Aaron Levine
Associate Dean for Research and Outreach, Professor
Member Of:
- Ivan Allen Dean's Office
- School of Public Policy
Office Location: Rich 221
Email Address: aaron.levine@pubpolicy.gatech.edu
Overview
Aaron D. Levine is Associate Dean for Research and Outreach in the Ivan Allen College of Liberal Arts and Professor in the School of Public Policy at Georgia Tech. His research addresses the intersection between public policy and biomedical innovation, especially in the context of stem cells, cell therapy, and assisted reproduction. He is a member of the leadership team for the NSF Engineering Research Center for Cell Manufacturing Technologies (CMaT), leading ethics and policy research for the center and previously served as Co-Director for CMaT's Engineering Workforce Development activities from 2017 to 2022. Since joining Georgia Tech, Aaron has participated as PI, co-PI or senior personnel, in $45M+ in sponsored funding, including NSF CAREER, IGERT, NRT and ERC awards. He serves as Vice-Chair for Bioethics on the International Society for Cell & Gene Therapy’s Committee on the Ethics of Cell and Gene Therapy and completed a three-year term as an elected member of the Board of Directors of the American Society for Bioethics and Humanities in 2022. From 2014 to 2023, he held an appointment as a Guest Researcher in the Division of Reproductive Health at the Centers for Disease Control and Prevention. He is also a long-time member of the International Society for Stem Cell Research, the Association for Public Policy Analysis and Management, and the American Association for the Advancement of Science (where he is also an honorary fellow).
Aaron has a long-standing interest in science communication and 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. He was an AAAS Leshner Leadership Institute Public Engagement Fellow for 2019-2020.
He 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.
Education:
- Ph.D., Princeton University, Public Affairs
- M.Phil., University of Cambridge, Biological Sciences
- B.S., University of North Carolina at Chapel Hill, Biology
Awards and
Distinctions:
Distinctions:
- Fellow, American Association for the Advancement of Science
Areas of
Expertise:
Expertise:
- Assisted Reproduction / Fertility Industry
- Biotechnology / Biomedical Research Policy
- Research Ethics
- Stem Cell Ethics And Policy
- Translation Of Emerging Technologies
Interests
Research Fields:
- Ethics and Philosophy of Science and Technology
- S&E Organizations, Education, Careers and Workforce
- Science, Technology, and Innovation Policy
Courses
- PHIL-3127: Sci, Tech & Human Values
- PST-3127: Sci,Tech & Human Values
- PST-4803: Special Topics
- PUBJ-8000: Joint GT/GSU PhD Program
- PUBP-3030: Policy Analysis
- PUBP-3130: Research Methods
- PUBP-3244: Stem Cell Policy Ethics
- PUBP-4699: Undergraduate Research
- PUBP-4803: Special Topics
- PUBP-6112: Research Dsgn-Polcy Sci
- PUBP-8803: Special Topics
- PUBP-8813: Special Topics
Publications
Selected Publications
Journal Articles
- Medical Crowdfunding to Access CAR-T Cell Therapy
In: The Lancet Oncology
Date: August 2019
View All Details about Medical Crowdfunding to Access CAR-T Cell Therapy
- Ethical Considerations in the Translation of CAR-T Cell Therapies
In: Cell & Gene Therapy Insights [Peer Reviewed]
Date: May 2018
View All Details about Ethical Considerations in the Translation of CAR-T Cell Therapies
- Contribution of Assisted Reproductive Technology to Overall Births by Maternal Age in the United States, 2012-2014
In: Journal of the American Medical Association [Peer Reviewed]
Date: March 2017
- Challenges in the commercialization and translation of cell therapies
In: BMC Biotechnology [Peer Reviewed]
Date: 2015
View All Details about Challenges in the commercialization and translation of cell therapies
- Self-regulation, compensation, and the ethical recruitment of oocyte donors.
