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


Susanne Rhoades, PhD

Associate Vice President, Diagnostic Development, Loxo@Lilly

Dr. Susanne Rhoades is currently Associate Vice President of Diagnostic Development Program Management at Loxo@Lilly. She has 11 years of CDx development experience and worked on a number of novel CDx development programs. She received her PhD in Pharmacology from Vanderbilt University School of Medicine.


Mark Kiel, MD, PhD

Chief Scientific Officer, Genomenon
Mark is the founder and chief scientific officer at Genomenon, where he oversees the company’s scientific direction and product development.
Selpercatinib is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test. For a full listing of approved indications and safety description, please click for full Prescribing Information. The labeling for selpercatinib contains warnings and precautions for hepatotoxicity (evidence of liver dysfunction), interstitial lung disease (ILD)/pneumonitis, hypertension, QT interval prolongation, hemorrhagic events, hypersensitivity, tumor lysis syndrome, risk of impaired wound healing, hypothyroidism, and embryo-fetal toxicity. This presentation was developed by Lilly Medical and is intended to be used by HCPs for medical, scientific, and educational purposes. VV-MED-132351 © 2022 Lilly USA, LLC. All rights reserved