Introduction to the Center for Diagnostics and Therapeutics

Established in 2014, the AGA Center for Diagnostics and Therapeutics joins the AGA Center for GI Innovation and Technology and the AGA Center for Microbiome Research and Education as the third center of the AGA Institute. The center’s mission statement, which was recently approved by the AGA Institute Governing Board, is “to support the development of therapies and diagnostic tests that will enhance human health and improve the lives of patients with digestive disorders.”

The Center for Diagnostics and Therapeutics operates under the guidance of its own scientific advisory board, the current members of which are listed in the table. The board has broad representation from academia, private practice, the pharmaceutical industry and FDA. Rajeev Jain, MD, AGAF, currently acts as our liaison with the AGA Institute Governing Board.

Broadly stated, the objective of the center is to “provide objective, independent guidance and facilitate relationships to the pharmaceutical, biotech, and diagnostics industries, policy makers, regulatory bodies, investors, and clinicians on the development of therapies and diagnostic tests.” Clearly, that is quite a broad remit, which is why we have such a diverse scientific advisory board.

What Has the Center Achieved So Far?

The center’s scientific advisory board met formally on three occasions in 2015 to help identify its precise role and to prioritize our efforts. Since the active participation of FDA is so critical to achieving our objectives, AGA Institute President Michael Camilleri, MD, AGAF, and I met with FDA personnel at their facility in June 2015. We have since established a set of issues on which we might collaborate, and have identified areas where the center may provide guidance to FDA on relevant matters. Our first suchcontribution was a detailed and comprehensive response to FDA’s draft guidance for industry titled “Gastroparesis: Clinical Evaluation of Drugs for Treatment.” Debra G. Silberg, MD, PhD, and Scott Harris, MD, AGAF, of the scientific advisory board, provided extensive input to that from the perspectives of the pharmaceutical industry and clinical investigators.

The first symposium held under the auspices of the Center for Diagnostics and Therapeutics concerned the issue of local versus central reading of endoscopic images in inflammatory bowel disease (IBD). This has implications for the design and interpretation of clinical trials of new agents in IBD and, potentially, for the routine clinical care of IBD patients. This symposium was held in Washington, D.C., on Oct. 2, 2015, and was attended by 57 audience members, including practicing gastroenterologists involved in clinical trials, personnel from the pharmaceutical industry and FDA employees. William Sandborn, MD, AGAF, had initially suggested this topic and helped devise the program. The center aims to publish the deliberations and conclusions from the conference in Clinical Gastroenterology and Hepatology as a whitepaper.

Future Plans for the Center

In 2016, there will be a Center for Diagnostics and Therapeutics-sponsored symposium at Digestive Disease Week® regarding the drug development process from the perspectives of a clinical investigator, a trial sponsor and FDA. We also plan to hold the first of a series of annual Drug Development Conferences. The 2016 conference, which Nimish Vakil, MD, AGAF, and I will co-chair, will focus on upper GI tract disorders. The program is currently being finalized. The conference will address unmet needs and potential therapeutic advances in GERD, eosinophilic esophagitis, functional dyspepsia and gastroparesis.

Center for Diagnostics and Therapeutics: “Open for Business”

We would be interested to hear from — and work with — pharmaceutical companies (no size too big/no size too small), or independent investigators developing new medicines or diagnostic tests for digestive disorders who may require guidance from thought leaders in the field. We do not claim to have all the answers, but we will work diligently to identify and work with the appropriate experts from within AGA membership.

We also see ourselves as taking an “honest broker” role in liaison between industry and FDA whenever appropriate. We aim to work with investigators, the industry and FDA in identifying and defining appropriate endpoints for clinical trials, and in the development and validation of useful biomarkers.

As suggested by our mission statement, these efforts are designed to facilitate the identification, evaluation and (where appropriate) approval of promising new medicines and diagnostic tests to improve the lives of our patients. This is an ambitious and worthwhile objective. If you have comments or suggestions for future activities for the Center for Diagnostics and Therapeutics, I would like to hear from you; please contact me by email at chowden@uthsc.edu, or contact our staff, Alison Kim, PhD, and Jennifer Conte, who we are extremely fortunate to have helping us at AGA headquarters.

Dr. Howden serves a consultant for Takeda, Otsuka, Ironwood, Allergan, Aralez and Pfizer Consumer Health. He has previously consulted for Yuhan, Mederi and Given Imaging. He also serves as a speaker for Takeda and Otsuka.

References

  1. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM455645.pdf; AGA comment letter available at http://www.regulations.gov/#!documentDetail;D=FDA-2015-D-2479-0004

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