Presentation: Clinical Development of Drugs for the Treatment of NASH: General Considerations, Challenges, and the Role of Clinical Pharmacology Shirley Seo, U.S. Food & Drug Administration 9:35 a.m.

by Covance Inc. updated on Tuesday, June 2, 2020 Thursday, April 30, 2020. 98 drug’s pharmacokinetics early during the drug development program in a dedicated 99 hepatic study to support appropriate dosing and dose adjustment across the spectrum of 100 NASH liver disease. Biomarkers & Diagnostics: growing influence on drug development for NAFLD/NASH. NASH is usually a silent disease with few or no symptoms.

He has substantial experience in the cardiovascular and metabolic space, including NASH, T1DM and T2DM, and has more than 20 years of experience in strategic drug development.
Dr. Filozof led multiple drug development programs in obesity and other metabolic diseases and has been actively involved in NASH clinical development since 2011. Therefore, drug development in NASH is a rapidly changing field. Developing drugs for NASH, a type of liver disease is an emerging field in medicine, which is expected to be extremely lucrative, capturing the imagination of pharma companies and plunging them in a race to market the first drug. Drug development. As with drug development for any disease state, many products in the early stages of testing are unlikely to ever receive FDA approval. NASH Drug Development Predictions 2019 was named the “Year of NASH”, but I believe we’re facing a longer course – years of NASH. Yet, mice carrying humanized (hepatic) PPARs could be key for the evaluation of multi-organ targeted anti-NASH therapies [80,81]. Gathering more NASH drug developers than ever before, the 4th NASH Summit (Boston, December 15-18 2020) includes 4 days of focused discussion and data sharing to give an unrivaled conference experience. NAFLD is also generally conceived as the hepatic manifestation of …
Hear from 80+ speakers and 350+ attendees all with one mission: to accelerate the successful development of NASH candidates.

She is an active member of the Liver Forum, member of the American Association for the Study of Liver Diseases steatohepatitis working group and the European Association for the Study of Diabetes NAFLD group. NASH is a kind of fatty liver disease characterized by inflammation and scarred tissue, which in turn can lead to liver cirrhosis and, in the some severe cases, cancer. Join this webinar for a discussion of NASH biomarkers, including: A brief introduction of NAFLD and NASH and the role of CK18 in these diseases, an overview of CK18 in NASH clinical trials, Bioanalytical validation of cCK18 for drug development / Biomarkers & Diagnostics: growing influence on drug development for NAFLD/NASH. A number of manufacturers are developing drugs to treat NASH, and approximately 95 drugs are in the pipeline worldwide at various stages of development. ... NASH is a severe condition characterized by steatosis and concomitant liver inflammation and fibrosis, for which no drug is yet available. Developing drugs for NASH: the race to market. In spite of its large patient population and potential life-threatening effects, no Food and Drug Administration approved treatments are on the market. Clinical development of anti-NASH drug therapies. Session 1: Liver Disease Pathophysiology and the Impact of Liver Dysfunction on Pharmacokinetics, Pharmacodynamics, Drug Safety and Efficacy The current understanding of NASH pathogenesis has led to broad efforts to target several features of the disease, alone or in combination, even in the absence of liver-guided therapies. As a result, it can progress for years – or even decades – undetected. Share Biomarkers and diagnostics are playing an ever-increasing role in drug development. The main reason behind the use of human-based models in PPAR-targeted anti-NASH drug development is connected with the important inter-species differences in the biology of PPARs [86,140]. NASH has been among the closely watched indications in biotech since January 2014, when Intercept Pharmaceuticals lit a fire under the field … NASH drug development strategy Challenge: A private biotech company with first in class, early lead compounds targeting a novel metabolic signaling protein engaged Alacrita’s NASH consultant to explore the best disease pathways for development. Anti-NASH Drug Development Hitches a Lift on PPAR Agonism.