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The involvement of academic research in drug discovery is consistently growing. However, academic projects seldom advance to clinical trials. Here, we assess the landscape of drug discovery within the National Centre of Competence in Research (NCCR) TransCure launched by the Swiss National Science Foundation to foster basic research and early-stage drug discovery on membrane transporters. This included transporters in central nervous system (CNS) disorders, which represent a huge unmet medical need. While idea championship, sustainable funding, collaborations between disciplines at the interface of academia and industry are important for translational research, Popperian falsifiability, strong intellectual property and a motivated startup team are key elements for innovation. This is exemplified by the NCCR TransCure spin-off company Synendos Therapeutics, a clinical stage biotech company developing the first selective endocannabinoid reuptake inhibitors (SERIs) as novel treatment for neuropsychiatric disorders. We provide a perspective on the challenges related to entering an uncharted druggable space and bridging the often mentioned "valley of death". The high attrition rate of drug discovery projects in the CNS field within academia is often due to the lack of meaningful animal models that can provide pharmacological proof-of-concept for potentially disruptive technologies at the earliest stages, and the absence of solid intellectual property.
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Descubrimiento de Drogas , Humanos , Fármacos del Sistema Nervioso Central/química , Fármacos del Sistema Nervioso Central/farmacología , Fármacos del Sistema Nervioso Central/uso terapéutico , Animales , Enfermedades del Sistema Nervioso Central/tratamiento farmacológico , AcademiaRESUMEN
BACKGROUND AIMS: With the increase in cell and gene therapy (CGT) clinical trials in recent years has come a subsequent increase in the number of contract development and manufacturing organizations (CDMOs). Successful transition from development and early-phase clinical trials to commercialization of a CGT product often depends on selecting the best-suited CDMO. However, many CGT companies are small biotech companies that lack expertise in the field or do not have experience selecting and transferring a process to a CDMO. METHODS: Given the interest in this topic, a roundtable with CGT developers and CDMO members at the 2023 annual meeting of the International Society of Cell and Gene Therapy Paris discussed these critical aspects of product development, including technical expertise, risk sharing and timing of partnerships. RESULTS AND CONCLUSIONS: Here, we'll analyze the considerations discussed by the panel and elaborate on other factors crucial for CGT development.
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Tratamiento Basado en Trasplante de Células y Tejidos , Terapia Genética , Humanos , Terapia Genética/métodos , Tratamiento Basado en Trasplante de Células y Tejidos/métodos , Contratos , Ensayos Clínicos como AsuntoRESUMEN
Green technology transfer can improve the economic benefits accrued by firms and promote regional green development. Patent value can comprehensively reflect the development prospects of green patents and is an important indicator for predicting green technology transfer. In order to explore the impact of patent value on green technology transfer, this study used a sample of 16,169 green technology patents from Chinese manufacturing industry, which were analyzed using the binary logistic regression model. The results suggest that the technical and economic value of green technology patent positively impact green technology transfer, while the effect of legal value is opposite. Industry competition strengthens the negative impact of the legal value of green technology patents on green technology transfer and weakens the positive impact of green technology patent's economic value. This study explores the factors impacting firms' green technology transfer from a value perspective and proposes suggestions for the transformation of green technology in firms.
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Industrias , Tecnología , ChinaRESUMEN
OBJECTIVE: The healthcare sector is a paramount and rapidly expanding industry in India. The pharmaceutical field in India has experienced substantial growth and transformation in recent times, making significant contributions to the global healthcare market. This comprehensive review delves into the most recent innovations in pharmaceutical technology transfer (TT), particularly in the context of tablet formulations from an Indian standpoint. SIGNIFICANCE: The pharmaceutical sector has grappled with various challenging issues, including the escalating costs of medications and the demand for patient-friendly products. METHODS: In this technological progress era, various cutting-edge pharmaceutical technologies, such as artificial intelligence (AI), and 3D and 4D printing, play pivotal roles in drug development. Tablets, the most promising and widely utilized dosage form worldwide, require a sophisticated approach to TT. Achieving a successful TT necessitates a dedicated team with well-defined objectives, improved documentation, and effective communication. RESULTS: The Indian Pharmaceutical Industry (IPI) possesses the potential to make significant contributions to the global healthcare sector. Moreover, we delve into the various phases of TT, highlighting the pivotal role of formulation development and process optimization in ensuring product quality, efficiency, and cost-effectiveness along with different models of TT. Additionally, we examine the challenges associated with TT and potential solutions, as well as the initiatives of the Indian government to bolster the Indian pharmaceutical sector's position as the "Pharmacy of the World". CONCLUSION: It is concluded that there is a need to contextualize and institutionalize the tech transfer policies for successful implementation for the benefit of the global population.
