Hansonwade will present the 4th NASH Summit in Boston from May 4-7, 2020. For its anticipated return, the forum is set to widen its program and congregate over 350+ industry stakeholders for presentations from global regulatory agencies and leading biopharma.
NASH, all eyes on the leaders of the race
It was only a few years ago that a positive mid-stage clinical trial for non-alcoholic steatohepatitis sent a Biotech's stock soaring. Today, NASH is estimated to represent a $35 billion market opportunity with two drugs poised to open the flood gates with the first approval in 2020.
Determining how the rest of market will evolve to capitalize on the individual niches of a multiple drug opportunity and comprehensively address this unmet medical need is the next challenge NASH drug developers are preparing for and will be partly defined by the success of the two front-runners.
- Ocaliva: Already approved to treat primary biliary cholangitis, Intercept have April 22 provisionally set for an FDA advisory panel as their first step to secure their approval and be the first NASH drug on the market.
- Elafibranor: Following close behind, French biotech Genfit have scheduled to release their phase 3 results in the first quarter of 2020. Despite initially missing the primary endpoint in a phase 2 study in NASH, Genfit has designed the RESOLVE-IT phase 3 study to focus on patients with more severe NASH exclusively, avoiding past failure chalked up to including too many patients with earlier stage disease.
Whilst any successful drug is tipped to deliver blockbuster sales, the race to market is far from easy and 2019 saw brought significant setbacks to leading candidates Selonsertib (Gilead) and Seladelpar (CymaBay), and delay to others including results from Cenicriviroc (Allergan) pushing back to late 2020.
The most comprehensive forum for NASH drug developers
With an exclusive focus on accelerating the development of effective and successful NASH candidates, the NASH Summit is an unrivaled opportunity for NASH industry stakeholders to network and discuss the latest breaking data from the first quarter of 2020 and setbacks in the latter part of 2019.
From discovery science to pricing and reimbursement strategies, preclinical models to multi-omics platforms, over 80 speakers will reveal their expert insights on how to move NASH candidates forward.
Snapshot of key presentations:
- “NASH in 2020, what have we learned and how will we react?” Jason Campagna, Chief Medical Officer, Intercept Pharmaceuticals
- “The end of the beginning in NASH therapy; ongoing challenges.” Scott Friedman, Dean for Therapeutic Discovery & Chief of the Division of Liver Diseases, Mount Sinai
- “Regulatory Guidance for NASH with Compensated Cirrhosis” Frank Anania, Acting Clinical Team Leader, Division of Gastroenterology & Inborn Errors Products, FDA
- “Regulatory Considerations for NASH with Liver Fibrosis & with Compensated Cirrhosis” Joachim Musaeus, Scientific Administrator & Product Lead Gastroenterology, EMA
- “NASH monotherapy: a tour of the FXR agonist menagerie” Michael Badman, Translational Medicine Expert, Novartis
- “Pedatric NAFLD/NASH drug development: regulatory guidelines, challenges and opportunity” Johannes Taminiau Pediatric Committee, EMA, Pediatric Gastroenterologist, University Hospital Antwerp/Paola Children’s Hospital