0 D6.3 Refined list of the relevant models addressing sustainability for all
stakeholders
777450 - PARADIGM
Patients Active in Research and Dialogues for an Improved Generation of Medicines
WP6 Sustainability Strategy
Lead contributor Vinciane Pirard (31 SARD) (SANOFI) Elisa Ferrer (2 EURORDIS)
Vinciane.Pirard@Sanofi.com elisa.ferrer@eurordis.org Other contributors Virginie Hivert (2 EURORDIS)
Kirsty Reid (14 EFPIA) Magda Chlebus (14 EFPIA) Eva Molero (13 SYNAPSE) Michael Wilbur (2 EURORDIS) Karina Huberman (3 EATG) Giulio Corbelli (3 EATG) Mathieu Boudes (1 EPF) Matthew May (1 EPF)
Nicholas Brooke (12 The Synergist) Daniel O’Connor (PILG, MHRA)
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Due date 31/10/2019
Delivery date 17/12/2019 Deliverable type R
Dissemination level CO
Description of Action Version Date
V1.3 17/12/2019
2 Table of Contents
Document History ... 3
Definitions ... 4
1. Publishable Summary ... 6
2. Introduction and objectives ... 7
3. Methodology... 8
4. Scenarios presented for consultation ... 10
5. Results of the consultation ... 10
5.1. Top-down signal: positive vs negative attributes ... 11
5.2. Reinforced by practice: positive vs negative attributes ... 12
5.3. One-stop shop approach: positive vs negative attributes ... 13
5.4. Patient engagement market approach: positive vs negative attributes ... 15
6. Limitations of this document ... 17
7. Conclusions and next steps ... 17
Annex 1: Consultation document and survey ... 19
Contents ... 21
Introduction and objectives ... 22
Instructions to answer the consultation ... 24
SCENARIO 1 TOP DOWN SIGNAL ... 25
Critical success factors for Scenario 1A and 1B to be successful ... 27
SCENARIO 2 REINFORCED BY PRACTICE ... 28
Critical success factors for Scenario 2A and 2B to be successful ... 30
References ... 31
Consultation survey – for preparation ... 32
Annex 1: Patient Engagement Market approach ... 33
3 Document History
Version Date Description V1.0 31/10/2019 First Draft V1.1 20/11/2019 Comments V1.2 4/12/2019 Second Draft V1.3 17/12/2019 Final Version
4 Definitions
Partners of the PARADIGM Consortium are referred to herein according to the following codes:
- EPF. EUROPEAN PATIENTS FORUM (Luxembourg) – Project Coordinator
- EURORDIS. EUROPEAN ORGANISATION FOR RARE DISEASES ASSOCIATION (France) - EATG. EUROPEAN AIDS TREATMENT GROUP (Germany)
- AE. ALZHEIMER EUROPE (Luxembourg) - AIFA. AGENZIA ITALIANA DEL FARMACO (Italy)
- HTAi. HEALTH TECHNOLOGY ASSESSMENT INTERNATIONAL (Canada) - IACS. INSTITUTO ARAGONES DE CIENCIAS DE LA SALUD (Spain) - FSJD. FUNDACIO SANT JOAN DE DEU (Spain)
- VU-ATHENA. STICHTING VU (The Netherlands)
- UOXF-CASMI. THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD (United Kingdom)
- EFGCP. EUROPEAN FORUM FOR GOOD CLINICAL PRACTICE (Belgium) - SYNERGIST. THE SYNERGIST (Belgium)
- SYNAPSE. SYNAPSE RESEARCH MANAGEMENT PARTNERS SL (Spain)
- EFPIA. EUROPEAN FEDERATION OF PHARMACEUTICAL INDUSTRIES AND ASSOCIATIONS (Belgium) - Project Leader
- MSD Corp. MERCK SHARP & DOHME CORP (United States) - UCB. UCB BIOPHARMA SPRL (Belgium)
- ABPI. THE ASSOCIATION OF THE BRITISH PHARMACEUTICAL INDUSTRY (United Kingdom) - AMGEN. AMGEN LIMITED (United Kingdom)
- BAYER. BAYER AKTIENGESELLSCHAFT (Germany)
- GSK. GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT (United Kingdom) - GRT. GRUENENTHAL GMBH (Germany)
- JANSSEN. JANSSEN PHARMACEUTICA NV (Belgium) - LILLY. Eli Lilly and Company Limited (United Kingdom) - LUNDBECK. H. LUNDBECK AS (Denmark)
- MERCK. MERCK KOMMANDITGESELLSCHAFT AUF AKTIEN (Germany) - NOVO NORDISK. NOVO NORDISK A/S (Denmark)
- PFIZER. PFIZER LIMITED (United Kingdom)
- ROCHE. F. HOFFMANN-LA ROCHE AG (Switzerland)
- SERVIER. INSTITUT DE RECHERCHES INTERNATIONALES SERVIER (France) - VFA. VERBAND FORSCHENDER ARZNEIMITTELHERSTELLER EV (Germany) - SARD. SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT (France) - NOVARTIS. NOVARTIS PHARMA AG (Switzerland)
- COVANCE. COVANCE LABORATORIES LTD (United Kingdom) - ALEXION. ALEXION SERVICES EUROPE (Belgium)
Consortium. The PARADIGM Consortium, comprising the above-mentioned legal entities
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Consortium Agreement. Agreement concluded amongst PARADIGM participants for the implementation of the Grant Agreement. Such an agreement shall not affect the parties’ obligations to the Community and/or to one another arising from the Grant Agreement.
PILG. PARADIGM International Liaison Group
6 1. Publishable Summary
The present deliverable includes the final steps of the path described in D6.2 to identify the core components of potential scenarios -and their respective interrelationships- designed to ensure the sustainability of the patient engagement practices and of the whole supportive ecosystem.
Here we describe the sustainability scenarios that were the subject of a consultation. The main objective of the consultation was to identify the preferences of PARADIGM stakeholders with regards to core components addressing the long-term sustainability of PE. Results showed a preference towards the need for a strong signal making patient engagement almost mandatory in medicine development, combined with a diverse and broad offering of services developed by a multitude of organisations. In this scenario, institutions (e.g. EMA, FDA) and organizations developing global standards (e.g. ICH, CIOMS guidelines) are important to drive the uptake of patient engagement and make it systematic. Stakeholder preferences will inform the sustainability road map defined in task 6.5.
