Final agenda Joint EFSPI/BBS Meeting: Precision & Innovative Medicine and Health Technology Assessment
Date: Monday, 28th June 2021, 15:00-17:30 CEST
Webinar: dial-in details will be communicated to registered participants
Please register until the 24th June via the following form; after registration, in due time, participants will receive a calendar invite with the dial-in details.
The webinar is free of charge.
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Link to recording
Fred Sorenson, Xcenda, Switzerland Welcome and Introduction
Dan O’Connor, MHRA, UK The UK’s Innovative Licensing and Access Pathway (ILAP) for medicines – A joint MHRA, NICE & SMC initiative
Karen Facey, University of Edinburgh, UK IMPACT HTA – Recommendations for Developing Rare Disease Treatments
Paul Cislo, Jinma Ren and Joseph C. Cappelleri, Pfizer, USA Adjusting Global Survival to Make Results More Relevant and Generalizable to Local Markets
Marc Buyse, IDDI and University of Hasselt, Belgium Net benefit and correlation between benefit and harms
Mark Belger and Marie-Ange Paget, Eli Lilly UK & France Closing the efficacy to effectiveness gap: Generalizing from RCTs to real world populations
Kirsten Herrmann, Exact Sciences, Germany Assessments and reimbursement of gene expression signature tests in Europe
Janneke Boersma, Roche, Netherlands Bridging the gap between Regulatory & HTA approval for Precision Medicine therapies: a case study from the Netherlands
Tay Salimullah, Novartis Gene Therapies, Switzerland & USA Acceptance and Uptake of Cell and Gene Therapies: Lessons Learned and Future Focus (an interactive Q&A that can be viewed on the recording)
Final announcement with agenda BBS Webinar: Impact of the COVID-19 pandemic on clinical trials
Date: Wednesday, 16th June 2021, 14:00-16:00 CEST
Webinar: dial-in details will be communicated to registered participants
The webinar is free of charge; however, registration is mandatory via the following form. After registration, in due time, registered participants will receive a calendar invite with the dial-in details.
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Link to recording
Anja Schiel, Chair Scientific Advice Working Party, EMA Overview on early experience of the impact of Covid-19 pandemic on clinical trials
Paul Delmar, Roche COVID-19 pandemics : Impact on Clinical Trials in a chronic progressing disease
Eva Hua, Novartis Hypothetical strategy for a case study affected by COVID-19 pandemic
Kelly Van Lancker, Ghent University The hypothetical estimand and its potential estimators in clinical trials impacted by COVID-19
Final announcement with agenda BBS Webinar: Statistical challenges in the clinical development of CAR T-cell therapies
Date: Monday, 22nd March 2021, 15:00-18:00 (CET)
Webinar: dial-in details will be communicated to registered participants
Please register until 18th March via the following form; after registration, in due time, participants will receive a calendar invite with the dial-in details.
The webinar is free of charge.
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Link to recording
Roland MARION-GALLOIS, BMS, Switzerland Welcome and Introduction
Caroline ARBER BATH, CHUV, Switzerland Introduction to Cell Therapies: A Clinical Perspective
Elina ASIKANIUS, FIMEA, Finland Perspective from EMA
Zhenzhen XU, FDA, USA Perspective from FDA
Khadija RANTELL, MHRA, UK Phase 2 / Phase 3, Treatment effect or therapeutic strategy effect?
Alessandro PREVITALI, BMS, Switzerland Phase 2 / Phase 3, Estimands in the context of cell therapy development
Nigel YATEMAN, Novartis, Switzerland Challenges for new CAR-T therapies
Oriana CIANI, Università Bocconi, Italy Introduction on Post-Approval challenges, reimbursement and HTA assessments
Andrea SMITH, G-BA, Germany HTA-Perspective on the assessment of CAR-T-Cell Therapies
Marcelo PASQUINI and Zhenuan HU, CIBMTR, USA CAR-T cell therapy registries
Final announcement BBS Training Series 2021: A gentle Introduction to Causal Thinking
Date: Tuesday, 2nd February 2021, 14:00-17:00 (CET)
Virtual event: dial-in details will be communicated to registered participants
This event is the first in the BBS Training Series 2021 and is free of charge. However, if you wish to attend, we kindly ask you to fill out the online registration form. Participants will receive an online meeting invitation shortly before the event, and slides will be made available to participants after the event.
Slide decks
Giusi Moffa, University of Basel and BBS board member, A gentle introduction to causal thinking: concepts and definitions
Björn Bornkamp, Novartis, Drug development, the ICH E9 addendum and causal inference
Dominik Heinzmann, Roche and BBS board member, Practical application with implementation details: Estimating the causal treatment effect in a subgroup defined by a post-baseline biomarker
The BBS and EFSPI planned to hold a one day HTA seminar on June 30 at Novartis, but due to the current COVID-19 situation, the organizers have decided to hold it this year as a shortened 2-hour webinar on the same date which is free to attend.
Flyer and full details on how to register
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Disclaimer: All comments which were made during the Webinar are from the speakers themselves, and do not necessarily represent the position of the companies and organizations which they represent.
Link to panel discussion recording
Chrissie Fletcher, GSK UK Celebrating 10 Years HTA SIG
Christoph Schürmann, IQWiG, Germany Health-related quality of life endpoints in benefit assessments: Demands and challenges as seen by IQWiG in Germany
Lara Wolfson, Merck USA Issues related to transparency with HTA dossiers
Mark Nuijten, A2M and Univ. of Maastricht, NL & ITU, Turkey An innovative pricing model to assess the price of expensive drugs with an orphan indication
Fred Sorenson, Xcenda, member of BBS board Introduction to moderated panel discussion
Final announcement & program Joint EFSPI / BBS Webinar: Estimands addendum is final: Anything new for oncology?
Date: Monday, 29th June 2020, 09:00-11:45
Webinar: dial-in details will be communicated to registered participants
After the publication of the final version of the ICH E9 addendum, the BBS jointly with EFSPI would like to offer a half-day webinar on the broad topic of estimands in oncology drug development.
The event will feature talks from statisticians and clinicians in industry, regulatory agencies, and academia.
Initially, this event was planned as a full-day seminar on the Novartis campus. Given the current COVID-19 situation we turn this event into a series of webinars.
If you’d like to attend please fill out the registration form. After registration you will receive a calendar invite with a webex link.
The webinar is free of charge.
The organizing committee members are Evgeny Degtyarev, Kaspar Rufibach, Bibiana Blatna, Marie- Laure Casadebaig, Lynda Grinsted, Lorenzo Guizzaro, Wolfgang Kothny, Giusi Moffa, Hans-Jochen Weber. The event is supported by the European special interest group “Estimands in oncology”, sponsored by PSI and EFSPI, which is also an ASA scientific working group: http://www.oncoestimand.org.
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Link to recording
Questions from the webinar chat addressed by the members of the organizing committee and panelists
Kaspar Rufibach, Roche, member of BBS board Welcome and scene setting
Anja Schiel, Norwegian Medicines Agency Experience with the estimand framework in oncology
Renaud Capdeville, Novartis Challenges and open questions in hematology: RATIFY
Tina Nielsen, Roche Challenges and open questions in hematology: GALLIUM
Hannes Buchner, Staburo & Ingolf Griebsch, Boehringer Ingelheim Treatment switching: challenges, estimands, and estimators
Stefan Englert, AbbVie Commentary on previous talks taking COVID-19 into account
