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Congress Center Basel

Apr 17, 2018 2:00 PM - Apr 19, 2018 11:00 PM

Messeplatz 21 , CH-4021 Basel , SWITZERLAND


Novel and Innovative Clinical Trial Designs: From Adaptive/Seamless Designs to the Trial of the Future

Session Chair(s)

Mireille  Muller, DrSc, PhD, MSc

Mireille Muller, DrSc, PhD, MSc

Regulatory Policy & Intelligence Director

Novartis Pharma AG, Switzerland

Multiple trial design options are required to increase efficiency in clinical trial conduct in increasingly complex conditions and smaller populations while maintaining scientific value and data quality to meet the wants of all stakeholders.

Learning Objective : i) identify and discuss the problems, also ethical and economical, related to phase II planning; ii) evaluate if the techniques adopted for planning phase II are correct, in order to collect enough information to plan the subsequent, eventual, phase III; iii) influence the decisions about phase II planning.


Michael  Krams, MD

Platform Trials: Michael Krams, MD

Vice President, Global Head of Quantitative Sciences

Janssen R&D, Johnson & Johnson, United States

Sacha  Wissink, PhD

Regulatory and HTA Challenges with Innovative Clinical Trials: Sacha Wissink, PhD

Executive Director, Regulatory Affairs Europe

MSD Netherlands, Netherlands

Benjamin  Hofner, PhD

Regulator’s Perspective: Master Protocols – Risks and Benefits: Benjamin Hofner, PhD

Head of Data Science and Methods

Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Germany

Daniele  De Martini, PhD

Empowering Phase II Clinical Trials To Reduce Phase III Failures: Daniele De Martini, PhD

Associate Professor

Milano-Bicocca University, Italy

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