Precision Oncology in Practice: Strategies to Drive the Next Generation of Oncology Studies
Precision medicine is no longer an emerging approach in oncology, it is the operating model. As biomarker-defined populations expand into earlier-line and adjuvant settings, sponsors are increasingly required to co-develop therapeutics with companion diagnostics, integrate liquid biopsy and ctDNA strategies, and generate decision-grade evidence from smaller, higher-stakes trials.
This webinar examines how precision oncology trials are evolving from a CRO perspective, with a focus on the practical considerations required to enable meaningful synergy between therapeutics, diagnostics, and underlying biology. Through medical, regulatory, and operational lenses, we will examine how companion diagnostics shape eligibility, how ctDNA informs adjuvant decision‑making, where execution gaps most commonly erode trial clarity, and how to navigate FDA/NCCN positions as well as the EU IVDR transition and ISO 20916:2024 expectations.
Designed for biotech and pharma teams advancing targeted oncology programs, this session moves beyond scientific promise to address what it takes to operationalize precision medicine at scale—without losing speed, confidence, or regulatory alignment.
Key Learnings
By the end of this webinar, attendees will be able to:
- Understand how precision medicine has become the default in oncology development, particularly in biomarker-led and adjuvant trial settings
- Evaluate how liquid biopsy and ctDNA can be used for patient selection and decision-making, rather than exploratory endpoints alone
- Decode where ctDNA/liquid biopsy best fits today (enrichment, MRD surveillance, adjuvant decision making) in light of NCCN and FDA positions
- Identify common operational and data-integration challenges in trials combining therapeutics, diagnostics, and molecular monitoring
- Apply practical CRO-led frameworks to design and deliver precision oncology studies that generate clearer, decision-ready outcomes
Speakers:
Short Bio:
- Over 20 years of clinical research experience across oncology and general medicine, with deep expertise in clinical operations and end-to-end project management of Phase I–IV investigational medicinal product trials
- Transitioned to Fortrea’s Medical Device and Diagnostics division four years ago, expanding leadership capabilities into the rapidly evolving device and diagnostics landscape
- Demonstrates a strong and sustained interest in regulatory affairs and quality assurance, contributing to the successful organisational implementation of the EU CTR, EU MDR, and EU IVDR through collaboration with Fortrea’s Regulatory Intelligence Office
- Provides strategic leadership across a diverse portfolio of medical device and diagnostic studies, ensuring operational excellence, regulatory alignment, and consistent delivery of high-quality outcomes
Short Bio:
- 25 years of combined clinical and basic science oncology research, along with clinical experience as an academic medical oncologist and industry subject matter expert, including:
- 10 years as an NCI-funded physician-scientist working on tumor immunology and innate immunity at academic NCI-designated cancer centers
- 20 years as an academic thoracic oncologist engaged in Phase I–III clinical research in lung and head & neck cancer
- Site-disease leader for thoracic oncology at an NCI-designated cancer center
- Industry experience in biomarker development and genomic profiling, including next-generation sequencing, RNA sequencing, and HRD signature
- Broad experience in developing and managing clinical trials across a wide range of oncologic sub-specialties, including lung, head & neck, GI, and breast cancer
Short Bio:
- 20 years of experience working with medical device and diagnostic regulations
- Master’s degree in software engineering and a Bachelor’s degree in electrical engineering
- Experience with medical devices worldwide (US, CA, EU, UK, AUS)
- Experience with diagnostics (IVDs, CDx, imaging)
- Experience with digital health technologies (SaMD, SiMD, MDSW, CDSS, etc.)