Key Points for Simultaneous Development and Approval of Medicine and Companion Diagnostics

ABSTRACT Personalized healthcare (PHC) is an approach to understand the heterogeneity of patients and diseases in order to develop targeted therapies, including diagnostic tests and medicines. These targeted therapies enable physicians to design and implement treatment plans according to each patient's molecular and genetic profile. In the conventional approach, all patients who have a particular disease are given the same treatment. In contrast, with PHC, patients are stratified into subgroups by testing them for the presence of specific molecules or genes called biomarkers before administering a drug. A molecular targeted therapy is then provided only to those patients who have a high likelihood of responding to the treatment. This approach is attracting interest around the world as a way of improving drug efficacy and safety. Areas such as oncology in particular are expected to play a central role in the development of PHC. The Roche Group is a pioneer in personalized healthcare and has made it a central part of its strategy. Chugai as a member of the Roche group, the market leader in Japan for antibody-based drugs and cancer medicines, is also strongly positioned to promote PHC and is proud to be playing a prominent role in helping to establish this approach in Japan. Chugai focuses primarily on developing novel medicines with first-in-class or best-in-class potential. Discovery research based on personalized healthcare is a key to achieving that goal. The search for biomarkers begins in the early stages of drug discovery, and research is conducted with PHC in mind. To promote personalized healthcare, the launch of a molecular targeted therapy must be accompanied by that of a companion diagnostic, which must also be established in clinical practice. Within above approaches, today, I would like to introduce some examples of simultaneous development and approval of medicine and companion diagnostics.