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Infectious diseases may cause serious morbidity and mortality in pregnant women, their foetuses, and infants; the risk associated with any newly emerging infectious disease (EID) is likely unknown at the time of its emergence. While the ongoing SARS-CoV-2 pandemic shows that the development of vaccines against new pathogens can be considerably accelerated, the immunization of pregnant women generally lags behind the general population. Guided by the priority pathogen list for WHO’s R&D Blueprint for Action to Prevent Epidemics, this workshop sought to define the evidence needed for use of vaccines against EIDs in pregnant and lactating women, using Lassa fever as a model. Close to 60 maternal immunization (MI) and vaccine safety experts, regulators, vaccine developers, Lassa fever experts, and investigators from Lassa-affected countries examined the critical steps for vaccine development and immunization decisions for pregnant and lactating women. This paper reports on key themes and recommendations from the workshop. Current practice still assumes the exclusion of pregnant women from early vaccine trials. A shift in paradigm is needed to progress towards initial inclusion of pregnant women in Phase 2 and 3 trials. Several practical avenues were delineated. Participants agreed that vaccine platforms should be assessed early for their suitability for maternal immunization. It was noted that, in some cases, nonclinical data derived from assessing a given platform using other antigens may be adequate evidence to proceed to a first clinical evaluation and that concurrence from regulators may be sought with supporting rationale. For clinical trials, essential prerequisites such as documenting the disease burden in pregnant women, study site infrastructure, capabilities, and staff experience were noted. Early and sustained communication with the local community was considered paramount in any program for the conduct of MI trials and planned vaccine introduction.

Highlights • The M&E/A framework was a critically important element of GVAP. • It was a cyclical process of monitoring, review, and recommendations for action. • Though a step in the right direction, it failed to hold all stakeholders accountable. • Several GVAP goals were aspirational and unrealistic for many countries., Introduction The Monitoring & Evaluation/Accountability (M&E/A) framework of the Global Vaccine Action Plan (GVAP) was used to report progress annually to the World Health Assembly (WHA). Methods Stakeholder feedback was obtained through five reviews consisting of surveys and semi-structured interviews conducted from 2017 to 2019. Participants consisted of individuals involved in the development and implementation of GVAP or its M&E/A process, national immunization managers, academics, representatives of non-governmental organizations, and civil society organizations. Results The feedback was mixed and contradictory for some components, though most participants reported that the M&E/A process was a highlight of GVAP and a step in the right direction. Several of the goals and targets were considered aspirational and unrealistic for many countries. There were mixed responses on whether it promoted accountability, especially at the country level. Discussion The mixed and contradictory views on the M&E/A processes and its impact suggested a failure of communication about its scope and intent. Though the process, especially the annual reporting to the WHA, kept immunization high on the global agenda, it failed to fully meet the expectations in promoting accountability. Engaging with countries to capture the local context in setting global goals and targets and promoting local M&E/A processes will be important to achieve accountability in the next decade.

Highlights • GVAP built visibility for immunization and was an improvement over prior plans. • GVAP implementation was incomplete due to limited awareness and stakeholder buy-in. • The GVAP Monitoring & Evaluation/Accountability framework gave valuable guidance. • Future strategies should build greater buy-in and communicate more effectively., Introduction The Global Vaccine Action Plan (GVAP), unanimously endorsed by the World Health Assembly in 2012, defined an ambitious strategy to improve immunization. At the end of the decade, significant progress has been made but four of the five GVAP goals are likely to be missed. This report describes a set of surveys and interviews relating to GVAP, conducted to inform the immunization strategy for the next decade. Methods Three surveys and two sets of semi-structured interviews were conducted from 2017 to 2019. Respondents consisted of immunization stakeholders at global, regional, and country levels, and included individuals who had been involved in the development and implementation of GVAP or its monitoring, evaluation and accountability (M&E/A) process; national immunization managers; academics; and personnel from non-governmental organizations and civil society organizations. Results The surveys and interviews gave consistent results. They highlighted the value of GVAP in increasing visibility for immunization and the benefits of the GVAP M&E/A framework. The main limitations of GVAP were identified as the limited ownership by countries and other stakeholders leading to incomplete implementation of the strategy and poor accountability for achieving GVAP targets. Discussion These results informed the review of GVAP and the development of its successor strategy, the Immunization Agenda 2030. In addition, these surveys and interviews identified two challenges in assessing the value of GVAP: the need to rely exclusively on stakeholder perspectives and difficulties in attributing benefits. These challenges are inherent in evaluating an over-arching strategy such as GVAP and should be factored into interpretation of the results.

