Drugs

Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics for Alcoholic Hepatitis and Alcohol Associated Liver Disease and Pediatric Irritable Bowel Syndrome and Pediatric Functional Constipation Workshop

Date:

March 26-28, 2018

Location:

White Oak Campus, Food and Drug Administration, Silver Spring, MD

I. BACKGROUND

The FDA and AASLD, ACG, AGA, NIAAA, and NASPGHAN have expressed a willingness to leverage their combined strengths for the joint development of the substantive actions of this workshop to focus on Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics for Alcoholic Hepatitis and Alcohol Associated Liver Disease and Pediatric Irritable Bowel Syndrome and Pediatric Functional Constipation. 

The specific topics for this workshop are related to Alcoholic Hepatitis and Alcohol Associated Liver Disease (March 26-27), and Pediatric Irritable Bowel Syndrome and Pediatric Functional Constipation (March 28).  The co-sponsored workshop will facilitate the ongoing dialogue among relevant parties on issues related to Alcohol Associated Liver Disease and  Alcoholic Hepatitis and Pediatric Irritable Bowel Syndrome and Pediatric Functional Constipation. 

Goals and Objectives

  • To provide presentations and discussions on what is known about alcoholic liver disease (ALD) including the definitions of subpopulations, natural history and current therapeutic interventions. To facilitate dialogue among industry, academia, and other stakeholders on common data elements needed to be included in clinical trials, clinical trial designs, potential surrogate and clinical benefit endpoints, and practical issues with managing clinical trials in this population according to the terms expressed in this co-sponsorship agreement.

  • To have discussions on what is known about pediatric IBS and PFC, including the definitions, natural history and currently utilized therapeutic interventions.
  • To provide presentations and additional discussions of recent updates to the diagnostic criteria, potential trial designs and appropriate trial endpoints, including patient/caregiver reported outcomes (PROs) for clinical trials intended to support marketing applications for drugs to treat pediatric IBS and PFC.
  • To have a discussion regarding the challenges of translating successfully utilized trial designs from adults to the pediatric population, in an aim to develop solutions to facilitate efficient drug development in the context of these issues.

Who Should Attend

This workshop is intended for a diverse group of scientists responsible for the evaluation of safety and efficacy of drugs intended to treat or prevent Alcohol Associated Liver Disease and Pediatric IBS-C and Pediatric Functional Constipation, as well as interested parties regarding ongoing efforts on research and development of drugs designed to treat or prevent these conditions, including patient advocates, patients and representatives from various agencies such as FDA, NIH, and others.

The primary audience includes leading academic experts, interested pharmaceutical companies, regulatory agencies, patient advocacy groups, non-profit organizations, scientists, clinicians from regulatory, academic, industrial and other healthcare sectors, scientists involved in drug development in those same industries, regulatory scientists, experts and leaders from industry, academia, regulatory government agencies in the US and abroad, patient representatives, healthcare providers, and other interested parties.

Contact

Dwayne Keels – GREAT@fda.hhs.gov

For the Alcoholic Hepatitis and Alcohol Associated Liver Disease session (March 26th-27th) on-site registration will not be available. Participants (both in-person attendees and remote participants) should register at https://www.surveymonkey.com/r/AlcoholicHepatitisWorkshopdisclaimer icon

For the Pediatric Functional Constipation session (March 28th) on-site registration will not be available. Participants (both in-person attendees and remote participants) should register at http://gi.org/national-affairs/fda/recent-acg-fda-committee-actions/great-5-registration-form/disclaimer icon

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