Testimonials
Hear From Past Attendees & this Year's Speakers on Why you and your Team Should Attend this Unmissable Conference
"Immuno-oncology clinical trial space is crowded and we have an ethical responsibility to try to learn from each study as much as possible. This meeting brings together the best experts on the biomarker identification field and allows us to change ideas and knowledge to maximize the value of clinical trials for the benefit of future cancer patients"
Sari Pesonen, Chief Scientific Officer, Valo Therapeutics
"The World Clinical Biomarker & CDx Summit is traditionally the most Companion Diagnostic focused conference in with presentations and discussions spanning from early candidate CDx biomarker clinical development programs through regulatory approval, commercialization and clinical implementation of CDx assays"
Jonathan Beer, Senior Director, Translational Sciences & Diagnostics, Bristol Myers Squibb
"The implementation of the IVDR in 2022 was the beginning of a new era of IVD device regulation. It was not just an ‘upgrade’ of the Directive, but a total paradigm shift incorporating a new classification scheme and detailed risk-based approach to the process. The new Regulation is a major and complicated adjustment for European manufacturers, but for manufacturers in the United States, is further complicated by differences in definitions, approach, and mindset between the EU Regulation and US FDA requirements. Gaining clarity and a foundational understanding of the key components of the IVDR as well as how they differ from US FDA Regulation of CDx products will be a value to those in attendance"
Anthony Kanavage, IVD Product Assessment Regional Team Manager & Product Expert, TÜV SÜD Americas
"It gives me an opportunity to absorb and learn from what external stakeholders in our industry are working on, concerned or enthusiastic about. It also provides an opportunity for me to contribute my thinking and perspectives to a broader audience"
Sid Mathur, Executive Director, Regulatory Affairs & Companion Diagnostics, Merck & Co
"These discussions aid in bringing biomarkers to the clinic more quickly and effectively. Previous attendance was great for networking in the space"
Josie Hayes, Director, Translational Oncology, Noetik
"Helps to stay current with biomarker discovery and clinical development while also giving the opportunity to network with peers"
Mike Kagey, Vice President, Translational Medicine, Leap Therapeutics
"The value in participating in this is to talk about experiences (successes and challenges) in CDx development. Further to discuss how we, as a field, can move towards more effective biomarker clinical implementation"
Robert H. Getzenberg, Medical Director Diagnostics, Oncology, Astellas Pharmaceuticals