Summary: Increasing emergence and spread of Nipah, ZIKV and Ebola case and potential outbreaks threats have been reported in several regions around the globe. Yet, emerging Nipah, Ebola and Zika viral diseases outbreaks have been indirectly linked to substantially globalization of trade and travel, climate change and intense urbanization impact, healthcare and socioeconomic inequities as well in affected community settings. Although no case has been documented in Saudi Arabia, there is a great risk of sudden emergence of any of these viruses and others via introducing among pilgrims coming from endemic regions during ritual ceremonies of mass gatherings. Consequently, promoting and investing on new and sensitive proven effective and innovative surveillance and monitoring approaches, including enhanced risk communication, improved integrated vectors surveillance in addition to improved sustainable highly pathogens surveillance control programs to human motility and environmental sanitation strategies all represent ‘One Health’ approach implementation strategic core. Initiation, development and implementation leaded by Saudi government and international stakeholders’ of new partnership, coordinated response leadership and resource mobilization for multidisciplinary and intersectorial advocacy on emerging viral disease outbreaks, accompanied with R&D roadmap and taskforce is crucial. More efforts in epidemiological and laboratory early screening and surveillance of highly pathogenic germs/microbes, and confirmation of asymptomatic and syndromic cases amongst suspected Hajj and Umrah pilgrims, local vulnerable populations and expatriate workers is vital in generating reliable data and data sharing platform for timely risk communication and tourist information update, appropriate immunization campaigns or safe and efficacious care delivery implementation. Moreover, increase Hajj/Umrah mass gathering emergency outbreak preparedness, pilgrims health education and engagement outreach, pre-, during and post programs coverage and effectiveness is needed through One Health approach integration in attaining pilgrims and local population health safety and security, in advancing Saudi sustainable health development goals. Keywords: Emerging, Nipah, Ebola and Zika virus, Outbreaks, Surveillance, Hajj, Saudi Arabia

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has rapidly spread around the globe leading to the COVID-19 pandemic. To mitigate the effects of the virus on public health and the global economy, vaccines were rapidly developed. In less than one year, with respect to usual clinical development rules, several vaccines have been put on the market and mass vaccination campaigns have been deployed. During the phase I to phase III clinical trials, most of these vaccines have demonstrated both their safety and efficacy. Despite questions remain about the impact of virus variants and the duration of the immune response, messenger RNA (mRNA)-based and adenoviral vectored vaccines have demonstrated an overall efficacy from 70 to 95% in both phase III trials and real life. In addition, all these vaccines also reduce the severe forms of the disease and might strongly impact the mortality which could change the course of the pandemic.

Highlights • Towards a large-Scale Integration of Renewable Energies in Morocco. • Current status of major RE projects in Morocco. • Key elements for successful transformation of the power system., Renewable energies are a sustainable, unlimited and decarbonised solution to address future energy challenges. In this context, Morocco has a considerable advantage to position itself on this promising market. Furthermore, renewable energies have been highlighted as a key strategic source for the country's green growth. Morocco has adopted the renewable energy path through a strategy targeted on the development of solar, wind and hydroelectric power to boost its energy policy by adapting it to the challenges posed by today's world. Nowadays, Morocco is facing a challenge to reach 52% by 2030 of its total renewable energy capacity, which will exceed 42% by the end of 2020. The main objective of this paper is to study a scenario for 2030 for the Moroccan electricity system and to identify the challenges that need to be addressed in order to accelerate the integration of renewable energies in the Moroccan energy mix and to achieve a possible export of such green energy towards Europe.