In: Hastings Center Report [Peer Reviewed]
Date: February 2010
Over the last couple of decades, oocyte donation has become common, important, and sometimes lucrative. Women who donate eggs are often offered fees, though ostensibly only to offset their expenses and limited to no more than $10,000, following recommendations adopted by the fertility industry. Is the industry adhering to its recommendations? A study of advertisements published in college newspapers raises questions.
View All Details about Self-regulation, compensation, and the ethical recruitment of oocyte donors.
All Publications
Books
- Cloning
Date: 2012
Would you drink milk from a cloned cow? Should we clone extinct or endangered species? Are we justified in using stem cells to develop cures? When will we clone the first human? Ever since Dolly the sheep, such questions have rarely been far from the public consciousness. Aaron Levine explains the science of cloning and guides readers around the thorny political and ethical issues that have developed. - Cloning
Date: 2009
Discusses the methods, regulation, and ethics of cloning in relation to agriculture, medicine, endangered species, and human beings. - Cloning (World Issues Today)
- Cloning: A Beginner's Guide
- Cloning: a beginner's guide
Date: 2007
Should we clone extinct or endangered species? Are we justified in using stem cells to develop cures? When will we clone the first human? Ever since Dolly the sheep, questions like these have rarely been far from the public consciousness, and cloning is now poised to revolutionize medicine, healthcare, and even the food we eat. Aaron Levine offers a masterful and accessible introduction to the science and development of cloning, right up to the present-day scandals surrounding attempts to clone humans. Guiding readers around the thorny political and ethical issues raised by such progress, Levine dispels the myths perpetuated by the media and sheds new light on the pros and cons of this fascinating and controversial topic. - States and Stem Cells: Policy and Economic Implications of State-Funded Stem Cell Research
Date: 2006
This volume considers the promise and pitfalls of the states' unprecedented venture into the world of scientific research funding. With commentary by Nobel Prize winner Paul Berg and Richard Codey, the path-breaking governor of New Jersey who was among the first to commit his state to funding stem cell research, the book offers readers unique insight into one of the most exciting policy innovations of the 21st century.
Journal Articles
- A Bibliometric Measure of Translational Science
In: Scientometrics [Peer Reviewed]
Date: August 2020
View All Details about A Bibliometric Measure of Translational Science
- Supply Chain Challenges and Issues Facing the Autologous Cell Manufacturing Industry
In: Cell & Gene Therapy Insights [Peer Reviewed]
Date: April 2020
- A multiscale simulation framework for the manufacturing facility and supply chain of autologous cell therapies
In: Cytotherapy [Peer Reviewed]
Date: October 2019
- Medical Crowdfunding to Access CAR-T Cell Therapy
In: The Lancet Oncology
Date: August 2019
View All Details about Medical Crowdfunding to Access CAR-T Cell Therapy
- Ethical Considerations in the Translation of CAR-T Cell Therapies
In: Cell & Gene Therapy Insights [Peer Reviewed]
Date: May 2018
View All Details about Ethical Considerations in the Translation of CAR-T Cell Therapies
- State differences in pluripotent and adult stem cell research, 2009-2016
In: Regenerative Medicine [Peer Reviewed]
Date: May 2018
View All Details about State differences in pluripotent and adult stem cell research, 2009-2016
- Medical societies, patient education initiatives, public debate and marketing of unproven stem cell interventions
In: Cytotherapy [Peer Reviewed]
Date: February 2018
- Assessing the use of assisted reproductive technology in the United States by non-United States residents
In: Fertility and Sterility [Peer Reviewed]
Date: November 2017
- Differences in the utilization of gestational surrogacy between states in the USA
In: Reproductive BioMedicine & Society [Peer Reviewed]
Date: September 2017
- Contribution of Assisted Reproductive Technology to Overall Births by Maternal Age in the United States, 2012-2014
In: Journal of the American Medical Association [Peer Reviewed]
Date: March 2017
- Navigating Bioethical Waters: Two Pilot Projects in Problem-Based Learning for Future Bioscience and Biotechnology Professionals
In: Science and Engineering Ethics 22, no. 6, pp. 1649-1667 [Peer Reviewed]
Date: 2016
- Part 6: The role of communication in better understanding unproven cellular therapies
In: Cytotherapy
Date: 2016
- Navigating Bioethical Waters: Two Pilot Projects in Problem-Based Learning for Future Bioscience and Biotechnology Professionals
In: Science and Engineering Ethics [Peer Reviewed]
Date: November 2015