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Many of the fundamental inventions of genome editing, including meganucleases, zinc finger nucleases (ZFNs), transcription activator-like effector nucleases (TALENs), and CRISPR, were first made at universities and patented to encourage commercial development. This gave rise to a diversity of technology transfer models but also conflicts among them. Against a broader historical and policy backdrop of university patenting and special challenges concerning research tools, we review the patent estates of genome editing and the diversity of technology transfer models employed to commercialize them, including deposit in the public domain, open access contracts, material transfer agreements, nonexclusive and exclusive licenses, surrogate licenses, and aggregated licenses. Advantages are found in this diversity, allowing experimentation and competition that we characterize as a federalism model of technology transfer. A notable feature of genome editing has been the rise and success of third-party licensing intermediaries. At the same time, the rapid pace of development of genome-editing technology is likely to erode the importance of patent estates and licensing regimes and may mitigate the effect of overly broad patents, giving rise to new substitutes to effectuate commercialization.
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Sistemas CRISPR-Cas , Edición Génica/métodos , Terapia Genética/métodos , Transferencia de Tecnología , Humanos , Patentes como AsuntoRESUMEN
Despite being one of the most effective adjunctive behavioral interventions in combination with medication for opioid use disorder, contingency management (CM) is one of the least available interventions in opioid treatment programs. This paradoxical state of affairs is perhaps the greatest example of the research-to-practice gap in the behavioral health field. Implementation science, a discipline that aims to identify replicable methods that can be used across settings and populations to bridge the gap between research and practice, can potentially help. Based on our team's experience implementing CM in opioid treatment programs, we detail five key lessons for researchers, clinicians, policy makers, and others seeking to implement and sustain CM in real-world settings. First, multiple barriers to CM implementation exist at both the counselor- and organization-levels, requiring multi-level solutions. Second, one-shot CM training alone is not sufficient for successful implementation: ongoing support is essential to achieve levels of intervention fidelity that will benefit patients. Third, assessing an organization's capacity for implementation prior to support provision can prevent costly mistakes. Fourth, implementors should plan for high staff turnover rates and expect the unexpected by developing detailed contingency plans. Finally, implementors should remember that the goal is to implement evidence-based CM and not simply incentives. We encourage colleagues to consider these lessons to increase the likelihood that CM can be implemented and sustained in a manner that improves the quality of care in opioid treatment programs.
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Analgésicos Opioides , Trastornos Relacionados con Opioides , Humanos , Estados Unidos , Trastornos Relacionados con Opioides/tratamiento farmacológico , Trastornos Relacionados con Opioides/prevención & control , Terapia Conductista , MotivaciónRESUMEN
Multi-drug resistance (MDR) developed in response to chemotherapy is one of the prominent causes of therapeutic failure. The major underlying factors that contribute to such malignancies include tumor microenvironment, genetic alterations, changes at the cellular level and most of all the heterogeneity of tumors. Recent advances in the field of oncology have prompted a mechanistic understanding of the human genome which is responsible for such alterations, upon which the therapy would be designed. Such an approach that administers drugs by targeting the molecular changes is attributed to precision medicine. Precision medicine helps design therapy as per the requirement of patients based on the sharing of similar complex tumor environments. This revolutionized approach would help in early detection, better targeting, improved patient compliance and survival along with much reduced toxicity otherwise evidenced in conventional cancer therapy. This review discusses the cause of MDR, highlighting the role of precision medicine in overcoming such critical events. Major limitations and future prospects are also highlighted.
