Conference Agenda

Welcome
Mace Rothenberg, MD, FACP, moderator, Chief Medical Officer, Pfizer and Co-Chair of the LSC

Problem statement, FDA guidance document, and introduction to agenda
Paul Kluetz, MD, Deputy Director, Oncology Center of Excellence, FDA

Moderated panel discussion

An interactive opportunity to hear what peer organizations are doing to address key challenges, to describe what they've tried, what's worked and what hasn't worked, and to share best practices

Expert panel

• Mace Rothenberg, MD, FACP, moderator, Chief Medical Officer, Pfizer and Co-Chair of the LSC
• Dave Reese, MD, Executive Vice President, R&D, Amgen and Co-Chair of the LSC
• Sean Khozin, MD, MPH, Global Head of Data Strategy, Janssen

• Donna Smiley, oncology clinical trial participant
• Craig Tendler, MD, Head of Oncology Late Phase Development and Global Medical Affairs, Janssen
• Julie Lepin, PhD, Vice President, Oncology Regulatory Affairs, Amgen
• Andrew Zimmer, Director, Data Donation Platform, Broad Institute of MIT & Harvard
• Kannan Natarajan, Head of Global Biometrics and Data Management, Global Products Development, Pfizer Inc

Discussion topics

• Managing patients on study
  • Administration of study medications (injectables); Performing study-mandated assessments for safety (SAE) and efficacy (OS, PFS); Managing patients on study who become sick with SARS-CoV-2
• Data management
  • The problem of missing data: how much? what kind? how to minimize? are all data equal? How is data being monitored?  Use of remote labs; imaging at non-study sites; use of telemedicine; reporting to sponsor; sacrificing secondary endpoints (biomarkers)
• Interpretation of clinical trial results with missing data
  • Censoring including deaths among COVID-positive patients; integrity of safety and efficacy inferences; Sensitivity analyses and other statistical methods to assess study integrity

Open discussion

Questions and comments will be submitted in writing, in real time, through the platform by attendees.  After brief opening remarks from the expert panel, the panel will respond to the attendee's questions.

Closing remarks
Paul Kluetz, MD, Deputy Director, Oncology Center of Excellence, FDA
Dave Reese, MD, Executive Vice President, R&D, Amgen and Co-Chair of the LSC