© 2015 Springer Science+Business Media DordrechtWe believe that the professional responsibility of bioscience and biotechnology professionals includes a social responsibility to contribute to the resolution of ethically fraught policy problems generated by their work. It follows that educators have a professional responsibility to prepare future professionals to discharge this responsibility. This essay discusses two pilot projects in ethics pedagogy focused on particularly challenging policy problems, which we call “fractious problems”. The projects aimed to advance future professionals’ acquisition of “fractious problem navigational” skills, a set of skills designed to enable broad and deep understanding of fractious problems and the design of good policy resolutions for them. A secondary objective was to enhance future professionals’ motivation to apply these skills to help their communities resolve these problems. The projects employed “problem based learning” courses to advance these learning objectives. A new assessment instrument, “Skills for Science/Engineering Ethics Test” (SkillSET), was designed and administered to measure the success of the courses in doing so. This essay first discusses the rationale for the pilot projects, and then describes the design of the pilot courses and presents the results of our assessment using SkillSET in the first pilot project and the revised SkillSET 2.0 in the second pilot project. The essay concludes with discussion of observations and results. - Assessing state stem cell programs in the United States: How has state funding affected publication trends?
In: Cell Stem Cell [Peer Reviewed]
Date: 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.
- Challenges in the commercialization and translation of cell therapies
In: BMC Biotechnology [Peer Reviewed]
Date: 2015
View All Details about Challenges in the commercialization and translation of cell therapies
- Conflicts of interest and effective oversight of assisted reproduction using donated oocytes
In: Journal of Law, Medicine and Ethics [Peer Reviewed]
Date: 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. - Positioning a Scientific Community on Unproven Cellular Therapies: The 2015 International Society for Cellular Therapy Perspective
- Risk Disclosure and the Recruitment of Oocyte Donors: Are Advertisers Telling the Full Story?
- Risk disclosure and the recruitment of oocyte donors: Are advertisers telling the full story?
In: Journal of Law, Medicine and Ethics [Peer Reviewed]
Date: 2014
This study analyzes 435 oocyte donor recruitment advertisements to assess whether entities recruiting donors of oocytes to be used for in vitro fertilization (IVF) procedures include a disclosure of risks associated with the donation process in their advertisements. Such disclosure is required by the self-regulatory guidelines of the American Society for Reproductive Medicine (ASRM) and by law in California for advertisements placed in the state. We find very low rates of risk disclosure across entity types and regulatory regimes, although risk disclosure is more common in advertisements placed by entities subject to ASRM's self-regulatory guidelines. Advertisements placed in California are more likely to include risk disclosure, but disclosure rates are still quite low. California-based entities advertising outside the state are more likely to include risk disclosure than non-California entities, suggesting that California's law may have a modest halo effect. Our results suggest that there is a significant ethical and policy problem with the status quo in light of the known and unknown risks of oocyte donation and the importance of risk disclosure to informed consent in the context of oocyte donation. © 2014 American Society of Law, Medicine & Ethics, Inc. - The origins of human embryonic stem cell research policies in the us states
In: Science and Public Policy [Peer Reviewed]
Date: August 2013
Stem cell research has emerged as a state-level science and technology policy issue in recent years in the USA, with some states supporting research in the field and others choosing to restrict it. In this paper, we systematically explore the factors that are associated with US states' adoptions of both supportive and restrictive stem cell policies. Our analysis identifies several factors, including partisan politics, existing morality policies, the strength of a state's scientific community and the policy environment in neighboring states, which influence the adoption of state stem cell policies. Our paper aims to advance the science and technology policy literature by providing insight into the factors that push states to adopt science policies when economic development goals conflict with ethical concerns. © The Author 2013.View All Details about The origins of human embryonic stem cell research policies in the us states
- Compliance with donor age recommendations in oocyte donor recruitment advertisements in the USA
In: Reproductive BioMedicine Online [Peer Reviewed]
Date: April 2013