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Neoplasias , Medicina de Precisión , Humanos , Neoplasias/tratamiento farmacológico , Neoplasias/genética , Oncología Médica , Microambiente Tumoral/genética , Resistencia a Múltiples Medicamentos/genéticaRESUMEN
International deployment of remote monitoring and virtual care (RMVC) technologies would efficiently harness their positive impact on outcomes. Since Canada and the United Kingdom have similar populations, health care systems, and digital health landscapes, transferring digital health innovations between them should be relatively straightforward. Yet examples of successful attempts are scarce. In a workshop, we identified 6 differences that may complicate RMVC transfer between Canada and the United Kingdom and provided recommendations for addressing them. These key differences include (1) minority groups, (2) physical geography, (3) clinical pathways, (4) value propositions, (5) governmental priorities and support for digital innovation, and (6) regulatory pathways. We detail 4 broad recommendations to plan for sustainability, including the need to formally consider how highlighted country-specific recommendations may impact RMVC and contingency planning to overcome challenges; the need to map which pathways are available as an innovator to support cross-country transfer; the need to report on and apply learnings from regulatory barriers and facilitators so that everyone may benefit; and the need to explore existing guidance to successfully transfer digital health solutions while developing further guidance (eg, extending the nonadoption, abandonment, scale-up, spread, sustainability framework for cross-country transfer). Finally, we present an ecosystem readiness checklist. Considering these recommendations will contribute to successful international deployment and an increased positive impact of RMVC technologies. Future directions should consider characterizing additional complexities associated with global transfer.
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Atención a la Salud , Telemedicina , Humanos , Lista de Verificación , Tecnología , Reino UnidoRESUMEN
An implementation proposal that seeks to globalize the scope of the sustainable technologies developed in the University laboratories is presented. This approach uses the generation of triple-impact projects placing people at the center of technological development to bring technical and scientific knowledge into a service design oriented to global sustainable solutions. This research is an approach to what a hub for scientific research, technological implementation, and human needs would look like by designing common environments in which to interact and expand knowledge in an iterated way through the experience of all the actors involved in technological implementation. As a control case, a new technology developed at the Universidad de Buenos Aires, consisting of using sustainable materials as tubular reactor fillers for water treatment was chosen. Based on data obtained within the framework of a University extension project, in which the water quality diagnosis for human consumption was carried out and cross-examined with the mathematical analysis of sorption, design parameters of the reactor, participatory design, and open source concepts application, different virtual environments were generated with distinct objectives: i) open design environment: publishing and mapping of installed sorption reactors, reactor model plans, and useful information related to drinking water quality (aimed at contributors of the open source design environment); ii) platform for academic actors linking: connecting data between prototyping lab for participatory design of sorption reactors (aimed at university research users); iii) information disclosure page: space where the implemented technology impact is displayed and shows options to contact researchers and request a reactor design diagnosis for another community (aimed at beneficiary users). A technological service designed to link the University with the community was proposed, by resolving one of the main gaps related to the possibility for communities to access public financing for self-managed improvement projects, increasing the appropriation of the adopted technology and democratizing public investment, making it sustainable over time.
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Calidad del AguaRESUMEN
The COVID-19 pandemic, which featured international pharmaceutical firms seeking to build global manufacturing networks to scale-up the supply of vaccines, has generated heightened interest in understanding the role of firm-to-firm technology transfer. While considerable attention has been given to tracking the extent of international vaccine technology transfer, we know little about how partnerships were established and work in practice. Understanding the challenges that such projects face, and how such challenges may be overcome, is crucially important. This paper provides an account of the partnership between the British-Swedish multinational pharmaceutical company AstraZeneca, the vaccine developer that has engaged in the most technology transfer and built the widest global manufacturing network, and Bio-Manguinhos, a public laboratory linked to Brazil's Ministry of Health. The case study demonstrates the importance of capabilities and regulatory flexibility. Moreover, the analysis highlights the role of political factors that affect the process of technology transfer, and innovation more broadly. Because of the risks involved and the need to quickly mobilize existing capabilities and build new ones, as well as the imperatives of coordinating among manufacturing and regulatory processes and allocating resources to make such arrangements feasible, technology transfer projects need to be enabled politically. Looking forward, the case study has implications for initiatives to expand technology transfer for broadened production of vaccines in the Global South.
