DRIVE Annual Forum 17th -18th September 2018, Rome

1. Acknowledgement
DRIVE project has received funding from the Innovative
Medicines Initiative 2 Joint Undertaking under grant
agreement No 777363, This Joint Undertaking receives
support from the European Union’s Horizon 2020
research and innovation programme and EFPIA.
Governance in DRIVE
Acknowledgement
DRIVE project has received funding from the Innovative
Medicines Initiative 2 Joint Undertaking under grant
agreement No 777363, This Joint Undertaking receives
support from the European Union’s Horizon 2020
research and innovation programme and EFPIA.
Laurence Torcel-Pagnon – Sanofi Pasteur
on behalf of WP1
DRIVE Annual Forum
17th-18th September 2018, Rome

2. From IMI Governance to DRIVE adaptation
IMI structure
Public-private
partnership
 Shared decision making
 Co-lead for activities
 Joint contribution
 Transparency of
interactions
 External Independant
advice
 Large participatory forum
DRIVE
Generation of brand specific
Vaccine Effectiveness
 One work package under public
health institutes oversight (studies
conduct)
 Limited EFPIA contribution providing
written comments on studies
through Independent Scientific
committee
 Independent Scientific Committee
responsible for review & approval of
studies documents
 EFPIA part of Quality Control and
Audit Committee to fulfill regulatory
obligations

3. From IMI structure to DRIVE project
IMI
DRIVE

4. Steering committee
Composition
50/50 parity between public
consortium and EFPIA
 16 members (work
package leaders and
coordinators)
Composition, members , Role and responsibilities, voting rights
Roles and Responsibilities
 Ensure alignment of activities
between the WPs and progress
towards common goal of success in
the Project
 Review and approve the WP1 to WP6
deliverables
 Recommend and approve changes
(work, budget…) for endorsement by
the General Assembly
 Prepare Project activity reports,
periodic reports, risk management
procedures, quality assurance plans,
prior to submission to the IMI2 JU
 Ensure effective external
communication
Voting rights
Each member has one vote
Decisions will be taken by
75% attending or represented
members
One chairperson = the public
coordinator

5. Independent Scientific Committee
Composition
Independent external experts
 5 members
 Public coordinator as an
observer
Composition, members , Role and responsibilities
Roles and Responsibilities
 Review WP7 studies
documents (protocol, SAP,
report)
 Receive written feedback
from EFPIA
 Decide on integration of
EFPIA comments or organize
point by point response with
WP7
 Advise on the independence
and transparency of the
scientific review
Compensation
Only travel accomodations

6. Quality Control and Audit Committee
Composition
Independent external experts
and EFPIA qualified
representatives
 4 members
 Public coordinator as an
observer
Composition, members , Role and responsibilities
Roles and Responsibilities
 Ensure that adequate quality
control in performed on sites
and supervise auditing for
the WP7 studies to allow
EFPIA fulfilling regulatory
obligations
 Develop check list for overall
quality assessment to
improve sites quality of the
data
 Oversight sites audits
conducted by CRO (when
needed)
 Advice on compliance and
conflict of interest
management
Compensation
Only travel accomodations

7. Independent
Scientific Committee
Hector Izurieta
Liz Miller
Mark Miller
Stefania Salmaso
Marianne van der Sande
Advisory committee members
Quality Control and
Audit committee
Jaime Ballester
Coree Forman
Ann-Marie Kirby
Nathalie Lavis

8. Workpackage 7
studies
Public health institutes
leadership
Several contributors from
public consortium
Develop generic protocols
Collect sites data
Develop statistical analysis
plan
Perform pooled analysis
Write brand specific influenza
vaccine effectiveness report
Work packages: role and way of working
Workpackages 1 to 6 /8
Guidelines tools framework
Joint public and private
leadership
Several contributors from public
and private consortium
Develop study tools for
improvement
Define framework for brand
specificities
Develop communication plan
Work on governance guidance
and necessary adaptation
Identify research topics for call
for tender

