This year the PSI Training Committee are delighted to offer 2 pre-conference courses again. Both of these courses will run on the afternoon of Sunday 7th
June and will be held at the same location used for the conference itself - at the Crowne Plaza Barcelona Fira Center. Both courses will be available for registration through the main conference registration portal, so please sign up when you register for the conference itself to avoid disappointment!
Course 1
Biomarker Informed Clinical Designs - Where Innovation Meets Precision: Concepts, Rationale, and Case Studies
Presenters: Sandeep M Menon and Weidong Zhang, Pfizer Inc.
Advancement of biomarker technologies such as omics, digital biomarkers have brought unprecedented opportunities to precision medicine development. Biomarkers in clinical studies are becoming indispensable in designing clinical trials owing to but not limited to;
1) heterogeneity of patient population defined by their molecular profiles
2) complex disease etiology that demands deep and broader understanding of biology
3) challenges and problems in evaluating PK/PD activities of new agents.
Rich biomarker data have presented drug developers tremendous opportunities to design clinical trials with better precision and efficiency, thus may greatly improve probability of trial success. For example, biomarker enrichment designs allow us to test the drug in a full spectrum of patient populations according to their biomarker status. In addition, analysis of biomarker data in clinical trials can provide guidance for objective and robust decisions to de-risk clinical development.
The first part of this course will give a comprehensive overview of clinical biomarker and latest major technologies such as next generation sequencing (NGS) for biomarker discovery and quantification. Statistical considerations and challenges such as data normalization, biomarker threshold development and using biomarker for decision making in clinical development will be discussed in detail.
The second part of this course will focus on the strategy of the biomarker assisted study designs that is important to assessment of biomarker performance and reliability regarding patient stratification for safety and efficacy. Specifically, novel designs including Bayesian adaptive designs and their merits and limitations will be discussed. Statistical methodologies and implications on regulatory submissions will also be presented. Case studies will be discussed for illustration.
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