Early Phase Oncology Trials: Overcoming FDA Hurdles in the New Administration

How have recent US Food and Drug Administration (FDA) policy changes disrupted early-phase oncology trials? What innovative strategies are being used to navigate current regulatory uncertainties? How to prepare for sudden shifts in FDA guidelines, including their impact on funding challenges when moving from Phase I to Phase II?

Join an insightful webinar designed specifically for sponsors interested in mastering the complexities of early-phase oncology trials during this time of pressing uncertainty. With funding and the evolving FDA landscape making it difficult to ensure a trial’s success, this webinar will provide the necessary guidance.

This webinar is a must-attend for sponsors looking to stay ahead in the ever-changing landscape of oncology trials. Whether seeking a better understanding of non-traditional designs or solutions to achieve financial predictability during this critical phase, the expert speakers will equip attendees with the insights needed to optimize and accelerate the drug development process.

Register for this webinar today to gain insights into navigating the evolving FDA regulations and their implications for early-phase oncology trials.

Speakers

Dr. Patrick Kelly, MD, Vice President, Medical Management, Syneos Health

Dr. Patrick Kelly has over 25 years of clinical research and clinical practice experience, including 15 years of academic and clinical leadership in hematology/oncology, followed by more than 15 years of global industry experience in early- and late-stage drug development with targeted anti-cancer agents. He is a renowned and board-certified pediatric hematologist/oncologist.

Notably, he has served key roles at several large pharma companies, where he played integral parts in advancing therapies and shaping the landscape of medical innovation. Patrick is a Former Chief Medical Officer at a large pharma company, where he designed the original HIBISCUS study. He has successfully led clinical activities for biologics, antibody-drug conjugates (ADCs) and small molecular therapeutics, resulting in multiple investigational new drug (IND) submissions and FDA approvals and contributed significantly to the advancement of treatments for various diseases.

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XQ Xue, Vice President, Biostatistics, Syneos Health

XQ Xue has 16 years of experience in biostatistics and 14 years in the CRO industry as a project statistician and consultant on adaptive design, complex innovative study design and statistical analyses.

He holds DrPH in biostatistics from University of North Carolina at Chapel Hill and MS in statistics from North Carolina State University. XQ has published works on optimal experiment design, adaptive design, dose escalation and dose finding, Bayesian adaptive design and survival data analysis.

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Patrick Melvin, Vice President, Therapeutic Strategy & Innovation, Syneos Health

Patrick Melvin is a highly experienced clinical research executive who has dedicated the last 20 years to leadership in hematology and oncology clinical drug development. This hematology and oncology experience includes oversight of programs ranging from first-in-human (FIH) studies through hybrid Phase I/II registration programs and large Phase III registration programs, including extensive experience in immuno-oncology and advanced therapy medicinal products (ATMP) space.

He has overseen more than 25 pivotal/registration programs, over a dozen of which have now resulted in US and global marketing authorizations, including marketing authorization for a “first-in-class” adoptive cell therapy. Patrick is a member of the American Society of Clinical Oncology (ASCO) and European Hematology Association.

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