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Articles 1 - 28 of 28
Full-Text Articles in Medicine and Health Sciences
Introducing Biosimilar Competition For Cell And Gene Therapy Products, Brian Canter, Sabine Sussman, Stephen Colvill, Nitzan Arad, Elizabeth Staton, Arti Rai
Introducing Biosimilar Competition For Cell And Gene Therapy Products, Brian Canter, Sabine Sussman, Stephen Colvill, Nitzan Arad, Elizabeth Staton, Arti Rai
Faculty Scholarship
This article provides an early analysis of the potential for creating future biosimilar competition for cell and gene therapies (CGTs) to lower prices and improve patient access, building on a unique set of interviews with relevant experts. Our discussion addressed regulatory, manufacturing, intellectual property, and market size challenges. Due to CGTs’ complexity, meeting the regulatory requirement of ‘high similarity with no clinically meaningful differences’ will be difficult. Gene therapies are likely better candidates for biosimilar development than cell therapies. Biosimilarity should be met when gene therapy biosimilars contain the same genetic sequence as a reference product, and the variability in …
Virtual Annual Meetings: A Path Toward Shareholder Democracy And Stakeholder Engagement, Yaron Nili, Megan Wischmeier Shaner
Virtual Annual Meetings: A Path Toward Shareholder Democracy And Stakeholder Engagement, Yaron Nili, Megan Wischmeier Shaner
Faculty Scholarship
From demanding greater executive accountability to lobbying for social and environmental policies, shareholders influence how managers run modern companies. In corporate doctrine, the principal venue reserved for shareholders to influence and engage with management and each other is the annual share-holders meeting. Historically, the annual meeting was a vibrant forum for share-holder democracy and occasionally even a platform for debating pressing social issues. For decades, however, the role of the annual meeting in corporate governance has been in decline, resulting in today’s largely pro forma annual meetings. This Article explores how technological integration can resurrect the annual meeting as the …
Adolescent Medical Decisionmaking Rights: Reconciling Medicine And Law, Doriane Lambelet Coleman, Philip M. Rosoff
Adolescent Medical Decisionmaking Rights: Reconciling Medicine And Law, Doriane Lambelet Coleman, Philip M. Rosoff
Faculty Scholarship
Dennis Lindberg came into his aunt’s care when he was in the 4th grade because his parents struggled with drug addiction and could not provide for him. At thirteen, he was baptized in his aunt’s faith as a Jehovah’s Witness. Just days after he turned fourteen, on November 6, he was diagnosed with acute lymphoblastic leukemia.
The prognosis was that Dennis had a 75% chance of cure with standard oncology treatment. Consistent with the requirements of his new faith, however, Dennis told his doctors, “I do not want to be treated if the requirement is that I would have to …
Reconciling Environmental Justice With Climate Change Mitigation: A Case Study Of Nc Swine Cafos, D. Lee Miller, Ryke Longest
Reconciling Environmental Justice With Climate Change Mitigation: A Case Study Of Nc Swine Cafos, D. Lee Miller, Ryke Longest
Faculty Scholarship
For thirty years, the swine industry has externalized severe environmental and health harms onto poor communities of color in Eastern North Carolina. This “Big Pig” problem is caused by the confinement, consolidation, and concentration of industrial hog operations within the low, flat, and economically marginalized Coastal Plain. Big Pig’s rise was not inevitable. As recently as 1982, more than 11,000 small swine farms freckled nearly all of North Carolina’s 100 counties. Then came the “boom” of consolidation and industrialization that transformed hog production into a highly consolidated and vertically integrated industry.