IVF using donated oocytes offers benefits to many infertile patients, yet the technique also raises a number of ethical concerns, including worries about potential physical and psychological risks to oocyte donors. In the USA, oversight of oocyte donation consists of a combination of federal and state regulations and self-regulatory guidelines promulgated by the American Society for Reproductive Medicine. This study assesses compliance with one of these self-regulatory guidelines-specifically, ASRM's preferred minimum age for donors of 21. To assess compliance, 539 oocyte donor recruitment advertisements from two recruitment channels (Craigslist and college newspapers) were collected and evaluated. Of these, 61% in the Craigslist dataset and 43% in the college newspaper dataset listed minimum ages between 18 and 20, which is inconsistent with ASRM's preferred minimum age recommendation of 21. Advertisements placed by oocyte donor recruitment agencies were more likely than advertisements placed by clinics to specify minimum ages between 18 and 20. These results indicate that ASRM should evaluate and consider revising its donor age guidelines. IVF using donated human eggs can help many patients who have difficulty having children. However, the technique also raises ethical concerns, including concerns about potential physical and psychological harms to egg donors. In the USA, oversight of egg donation relies on a combination of federal and state regulation and professional self-regulation. Governmental regulations address only limited aspects of egg donation, such as the potential spread of infectious diseases and the reporting of success rates, leaving voluntary guidelines developed by an association of medical professionals to address most issues, including ethical concerns raised by the practice. One of these voluntary guidelines recommends that egg donors should be at least 21 years of age. In this article, we analysed 539 egg donor recruitment advertisements published on Craigslist and in college newspapers to see whether fertility clinics and egg donor recruitment agencies follow this recommendation. We found that 61% of advertisements in the Craigslist dataset and 43% of advertisements in the college newspaper dataset listed minimum ages between 18 and 20 and, thus, did not follow the recommendation that egg donors be at least 21 years of age. Advertisements placed by egg donor recruitment agencies were more likely than advertisements placed by fertility clinics to list minimum ages between 18 and 20. These results indicate that the American Society for Reproductive Medicine should evaluate and consider revising its donor age guidelines. © 2012, Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved. - Compliance with Donor Age Recommendations in Oocyte Donor Recruitment Advertisements in the USA
- State stem cell policy and the geographic preferences of scientists in a contentious emerging field
In: Science and Public Policy [Peer Reviewed]
Date: December 2012
In the USA, stem cell research policy has been addressed at both federal and state levels. This paper focuses on the heterogeneous state policy environment and compares data from surveys of stem cell scientists and other biomedical researchers to evaluate the impact of supportive state policies on stem cell scientists' geographic preferences. At least early in the development of the field, permissive state policies were a strong predictor of scientists' geographic preferences. Combined with an analysis of scientists' policy awareness and explanations of their preferences, these findings suggest that supportive state science policies have influenced scientists' geographic preferences and, at least in the case of stem cell research where federal funding restrictions are prevalent, may help states to successfully recruit scientists. © The Author 2012. Published by Oxford University Press. All rights reserved. - Improving oversight of innovative medical interventions in Texas, USA
In: Regenerative Medicine
Date: July 2012
View All Details about Improving oversight of innovative medical interventions in Texas, USA
- The Roles and Responsibilities of Physicians in Patients' Decisions about Unproven Stem Cell Therapies
In: Journal of Law, Medicine and Ethics [Peer Reviewed]
Date: March 2012
