Niels Westergaard, PhD, DScBiopeopleUniversity of CopenhagenDenmark

Building Knowledge & Competences for Patients’ Involvement in Medicines R&D

The project is receiving support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n° 115334, resources of which are composed of financial contribution from the European Union's Seventh Framework Programme (FP7/2007-2013) and EFPIA companies.

“Bring to life with EUPATI examples”

Why patient involvement

Industry

Doctors

PatientsParadigm shift

TodayAre largely unaware about: • Clinical trials• Translational research• Personalized medicine• Pharmacoeconomics • Their potential supportive roles in

those areas

EUPATI Vision for 2020Educate patients to be active in the Drug Development process – • Participation in clinical trials • Protocol design• Informed consent• Ethical review process, • Marketing authorization, • Value assessment • Healthcare policy• Others

Shared goal:Getting the right treatment to the

right patients

The EUPATI Paradigm

Getting the right information to the right people at the right time and in a useful format is just as important as developing the information in the first place

Diligent Approach

Iterative Process

Right informationUseful format

Right PeopleRight time

Tools:• Resource Review• Focus Groups across EU• EUPATI Nat. Platforms/• National Liaison Teams

Advisors:• Regulatory Advisory Panel• Project Advisory Board• Ethics Panel

Unique Product

Audiences: advocacy leaders and the public at large

EUPATI Certificate Training Programme Academic Modular Certificate Programme Patient Ambassadors in committees, R&D teams, … Patient Journalists raising awareness Patient Trainers for patient communities & networks

100 patient advocates

12.000patient advocates

100.000individuals

EUPATI Educational Toolbox Educational tools for patient advocates Variety of distributable formats: Paper-based booklets,

presentations, eLearning, webinars, videos etc.

EUPATI Internet Library Patients & lay public at large, e.g. on specific aspects of

the development process of medicines for patients with low (health) literacy.

Wiki, YouTube, films and/or cartoons

EUPATI Certificate Programme Syllabus (Audience 1)

The syllabus for the EUPATI certificate programme is divided into 6 distinct modules covering the complete process of medicines development.

Within each sub-topic, learning outcomes indicate what students will learn by completing the lessons.

Throughout the blended learning offering students should become familiar with the language used by the different stakeholders involved in medicines development, and be able to understand the relevance of guidelines set by the regulatory authorities.

EUPATI Certificate Programme Syllabus (Audience 1)

Discovery of Medicines & Planning of Medicines Development

Exploratory and Confirmatory Clinical Development

Regulatory Affairs, Medicinal product Safety, Pharmacovigilance

and Pharmaco-epidemiology

Non-Clinical Testing and Pharmaceutical Development

Clinical Trials

HTA and the economics of healthcare

6 Modules and 133 Topics

Syllabus examples (Audience 1)

Phases of clinical development: “Exploratory” and “Confirmatory” clinical development versus “Phases I-IV of clinical development”.

Describe the process of medicine development and identify critical factors and decisions points

Applicability of pharmacokinetics to dosage regimen and study design

Outline the basic principles of pharmakokinetics and their application to dose finding. Applicability of such principles in subsequent phases of drug development

Topic 3.1 – 3.14

3.1

3.8

Learning outcomes

Exploratory and Confirmatory Clinical Development

Syllabus examples (Audience 1)

Investigator Brochure: content, review and maintenance

Understand the purpose of the clinical investigator brochure  Explain and demonstrate the overall approval process ......

Critical review of clinical study report, publications and communications of study results to patients

Recognise the purpose of clinical study reports and publications

Critically analyse the communication of study results to patients

State the purpose and employment of different means to report patient outcomes (including ways in which patientient/PO can get involved

Topic 4.1 - 4.37

4.1

4.35

Learning outcomesClinical Trials

EUPATI Toolbox Topics (Audience 2)

The EUPATI Toolbox will take the form of an online resource centre that will provide comprehensive information on more than 100 different sub-topics of the medicines development process.

Users will be able to view material online and also download it for their own use as is, or as parts of their own work.

EUPATI Toolbox Topics; (Audience 2)

Discovery of Medicines & Planning of Medicines Development

Exploratory and Confirmatory Clinical Development

Regulatory Affairs, Medicinal product Safety, Pharmacovigilance

and Pharmaco-epidemiology

Non-Clinical Testing and Pharmaceutical Development

Clinical Trials

HTA and the economics of healthcare

Same principle as for Audience 1

Syllabus examples (Audience 2)

Investigator Brochure: content, review and maintenance

Critical review of clinical study report, publications and communications of study results to patients

Topic 4.1 - 4.37

4.1

4.35

No learning outcomes

Clinical Trials

What are we creating?

EUPATI Certificate Training Programmee-learning Classroom style face to face teachingEnglish

EUPATI Educational ToolboxRepository:- video, webcast, pdf, presentation, ebook, print ready material (booklets, pamphlets, etc), audioEnglish, French, German, Spanish, Polish, Russian, Italian

EUPATI Certificate Training ProgrammeWebPagesStreamed mediaEnglish, French, German, Spanish, Polish, Russian, Italian