%0 Journal Article %J Semin Cancer Biol %D 2018 %T Perspectives on the integration of Immuno-Oncology Biomarkers and drugs in a Health Care setting. %A K Vermaelen %A A Waeytens %A O Kholmanskikh %A Marc Van den Bulcke %A Els Van Valckenborgh %K Antineoplastic Agents %K Biomarkers, Tumor %K Delivery of Health Care %K Humans %K Immunotherapy %K Medical Oncology %K Neoplasms %X

Immunotherapies, specifically checkpoint inhibitors, are becoming an important component in cancer care with the most application now in melanoma and lung cancer patients. Some drawbacks that converge with this new evolution are the rather low response rates to these drugs and their high cost with a significant economic impact on the health care system. These major challenges can likely be circumvented by implementing a "personalized immuno-oncology" approach to accomplish a selection of optimal responders based on biomarkers. In this paper we first discuss the legal framework for the development of valuable in vitro diagnostics. Based on a case study in lung cancer, the clinical validity and utility requirements of predictive immuno-oncology biomarkers is highlighted and an overview is given on the evolution towards multiplex or omics-based assays together with its challenges and pitfalls. Finally, some initiatives between the public and private sector are pinpointed to sustain the future access to innovative medicines in cancer therapy at a reasonable cost.

%B Semin Cancer Biol %V 52 %8 2018 10 %G eng %N Pt 2 %R 10.1016/j.semcancer.2017.11.011 %0 Journal Article %J Arch Public Health %D 2018 %T Roadbook for the implementation of next-generation sequencing in clinical practice in oncology and hemato-oncology in Belgium. %A Els Van Valckenborgh %A Aline Hébrant %A Aline Antoniou %A Wannes Van Hoof %A Johan Van Bussel %A Patrick Pauwels %A Roberto Salgado %A Waltruda van Doren %A Anouk Waeytens %A Marc Van den Bulcke %X

In the field of oncology research, next-generation sequencing has contributed significantly to the discovery of DNA mutations associated with diagnosis and prognosis. It also aids in the development of targeted therapies to specific mutations and the rise of personalized medicine. As part of molecular diagnostics in cancer patients, analysis by next-generation sequencing is becoming part of routine clinical practice. The introduction of this complex technology in a healthcare system comes with multiple challenges and requires a clear action plan. Such an action plan, as outlined in this paper, was developed in Belgium and includes steps in ensuring the quality and indications of NGS testing, installing data registration and tackling ethical issues. A final step is to perform a pilot study to control the access, quality, harmonization and expertise in DNA testing. This action plan can serve as a guide for similar initiatives by other countries to facilitate NGS implementation in clinical practice.

%B Arch Public Health %V 76 %8 2018 %G eng %R 10.1186/s13690-018-0295-z