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The Paris Agreement has made combating climate change a priority and has incentivised innovationfor the greentech industry. Higher education institution[s] (HEI[s]) play an important role in fueling this innovation by developing disruptive technologies and support the creation of start-up companies that take the risk to bring these technologies to the market. The successful spinning out of such start-ups relies on the HEIs nurturing anecosystem with multiple actors as well as internal mechanisms to transfer such technologies to the start-up. HEIs have dedicated offices involved in technology transfer (TTO) that provide an interface between all the different actors (inventors, founders, start-up, investors, etc.). The TTO of an HEI also plays a central role in the technology transfer by providing the licence agreements granting start-ups the rights to use a technology developed by the HEI. This review summarises the role of a TTO and the practice of making the licensing process as transparent as possible for start-up founders and investors.
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Scale-up and transfer of lyophilization processes remain very challenging tasks considering the technical challenges and the high cost of the process itself. The challenges in scale-up and transfer were discussed in the first part of this paper and include vial breakage during freezing at commercial scale, cake resistance differences between scales, impact of differences in refrigeration capacities, and geometry on the performance of dryers. The second part of this work discusses successful and unsuccessful practices in scale-up and transfer based on the experience of the authors. Regulatory aspects of scale-up and transfer of lyophilization processes were also outlined including a topic on the equivalency of dryers. Based on an analysis of challenges and a summary of best practices, recommendations on scale-up and transfer of lyophilization processes are given including projections on future directions in this area of the freeze drying field. Recommendations on the choice of residual vacuum in the vials were also provided for a wide range of vial capacities.
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Liofilización , Transferencia de Tecnología , Tecnología Farmacéutica , Temperatura , Guías como AsuntoRESUMEN
This study aimed at assessing farmers' perceptions and acceptance of the proposed breeding strategy of Instituto Veterinario de Investigaciones Tropicales y de Altura (IVITA), located in the Central Andes of Peru. A total of 34 farmers, who had received guinea pigs from IVITA, were interviewed. The questionnaire was performed in Spanish language and covered topics about the guinea pig production, feeding, mating system, training, the main products, perception and acceptance of crossbred lines ("cuy RG"), and the farmers' comment about the terminal crossbred animal ("cuy G"). The preferred feeding strategy was a combination of forage and supplement. All farmers implemented a controlled mating system. Most farmers had received training on feeding, reproduction, management, equipment, and facilities. The main product is animals for slaughter. The 82.40% of farmers reported that they do not purchase guinea pigs from IVITA anymore, because they are highly susceptibility to lymphadenitis, which is a highly contagious disease and causes swollen lymph nodes and affects the meat quality. Most of the respondents classified the "cuy RG" and "cuy G" as suitable for meat production and were satisfied with the performance of the animals. Therefore, 58.80% of respondents already recommended "cuy RG" to other farmers. However, 17.70% of the respondents would not recommend these animals because they are susceptible to disease, especially lymphadenitis. Therefore, IVITA should engage in more structured dialogue with farmers and regularly include their opinion in future improvement of its breeding strategies. This could help to reach higher acceptance rates by farmers.
