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Regulatory FAQs for developing companion diagnostics

A companion diagnostics (CDx) assay, according to the US-America Food and Drug Administration (FDA) guidance, is defined as an IVD device which provides information that is essential for the safe and effective use of a corresponding therapeutic product. The need for CDx has been growing in the past decades, along with the number of potential targeted therapies.

In this on-demand webinar we will discuss how every CDx development situation is unique and early discussions with regulatory and developing quality systems are necessary to clarify the biomarker intended use. In addition, we will learn how to evaluate and select the right partner capable to develop strategy using a risk-based approach, file, and commercialize a successful IVD product globally.

Complete the form below to listen to our webinar and receive an adjoining presentation deck on:

  • An overview of companion diagnostics.
  • Defining the intended use of biomarkers and importance of defining global regulatory strategy early.
  • Assessing risk and opportunity of drug and CDx co-development.


Kasey Kime

Kasey Kime

Senior Manager, Regulatory Affairs Clinical and Compliance Life Science Solutions, Thermo Fisher Scientific

Kasey has fifteen years of global quality and regulatory affairs experience in Life Sciences. She is part of Thermo Fisher Scientific’s regulatory affairs division and is overseeing regulatory compliance of technologies developed for cell and gene therapy applications. Her areas of expertise include raw material risk assessment for biopharmaceutical development and regulatory compliance of instruments and consumables developed for automating cell and gene therapy manufacturing. Kasey holds a Bachelor's Degree in Medical Laboratory Science and postgraduate degrees in both Microbiology and Quality Systems Management.

K A Ajit-Simh

K A Ajit-Simh

President, Shiba Biotechnology Inc.

Aijt established Shiba Biotechnology Inc. in 1999 to provide regulatory compliance, quality strategy, and support to the biotechnology, pharmaceutical, and medical device industry. Ajit has worked with several multi-national pharmaceutical companies and products over his 30+ years in this industry. Ajit has successfully hosted U.S. FDA and EMA inspections and conducted several mock pre-approval inspections (PAI) which led to successful outcomes. He is a member of PDA and is an adjunct professor and instructor at SDSU in regulatory affairs.

Naresh Nayyar

Naresh Nayyar, Ph.D.

Vice President Regulatory Affairs, Turning Point Therapeutics

Naresh Nayyar, Ph.D. is an experienced regulatory affairs leader with broad experience in clinical/companion diagnostic/CMC and post-approval drug development activities. These include EU MAA, BLA, and sNDA approvals as well as multiple post-approval supplements. Currently he is Vice President of Regulatory Affairs at Turning Point Therapeutics. Naresh is experienced in preparing teams for regulatory agency meetings (pre-IND, Type B/C, EOP2, pre-NDA, and Clarification Meetings), managing interface with agencies, organizing regulatory agency meetings, preparing submissions, and negotiating and interacting with US and international regulatory agencies.