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

Agenda BBS Seminar Biomarker analyses PDF

This BBS seminar takes place on Monday 13 March 2017 15:00-16:30.
Location: Roche ITC Learning Center, Aeschenvorstadt 56, Basel

Agenda BBS Seminar Safety monitoring during the life cycle of a drug PDF

This BBS seminar takes place on Tuesday 29 November 2016 15:00-17:00.
Location: Actelion Pharmaceuticals, Hegenheimermattweg 95, Robert Cawthorn Auditorium (Building H95), 4123 Allschwil, Switzerland

Conny Berlin, Safety monitoring during the life cycle of a drug
Yusuf Tanrikulu, Signal Detection – Quantitative Analysis of Safety Data
Pritibha Singh, Adverse Drug Reaction (ADR)
screening in clinical trials

Gianmario Candore, Screening for adverse reactions in EudraVigilance
Soheila Aghlmandi, Choice of priors in rare events
meta-analysis

Agenda BBS Seminar Synthesis of Evidence: Observational studies and Meta-analysis PDF

This BBS seminar takes place on Monday 14 November 2016 15:00-17:45.
Location: Roche Learning Center, IT Training Center, Aeschenvorstadt 56, Basel

Agenda Ad-hoc BBS Seminar Missing Data and Graphical Models PDF

This BBS seminar takes place on Monday 17 October 2016 15:00-17:00.
Location: Roche Learning Center, IT Training Center, Aeschenvorstadt 56, Basel

Agenda PSI/BBS one day meeting Time-to-Event and Recurrent Event Endpoints PDF

This PSI/BBS one day meeting takes place on Wednesday 14 September 2016 8:30-16:00.
Location: Novartis Pharma AG, Novartis Campus, CH-4056 Basel, Switzerland
For more information see also http://psiweb.org/events/psi-events/2016/09/14/default-calendar/time-to-event-and-recurrent-event-endpoints

Agenda BBS Seminar Adaptive Designs PDF

This BBS seminar takes place on Wednesday 4 May 2016 9:00-11:30.
Location: Novartis Campus, Auditorium of building WSJ-210 (1st floor)

Franz König, Regulatory and methodological issues in adaptive designs for confirmatory trials
Peter Bauer, DMC membership experience
David Lawrence, Using a DMC for dose selection in a phase IIb/III adaptive design: the INHANCE study
Alexander Strasak, Adaptive seamless phase II/III study in gastric cancer