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1.
Cytotherapy ; 25(7): 712-717, 2023 07.
Artigo em Inglês | MEDLINE | ID: mdl-37097267

RESUMO

Patient interest in non-trial access pathways to investigational cell-and gene-based interventions, such as expanded access in the USA, is increasing, while the regulatory and business environments for non-trial access in the cell and gene therapy field are shifting. Against this background, in 2022 the International Society for Cell & Gene Therapy (ISCT) established a Working Group on Expanded Access to identify practical, ethical, and regulatory issues emerging from the use (and possible misuse) of the expanded access pathway in the cell and gene therapy field. In this Short Report, the Working Group sets the stage for its future activities by analyzing the history of expanded access and identifying three examples of questions that we anticipate arising as uses of expanded access for investigational cell and gene-based interventions increase and evolve.


Assuntos
Ensaios de Uso Compassivo , Drogas em Investigação , Humanos , Terapia Genética , Engenharia Genética
2.
Cytotherapy ; 25(9): 920-929, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37517865

RESUMO

The field of regenerative medicine, including cellular immunotherapies, is on a remarkable growth trajectory. Dozens of cell-, tissue- and gene-based products have received marketing authorization worldwide while hundreds-to-thousands are either in preclinical development or under clinical investigation in phased clinical trials. However, the promise of regenerative therapies has also given rise to a global industry of direct-to-consumer offerings of prematurely commercialized cell and cell-based products with unknown safety and efficacy profiles. Since its inception, the International Society for Cell & Gene Therapy Committee on the Ethics of Cell and Gene Therapy has opposed the premature commercialization of unproven cell- and gene-based interventions and supported the development of evidence-based advanced therapy products. In the present Guide, targeted at International Society for Cell & Gene Therapy members, we analyze this industry, focusing in particular on distinctive features of unproven cell and cell-based products and the use of tokens of scientific legitimacy as persuasive marketing devices. We also provide an overview of reporting mechanisms for patients who believe they have been harmed by administration of unapproved and unproven products and suggest practical strategies to address the direct-to-consumer marketing of such products. Development of this Guide epitomizes our continued support for the ethical and rigorous development of cell and cell-based products with patient safety and therapeutic benefit as guiding principles.


Assuntos
Terapia Baseada em Transplante de Células e Tecidos , Marketing , Humanos , Medicina Regenerativa , Terapia Genética
3.
Cytotherapy ; 21(10): 1081-1093, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31445816

RESUMO

BACKGROUND AIMS: Autologous cell therapy (AuCT) is an emerging therapeutic treatment that is undergoing transformation from laboratory- to industry-scale manufacturing with recent regulatory approvals. Various challenges facing the complex AuCT manufacturing and supply chain process hinder the scale out and broader application of this highly potent treatment. METHODS: We present a multiscale logistics simulation framework, AuCT-Sim, that integrates novel supply chain system modeling algorithms, methods, and tools. AuCT-Sim includes a single facility model and a system-wide network model. Unique challenges of the AuCT industry are analyzed and addressed in AuCT-Sim. Decision-supporting tools can be developed based on this framework to explore "what-if" manufacturing and supply chain scenarios of importance to various cell therapy stakeholder groups. RESULTS: Two case studies demonstrate the decision-supporting capability of AuCT-Sim where one investigates the optimal reagent base stocking level, and the other one simulates a reagent supply disruption event. These case studies serve as guidelines for designing computational experiments with AuCT-Sim to solve specific problems in AuCT manufacturing and supply chain. DISCUSSION: This simulation framework will be useful in understanding the impact of possible manufacturing and supply chain strategies, policies, regulations, and standards informing strategies to increase patient access to AuCT.


