Accelerating Phase 1 decisions with liquid biopsy: From early signals to actionable insights

Phase 1 oncology studies play a critical role in establishing safety, dose selection, and early signs of clinical activity. However, meaningful efficacy readouts often emerge only after substantial enrollment and follow-up, delaying key development decisions. When promising signals are absent — or when unexpected biological findings emerge — late-stage pivots can significantly increase development timelines, costs, and operational complexity.

Recent advances in liquid biopsy and epigenomic profiling offer the opportunity to generate molecular insights earlier in clinical development. By leveraging non-invasive blood-based approaches, biopharma teams can evaluate tumor dynamics, molecular response, and biologic activity before traditional endpoints mature, helping inform development strategy with greater confidence.

Attendees will learn:

Why relying solely on traditional clinical endpoints in Phase 1 studies can delay critical development decisions and increase program risk.
How emerging liquid biopsy technologies can provide earlier visibility into treatment response, biological activity, and patient heterogeneity.
The utility of non-destructive methylation profiling, tumor fraction assessment, and methylation-based signatures for generating translational insights from a simple blood draw.
How molecular response assessments may complement conventional efficacy endpoints to support dose optimization and expansion cohort strategy.
Real-world examples demonstrating how ctDNA and epigenomic biomarkers informed dosing decisions, patient selection strategies, and early signal detection in oncology development programs.
Practical considerations for incorporating liquid biopsy endpoints into Phase 1 study design to accelerate learning and reduce uncertainty in early development.

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Jean-Francois Martini

Senior Director of Translation Strategy & Applications, Guardant Health

Jean-François Martini has extensive biopharma industry experience in pharmacology and clinical translational sciences. He is currently heading the Translational Strategy group at Guardant Health. He was previously at Pfizer where he had increasing responsibilities within the Translational Science organization, including diagnostics and translational lead for lorlatinib, encorafenib and supported the diagnostics and translational strategies for the cell cycle modulators, the Renal Cell Cancer franchise, and the gene therapy programs. Prior to Pfizer, he held various positions in Translational Medicine at Exelixis. He earned his PhD in Molecular and Cellular Endocrinology from University Paris XI, France, and completed his postdoctoral fellowship at UCSF.

Chuck Caldwell

Director of Translational Oncology, Pfizer

Chuck Caldwell is a Director of Translational Oncology at Pfizer, where he leads translational strategy and biomarker-driven decision-making supporting a broad clinical development portfolio. With over a decade of industry experience spanning Pfizer, Seagen, and Flagship Biosciences, he has built deep expertise in cancer biology, novel drug modalities, and emerging biomarker technologies. Prior to his transition to industry, Chuck developed an early interest in clinical biomarker research as the basis of his Biomedical Engineering PhD at the University of Missouri, followed by his postdoctoral fellowship researching lung cancer at the Fred Hirsch Biomarker Lab at the University of Colorado.

Moderator

Justin Odegaard

SVP of Product, Guardant Health

Dr. Odegaard is the Senior Vice President of Product at Guardant Health, Inc., where he has spent the 10 years building, validating, and commercializing cancer molecular diagnostics. He trained in surgical and molecular pathology (MD) and immunology and physiology (PhD) at Stanford University, where he also served on the consulting faculty. Prior to Guardant Health, he also worked at the University of California San Francisco, at OneOme Laboratories, and at Lifecode, Inc.