Running separate protocols for multiple investigational products and disease subpopulations slows development and duplicates infrastructure. There is growing interest in accelerating drug development by creating master protocol trial designs that simultaneously evaluate multiple investigational products and various disease subpopulations under a single overarching protocol and infrastructure, eliminating the need for individual trial protocols. This webinar will cover how master protocol trial design streamlines development, improves coordination and enhances operational efficiency.
Master protocols, also known as complex clinical trials, offer adaptive design flexibility. This allows researchers to modify the study by eliminating fewer promising treatments or advancing treatments that show better performance to different phases of the study. In this webinar, the featured speaker will explore the benefits and challenges of master protocols, as well as strategies for successful implementation and operationalization.
Register for this webinar to learn how master protocol trial design enhances efficiency, collaboration and decision-making in clinical research.
Speaker
Melanie Owen, MS, Executive Director, HemOnc Portfolio Delivery Lead, PPD, Clinical Research Group of Thermo Fisher Scientific
Melanie Owen is responsible for the oversight of a portfolio delivery of Hematology/Oncology global projects at PPD. She has been working in the field of pharmaceutical drug development for over 28 years, in which she spent 23 years in project management working in multiple therapeutic indications with a focus in Oncology and Hematology. Currently, she is the master protocol specialty pillar head within PPD Oncology and has over 9 years of Master Protocol study experience. Melanie is a certified Medical Technologist receiving her bachelor’s degree from West Liberty State College and a master’s degree in technology management from Northern Kentucky University.
Message Presenter
Who Should Attend?
This webinar will appeal to:
- Biotech and biopharma companies interested in master Protocol studies
- Healthcare Providers and Clinicians involved in the management of clinical research trials for oncology patients
- Clinical Research Investigators and Site Directors
- Patient advocacy groups
- Researchers involved with clinical operations of oncology studies
What You Will Learn
Attendees will:
- Understand the key benefits of master Protocols
- Identify the key challenges of master Protocols and strategies to address them
- Learn about the three types of master protocols and how to optimize each of these designs
- Gain practical insights into implementation and operationalization
Xtalks Partner
Thermo Fisher Scientific Inc
The PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, enables customers to accelerate innovation and increase drug development productivity. Utilizing patient-centered strategies and data analytics, their capabilities cover multiple therapeutic areas and include early development, all phases of clinical development, peri- and post-approval, novel approaches to patient recruitment and investigator sites, and comprehensive laboratory services. Recognized as a global industry leader in accelerating promising medicines from early development through regulatory approval and market access, they serve pharma, biotech, medical device and government organizations with custom-tailored solutions, including full-service partnerships and functional service partnerships. As a strategic partner in clinical development and analytical services, they apply cutting edge technologies, therapeutic expertise and a firm commitment to quality to help customers deliver life-changing therapies.
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