Kidney Donation And The Consent Of The Poor, Philip J. Cook, Kimberly D. Krawiec
Kidney Donation And The Consent Of The Poor, Philip J. Cook, Kimberly D. Krawiec
Faculty Scholarship
In "Consentability," Nancy Kim tackles an important and current topic—in an age of increasing options about how to live, die, and procreate, what limits, if any, should the law place on those choices? "Consentability" is a valuable resource for scholars and policymakers alike, summarizing the arguments for and against government intrusion on the choices of consenting adults with encyclopedic thoroughness. After weighing the arguments, Kim proposes that “bodily integrity exchanges” be permitted, subject to limitations. Although we agree with the general conclusion that bodily integrity exchanges should be permitted, we disagree with the specific limitations that treat the decisions of …
The Enhanced Danger Of Physicians’ Off-Label Prescribing, Doriane Lambelet Coleman, Philip M. Rosoff
The Enhanced Danger Of Physicians’ Off-Label Prescribing, Doriane Lambelet Coleman, Philip M. Rosoff
Faculty Scholarship
The COVID-19 pandemic represents a major challenge to both technologically advanced and resource-poor countries. There are currently no effective treatments for severe disease other than supportive care and advanced life support measures, including the use of mechanical ventilators. With the urgency and necessity bred from desperation, there have been many calls to utilize unproven therapies, such as hydroxychloroquine, for which little evidence of efficacy exists. We have previously argued that such off-label use, while legal, is problematic (and even dangerous) and have suggested several regulatory remedies that could protect patients and advance their interests while preserving the reasonable authority of …
If We Pay Football Players, Why Not Kidney Donors, Philip J. Cook, Kimberly D. Krawiec
If We Pay Football Players, Why Not Kidney Donors, Philip J. Cook, Kimberly D. Krawiec
Faculty Scholarship
Ethicists who oppose compensating kidney donors claim they do so because kidney donation is risky for the donor’s health, donors may not appreciate the risks and may be cognitively biased in other ways, and donors may come from disadvantaged groups and thus could be exploited. However, few ethical qualms are raised about professional football players, who face much greater health risks than kidney donors, have much less counseling and screening concerning that risk, and who often come from racial and economic groups deemed disadvantaged. It thus seems that either ethicists—and the law—should ban both professional football and compensated organ donation, …
Organ Entrepreneurs, Kieran Healy, Kimberly D. Krawiec
Organ Entrepreneurs, Kieran Healy, Kimberly D. Krawiec
Faculty Scholarship
The supply of human organs for transplantation might seem an unlikely place to begin thinking about entrepreneurship. After all, there is no production market for human organs and, with the surprising exception of Iran, legal rules around the world make the sale of human organs for transplantation a criminal offense. Yet entrepreneurs have been present throughout the history of organ transplantation — a history of the active exploration, innovation, and management of a potentially very controversial exchange at the seemingly clear boundaries that separate giving from selling, life from death, and right from wrong.
This article explores the role of …
Repugnance Management And Transactions In The Body, Kieran Healy, Kimberly D. Krawiec
Repugnance Management And Transactions In The Body, Kieran Healy, Kimberly D. Krawiec
Faculty Scholarship
Researchers have made progress in understanding the role of repugnance in transactions involving the human body. Yet, often, the focus remains on exchange between individuals and how they mentally cope (or not) with repugnance. But these exchanges also entail a “vertical” dimension in which organizational and state actors both directly manage repugnance and also limit the repugnance management tools available to the marketplace. Analyzing repugnance and its management as an organizational and regulatory problem, in addition to an individual one, suggests that a single, harmonized system of exchange in bodily goods is unlikely to emerge with the passage of time.
Pharmaceutical M&A Activity: Effects On Prices, Innovation, And Competition, Barak D. Richman, Will Mitchell, Elena Vidal, Kevin Schulman
Pharmaceutical M&A Activity: Effects On Prices, Innovation, And Competition, Barak D. Richman, Will Mitchell, Elena Vidal, Kevin Schulman
Faculty Scholarship
The rise of blockbuster pharmaceutical acquisitions has prompted fears that unprecedented market concentration will weaken competition. Two of the most prominent concerns focus on the upstream and downstream ends of the pharmaceutical industry: (1) the concern that these mergers will concentrate the market for discovery and will therefore lead to fewer discoveries; and (2) the concern that merging large marketing, sales, and distribution forces will strengthen the hands of select pharmaceutical manufacturers and weaken downstream competition. Having considered potential dynamic effects in the industry and conducted a series of preliminary interviews with knowledgeable observers, though, this Article argues that neither …
We Have The Tools To End Hiv: Benefits, Barriers, And Solutions To Expanded Utilization Of Pre-Exposure Prophylaxis (Prep) In The Us Deep South, Jason Ervin, Allison Weller Tikare, Carolyn Mcallaster
We Have The Tools To End Hiv: Benefits, Barriers, And Solutions To Expanded Utilization Of Pre-Exposure Prophylaxis (Prep) In The Us Deep South, Jason Ervin, Allison Weller Tikare, Carolyn Mcallaster
Faculty Scholarship
No abstract provided.
