Jan-2021
ECONOMIC FOOTPRINT OF CTs IN BELGIUM
STRATEGIC PLAN TO PROMOTE CTs
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Ingrid Maes
Director Pharma, Healthcare and Life Sciences
PwC
Sponsored by:
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2
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Ingrid Maes – Economic footprint of CTs in Belgium
1. Actual situation on clinical trials in Belgium
2. Future evolutions in clinical research
3. Conclusions and recommendations
3 Ingrid Maes – Economic footprint of CTs in Belgium
Content
1. Actual situation on clinical trials in Belgium
2. Future evolutions in clinical research
3. Conclusions and recommendations
4 Ingrid Maes – Economic footprint of CTs in Belgium
Content
5
Past Now Future
2006 2012 2020
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)
Past trends:
Group Nr. of
respondents
Health Authority 2
Research based pharma 17
CROs 8
Hospital Direction 9
Ethical Committees 9
HC practicioners/
Investigators
5
Patient Organisations 3
Ingrid Maes – Economic footprint of CTs in Belgium
Actual CT situation in Belgium
6
Since 2008 continuous decline in industry-driven CTs. Exploratory studies (I+II) stable.
Source: CTA FAGG database Source: CTA FAGG database
-6%
-22%
+17%
+8%
EVOLUTION OF NUMBER OF CTS (TOTAL) EVOLUTION OF NUMBER OF CTS (PER PHASE)
-4%
-20%
YEAR
# O
F C
LIN
ICA
L T
RIA
LS
Ingrid Maes – Economic footprint of CTs in Belgium
2006-2012 number of CTs
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
“In your opinion,
what would be the
impact of a decline in
CTs in Belgium?”
Ingrid Maes – Economic footprint of CTs in Belgium
Potential consequences of declining number
of CTs in Belgium
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.
0%
20%
40%
60%
80%
100%
EXPLORATORY CONFIRMATORY
Full Development
Single CT
Operational 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
Sponsors mostly outsource specific functional
aspects of their CTs
Do you work on a preferred supplier basis with your clients?
Sponsor CRO 20%
80%
No
Yes
Sponsor IOP 10%
90%
No
Yes
8
Functional Aspects
Ingrid Maes – Economic footprint of CTs in Belgium
Shift in in- and outsourcing
9
Source: CTA FAGG database
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.
*"clock-stop period” was excluded from this calculation.
Ph II, III and IV
Ph 0 and I
EVOLUTION OF NUMBER OF DAYS FROM REQUEST FOR APPROVAL
TO FINAL APPROVAL
28 days
15 days
Ingrid Maes – Economic footprint of CTs in Belgium
Actual status of CT processes:
Time to CA approval
10
70% of CTs are evaluated by 5 leading ECs
Source: CTA FAGG database
YEAR
% SINGLE OPINIONS OF TOP 5 ETHIC COMMITTEES ON TOTAL SINGLE OPINIONS
Ingrid Maes – Economic footprint of CTs in Belgium
Actual status of CT processes:
EC Approval process
11
Drivers location-choice (General)
* Chart depicts relative values, not absolutes
** PwC global study shows cost to be a highly critical factor
Drivers for Belgium
“What are the most important factors when
choosing the CT location (global)?”
PwC Global Study
Approval Time
Quality
Expertise
Access to
Patient
Populations
Processes
Cost**
Access
to CT sites
Market
Potential
Approval Time
Quality
Expertise
Access to
Patient
Populations
Processes
Cost**
Access
to CT sites
Market
Potential
“What are the key drivers for choosing
Belgium as a CT location?”
Ingrid Maes – Economic footprint of CTs in Belgium
General drivers for location choice vs. drivers
for choosing Belgium*
12
Resources
Improve access to patients;
Pathology orientation;
Target groups of patients
Training & Education
Share best practices;
Standardise & uniformisation;
Stronger Branding;
Raise ethical know-how
Data & Technology
Build CT & patient registry;
through an IT portal
Legal/Regulatory Framework
Facilitate access to innovative drugs;
Cap costs
Incentives
Provide incentives
Network
Build collaborative expertise centres;
Public/Private coordination hub
Processes
Standardise & Centralise
stakeholder
recommendations towards
attracting more CTs in Belgium
a b
c
d
e
f
g
Demand a CT environment that better facilitates the execution of CTs
Ingrid Maes – Economic footprint of CTs in Belgium
Stakeholders recommendations
1. Actual situation on clinical trials in Belgium
2. Future evolutions in clinical research
3. Conclusions and recommendations
13 Ingrid Maes – Economic footprint of CTs in Belgium
Content
14
Past Now Future
2006 2012 2020
Future evolutions
Ingrid Maes – Economic footprint of CTs in Belgium
Trends in clinical trials
Future Trends
Evidence Based Medicine evolves to a
continuous process of data gathering in
clinical practice
More collaborative models
More evidence required for and from early
development
New EU regulatory environment
15
Opportunity
Increased demand for post approval
continous data gathering, reimbursment
renewals (live-licensing)
Create a network of expertise centres
Translational research will drive
additional data gathering and CTs
Upgrade local expertise, ameliorate
legal framework for biobanks, maintain
timelines.