Assuntos
Algoritmos , Terapia Baseada em Transplante de Células e Tecidos , Simulação por Computador , Indústria Farmacêutica , Manufaturas/provisão & distribuição , Instalações Industriais e de Manufatura , Terapia Baseada em Transplante de Células e Tecidos/economia , Terapia Baseada em Transplante de Células e Tecidos/métodos , Terapia Baseada em Transplante de Células e Tecidos/normas , Terapia Baseada em Transplante de Células e Tecidos/estatística & dados numéricos , Comércio , Indústria Farmacêutica/economia , Indústria Farmacêutica/organização & administração , Indústria Farmacêutica/normas , Indústria Farmacêutica/estatística & dados numéricos , Utilização de Equipamentos e Suprimentos/estatística & dados numéricos , Humanos , Manufaturas/economia , Manufaturas/estatística & dados numéricos , Instalações Industriais e de Manufatura/economia , Instalações Industriais e de Manufatura/normas , Instalações Industriais e de Manufatura/estatística & dados numéricos , Instalações Industriais e de Manufatura/provisão & distribuição , Controle de Qualidade , Indicadores de Qualidade em Assistência à Saúde , Transplante Autólogo , Estados Unidos/epidemiologia
4.
Cytotherapy ; 20(2): 165-168, 2018 02.
Artigo em Inglês | MEDLINE | ID: mdl-29239793

RESUMO

Businesses marketing unproven stem cell interventions proliferate within the U.S. and in the larger global marketplace. There have been global efforts by scientists, patient advocacy groups, bioethicists, and public policy experts to counteract the uncontrolled and premature commercialization of stem cell interventions. In this commentary, we posit that medical societies and associations of health care professionals have a particular responsibility to be an active partner in such efforts. We review the role medical societies can and should play in this area through patient advocacy and awareness initiatives.


Assuntos
Marketing , Defesa do Paciente , Sociedades Médicas , Transplante de Células-Tronco , Comportamento Cooperativo , Humanos , Medicina Regenerativa , Estados Unidos
6.
Sci Eng Ethics ; 22(6): 1649-1667, 2016 12.
Artigo em Inglês | MEDLINE | ID: mdl-26563215

RESUMO

We 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.


Assuntos
Biotecnologia/educação , Biotecnologia/ética , Ética Profissional/educação , Ciência/educação , Ciência/ética , Engenharia/educação , Engenharia/ética , Humanos , Projetos Piloto , Aprendizagem Baseada em Problemas , Responsabilidade Social
7.
BMC Biotechnol ; 15: 70, 2015 Aug 07.
Artigo em Inglês | MEDLINE | ID: mdl-26250902

RESUMO

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.


Assuntos
Terapia Baseada em Transplante de Células e Tecidos/tendências , Humanos
9.
Artigo em Inglês | MEDLINE | ID: mdl-39045646

RESUMO

Unproven cell-based interventions (CBIs) emerged early in the 2000s as a particularly problematic form of unproven therapy and remain a vexing policy problem to this day. These unproven interventions can harm patients both physically and financially and can complicate the process of developing a rigorous evidence base to support the translation of novel stem cell or other cell therapies. In this concise review, we examine the emergence of unproven CBIs and the various policy approaches that have been pursued or proposed to address this problem. We review the evolution of this field over the last 2 decades and explore why these policy efforts have proven challenging. We conclude by highlighting potential directions that the field could evolve and urging continued attention to both current and future forms of unproven CBIs to minimize future risks to patients and the field and to promote the development of evidence-based cell therapies.

10.
Reprod Biomed Online ; 26(4): 400-5, 2013 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-23337419

RESUMO

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.


Assuntos
Fidelidade a Diretrizes , Doação de Oócitos/ética , Adolescente , Adulto , Publicidade , Fatores Etários , Feminino , Humanos , Internet , Controle Social Formal , Estados Unidos
12.
Front Bioeng Biotechnol ; 10: 949280, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36204464

RESUMO

Biomaterials--from implanted iron teeth in the second century to intraocular lenses, artificial joints, and stents today--have long been used clinically. Today, biomaterials researchers and biomedical engineers are pushing beyond these inert synthetic alternatives and incorporating complex multifunctional materials to control biological interactions and direct physiological processes. These advances are leading to novel strategies for targeted drug delivery, drug screening, diagnostics and imaging, gene therapy, tissue regeneration, and cell transplantation. While the field has survived ethical transgressions in the past, the rapidly expanding scope of biomaterials science, combined with the accelerating clinical translation of this diverse field calls for urgent attention to the complex and challenging ethical dilemmas these advances pose. This perspective responds to this call, examining the intersection of research ethics -- the sets of rules, principles and norms guiding responsible scientific inquiry -- and ongoing advances in biomaterials. While acknowledging the inherent tensions between certain ethical norms and the pressures of the modern scientific and engineering enterprise, we argue that the biomaterials community needs to proactively address ethical issues in the field by, for example, updating or adding specificity to codes of ethics, modifying training programs to highlight the importance of ethical research practices, and partnering with funding agencies and journals to adopt policies prioritizing the ethical conduct of biomaterials research. Together these actions can strengthen and support biomaterials as its advances are increasingly commercialized and impacting the health care system.

