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ADAPT-SMART

Accelerated Development of Appropriate Patient Therapies: a Sustainable, Multi-stakeholder Approach from Research to Treatment-outcomes - Sofia ref.: 115890

Total Cost €

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EC-Contrib. €

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Partnership

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Project "ADAPT-SMART" data sheet

The following table provides information about the project.

Coordinator
STICHTING LYGATURE 

Organization address
address: JAARBEURSPLEIN 6
city: UTRECHT
postcode: 3521 AL
website: http://www.lygature.org/

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country Netherlands [NL]
 Project website http://www.adaptsmart.eu/
 Total cost 4˙064˙146 €
 EC max contribution 1˙130˙000 € (28%)
 Programme 1. H2020-EU.3.1.7.13. (Other)
 Code Call H2020-JTI-IMI2-2015-04-two-stage
 Funding Scheme IMI2-CSA
 Starting year 2015
 Duration (year-month-day) from 2015-07-01   to  2018-04-30

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    STICHTING LYGATURE NL (UTRECHT) coordinator 522˙000.00
2    NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE UK (MANCHESTER) participant 232˙500.00
3    THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD UK (OXFORD) participant 135˙500.00
4    EURORDIS - EUROPEAN ORGANISATION FOR RARE DISEASES ASSOCIATION FR (Paris) participant 78˙000.00
5    FORUM EUROPEEN DES PATIENTS (FPE) LU (LUXEMBOURG) participant 78˙000.00
6    AGENZIA ITALIANA DEL FARMACO IT (ROMA) participant 28˙000.00
7    HAUTE AUTORITE DE SANTE FR (SAINT DENIS LA PLAINE CEDEX) participant 28˙000.00
8    ZORGINSTITUUT NEDERLAND NL (DIEMEN) participant 28˙000.00
9    AbbVie Ltd UK (Maidenhead) participant 0.00
10    AMGEN BE (Bruxelles) participant 0.00
11    ASTELLAS PHARMA EUROPE LTD UK (CHERTSEY) participant 0.00
12    ASTRAZENECA AB SE (SODERTAELJE) participant 0.00
13    Bayer Pharma AG DE (Berlin) participant 0.00
14    BOEHRINGER INGELHEIM INTERNATIONALGMBH DE (INGELHEIM) participant 0.00
15    BRISTOL-MYERS SQUIBB COMPANY CORP US (NEW YORK) participant 0.00
16    Eli Lilly and Company Limited UK (Basingstoke) participant 0.00
17    F. HOFFMANN-LA ROCHE AG CH (BASEL) participant 0.00
18    FEDERATION EUROPEENNE D'ASSOCIATIONS ET D'INDUSTRIES PHARMACEUTIQUES BE (BRUXELLES) participant 0.00
19    GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT LTD. UK (BRENTFORD) participant 0.00
20    H. LUNDBECK AS DK (VALBY) participant 0.00
21    INSTITUT DE RECHERCHES INTERNATIONALES SERVIER FR (SURESNES) participant 0.00
22    IPSEN INNOVATION SAS FR (LES ULIS) participant 0.00
23    JANSSEN PHARMACEUTICA NV BE (BEERSE) participant 0.00
24    LYSOGENE FR (NEUILLY SUR SEINE) participant 0.00
25    MASSACHUSETTS INSTITUTE OF TECHNOLOGY US (CAMBRIDGE) participant 0.00
26    MERCK KOMMANDITGESELLSCHAFT AUF AKTIEN DE (DARMSTADT) participant 0.00
27    MERCK SHARP & DOHME CORP US (WHITEHOUSE STATION NJ) participant 0.00
28    NOVARTIS PHARMA AG CH (BASEL) participant 0.00
29    NOVO NORDISK A/S DK (BAGSVAERD) participant 0.00
30    PFIZER LIMITED UK (SANDWICH) participant 0.00
31    SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT FR (Chilly Mazarin) participant 0.00
32    SHIRE INTERNATIONAL GMBH CH (ZUG) participant 0.00
33    SUNDHEDSSTYRELSEN DK (KOBENHAVN) participant 0.00
34    THE EUROPEAN MEDICINES AGENCY UK (LONDON) participant 0.00
35    UCB BIOPHARMA SRL BE (BRUXELLES) participant 0.00

Mappa

 Project objective

Progress in the life sciences and related technologies offer great potential for therapeutic benefits to patients in need. However, major adaptations to current paradigms of bringing medicines to patients are required in order to realize that potential and to address important challenges in the healthcare ecosystem. Against this background, several initiatives are exploring new pathways to market, collectively referred to as Medicines Adaptive Pathways to Patients (MAPPs). The ADAPT-SMART consortium is aligning a limited number of major stakeholders eager to progress towards MAPPs implementation. It will act as a neutral collaborative platform that will engage industry, SMEs, regulators, Health Technology Assessment bodies (HTAs), payers, governments, clinicians and patients. The ADAPT-SMART consortium will contribute to align understanding of the impact of MAPPs, to share learnings between all stakeholders, and to allow the field to actively work towards MAPPs implementation. The impact of the ADAPT-SMART CSA will be a result of the delivery of • actionable advice/recommendations to IMI on how to best leverage results from past/current projects; • concrete proposals for future (IMI) projects; • actionable advice/recommendations and information to other actors in the healthcare environment; • synthesis of learnings from pilot projects and case studies with relevance to MAPPs; • communication of CSA outcomes by way of publications and conference presentations. This CSA will increase the probability of successful implementation of MAPPs and accelerate access to crucial therapies, thus improving the position of both the patients in need of novel treatments and the research-based pharmaceutical industry.

