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

Dansk Selskab for Farmakoepidemiologi / Danish Society for Pharmacoepidemiology, [email protected]

DSFE & Lif Whitepaper on

Industry-Academia Collaborations

Anton Pottegård


Aim

Inthisjointpaper,DSFEandLifwishestodescribethetwoassocia0ons'approachtotheuseofhealthdatafromDanishregistriesand

setouttheprinciplesforcollabora0onbetweenpublicsectorresearchersandthe

pharmaceu<calindustryforpharmacoepidemiologicalstudies.


The reality of Real World Data in a Nordic context

Possibilities and barriers for collaboration

between academia and industry

Anton Pottegård


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


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…


”pretty picture”


Safety comes first…


1 of 4



Safety studies

Utilization studies Pragmatic trials

Comparative-effectiveness studies Creative uses…



2 of 4

Guidelines are available…


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…


3 of 4

It’s nice to have a coordinating center…


Coordinating center…

Research partners

Sponsor

CRO/ARO

EMA


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…


4 of 4

We need to understand one another…


Study centers

Sponsor

CRO/ARO

EMA

Understand one another…


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



Contract research vs.

Research collaborations



Safety comes first… Guidelines are available…

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


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

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


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

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


Highlights Contractual basis

Publication of scientific results Relevant competencies

Involvement of third party


Relevant competencies


Proposal

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

Introduction

Industry-track

Academia-track

Joint sessions


Anton Pottegård [email protected]

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

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

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