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 Seminar Innovative model-based dose escalation designs: what next? PDF
Registration: Free, please send an email to Barbora Martinec barbora.martinec@roche.com

This BBS seminar takes place on Monday 26 June 2017 13:30-17:00.
Location: Roche IT Training Center, Aeschenvorstadt 56, 4051 Basel

Daniel Sabanés Bové, Model-based D/E designs: Current status and next steps
Daniel Lorand, Tailoring dose escalation designs to early clinical development goals
Andreas Krause, Guiding dose escalation studies in Phase 1 with unblinded modeling

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?

Program BBS Spring Seminar The use of external data for decision making PDF

This BBS seminar takes place on Friday 5 May 2017 9:00-17:00.
Please register by sending an email in advance to fred.sorenson@xcenda.com
Registration will close on Thursday 27 April 2017
Location: Actelion Auditorium How to get to Actelion Allschwil

David Evans, Reality and Real-World Data
Ralf Bender, Use of registries and observational data in the benefit assessment of medical interventions
Frank Bretz, Threshold-crossing: A Useful Way to Establish the Counterfactual in Clinical Trials?
David Dejardin, Dynamic borrowing of historical data: Performance and comparison of existing methods based on a case study
Eva-Maria Didden, GetReal: 3 Years on!
Tim Friede, The Use of External Data for Decision Making