 Work performed, outcomes and results:  advancements report(s) 

 Deliverables

List of deliverables.
Identification of legal constraints for MAPPs Documents, reports 2019-10-08 14:17:21
Short report-horizon scanning of future IMI and non-IMI projects with release of a summary of the findings Documents, reports 2019-10-08 14:17:59
Operational portal to allow for internal team information Other 2019-10-08 14:17:41
Map of the different transition/engagement moments with stakeholders, and identify the information and data needs of these stakeholders at each of these moments Documents, reports 2019-10-08 14:17:15
Update D1.02 – Document- analysis of already completed IMI and non-IMI projects and their outputs Documents, reports 2019-10-08 14:18:05
Recommendations on applicability of managed entry agreements and pricing arrangements to possible adaptive scenarios Documents, reports 2019-10-08 14:17:39
Matrix that contrasts decision points in current vs. future processes by stakeholder groups and implications for a roadmap for implementation. (workshop in M7) Documents, reports 2019-10-08 14:17:17
Document-analysis of already completed IMI and non-IMI projects and their outputs Documents, reports 2019-10-08 14:17:45
Briefing documents during project about EMA pilots to relevant leads of the working groups in the project Documents, reports 2019-10-08 14:17:16
Create ADAPT SMART infographic Other 2019-10-08 14:17:48
Detailed work plan for each deliverable including staffing 1 Documents, reports 2019-10-08 14:17:40
Organisation of closing event Other 2019-10-08 14:18:03
Inventory and analysis of increased uncertainties for patients and other stakeholders and the issues these raise Documents, reports 2019-10-08 14:17:37
Proposal for pragmatic operational criteria for the respective decision(s) to use the MAPPs pathway, the timing and the stakeholders needed for this decision. (workshop in M6, briefing document M4) Documents, reports 2019-10-08 14:18:07
Detailed work plan for each deliverable including staffing 3 Documents, reports 2019-10-08 14:17:20
List of relevant stakeholders (and updated) Other 2019-10-08 14:17:42
Inventory/Paper on the available managed entry agreements, including pricing models and their experiences as judged by the different stakeholders Documents, reports 2019-10-08 14:17:42
Glossary with agreed operational definitions of the terms used in international literature Documents, reports 2019-10-08 14:18:08
Report with recommendations on current tools and systems to guide the appropriate use by the targeted patient groups, both at the European and national level (also input for D3.09). (workshop in M16) Documents, reports 2019-10-08 14:17:15
Review/paper on the ethical and legal aspects of prescribing and use by target populations Documents, reports 2019-10-08 14:17:40
Collaborative research proposals based on gap analysis Documents, reports 2019-10-08 14:18:08
Gap analysis and where appropriate recommendations for projects addressing enablers of decision making in an adaptive environment (e.g. managing uncertainties at HTA level). (interim: M6, M18) Documents, reports 2019-10-08 14:17:20
Position paper on the impact of adaptive licencing and adaptive access on IP and regulatory data protection periods and recommendations Documents, reports 2019-10-08 14:17:39
Project templates and materials for communication Other 2019-10-08 14:17:42
Six-monthly reports on project progress and completion (first in M6, then every 6 months) Documents, reports 2019-10-08 14:17:43
Points to consider document on ethical and legal aspects of adaptive decision-making and recommendations on how these can be addressed Documents, reports 2019-10-08 14:17:43
Project meetings scheduled and organized Other 2019-10-08 14:17:46
Management of IP Other 2019-10-08 14:17:45
Detailed work plan for each deliverable including staffing 2 Documents, reports 2019-10-08 14:18:06
Press releases (various releases during project) Other 2019-10-08 14:17:48
Project website Websites, patent fillings, videos etc. 2019-10-08 14:17:42
Select methods, toolset (such as the Janus program) and datasets to perform scenario studies in order to facilitate stakeholder’s engagement Documents, reports 2019-10-08 14:18:08
Reports to IMI (first in M18, then M30) Documents, reports 2019-10-08 14:17:45
Detailed project plans/tools for use by the consortium Documents, reports 2019-10-08 14:17:41
External communications plan (and updated) Documents, reports 2019-10-08 14:17:42

Take a look to the deliverables list in detail:  detailed list of ADAPT-SMART deliverables.

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The information about "ADAPT-SMART" are provided by the European Opendata Portal: CORDIS opendata.

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