A Precision Medicine Roadmap for Rx and CDx Co-development and Regulatory Approval in Japan

Precision medicine and pharmacogenomics are unlocking a new generation of therapeutics for patients with rare genetic diseases and cancers associated with pathogenic gene variants. Critical to the success of these targeted therapies is the ability to precisely classify the genetic basis of disease and drug response – and identify scientific evidence of pharmacogenetic gene-drug associations that not only informs clinical trial design and companion diagnostic development, but also meets the requirements of regulatory agencies in different countries. Is your companion diagnostic development strategy optimized for the unique challenges of precision medicine?

In this webinar, Dr. Susanne Rhoades of Loxo@Lilly will provide an overview of the Loxo@Lilly approach to co-developing precision therapies and companion diagnostics, such as selpercatinib (Retevmo^®), a kinase inhibitor used for the treatment of certain rare cancers caused by abnormal RET genes, and Oncomine™ Dx Target Test (ODxTT), a next generation sequencing test from Thermo Fisher Scientific. She’ll discuss the hurdles the Loxo@Lilly team encountered when applying for selpercatinib and ODxTT co-approval by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. Feedback from the PMDA, however, prompted a change in the submission strategy for the clinical validation of the ODxTT.

You’ll learn:

• How to discern if the timeline should be driven by Rx/CDx co-approval or co-launch
• Key CDx bridging study design elements and steps to facilitate regulatory review and co-approvals
• How to leverage AI-powered genomic knowledgebases to make genetic-evidence-based risk and benefit decisions – and select only documented pathogenic gene variants to include in claims