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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 €

EC-Contrib. €

Partnership

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Outcomes and
results

ADAPT-SMART project word cloud

Explore the words cloud of the ADAPT-SMART project. It provides you a very rough idea of what is the project "ADAPT-SMART" about.

exploring progress realize publications health adaptive collectively align adapt communication collaborative payers life advice paradigms benefits environment bodies sciences pilot act htas imi share aligning stakeholders smart learnings accelerate conference outcomes actors regulators presentations limited position medicines recommendations healthcare treatments therapies actively relevance synthesis engage industry ecosystem probability platform successful leverage proposals eager technologies governments smes pharmaceutical clinicians market neutral actionable csa therapeutic background adaptations patients mapps

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 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.	NL (UTRECHT)	coordinator	522˙000.00
2	NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Organization address address: LEVEL 1A CITY TOWER PICCADILLY PLAZA city: MANCHESTER postcode: M1 4BT website: www.nice.org.uk contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (MANCHESTER)	participant	232˙500.00
3	THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD Organization address address: WELLINGTON SQUARE UNIVERSITY OFFICES city: OXFORD postcode: OX1 2JD website: www.ox.ac.uk contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (OXFORD)	participant	135˙500.00
4	EURORDIS - EUROPEAN ORGANISATION FOR RARE DISEASES ASSOCIATION EURORDIS - EUROPEAN ORGANISATION FOR RARE DISEASES ASSOCIATION Organization address address: RUE DIDOT 96 city: Paris postcode: 75014 website: www.eurordis.org contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (Paris)	participant	78˙000.00
5	FORUM EUROPEEN DES PATIENTS (FPE) FORUM EUROPEEN DES PATIENTS (FPE) Organization address address: RUE DICKS 14 city: LUXEMBOURG postcode: 1417 website: http://www.eu-patient.eu/ contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	LU (LUXEMBOURG)	participant	78˙000.00
6	AGENZIA ITALIANA DEL FARMACO AGENZIA ITALIANA DEL FARMACO Organization address address: VIA DEL TRITONE 181 city: ROMA postcode: 187 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IT (ROMA)	participant	28˙000.00
7	HAUTE AUTORITE DE SANTE HAUTE AUTORITE DE SANTE Organization address address: AVENUE DU STADE DE FRANCE 5 city: SAINT DENIS LA PLAINE CEDEX postcode: 93218 website: http://www.has-sante.fr/portail/jcms/j_5/accueil contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (SAINT DENIS LA PLAINE CEDEX)	participant	28˙000.00
8	ZORGINSTITUUT NEDERLAND ZORGINSTITUUT NEDERLAND Organization address address: EEKHOLT 4 city: DIEMEN postcode: 1112XH website: www.zorginstituutnederland.nl contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NL (DIEMEN)	participant	28˙000.00
9	AbbVie Ltd AbbVie Ltd Organization address address: Vanwall Road city: Maidenhead postcode: SL6 4XE website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (Maidenhead)	participant	0.00
10	AMGEN AMGEN Organization address address: Avenue Ariane 5 city: Bruxelles postcode: 1200 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	BE (Bruxelles)	participant	0.00
11	ASTELLAS PHARMA EUROPE LTD ASTELLAS PHARMA EUROPE LTD Organization address address: 2000 HILLSWOOD DRIVE city: CHERTSEY postcode: KT16 0RS website: www.astellas.eu contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (CHERTSEY)	participant	0.00
12	ASTRAZENECA AB ASTRAZENECA AB Organization address address: Vastra Maelarhamnen city: SODERTAELJE postcode: 151 85 website: www.astrazeneca.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	SE (SODERTAELJE)	participant	0.00
13	Bayer Pharma AG Bayer Pharma AG Organization address address: Muellerstrasse 178 city: Berlin postcode: 13353 website: www.bayerpharma.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (Berlin)	participant	0.00
14	BOEHRINGER INGELHEIM INTERNATIONALGMBH BOEHRINGER INGELHEIM INTERNATIONALGMBH Organization address address: BINGER STRASSE city: INGELHEIM postcode: 55218 website: www.boehringerâ€ingelheim.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (INGELHEIM)	participant	0.00
15	BRISTOL-MYERS SQUIBB COMPANY CORP BRISTOL-MYERS SQUIBB COMPANY CORP Organization address address: PARK AVENUE 345 city: NEW YORK postcode: 10154 website: http://www.bms.com/landing/data/index.html contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	US (NEW YORK)	participant	0.00
16	Eli Lilly and Company Limited Eli Lilly and Company Limited Organization address address: Lilly House, Priestley Road city: Basingstoke postcode: RG24 9NL website: www.lilly.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (Basingstoke)	participant	0.00
17	F. HOFFMANN-LA ROCHE AG F. HOFFMANN-LA ROCHE AG Organization address address: GRENZACHERSTRASSE 124 city: BASEL postcode: 4070 website: www.roche.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	CH (BASEL)	participant	0.00
18	FEDERATION EUROPEENNE D'ASSOCIATIONS ET D'INDUSTRIES PHARMACEUTIQUES FEDERATION EUROPEENNE D'ASSOCIATIONS ET D'INDUSTRIES PHARMACEUTIQUES Organization address address: RUE DU TRONE 108/1 city: BRUXELLES postcode: 1050 website: www.efpia.eu contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	BE (BRUXELLES)	participant	0.00
19	GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT LTD. GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT LTD. Organization address address: Great West Road 980 city: BRENTFORD postcode: TW89GS website: www.gsk.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (BRENTFORD)	participant	0.00
20	H. LUNDBECK AS H. LUNDBECK AS Organization address address: OTTILIAVEJ 7-9 city: VALBY postcode: 2500 website: www.lundbeck.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DK (VALBY)	participant	0.00
21	INSTITUT DE RECHERCHES INTERNATIONALES SERVIER INSTITUT DE RECHERCHES INTERNATIONALES SERVIER Organization address address: RUE CARNOT 50 city: SURESNES postcode: 92284 website: www.servier.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (SURESNES)	participant	0.00
22	IPSEN INNOVATION SAS IPSEN INNOVATION SAS Organization address address: AVENUE DU CANADA - ZONE INDUSTRIELLE DE COURTABOEUF 5 city: LES ULIS postcode: 91940 website: http://www.ipsen.com/fr contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (LES ULIS)	participant	0.00
23	JANSSEN PHARMACEUTICA NV JANSSEN PHARMACEUTICA NV Organization address address: TURNHOUTSEWEG 30 city: BEERSE postcode: 2340 website: www.janssenpharmaceutica.be contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	BE (BEERSE)	participant	0.00
24	LYSOGENE LYSOGENE Organization address address: 18-20 RUE JACQUES DULUD city: NEUILLY SUR SEINE postcode: 92200 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (NEUILLY SUR SEINE)	participant	0.00
25	MASSACHUSETTS INSTITUTE OF TECHNOLOGY MASSACHUSETTS INSTITUTE OF TECHNOLOGY Organization address address: MASSACHUSETTS AVENUE 77 city: CAMBRIDGE postcode: 2139 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	US (CAMBRIDGE)	participant	0.00
26	MERCK KOMMANDITGESELLSCHAFT AUF AKTIEN MERCK KOMMANDITGESELLSCHAFT AUF AKTIEN Organization address address: FRANKFURTER STRASSE 250 city: DARMSTADT postcode: 64293 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (DARMSTADT)	participant	0.00
27	MERCK SHARP & DOHME CORP MERCK SHARP & DOHME CORP Organization address address: ONE MERCK DRIVE city: WHITEHOUSE STATION NJ postcode: 8889 website: www.merck.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	US (WHITEHOUSE STATION NJ)	participant	0.00
28	NOVARTIS PHARMA AG NOVARTIS PHARMA AG Organization address address: LICHTSTRASSE 35 city: BASEL postcode: 4056 website: www.novartis.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	CH (BASEL)	participant	0.00
29	NOVO NORDISK A/S NOVO NORDISK A/S Organization address address: NOVO ALLE 1 city: BAGSVAERD postcode: 2880 website: www.novonordisk.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DK (BAGSVAERD)	participant	0.00
30	PFIZER LIMITED PFIZER LIMITED Organization address address: RAMSGATE ROAD city: SANDWICH postcode: CT13 9NJ website: www.pfizer.co.uk contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (SANDWICH)	participant	0.00
31	SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT Organization address address: Pierre Brossolette 1 city: Chilly Mazarin postcode: 91380 website: www.sanofi-aventis.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (Chilly Mazarin)	participant	0.00
32	SHIRE INTERNATIONAL GMBH SHIRE INTERNATIONAL GMBH Organization address address: ZAHLERWEG 10 city: ZUG postcode: 6300 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	CH (ZUG)	participant	0.00
33	SUNDHEDSSTYRELSEN SUNDHEDSSTYRELSEN Organization address address: ISLANDS BRYGGE 67 city: KOBENHAVN postcode: 2300 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DK (KOBENHAVN)	participant	0.00
34	THE EUROPEAN MEDICINES AGENCY THE EUROPEAN MEDICINES AGENCY Organization address address: 30 CHURCHILL PLACE CANARY WHARF city: LONDON postcode: E14 5EU website: http://www.ema.europa.eu/ contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (LONDON)	participant	0.00
35	UCB BIOPHARMA SRL UCB BIOPHARMA SRL Organization address address: ALLEE DE LA RECHERCHE 60 city: BRUXELLES postcode: 1070 website: www.ucb.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	BE (BRUXELLES)	participant	0.00

