Sungyong Chang
Assistant Professor of Strategy and Entrepreneurship at London Business School
bio
Sungyong’s research explores innovation, creativity and firm growth strategies using computational modelling and big-data analysis. His particular focus is on high-tech and cultural industries where innovation and creativity matter most. First, Dr Chang’s research focuses on how new entrants overcome their disadvantages in capabilities and capital to compete against industry leaders. Second, his research focuses on the perspective that views firms as bundles of interdependent choices. Specifically, he explores how firms identify promising business ideas or talent under complexity, which limits complete understandings of the performance implications of each business decision.
Dr Chang’s research bridges strategy and computational social science – the use of large-scale data to investigate firm’s strategies and people’s behaviour. With growing volumes of data on every aspect of firm’s decision and our daily lives – his work examines some of the major questions in the social sciences.
He won the Peter J. Buckley and M. Casson Dissertation Award from the Academy of International Business in 2019 and Distinguished PhD Paper Award from Strategic Management Division of the Academy of Management in 2018. He also won LBS Best Teacher Award – MiM in 2019, 2020, and 2021. His work has been published in top-tier publications such as the Organization Science and Strategic Management Journal. He is an editorial board member of Strategic Management Journal.
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.
