- Ethics and Philosophy of Science and Technology
- Science, Technology, and Innovation Policy
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.
Refereed Journal article – February 2015© 2015 Elsevier Inc. All rights reserved. Several states responded to federal funding limitations placed on human embryonic stem cell research and the potential of the field by creating state stem cell funding programs, yet little is known about the impact of these programs. Here we examine how state programs have affected publication trends in four states.Cell Stem Cell. 16. Issue 2. 115 - 118. ISSN 1934-5909. DOI 10.1016/j.stem.2015.01.007.
Refereed Journal article – 2015© 2015 American Society of Law, Medicine & Ethics, Inc. Oocyte donation raises conflicts of interest and commitment for physicians but little attention has been paid to how to reduce these conflicts in practice. Yet the growing popularity of assisted reproduction has increased the stakes of maintaining an adequate oocyte supply and (where appropriate) minimizing conflicts. A growing body of professional guidelines, legal challenges to professional self-regulation, and empirical research on the practice of oocyte donation all call for renewed attention to the issue. As empirical findings better inform existing conflicts and their potential harms, we can better attempt to reduce these conflicts. To that end, the article first describes the nature of conflicts in oocyte donation and relevant regulations and professional guidelines. We then describe studies on conflicts at four phases of oocyte donation: recruitment, screening, stimulation, and post-stimulation monitoring. Next we consider three models for conflict reduction in medicine generally: improved professional self-regulation, outright restriction like Stark anti-referral laws, or the use of conflict mediators, like in living organ donation. We ultimately conclude that improved professional self-regulation is a reasonable starting place for oocyte donation.Journal of Law, Medicine and Ethics. 43. Issue 2. 410 - 424. ISSN 1073-1105. DOI 10.1111/jlme.12257.
Non-Refereed Journal article – 2015Cytotherapy. 17. Issue 12. 1663 - 1666. ISSN 1465-3249. DOI 10.1016/j.jcyt.2015.10.007.
Refereed Journal article – 2015BMC Biotechnology. 15. Issue 70. BioMed Central. ISSN 1472-6750. DOI 10.1186/s12896-015-0190-4.