Dansk Selskab for GCP

30th of August 2017

Niels Westergaard, dr.pharm

Biopeople, Københavns Universitet.

www.biopeople.eu

Patient Involvement in Medicines R&D

Biopeople

Denmark’s Life Science Cluster

Cluster organisation since 2005 - Centre at the

Faculty of Health and Medical Sciences, University

of Copenhagen

Since 2010 part of the national innovation

programme by the Ministry of Higher Education and

Science

Partnership with supporting community covering all

of Denmark

• ESCA Gold since 2013

We focus on setting up:

•Cross disciplinary projects

•Public private partnerships

•Internationalisation

Cartoons: Jens Hage; www.hage.dk

Personalised Health Care:

•Personalised medicine

•Biomarkers

•Patient empowerment

•Regulatory science

We integrate SMEs, Public

and Academic partners into

global value chains

Tools:

•Matchmaking events

•Knowledge tranfer

•Innovation projects

•Strategy development

In Brief

Biopeople – project preview

• 2012-2017 EUPATI (EU IMI)

• Sustainable EUPATI Activities

• EUPATI Platform Denmark (patient organisations, academia, industry)

• 2015-2018 Biomarkers as an Emerging Growth Area in DK

• Bio-agora (UCPH, DTU)

Biomarkers as an emerging growth area in Denmark

Biomarkers as an emerging growth area in Denmark

Pharmacokinetic “What the body does to the drug”

Absorbtion Distribution Metabolisme Excretion

Pharmacodynamic “What the drug does to the body”

Receptors Enzymes Ion Channels Immune System

Biological response e.g. blood pressure

Genetic Polymorphisms

Pharmacogenomics

Variables Gender, Race, Body size Renal/hepatic function Gastric pH Drug-Drug interaction Concomitant diseases Compliance

Variables Gender, Race, Drug-Drug interaction Environmental Factors Concomitant diseases Placebo effects Tolerance Tachyphylaxis

Biomarker identification, development and clinical validation

Key Tool

Biomarkers as an emerging growth area in Denmark

Project Aim

• The aim of the project is to create better opportunities in Denmark for prevention of diseases, diagnosis and treatment by facilitating cross disciplinary collaborations, in a partnership model of ICT, research and clinical development having end users/ patient centricity, on the identification, validation and use of biomarkers.

• In parallel, the project will investigate how to build a “Danish Infrastructure Model” on biomarker development in a Public-Private-Partnerships among all stakeholders in order to strengthen biomarker innovation

• To support the Danish National Strategy on Personalised Medicine: http://www.sum.dk/Sundhedsprofessionelle/Personlig-medicin.aspx Patienten I Centrum

Biomarkers as an emerging growth area in Denmark

Partnership Model

Information and communication technology ICT

User centricity

Research Clinical Development

Mission To strengthen the development of Personalised/precision medicine

and companion diagnostics in Denmark

Biomarkers.dk

Tool to secure that all key stake holders are on the same page (Health Literacy)

European Patients Academy on Therapeutic Innovation (EUPATI)

Toolbox: www.eupati.eu

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.

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can really make a unique

difference to patient

empowerment and to

medicines R&D.

You can help us to make

it a success.

Statement

“New winds are blowing across Europe

toward a paradigm shift of having patients actively involved in medicines R&D”

Patient focused medicines development: Introducing a paradigm shift

Industry

Patients

Clinic/

Academia Regulators

Shared goal:

Getting the right

treatment to the

right patients

Practical “Roadmap” on patient involvement in R&D: Patient organizations’ and expert patients’ contribution to the whole R&D development life

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Research design

and Planning

Design of Protocol:

Informed Consent Study reporting

Post-study communication

Patient Info

Leaflet

Trial steering committee

Investigators Meeting:

Level of expertise in the disease area required:

medium high

Data Monitoring Committee Practical

con-

siderations

Health Technology Assessment

Protocol

Synopsis: design,

comparators

Research

priorities

Setting

research

priorities:

Fundraising

Information to

trial participants

Research conduct and

operations

Source: Geissler, Ryll,

EPALCO (2014, unpublished)

Regulatory affairs

Dissemination,

communication,

post-approval

The goal for EUPATI

EUPATI will provide scientifically reliable, objective, comprehensive

information on medicines development from A to Z to be used by

patients and patients organizations across Europe to increase their

capacity to be effective advocates and advisors

The material will be neutral i.e.

