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.
Speakers
Bin Pan, PhD, Executive Director of Operational Strategy, Ergomed Clinical Research
With 25 years of experience in clinical research and a strong focus on oncology clinical development, Bin Pan brings a wealth of expertise and leadership. Her professional journey spans roles with increasing responsibilities in clinical operations, trial management, oversight and operational strategy, working across pharma, biotech and CRO companies.
Bin earned her PhD in Molecular Biology, providing her with deep scientific insight and a strong foundation in advancing innovative treatments. She is passionate about the advancements in precision medicine and immuno-oncology that have transformed the treatment landscape. Yet, she recognizes that patients, particularly those suffering from rare cancers, still face significant unmet needs.
Message Presenter
Juliet Moritz, Senior Vice President of Strategic Solutions & Patient Centricity, Ergomed Clinical Research
Before joining Ergomed, Juliet Moritz held executive and leadership positions at Premier Research, PPD (Thermo Fisher) and Pfizer. She began her career at the bedside as the Study Coordinator at a large US academic institution and has maintained a fierce commitment to patient centricity.
In her current role, Juliet focuses on developing comprehensive strategies for clinical research studies and development programs. She is passionate about taking a holistic approach based on thorough feasibility research and drawing deep insights from clinicians and the patient community.
Juliet is also renowned for her innovative approaches to clinical trial design and operational offerings, showcasing her commitment to genuine patient-centric research.
Based in Philadelphia, Juliet holds a Bachelor of Science in Biology from the University of Pennsylvania and a Master of Public Health degree from Drexel University. She also pursued a doctorate in Bioethics at Albany Medical School.
Message PresenterWho Should Attend?
This webinar will appeal to those working in the following areas or having the following job titles:
- Clinical trial sponsors
- Clinical Operations Professionals and Study Managers
- Medical and scientific teams involved in early-phase oncology research
- Regulatory affairs and compliance specialists
- CROs and site personnel managing FIH oncology trials
- Anyone involved in oncology drug development seeking insights into trial design and executi
What You Will Learn
Attendees will learn about:
- Essential considerations for designing and executing FIH oncology trials
- Best practices for preparing a robust IND package to streamline regulatory approval
- Strategies for effective dose escalation planning and patient safety monitoring
- Practical approaches to site initiation, patient recruitment and cohort management
- Insights into overcoming operational and regulatory challenges in early-phase oncology trials
Xtalks Partner
Ergomed
Established in 1997, Ergomed is a global leader in delivering specialized services in oncology, rare disease, and complex trials to the pharmaceutical and biotech sectors. Our comprehensive support covers the entire clinical trial process, from early phase to post-approval, offering full-service, industry-leading clinical trial management solutions as a trusted partner. Our integrated service model helps life sciences companies meet regulatory obligations, maximize drug development success, and enhance the patient experience.
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