Presentations, Partners in Progress: Cancer Patient Advocates and FDA Public Workshop III
Introductory Comments
- Kristen Santiago, LUNGevity Foundation
- Vanessa Cramer, Ovarian Cancer Research Alliance
- Victoria Manax, Pancreatic Cancer Action Network
Session 1: Introduction to the Role of FDA
- Primer on Drug Development
Preeti Narayan - Avoiding Pitfalls in Drug Development
Vishal Bhatnagar
Session 2: How Patients Engage
- How FDA Involves Patient Advocates
Susan Chittooran - How NCI Involves Research Advocates
Amy Williams - How Patient Advocates Participate in Drug Development, Personal Perspective of a Patient Advocate
Susan Leighton
Session 3: Oncology Center of Excellence’s Outreach Efforts
- OCE’s Patient-Focused Drug Development and Outreach Efforts
Paul Kluetz - Oncology Center of Excellence Patient-Focused Drug Development Updates
Janice Kim
Session 4: Insights Into Cancer Drug Development
- Clinical Trial Study Population vs. Real World Patients: Narrowing the Divide
Lola Fashoyin-Aje - Expanded Access to Investigational Drugs
Virginia Kwitkowski
Session 5: Patient-Focused Drug Development
- FDA Reviewer Perspective: PROs in the Benefit/Risk Assessment
Bindu Kanapuru - Assessing Physical Function in Cancer Patients
Paul Kluetz - Project PatientVoice
Janice Kim & Vishal Bhatnagar
Session 6: Updates From FDA Centers
- Overview of 2019 CDER Drug Approvals in Hematology/Oncology
Michael Menefee, Center for Drug Evaluation and Research - Overview of Recent CBER Cancer Product Approvals
Poornima Sharma, Center for Biologics Evaluation and Research - Update from the Center for Devices & Radiologic Health (CDRH)
Tara Ryan, Center for Devices and Radiological Health