[Statlist] BBS Webinar on Statistical Challenges in the Clinical Development of CAR-T Cell Therapies

[Marion-Gallois, Roland]

Dear Colleagues.
The Basel Biometric Section is organizing a free webinar on
"Statistical Challenges in the Clinical Development of CAR-T Cell Therapies"
Monday, March 22, 2021, 15:00 to 18:00 (CET)

Program
Developing CAR-T Cell therapies has unique challenges not observed with traditional drugs. On top of the manufactory and logistical challenges, clinical development is facing unique statistical questions which need to be resolved for delivering view of the treatment effect.

The Basel Biometric Section (BBS) is pleased to host a scientific meeting on this relevant and far-reaching topic. The purpose is to bring together experts from the pharmaceutical industry, academia and the European and US regulatory bodies to present the current state of the art and discuss the statistical and other challenges and opportunities of CAR-T cell therapies.

Caroline ARBER BATH, CHUV, Switzerland:         Introduction: a clinical perspective
Elina ASIKANIUS, FIMEA, Finland:                      Perspectives from EMA
Zhenzhen XU, FDA, USA:                              Perspectives from FDA
Khadija RANTELL, MHRA, UK:                                  Treatment effect or therapeutic strategy effect?
Alessandro PREVITALI, BMS, Switzerland:            Estimands in the context of cell therapy development
Nigel YATEMAN, Novartis, Switzerland:               Challenges for new CAR-T therapies
Oriana CIANI, Uni. Bocconi, Italy       :                          Post-Approval challenges, reimbursement and HTA
Katerina BAKUNINA, EBMT, Netherlands &
Marcelo PASQUINI, CIBMTR, USA:                        Registries
Andrea SMITH, G-BA, Germany:                            HTA / payer perspective
All speakers + Daniel LI, BMS, USA + Frank PETAVY, EMA, NL:     Panel discussion

Registrations are opened here: Click here to Register<https://forms.gle/gSpJFqSAHdKH33N98>

More information will be updates on BBS website: http://bbs.ceb-institute.org/



Best regards

Roland MARION-GALLOIS
Director Statistics - MA&MA | Biometrics and Data Science

Roland.Marion-Gallois using bms.com
Office +41 32 729 61 34
Mobile +41 79 552 83 90

Bristol Myers Squibb
Route de Perreux 1, 2017 Boudry, Switzerland
www.bms.com

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