Announcement BBS/EFSPI seminar Small populations and level of evidence
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
Program BBS Seminar: RCTs, personalized medicine, and surrogacy
Date: Tuesday, June 26, 2018, 15:30-17.45
Venue: Auditorium Building 71, Roche Campus, Grenzacherstrasse, Basel
The BBS would like to offer a half-day seminar on topics related to clinical trials and personalized medicine with three eminent speakers. All talks will be accessible to general biostatisticians and highlight the relevance of these topics for clinical research and drug development.
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) until 19th June.
Tomasz Burzykowski, Evaluation of Time-to-event Surrogate Endpoints Using Accelerated Failure-time Models
Everardo D. Saad, Precision Medicine Needs Randomized Trials
Marc Buyse, A statistical approach for personalized medicine and benefit / risk assessment
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
Program BBS / PSI 1-Day Scientific Meeting: Empower the immune system to fight cancer PDF
This BBS / PSI meeting takes place on Thursday 15 June 2017 9:00-16:15.
Location: Roche IT Centre Auditorium – Building 655 – Aeschenvorstadt 56, 4051 Basel, CH
Jorge Martinalbo, Realising the potential of cancer immunotherapy
Andrew Stone, Statistical issues in the development of cancer immunotherapy
Daniel Sabanés Bové, Bayesian Learning in Early Phase Cancer Immunotherapy: A Case Study
Matt Whiley, An adaptive phase II basket trial design
Dominik Heinzmann, Statistical, clinical and ethical considerations when minimizing confounding for overall survival in cancer immunotherapy trials
Claude Berge, Statistical Challenges in Immunotherapy: Non Proportional Hazard Model
Sergio Fracchia, Challenges in development and approval: the case of cell based therapeutics
Fred Sorenson, Cancer Immunotherapy from the Health Technology Assessment (HTA) and Payer Perspectives
Nicholas Latimer, Estimating survival benefit for health technology assessment: New challenges presented by immuno-oncology treatments?
