Output

Jaki, T., Gordon, A., Forster, P., Bijnens, L., Bornkamp, B., Brannath, W., Fontana, R., Gasparini, M., Hampson, L.V., Jacobs, T., Jones, B., Paoletti, X., Posch, M., Titman, A., Vonk, R., Koenig, F. (2018 ) A proposal for a new PhD level curriculum on quantitative methods for drug development. Pharmaceutical Statistics, 1-14.

A Benchmark for Dose Finding Studies with Continuous Outcomes

Pavel Mozgunov, Thomas Jaki & Xavier Paoletti. 6th Early Phase Adaptive Trials Workshop, Los Angeles, USA (November 2018)

A robust Bayesian hierarchical model to incorporate preclinical animal data into a phase I dose-escalation trial

Haiyan Zheng, Lisa Hampson & Simon Wandel, 6th Early Phase Adaptive Trials Workshop, Los Angeles, USA (November 2018)

Information Theory in Dose-Finding: Improving Safety of the CRM

Thomas Jaki & Pavel Mozgunov, 6th Early Phase Adaptive Trials Workshop, Los Angeles, USA (November 2018).

An ethical non-parametric design for selecting arms in a multi-arm clinical trial

Thomas Jaki & Pavel Mozgunov, International Society for Clinical Biostatistics (ISCB) 2018, Melbourne, Australia

A Bayesian model to estimate the cutoff and the clinical utility of a biomarker assay

Eleni Vradi, Werner Brannath, Thomas Jaki & Richard Vonk. IBC (2018), Barcelona.

Incorporating historical information in biosimilar trials

Johanna Miekle, Heidi Schmidli & Byron Jones. IBC 2018 (Barcelona, Spain).

An information-theoretic Phase I/II design for molecularly targeted agents that does not require an assumption of monotonicity

Pavel Mozgunov & Thomas Jaki. IBC 2018, Barcelona, Spain

A Bayesian hierarchical model to incorporate pre-clinical data from multiple species into a phase I first-in-man trial

Haiyan Zheng, Lisa Hampson & Simon Wandel. IBC (2018), Barcelona

About IDEAS: What’s the Big Idea?

An overview of the objectives and training of the IDEAS Network. Presented at IBC 2018 (Barcelona) and ISCB 2018 (Melbourne)

A Bayesian model to estimate the cutoff and the clinical utility of a biomarker assay

Eleni Vradi, Thomas Jaki, Werner Brannath & Ricahard Vonk. PSI, 4th June 2018 (Amsterdam)

Scale Loss Score (SLoS): a novel measure of drug benefit-risk assessment

Gaëlle Saint-Hilary, Veronique Robert, Mauro Gasparini & Pavel Mozgunov. PSI Conference 2018, Amsterdam and IBC 2018, Barcelona

Presentation by Nicolas Ballarini to the 14th YSA PhD Symposium (June 2018)

“Graphical displays for subgroup analysis in clinical trails”

Graphical displays for subgroup analysis in clinical trials

N. Ballarini, Y.D.Chiu, F. Koenig, M. Posch, T. Jaki. Best Poster Award, PSI 2018, Amsterdam

Improving Design, Evaluation and Analysis of early drug development Studies

Julia Niewczas, N. Ballarini, M. Posch, F. Koenig, T. Jaki. The 14th Young Scientist Association Symposium, 7th & 8th June 2018, Vienna

Challenges and opportunities for sequential knowledge integration within a Bayesian PK/PD modeling framework

Fabiola La Gamba, Tom Jacobs, Jan Serroyen, Helen Geys & Christel Faes. PSI Annual Conference, Amsterdam (4th June 2018)

Improving a safety of the Continual Reassessment Method via a modified allocation rule

Pavel Mozgunov, Thomas Jaki. PSI Annual Conference, Amsterdam (4th June 2018)

A Bayesian information theoretic design for Phase I dose finding trials without monotonicity assumption

Pavel Mozgunov & Thomas Jaki. PSI One-Day Meeting on Bayesian Methods for Dose Finding and Biomarkers (28th February 2018)

Randomized dose-escalation design for drug combination cancer trials with immunotherapy

Pavel Mozgunov, Thomas Jaki & Xavier Paoletti. PSI Conference, 2017

Subgroup identification in dose-finding trials via model-based recursive partitioning

Marius Thomas. ZeSOB Kolloquium, November 2017, Oldenburg, Germany

How much evidence is provided prior to approval? An updated systematic review of biosimilar applications in Europe.

