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Bringing NGS into Drug Development: The Impact of Sequencing on the Future of Clinical Trials and Drug Registration
Session Chair(s)
Michael James Doherty
Head of Product Development
Foundation Medicine, United States
Next-generation sequencing technology (NGS), ‘-omics’, increased computational power and “Big Data” are leading to a world of “precision medicine” in which an individual patient’s genomic/phenotypic profile can be matched to a specific treatment. Trials are already underway to develop this “treatment matching” pathway. Additionally, in clinical practice, many major centres are offering comprehensive molecular diagnostic profiling to patients to augment commercially available panels. It is only a matter of time before it becomes part of standard medical practice. This session aims to discuss the impact on the way clinical trials are designed and the way this approach could drive changes in the regulatory processes.
Speaker(s)
Panel discussion
Hans-Georg Eichler, MD, MSc
Austrian Association of Social Security Bodies, Austria
Consulting Physician
Panel discussion
Jennifer Dudinak-Dickson, PharmD
Bristol Myers Squibb , United States
Senior Vice President, Global Regulatory Sciences
Panel discussion
Benoit Destenaves, PharmD
AstraZeneca, United Kingdom
Director, Head of Molecular Diagnostics Labs & Pharmacogenomics
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