The global regulatory landscape for companion diagnostics has significantly evolved over the past few years, including in important markets such as the European Union, the United Kingdom, Australia, and China. Co-development planning between diagnostic and Pharma companies should consider ex-US regulatory strategy as early as possible to mitigate costly barriers to entry or delays in global testing.  This presentation will review how companion diagnostics are currently regulated in different regions, and will discuss best practices for coordinating activities between the diagnostic company, the Pharma partner, and regulators.  Further, global best practices regarding the regulation of companion diagnostics will be explored.

As personalized medicine continues to advance rapidly, in vitro diagnostics (IVDs) are increasingly being used as the primary driver for patient treatment decisions. When an IVD is essential for safe and effective use of a therapeutic, accurate and reliable IVDs are critical for optimal treatment decisions. CDRH’s policy, regulatory review, and vision of the future for such IVDs will be discussed.

While the health care system moves beyond the immediate ramifications of the COVID-19 pandemic, the frontiers of personalized medicine are rapidly advancing with the efficient approval of new diagnostic tools and treatments that will expand the field with implications for patients with rare genetic diseases, cancers, and some common diseases. New diagnostic tools and trends involving liquid biopsy, tissue agnostic oncology indications, and early detection, as well as newly approved molecularly targeted drugs and cell-based and gene therapies will be highlighted to provide a look at where the field is and where it is going.

Precision or personalized medicine (PM) covers multiple initiatives, including the use of diagnostic (Dx)/companion-diagnostic (CDx) in drug development. A PM-driven approach can expedite and de-risk new drug launches while simultaneously improving clinical efficacy. This presentation will focus on the strategic applications of diagnostics in drug development and tactical consideration to successfully implement and deliver value through a PM-driven approach. 

This presentation will discuss biomarker identification processes within drug development teams, highlighting the types of biomarkers investigated, the processes used to identify biomarkers, and technical decisions for predictive biomarker selection and putative companion diagnostic partnerships.

Precision medicine has been gaining traction.  Diseases that appear similar in pathology often arise from distinct underlying etiologies. These differences have consequences for patients and for companies.  Patients may suffer and clinical trials may fail when therapeutic agents are administered to the wrong patients. Companion diagnostics ensure that therapies are administered only to patients who can benefit from them. Current trends in patent law pose challenges to the protection of innovative technologies. This presentation will provide actionable strategies for the protection of innovations in the companion diagnostic and precision medicine arenas. 

- What are the major challenges and pain points within the current CDx regulatory framework?

- Will the proposed FDA/OCE CDx pilot program effectively address the existing pain points?

- What practical aspects should the CDx pilot program consider to improve patient access to the testing while ensuring reliability and accuracy?​​

Presentation will address the challenges of current CDx regulation from a pharmaceutical industry perspective, using examples such as the necessity of CDx, the use and review of local lab tests, and the process of study risk determination and IDE planning and execution. The presentation will also compare the current CDx regulation with the proposed FDA Oncology Dx pilot program and explore the implications of the landscape changes. Finally, the speaker will identify some key hurdles for the new framework to roll out and invite more discussion.