Liver Disorders
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Global Liver Institute Launches Final Nonalcoholic Steatohepatitis (NASH) Externally-Led Patient Focused Drug Development Meeting Outcome Report

Published Online: March 21st 2022
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(Washington, DC, Wednesday, March 9, 2022)—Today, Global Liver Institute (GLI) is proud to launch the final NASH Externally-Led Patient Focused Drug Development Meeting Outcome Report.

On November 4th 2021, Global Liver Institute led an Externally Led Patient-Focused Drug Development Meeting on NASH. This GLI led EL-PFDD meeting on NASH provided regulators, and drug developers the invaluable opportunity to hear from patients and caregivers directly about the challenges and burdens of this life-threatening condition.

“…for many NASH patients their house is figuratively on fire and they’re willing to take some risk so you know I’m being repetitive but I feel like I can’t say it enough please consider the patient perspective during your evaluations…” – Tony Villiotti, NASH EL-PFDD Meeting Panelist, and President of NASH kNOWledge.

Participants and panelists emphasized a variety of critical points throughout the meeting, the patient and caregiver survey, and this final report. This includes the lack of adequate educational support, the lack of public awareness, the social, physical, and emotional impact that NASH has on their lives, the lack of a unified approach in early detection and management of NASH, the challenges in managing NASH symptoms, their perspectives on the balance between potential future therapy risks and benefits, the importance of patient-centric endpoints, the challenges in getting diagnosed, their experiences with liver biopsy including the burden associated with and the ineffectiveness of the diagnostic tool, and the need to improve NASH clinical trial design.

“Just this time alone since we started planning this NASH EL-PFDD meeting to the conclusion of this event, there have been patients that have died, there are patients that have progressed from early stages of NASH to more advanced stages, there are patients that have progressed to liver cancer or to needing a liver transplant. The urgency that we all feel as patients and caregivers can not be overstated. If we can make regulatory time a little closer to patient time, that will serve everyone.” – Donna Cryer, NASH EL-PFDD Meeting Moderator, and CEO and Founder of GLI

GLI appreciated the support of the liver advocacy community, and GLI’s Liver Action Network (LAN) on this monumental meeting including Community Liver Alliance, Fatty Liver Alliance, Fatty Liver Foundation, Liver Coalition of San Diego, Liver Health Foundation, Midsouth Liver Alliance, NASH kNOWledge, Northeast Ohio Liver Alliance, and the Texas Liver Foundation.


About Global Liver Institute 

Global Liver Institute (GLI) is a 501(c)3 nonprofit organization founded in the belief that liver health must take its place on the global public health agenda commensurate with the prevalence and impact of liver illness. GLI promotes innovation, encourages collaboration, and supports the scaling of optimal approaches to help eradicate liver diseases. Operating globally, GLI is committed to solving the problems that matter to liver patients and equipping advocates to improve the lives of individuals and families impacted by liver disease. Follow GLI on TwitterFacebookInstagramLinkedIn, and YouTube.

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