whitepaper on industry-academia collaborations · dansk selskab for farmakoepidemiologi / danish...

Dansk Selskab for Farmakoepidemiologi / Danish Society for Pharmacoepidemiology, dsfe@dsfe.dk

DSFE & Lif Whitepaper on

Industry-Academia Collaborations

Anton Pottegård

Dansk Selskab for Farmakoepidemiologi / Danish Society for Pharmacoepidemiology, dsfe@dsfe.dk

Dansk Selskab for Farmakoepidemiologi / Danish Society for Pharmacoepidemiology, dsfe@dsfe.dk

Dansk Selskab for Farmakoepidemiologi / Danish Society for Pharmacoepidemiology, dsfe@dsfe.dk

Aim

Inthisjointpaper,DSFEandLifwishestodescribethetwoassocia0ons'approachtotheuseofhealthdatafromDanishregistriesand

setouttheprinciplesforcollabora0onbetweenpublicsectorresearchersandthe

pharmaceu<calindustryforpharmacoepidemiologicalstudies.

Dansk Selskab for Farmakoepidemiologi / Danish Society for Pharmacoepidemiology, dsfe@dsfe.dk

The reality of Real World Data in a Nordic context

Possibilities and barriers for collaboration

between academia and industry

Anton Pottegård

Dansk Selskab for Farmakoepidemiologi / Danish Society for Pharmacoepidemiology, dsfe@dsfe.dk

Conflicts of interest

I have participated in research projects funded by

Alcon, Almirall, Astellas, Astra-Zeneca, Boehringer-Ingelheim, and Servier, all with

funds paid to the institution where I am employed. I have never received any personal fees.

All are irrelevant to this presentation

extremely

Dansk Selskab for Farmakoepidemiologi / Danish Society for Pharmacoepidemiology, dsfe@dsfe.dk

Safety comes first… Guidelines are available…

It’s nice to have a coordinating center… We need to understand one another…

Communication is key… Legislation is in place, but room for improvement…

Dansk Selskab for Farmakoepidemiologi / Danish Society for Pharmacoepidemiology, dsfe@dsfe.dk

”pretty picture”

Dansk Selskab for Farmakoepidemiologi / Danish Society for Pharmacoepidemiology, dsfe@dsfe.dk

Dansk Selskab for Farmakoepidemiologi / Danish Society for Pharmacoepidemiology, dsfe@dsfe.dk

Safety comes first…

Dansk Selskab for Farmakoepidemiologi / Danish Society for Pharmacoepidemiology, dsfe@dsfe.dk

Safety comes first…

Dansk Selskab for Farmakoepidemiologi / Danish Society for Pharmacoepidemiology, dsfe@dsfe.dk

1 of 4

Safety comes first…

Dansk Selskab for Farmakoepidemiologi / Danish Society for Pharmacoepidemiology, dsfe@dsfe.dk

Safety studies

Utilization studies Pragmatic trials

Comparative-effectiveness studies Creative uses…

Safety comes first…

Dansk Selskab for Farmakoepidemiologi / Danish Society for Pharmacoepidemiology, dsfe@dsfe.dk

2 of 4

Guidelines are available…

Dansk Selskab for Farmakoepidemiologi / Danish Society for Pharmacoepidemiology, dsfe@dsfe.dk

You need a thorough (preplanned) study protocol

The academic partner needs the right to publish

the study findings, regardless of outcome

Guidelines Good Pharmacovigilance Practice (GVP), Module VIII [EMA]

Good Pharmacoepidemiological Practice (GPP) [ISPE] Code of Conduct [ENCePP]

Guidelines are available…

Dansk Selskab for Farmakoepidemiologi / Danish Society for Pharmacoepidemiology, dsfe@dsfe.dk

3 of 4

It’s nice to have a coordinating center…

Dansk Selskab for Farmakoepidemiologi / Danish Society for Pharmacoepidemiology, dsfe@dsfe.dk

Coordinating center…

Research partners

Sponsor

CRO/ARO

EMA

Dansk Selskab for Farmakoepidemiologi / Danish Society for Pharmacoepidemiology, dsfe@dsfe.dk

But why?

1)  Double arms length is always nice (especially in studies of safety concerns!)

2)  We know them and they know us and our data 3)  They take care of all the bureauratic bull**** 4)  They have access to ad-hoc experts 5)  They can focus on (and have specific expertise in)

facilitating the process 6)  They are in a better position to ‘push back’ if either

academia or industry does not behave 7)  They know enough about both worlds (industry and

academia) to translate…

Dansk Selskab for Farmakoepidemiologi / Danish Society for Pharmacoepidemiology, dsfe@dsfe.dk

4 of 4

We need to understand one another…

Dansk Selskab for Farmakoepidemiologi / Danish Society for Pharmacoepidemiology, dsfe@dsfe.dk

Study centers

Sponsor

CRO/ARO

EMA

Understand one another…

Dansk Selskab for Farmakoepidemiologi / Danish Society for Pharmacoepidemiology, dsfe@dsfe.dk

Why ”start of data collection”? Why such a horribly convoluted protocol?

Why such weird headers for the final study report?

Answer: GVP Module VIII.B

Understand one another…

Dansk Selskab for Farmakoepidemiologi / Danish Society for Pharmacoepidemiology, dsfe@dsfe.dk

Contract research vs.

Research collaborations

Understand one another…

Dansk Selskab for Farmakoepidemiologi / Danish Society for Pharmacoepidemiology, dsfe@dsfe.dk

Safety comes first… Guidelines are available…

It’s nice to have a coordinating center… We need to understand one another…

Dansk Selskab for Farmakoepidemiologi / Danish Society for Pharmacoepidemiology, dsfe@dsfe.dk

Dansk Selskab for Farmakoepidemiologi / Danish Society for Pharmacoepidemiology, dsfe@dsfe.dk

We need to use these data … with due respect to data privacy.

Both parties needs relevant competencies. Current collaborations live up to this!

Dansk Selskab for Farmakoepidemiologi / Danish Society for Pharmacoepidemiology, dsfe@dsfe.dk

Guidelines Good Pharmacovigilance Practice (GVP), Module VIII [EMA]

Good Pharmacoepidemiological Practice (GPP) [ISPE] Code of Conduct [ENCePP]

Dansk Selskab for Farmakoepidemiologi / Danish Society for Pharmacoepidemiology, dsfe@dsfe.dk

Highlights Contractual basis

Publication of scientific results Relevant competencies

Involvement of third party

Dansk Selskab for Farmakoepidemiologi / Danish Society for Pharmacoepidemiology, dsfe@dsfe.dk

Relevant competencies

Dansk Selskab for Farmakoepidemiologi / Danish Society for Pharmacoepidemiology, dsfe@dsfe.dk

Proposal

Reading material -  GPP -  GVP, modul VIII -  ENCePP -  Previous protocols -  Previous study reports

Introduction

Industry-track

Academia-track

Joint sessions

Dansk Selskab for Farmakoepidemiologi / Danish Society for Pharmacoepidemiology, dsfe@dsfe.dk

Anton Pottegård apottegaard@health.sdu.dk

Acknowledgments

Jesper Hallas Jordi Castellsague

Michael Busch-Sørensen Susana Perez-Gutthann

Morten Andersen Kari Furu

Helle Kieler Espen Jimenez Solem

Jakob Bjerg Larsen The DSFE board