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Manufacturing and testing of pharmaceutical products frequently occur in multiple facilities within a company's network. It is of interest to demonstrate equivalence among the alternative testing/manufacturing facilities to ensure product consistency and quality regardless of the facility where it was manufactured/tested. In the Frequentist framework, equivalence testing is well established when comparing two labs or manufacturing facilities; however, when considering more than two labs or production sites, the Frequentist approach may not always offer appropriate or interpretable estimates for demonstrating equivalence among all of them simultaneously. This paper demonstrates the utility of Bayesian methods to the equivalence assessment of multiple groups means, with a comparison against traditional Frequentist methods. We conclude that a Bayesian strategy is very useful for addressing the problem of multi-group equivalence. While it is not our intention to argue that Bayesian methods should always replace Frequentist ones, we show that among the advantages of a Bayesian analysis is that it provides a more nuanced understanding of the degree of similarity among sites than the hypothesis testing underpinning the Frequentist approach.

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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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Introduction: The utility of ChatGPT in research is ambiguous, serving as both a boon and bane and presenting challenges and opportunities. Accordingly, this study aimed to delineate the merits and demerits of ChatGPT within the realm of research. Methods: A meta-synthesis methodology involving a seven-step process was adopted to pursue the research objectives. Data were collected from comprehensive studies across specialized research databases, such as Science Direct, Springer, Eric, Emerald, Sage Journals, Wiley Online Library, PubMed, and Google Scholar, within the time frame spanning from 2022 to 2023. A total of 57 articles were meticulously chosen for analysis through judgmental sampling. Subsequently, key concepts were distilled from these articles and categorized using the thematic analysis approach while considering Karl Llewellyn's octagonal model from 1963. Results: The outcomes underwent scrutiny employing the thematic analysis strategy devised by Wolcott. The results about the capabilities and constraints of ChatGPT encompass eight dimensions, including formulating the research problem, reviewing relevant literature, selecting an appropriate research design, defining the population and choosing the sample, collecting data, analyzing data, interpreting data, and discussing and drawing conclusions. The credibility of these dimensions was substantiated through adherence to the criteria established by Lincoln and Guba. Conclusion: ChatGPT manifests myriad potentialities and constraints within the research purview based on the results. In light of the expeditious progression of artificial intelligence across multifarious domains, integrating this technological paradigm in research becomes an inexorable imperative, and excluding its use in research is untenable. Thus, policymakers and higher education strategists should devise policies that harness ChatGPT's potential in research endeavors, engendering many opportunities.

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Obesity is a chronic disease, and while weight loss is achievable, long-term weight loss maintenance is difficult and relapse common for people living with obesity. Aiming to meet the need for innovative approaches, digital behavior change interventions show promise in supporting health behavior change to maintain weight after initial weight loss. Implementation of such interventions should however be part of the design and development processes from project initiation to facilitate uptake and impact. Based on the development and implementation process of eCHANGE, an evidence-informed application-based self-management intervention for weight loss maintenance, this manuscript provides suggestions and guidance into; (1) How a service design approach can be used from initiation to implementation of digital interventions, and (2) How a technology transfer process can accelerate implementation of research-based innovation from idea to market.

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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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Technology transfer (TT) is a necessary, yet complex process to convey and disseminate scientific knowledge to the commercial sector. However, multiple barriers in TT can impede commercialization and innovative progress. To cultivate a deeper understanding, we conducted five interviews with strategic, elite leaders in different areas of TT in the United States. Experts shared their perspectives on the current state of TT, what needs improvement, and potential solutions to enhance the TT landscape, with a focus on biotechnology and medical devices. The formation of strong management teams, a comprehension of the regulatory, reimbursement, and funding pathways and policies, and thorough market assessments were noted as key aspects for venture success. Collaboration with Technology Transfer Offices (TTOs), industry experts, and strategic partners are also essential to support academic innovators and guide them throughout the complex commercialization process. There is agreement that a venture should have a defined vision and clear goals with a robust business case for the innovation; early involvement of TTOs is essential. Comprehension of the complexities and key facets of TT, while also streamlining the process, will better position biomedical innovators for success.

