Oncology drug development is often at the forefront of innovation, answering the call to accelerate timelines, personalize treatments and improve patient access. The same is true when it comes to advanced technologies and strategies like artificial intelligence (AI) and real-world evidence (RWE). Together with evolving regulatory requirements, AI and RWE are reshaping oncology trials.
Dive into the details with the featured speakers as they discuss the current regulatory landscape, including the FDA’s AI initiatives, guidance on RWE and how global agencies are approaching AI in drug development. They’ll further explore practical applications of AI and RWE across the clinical lifecycle of an oncology program, from enhancing diagnostic accuracy and optimizing patient recruitment to enabling personalized medicine and post-marketing surveillance.
Register for the webinar to better understand how AI and RWE can drive smarter, faster oncology drug development while staying aligned with regulatory expectations.
Speakers
Meera Belur, Executive Director, Oncology Program Strategy, Premier Research
Meera Belur is an integral member of the oncology leadership team at Premier Research, responsible for providing strategic planning, coordination, knowledge and expertise for oncology and hematology projects. She brings more than 20 years of industry experience in academia, small biotech firms, large pharmaceutical companies and CROs.
Before joining Premier, Ms. Belur served as the Portfolio Group Head for a large pharmaceutical company, overseeing radioligand, CAR-T and gene therapy assets within the oncology business unit. She has a diverse background in global clinical operations, drug development and project management, with a proven track record of providing strategic leadership and successfully managing multiple aspects of numerous global Phase I-IV clinical trials across various therapeutic areas. Meera is renowned for building and maintaining top-tier project management teams.
Message Presenter
Cathy Gatza, PhD, Vice President, Regulatory Strategy, Premier Research
Catherine Gatza, PhD, is an experienced Regulatory Strategist with over 11 years of experience in both consulting and the sponsor side of the pharmaceutical industry. Dr. Gatza is skilled in the development of strategic and streamlined drug development programs across multiple therapeutic areas, with a specialization in 505(b)(2) applications. She has led the development of regulatory strategy for small, mid and large pharmaceutical companies, from early-stage proof-of-concept to NDA submissions and approvals, as well as post-approval support for small molecules, biologics, fixed dose combination and drug-device combination products. She has extensive experience in leading multidisciplinary teams to support drug development programs.
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Dr. Gatza has a PhD in Cell and Molecular Biology from Baylor College of Medicine and completed a postdoctoral fellowship in breast and colon cancer at Duke University Medical Center.
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Who 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:
- The global regulatory landscape and appetite for RWE and AI in oncology drug development
- The role of RWE and AI in oncology clinical trials
- Forward-looking trends and ways to adapt to a future with more AI-enabled trials
Xtalks Partner
Premier Research
Premier Research, a global clinical research, product development, and consulting company, is dedicated to helping innovators transform life-changing ideas and breakthrough science into new medical treatments. We offer strategic solutions across the entire development lifecycle, from pre-clinical through commercialization, specializing in smart study design and full-service clinical trial management.
Leveraging technology and therapeutic expertise, we deliver clean, conclusive data with a focus on reducing development timelines, securing access to the right patients, and effectively navigating global regulations to ensure submission-ready results.
As an organization that puts patients first, we pride ourselves on helping customers answer the unmet needs of patients across a broad range of medical conditions. Visit premier-research.com.
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