A review on risk assessment of formulation development and technology transfer of COVID-19 vaccines / Una revisión sobre la evaluación de riesgos del desarrollo de formulaciones y la transferencia de tecnología de las vacunas COVID-19

Background: COVID-19 pandemic situation made the pharmaceutical companies develop the vaccine with different formulations in a short period. Objectives: The main objective of the review is to focus on different types of vaccine formulations available globally and the importance of technology transfer in vaccine development associated with potential risks. Results: Research on vaccine development led to various types of vaccines, such as Inactivated vaccines, Live Attenuated vaccines, Ribonucleic acid (RNA) and Deoxyribonucleic acid (DNA) vaccines, viral vector vaccines, and Protein Subunit Vaccines for COVID-19. But the process of vaccine development and technology transfer is lined with various risks and challenges. Through risk assessment, we found some major potential risks involved in product development; this leads to a smoother and more efficient method to develop safe vaccines available for public health. Conclusions: This review will explain the significance of technology collaboration for the faster development of various formulations of vaccines globally

Antecedentes: La situación de pandemia de COVID-19 hizo que las empresas farmacéuticas desarrollaran la vacuna con diferentes formulaciones en un corto período. Objetivos: El objetivo principal de la revisión es centrarse en los diferentes tipos de formulaciones de vacunas disponibles a nivel mundial y la importancia de la transferencia de tecnología en el desarrollo de vacunas asociado con los riesgos potenciales. Resultados: La investigación sobre el desarrollo de vacunas condujo al desarrollo de varios tipos de vacunas, como vacunas inactivadas, vacunas vivas atenuadas, vacunas de ácido ribonucleico (ARN) y ácido desoxirribonucleico (ADN), vacunas de vectores virales y vacunas de subunidades de proteínas para COVID-19. Pero el proceso de desarrollo de vacunas y transferencia de tecnología está lleno de varios riesgos y desafíos. A través de la evaluación de riesgos, encontramos algunos riesgos potenciales importantes involucrados en el desarrollo de productos, lo que conduce a un método más fluido y eficiente para desarrollar vacunas seguras disponibles para la salud pública. Conclusiones: Esta revisión dará una idea de la importancia de la colaboración tecnológica para el desarrollo más rápido de varias formulaciones de vacunas a nivel mundial

Multivariate Pharma Technology Transfer Analysis: Civilization Diseases and COVID-19 Perspective.

The importance of studying civilization diseases manifests itself in the impact of changing lifestyles, on the number of deaths and causes of death. Technology transfer plays an important role in the prevention and treatment of these diseases. Through this, it is possible to transfer new treatments and diagnostics to clinics and hospitals more quickly and effectively, which leads to better healthcare for patients. Technology transfer can also aid in the development of new drugs and therapies that can be effective in the treatment of civilization diseases. The paper aims to evaluate the technology transfer process in the field of civilization diseases, using COVID-19 as an example of a pandemic that requires quick development and transfer of technology. To achieve the assumed goal, we propose a multivariate synthetic ratio in the field of civilization diseases (SMTT-Synthetic Measure of Technology Transfer) to analyze data from the Global Data database. We used sub-measures like SMTT_value (Synthetic Measure of Technology Transfer_value) and SMTT_quantity (Synthetic Measure of Technology Transfer_quantity) to measure technology transfer and put the data into a graph. Our analysis focuses on 14 diseases over a period of 10 years (2012-2021) and includes nine forms of technology transfer, allowing us to create a tool for analysing the process in multiple dimensions. Our results show that COVID-19 is similar in terms of technology transfer to diseases such as diabetes, cardiovascular diseases, neurodegenerative diseases, and breast cancer, even though data for COVID-19 is available for only 2 years.

Exploring the role of R&D collaborations and non-patent IP policies in government technology transfer performance: Evidence from U.S. federal agencies (1999-2016).

Around the world, governments make substantial investments in public sector research and development (R&D) entities and activities to generate major scientific and technical advances that may catalyze long-term economic growth. Institutions ranging from the Chinese Academy of Sciences to the French National Centre for Scientific Research to the Helmholtz Association of German Research Centers conduct basic and applied R&D to create commercially valuable knowledge that supports the innovation goals of their respective government sponsors. Globally, the single largest public sector R&D sponsor is the U.S. federal government. In 2019 alone, the U.S. government allocated over $14.9 billion to federally funded research and development centers (FFRDCs), also known as national labs. However, little is known about how federal agencies' utilization of FFRDCs, their modes of R&D collaboration, and their adoption of non-patent intellectual property (IP) policies (copyright protection and materials transfer agreements) affect agency-level performance in technology transfer. In particular, the lack of standardized metrics for quantitatively evaluating government entities' effectiveness in managing innovation is a critical unresolved issue. We address this issue by conducting exploratory empirical analyses of federal agencies' innovation management activities using both supply-side (filing ratio, transfer rate, and licensing success rate) and demand-side (licensing income and portfolio exclusivity) outcome metrics. We find economically significant effects of external R&D collaborations and non-patent IP policies on the technology transfer performance of 10 major federal executive branch agencies (fiscal years 1999-2016). We discuss the scholarly, managerial, and policy implications for ongoing and future evaluations of technology transfer at federal labs. We offer new insights and guidance on how critical differences in federal agencies' interpretation and implementation of their R&D management practices in pursuit of their respective missions affect their technology transfer performance outcomes. We generalize key findings to address the broader innovation processes of public sector R&D entities worldwide.

Vaccine innovation model: A technology transfer perspective in pandemic contexts.

