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

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 (slide deck currently not available)

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

Final announcement

Precision medicine aims to tailor disease prevention, diagnosis and treatment to the individual patient, based on their individual features extracted from multiple types of data (such as multi-omics, imaging, patient history, lifestyle and environmental factors).

Advances in screening platforms and the availability of big data are fueling the scientific progress in precision medicine, spanning the early stage of drug discovery all the way through translation into clinical practice. Adequate use of statistical and computational methods are critical to its successful implementation in clinics.

The Basel Biometric Section (BBS) and the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) are pleased to host a European scientific meeting on this relevant and far-reaching topic. The purpose is to bring together experts from the pharmaceutical industry, academia and the European regulatory bodies to present the current state of the art and discuss the challenges and opportunities ahead.

The seminar takes place on June 4, 2019 from 9:00-17:00
Venue: Actelion Pharmaceuticals, Hegenheimermattweg 95, Allschwil, Switzerland

TO REGISTER PLEASE GO TO: www.efspi.org

Presentations

Niko Beerenwinkel, Bioinformatics for precision oncology (slide deck not available)

Stephen Senn, Precision medicine: The honeymoon is over. It’s high time for tough love

Tomasz Burzykowski, Generalized pairwise comparisons for precision medicine

Adam Heathfield, Valuation of Regenerative Medicine/Advance Therapeutics (RM/ATs): Challenges and opportunities for creating a better framework

JackKuipers, Mutational interactions define novel cancer subgroups: can they inform precision oncology?

Mario Ouwens, Difficulties with network meta-analysis when starting to use PDL1 thresholds

Georgina Bermann, Cardiovascular medicine: approaches to the use of early biomarker response to identify a patient subgroup with enhanced therapeutic benefit

Laurent Essioux, Examples of personalized Healthcare at Roche: statistical perspectives

Final Announcement BBS Spring Seminar Synthetic controls – what do we need and how far can we go?

The seminar takes place on May 10, 2019 from 9:00-16:30
Venue: Roche Auditorium, Viaduktstrasse, Basel

The seminar is free of charge. For organizational reasons please register by sending an email in advance to fred.sorenson@xcenda.com
Registration will close by Friday, April 26, 2019

Tom Brookland, RWD/RWE Global Regulatory Overview
Kaspar Rufibach and Hans Ulrich Burger, External controls in drug development
Somnath Sarkar, Considerations for Developing External Control Arm from Real-World Data
Laurence Colin and Yue Li, Making better use of early phase safety data
Cornelia Dunger-Baldauf, For the sake of the patient – reducing placebo exposure by using historical controls
Gonzalo Duran-Pacheco, Electronic Health Records used to derive Control Arms for Single-Arm oncology trials: Proof of concept using RCT’s in lung cancer
Chris Harbron, A Decision Making Framework For Utilising External Control Arms
Meinhard Kieser, Synthetic controls – what do we need and how far can we go? Rejoinder
Norbert Benda, Synthetic controls – what do we need and how far can we go? Rejoinder
Kit Roes, Synthetic controls – what do we need and how far can we go? Rejoinder
Jan Müller-Berghaus, Synthetic controls – what do we need and how far can we go? Rejoinder
(no slide deck available)
Anja Schiel, Synthetic controls – what do we need and how far can we go? Rejoinder
(no slide deck available)