The Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by Duke University and the U.S. Food and Drug Administration (FDA), will release new resources for the development of master protocol platforms in a free public webinar on Tues., Oct. 13, 2020 from 11:00am – 12:00pm EDT.
Interest in master protocol development continues to grow, especially in light of the COVID-19 pandemic – but, until now, there has not been a comprehensive toolkit available to guide organizations through the key elements of master protocol design and stakeholder involvement.
Targeted for early adopters who are new to the development of a master protocol study, the resources – including a high-level roadmap, value propositions guide, FDA engagement tool, case studies and more – provide an outline to follow as you plan for a master protocol study.
Attendees will learn how to engage with key stakeholders early in the master protocol study planning process to address key roadblocks, and better understand the unique design, operational, and business development considerations that are required for a master protocol study.
The webinar will be led by:
- Abby Bronson, Edgewise Therapeutics
- Marianne Chase, Massachusetts General Hospital
- Daniel Millar, Janssen R&D
- Nick Richardson, FDA, CDER
CTTI hopes those interested can join and learn more.
Call to Action: For more information contact Rae Holiday with CTTI. Cell 202-320-5134; email [email protected].