AGA Center for Diagnostics & Therapeutics

Drug development is a complex, time-consuming and expensive process requiring the cooperation of various stakeholders. To help facilitate this process, the AGA Center for Diagnostics and Therapeutics provides objective, independent guidance to companies, regulators, investors and health-care professionals on the development of new therapies and diagnostic tests for digestive disorders.

Expertise and Opportunities

• Identification of Experts and Organization of Expert Meetings

• Clinical Study Design and Endpoint Development

• Development of Educational Programs and Resources

We invite AGA partners to suggest other issues facing the drug and diagnostic industries related to clinical development and regulatory approval.

Resources

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Meeting Coverage

Read GI & Hepatology News’ coverage of the 2016 AGA Drug Development Conference, which focused on new and emerging drugs for the treatment of GERD, gastroparesis, EoE and dyspepsia.

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FDA Comment Letter

The AGA Center for Diagnostics and Therapeutics submitted comments on FDA’s 2015 draft guidance document entitled “Gastroparesis: Clinical Evaluation of Drugs for Treatment.”

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Introduction to the Center

Learn more about why the center was established and its work in the drug and diagnostic space in this AGA Perspectives editorial by Dr. Colin Howden.

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GERD Treatment Overview

Dr. Colin Howden, chair of the center, discusses the highs and lows of drug development for gastroesophageal reflux disease in a blog post on Applied Clinical Trials.

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Functional Dyspepsia Trial Design

In this blog post, center board member Dr. Nimish Vakil discusses the need for improved definitions and clinical trials to develop treatment for this common condition.

Latest News

Scientific Advisory Board

Colin W. Howden, MD, AGAF, Chair

Colin W. Howden, MD, AGAF, Chair

Chief of Gastroenterology, University of Tennessee Health Science Center, Memphis, TN

J. Summer Bell III, MD, AGAF

Gastroenterology Ltd., Virginia Beach, VA

M. Scott Harris, MD, AGAF

Avaxia Biologics and Georgetown University, Washington, DC

Jessica Lee, MD*

Professor of Medicine, Yale University School of Medicine, Fairfield, CT

William J. Sandborn MD, AGAF

Chief, Gastroenterology Division; Director, UCSD IBD Center, University of California, San Diego, CA

Stephan R. Targan, MD, AGAF

Director, F. Widjaja Foundation, Inflammatory Bowel and Immunology Research Institute, Cedars-Sinai Medical Center, Los Angeles, CA

Teresa L. Wright, MD, AGAF

Product Development Immunology and Infectious Disease, Genentech, San Francisco, CA

Donna Griebel, MD*

Supervisory Medical Officer, FDA Center for Drug Evaluation and Research, Silver Spring, MD

Loren Laine, MD, AGAF

Professor of Medicine, Yale University School of Medicine, Fairfield, CT

Andrew Mulberg, MD*

Supervisory Medical Officer, FDA Center for Drug Evaluation and Research, Silver Spring, MD

Debra G. Silberg, MD, PhD

Senior Director, Clinical Development, Shire Pharmaceuticals, Wayne, PA

Nimish B. Vakil, MD, AGAF

Clinical Professor of Medicine, University of Wisconsin Medical School, Summit, WI

*Denotes non-voting member.

Are you ready to take the next step?

To learn more about the center, please contact Alison Kim, senior director of research and innovation.

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301-654-2055

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4930 Del Ray Ave.
Bethesda, MD 20814

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