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Agenda BBS Training: Machine Learning in clinical drug development

Date: Monday, 21st February 2022, 14:00 – 18:00 CET

Virtual event: dial-in details will be communicated to registered participants

The seminar is free of charge. However, if you wish to attend, we kindly ask you to fill out the registration form by 17th February 2022 for organizational reasons.

First announcement BBS Webinar: COVID-19 pandemic and how we deal with data

Date: Tuesday, 27th July 2021, 14:00-16:30 CET
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

Tim Friede, University Medical Center of Göttingen Data and Statistics as a basis for decision making: A discussion of the Corona pandemic

Thorsten Lehr, Saarland University Forecasting: What do we learn?

Thierry Van Effelterre, J&J Vaccination trials: What do we know about long-term efficacy measures and other questions

Fei Chen, Janssen Statistical Considerations Underlying a COVID-19 Vaccine Phase 3 Design

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

Announcement & program (with abstracts) BBS Webinar: Graphics for decision-making in biomedical research and drug development

Date: Monday, 8th March 2021, 14:00-17:00
Webinar: dial-in details will be communicated to registered participants

Please register until 28th February via the following form After registration participants will receive a calendar invite with the dial-in details (in the first week of March).

The webinar is free of charge.

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Link to recording

Hannah Diehl and Tamara Broderick (MIT), Andy Stein and Niladri Roy Chowdhury (Novartis) The “See”-Value App: Visual Decision Making for Drug Development

Neil McQuarrie (Flatiron) Better understanding and reacting on impact of COVID-19 on RWD collection by combining statistics with visualization

Tadeusz Lewandowski (Roche) Interactive clinical study visualisation in enabling the faster decision making

Markus Lange (Novartis) Unraveling a single number – using graphics to explain Probability of Success

Anne-Marie Meyer (Roche) Population Level Analytics for pandemic response: Predicting vaccine uptake and vaccine hesitancy

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

Final announcement Joint EFSPI / BBS Webinar: The application of estimands from a Neuroscience perspective

Date: Tuesday, 3rd November 2020, 13:00-16:00
Webinar: dial-in details will be communicated to registered participants

If you’d like to attend please fill out the registration form. After registration, you will receive a calendar invite with the Webex details. Slides will be made available after the event. Some of the talks might be recorded, pending speaker approval.
The webinar is free of charge.

The organizing committee members are Hans Ulrich Burger, Khadija Rantell, Nikolaos Sfikas, Peter Quarg on behalf of the European working group on Estimands in Neuroscience.

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Link to recording

Hans Ulrich Burger (BBS president) Welcome and introduction to the estimand framework

Nikolaos Sfikas (Novartis) Outline of an estimand strategy in MS

Mette Krog Josiassen (Lundbeck) and Peter Quarg (Novartis) Outline of an estimand proposal in migraine prevention and neuropathic pain

Paul Delmar (Roche) Using the Estimand Framework to address challenges in AD clinical trial with a closer look at the hypothetical strategy

Carrie Li (Roche) Estimands in Huntington’s disease

Andrew Hartley (PPDI) Impact of Covid-19 on studies in Neuroscience

Joel Raffel (MHRA) and Khadija Rantell (MHRA) Regulatory aspects of the estimand framework: Clinical and statistical perspectives

Anja Schiel (Norwegian agency and CHMP member) Panel discussion including all speakers

Announcement & program (with abstracts) BBS Webinar: RCTs meeting causal inference: principal stratum strategy and beyond

Date: Monday, 7th September 2020, 14:00-17:00
Webinar: dial-in details will be communicated to registered participants

Please register via the following form After registration you will receive a calendar
invite with a webex link.

Attendees are invited to ask questions via the chat function in webex. These questions will either be
commented on during the event or answered in writing and posted online.

The webinar is free of charge.

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Link to recording

Questions from the webinar chat addressed by the members of the organizing committee and panelists

Kaspar Rufibach (member of BBS board and co-lead industry working group
“estimands in oncology”) Welcome and scene setting

Vanessa Didelez (Keynote speaker, Leibniz Institute for Prevention Research
and Epidemiology – BIPS, Bremen) Time-Varying Treatments in Observational Studies: Lessons for Clinical Trials

Jack Bowden (University of Exeter) Connecting Instrumental Variable methods for causal inference to the Estimand Framework

Kelly van Lancker (Ghent University) Efficient, doubly robust estimation of the effect of dose switching for switchers in a randomised clinical trial

Björn Bornkamp (Novartis) Principal Stratum Strategy: Potential Role in Drug Development

Dominik Heinzmann (Roche) Principal stratum strategy to investigate anti-drug antibody impact on cancer immunotherapy outcome

Aiesha Zia (Novartis) Exploring estimation approaches for principal stratum estimands in Phase III randomized trials in CAR-T anti-cancer therapy

Fabrizia Mealli (University of Florence) The ICH E9 addendum from an academic causal inference perspective and feedback on the previous talks

Giusi Moffa (member of BBS board) Next webinars and closure