In this free webinar, learn about the essential considerations for designing and executing first-in-human (FIH) oncology trials. The featured speakers will share best practices for preparing a robust investigational new drug (IND) package to streamline regulatory approval. The speakers will also discuss strategies for effective dose escalation planning and patient safety monitoring. Attendees will gain insight into practical approaches to site initiation, patient recruitment and cohort management as well as overcoming operational and regulatory challenges in early-phase oncology trials.
TORONTO, April 2, 2025 /PRNewswire-PRWeb/ -- First-in-human (FIH) oncology trials serve as a pivotal transition from preclinical research to patient care, marking the first step in validating the safety and biological activity of a novel therapeutic in humans. These early-phase studies generate essential data on dosing, pharmacokinetics and preliminary efficacy signals, setting the stage for subsequent clinical development.
FIH oncology trials require careful preparation and strategic implementation from study design and investigational new drug (IND) submission to site startup, patient recruitment and cohort management. To ensure success, sponsors must navigate a host of challenges to ensure safety, timeliness and scientific validity.
This webinar will highlight key considerations and best practices for designing and executing FIH oncology trials, offering practical solutions to help sponsors navigate the regulatory, operational and clinical hurdles inherent to these studies. The key topics will include:
- Preparing a robust IND package
- Developing a clear plan for dose escalation
- Streamlining site initiation and patient recruitment
- Managing cohorts and safety review committees
Register for this webinar to explore best practices such as regulatory preparation, site initiation, cohort management and safety monitoring for designing and executing first-in-human oncology trials.
Join experts from , Bin Pan, PhD, Executive Director of Operational Strategy; and Juliet Moritz, Senior Vice President of Strategic Solutions & Patient Centricity, for the on Thursday, April 24, 2025, at 10am EDT (4pm CEST/EU-Central).
For more information or to register for this event, visit .
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
For information about hosting a webinar visit
Media Contact
Vera Kovacevic, Xtalks, +1 (416) 977-6555 x371, [email protected],
SOURCE Xtalks
Share this article