14.
HEC Forum ; 23(1): 15-30, 2011 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-21170752

RESUMO

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.


Assuntos
Regulamentação Governamental , Doação de Oócitos/ética , Canadá , Política de Saúde , Humanos , Doação de Oócitos/legislação & jurisprudência , Técnicas de Reprodução Assistida/ética , Reino Unido , Estados Unidos
15.
Stem Cell Reports ; 16(11): 2567-2576, 2021 11 09.
Artigo em Inglês | MEDLINE | ID: mdl-34653406

RESUMO

The significant morbidity and mortality of coronavirus disease 19 (COVID-19) prompted a global race to develop new therapies. These include interventions using cell- or cell-derived products, several of which are being tested in well-designed, properly controlled clinical trials. Yet, the search for cell-based COVID-19 treatments has also been fraught with hyperbolic claims; flouting of crucial regulatory, scientific, and ethical norms; and distorted communication of research findings. In this paper, we critically examine ethical issues and public communication challenges related to the development of cell-based therapeutics for COVID-19. Drawing on the lessons learned from this ongoing process, we argue against the rushed development of cell-based interventions. We conclude by outlining ways to improve the ethical conduct of cell-based clinical investigations and public communication of therapeutic claims.


Assuntos
COVID-19/terapia , Comunicação , Pandemias/ética , SARS-CoV-2 , Transplante de Células-Tronco/ética , Terapêutica/ética , Humanos
17.
Hastings Cent Rep ; 40(2): 25-36, 2010.
Artigo em Inglês | MEDLINE | ID: mdl-20391847

RESUMO

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.


Assuntos
Fertilização in vitro/economia , Fertilização in vitro/ética , Doadores Vivos , Doação de Oócitos/economia , Doação de Oócitos/ética , Adulto , Mercantilização , Feminino , Humanos , Doadores Vivos/ética , Doadores Vivos/legislação & jurisprudência , Marketing , Adulto Jovem
18.
Scientometrics ; 125(3): 2349-2382, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33746311

RESUMO

Science funders are increasingly requiring evidence of the broader impacts of even basic research. Initiatives such as NIH's CTSA program are designed to shift the research focus toward more translational research. However, tracking the effectiveness of such programs depends on developing indicators that can track the degree to which basic research is influencing clinical research. We propose a new bibliometric indicator, the TS score, that is relatively simple to calculate, can be implemented at scale, is easy to replicate, and has good reliability and validity properties. This indicator is broadly applicable in settings where the goal is to estimate the degree to which basic research is used in more applied downstream research, relative to use in basic research. The TS score should be of use for a variety of policy analysis and research evaluation purposes.

19.
Nat Biotechnol ; 24(7): 865-6, 2006 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-16841069

RESUMO

State and national research policies governing human embryonic stem cell science are affecting the career plans of scientists in this exciting but controversial field.


Assuntos
Pesquisa Biomédica/legislação & jurisprudência , Mobilidade Ocupacional , Pesquisadores/estatística & dados numéricos , Apoio à Pesquisa como Assunto/legislação & jurisprudência , Células-Tronco/citologia , Pesquisadores/tendências , Apoio à Pesquisa como Assunto/normas , Estados Unidos
20.
Regen Med ; 13(3): 309-320, 2018 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-29715066

RESUMO

AIM: To examine how the geographic distribution of pluripotent and adult stem cell research publications within the USA differs from other areas of biomedical research. MATERIALS & METHODS: Publication count data for pluripotent stem cell research, adult stem cell research and a comparison group representative of biomedical research more broadly were collected and analyzed for each US state from 2009 to 2016. RESULTS: The distribution of pluripotent stem cell research differed from the other fields with overperformance in pluripotent stem cell research observed in California, as well as Wisconsin, Massachusetts, Maryland and Connecticut. CONCLUSION: Our analysis suggests that permissive state stem cell policy may be one of the several factors contributing to strong state performance in pluripotent stem cell research.


Assuntos
Células-Tronco Adultas , Células-Tronco Pluripotentes , Pesquisa com Células-Tronco/legislação & jurisprudência , Animais , Humanos , Estados Unidos
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