Highlights • Process Flow Charts providing guidance on how to develop and licence a new veterinary vaccine. • The importance of producing a clear Target Product Profile (TPP) for a new veterinary vaccine. • What is required in order to move a new vaccine project from discovery through to development. • The differences between the human and veterinary vaccine development processes. • The commercial vaccine regulatory process leading to a marketing authorisation for a new product. • Identification of potential bottlenecks to the rapid development of a new veterinary vaccine., The UK Government recognised the importance of vaccines in the control of new emerging disease threats and in 2015 established the UK Vaccine Network to focus on specific areas of need. One of these was the understanding of what is involved in the development of a new vaccine and what are the potential bottlenecks to a rapid response in the face of an epidemic such as Ebola, MERS and more recently COVID-19. A Working Group was established to initially produce a Vaccine Development Process Map for a Human Vaccine. However, in view of the importance of animal wellbeing and the significant impact of diseases with Zoonotic potential, a similar Map has been created outlining the Veterinary Vaccine Development Process. This paper describes the production of that Map and covers the process from the generation of a Target Product Profile (TPP) through Discovery and Feasibility, and on to Product Development and Registration.

Summary: Progress in medicine hinges on the successful translation of basic science discoveries into new medical devices, diagnostics, and therapeutics. âTechnology transferâ is the process by which new innovations flow from the basic research bench to commercial entities and then to public use. In academic institutions, intellectual property rights do not usually fall automatically to the individual inventor per se, but most often are the property of the institution. Technology transfer offices are tasked with seeing to it that such intellectual property rights are properly managed and commercialized. This 2-part series explores the technology transfer process from invention to commercialization. Part 1 reviews basic aspects of intellectual property rights, primarily patents and copyrights. Part 2 will discuss the ways in which inventions become commercialized through startup companies and licensing arrangements with industry players. Key Words: copyright, intellectual property, patent, technology transfer

Treatment of HIV has long faced the challenge of high mutation rates leading to rapid development of resistance, with ongoing need to develop new methods to effectively fight the infection. Traditionally, early HIV medications were designed to inhibit RNA replication and protein production through small molecular drugs. Peptide based therapeutics are a versatile, promising field in HIV therapy, which continues to develop as we expand our understanding of key protein-protein interactions that occur in HIV replication and infection. This review begins with an introduction to HIV, followed by the biological basis of disease, current clinical management of the disease, therapeutics on the market, and finally potential avenues for improved drug development., Graphical abstract This review discusses the biological basis of HIV, the current clinical management of the disease, the therapeutics developed to treat HIV, and the potential strategies for improving HIV drug development. It explores new methods for developing HIV therapeutics that aim to produce effective drugs in the treatment of HIV. Specifically, it looks at peptide inhibitors currently being researched that show promise for HIV treatment.Image 1, Highlights • HIV hard to control, manage, and infectious with billions spent on research for prevention and treatment. • This review summarizes the biological basis of HIV, current management, and improved drug development. • It explores peptide inhibitors as a promising new therapeutic for HIV treatment.

Objective To explore factors associated with a successful research atmosphere by investigating the distribution of articles published in the field of urology in 2015 amongst different world regions, as research is undoubtedly a valuable tool that can help shape the future of human health. Methods The Scopus® database was searched for publications made by Urology journals enlisted in the SCImago journal and country rank website. Details about each article type, language, and country of origin were collected. Journals’ bibliometric measures, as well as their country of origin and the number publications since the year 1996 were also collected. Countries were divided according to the United Nations geoscheme. Results In all, 80 of 93 registered Urology journals publishing a total of 10,181 articles were included in the study. Results reveal that the highest contribution came from North America (37.4%) followed by Europe (29.4%), Asia (26.5%), South America (2.2%), Africa (1.9%), and Oceania (1.7%). Bibliometric analysis of the published articles showed significantly higher impact measures amongst North American publications, followed by those from Europe, Oceania, South America, Asia, and Africa (P