Capitalizing on the hype surrounding stem cell research, numerous clinics around the world offer "stem cell therapies" for a variety of medical conditions. Despite questions about the safety and efficacy of these interventions, anecdotal evidence suggests a relatively large number of patients are traveling to receive these unproven treatments - a practice called "stem cell tourism." Because these unproven treatments pose risks to individual patients and to legitimate translational stem cell research, stem cell tourism has generated substantial policy concern and inspired attempts to reduce these risks through the development of guidelines for patients and medical practitioners. This paper examines the roles and responsibilities of physicians in patients' home countries with respect to patients' decisions to try unproven stem cell therapies abroad. Specifically, it examines professional guidance from two organizations - the American Medical Association and the International Society for Stem Cell Research - and assesses physicians' professional and legal obligations to patients considering unproven stem cell therapies. Then, drawing on qualitative interviews conducted with patients who traveled abroad for unproven stem cell treatments, it explores the roles that physicians actually play in patients' decisions and compares these actual roles with their professional and legal responsibilities. The paper concludes with a discussion of strategies to help improve the guidance physicians provide to patients considering unproven treatments. © 2012 American Society of Law, Medicine & Ethics, Inc.. - Access to human embryonic stem cell lines
In: Nature Biotechnology [Peer Reviewed]
Date: December 2011
View All Details about Access to human embryonic stem cell lines
- The oversight and practice of oocyte donation in the United States, United Kingdom and Canada
In: HEC Forum [Peer Reviewed]
Date: March 2011
In vitro fertilization using donated oocytes is an important medical technique that provides the only option for some infertile patients to have children. The technique remains ethically contentious, however, and, as a result of this controversy, different oversight approaches have been developed in countries around the world. This paper examines the oversight and practice of oocyte donation in Canada, the United Kingdom and the United States to examine how policy choices have influenced the development and use of this medical technology. Examining per capita utilization of oocyte donation in these three countries provides evidence that supply-side policies-specifically policies affecting the compensation of potential oocyte donors-have substantially influenced the use of this technology. These results should provide useful insight for policymakers developing or revising oocyte donation policies. © 2010 Springer Science+Business Media B.V. - Policy uncertainty and the conduct of stem cell research
In: Cell Stem Cell [Peer Reviewed]
Date: February 2011
A survey of U.S. stem cell scientists shows that uncertainty following the legal challenge to the Obama Administrations hESC research policy has negative scientific and economic impacts and affects a range of stem cell scientists, not just those working with hESCs. The international implications of these results are also discussed. © 2011 Elsevier Inc.View All Details about Policy uncertainty and the conduct of stem cell research
- Tracking and assessing the rise of state-funded stem cell research
In: Nature Biotechnology [Peer Reviewed]
Date: December 2010
View All Details about Tracking and assessing the rise of state-funded stem cell research
- Science policy and the geographic preferences of stem cell scientists: Understanding the appeal of China and Singapore
In: New Genetics and Society [Peer Reviewed]
Date: June 2010
As scientific advances increasingly pose ethical questions, policymakers must decide how, if at all, to integrate controversial lines of inquiry into existing national innovation systems. This study examines human embryonic stem cell science, a controversial but promising field characterized by an unusually heterogeneous policy environment. This study first assesses this policy environment's impact on stem cell scientists' geographic preferences and finds that permissive policies are a statistically significant predictor of stem cell scientists' preferred countries. Next, China and Singapore, two emerging leaders in the field, are examined in greater detail. China appeals to US scientists across biomedical research fields, but this appeal is largely limited to members of the Chinese disapora. In contrast, Singapore's appeal is more specific to stem cell scientists. © 2010 Taylor & Franci. - Insights from patients' blogs and the need for systematic data on stem cell tourism.
In: The American journal of bioethics : AJOB
Date: May 2010
Open Peer Commentary - The Troubling History of Regulating Reproduction
In: Public Administration Review
Date: March 2010
View All Details about The Troubling History of Regulating Reproduction
- Self-regulation, compensation, and the ethical recruitment of oocyte donors.
In: Hastings Center Report [Peer Reviewed]
Date: February 2010
Over the last couple of decades, oocyte donation has become common, important, and sometimes lucrative. Women who donate eggs are often offered fees, though ostensibly only to offset their expenses and limited to no more than $10,000, following recommendations adopted by the fertility industry. Is the industry adhering to its recommendations? A study of advertisements published in college newspapers raises questions.