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Digital health technologies (DHTs) at the intersection of health, medical informatics, and business aim to enhance patient care through personalised digital approaches. Ensuring the efficacy and reliability of these innovations demands rigorous clinical validation. A PubMed literature review (January 2006 to July 2023) identified 1250 papers, highlighting growing academic interest. A focused narrative review (January 2018 to July 2023) delved into challenges, highlighting issues such as diverse regulatory landscapes, adoption issues in complex healthcare systems, and a plethora of evaluation frameworks lacking pragmatic guidance. Existing frameworks often omit crucial criteria, neglect empirical evidence, and clinical effectiveness is rarely included as a criterion for DHT quality. The paper underscores the urgency of addressing challenges in accreditation, adoption, business models, and integration to safeguard the quality, efficacy, and safety of DHTs. A pivotal illustration of collaborative efforts to address these challenges is exemplified by the Digital Health Validation Center, dedicated to generating clinical evidence of innovative healthcare technologies and facilitating seamless technology transfer. In conclusion, it is necessary to harmonise evaluation approaches and frameworks, improve regulatory clarity, and commit to collaboration to integrate rigorous clinical validation and empirical evidence throughout the DHT life cycle.

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BACKGROUND: There is growing evidence that telemedicine can improve the access to and quality of health care for nursing home residents. However, it is still unclear how to best manage and guide the implementation process to ensure long-term adoption, especially in the context of a decline in telemedicine use after the COVID-19 crisis. OBJECTIVE: This study aims to identify and address major challenges for the implementation of televisits among residents in a nursing home, their caring nurses, and their treating general practitioners (GPs). It also evaluated the impact of televisits on the nurses' workload and their nursing practice. METHODS: A telemedical system with integrated medical devices was introduced in 2 nursing homes and their cooperating GP offices in rural Germany. The implementation process was closely monitored from the initial decision to introduce telemedicine in November 2019 to its long-term routine use until March 2023. Regular evaluation was based on a mixed methods approach combining rigorous qualitative approaches with quantitative measurements. RESULTS: In the first phase during the COVID-19 pandemic, both nursing homes achieved short-term adoption. In the postpandemic phase, an action-oriented approach made it possible to identify barriers and take control actions for long-term adoption. The implementation of asynchronous visits, strong leadership, and sustained training of the nurses were critical elements in achieving long-term implementation in 1 nursing home. The implementation led to enhanced clinical skills, higher professional recognition, and less psychological distress among the nursing staff. Televisits resulted in a modest increase in time demands for the nursing staff compared to organizing in-person home visits with the GPs. CONCLUSIONS: Focusing on health care workflow and change management aspects depending on the individual setting is of utmost importance to achieve successful long-term implementation of telemedicine.

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It is important to use evidence-based programs and practices (EBPs) to address major public health issues. However, those who use EBPs in real-world settings often require support in bridging the research-to-practice gap. In the US, one of the largest systems that provides such support is the Substance Abuse and Mental Health Services Administration's (SAMHSA's) Technology Transfer Center (TTC) Network. As part of a large external evaluation of the Network, this study examined how TTCs determine which EBPs to promote and how to promote them. Using semi-structured interviews and pre-testing, we developed a "Determinants of Technology Transfer" survey that was completed by 100% of TTCs in the Network. Because the study period overlapped with the onset of the COVID-19 pandemic, we also conducted a retrospective pre/post-pandemic comparison of determinants. TTCs reported relying on a broad group of factors when selecting EBPs to disseminate and the methods to do so. Stakeholder and target audience input and needs were consistently the most important determinant (both before and during COVID-19), while some other determinants fluctuated around the pandemic (e.g., public health mandates, instructions in the funding opportunity announcements). We discuss implications of the findings for technology transfer and frame the analyses in terms of the Interactive Systems Framework for Dissemination and Implementation.

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The local manufacture of advanced pharmaceutical products has been a long-standing objective of health and industry policy in many developing countries, including in Latin America. This strategy has been applied to fight epidemics such as HIV/AIDS, malaria, and the COVID-19 pandemic. However, we still know little about the politics and governance that enable such arrangements, especially when there is no consent from the originator company. This study focuses on the case of Brazil, a country that is well-known for its health-industry policy, which includes the local production of direct-acting antivirals (DAAs), a new treatment for hepatitis C. We seek to explain the factors that have contributed to Brazil's successful production of generic versions of DAAs, and, later, to the decision by the Ministry of Health (MoH) to procure drugs from multinational pharmaceutical companies rather than from local laboratories. A lack of support for domestic production by important stakeholders, the patent holder's attempt to block domestic production and the MoH's adoption of more modern treatment guidelines under a different procurement logic all created an unfavourable environment for local production and procurement of DAAs. Our study draws implications for middle-income countries that wish to produce drugs domestically without voluntary license agreements.

