Talks
to come
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Regulatory considerations on complex clinical trials and adaptive designs with Bayesian design elements (Agenda)
PSI Conference 2024, Amsterdam, The Netherlands, 16. - 19.06.2024.
2024
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Vaccine development - Lessons learned from COVID-19 and other vaccines development programs
7th ISBS Symposium, Baltimore, USA, 06. - 09.03.2024.
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Panelist: Navigating the Future: Statistical Innovation in Drug Development and Regulatory Science
with Ralf Herold (EMA), Mark Levenson (CDER, FDA), Michael Proschan (NIAID), John Scott (CBER, FDA)
7th ISBS Symposium, Baltimore, USA, 06. - 09.03.2024.
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Panelist: Interpretation of results from hierarchical testing of multiple endpoints and in subgroups in cancer clinical trials
Project Significant, Online, 13.02.2024.
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Klinische Relevanz: Umsetzbares Konzept für die Regulation?
Klinik Klub, Paul-Ehrlich-Institut, Langen, 08.02.2024.
2023
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Panelist: Considerations in requiring blinded independent central review of radiologic scans in randomized cancer clinical
trials when progression-free survival is the primary endpoint
Project Significant, Online, 12.12.2023.
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Complex clinical trials: Settingt the scene
ACT EU PA08 multi-stakeholder methodology workshop, Amsterdam, The Netherlands, 23.11.2023.
Workshop Report
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Study Design and Statistical Methods for platform trials (with Franz König)
DIA Innovating Clinical Trials in Europe, Online, 15. - 16.11.2023.
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Statistical considerations for CAR-T cell development: Updates from an European regulator
BBS Workshop - Pre-approval and Post-approval Challenges in the Clinical Development and Reimbursement
of CAR-T Cell Therapies, Online, 04. - 05.10.2023.
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Session chair: Synthetic and other baseline covariates: The promise of smaller and faster clinical trials through prognostic digital twins
8th EFSPI Regulatory Statistics Workshop, Basel, Switzderland, 13. - 14.09.2023.
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Statistical and regulatory lessons learned during the pandemic
CEN 2023, Basel, Switzderland, 03. - 07.09.2023.
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Master Protocols & Platform Trials: Considerations from EU-PEARL and the European Regulatory Network
vfa Unterausschuss Nutzenbewertung, Online, 21.06.2023.
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Session 3 - The future ahead: the sustainability of EU-PEARL's framework and set of tools
(Slides)
EU-PEARL: Closing event, Brussels, Belgium, 25.04.2023.
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Panelist:Platform trials - findings from the EU-PEARL initiative
ADMTP 2023, Basel, Switzderland, 19.04. - 21.04.2023.
2022
2021
2020
Experience with platform trials in CTAs
EU-PEARL Stakeholder Workshop on Platform Trials 22.10.2020.
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A European Regulator's View on Master Protocols
DIA Master Protocol Workshop 2020, Virtual, 08. - 09.10.2020.
Session 7: Global Regulatory Landscape/Perspectives
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Statistical issues in drug development - The role of statisticians in regulatory agencies
Kolloquium Statistische Methoden in der empirischen Forschung, Virtual, 24.11.2020.
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Session: Kinder? Karriere? Beides!
(H Buchner, A Zapf, B Hofner, J Igel, M Wright, CU Kunz)
GMDS & CEN-IBS 2020, Berlin, 06.-11.09.2020.
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Confirmatory Adaptive Designs - A Regulatory Perspective
GMDS & CEN-IBS 2020, Berlin, 06.-11.09.2020.
Canceled due to COVID-19
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Tutorial: Recurrent events in clinical trials
GMDS & CEN-IBS 2020, Berlin, 06.-11.09.2020.
Canceled due to COVID-19
2019
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RWD aspects in a gene-therapy approval
4th EFSPI Workshop on Regulatory Statistics, Basel, Switzerland, 23.-24.09.2019.
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Statistical issues in drug development and the role of statisticians in regulatory agencies
Institutskolloquium, IMBIE, Universität Bonn, 01.08.2019
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Statistical issues in drug development and the role of statisticians in regulatory agencies
DAGStat
2019, München, 18.-22.03.2019.
