European Federation of Statisticians in the

Pharmaceutical Industry(EFSPI)

July 2015

What is EFSPI?

• EFSPI = European Federation of Statisticians in the Pharmaceutical

Industry

• Founded in 1992

• EFSPI is an “umbrella”, non-profit making organisation

• A federation of National European Groups

• Now have 10 national groups

• No individual members

• Our national organisations collectively represent 2800 members

• Each organisation has 2 members on the EFSPI Council

• Website: www.efspi.org

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BelgiumBelgiumSBS/BVSSBS/BVS

DenmarkDenmarkDSBSDSBS

Finland Finland SSLSSL

FranceFranceSFdSSFdS

GermanyGermanyAPFAPF

ItalyItalyBIASBIAS

NetherlandsNetherlandsPSDMPSDM

SwedenSwedenFMSFMS

SwitzerlandSwitzerlandBBSBBS

United KingdomUnited KingdomPSIPSI

EFSPI members

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BelgiumBelgiumSBS/BVSSBS/BVS

DenmarkDenmarkDSBSDSBS

Finland SSLFinland SSL

FranceFranceSFdSSFdS

GermanyGermanyAPFAPF

ItalyItalyBIASBIAS

NetherlandsNetherlandsPSDMPSDM

SwedenSwedenFMSFMS

SwitzerlandSwitzerlandBBSBBS

United KingdomUnited KingdomPSIPSI

EFSPI Council Members

Emmanuel Quinaux, An Vandenbosch

Arne Haahr Andreasen, Birgitte Biilmann Rønn

Teppo Huttunen, Sami Virtanen

François Aubin, Maylis Coste

Christoph Gerlinger, Frank Langer

Giampaolo GiacovelliPaolo Morelli

Egbert Biesheuvel, Stefan Driessen

Mattis Gottlow , Magnus Kjaer

Marisa Bacchi, Hans Ulrich Burger

Mark Morris,Chrissie Fletcher

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EFSPI Objectives

• To promote professional standards of statistics and the standing of

the statistical profession in the pharmaceutical industry

• To offer a collective expert input on statistical matters to national and

international authorities and organisations

• To exchange information on and harmonise attitudes to the practise

of statistics in the European Pharma Industry and within member

groups

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EFSPI Officers and Key Roles ( 2015)

• President / Communications – Chrissie Fletcher

• Vice-President – Marisa Bacchi

• Treasurer – Birgitte Biilmann Rønn

• Scientific Lead – Egbert Biesheuvel

• Regulatory Lead – Christoph Gerlinger

• Statistical Leaders Chair – Stefan Driessen

• Website – Francois Aubin

• EFSPI Executive Office – Julie Mellish, KSAM 6

EFSPI Activities

• Regulatory Affairs (joint committee with PSI)

• co-ordinates review of regulatory guidance within EU Statistical

Community

• Works with Scientific to identify topics for scientific debate

• Scientific

• Organise series of scientific forums for discussion and

collaboration

• Share and disseminate materials to EU Statistical Community

• Communications

• Distribute quarterly newsletters, and seek collaborations with

other relevant associations

• Statistical Leaders Meeting

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EFSPI – Regulatory affairs

• For example input in FDA guideline on non-inferiority

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EFSPI – Regulatory affairs

• For example viewpoint on data transparency

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EFSPI – Scientific Affairs

2015 (current plan):

• EFSPI/BBS Health Technology Assessment meeting

• PSI/EFSPI Estimands and sensitivity analyses meeting

• EFSPI Late Phase Dose finding studies meeting

• EFSPI Biomarkers and subgroup analyses meeting

2014:

• EFSPI Health Technology Assessment meeting

• BBS/EFSPI Data transparency meeting

2013:

• EFSPI/BBS Health Technology Assessment meeting

• EFSPI/PSI Structured benefit-risk assessment meeting

• EFSPI Survival analysis and its applications meeting

• EFSPI Data transparency workshop

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EFSPI – Communications

www.efspi.org

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Monthly newsletters

New website

Statistics Leaders Meetings

• Forum of senior statistics leaders in EU from across the industry

(managers and key opinion leaders in statistics)

• Meets annually (since 2010) to discuss and address strategic

challenges, enabling networking and exchange of information on

key developments in the industry

• Opportunities for SIGs to bring topics for scientific discussion

and seek advice/direction

• Share key news and use email distribution list to seek input

between meetings, may hold adhoc teleconferences as needed

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EU Statistical Leaders – key topics discussed in previous meetings

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IntegratedData Analysis

Leadership and managing through change

Data transparency Emerging trends in statistics

Current SIGs*

• Biomarker (leader = Athula Herath, heratha@MedImmune.com )

• Benefit-risk (leader = Alexander Schacht, schacht_alexander@lilly.com )

• Health Technology Assessment, HTA (leader = Chrissie Fletcher, fletcher@amgen.com )

• Integrated Data Analysis (leader = Byron Jones, byron.jones@novartis.com)

• Medical Devices (leader = Roland Marion-Gallois , roland.marion-gallois@medtronic.com )

• Modelling & Simulation (leader = Chris Campbell, ccampbell@mango-solutions.com )

• Real World data (leader = George Quartey, quarteyg@gene.com )

• Toxicology (leader = Gareth Thomas, ThomasG@UKOrg.Huntingdon.com)

* Majority of SIGs formed under leadership of PSI and subsequently expanded to include EFSPI members

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EFSPI working group on data sharing

• Lead Sally Hollis (AZ) and Uli Burger (Roche) • Objectives:

– To identify and prospectively prioritize statistical issues in data transparency

– To co-ordinate statistical contributions across Europe to the data transparency debate

– To disseminate relevant information on the topic across the statistical community

– To develop and share a vision of the potential longer term impact of data transparency.

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EFSPI working group on data sharing

• Five work streams– Providing continuous input in EMA/EFPIA

(Christoph Gerlinger, Bayer, Chrissie Fletcher, Amgen)

– Recommendations for re-analysis practices (Chrissie Fletcher, Amgen, Sally Hollis, AstraZeneca)– Future impact on biostatistics

(Nick Manamley , Amgen)– Minimal requirements for data sharing

(Rebecca Sudlow , Roche, Janice Branson, Novartis)– Ensuring patient data confidentiality

(Katherine Tucker, Roche)

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European Federation of Statisticians in the

Pharmaceutical Industry(EFSPI)

For more information, visit our website:

www.efspi.org