210 - Registration Trials versus Clinical Practice: Challenges Associated with Newly Approved Antimicrobials

10/5/2019

8:00 AM - 9:00 AM

Room: Walter E. Washington Convention Center, 144 ABC

MOC Credit: Maximum of 1.0 hours of MOC Credit
CME Credit: Maximum of 1 hours of AMA PRA Category 1 Credit™
ACPE Credit: ACPE 1 knowledge-based contact hours of pharmacy CE
ACPE Number: 0221-9999-19-394-L04-P

Learning Objectives:

At the conclusion of this session, participants will be able to:

review the regulatory pathways for new antimicrobial agents
recognize the challenges in designing and implementing registrational trials
discuss ongoing efforts to conduct trials that reflect clinical practice

Presentations:

8:00 AM - 9:00 AM
1908 - Registration Trials versus Clinical Practice: Challenges Associated with Newly Approved Antimicrobials
Sumathi Nambiar, MD, MPH – Food and Drug Administration
8:00 AM - 9:00 AM
1907 - Registration Trials versus Clinical Practice: Challenges Associated with Newly Approved Antimicrobials
Lindsey R. Baden, MD, MSc – Brigham and Women's Hospital

Moderator(s)

Yohei Doi, MD, PhD

Associate Professor of Medicine
University of Pittsburgh
Pittsburgh, Pennsylvania

Disclosure: Astellas: Grant/Research Support
Entasis: Advisory Board
Kanto Chemical: Grant/Research Support
MSD: Grant/Research Support, Other Financial or Material Support, Speaking Fee
Pfizer: Consultant, Grant/Research Support
Shionogi: Grant/Research Support, Speaking Fee
VenatoRx: Advisory Board
Cesar Arias, MD, MSc, PhD

Professor
University of Texas Health Science Center
Houston, TX

Disclosure: American Society for Microbiology: Fees for Editor of Antimicrobial Agents and Chemotherapy. Money paid to University, Other Financial or Material Support
Entasis Pharmaceuticals: Grant/Research Support, Research Grant
MeMed Diagnostics: Grant/Research Support, Research Grant
Merck: Grant/Research Support, Research Grant
UptoDate: Other Financial or Material Support, Royalties from a Chapter

Speaker(s)

LB

Lindsey Baden, MD, MSc

Attending Physician
Brigham and Women's Hospital
Boston, Massachusetts

Disclosure: Nothing to disclose
SN

Sumathi Nambiar, MD, MPH

Division Director
Food and Drug Administration
Silver Spring, MD

Disclosure: Nothing to disclose