9. Study platform governance
Quality Control &
Audit Committee
Independent external
experts and vaccine
manufacturers
Independent Scientific
Committee
Scientific oversight
Independent external experts
Work package 7
Studies conduct
Public action
Public
consortium
Steering Committee
Shared decision making
with equal voting rights
50% public-50% vaccine manufacturers
Public
consortium
Vaccine
manufacturers
Public health
professionals and
health providers
Competent
regulatory
authorities
Work package 5
Communication
Joint action
Public
consortium
Vaccine
manufacturers
Public
consortium
Work package
8
Ethics
Joint action
Public
consortium
Vaccine
manufacturers

10. • Provide yearly robust brand-specific influenza vaccine
effectiveness estimates in Europe, covering different
settings and target populations, communicating the
results to various stakeholders (mainly public health
professionals) and submitting the results to the
regulatory agencies as per EMA guidelines requirements.
Study platform objective

11. • Study design is carried out by public partners in Work Package
7 (WP7).
• Data collection is carried out at several independently
operating study sites. They remain owners of the data they
collect and are free to perform site analyses and to publicise
their own results.
• New collaborators are selected by the Steering Committee on
a yearly basis through a public call with pre-defined criteria.
• Pan-European pooled analyses are performed by
statisticians and data analysts at P95, a small-medium sized
enterprise.
Way of working

12. • Study documents (protocols, statistical analyses, reports and
publications) are assessed by the Independent Scientific
Committee (ISC). Vaccine manufacturers provide written
comments on these documents to the ISC. They are not
permitted access to the data or involvement in the conduct of
the studies.
Way of working

13. • The Quality Control and Audit Committee advises on
compliance and quality of the studies.
• Data quality control and audits are performed, if required,
by a third party on behalf of the vaccine manufacturers to meet
their regulatory requirements.
• Ethics requirements for the study platform are set by public
and private partners in Work Package 8 (WP8).
• A pan-European pooled analysis report is produced at the
end of each season by public partners in WP7, with brand-
specific influenza vaccine effectiveness estimates. This is jointly
submitted by all vaccine manufacturers to competent
authorities to fulfil their regulatory obligations.
Way of working

14. • Results are presented in scientific meetings and in peer-
reviewed publications by public partners and a summary is
published on the DRIVE website. Public and private partners in
Work Package 5 (WP5) communicate this to public health
professionals and health care providers.
Way of working

15. • Consortium of 15 partners committed to provide
project outputs to IMI and fulfilling expected
contributions along 5 years
• Research Agenda developed to address knowledge
gaps on influenza vaccine effectiveness
• Identify on what DRIVE should work on
• Develop synergies with other projects/initiatives/groups
• Identify gaps for call for tender
-> DRIVE invites Public health institutes and study sites
capable of researching influenza vaccine effectiveness to
join the network
Expansion of the Consortium

16. Public health institutes are welcome to join the DRIVE
project at any time to increase the data platform capacity
 Yearly, a public call for tenders is open (Mar–>Aug)
 open to any European organization, institution or network
 aims to fill in identified data gaps (settings, countries, populations,
brands) and to develop novel and innovative approaches
New comers will be invited
to participate in scientific and methodological discussions on studies
(lead by WP7)
to attend the Annual Forum meeting and contribute to the
discussions on innovative and approaches to influenza vaccine
effectiveness (lead by consortium)
Funding is coming from IMI not from Vaccines manufacturers
Governance for new comers

17. From a prototype to a sustainable platform
• Starting with one governance model (based on
ADVANCE guidelines)
• Yearly evaluation after each season
• collecting insights from DRIVE partners and perceptions from
external stakeholders
• Reviewing efficiency of governance process in place
 governance adaptation when needed implemented for
the next season
• After the 5 years project, propose a sustainable public-
private platform to generate brand specific influenza
vaccine effectiveness data
Governance evaluation and adaptation

18. Any questions?

19. www.drive-eu.org
Acknowledgement
DRIVE project has received funding from the Innovative
Medicines Initiative 2 Joint Undertaking under grant
agreement No 777363, This Joint Undertaking receives
support from the European Union’s Horizon 2020
research and innovation programme and EFPIA.