Dr. Corinna Wolf
Title of Presentation
“Establishing a biorepository tailored towards companion diagnostics development”
Date and Place
Dr. Corinna Wolf is a Senior Scientist Clinical Biomarker Informatics & Biobanking at Merck. She is working on the establishment of a biorepository meeting the requirements for companion diagnostics development with respect to sample quality, annotation and appropriate consent status. After taking her PhD at the University of Heidelberg in biochemistry and cell biology, she did a postdoc at Roche in personalized healthcare, focusing on tissue quality aspects and their impact on biomarker assays. Subsequently, she coordinated the setup of the Munich Biobank Alliance within the Leading-Edge Cluster “m4 – Personalized Medicine”, taking care of the project and quality management.
In today’s clinical research, the development of companion diagnostics (CDx) is key to enable the safe and efficacious treatment of patients in a personalized manner. During discovery, development and approval of such device, a lot of challenges are encountered. High quality, well annotated samples are of utmost importance for the successful development and validation of CDx. Especially in large, multicentric clinical trials necessary for drug approval, it is extremely difficult to collect samples with high, comparable quality across all clinical sites – along with the wealth of information requested by Health Authorities. From the perspective of a drug developer, we will present an approach to tackle such challenges and discuss how CDx development may benefit from collaboration models with academic biobanks. The global footprint of clinical trials adds complexity to obtain appropriate consent from participants for CDx development. Different legislation and ethical attitudes result in a variety of rules and constraints to use the samples for future research. CDx development, however, often requires a broad consent as in some cases a promising biomarker may be discovered even after completion of the trial – and the potential need for a retrospective analysis may arise. Hence, (re-)use of clinical samples requires a reliable information system enabling a structure representation of detailed consent attributes along with the samples and their annotation. We will showcase our approach of establishing a biorepository tailored towards the specific needs for biomarker discovery and CDx development.