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Governance in DRIVE - Laurence Torcel-Paignon Sanofi Pasteur

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

Published in: Health & Medicine
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Governance in DRIVE - Laurence Torcel-Paignon Sanofi Pasteur

  1. 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. 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. 3. From IMI structure to DRIVE project IMI DRIVE
  4. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 18. Any questions?
  19. 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.

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