Paradigm

What Paradigm does

PARADIGM (Patients Active in Research and Dialogues for an Improved Generation of Medicines) is a public-private partnership and framework project for patient engagement in the medicines development lifecycle. Operated under the Innovative Medicines Initiative 2 (IMI2) and co-led by the European Patients' Forum (EPF) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), the project ran from 1 March 2018 to 31 August 2020 and assembled a 34-member consortium of pharmaceutical companies (Janssen, Novartis, GSK, Bayer, Pfizer, Roche, MSD, Novo Nordisk), patient organizations (EURORDIS, EATG, Alzheimer Europe), regulatory bodies (EMA), HTA agencies (HTAi), and academic institutions (University of Oxford, VU Amsterdam).

The project's core technology is the PARADIGM Patient Engagement Toolbox, a centralized repository of co-created recommendations, tools, templates, and frameworks targeting three key decision-making points: research priority setting, clinical trial design, and early dialogues with regulators and HTA bodies. Notable technical components include a Code of Conduct for Patient Engagement, a Monitoring and Evaluation Framework with 87 metrics across four evaluation components, an 8-document Community Advisory Boards Toolkit, Conflict of Interest Management Tools, Enhanced EUPATI Industry Guidance, Patient Representative Identification recommendations, reporting/dissemination guidance, and required-capability recommendations. All outputs are freely distributed through the project website in multiple languages.

PARADIGM does not operate a commercial revenue model. It was funded through IMI2 Joint Undertaking under grant agreement no 777450, with total funding estimated at €23.4 million, sourced from the European Union's Horizon 2020 research programme and EFPIA. All deliverables are provided at no cost. The project's primary 'users' are pharmaceutical and biotechnology companies, HTA bodies, patient organizations, regulatory authorities, and academic research institutions, with distribution supported by the PARADIGM International Liaison Group (PILG) network of 13+ aligned organizations. Operating status is closed as of the formal project end date.

Name

Paradigm

Legal name

PARADIGM (Patients Active in Research and Dialogues for an Improved Generation of Medicines)

Website

https://imi-paradigm.eu

Company type

Private

Founded year

2018

Operating status

Closed

Headcount range

51–100 employees

Short description

PARADIGM is a now-closed IMI2 public-private partnership that built a co-created framework and toolbox for structured patient engagement across the medicines development lifecycle, serving pharma companies, HTA bodies, regulators, patient organizations, and academia.

Ownership category

akta.pro rank

Product category

Patient Engagement Research Services

NAICS

Scientific Research and Development Services (5417), Professional, Scientific, and Technical Services (541)

SIC

Services-Health Services (8000), Services-Misc Health & Allied Services, Nec (8090)

akta.pro primary industry

Patient Education, Content & Personalized Journey Orchestration (HLACAEAE)

akta.pro secondary industry

Care Management & Coordination Platforms (case/disease management workflows) (HLACAHAD)

Keywords

• Patient engagement frameworks
• Medicines development tools
• Clinical trial design
• Health technology assessment
• Patient advocacy resources

Headquarters

HQ city

Brussels

HQ country

Belgium

HQ region

Europe

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales

Distribution channels2 records

Marketing channels7 records

Core offering

PARADIGM provides co-created recommendations, tools, and background information through its Patient Engagement Toolbox to enable structured, effective, meaningful, ethical, and sustainable patient engagement across the medicines development lifecycle. The framework targets three key decision-making points—research priority setting, clinical trial design, and early dialogues with regulators and HTA bodies—and includes specialized sub-products such as a Monitoring and Evaluation Framework with 87 metrics, a Community Advisory Boards Toolkit, a Code of Conduct, conflict of interest management tools, and capability recommendations.

Product overview

PARADIGM (Patients Active in Research and Dialogues for an Improved Generation of Medicines) is a public-private partnership providing a framework for meaningful, impactful, ethical, and sustainable patient engagement across the medicines development lifecycle. The core offering is the PARADIGM Patient Engagement Toolbox, which houses multiple co-created tools and resources targeting three key decision-making points: research priority setting, design of clinical trials, and early dialogues with regulators and HTA bodies. The toolbox includes specialized sub-tools for specific stakeholder needs such as HTA bodies, monitoring and evaluation frameworks, community advisory board guidance, conflict of interest management, industry working practices enhancement, patient representative identification, reporting standards, and capability recommendations.

