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DIA Europe 2019 has ended
Wednesday, February 6 • 15:15 - 16:15
#S0903: Histology-Independent Indications

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Component Type: Session

Biological drivers that define cancer course across anatomical sites and histologies offer an opportunity to select populations sensitive to specific drugs based on those drivers, independently of the specific site or histology. The FDA regulatory approvals of the first medicines in 2017 marked an important milestone that a cancer treatment may be approved based on a common biomarker rather than the anatomic location in the body where the tumor originated, and therefore established a precedent for histology-independent labels. With increasing accessibility to genetic analysis tools such as next-generation sequencing, this type of personalized therapy has become a reality, both during clinical development and in clinical practice. This session aims to provide an exchange of views from different stakeholders about situations where a site and histology-independent clinical development might be a viable option and the associated challenges in terms of drug development, benefit-risk evaluation and health-technology assessment. A second part of the discussion mainly focusing on challenges for the value assessment of these drugs will be held in session 0606.

Chair

Chitkala Kalidas

Speaker

Panelist
Claus Bolte

Panelist
Sophie Cooper

Panelist
Mike Holmes

Panelist
Amy McKee

Panelist
Daniela Melchiorri



Speakers
CB

Claus Bolte

Head of Authorisation, Swissmedic
avatar for Sophie Cooper

Sophie Cooper

Scientific Adviser, National Institute for Health and Care Excellence (NICE)
Sophie Cooper is currently a Scientific Adviser in the Science Policy and Research programme at NICE, following several years’ experience in NICE's Technology Appraisals programme. Her role involves developing Institute responses to science policy issues and undertaking and commissioning... Read More →
MH

Mike Holmes

Associate Vice President, Global Medical Affairs Oncology, MSD
CK

Chitkala Kalidas

VP and Head Oncology Regulatory Affairs, Bayer
AM

Amy McKee

Deputy Director FDA/Oncology Center of Excellence, FDA
DM

Daniela Melchiorri

Member CHMP, University of Roma


Wednesday February 6, 2019 15:15 - 16:15
DIAlogue Space Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria