Agenda

WORKSHOP AGENDA

March 22, 2019
8:00am to 4:00pm
FDA White Oak Campus Building 31, Great Room

8:00 – 8:30AM
Registration

8:30 – 8:35AM
Opening Remarks:

David Arons, JD, National Brain Tumor Society
Richard Pazdur, MD, US Food and Drug Administration
Wendy Selig, MSJ, WSCollaborative

8:35 – 8:45AM
Presenting the Challenge
Joohee Sul, MD, Workshop Co-Chair, US Food and Drug Administration
Patrick Wen, MD, Workshop Co- Chair, Dana Farber Cancer Institute

8:45 – 9:45AM
Session I: Defining the Problem of CNS Metastases
Laleh Amiri-Kordestani, MD, Co-Chair, US Food and Drug Administration
Greg Riely, MD, Co-Chair, Memorial Sloan Kettering Cancer Center

Discussant Presentation:
Clinical Management of CNS Metastasis, 2019: Current Strategies, Investigations, and Key Challenges
Mike Davies, MD, MD Anderson Cancer Center

Panel:
Laleh Amiri-Kordestani, MD, & Greg Riely, MD, Moderators
Manmeet Ahluwalia, MD, Cleveland Clinic
Mike Davies, MD, MD Anderson Cancer Center
Victoria Ebiana, MD, Merck
Derrick Queen, Patient
Luke Walker, MD, Seattle Genetics

9:45 – 11:00AM
Session II: Key Issues for Clinical Development for Brain Mets

Nancy Lin, Co-Chair, Dana Farber Cancer Institute
Chana Weinstock, Co-Chair, US Food and Drug Administration

Discussant Presentations:

• Identifying Targets for Brain Mets Clinical Studies
  Priscilla Brastianos, Massachusetts General Hospital
• Selecting Drug Candidates for Brain Mets
  Nancy Lin, Dana Farber Cancer Institute
• Issues with Conducting Brain Mets Clinical Trials
  Kim Margolin, City of Hope
• Standardizing Brain Mets Response Assessment
  Ben Ellingson, University of California, Los Angeles

Q&A

Session Recap:  Chana Weinstock, US Food and Drug Administration

11:00 – 11:15AM
Break

11:15 – 2:30PM
Session III: Clinical Benefit in Patients with Brain Mets

Carey Anders, Co-Chair, Duke University
Tatiana Prowell, Co-Chair, US Food and Drug Administration

11:15-12:30PM
Discussant Presentations:

• Regulatory Definition of “Clinical Benefit”
  Paul Kluetz, US Food and Drug Administration

Designing an Endpoints Framework for CNS Metastases
Carey Anders, Moderator

Panel: Terri Armstrong, National Cancer Institute
Shelly Engfer-Triebenbach, Patient
Chitkala Kalidas, Bayer Pharmaceuticals
Ben Levy, Sibley Memorial Hospital
Jeff Wefel, MD Anderson Cancer Center
Arvin Yang, Bristol-Myers Squibb

Q&A 

Panel Recap: Carey Anders, Duke University

12:30 – 1:00PM
Lunch

1:00 – 2:30PM
Discussant Presentations:

• Regulatory Challenges for CNS Metastases
  Shanthi Marur, US Food and Drug Administration 

Rethinking Trial Designs for Stimulating Product Development for CNS Metastases
Tatiana Prowell, Moderator

Panel: Michael Atkins, Georgetown University
Kim Blackwell, Eli Lilly and Company
Vinai Gondi, Northwestern Medicine
Pallavi Mishra-Kalyani, US Food and Drug Administration
Hussein Tawbi, MD Anderson Cancer Center
Lynda Weatherby, Patient

Q&A

Panel Recap: Tatiana Prowell, US Food and Drug Administration

2:30 – 3:30PM
Session IV: Therapy Development: Challenges & Opportunities

Joohee Sul, Co-Chair, US Food and Drug Administration
Patrick Wen, Co-Chair, Dana Farber Cancer Institute

Defining Strategies to Advance Product Development

Panel: Lauren Abrey, Novartis
Caroline Chung, MD Anderson Cancer Center
Nancy Lin, Dana Farber Cancer Institute
Kim Margolin, City of Hope
Tatiana Prowell, US Food and Drug Administration
Greg Riely, Memorial Sloan Kettering Cancer Center
Peggy Zuckerman, Patient

Q&A

3:30 – 3:40PM
Overview of the American Brain Tumor Association’s Metastatic Brain Tumor Initiative

Ralph DeVitto, American Brain Tumor Association
Nicole Willmarth, American Brain Tumor Association

3:40 – 4:00PM
Summary & Next Steps

David Arons, National Brain Tumor Society
Joohee Sul, US Food and Drug Administration
Patrick Wen, Dana Farber Cancer Institute

 4:00PM
Adjourn

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