Map

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.

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 â€“ 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 stakeholderâ€™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.

Publications

List of publications.
year	authors and title	journal	last update
2018	Hans-Georg Eichler, Richard Barker, Nicola Bedlington, Jacoline C. Bouvy, AndrÃ© W. Broekmans, Anna Bucsics, Francesca Cerreta, Solange Corriol-Rohou, Alicia Granados, Yann Le Cam, Ad Schuurman The evolution of adaptiveness: balancing speed and evidence published pages: , ISSN: 1474-1776, DOI: 10.1038/nrd.2018.90	Nature Reviews Drug Discovery	2019-05-16
2017	C. Sapede Patient Access in the Context of Adaptive Pathways for Medicines: What Could Make It Work? published pages: 11-13, ISSN: , DOI:	Value and Outcomes Spotlight	2019-05-15
2018	Hans-Georg Eichler, Nicola Bedlington, Mathieu Boudes, Jacoline C. Bouvy, AndrÃ© W. Broekmans, Francesca Cerreta, Stuart D. Faulkner, Sue Forda, Angelika Joos, Yann Le Cam, Mark Mayer, Vinciane Pirard, Solange Corriol-Rohou Medicines Adaptive Pathways to Patients: Why, when and how to engage? published pages: , ISSN: 0009-9236, DOI: 10.1002/cpt.1121	Clinical Pharmacology & Therapeutics	2019-05-15

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