First 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.

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

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

Final announcement BBS Webinar: Aspects of COVID-19 pandemic

Date: Wednesday, 3rd June 2020, 10am – 12pm
Venue: Webinar

Please register via the following link

Please send questions for the panel discussion to Hans Ulrich Burger hans_ulrich.burger@roche.com (or use the chat room during the meeting)

Jean Lang, Sanofi Pasteur Overview on SARS-CoV2 & Challenges for COVID-19 Vaccine Development at Pandemic Speed

Christian Althaus, ISPM, University of Bern Early transmission, pandemic spread and severity of COVID-19

Karin Meiser, Novartis Specific aspects of a clinical trial targeting Covid-19

Jenny Devenport, Roche The influence of investigator initiated studies in the COVID-19 pandemic

Final announcement & program BBS Virtual Seminar: Impact of COVID-19 on clinical trials

Date: Wednesday, 6th May 2020, 10am – 12pm
Venue: Virtual event

Please register via e-mail to Laurence Guillier laurence.guillier@roche.com

Please send questions for the panel discussion to Hans Ulrich Burger hans_ulrich.burger@roche.com

Frank Pétavy, EMA EMA perspective and guidance on COVID-19

Natalie Dimier, Roche Industry perspective on COVID-19 (1/3)

Mouna Akacha, Novartis Industry perspective on COVID-19 (2/3)

Cristina Sotto, J&J Industry perspective on COVID-19 (3/3)

Marcel Wolbers, Roche Short Overview of Pharmaceutical Industry COVID-19 Biostatistics Working Group

Evgeny Degtyarev, Novartis Short overview on COVID-19 from the Cross-Industry Oncology Estimands Working Group

Final Announcement BBS Seminar Network meta-analysis: methods and applications

The BBS is pleased to host a half-day seminar on network meta-analysis methods and applications.
The talks will present recent methodological advances and challenges as well as case studies from
the pharmaceutical industry and academia. We welcome all quantitative scientists to this event, which
will be a great opportunity to meet with colleagues and exchange ideas on this emerging and vibrant
field.

The seminar is free of charge but registration is mandatory for organizational reasons. Please register
via email to fred.sorenson@xcenda.com by Tuesday, January 21st, 2020, the latest.

The seminar takes place on February 4th, 2020 from 13:00-17:30
Venue: Roche Auditorium Building 92, Grenzacherstrasse 124, 4070 Basel

Sylwia Bujkiewicz, Bivariate network meta-analysis for surrogate endpoint evaluation

Gerta Rücker, Component network meta-analysis compared to a matching method in a disconnected network: a case study

Georgia Salanti, CINeMA: a framework and web application to evaluate the confidence in network meta-analysis results

Mark Pletscher, Network meta-analysis of treatments for previously untreated
metastatic PD-L1-positive triple-negative breast cancer

Bartosz Jenner, An experience with indirect treatment comparisons using MAIC methods in a rare disease (slide deck not available)

Marius Thomas, A network meta-analysis to compare efficacy of treatment options for relapsing-remitting multiple sclerosis

Check out the event dedicated page for a summary of the day.

The BBS is pleased to host a full-day seminar on predictive modelling, machine learning, and causality with several eminent speakers. The talks will present recent methodological advances and challenges as well as case studies from the pharmaceutical industry and academia. We welcome all quantitative scientists to this event which will be a great opportunity to meet with colleagues and exchange ideas on this emerging and vibrant field.

The seminar is free of charge but registration is mandatory for organizational reasons. Please register via email to fred.sorenson@xcenda.com by Friday, October 18, 2019, the latest.

Date: Friday, November 1st, 2019, 08:30-16:45

Venue: Auditorium Roche Builing 683, Viaduktstrasse 31-35, Basel

Full program in pdf – with abstracts

Meeting agenda in pdf

Slide decks

Ewout Steyerberg, Clinical prediction models in the age of artificial intelligence and big data

Willi Sauerbrei, The EQUATOR networkand guidelines for prediction models

Torsten Hothorn, Score-based transformation learning

Peter Bühlmann, Causal regularization for distributional robustness and replicability

Giusi Moffa, Predicting putative intervention effects after causal structure learning from survey data

Andrew Shattock, Using machine learning and disease models to evaluate target product profiles of novel interventions (No slide deck available)

FedericoMattiello, Identifying high-risk patients in Non-Hodgkin lymphoma (and trying to get insights into the disease biology)

Mark Baillie, Novartis benchmarking initiative: making sense of AI

Chris Harbron, Experiences from running internal prediction challenges within a pharmaceutical company

August 21, 2019 from 9:00 – 16:00
Location: Roche, Building 001, Auditorium 2nd Floor

This Seminar is free of charge.
Please register via the BES homepage
Registration closes on August 9, 2019

Agenda

Miguel Hernan, Beyond intention-to-treat. Causal inference guidelines for causal inference
Christine Fletcher, The Final ICH E9(R1) E9 addendum
Frank Pétavy, A regulator’s perspective
Valentine Jehl, Adverse reactions confounded by prior medication: (how) can causal inference solve the problem? (No slide deck available)
Thibaut Sanglier, Treatment sequencing and effectiveness: challenges and considerations (No slide deck available)
Nikolaos Sfikas, Principal stratification techniques in the context of regulatory decision making (No slide deck available)
Jack Bowden, Implementing the Principal Stratum estimand strategy using Instrumental Variable methods: An emulation of the CANTOS trial

Date: August 19-20, 2019
Time: 9:00 – 17:00
Location: Roche Auditorium, Building 001, Auditorium 2nd Floor Fee: Industry: CHF 200 / Academia: CHF 100 / Students: 10 seats available free of charge
Registration: By e-mail to fred.sorenson@xcenda.com

Flyer