View All Details about Self-regulation, compensation, and the ethical recruitment of oocyte donors.
- Stem cell Tourism: Assessing the State of Knowledge
In: SCRIPTed: A Journal of Law, Science and Technology [Peer Reviewed]
Date: 2010
Policy concern about patients traveling in search of unproven stem cell based interventions (SCBIs) – a practice known as “stem c ell tourism” – has grown in recent years. These concerns are driven by the lack of convincing evidence of the safety or efficacy of these interventions and the resulting worry that individuals pursuing these unproven treatments may be putting themselves unnecessarily at risk and, perhaps, hindering legitimate translational stem cell research. This article reviews existing literature on stem cell tourism, focusing in particular on what is known about the providers of unproven SCBIs, the patients who pursue these interventions, and the outcomes of such interventions. The article concludes by highlighting gaps in the existing literature base and suggesting questions f or future investigation.View All Details about Stem cell Tourism: Assessing the State of Knowledge
- Tracking the rise of stem cell tourism
In: Regenerative Medicine [Peer Reviewed]
Date: 2010
Aims: Driven by hype surrounding stem cell research, a number of clinics around the world currently offer 'stem cell therapies to patients. These unproven interventions have attracted policy interest owing to the risks they may pose to patients and to the progress of legitimate translational stem cell research, yet remarkably little data exists about the patients who undergo these unproven therapies or their experiences. We sought to characterize this patient population. Materials & methods: We developed a comprehensive data set of blogs written by patients (or their caretakers) about their experiences with unproven stem cell therapies. Results & conclusions: Analyzing these data suggests that unproven stem cell therapies are increasing rapidly in popularity and are attracting a wide range of patients - both young and old and with a diverse collection of medical conditions. These results should help clinicians advise individual patients and help policymakers devise strategies to mitigate the risks these treatments pose. © 2010 Future Medicine Ltd.View All Details about Tracking the rise of stem cell tourism
- Response to Letter from Löser et al.
In: Cell Stem Cell [Peer Reviewed]
Date: August 2008
- Policy considerations for states supporting stem cell research: Evidence from a survey of stem cell scientists
In: Public Administration Review [Peer Reviewed]
Date: July 2008
Five states now provide funding for stem cell research, and many states are developing or debating stem cell research policies. Despite this interest, little data exist to help policy makers design policies or forecast the impact of new legislation. This article reports novel data from two surveys: one directed at those most affected by these policies - stem cell scientists - and one at a group of biomedical researchers working in less contentious fields. These data identified relatively high mobility among stem cell scientists, particularly in states with restrictive policies, and a strong preference for states with permissive policies. These findings suggest that state-specific policies may prove to be effective recruiting tools. They also suggest specific recruitment strategies and highlight the importance of first-mover advantage as states compete for the same limited pool of mobile scientists. This research aims to provide a factual basis to support ongoing policy formulation in the area. © 2008 The American Society for Public Administration. - Identifying Under- and Overperforming Countries in Research Related to Human Embryonic Stem Cells
In: Cell Stem Cell [Peer Reviewed]
Date: June 2008
Human embryonic stem cell (hESC) science is governed by a patchwork of policies that vary both between and within countries. To assess how this atypical environment may have influenced this field's development, publication data were analyzed to evaluate the relative performance of countries in the cumulative production of hESC-related research articles versus other areas of biomedical research. Overperforming countries generally offered permissive policy environments for hESC research, while underperforming countries were characterized by protracted policy debates and ongoing uncertainty, regardless of their current policy environment. © 2008 Elsevier Inc. All rights reserved. - Research policy and the mobility of US stem cell scientists
In: Nature Biotechnology [Peer Reviewed]
Date: July 2006
View All Details about Research policy and the mobility of US stem cell scientists
- A case for government-sponsored monitoring of preimplantation genetic diagnosis in the United States
In: Journal of Public and International Affairs
Date: March 2005