Differentiator

Problem solved

Functional benefit

Products and services

• PARADIGM Patient Engagement Toolbox A centralized hub of co-created recommendations, tools, and relevant background information designed to make patient engagement in medicines development easier for pharmaceutical companies, patient organizations, regulatory bodies, HTA agencies, and academic institutions.
• Patient Engagement in Early Dialogues: Tools for HTA Bodies Adaptable tools and resources for Health Technology Assessment (HTA) bodies to simplify patient engagement processes in Early Dialogues with regulators and medicines developers. Co-developed with the HTAi Patient & Citizen Involvement in HTA Interest Group.
• Patient Engagement Monitoring and Evaluation Framework A framework with 87 metrics organized across four key evaluation components—Input, Activities/Process, Learning and Change, Impact—plus 15 contextual factors to help stakeholders self-evaluate patient engagement in medicines development and measure return on engagement.
• Community Advisory Boards (CABs) Toolkit Guidance document and templates containing 8 documents to support patient communities and pharmaceutical companies in setting up, running, or engaging with Community Advisory Boards.
• Code of Conduct for Patient Engagement An overarching code defining common values, ethical principles, and rules for collaboration among all stakeholders involved in patient engagement activities within medicines development, including contractual framework, conflict of interest, and representativeness guidance.
• Conflict of Interest Management Tools A set of tools including guidance documents, short guidance, activity logs, and educational scenarios to help manage competing interests and conflicts of interest in multi-stakeholder patient engagement environments.
• Enhanced EUPATI Industry Guidance Enhanced sections of the EUPATI Guidance for Patient Involvement in Medicines R&D, including suggested working practices and events/hospitality checklists for pharmaceutical industry-led activities.
• Recommendations on Identification of Patient Representatives Guidance on how to find the right match for patient engagement activities, including recommendations on elements for identifying patients and their representatives, competency tables, and selection methods.
• Guidance for Reporting and Dissemination of Patient Engagement Activities Practical guidance including guiding principles, checklists, and templates to help organizations develop adequate reporting and dissemination plans for patient engagement activities.
• Recommendations on Required Capabilities for Patient Engagement Recommendations on competencies (knowledge, skills, and behaviours) and resources that stakeholder organizations should have to plan, implement, and evaluate meaningful patient engagement activities, building on PFMD's Patient Engagement Quality Guidance.

Quantifiable outcome

• 87 validated metrics for monitoring and evaluating patient engagement impact across medicines development lifecycle
• +2 more outcomes

Segments5 records

Ideal customer profiles5 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

16 partnerships are on record, tiered core (co-lead), flagship and major.

• European Patients' Forum (EPF)core (co-lead)Strategic or Co-development PartnerPARADIGM is co-led by European Patients' Forum, which serves as a key partner in developing patient engagement frameworks and ensuring the patient voice is central to all project activities. EPF provides leadership through Secretary-General Nicola Bedlington.
• EFPIA (European Federation of Pharmaceutical Industries and Associations)core (co-lead)Strategic or Co-development PartnerEFPIA co-leads PARADIGM representing the pharmaceutical industry perspective. Director Science Policy Magda Chlebus represents EFPIA in the consortium. EFPIA provides industry expertise and helps ensure frameworks are practical for pharma companies.
• Patient Focussed Medicines Development (PFMD)flagshipStrategic or Co-development PartnerPFMD collaborates with PARADIGM on patient engagement frameworks and tools. Nicholas Brooke from PFMD participates in PILG. PFMD's Patient Engagement Quality Guidance serves as underlying framework for PARADIGM's capability recommendations.
• European Patient Academy on Therapeutic Innovation (EUPATI)flagshipStrategic or Co-development PartnerEUPATI focuses on patient education and training. The PILG includes EUPATI representation, and PARADIGM builds upon and aligns with EUPATI platforms and resources.
• HTAi (Health Technology Assessment International)majorStrategic or Co-development PartnerHTAi Patient & Citizen Involvement in HTA Interest Group co-developed the HTA Early Dialogues toolkit. Neil Bertelsen and Ann Single contributed as main authors. HTAi provides methodology support for HTA body engagement tools.
• Janssen (Pharmaceutical Companies of Johnson & Johnson)majorStrategic or Co-development PartnerJanssen is an active consortium member with Daniel De Schryver (Patient Engagement and Advocacy Lead EMEA) contributing to multiple tools including CABs toolkit and Code of Conduct. Represents 'with patients' approach in the consortium.
• NovartismajorStrategic or Co-development PartnerNovartis contributes through Laura McKeaveney (Global Head of Patient Advocacy) and Michaela Dinboeck (Senior Director Patient Engagement) to multiple project deliverables. Strong commitment to patient involvement in medicine development.
• GSK (GlaxoSmithKline)majorStrategic or Co-development PartnerGSK participates with Kay Warner (Patient Engagement Lead) as main author on EUPATI enhancement tools and other resources. Represents 'Patients in Partnership' approach.
• Bayer AGmajorStrategic or Co-development PartnerBayer contributes through Dr. Matthias Gottwald (Head of R&D Policy and Networking) and Wolf See (coordination of multiple tools). Provides industry leadership on patient engagement practices.
• RochemajorStrategic or Co-development PartnerRoche participates through Irmi Gallmeier (Senior International Health Policy Leader) and Iris Van den Brande contributing to various work packages and tools.
• European Medicines Agency (EMA)majorStrategic or Co-development PartnerEMA Head of Public Engagement Juan Garcia Burgos supports PARADIGM, seeing it as opportunity to agree on key principles for patient engagement. EMA contributes to ensuring frameworks inform regulatory practice.
• EURORDIS (Rare Diseases Europe)majorStrategic or Co-development PartnerEURORDIS contributes through Elisa Ferrer, Maria Cavaller, and Virginie Hivert as main authors of conflict of interest tools and PE capabilities recommendations. Represents rare disease patient perspective.
• European AIDS Treatment Group (EATG)majorStrategic or Co-development PartnerEATG is an active consortium member with Koen Block (Executive Director) and Karina Huberman contributing to coordination and multiple tools including CABs, conflict of interest, and code of conduct.
• Alzheimer EuropemajorStrategic or Co-development PartnerAlzheimer Europe represents Jean Georges (Executive Director) and contributes Ana Diaz as main author on reporting/dissemination and CABs tools. Focuses on dementia patient involvement in research.
• University of OxfordmajorStrategic or Co-development PartnerOxford University contributes Stuart Faulkner (Programme and Operations Manager) and Laiba Husain as main authors on reporting and M&E tools. Provides academic rigor to framework development.
• Vrije Universiteit Amsterdam (VU Amsterdam)majorStrategic or Co-development PartnerVU Amsterdam's Athena Institute contributes Lidewij Vat, Callum Gunn, and Jacqueline Broerse as main authors of the Monitoring and Evaluation Framework. Leads participatory action research methodology.

