Agenda
AAADV Pre-Workshop for Patient Advocates
Location: Salon H
Date: Tuesday, May 7, 2019
Time: 12:30 PM-5:00 PM
11:45 AM-12:30 PM
Registration
12:30 PM-1:00 PM
Introduction/ Challenges and Questions for the Day
Speakers
| H Kim Lyerly, MD | DAAD Director and Duke University |
| Mary (Dicey) Jackson Scroggins M.A. | (International Gynecologic Cancer Society) |
| Virginia Kwitkowski, MS, ACNP-BC | FDA, Div. of Hematology Products |
| Rea Blakey | FDA, Oncology Center of Excellence |
1:00 PM-1:15 PM
Drug Development and Terminology
Speakers
| Candis Morrison, PhD, CRNP | FDA, Div. of Hematology Products |
1:15 PM-2:30 PM
Drug Development 101
What information is necessary before human testing is begun?
| Stephanie Aungst, PhD | FDA, Div. of Hematology Oncology Toxicology |
How clinical pharmacology studies contribute information how drugs are used?
| Amal Ayyoub, BPharm, PhD | FDA, Div. of Clinical Pharmacology V |
Stages of clinical drug development leading to approval.
| Vishal Bhatnagar, MD | FDA, Div. of Hematology Products |
Q&A
2:30 PM-2:45 PM
BREAK
2:45 PM-3:45 PM
Challenges and Opportunities for Advocates in Cancer Drug Development
Speakers
| John Freimuth, M.A. | NCI Office of Advocacy Relations |
| Salina Miller, M.S., M.B.A. | FDA Patient Representative Program® |
| CDR Eleni Anagnostiadis, RPh, MPM | FDA Patient Affairs and Stakeholder Engagement |
| Mary (Dicey) Jackson Scroggins, M.A. | International Gynecologic Cancer Society |
Q&A
3:45 PM- 4:15 PM
Pitfalls in Drug Development
| Shaily Arora, PharmD | FDA, Division of Oncology Products I |
4:15 PM-4:30 PM
How Patients Access Investigational Drugs
| Virginia Kwitkowski, MS, ACNP-BC | FDA, Div. of Hematology Products |
4:30 PM-4:45 PM
Overview of Project Patient Voice
| Vishal Bhatnagar, MD | FDA, Division of Hematology Products |
| FDA, Oncology Center of Excellence |
4:45 PM-5:00 PM
Q&A (Faculty)
• Wrap Up