Hiv/Aids Care And Prevention Infrastructure In The U.S. Deep South, Susan S. Reif, Kristen Sullivan, Elena Wilson, Miriam Berger, Carolyn Mcallaster
Hiv/Aids Care And Prevention Infrastructure In The U.S. Deep South, Susan S. Reif, Kristen Sullivan, Elena Wilson, Miriam Berger, Carolyn Mcallaster
Faculty Scholarship
No abstract provided.
Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii, Arti K. Rai
Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii, Arti K. Rai
Faculty Scholarship
As finding breakthrough small-molecule drugs gets harder, drug companies are increasingly turning to “large molecule” biologics. Although biologics represent many of the most promising new therapies for previously intractable diseases, they are extremely expensive. Moreover, the pathway for generic-type competition set up by Congress in 2010 is unlikely to yield significant cost savings.
In this Article, we provide a fresh diagnosis of, and prescription for, this major public policy problem. We argue that the key cause is pervasive trade secrecy in the complex area of biologics manufacturing. Under the current regime, this trade secrecy, combined with certain features of FDA …
Markets, Morals, And Limits In The Exchange Of Human Eggs, Kimberly D. Krawiec
Markets, Morals, And Limits In The Exchange Of Human Eggs, Kimberly D. Krawiec
Faculty Scholarship
No abstract provided.
Hiv Infrastructure Study Birmingham, Alabama, Susan S. Reif, Kristen Sullivan, Carolyn Mcallaster, Miriam Berger
Hiv Infrastructure Study Birmingham, Alabama, Susan S. Reif, Kristen Sullivan, Carolyn Mcallaster, Miriam Berger
Faculty Scholarship
No abstract provided.
A Closer Look: Deep South Has The Highest Hiv-Related Death Rates In The United States, Susan S. Reif, Donna Safley, Carolyn Mcallaster
A Closer Look: Deep South Has The Highest Hiv-Related Death Rates In The United States, Susan S. Reif, Donna Safley, Carolyn Mcallaster
Faculty Scholarship
No abstract provided.
One Size Does Not Fit All: What Does High Impact Prevention Funding Mean For Community-Based Organizations In The Deep South?, Carolyn Mcallaster, Jerry Fang
One Size Does Not Fit All: What Does High Impact Prevention Funding Mean For Community-Based Organizations In The Deep South?, Carolyn Mcallaster, Jerry Fang
Faculty Scholarship
No abstract provided.
Hiv Infrastructure Study Jackson, Mississippi, Susan S. Reif, Elena Wilson, Carolyn Mcallaster, Miriam Berger
Hiv Infrastructure Study Jackson, Mississippi, Susan S. Reif, Elena Wilson, Carolyn Mcallaster, Miriam Berger
Faculty Scholarship
No abstract provided.
Hiv Infrastructure Study Columbia, Sc, Susan S. Reif, Elena Wilson, Carolyn Mcallaster
Hiv Infrastructure Study Columbia, Sc, Susan S. Reif, Elena Wilson, Carolyn Mcallaster
Faculty Scholarship
No abstract provided.
Hiv Infrastructure Study Baton Rouge, Susan S. Reif, Elena Wilson, Carolyn Mcallaster, Casteel Scherger
Hiv Infrastructure Study Baton Rouge, Susan S. Reif, Elena Wilson, Carolyn Mcallaster, Casteel Scherger
Faculty Scholarship
No abstract provided.
Introduction: For Love Or Money? Defining Relationships In Law And Life, Kimberly D. Krawiec, Marion Crain
Introduction: For Love Or Money? Defining Relationships In Law And Life, Kimberly D. Krawiec, Marion Crain
Faculty Scholarship
No abstract provided.
Proposition 26: The Cost To All Women, Emma S. Ketteringham, Allison Korn, Lynn M. Paltrow
Proposition 26: The Cost To All Women, Emma S. Ketteringham, Allison Korn, Lynn M. Paltrow
Faculty Scholarship
No abstract provided.
Who Let The Dog Out? Implementing A Successful Therapy Dog Program In An Academic Law Library, Julian Aiken, Femi Cadmus
Who Let The Dog Out? Implementing A Successful Therapy Dog Program In An Academic Law Library, Julian Aiken, Femi Cadmus
Faculty Scholarship
No abstract provided.
