Immunotherapy has transformed the oncology treatment landscape, offering more targeted and durable approaches across a growing range of malignancies. However, unlike traditional cancer treatments, immune-based therapies introduce a unique spectrum of immune-related adverse events (irAEs) that can significantly impact patient safety, trial continuity and overall program success if not managed effectively1.
In this webinar, attendees will learn practical strategies for adverse event management in oncology clinical trials, with a focus on immune-based therapies. The expert speakers will discuss the importance of cross-functional collaboration among sponsors, medical monitors and investigative sites. The session will also examine the role of standardized irAE grading and management guidelines, as well as how technology and site training can improve consistency, patient retention and site confidence.
Register for this webinar to gain actionable insights into how proactive irAE management can help protect promising oncology assets while supporting safer, more efficient trial execution.
- J Clin Oncol 44, 2026 (suppl 16; abstr e23311)
Speakers
Gwyn Bebb, MD, PhD, SVP, Head of Medical Affairs and Medical Oncology Strategy Lead, Premier Research
Dr. Gwyn Bebb brings more than 30 years of clinical research experience across academia and the biotechnology industry, with a proven track record spanning CROs and drug development.
Prior to joining Premier, Gwyn served for two and a half years as Senior Vice President and Head of Oncology at a large CRO, where he led a global team of oncologists overseeing a broad portfolio of clinical trials across multiple cancer indications. Before that, as a Clinical Research Medical Director in Global Development in pharma, he advanced a bispecific T-cell engager into a confirmatory Phase 3 trial in small-cell lung cancer.
Earlier in his career, Gwyn was a Professor in the Department of Medicine at the University of Calgary, Alberta, Canada. There, he directed the Clinical Trials Unit at the Tom Baker Cancer Centre and established a provincial lung cancer database to evaluate real-world patient outcomes in relation to molecular markers studied in his research laboratory.
Gwyn earned his undergraduate degree in Natural Sciences from the University of Cambridge, his Medical Degree from the University of Oxford and a Doctorate in Molecular Pathology from the University of British Columbia in Vancouver, Canada. He resides in Los Angeles, California.
Message Presenter
Salini Naidu, MD, Senior Medical Director III, Medical Oncology and Oncology Strategy, Medical Affairs, Premier Research
Dr. Salini Naidu is a Hematology Oncology Physician who provides strategic medical oversight and therapeutic expertise over global oncology clinical trials at Premier. She brings 20+ years of clinical oncology trial experience from site-level care as a PI that includes developing tailored treatment plans using chemotherapy, immunotherapy, biologics and targeted therapies for her patients on or off trial protocols based on their individual needs.
As Senior Medical Director in Oncology, she has provided therapeutic and strategic oversight on countless global oncology clinical trials leading to FDA Fast Track designations and approvals. She has developed a systematic approach to deliver operational excellence to medical oversight for more consistent quality-driven AE management and safety oversight, resulting in improved patient retention.
Dr. Naidu received her MD from the University of Illinois College of Medicine; Internal Medicine residency training at Massachusetts General Hospital and Brigham Healthcare System-Boston; Hematology-Oncology Fellowship training in North Carolina; BMT training at UNC; and Oncology research training at Duke.
Message PresenterWho Should Attend?
This webinar will benefit Managers and above at biotech and specialty pharma companies with job functions including, but not limited, to:
- Drug Development
- Clinical Operations
- Medical Affairs
- Regulatory Affairs
- Project Management
What You Will Learn
Attendees will gain insights into:
- Efficient cross-functional coordination to support successful ir-AE management
- Standardized approaches to ir-AE guidelines and grading
- How improved ir-AE management can lead to better patient safety and retention
Xtalks Partner
Premier Research
Premier Research International LLC (Premier) is a global leader in clinical research and consulting services with expertise in driving an efficient and effective path to market for the life sciences industry.
Premier is built with the needs of biotech in mind, turning breakthrough science into life-changing drugs, devices, and diagnostics by addressing trial complexity, overcoming development hurdles, and demonstrating product value.
Leveraging deep therapeutic expertise, innovative technology, and product development operational proficiency—from preclinical planning to clinical trial execution and commercialization—our integrated approach offers personalized, end-to-end solutions to identify the pertinent data and insight necessary to make informed decisions earlier and deliver accelerated development timelines for a smarter, faster path to approval. To learn more visit premier-research.com.
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