• Not disease specific

• Not medicine specific

• Not pharma specific

Important

EUPATI is developing education targeted to different levels

EUPATI Patient Experts Training Course -- for expert patients

20

100 patient

experts

12.000 patient

advocates

100.000 individuals

EUPATI Educational Toolbox -- for patient advocates

EUPATI Internet Library -- for the health-interested public

English French German

Spanish Polish Italian Russian

English

Audience 1

Expert-Level Training Course

plus

Online self-learning combined with 2 face-to-face meetings

Approx. 250 hours of e-learning and 8-10 days for

two F2F meetings

Overview of the course modules

Module 1 Discovery of medicines and Planning of Medicines

Development

Module 2 Non-Clinical Testing and Pharmaceutical Development

Module 3 Exploratory and Confirmatory Clinical Development

Module 4 Clinical Trials

Module 5 Regulatory Affairs, Medicinal Product safety,

Pharmacovigalence and Pharmacoepidemiology

Module 6 Health Technology Assessment (HTA) principles and practices

EUPATI Fellow

The EUPATI Toolbox on Medicines R&D

EUPATI Toolbox on Medicines R&D in 7+ languages: Huge demand

• In English, French, Italian, Spanish, German, Polish, Russian and DK

• >100.000 unique

users in 1 year

• Visitors from 149

countries

https://dk.eupati.eu/

EUPATI Toolbox on Medicines R&D:

>3.500 content items

Infographics

Articles PowerPoints

Fact sheets

The EUPATI Guidances on the interaction of patients with regulators, HTA bodies, industry and ethics committees

EUPATI Guidances to support the interaction with patient organisations in R&D

EUPATI has developed guidances for the interaction of patient organisations with stakeholders

in industry-led R&D

in HTA bodies

in regulatory processes

in ethics committees Available for download at EUPATI.eu > Resources > Guidances

The EUPATI National Platforms

EUPATI Danmark

EUPATI Danmarks vision er ”At uddanne patienter til at deltage aktivt i medicinudvikling”.

EUPATI Danmarks mål: • at øge patienters kendskab til udvikling og regulering af lægemidler

• at arbejde for patientinvolvering og partnerskaber med medicinudviklere

• at uddanne patienter til at indgå i råd, udvalg og etiske komiteer

• at medvirke til udvikling af best-practices for patientinvolvering i forskning, udvikling og evaluering af medicin

EUPATI Danmark informerer ikke om sygdomsspecifik behandling, men udelukkende om generelle principper for forskning og udvikling. For information om sygdomsspecifik medicin og behandling henviser vi til sundhedsprofessionelle og patientorganisationer.

https://dk.eupati.eu/

EUPATI Danmark 2017

Apotekskommunikation • Forskningsprojekt ledet af KU, Institut for farmaci

Nordisk Ministerråd • Fælles etisk godkendelse af kliniske studier

• Datadeling i forskning

• Nordic Trial Alliance

Diabetesforeningen • Forskningsprojekt med Dansk Diabetes Akademi, DDA

• EUPATI underviser Diabetesforeningens medlemmer

Etablering af EUPATI Nordics • EUPATI Danmark er iværksætter og tovholder

Se; https://biopeople.eu/calendar/

ETISKE OVERVEJELSER VED PATIENTDELTAGELSE I AFPRØVNING AF LÆGEMIDLER

Time; 19-09-2017 15:00 - 18:00

Organizer; EUPATI DANMARK

Location: Københavns Universitet – Auditorium 4 Universitetsparken 2 2100 - København Ø

Patientdeltagelse i afprøvning og vurdering af lægemidler er afgørende for at få viden om, hvordan lægemidlet virker, og for at skabe størst mulig sikkerhed for patienterne. Men det rejser også en række etiske spørgsmål og dilemmaer, som vi stiller skarpt på fra forskellige vinkler.

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Biomarker Agora 2017