- Ethics and Philosophy of Science and Technology
- S&E Organizations, Education, Careers and Workforce
- Science, Technology, and Innovation Policy
Aaron D. Levine is an Associate Professor in the School of Public Policy at Georgia Tech and a Guest Researcher in the Division of Reproductive Health at the Centers for Disease Control and Prevention. His research focuses on the intersection between public policy and bioethics. Much of his recent work has examined the development of stem cell science, particularly research using human embryonic stem cells, and the oversight of contentious areas of medicine, such as assisted reproductive technology. In 2012, he received a five-year NSF CAREER award to examine the impact of ethical controversy on graduate science education and the development of scientific careers. He is the author of Cloning: A Beginner’s Guide (Oneworld Publications, 2007), an accessible introduction to the science of cloning and embryonic stem cells and the ethical and policy controversies this science inspires.
Aaron completed his Ph.D. in Public Affairs at Princeton University, where his dissertation research examined the impact of public policy on the development of human embryonic stem cell science. He also holds an M. Phil. from the University of Cambridge, where, as a Churchill Scholar, he studied computational biology at the Sanger Centre and developed algorithms to help analyze the human genome sequence, and a B.S. in Biology from the University of North Carolina at Chapel Hill, where he was a Morehead Scholar
Non-Refereed Journal Article – 2016Cytotherapy. 18. Issue 1. 143 - 148. ISSN 1465-3249. DOI 10.1016/j.jcyt.2015.11.002.
Non-Refereed Conference – August 2015© 2015 Dodson and Levine. Background: Cell therapies are an emerging form of healthcare that offer significant potential to improve the practice of medicine and provide benefits to patients who currently have limited or no treatment options. Ideally, these innovative therapies can complement existing small molecule, biologic and device approaches, forming a so-called fourth pillar of medicine and allowing clinicians to identify the best treatment approach for each patient. Despite this potential, cell therapies are substantially more complex than small molecule or biologic interventions. This complexity poses challenges for scientists and firms developing cell therapies and regulators seeking to oversee this growing area of medicine. Results: In this project, we retrospectively examined the development of seven cell therapies - including three autologous interventions and four allogeneic interventions - with the aim of identifying common challenges hindering attempts to bring new cell therapies to market. We complemented this analysis with a series of qualitative interviews with experts in various aspects of cell therapy. Through our analysis, which included review of extant literature collected from company documents, newspapers, journals, analyst reports and similar sources, and analysis of the qualitative interviews, we identified several common challenges that cell therapy firms must address in both the pre- and post-market stages. Key pre-market challenges included identifying and maintaining stable funding to see firms through lengthy developmental timelines and uncertain regulatory processes. These challenges are not unique to cell therapies, of course, but the novelty of cell-based interventions complicates these efforts compared to small molecule or biologic approaches. The atypical nature of cell therapies also led to post-market difficulties, including challenges navigating the reimbursement process and convincing providers to change their treatment approaches. In addition, scaling up production, distributing cell therapies and managing the costs of production were challenges that started pre-market and continued into the post-market phase. Conclusions: Our analysis highlights several interrelated challenges hindering the development of cell therapies. Identifying strategies to address these challenges may accelerate the development and increase the impact of novel cell therapies.15. Issue 1. DOI 10.1186/s12896-015-0190-4.