Agenda Strategic Review and Learning Meeting CHMP PDCO CAT

Transcription

1 Agenda Strategic Review and Learning Meeting CHMP PDCO CAT Oslo, May Monday May 7 s 19:00 Registration 19:00 Welcome reception, Radisson Blu Plaza Hotel Tuesday May 8 08:00 Registration Speakers 08:30 Welcome to Oslo Audun Hågå NOMA Director General and Assena Stoimenova Bulgarian Executive Director 08:40 10:25 Joint session CHMP/CAT/PDCO Chair: Audun Hågå 08:40-09:05 HTA crash course Einar Andreassen 09:05-09:30 HTA-MA interactions - Norwegian experiences Spinraza and Kymriah 09:30 09:40 'Brave new world' Anja Schiel 09:40 10:05 Does early MA lead to early access? Reflections and visions 10:05 10:25 Discussion 10:25-10:45 Coffee break 10:45-12:30 Joint session CHMP/CAT/PDCO Chair: Svein Rune Andersen 10:40 11:10 Gene therapy medicinal products in haemophilia Einar Andreassen, Rune Kjeken Audun Hågå Alexandre Moreau

2 11:10 11:40 Genome Editing Regulatory and Scientific aspects 11:40 12:10 Adolescent populations at the time of MA challenges and awareness 12:10 12:30 Discussion 12:30 13:30 Lunch break 13:30 17:00 Joint session CAT/PDCO Session chairs: Martina Schüssler-Lenz and 13:30-13:50 The peadiatric regulation and PDCO responsibilities 13:50-14:10 The ATMP regulation and CAT responsibilities Patrick Celis Martina Schüssler-Lenz 14:10-14:50 Case study 1 AVXS-101 for SMA The CAT perspectives: Experiences on the PRIME process - Kick-off Hans Ovelgonne meeting and milestones challenges - interaction The PDCO perspectives: Experiences Sylvie Benchetrit on the PIP -timely submission - PIP alignment - challenges - interaction Conclusion: What worked well, what could be improved, LL for CAT/ PDCO interaction 14:50-15:30 Case study 2 BMN270, a factor 8 raav for haemophilia The CAT perspective & PRIME experience Discussion on paediatric questions CAT-PDCO interaction (all) 15:30-16:00 Coffee break 16:00-17:00 Interaction CAT-PDCO Current mode of interaction PDCO reflecting PDCO-CHMP interaction Proposal for future PDCO-CAT interaction Conclusion 13:30 17:00 Separate session CHMP Session chair: Tomas Salmonson Rune Kjeken Patrick Celis & Giovanni Lesa Martina Schüssler-Lenz & Dirk Mentzer

3 13:30-14:30 Companion diagnostics Harald Enzmann; Falk Ehmann, EMA (phone) 14:30-14:50 Independence of the two assessment teams/rapporteurs in different procedures 14:50-15:10 Coffee break Jordi Llinares Garcia (EMA) 15:10-15:30 Geriatric population Katarina Vučić 15:30-16:30 Biosimilars Jan Mueller-Berghaus, Johann Lodewijk Hillege Evening social program Guided tour Oslo Opera House Dinner Wednesday May 9 All three committees arrange separate sessions PDCO 09:00-13:00 Session chair: and Siri Wang PIP overview by therapeutic area: Duchenne Muscular Dystrophy + discussion FDA-PDCO how to improve interaction Experiences & proposals, + discussion Age staggering pros and cons reflections, + discussion The Duchenne group Chrissi Pallidis / Ralph Bax Siri Wang Oncology PIP strategy Koen Norga Medicinal product development in adults has an impact on the unmet medical needs in paediatrics (Work plan action point)

4 CHMP 08:30-13:00 Session chair: Tomas Salmonson Estimands: deciding which treatments effect a trial should try to estimate. 08:30-09:30 Benefit-risk, related to documenting of medicines evaluation 09:30-10:10 Combination therapies: is it necessary to determine the contribution of each individual component? 10:10-10:30 Coffee break & check out Rob Hemmings Evaluation of dossiers based on single arm trials Carla Herberts CAR-T cells in the real world what impact will they have in the clinic? Advanced Therapeutic Medicinal Products and the challenges they pose for HTA s; Feedback from the DIA session 2018 Alexander Fosså Anja Schiel 12: Wrap up Martina Schüssler-Lenz Lunch Kristina Dunder; Francesco Pignatti, EMA Jorge Camarero Jiménez 10:30-11:20 Quality of life and missing data Rob Hemmings 11:20-11:50 (Mis)use of P-values Anja Schiel 11:50-12:15 Wrap up Tomas Salmonson

5 CAT 09:00-13:00 Session chair: Martina Schüssler-Lenz Estimands: deciding which treatments effect a trial should try to estimate. Rob Hemmings Evaluation of dossiers based on single arm trials Carla Herberts CAR-T cells in the real world what impact will they have in the clinic? Advanced Therapeutic Medicinal Products and the challenges they pose for HTA s; Feedback from the DIA session 2018 Alexander Fosså Anja Schiel 12: Wrap up Martina Schüssler-Lenz Lunch