bio
Prior to joining the doctoral program, Sukhun worked as a semiconductor engineer at Samsung Electronics and also led an Internet startup in 2010. These roles afforded him a diverse set of experiences, such as designing products to managing a venture, which informs his research.
Sukhun’s research interests lie in strategy, entrepreneurship, and innovation with a particular focus on biopharmaceutical and high-tech industry.
Publications
Implementation of 21st Century Cures Act Expanded Access Policies Requirements
Abstract
The US Food and Drug Administration (FDA) expanded access pathway allows patients with life-threatening or serious conditions to access investigational drugs outside of trials, under certain conditions. The 21st Century Cures Act (“Cures Act”) requires certain drug companies to publicly disclose their expanded access policies. We characterized the proportion of applicable US biopharmaceutical companies, with an oncology related drug, implementing Cures Act requirements for expanded access policies and whether available policies contain the information described in the Act. We found about one-third of applicable biopharmaceutical companies (32%, 140/423) implemented the Cures Act requirement to have a public expanded access policy. Less than one-third of public policies contained all described information (31%, 44/140). Larger companies and those with at least one drug receiving an FDA expedited designation (59% vs. 21%; P < 0.001), or at least one FDA-approved drug (57% vs. 28%; P < 0.001) were more likely to have a public policy. Our results suggest the Cures Act may be having a limited impact on its goals of supporting timely medical decisions and closing informational gaps for patients and doctors around expanded access to investigational oncology therapies, especially for products sponsored by smaller and newer companies.