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Ambiente , Agricultores , Animales , Cobayas , Humanos , Perú , Encuestas y Cuestionarios , ReproducciónRESUMEN
The management and governance of our surface waters is core to life and prosperity on our planet. However, monitoring data are not available to many potential users and the disparate nature of water bodies makes consistent monitoring across so many systems difficult. While satellite Earth observation (EO) offers solutions, there are numerous challenges that limit the use of satellite EO for water monitoring. To understand the perceptions of using satellite EO for water quality monitoring, a survey was conducted within academia and the water quality management sector. Study objectives were to assess community understanding of satellite EO water quality data, identify barriers in the adoption of satellite EO data, and analyse trust in satellite EO data. Most (40 %) participants were beginners with little understanding of satellite EO. Participants indicated problems with satellite EO data accessibility (31 %) and interpretability (26 %). Results showed a high level of trust with satellite EO data and higher trust with in-situ EO data. This study highlighted the gap between water science, applied social science, and policy. A transdisciplinary approach to managing water resources is needed to bridge water disciplines and take a key role in areas such as social issues, knowledge brokering, and translation.
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In the past 15â years, we've experienced an unprecedented series of crises, including financial (2008), health (2020), and most recently the supply chain disruptions and the energy emergency in Europe, caused by the war in Ukraine (2022). On top of that, climate change still poses a serious threat to our lives and our planet. These interconnected challenges create tremendous societal problems and compromise the viability of the chemical industry in an environment of price volatility and high inflation. Thus, the International Union of Pure and Applied Chemistry (IUPAC) has launched a series of actions to tackle this and raise awareness of the role of chemistry in solving our major threats. Since 2019, IUPAC has identified the "Top Ten Emerging Technologies in Chemistry" to connect chemical researchers with industry, bridging the gap between science and innovation, maintaining the current competitiveness of the chemical industry, as well as tackling our most pressing global challenges.
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BACKGROUND: Intersecting opioid overdose, COVID-19, and systemic racism epidemics have brought unprecedented challenges to the addiction treatment and recovery workforce. From 2017 to 2020, the New England Addiction Technology Transfer Center (ATTC) collected data in real-time on the training and technical assistance (TA) requested and attended by the front-line workforce. This article synthesizes practice-based evidence on the types of TA requests, topics of TA, attendance numbers, and socio-demographics of TA attendees over a 3-year period spanning an unprecedented public health syndemic. METHODS: We assessed TA events hosted by the New England ATTC using SAMHSA's Performance Accountability and Reporting System post-event survey data from 2017 to 2020. Events were coded by common themes to identify the most frequently requested training types/topics and most frequently attended training events. We also evaluated change in training topics and attendee demographics over the three-year timeline. RESULTS: A total of 258 ATTC events reaching 10,143 participants were analyzed. The number of TA events and attendance numbers surged in the 2019-2020 fiscal year as TA events shifted to fully virtual during the COVID-19 pandemic. The absolute number of opioid-related events increased, but the relative proportion remained stable over time. The relative proportions of events and attendance rates focused on evidence-based practice and health equity both increased over the 3-year period, with the largest increase after the onset of the pandemic and the murder of George Floyd. As events shifted to virtual, events were attended by providers with a broader range of educational backgrounds. CONCLUSIONS: Results of the current analysis indicate that the demand for TA increased during the pandemic, with a prioritization of TA focused on evidence-based practice and health equity. The practice-based evidence generated from the New England ATTC may help other training and TA centers to anticipate and nimbly respond to the needs of the workforce in the face of the intersecting epidemics.
