Non-alcoholic steatohepatitis (NASH) is fast becoming a highly competitive drug development race; the high prevalence of the disease, the substantial costs of complications, and the lack of any approved treatments represent a significant marker opportunity. However, as NASH has only relatively recently been recognized as a distinct medical problem, new ground is being broken all the time not only in terms of drug development but in terms of drug assessment. Regulators need to be sure that any novel drug approved has an acceptable risk-benefit profile considering the potentially large population that may be exposed to the new treatment.
The Global NASH Congress 2018 is running over Monday 26 and Tuesday 27 February in London, and DRG is attending to hear the latest on the disease, diagnostics, and drugs that may be able to improve management. One key area of discussion is the regulatory situation for a disease with no approved treatments as both drug developers and regulators are running blind to some degree. Importantly, expert speaker from both pharma companies and regulatory bodies are represented, each offering their insights on various aspect of the evolving drug approval process for novel NASH candidates.
Amongst others, Professor Peter Mol, Vice-Chair of the EMA Scientific Advice Working Party is lecturing on regulators’ perspectives of the importance of cardiovascular outcomes and clinical trial design. For the drug developers, Novo Nordisk’s Dr Richard Torstenson, a senior regulatory affairs specialist, is discussing the current disconnect between drug development strategies for various metabolic pathways and the regulatory guidance currently available. To cap it all off, a round table discussion, entitled “The road to drug approval for NASH – what does it take to make new treatments available to patients”, will walk through various aspects of drug development and highlight several of the key challenges facing the numerous drug candidates in the NASH pipeline today.
For other highlights of the Global Engage NASH 2018 Congress, please check out my colleague Andrew Frost’s thoughts here.
For DRG’s assessment of the NASH market, please click here.