Drugs

Primary Sclerosing Cholangitis (PSC) Workshop with the FDA, AASLD, ACG, AGA and NASPGHAN. The meeting will be held March 3 – 4, on the FDA White Oak Campus, in Silver Spring, Maryland

 

Goals and Objectives:

This two day workshop will provide a forum for discussion of issues related to PSC by academic specialists and researchers, industry, the FDA, representatives from the European Medical Authority (EMA) and other international regulatory agencies, and the patient community. The workshop will provide presentations and discussions on what is known about PSC, the definition, natural history and current therapeutic interventions for PSC, also presentations and additional discussions of potential trial designs and endpoints, including surrogate endpoints for clinical trials intended to support marketing applications for drugs to treat PSC in both adults and children.
 
Who Should Attend:

Academic investigators and researchers, FDA and international regulatory personnel, industry representatives, patient advocacy groups, and the patient community should all attend this workshop.

 
Contact:

AASLD:

Denise Seise, Senior Director, Meetings and Education
1001 N Fairfax St #400
Alexandria, VA 22314, 703-740-9384
dseise@aasld.org

ACG:

Brad Conway, VP, Public Policy
6400 Goldsboro Rd #200
Bethesda, MD 20817
BConway@gi.org

AGA:

Joshua Keepes, Director of Regulatory Affairs
4930 Del Ray Ave.
Bethesda, MD 20814, 240-482-3223
jkeepes@gastro.org

NASPGHAN:

Margaret Stallings, MD, Executive Director
1501 Bethlehem Pike
Flourtown, PA 19031
mstallings@naspghan.org

FDA

Lara Dimick-Santos, MD, Medical Reviewer, Liver Products Specialist                      
White Oak building 22, Room 5327
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 21029. 301-796-4843
lara.dimick@fda.hhs.gov

 

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