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This article contrasts the different approaches to COVID-19 vaccine development adopted by Oxford University, on one hand, and Texas Children's Hospital and Baylor College of Medicine (collectively, Texas), on the other hand. Texas was praised widely in the press and academic literature for adopting an "open source" approach to vaccine development. Oxford, however, chose to license its vaccine technology to pharmaceutical manufacturer AstraZeneca and received significant public criticism as a result. Yet the Oxford vaccine reached far more individuals in developing countries than the Texas vaccine. We compare the two vaccines' experiences, drawing attention to a constellation of interrelated elements that contribute to a successful vaccine production program, including not only IP licensing, but also timing, technology transfer, and resource mobilization, all in the context of the prevailing funding environments. This comparative analysis sheds light on how the innovation ecosystem functioned during the COVID-19 pandemic, providing useful insights for policy makers and advocates as they prepare for future pandemics and other global health challenges.

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This paper analyzes the technology-related outputs from The National Institute of Disability, Independent Living, and Rehabilitation Research (NIDILRR). We seek to answer the questions: What are the types and frequency of assistive technology (AT) technology transfer (ATTT) outputs from NIDILRR grants? How does NIDILRR's ATTT generation compare to other granting organizations? What types of ATTT outputs occur, how, and what is the relative productivity of the most frequently funded universities and small businesses performing with funding by NIDILRR grants? An online search was conducted for indications of ATTT from grants funded from 1983-2021 through publicly available databases, the National Rehabilitation Information Center (NARIC), and the internet. This data was then categorized across relevant output types and analyzed. NIDILRR funded 662 organizations and 951 different investigators from 1983 to 2021. The NIDILRR-funded portfolio includes 6,996 papers, 438 informational websites, 163 patents, 120 software products, and 29 hardware products. Compared to the National Institutes of Health (NIH), NIDILRR produced slightly more products per dollar. Our results highlight the substantial portfolio of technology-related outputs generated with NIDILRR funding and demonstrate how productivity measures can be calculated to guide future funding strategies.

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Infectious diseases (IDs) are a leading cause of death. The diversity and adaptability of microbes represent a continuing risk to health. Combining vision with passion, our transdisciplinary medical research team has been focussing its work on the better management of infectious diseases for saving human lives over the past five decades through medical discoveries and innovations that helped change the practice of medicine. The team used a multiple-faceted and integrated approach to control infectious diseases through fundamental discoveries and by developing innovative prevention tools and rapid molecular diagnostic tests to fulfill the various unmet needs of patients and health professionals in the field of ID. In this article, as objectives, we put in context two main research areas of ID management: innovative infection prevention that is woman-controlled, and the rapid molecular diagnosis of infection and resistance. We also explain how our transdisciplinary approach encompassing specialists from diverse fields ranging from biology to engineering was instrumental in achieving success. Furthermore, we discuss our vision of the future for translational research to better tackle IDs.

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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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Ciguatera, a global issue, lacks adequate capacity for ciguatoxin analysis in most affected countries. The Caribbean region, known for its endemic ciguatera and being home to a majority of the global small island developing states, particularly needs established methods for ciguatoxin detection in seafood and the environment. The radioligand receptor binding assay (r-RBA) is among the in vitro bioassays currently used for ciguatoxin analysis; however, similarly to the other chemical-based or bioassays that have been developed, it faces challenges due to limited standards and interlaboratory comparisons. This work presents a single laboratory validation of an r-RBA developed in a Cuban laboratory while characterizing the performance of the liquid scintillation counter instrument as a key external parameter. The results obtained show the assay is precise, accurate and robust, confirming its potential as a routine screening method for the detection and quantification of ciguatoxins. The new method will aid in identifying high-risk ciguatoxic fish in Cuba and the Caribbean region, supporting monitoring and scientific management of ciguatera and the development of early warning systems to enhance food safety and food security, and promote fair trade fisheries.

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Technology transfer centers (TTCs) facilitate the movement of evidence-based practices in behavioral healthcare from theory to practice. One of the largest such networks is the Substance Abuse and Mental Health Services Administration's (SAMHSA) TTC Network. This brief report shares findings from an organizational network analysis (ONA) of the network conducted as part of an external evaluation. For non-supervisory TTCs (n = 36) across three focus areas (addiction, prevention, and mental health), the authors computed network density, harmonic closeness, and non-null dyadic reciprocity for five types of interactions (e.g., "collaborated in workgroups"), then, for each interaction type, used Welch's T-test to compare mean harmonic closeness of standalone TTC grantees versus multiple-TTC grantees. ONA identified potentially isolated regional TTCs as well as mismatches between some centers' desired scope and their network centrality and enabled investigation of broader questions around behavioral health support systems. The approach appears useful for evaluating TTCs and similar support networks.

