45th Annual Society for Case Research & Global Jesuit Case Series Summer Workshop

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Balancing Ethics, Strategy, and Regulation: Mesoblast's Journey with Drug Ryoncil

The managing director of an Australian biotechnology company, Mesoblast, and its CFO were sued in an investor class action complaint in October 2020. Investors claimed they suffered severe losses due to unethical and illegal Mesoblast behavior. This included misleading statements and failure to disclose important clinical information about Mesoblast’s drug candidate, Ryoncil. Mesoblast settled the lawsuit and asked the FDA to accelerate Ryoncil’s approval without conducting the new clinical trials FDA suggested. In retrospect, the managing director wondered if paying fines and asking the FDA to accelerate the Ryoncil approval process was a more effective strategic management approach than conducting the new clinical trials FDA suggested. Students are asked to assess the effectiveness of past management decisions in ethics, legal/regulatory affairs, and strategic formulation.