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COVID-19 , Trastornos Relacionados con Sustancias , COVID-19/epidemiología , Humanos , Pandemias , Salud Pública/métodos , Trastornos Relacionados con Sustancias/epidemiología , Trastornos Relacionados con Sustancias/terapia , Recursos HumanosRESUMEN
Health technology assessment (HTA) is commonly used to guide evidence-informed decisions to optimize resource use, prioritize policies, and support countries to achieve universal health coverage. Producing HTAs requires time, scientific expertise, and political commitment, but these are not available in all settings - especially in low- and middle-income countries (LMIC) where HTA processes may be less institutionalized. Transferring and adapting existing HTAs to local settings may offer a solution while reducing duplication efforts. This scoping review aims to provide an overview of tools, methods, approaches, and considerations which can aid HTA transfers. We systematically searched (from 2005 to 2020) six databases and, using predefined inclusion criteria, included twenty-two studies. Data extraction followed a structured process, while synthesis was more iterative. We identified a common approach for HTA transfers. It follows the de novo process of undertaking original HTAs, but with additional steps to assess relevance (applicability), quality, and transferability, as well as steps to adapt parameters where necessary. The EUnetHTA Adaptation Toolkit was the only tool that provided guidance for adapting multiple HTA domains. Other tools were specific to systematic reviews (n = 1) or economic evaluations (n = 12), where one provided guidance for systematic reviews of economic evaluations. Eight papers reported transferring an HTA, with only one transferring to an LMIC. Finally, we reported issues that may facilitate or hinder transferability. In conclusion, we identified fourteen transfer approaches in the form of guidance or checklists, but harmonized and pragmatic guidance for HTA transfers to suit settings with limited HTA capacity seems warranted.
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Lista de Verificación , Evaluación de la Tecnología Biomédica , Revisiones Sistemáticas como Asunto , Evaluación de la Tecnología Biomédica/métodos , Análisis Costo-Beneficio , Tecnología BiomédicaRESUMEN
Given that technology transfer provides an important boost for promoting national economic development, technology transfer policy (TTP) has attracted more and more attention from academia and industry. The government issued many policies. However, the implementation effect of TTP still needs to be clarified. This study is carried out from the progressive level of "text content-influence path-implementation effect.'' It aims to adopt a systematic analysis method to analyze policy tools and policy implementation stages, then builds a conceptual framework of the influence path of TTP. Then the relationship between variables in the qualitative model was clarified, and the system dynamics (SD) model was used to build a quantitative model with four feedback loops. Finally, taking Liaoning, China as an example, the system simulation and sensitivity analysis of the main parameters are implemented in Vensim PLE. Different policy tools have different roles in the TTP impact stages of research, transfer, and industrialization. Based on the data of 2013-1019, the SD model constructed in this paper can be used to predict the implementation effect of TTP during 2020-2015. Simulation and sensitivity analysis results provide practical enlightenment for government departments to improve the implementation effect of the existing TTP. This study also provides other researchers with a systematic understanding for improving the implementation effect of TTP with a "text content-influence path-implementation effect" conduction chain and provides new insights for further research on TTP.
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This study explores the emergence of a new entrepreneurship phenomenon (digital social entrepreneurship) as a result of the collaboration among many agents (N-Helix), given the government's limited capacity to respond to the stakeholders' needs satisfaction related to an exogenous event (e.g., the COVID-19 pandemic). Our theory development is based on three ongoing academic debates related to (a) the unrepresentativeness of the stakeholder theory in entrepreneurship research; (b) the emergence of digital social entrepreneurship (DSE) as a bridge between stakeholders' needs, socio-economic actors, and digital-social initiatives; and (c) the role of N-Helix collaborations to facilitate the emergence of global knowledge-intensive initiatives and the rapid adoptions of open innovations. Our results support our assumptions about the positive mediation effect of DSE in the relationship between N-Helix collaborations and stakeholders' satisfaction. Notably, results show how pandemic has intensified these relationships and how DSE in N-Helix collaborations can generate social impacts globally. Some implications for policy-makers have emerged from our results that should be considered during/post-COVID-19 pandemic.
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In the present paper, a software framework comprising the implementation of Model Predictive Control-a popular industrial control method-is presented. The framework is versatile and can be run on a variety of target systems including programmable logic controllers and distributed control system implementations. However, the main attractive property of the framework stems from the goal of achieving smooth technology transfer from the academic setting to real industrial applications. Technology transfer is, in general, difficult to achieve, because of the apparent disconnect between academic studies and actual industry. The proposed software framework aims at bridging this gap for model predictive control-a powerful control technique which can result in substantial performance improvement of industrial control loops, thus adhering to modern trends for reducing energy waste and fulfilling sustainable development goals. In the paper, the proposed solution is motivated and described, and experimental evidence of its successful deployment is provided using a real industrial plant.