How has the regulatory landscape changed for companion diagnostics?

Precision medicine shifts the direction of drug development from traditional clinical trials, which are based on broad eligibility criteria and measure average outcomes for all patients recruited, to biomarker-based approaches. The concept of a biomarker has expanded to complex algorithms and digital biomarkers. For example, ctDNA assays involve multiple analytes, each generating a signal which are used by AI algorithm is used to optimize clinical use.

In drug development, biomarkers can be used to define drug target selection, patient selection, enrichment, dose selection, safety assessment, and efficacy assessment.  In oncology, predictive biomarkers have been associated with about 60% of new oncology drugs, and there is increasing number of drugs approved with a companion diagnostic. Development of Companion Diagnostics require early collaboration between biopharma and IVD or medical technologies experts.

Key Topics

During this webinar, Dr Estelle Russek-Cohen and Dr Natalia Muehlemann will discuss

• Evolving regulatory landscape for Companion Diagnostics
• Regulatory considerations for AI-based approaches
• Integrating Companion Diagnostics into your development program

Speakers

Estelle Russek-Cohen, PhD,  Expert Advisor, Cytel

Estelle is a statistical and regulatory consultant supporting biopharma and MedTech companies with their clinical development programs. Prior to this, Estelle gained invaluable experience working for over 15 years across three FDA divisions.

In 2004, Estelle joined the Center for Devices and Radiological Health (CDRH) where she worked on diagnostic device submissions throughout the center, serving as a reviewer for the earliest genomic devices. Estelle became a Deputy Division Director and then Division Director for the Center for Biologics (CBER) where she provided final sign off for many biologic products including gene and cell therapies. She also provided advice on diagnostic submissions in CBER that were regulated as devices or biologics and on statistical aspects of post-market safety studies (FDA’s Sentinel initiative).  Estelle has worked on numerous guidance documents while at FDA and developed a CBER initiative to advance adaptive designs and proposed the FDA complex innovative design pilot program which became part of a PDUFA initiative.

Natalia (Natasha) Muehlemann, MD, MBA, VP Consulting, Cytel  

Natalia has over 20 years of experience in Life Sciences across several therapeutic areas, including intensive care, oncology, neurology, cardiovascular and metabolic diseases, and combines medical, statistics & data science and strategic expertise enhancing value through evidence generation, advanced analytics and stakeholders’ engagement.

Natalia joined Cytel as VP, Strategic Consulting at Cytel, in 2020. At Cytel she is focusing on the integration of innovative adaptive frequentists, Bayesian designs, Machine Learning methods and RWE into comprehensive clinical development strategies that combine clinical, regulatory, market access and financial considerations. Prior to Cytel, Natalia was Global Category Head, Acute Care – Oncology – Devices at Nestle Health Sciences.