Joahnna Mielke, Byron Jones, Franz Koenig, Bernd Jilma. 2nd Annual Biosmiliars Forum, October 2017, Budapest

Subgroup identification for dose-finding trials via model-based recursive partitioning

Marius Thomas, Bjoern Bornkamp, Heidi Seibold, Torsten Hothorn. CEN ISBS, 2017, Vienna

Subgroup identification for dose-finding trials via model-based recursive partitioning

Marius Thomas, Bjoern Bornkamp, Heidi Seibold, Torsten Hothorn. ISBS, July 2017, Vigo

A flexible non-parametric dose-finding design for Phase II clinical trials

Pavel Mozgunov & Thomas Jaki. PSI Conference 2017, London

PSI translational day, 30. 03. 2017 (Haiyan Zheng, Lancaster)

PSI translational day, 30. 03. 2017 (Thomas Jaki, Lancaster)

PSI translational day, 30. 03. 2017 (Richardus Vonk, Bayer)

Marius Thomas, Comparing Novel Approaches to Subgroup Analyses in Clinical Trials, JSM 2016

Thomas Jaki, A weighted differential entropy based approach for dose-escalation trials, 5th Early Phase Adaptive Trials Workshop

Haiyan Zheng, A Bayesian decision-theoretic approach to incorporating pre-clinical information into phase I clinical trials, ISCB 2016

Fabiola La Gamba, A Bayesian PK/PD model for synergy, NCS2016 Conference, Corpus Christi College – 4th – 6th October 2016

T Jaki “Improving Design, Evaluation and Analysis of Early Drug Development Studies (IDEAS)” at the PSI conference on the 24th May 2016

International Biometric Society and IDEAS Joint Seminar: 29th November 2018, Medical University of Vienna

Join IDEAS on the 29th November 2018 for a joint seminar with IBS (Vienna and Styria region). Please see the attached agenda for a full list of talks and link to the registration form.

Shakespeare, Biosimilars and Switching

Byron Jones, Novartis

Bayes, Biosimilars and Sir Mick Jagger

Byron Jones, Novartis

Nicolas Ballarini’s talk to the Universidad Nacional de Rosario, Argentina (in Spanish)

A presentation on IDEAS and each research project

Mielke, J & Joachim Kunert (2018) Efficient designs for the estimation of mixed and self carryover effects

Discussion document co-authored by our early stage researcher, Johanna.

Marius Thomas to present his latest research at the Centre of Statistics in Oldenburg & Bremen on 27/11/2017

Young Statisticians Seminar (25th October 2017), Vienna

EMA “Draft Guideline on evaluation of anticancer medicinal products in man”

T Jaki has been invited to represent IDEAS at the “Design of Experiments in Drug Development open for business” workshop at the Isaac Newton Institute, Cambridge.

B Jilma was spoke at the Biosimilars Development – From Pre Clinic to Market event in Berlin on 27th January 2016 Details of the workshop can be found at the following link.

Interval estimation for dose-finding studies

A summary of our ESR Saswati Saha’s work with IDEAS

Subgroup analyses in early-phase clinical trials

A summary of our ESR Marius Thomas’s work with IDEAS

Statistical methods for phase I/II trials of molecularly targeted agents in oncology

A summary of our ESR Maria-Athina Altzerinakou’s work with IDEAS

Innovative designs for combination of therapies

A summary of our ESR Jose Luis Jimenez’s work with IDEAS

Detecting pharmacodynamic drug-drug interactions

A summary of our ESR Fabiola La Gamba’s work with IDEAS

Bayesian knowledge integration for an in vitro–in vivo correlation model

A summary of our ESR Elvira Erhardt’s work with IDEAS

Statistical aspects of animal to human translation

A summary of our ESR Eleni Vradi’s work with IDEAS

Bias and precision in early phase adaptive studies and its consequences for the decisions about conducting and designing confirmatory studies”

A summary of our ESR Arsenio Nhacolo’s work with IDEAS

Switchability assessment of biosimilars

A summary of our ESR Johanna Mielke’s research with IDEAS.

Development of a biomarker score to identify a subgroup of treatment responders

A summary of our ESR Nicolas Ballarini’s research with IDEAS.

Monitoring clinical trials using short-term information when long-term information is missing

A summary of our ESR Julia Niewczas’ research with IDEAS

Investigation of the gain in efficiency from using a Gamma threshold model for joint modelling of PFS and OS in oncology trials

A summary of our ESR Enya Weber’s research with IDEAS

Incorporating preclinical information into phase I first-in-man trials

A summary of our ESR Haiyan Zheng’s research with IDEAS

Dose finding for combination trials with many treatments

A summary of our ESR Pavel Mozgunov’s research with IDEAS

Innovative adaptive designs in oncology clinical trials with drug combinations

Jose L. Jimenez
Politecnico di Torino, Italy
November, 2018.

Statistical topics in clinical biosimilar development

Johanna Mielke
TU Dortmund, Germany
July, 2018