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, MDDAAD Director and Duke University
Mary (Dicey) Jackson Scroggins M.A. (International Gynecologic Cancer Society)
Virginia Kwitkowski, MS, ACNP-BCFDA, Div. of Hematology Products
Rea BlakeyFDA, Oncology Center of Excellence
1:00 PM-1:15 PM
Drug Development and Terminology
Speakers
Candis Morrison, PhD, CRNPFDA, 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, PhDFDA, Div. of Clinical Pharmacology V

    Stages of clinical drug development leading to approval.

    Vishal Bhatnagar, MDFDA, 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, PharmDFDA, Division of Oncology Products I
    4:15 PM-4:30 PM
    How Patients Access Investigational Drugs
    Virginia Kwitkowski, MS, ACNP-BCFDA, Div. of Hematology Products
    4:30 PM-4:45 PM
    Overview of Project Patient Voice
    Vishal Bhatnagar, MDFDA, Division of Hematology Products

    Bellinda King-Kallimanis, Ph.D.

    FDA, Oncology Center of Excellence
    4:45 PM-5:00 PM
    Q&A (Faculty)

    • Wrap Up