This work identifies the innovations that made it possible for the Bio-Manguinhos/Fiocruz Immunobiological Technology Institute to engage in the entire production of the Oxford/AstraZeneca vaccine (ChAdOx1 nCov-19) in Brazil, just 1.8 years after the COVID-19 pandemic was declared. The results were summarized in a case-based innovation model composed of 11 workstreams, 32 stages, 22 gates, 11 innovations, and 38 events. In terms of research contributions, three were found: (i) the identification of firm and government-level innovations allowing the substantial reduction in the COVID-19 vaccine time-to-market in Brazil; (ii) the presentation of empirical evidence supporting the new Outbreak Paradigm for vaccine research, development, and production; and (iii) the proposition of a conceptual model for describing innovations through the vaccine value chain in pandemic contexts, particularly when technology transfer is involved.

University Technology Transfer Has Failed to Improve Access to Global Health Products during the COVID-19 Pandemic.

Publicly funded research has contributed enormously to many products that were developed in the face of the COVID-19 pandemic. Yet universities' technology transfer practices have failed to ensure that these products are available in low- and middle-income settings. Drawing upon the example of the lipid nanoparticle delivery technology - which was developed in and around the University of British Columbia in Vancouver, BC, and incorporated into the Pfizer/BioNTech COVID-19 vaccine - we show the divide between the university's stated principles to serve global health and technology transfer in practice. We outline three policy actions to realign universities' technology transfer practices in the service of global health.

Commentary: University Technology Transfer Has Made a Significant Contribution to Fighting COVID-19 while Ensuring Global Access.

This paper reviews the response by public sector research organizations and their technology transfer offices to the COVID-19 pandemic. It shows that leading universities and technology transfer associations quickly enacted licensing principles for the duration of the pandemic to maximize availability and minimize delays in translating public sector research institutes' (PSRIs') COVID-19 inventions to the public - in both the developed and the developing world - while waiving payment of royalties. It discusses examples of vaccines, drugs, diagnostics and personal protective equipment that were developed in PSRIs and swiftly deployed throughout the world on socially responsible terms. It reviews the case cited by Herder et al. (2022) and concludes that their proposed mandates are unnecessary and may inhibit the free flow of healthcare innovation from bench to bedside.

Bound by Infinities: Technology, Immediacy and Our Environmental Crisis.

This paper explores the relationship between human desire, technology, and imagination, emphasizing (1) the phenomenology of this relationship, and (2) its ontological and ecological ramifications. Drawing on the work of Bion and Winnicott, the paper will develop a psychoanalytic container for attitudes contributing to our current climate-based crisis, paying special attention to the problematic effect technology has had on our sense of time and place. Many of our technologies stunt sensuous engagement, collapse psychic space, diminish our capacity to tolerate frustration, and blind us to our dependence on worlds beyond the human. In short, our technologies trouble our relationship to our bodies and other bodies. The paper argues that omnipotent fantasies organizing our relationship to technology, to each other, and to the nonhuman world, have cocooned us in a kind of virtual reality that devastates a sense of deep obligation to the environment.

Patents and technology transfer in CRISPR technology.

CRISPR technology has revolutionized biological research in the last decade and many academic institutions and companies have patented CRISPR systems and applications. Several patents have been filed for various applications of CRISPR in different industries such as agriculture, synthetic biology, bio-nanotechnology and precision medicine. Despite tremendous pressure on the technology transfer teams, several startups and spin-out companies are already using CRISPR technologies for commercial applications. In this chapter, we discuss the different CRISPR nucleases and their applications. Secondly, we detail our current opinion and perspective on the CRISPR patent and technology landscape for non-mammalian systems. We present two case-studies on CRISPR diagnostics companies, SHERLOCK and Mammoth Biosciences, who are currently at the forefront of establishing diagnostics platforms for coronavirus (SARS-CoV-2) detection. Finally, our chapter identifies future advancements and possible challenges that CRISPR technology might face in non-mammalian systems.

A blueprint for academic laboratories to produce SARS-CoV-2 quantitative RT-PCR test kits.

Widespread testing for the presence of the novel coronavirus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals remains vital for controlling the COVID-19 pandemic prior to the advent of an effective treatment. Challenges in testing can be traced to an initial shortage of supplies, expertise, and/or instrumentation necessary to detect the virus by quantitative RT-PCR (RT-qPCR), the most robust, sensitive, and specific assay currently available. Here we show that academic biochemistry and molecular biology laboratories equipped with appropriate expertise and infrastructure can replicate commercially available SARS-CoV-2 RT-qPCR test kits and backfill pipeline shortages. The Georgia Tech COVID-19 Test Kit Support Group, composed of faculty, staff, and trainees across the biotechnology quad at Georgia Institute of Technology, synthesized multiplexed primers and probes and formulated a master mix composed of enzymes and proteins produced in-house. Our in-house kit compares favorably with a commercial product used for diagnostic testing. We also developed an environmental testing protocol to readily monitor surfaces for the presence of SARS-CoV-2. Our blueprint should be readily reproducible by research teams at other institutions, and our protocols may be modified and adapted to enable SARS-CoV-2 detection in more resource-limited settings.

Telepsychiatry, Hospitals, and the COVID-19 Pandemic.

Calls for social distancing amid the COVID-19 pandemic have renewed attention on the utility of telepsychiatry. Although considerable evidence supports use of telepsychiatry in outpatient settings, telepsychiatry in hospitals is less studied and less developed. The COVID-19 pandemic may lead to rapid adoption of telepsychiatry by hospitals, and this column explores opportunities hospital-based telepsychiatry offers for staffing, patient and staff safety, social connection, and real-time responsiveness. Because hospital-based telepsychiatry brings unique challenges compared with outpatient telepsychiatry, this column also proposes a research agenda for studying and supporting adoption of these technologies in hospital settings.