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Young Statisticians Panel Discussion: "What to do after graduating? Your career options in Biostatistics"
DAGStat 2019,
München, 18.-22.03.2019.
2018
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A regulator's view on innovative
clinical trial designs in oncology
Moderne Studiendesigns in der Onkologie - Notwendigkeit, Methoden und Anwendungen, Heidelberg, 23.10.2018.
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Innovative trials in oncology - A regulator's view on master protocols
3rd EFSPI Workshop, Basel, Switzerland, 24.-25.09.2018.
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Stats and Drugs and Rock 'n' Roll - Die Rolle der Statistik in der Zulassung
Antrittsvorlesung, Friedrich-Alexander-Universität Erlangen-Nürnberg, 24.08.2018.
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An Update and a discussion on master protocols
Klinik Klub, Paul-Ehrlich-Institut, Langen, 15.08.2018.
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Boosting methods for complex biological and biomedical applications
Habilitationskolloquium, Friedrich-Alexander-Universität Erlangen-Nürnberg, 11.07.2018.
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Mastering innovative trial designs: Master protocols, basket, umbrella and platform trials
Institutskolloquium, IMBEI, Mainz, 28.06.2018.
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Regulatory Town Hall
PSI Conference 2018, Amsterdam, 03.-06.06.2018.
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Mastering innovative trial designs: Master protocols, basket, umbrella and platform trials
Heidelberger Kolloquium Medizinische Biometrie,
Informatik und Epidemiologie, Heidelberg, 28.05.2018.
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Adaptive Pathways and Conditonal Approval - A Critical Appraisal
Internes Seminar, Paul-Ehrlich-Institut, Langen, 26.04.2018.
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Master Protocols - Risks and Benefits
Session on Novel and Innovative Clinical Trial Designs, DIA Europe 2018, Basel, Switzerland, 17.-19.04.2018.
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Master Protocols: Chances and challenges in drug development
Biometrisches Kolloquium, Goethe-Universität, Frankfurt, 25.03. - 28.03.2018.
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Estimands and sensitivity analysis in clinical trials
Forum Biomedizinische Arzneimittel, Paul-Ehrlich-Institut, Langen, 18.01.2018.
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Estimands and sensitivity analysis in clinical trials - ICH-E9(R1) addendum
Projektgruppe - Biometrie in der Ethikkommission, Klinikum Großhadern, München, 13.01.2018.
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Moderne Studiendesigns: Methodik und biometrische Vor- und Nachteile für die Arzneimittelentwicklung
Projektgruppe - Biometrie in der Ethikkommission, Klinikum Großhadern, München, 13.01.2018.
2017
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Biostatistische Aspekte flexibler Studiendesigns - Definitionen, Chancen und Risiken
5. PEI-DKTK Workshop, Paul-Ehrlich-Institut, Langen, 27.11.2017.
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Moderne Studiendesigns: Methodik und biometrische Vor- und Nachteile für die Arzneimittelentwicklung
Gemeinsame Dialogveranstaltung - Komplexe Studiendesigns, BfArM, Bonn, 20.11.2017.
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Schätzen & Testen
Assessorentraining, Paul-Ehrlich-Institut, Langen, 06.10.2017.
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(Draft) Guideline on multiplicity issues in clinical trials
Forum Biomedizinische Arzneimittel, Paul-Ehrlich-Institut, Langen, 14.06.2017.
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Adaptive Pathways & Conditional Approval - A critical appraisal
Klinik Klub, Paul-Ehrlich-Institut, Langen, 18.04.2017.
2016
2015
Webinar:
Reporting
for Reproducibility: Best practices for reporting methods and results
Joint presentation with William Irish, Dana Turner, William G. Jacoby
and Rachel Zawanda.
Wiley Author Services @ Brighttalk, 12.11.2015
Boosting Beyond the Mean: Model Building and Variable Selection in the GAMLSS Framework
Department of Statistics, Faculty of Economics and Statistics,
Universität Innsbruck. 05.11.2015.
Application of state-of-the-art machine learning techniques to the
PM data on autism-spectrum disorders - Boosting with false discovery
control
Conference on Phenotype MicroArray Analysis of Cells 2015, Florence, 10.09. - 12.09.2015.
