Friends of Cancer Research is proud to announce a forum focusing on the acceleration of pediatric drug development.  In oncology, pediatric drug development can face unique challenges. However, molecularly targeted agents, as well as innovative clinical trial approaches offer opportunities to address the shortfall of new oncology drugs developed for pediatric cancer patients. This half-day forum will assess the feasibility and potential design of mechanism-of-action based Phase I/II master trial platforms for concurrently studying multiple molecules across a range of relevant pediatric tumor types. This forum will also discuss prioritization criteria that may help identify the most promising molecules to take forward from a master trial into pivotal studies. 

Meeting Agenda

8:30am - Registration and Breakfast

9:00am - Welcoming Remarks

Ellen Sigal, Friends of Cancer Research

Session 1: Challenges & Opportunities in Pediatric Oncology

9:05am - Pediatric Oncology Drug Development Landscape, Mark Fleury, American Cancer Society Cancer Action Network             

 9:15am - Innovative Trial Designs: Pediatric MATCH, Nita Seibel, National Cancer Institute

9:30am - Capturing Data from Clinical Practice: TAPUR, Katherine Janeway, Dana-Farber Cancer Institute

9:45am - Master Protocols for Early Signal Seeking: iMATRIX, Raphaël Rousseau, Genentech   

10:00am - Multistakeholder Pediatric Oncology Platform: ESMART, Gilles Vassal, Gustave Roussy Cancer Centre

10:15am - Pediatric Drug Regulatory Considerations, Greg Reaman, FDA 

10:25am - Real World Experience from the Trenches, Raymond Rodriguez-Torres, Live Like Bella Childhood Cancer Foundation 

10:35am - Break

Session 2: Considerations for Pediatric Master Protocols

10:50am: Roundtable Panel Discussion

Panelists will be covering a list of topics detailed below:

Moderator: Peter Adamson (Children's Hospital of Philadephia)

 10:50am - Trial Design and Molecular Prioritization Criteria 

• Discussants: Bouchra Benettaib (Celgene), Kenan Onel (Northwell Health), Eric Rubin (Merck)

11:20am - Role of a Multi-Stakeholder Decision-Making Body and Governance

• Discussants: Shakuntala Malik (NCI), Pam Mangat (ASCO)

 11:50am - Logistical and Operational Considerations/Challenges

• Discussants: Kenneth Cohen (Johns Hopkins), Giles Robinson (St. Jude)

 12:20pm - Fulfilling Regional Pediatric Regulations and Addressing Globalization Challenges

• Discussants: Martha Donoghue (FDA), Tahira Khan (Genentech), Gilles Vassal (Gustave Roussy Cancer Centre)

12:50pm - Closing Remarks

Jeff Allen, Friends of Cancer Research

Supported by: