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)
Announcement
The seminar takes place on June 27, 2018 from 9:00am to 5:00pm
Venue: Idorsia Pharmaceuticals, Hegenheimermattweg 91, Allschwil, Switzerland
TO REGISTER PLEASE GO TO: www.efspi.org
Introduction, European Statistical Meeting onSmall populations and level of evidence
Daniel O’Connor, Rare diseases and orphan drugs: A Regulator’s (clinical)Perspectives
Stephen Senn, In search of the lost loss function
Henriette Thole, The potential and challenges of registry use when generating evidence in small populations
Anja Schiel, Rare diseases and orphan drugs:The HTA perspective
Adele Morganti, Borrowing external controls for an event-driven pediatric trial in PAH: a case study
Andreas Kaiser, Bayesian analysis for small sample size trials using informative priors derived from historical data
Elina Asikanius, Using a non-interventional study to strengthen the evidence collected in a Phase III program: a Hemophilia A case Study
Hans Hockey & Kristian Brock, Hockey sticks and broken sticks – a design for a single-treatment, placebo-controlled, double-blind, randomized clinical trial suitable for chronic diseases
Final Announcement
BBS Spring Seminar New developments in HTA, adaptive designs and multiplicity – in remembrance of Willi Maurer
The Seminar fee is 100 CHF for industry and free for all others
Please register by sending an email in advance to fred.sorenson@xcenda.com
Registration will close by Friday, April 13, 2018
The seminar takes place on April 17, 2018 from 9:00-17:00
Novartis Auditorium, Fabrikstrasse 15
Jason Wang, Sense and sensibility of estimands for health technology assessment (HTA)
Christoph Gerlinger, EQ-5D-5L Utility Index for different countries
Susan Edwards, Whose perspective? Implications on cost-effectiveness modelling of differences between country value sets (a case study)
Carsten Schwenke, Real World Evidence and HTA – Experiences with IQWiG
Tim Friede, HTA AND SAFETY Some results of the ATF / APF Project Group, an ongoing empirical investigation and some personal views
Announcement BBS Seminar Competing Risks and Multi-State Models: Overview and Case Studies
The BBS would like to offer a half-day seminar on competing risks and multi-state models. The seminar will provide an overview of these topics by academic speakers and several case studies from industry and academia. All talks will be accessible to general biostatisticians and highlight the relevance of these topics for clinical research and drug development.
Scientific committee: Dietrich Knoerzer (Roche), Amanda Ross (Swiss TPH), Kaspar Rufibach (Roche), Marc Vandemeulebroecke (Novartis), Simon Wandel (Novartis), Marcel Wolbers (Roche)
The seminar is free of charge. For registration however please send an informal e-mail to Laurence Guillier (laurence.guillier@roche.com) or Barbora Martinec (barbora.martinec@roche.com).
The seminar takes place on March 20, 2018 13:30-17:15.
Venue: Room “Kilimanjaro”, Swiss TPH, Socinstrasse 57, Basel
Claudia Schmoor, Competing risks with applications to oncology
Jan Beyersmann, Analysis of co-time-to-event outcomes in randomized clinical trials
Ekkehard Glimm and Lillian Yau, A discrete semi-Markov model for the effect of need-based treatments on the disease states
Announcement BBS Course Group-Sequential and Adaptive Confirmatory Clinical Trial Designs, With R Practicals
For industry participants, a fee of Sfr 70 per participant will be charged via company-wise block bookings. Participants from other institutions (academia, collaborative groups) are asked to pay Sfr 20 in cash when registering at the beginning of the event. For organizational reasons, the number of participants is limited, on a first come first served basis. Please register no later than 16th February by sending an e-mail to Laurence Guillier (laurence.guillier@roche.com) or Barbora Martinec (barbora.martinec@roche.com). Since seats are limited and for catering purposes, we also ask participants to cancel their participation as early as possible in case they have registered and cannot attend, so that we can give others a chance to attend.
The course takes place on March 1, 2018 8:20-17:00.
Venue: Roche Building 683 Viaduktstrasse, Auditorium
Program BBS Seminar Future of Biomedical Research: Are we ready? & BBS General Assembly 2017
The seminar is free of charge. For registration however please send an informal e-mail to Laurence Guillier (laurence.guillier@roche.com) or Barbora Martinec (barbora.martinec@roche.com).
The seminar takes place on November 14, 2017 14:30-17:00.
Venue: Novartis Campus Basel, WSJ-Fabrikstr-6-U2-Auditorium
Program BBS Seminar Emerging topics for statistical methodology in drug development: Estimands and advanced analytics
The seminar is free of charge. For registration however please send an informal e-mail to Laurence Guillier (laurence.guillier@roche.com) or Barbora Martinec (barbora.martinec@roche.com).
The seminar takes place on September 11, 2017 9:00-15:30.
Venue: Roche IT Training Center, Aeschenvorstadt 56, 4051 Basel