Preimplantation genetic diagnosis (PGD), a modified version of in vitro fertilization in which individual embryos are screened for specific genetic characteristics prior to implantation, provides a powerful way for parents suffering from infertility to increase their chances of having healthy children. In its various forms, PGD allows parents to screen for gender, providing a means for avoiding X-linked diseases, chromosomal abnormalities, such as translocations and aneuploidies, and single-gene disorders. Beyond these standard uses, PGD could potentially be used to select for any genetic trait, and this aspect of the technology has raised concerns that it may be used either intentionally or unintentionally for eugenic purposes. At present, reproductive medicine is only loosely regulated in the United States and new technologies, such as PGD, are almost entirely unregulated. This paper argues that given the lack of consensus regarding the ethical acceptability of PGD and embryo selection techniques, the government has an interest in gathering and reporting data on the use of PGD in the United States. Taking a proactive role now, rather than allowing the use of PGD to continue growing unscrutinized, will give society the chance to make thoughtful and deliberate decisions about its use. - Trends in the geographic distribution of human embryonic stem-cell research
In: Politics and the Life Sciences [Peer Reviewed]
Date: September 2004
View All Details about Trends in the geographic distribution of human embryonic stem-cell research
- A computational scan for U12-dependent introns in the human genome sequence
In: Nucleic acids research [Peer Reviewed]
Date: 2001
U12-dependent introns are found in small numbers in most eukaryotic genomes, but their scarcity makes accurate characterisation of their properties challenging. A computational search for U12-dependent introns was performed using the draft version of the human genome sequence. Human expressed sequences confirmed 404 U12-dependent introns within the human genome, a 6-fold increase over the total number of non-redundant U12-dependent introns previously identified in all genomes. Although most of these introns had AT-AC or GT-AG terminal dinucleotides, small numbers of introns with a surprising diversity of termini were found, suggesting that many of the non-canonical introns found in the human genome may be variants of U12-dependent introns and, thus, spliced by the minor spliceosome. Comparisons with U2-dependent introns revealed that the U12-dependent intron set lacks the 'short intron' peak characteristic of U2-dependent introns. Analysis of this U12-dependent intron set confirmed reports of a biased distribution of U12-dependent introns in the genome and allowed the identification of several alternative splicing events as well as a surprising number of apparent splicing errors. This new larger reference set of U12-dependent introns will serve as a resource for future studies of both the properties and evolution of the U12 spliceosome.View All Details about A computational scan for U12-dependent introns in the human genome sequence
- The transcriptome of Arabidopsis thaliana during systemic acquired resistance
In: Nature genetics [Peer Reviewed]
Date: 2000
Infected plants undergo transcriptional reprogramming during initiation of both local defence and systemic acquired resistance (SAR). We monitored gene-expression changes in Arabidopsis thaliana under 14 different SAR-inducing or SAR-repressing conditions using a DNA microarray representing approximately 25-30% of all A. thaliana genes. We derived groups of genes with common regulation patterns, or regulons. The regulon containing PR-1, a reliable marker gene for SAR in A. thaliana, contains known PR genes and novel genes likely to function during SAR and disease resistance. We identified a common promoter element in genes of this regulon that binds members of a plant-specific transcription factor family. Our results extend expression profiling to definition of regulatory networks and gene discovery in plants.View All Details about The transcriptome of Arabidopsis thaliana during systemic acquired resistance
- Medical societies, patient education initiatives, public debate and marketing of unproven stem cell interventions
Chapters
- Gamete donation
Date: 2014
- The roles and responsibilities of physicians in patients’ decisions about unproven stem cell therapies
- Research governance
Date: 2012
- Stem cell research and human cloning
- The rise of state-sponsored stem cell research in the United States
Conferences
- Challenges in the translation and commercialization of cell therapies
Date: 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.View All Details about Challenges in the translation and commercialization of cell therapies
- Policy uncertainty, ethical considerations and the funding of stem cell science
- Policy uncertainty, ethical controversy and emerging technologies: Lessons from the funding of stem cell science
- Policy uncertainty, ethical controversy and emerging technologies: Lessons from the funding of stem cell science