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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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Resumo: A inovação é um elemento fundamental para o desenvolvimento e crescimento, mas constituída por um processo demorado de acúmulo de conhecimento. Uma das formas de acelerar tal processo é por meio da transferência de tecnologia. Este artigo mapeou as particularidades da transferência de tecnologia para a vacina contra COVID-19, celebrado entre a AstraZeneca e o Instituto de Tecnologia em Imunobiológicos (Bio-Manguinhos), Fundação Oswaldo Cruz, bem como reconheceu os seus facilitadores, seus entraves e suas lacunas. Para tanto, foi realizada uma análise desde a etapa da seleção do parceiro mais adequado até a incorporação da nova tecnologia. A metodologia utilizada se baseou em uma ampla revisão bibliográfica sobre o tema, aliada ao estudo de caso. Os resultados apontaram que, apesar de muitas ações ainda precisarem ser realizadas para que os ganhos de capacidade tecnológica sejam potencializados, as lições aprendidas com o processo de transferência de tecnologia servirão de aprendizado e serão utilizadas nos acordos futuros e em andamento.

Resumen: La innovación es un elemento fundamental para el desarrollo y el crecimiento, pero consiste en un proceso de acumulación de conocimiento que requiere mucho tiempo. Una de las formas de acelerar este proceso es mediante la transferencia de tecnología. Este artículo mapeó las particularidades del proceso de transferencia de tecnología para la vacuna contra la COVID-19, celebrado entre AstraZeneca y el Instituto de Tecnología en Inmunobiológicos (Bio-Manguinhos), Fundación Oswaldo Cruz, además de reconocer los facilitadores, obstáculos y brechas. Para ello se realizó un análisis, desde la etapa de selección del socio más adecuado hasta la incorporación de la nueva tecnología. La metodología utilizada se basó en una amplia revisión bibliográfica sobre el tema, combinada con el estudio de caso. Los resultados mostraron que, si bien aún es necesario llevar a cabo muchas acciones para maximizar las ganancias de capacidad tecnológica, las lecciones aprendidas del proceso de transferencia de tecnología servirán como lecciones y se utilizarán en acuerdos futuros y en curso.

Abstract: Innovation is an essential element for development and growth, but it consists of a long process of knowledge accumulation, so technology transfer is used to accelerate this process. This study mapped the particularities of the technology transfer process for the COVID-19 vaccine between AstraZeneca and the Institute of Technology in Immunobiologicals (Bio-Manguinhos), Oswaldo Cruz Foundation, and identified enablers, obstacles, and gaps. Our analysis investigated the process from selection of the most suitable partner to incorporation of the new technology based on a comprehensive literature review on this topic, combined with a case study. The results showed that, although many actions still have to be performed to maximize technology capacity gains, the lessons learned from the technology transfer process will be used in future and ongoing agreements.

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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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Introduction Traditional medical education has leaned heavily on memorization, pattern recognition, and learned algorithmic thinking. Increasingly, however, creativity and innovation are becoming recognized as a valuable component of medical education. In this national survey of Association of American Medical Colleges (AAMC) member institutions, we seek to examine the current landscape of exposure to innovation-related training within the formal academic setting. Methods Surveys were distributed to 168 of 171 AAMC-member institutions (the remaining three were excluded from the study for lack of publicly available contact information). Questions assessed exposure for medical students among four defined innovation pillars as follows: (1) medical humanities, (2) design thinking, (3) entrepreneurship, or (4) technology transfer. Chi-squared analysis was used to assess statistical significance between schools, comparing schools ranked in the top 20 by the US News and World Report against non-top 20 respondents, and comparing schools that serve as National Institutes of Health (NIH) Clinical and Translational Science Awards (CTSA) program hubs against non-CTSA schools. Heat maps for geospatial visualization of data were created using ArcGIS (ArcMAP 10.6) software (Redlands, CA: Environmental Systems Research Institute). Results The overall response rate was 94.2% with 161 schools responding. Among respondents, 101 (63%) reported having medical humanities curricula at their institution. Design thinking offerings were noted at 51/161 (32%) institutions. Support for entrepreneurship was observed at 51/161 institutions (32%), and technology transfer infrastructure was confirmed at 42/161 (26%) of institutions. No statistically significant difference was found between top 20 schools and lower 141 schools when comparing schools with no innovation programs or one or more innovation programs (p=0.592), or all four innovation programs (p=0.108). CTSA programs, however, did show a statistically significant difference (p<0.00001) when comparing schools with no innovation programs vs. one or more programs, but not when comparing to schools with all four innovation programs (p=0.639). Conclusion This study demonstrated an overwhelming prevalence of innovation programs in today's AAMC medical schools, with over 75% of surveyed institutions offering at least one innovation program. No statistically significant trend was seen in the presence of zero programs, one or more, or all four programs between top 20 programs and the remaining 141. CTSA hub schools, however, were significantly more likely to have at least one program vs. none compared to non-CTSA hub schools. Future studies would be valuable to assess the long-term impact of this trend on medical student education.