Scale indicators3 records

Recent moves6 records

Expansion highlights4 records

Direct peers

• Patient Focused Medicines Development (PFMD): PFMD is a multi-stakeholder collaborative that, like PARADIGM, builds co-created patient engagement frameworks and quality guidance used across medicines development; PARADIGM's PE Capability recommendations explicitly build on PFMD's Patient Engagement Quality Guidance, making them the closest direct peer.
• TransCelerate BioPharma: TransCelerate is a pharma consortium developing shared solutions to streamline drug development, including patient engagement and clinical trial efficiency initiatives; member overlap with PARADIGM and shared goal of harmonizing industry R&D practices make it a direct peer.
• EURORDIS - Rare Diseases Europe: EURORDIS is a major PARADIGM consortium member contributing to conflict-of-interest and PE capabilities tools, and operates its own patient engagement programs across rare disease drug development, making it both a collaborator and parallel patient engagement framework-builder.
• Clinical Trials Transformation Initiative (CTTI): CTTI is a multi-stakeholder initiative developing evidence-based practices to improve clinical trials, including patient engagement recommendations; it overlaps directly with PARADIGM's clinical trial design decision point.
• European Patient Academy on Therapeutic Innovation (EUPATI): EUPATI is an IMI-funded patient education and training initiative that produces patient-expert training and guidance for medicines R&D, with which PARADIGM co-developed 'Enhanced EUPATI Industry Guidance'; both address patient capacity-building for engagement across the medicines lifecycle.

Broad incumbents

• Drug Information Association (DIA): DIA is an established global life sciences professional association running working groups and conferences on patient engagement in drug development; it serves as a broader-platform incumbent that hosts and disseminates patient engagement frameworks comparable to PARADIGM's.

Regional players

• PCORI (Patient-Centered Outcomes Research Institute): PCORI is a US-based non-profit funding comparative clinical effectiveness research with mandated patient engagement, comparable in mission to PARADIGM's patient involvement in research priority setting; it operates primarily under US funding and regulatory context.
• NIHR (National Institute for Health and Care Research) Patient and Public Involvement: NIHR's INVOLVE/PPI program is the UK's national patient and public involvement infrastructure for health and social care research, sharing PARADIGM's mission of embedding patient voices in research but operating primarily in a UK regulatory and funding context rather than pan-European.

Others

• European Medicines Agency (EMA) Patient Engagement: EMA is a PARADIGM consortium member and operates its own patients and consumers working party and engagement frameworks for regulatory processes; as a regulator and framework-publisher rather than a competitive initiative, it is an adjacent enabling stakeholder in the same ecosystem.

Emerging players

• Cochrane Consumer Network: Cochrane's Consumer Network engages patients and caregivers in evidence synthesis and systematic review production; while primarily evidence-review focused, it shares PARADIGM's ethos of meaningful patient involvement in research and overlaps on methods and best practices.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/imi_paradigm
• LinkedInlinkedin.com/company/imi-paradigm-patient-engagement

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about Paradigm