- Public policy and the future of somatic cell nuclear transfer research
- Public policy, ethical controversy and the oversight of emerging technologies
- Regenerative medicine and the challenge of unproven stem cell ‘therapies’
- Assessing patients’ experiences with unproven stem cell based interventions
- Understanding the origins and impact of the heterogeneous policy environment for egg donation
- Academic entrepreneurship and state stem cell policy
- Academic entrepreneurship and state stem cell policy
- Challenges in the translation and commercialization of cell therapies
- Gamete donation, conflicts of interest and the ethical shortcomings of self-regulation in the U.S. fertility industry
- International policy heterogeneity and variability in the use of assisted reproduction with donated oocytes
- The roles and responsibilities of physicians in patients’ decisions about unproven stem cell therapies
- Patients’ experiences with unproven stem cell therapies – a preliminary assessment
- The origins of state human embryonic stem cell research policies
- Assessing the influence of state stem cell policies on scientists’ careers
- Collaboration amid controversy: Assessing the impact of the human embryonic stem cell policy patchwork on scientific collaboration
- Identifying under- and over-performing countries in research related to human embryonic stem cells
- Identifying under- and over-performing countries in research related to human embryonic stem cells
- Identifying under- and over-performing countries in research related to human embryonic stem cells
- Developing scientific strength amid ethical controversy: Human embryonic stem cell science in China and Singapore
- State stem cell policies and the geographic preferences of U.S. stem cell scientists
- Trends in the movement of scientists between China and the United States and implications for future collaborations
- Geographic trends in research related to human embryonic stem cells
- Collaboration amid controversy: Assessing the impact of the human embryonic stem cell policy patchwork on scientific collaboration
- Self-regulation, compensation and the ethical recruitment of oocyte donors
- Self-regulation, compensation and the ethical recruitment of oocyte donors
- The origins of state human embryonic stem cell research policies
Working Papers
- Embryonic stem cell research in China
- Policy Considerations for States Supporting Stem Cell Research: Evidence from a Survey of Stem Cell Scientists
Date: 2006
Five states now provide funding for stem cell research and numerous states are developing or debating stem cell research policies. Yet despite this interest, few data exist to help policymakers design policies or forecast their impact. This article reports novel data from two surveys: one directed at those most affected by these policies - stem cell scientists themselves - and one at a group of biomedical researchers from less contentious fields. These data identified relatively high mobility among stem cell scientists, particularly those in states with restrictive policies, and a strong preference for states with permissive policies. These findings suggest state-specific policies may prove to be effective recruiting tools. They also suggest specific recruitment strategies and highlight the importance of first-mover advantage as several states compete to recruit from the same limited pool of mobile scientists. This research aims to provide a factual basis to support ongoing policy formulation in the area.
Posters
- Access to and use of human embryonic stem cell lines by stem cell scientists
- Assessing patient experiences with unproven stem cell therapies – a preliminary report
- Assessing the emergence of China and Singapore in human embryonic stem cell science
- Assessing the emergence of China, India and Singapore inhuman embryonic stem cell science
- Challenges in the translation and commercialization of cell therapies
- Collaboration amid controversy: Assessing the impact of the human embryonic stem cell policy patchwork on scientific collaboration
- Ethical contention and the development of careers in stem cell science
- Ethical controversy, graduate education and the development of scientific careers
- Ethical controversy, graduate education and the development of scientific careers
- Ethical debates, human embryonic stem cellresearch policy and the mobility of stemcell scientists
- Improved splice site prediction by considering local GC content
- Mapping the rise of experimental stem cell therapies: patient demographics
- Policy uncertainty, research funding and the conduct of stem cell science
- Policy uncertainty, research funding and the conduct of stem cell science
- The rise and future of the stem cell states
- Tracking the rise of stem cell tourism
Thesis / Dissertations
- Bioinformatics Approaches to RNA Splicing
- Gene Expression during Arabidopsis Disease Resistance: The Transcriptional Program of Systemic Acquired Resistance
- Human Embryonic Stem Cell Research amid Regulatory Uncertainty