Ingrid Maes – Economic footprint of CTs in Belgium
Opportunities based on future environment to
boost clinical research activities in Belgium
16
What changes are needed for your organisation to allocate more CTs to Belgium?
Percentage of respondents that want...
(specialised research networks)
(patient recruitment)
Standardization
Networking
Transparency in CT costs
More efficient CT process
Better Ethical Committee
approval process
Tools for recruitment
Ingrid Maes – Economic footprint of CTs in Belgium
Stakeholder needs in order to allocate more
CTs in Belgium
17
LEAD: INFARMA
Advocacy activities (gov’t, industry, ...) & public education
Transparency (self-regulation doc, CT registry websites)
LEAD: LEEM & CeNGEPS (public-private)
Development of national network of CT centres
Patient recruitment (CT registry, website, awareness, ...)
LEAD: ABPI & MHRA
Improving legal framework (IPO, clarity, ...)
Access to information for industry (toolkits, web, routemaps, ...)
LEAD: NEFARMA
Standardization/one-stop shop concept (forms, contracts,...)
Professionalization (performance monitoring, training, ...)
Patient participation (volunteer registry, ...)
LEAD: MINISTRY OF HEALTH
“Healthy Growth” Plan
Improving conditions for private-public partnerships in health
research & innovation
PUBLIC-
PRIVATE
DRIVEN
SECTOR
DRIVEN
LEAD: Pharma.be
Standardization of documents ( IC, contracts...)
Professionalization (website, working groups with agencies)
Ingrid Maes – Economic footprint of CTs in Belgium
Initiatives taken by EU countries to attract CTs
18
“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)
Ingrid Maes – Economic footprint of CTs in Belgium
Relevance of other country best practices for
Belgium
1. Actual situation on clinical trials in Belgium
2. Future evolutions in clinical research
3. Conclusions and recommendations
19 Ingrid Maes – Economic footprint of CTs in Belgium
Content
20
STRATEGIC INITIATIVES RECOMMENDATIONS
Network of Specialised Centres (CoE)
with specific patient populations
Supportive Governmental Framework
Standardisation
One stop shop
2 1
3
Build expertise
networks
Share best
practices &
ethical know-how
Improve access
to patients, target
groups
of patients,
pathology
orientation
Build CT & Patient Registry through IT portal
Standardisation & uniformisation
Facilitate access to innovative drugs & cap costs
Provide supportive incentives
Public/Private
coordination
hub
Standardise &
Centralise
Stronger
branding
Improve access
to patients
Ingrid Maes – Economic footprint of CTs in Belgium
3 key Strategic Initiatives can help attract
more CTs to Belgium
21
Standardization
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
Strategic Initiatives
1
Ingrid Maes – Economic footprint of CTs in Belgium
Actions proposed to each of the different
stakeholders
22
Standardization 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
Strategic Initiatives
1 2
Ingrid Maes – Economic footprint of CTs in Belgium
Actions proposed to each of the different
stakeholders
23
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
Strategic Initiatives
1 2 3
Ingrid Maes – Economic footprint of CTs in Belgium
Actions proposed to each of the different
stakeholders
Standardisation
(One stop shop)
24
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:
Network of
Specialised
Centres
Supportive
Governmental
Framework
Ingrid Maes – Economic footprint of CTs in Belgium
Conclusions
25
Contact
Ingrid Maes
ingrid.maes@pwc.be
www.pwc.be/pharma
www.pwc.com/be/healthcare
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Sponsored by:
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PwCon behalf of:
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PwCon behalf of:
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Ingrid Maes – Economic footprint of CTs in Belgium
Thank you!