(Invited Talk)
Reproducible Research: Rationales, a Review, and Recommendations
OpenML Workshop 2015, Eindhoven, NL, 02.09. - 04.09.2015.
(Invited Talk)
Boosted negative binomial hurdle models for spatiotemporal abundance of sea birds (pdf)
IWSM 2015, Linz, 06.07. - 10.07.2015.
Kernel Boosting
Institut für
Genetische Epidemiologie, Universitätsmedizin Götingen,
11.06.2015.
Short Course: Reproducible Research
by Benjamin Hofner and Lutz Edler
as part of Biometrisches Kolloquium 2015.
2014
Variable Selection Methods: How to Boost Your Model (pdf)
University of Essex, Colchester, UK. 07.10.2014
Short Course: Boosting for statistical modelling
by Benjamin Hofner and Andreas Mayr
at the University of Essex, Colchester, UK.
Date: 06.10.2014
Tutorial: Model-based Boosting with Variable Selection
(as part of the short course "Methods for Variable Selection")
GMDS-Jahrestagung 2014, Götingen,
07.09.-10.09.2014
Biomarker discovery: controlling false discoveries in high dimensional situations (pdf)
ISCB Vienna 2014, Wien,
24.08.-28.08.2014
Short Course: Boosting for statistical modelling
by Benjamin Hofner and Andreas Mayr
as part of the IWSM 2014 in Götingen, 13.07.2014.
Controlling false discoveries in high dimensional situations: Boosting with stability selection (pdf)
Biometrische Kolloquium 2014,
Bremen, 10.03. - 13.03.2014
2013
2012
2011
Boosting in Structured Additive Models (pdf)
Disputation, Institut für Statistik, LMU München, 05.12.2011
gamboostLSS: boosting generalized additive models for location,
scale and shape
(Abstract,
Slides)
(joint work with Andreas Mayr, Nora Fenske, Thomas Kneib and Matthias
Schmid)
useR!
2011, University of Warwick, Coventry, UK, 16.08.2011 -
18.08.11
Tutorial: Boosting with the mboost package
(together with A. Mayr, M. Schmid (FAU Erlangen-Nürnberg) and N. Robinzonov (LMU München))
Statistical Computing 2011,
Schloss Reisensburg (Günzburg), 22.05. - 25.05.2011
Tutorial: Lineares Modell, ANOVA, und Verallgemeinerungen des linearen Modells
BioStats 2011 Workshop,
DSMZ (Braunschweig), 22.03. - 24.03.2011
2010
2009
Poster:
Biased Model Selection: Possible Solutions for Boosting (pdf)
(joint work with Torsten Hothorn, Thomas Kneib and Matthias Schmid,
presented by Matthias Schmid)
2009 Conference of the Working Group
"Statistical Methods in Bioinformatics", München, 17.09. - 18.09.2009
Biased Model Selection: Possible Solutions for Boosting (pdf)
(joint work with Torsten Hothorn, Thomas Kneib and Matthias Schmid)
Statistical Computing 2009, Schloss Reisensburg (Günzburg), 28.06.-01.07.2009
CoxFlexBoost: Fitting Structured Survival Models (pdf)
(joint work with Torsten Hothorn and Thomas Kneib)
useR! 2009, Rennes, France, 08.07.09 - 10.07.09
Biased Model Selection: Possible Solutions for Boosting (pdf)
(joint work with Torsten Hothorn, Thomas Kneib and Matthias Schmid)
Institutskolloquium, FAU Erlangen-Nürnberg, 17.06.2009
Model-Based Boosting: Unbiased Variable Selection and Model Choice (pdf)
(Abstract available on the Kolloquium-Site)
(joint work with Torsten Hothorn, Thomas Kneib and Matthias Schmid)
Institutskolloquium, LMU München, 10.06.2009
Bernd-Streitberg-Preis 2009:
Variable Selection and Model Choice in Survival Models with Time-Varying Effects (pdf)
(joint work with Torsten Hothorn und Thomas Kneib)
Biometrisches Kolloquium 2009, Hannover, 17.03.09 - 19.03.09
Variable Selection and Model Choice in
Structured Survival Models (pdf)
(joint work with Torsten
Hothorn und Thomas Kneib)
Biometrisches Kolloquium 2009, Hannover, 17.03.09 - 19.03.09
2008
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