European Federation of Statisticians in the Pharmaceutical Industry (EFSPI)

1. European Federation of Statisticians in the Pharmaceutical Industry(EFSPI) July 2015

2. 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

3. France SFdS Finland SSL Germany APF Denmark DSBS Italy BIAS Belgium SBS/BVS Netherlands PSDM United Kingdom PSI Switzerland BBS Sweden FMS EFSPI members

4. France SFdS Finland SSL Germany APF Denmark DSBS Italy BIAS Belgium SBS/BVS Netherlands PSDM Switzerland BBS United Kingdom PSI Sweden FMS EFSPI Council Members François Aubin, Maylis Coste Christoph Gerlinger, Frank Langer Teppo Huttunen, Sami Virtanen Giampaolo Giacovelli Paolo Morelli Arne Haahr Andreasen, Birgitte Biilmann Rønn Emmanuel Quinaux, An Vandenbosch Egbert Biesheuvel, Stefan Driessen Mark Morris, Chrissie Fletcher Mattis Gottlow , Magnus Kjaer Marisa Bacchi, Hans Ulrich Burger

5. 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

6. 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

7. 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

8. EFSPI – Regulatory affairs • For example input in FDA guideline on non-inferiority

9. EFSPI – Regulatory affairs • For example viewpoint on data transparency

10. 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

11. EFSPI – Communications www.efspi.org Monthly newsletters New website

12. 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

13. EU Statistical Leaders – key topics discussed in previous meetings Career Development Health Technology Assessment Medical Devices Benefit-Risk Comparative effectiveness & network meta-analysis Integrated Data Analysis Totality of evidence & observational research Leadership and managing through change Emerging trends in statistics Data transparency

14. 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

15. 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. 15

16. 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) 16

17. European Federation of Statisticians in the Pharmaceutical Industry(EFSPI) For more information, visit our website: www.efspi.org