Price And Pretense In The Baby Market, Kimberly D. Krawiec
Price And Pretense In The Baby Market, Kimberly D. Krawiec
Faculty Scholarship
Throughout the world, baby selling is formally prohibited. And throughout the world babies are bought and sold each day. As demonstrated in this Essay, the legal baby trade is a global market in which prospective parents pay, scores of intermediaries profit, and the demand for children is clearly differentiated by age, race, special needs, and other consumer preferences, with prices ranging from zero to over one hundred thousand dollars. Yet legal regimes and policymakers around the world pretend that the baby market does not exist, most notably through prohibitions against “baby selling” – typically defined as a prohibition against the …
Compulsory Licensing Of Patented Pharmaceutical Inventions: Evaluating The Options, Jerome H. Reichman
Compulsory Licensing Of Patented Pharmaceutical Inventions: Evaluating The Options, Jerome H. Reichman
Faculty Scholarship
In this Comment, the author traces the relevant legislative history pertaining to compulsory licensing of patented pharmaceuticals from the TRIPS Agreement of 1994 to the 2003 waiver to, and later proposed amendment of, article 31, which enables poor countries to obtain needed medicines from other countries that possess manufacturing capacity. The Comment then evaluates recent, controversial uses of the relevant legislative machinery as viewed from different critical perspectives. The Comment shows how developing countries seeking access to esential medicines can collaborate in ways that would avoid undermining incentives to innovation and other social costs attributed to compulsory licensing. It ends …
Rethinking The Role Of Clinical Trial Data In International Intellectual Property Law: The Case For A Public Goods Approach, Jerome H. Reichman
Rethinking The Role Of Clinical Trial Data In International Intellectual Property Law: The Case For A Public Goods Approach, Jerome H. Reichman
Faculty Scholarship
This article is a later version of the author's presentation at the Eleventh Annual Honorable Helen Wilson Nies Memorial Lecture March 26, 2008. Clinical trials are currently used to test drugs; however, the risk and cost of clinical trials are increasing so drastically that the clinical trials may become unsustainable. This article evaluates the legal and economic trends of intellectual property protection for pharmaceutical clinical trial data. The protection of clinical trials has become an alternative to patents as market exclusivity encourages the development and testing of unpatentable pharmaceuticals. This author argues that clinical trials should be treated as a …
Using Decision Analysis To Improve Malaria Control Policy Making, Jonathan B. Wiener, Randall A. Kramer, Katherine L. Dickinson, Richard M. Anderson, Vance G. Fowler, Marie Lynn Miranda, Clifford M. Mutero, Kathryn A. Saterson
Using Decision Analysis To Improve Malaria Control Policy Making, Jonathan B. Wiener, Randall A. Kramer, Katherine L. Dickinson, Richard M. Anderson, Vance G. Fowler, Marie Lynn Miranda, Clifford M. Mutero, Kathryn A. Saterson
Faculty Scholarship
Malaria and other vector-borne diseases represent a significant and growing burden in many tropical countries. Successfully addressing these threats will require policies that expand access to and use of existing control methods, such as insecticide-treated bed nets (ITNs) and artemesinin combination therapies (ACTs) for malaria, while weighing the costs and benefits of alternative approaches over time. This paper argues that decision analysis provides a valuable framework for formulating such policies and combating the emergence and re-emergence of malaria and other diseases. We outline five challenges that policy makers and practitioners face in the struggle against malaria, and demonstrate how decision …
Does Falling Smoking Lead To Rising Obesity?, Jonathan Gruber, Michael D. Frakes
Does Falling Smoking Lead To Rising Obesity?, Jonathan Gruber, Michael D. Frakes
Faculty Scholarship
The strong negative correlation over time between smoking rates and obesity have led some to suggest that reduced smoking is increasing weight gain in the U.S.. This conclusion is supported by the findings of Chou et al. (2004), who conclude that higher cigarette prices lead to increased body weight. We investigate this issue and find no evidence that reduced smoking leads to weight gain. Using the cigarette tax rather than the cigarette price and controlling for non-linear time effects, we find a negative effect of cigarette taxes on body weight, implying that reduced smoking leads to lower body weights. Yet …