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Slides

FDA will provide a summary of FDA’s current thinking on the published draft guidance documents: Non-cirrhotic Non-alcoholic Steatohepatitis (NASH): Developing Drugs for Treatment, and Non-alcoholic Steatohepatitis in Compensated Cirrhosis: Developing Drugs for Treatment.

TOPICS

• Phase 2 drug development for NASH
• Clinical trial inclusion/exclusion for phase 3 NASH trials
• Surrogate efficacy endpoints that have been acknowledged by FDA as reasonably likely to predict clinical benefit
• Clinical endpoints for the confirmation of clinical benefit
• Strategies at clinical drug development for NASH

LEARNING OBJECTIVES

After this webinar, participants will be able to…

• Confirm the reasons why NASH is a serious condition as defined in 21 CFR regulation.
• Understand the importance of early clinical development and proof-of-concept trials.
• Describe the rationale for the choice of the surrogate endpoint reasonably likely to predict clinical benefit.
• Describe the endpoints used to characterize the confirmation of clinical benefit.

AUDIENCE

• Regulatory affairs professionals working on NASH drug development
• Pharmaceutical and academic researchers enrolling patients into NASH drug development programs
• Consultants focused on providing advice to sponsors involved in NASH drug development
• Clinical research coordinators overseeing research in NASH
• Healthcare professionals specializing in gastroenterology and hepatology

FDA SPEAKERS

Toru Matsubayashi, MD, MSPH
Medical Reviewer
Division of Hepatology and Nutrition | Office of Immunology and Inflammation | CDER | FDA

Frank Anania, MD
Deputy Director
Division of Hepatology and Nutrition | Office of Immunology and Inflammation | CDER | FDA

Joseph Toerner, MD, MPH
Director
Division of Hepatology and Nutrition | Office of Immunology and Inflammation | CDER | FDA

FDA RESOURCES

Guidance for Industry: Noncirrhotic Nonalcoholic Steatohepatitis with Liver Fibrosis: Developing Drugs for Treatment

Guidance for Industry: Nonalcoholic Steatohepatitis with Compensated Cirrhosis: Developing Drugs for Treatment

CONTINUING EDUCATION

• This webinar has been has been approved for 1.5 continuing education units for physicians, pharmacists, and nurses. See CE announcement for more details.
• Real-time attendance is required for continuing education credits and certificates.
• Certificates are only available during the two weeks post-event.
• This course:
  • has been pre-approved by RAPS as eligible for up to 1 credit towards a participant’s RAC recertification upon full completion.
  • has been pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
  • has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.
  • has been approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

QUESTIONS
Please contact [email protected] for all technical questions.
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