In this free webinar, gain insight into how recent FDA and Trump Administration changes affect early-phase oncology trials with effective strategies to adapt and thrive in an evolving landscape. Attendees will learn about handling complex data in non-traditional study designs by ensuring patient safety while avoiding overcomplication. The featured speakers will discuss the latest regulatory guidance to ensure patient safety and market success, including the impact of Project Optimus on early phase trial guidance and country selection strategies. The speakers will also share how to tackle the challenges of inflexible delivery models, frequent change orders and funding issues that can make advancing to Phase II particularly difficult.
TORONTO, April 29, 2025 /PRNewswire-PRWeb/ -- 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.
Join experts from Syneos Health, Dr. Patrick Kelly, MD, Vice President, Medical Management; XQ Xue, Vice President, Biostatistics; and Patrick Melvin, Vice President, Therapeutic Strategy & Innovation, for the live webinar on Friday, May 16, 2025, at 11am EDT (5pm CEST/EU-Central).
For more information, or to register for this event, visit Early Phase Oncology Trials: Overcoming FDA Hurdles in the New Administration.
ABOUT XTALKS
Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars and digital content to the global life science, food, healthcare and medical device communities. Every year, thousands of industry practitioners (from pharmaceutical, biotechnology, food, healthcare and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps professionals stay current with industry developments, regulations and jobs. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.
To learn more about Xtalks visit https://xtalks.com
For information about hosting a webinar visit https://xtalks.com/why-host-a-webinar/
Media Contact
Vera Kovacevic, Xtalks, +1 (416) 977-6555 x371, [email protected], https://xtalks.com
SOURCE Xtalks
Share this article