As acceptance of flexible trial designs continues to advance, many sponsors are increasingly exploring alternate methods of dose escalation to support identification of a maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) in open-label early phase or First-in-Human studies. Bayesian dose escalation designs have also coincided with advances in oncology therapy development, such as immunotherapies and antibody drug conjugates. These flexible methods may be more appropriate than those initially designed for chemotherapy drug development.
In this webinar, the featured speaker will discuss and cover:
- Common types of open-label adaptive dose escalation designs
- Comparisons with rule-based designs
- How to apply and use these designs in oncology therapy development
- How to determine which design is best suited for a clinical trial
Register to learn the benefits of Bayesian dose escalation designs for oncology therapy development.
Speaker
Vanessa Beddo, PhD, VP, Biostatistical Consulting, Allucent
Vanessa Beddo, PhD has more than 15 years’ professional experience in clinical trial design and analysis. In her current position as VP of Biostatistical Consulting at Allucent, she is responsible for internal consultation with respect to study planning and use of statistical methods, as well as client involvement in business development and consultancy capacities. As part of her external consultancy duties, she serves as a key member of strategic drug development teams for Allucent clients, providing innovative and complex study design solutions in support of efficiently navigated regulatory paths. She is also responsible for regulatory body interactions on an ongoing basis throughout program life cycles on behalf of her clients.
Prior to this role, Dr. Beddo served in various management roles, involving oversight of statistical and programming staff and leadership with respect to departmental initiatives, processes and training. Her experience also includes clinical development of pharmaceuticals and biologics, having served as the Lead Statistician on Phase I-IV clinical trials, and drug submissions leading to successful drug approvals.
Dr. Beddo holds a BS in applied mathematics, MS in mathematics and PhD in statistics from the University of California, Los Angeles.
Message PresenterWho Should Attend?
This webinar will appeal to VPs, directors, managers and department heads working within:
- Clinical Research
- Clinical Operations
- Biostatistics and Data Science
- Project Management
- Regulatory Affairs
- Medical Affairs
- Research and Development
- Clinical Pharmacology
What You Will Learn
Attendees will learn:
- Common types of open-label adaptive dose escalation designs
- Comparisons with rule-based designs
- How to apply and use these designs in oncology therapy development
- How to determine which design is best suited for a clinical trial
Xtalks Partner
Allucent
Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. The company is purpose-built through the convergence of leading providers to address this unmet need. Today, Allucent is a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics and clinical pharmacology across a variety of therapeutic areas. With more than 30 years of experience in over 60 countries, Allucent’s individualized partnership approach provides experience-driven insights and expertise to assist its clients in successfully navigating the complexities of delivering novel treatments to patients.
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