Introduction The Safety Pharmacology Society (SPS) and National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs) conducted a survey and workshop in 2015 to define current industry practices relating to housing of non-rodents during telemetry recordings in safety pharmacology and toxicology studies. The aim was to share experiences, canvas opinion on the study procedures/designs that could be used and explore the barriers to social housing. Methods Thirty-nine sites, either running studies (Sponsors or Contract Research Organisations, CROs) and/or outsourcing work responded to the survey (51% from Europe; 41% from USA). Results During safety pharmacology studies, 84, 67 and 100% of respondents socially house dogs, minipigs and non-human primates (NHPs) respectively on non-recording days. However, on recording days 20, 20 and 33% of respondents socially house the animals, respectively. The main barriers for social housing were limitations in the recording equipment used, study design and animal temperament/activity. During toxicology studies, 94, 100 and 100% of respondents socially house dogs, minipigs and NHPs respectively on non-recording days. However, on recording days 31, 25 and 50% of respondents socially house the animals, respectively. The main barriers for social housing were risk of damage to and limitations in the recording equipment used, food consumption recording and temperament/activity of the animals. Conclusions Although the majority of the industry does not yet socially house animals during telemetry recordings in safety pharmacology and toxicology studies, there is support to implement this refinement. Continued discussions, sharing of best practice and data from companies already socially housing, combined with technology improvements and investments in infrastructure are required to maintain the forward momentum of this refinement across the industry.

In Japan, a research center network consisting of Kyoto University to provide clinical-grade induced Pluripotent Stem Cells (iPSC) and several major research centers to develop iPSC-based regenerative therapies was formed for the clinical application of iPSCs. This network is under the supervision of a newly formed funding agency, the Japan Agency for Medical Research and Development. In parallel, regulatory authorities of Japan, including the Ministry of Health, Labour and Welfare, and Pharmaceuticals and Medical Devices Agency, are trying to accelerate the development process of regenerative medicine products (RMPs) by several initiatives: 1) introduction of a conditional and time-limited approval scheme only applicable to RMPs under the revised Pharmaceuticals and Medical Devices Act, 2) expansion of a consultation program at the early stage of development, 3) establishment of guidelines to support efficient development and review and 4) enhancement of post-market safety measures such as introduction of patient registries and setting user requirements with cooperation from relevant academic societies and experts. Ultimately, the establishment of a global network among iPSC banks that derives clinical-grade iPSCs from human leukocyte antigens homozygous donors has been proposed. In order to share clinical-grade iPSCs globally and to facilitate global development of iPSC-based RMPs, it will be necessary to promote regulatory harmonization and to establish common standards related to iPSCs and differentiated cells based on scientific evidence., Highlights • Overview of collaborative research center network program related to iPSC-based regenerative therapies in Japan. • Recent initiatives that promote R&D and review of regenerative medicine products by regulatory authorities of Japan. • Challenges related to global cooperation among iPSC banks overseas under current regulations.

Construction and demolition (C&D) waste recycling constitutes an indispensable component in the overall waste management strategy. Unlike the traditional recycling approaches whereby C&D waste is transported to off-site facilities for treatment, construction managers are actively exploring the possibility of on-site recycling where C&D waste is treated directly at source. This study reports the barriers and facilitators of implementing on-site C&D waste recycling by contextualizing it in Hong Kong. It does so by adopting a mixed-method approach combining case study, site visits, and interviews. It is discovered that the barriers include (1) site space constraints, (2) narrow window of opportunity to trade recycled products, (3) vulnerable business case, (4) lack of support from off-site recycling, and (5) lack of government policy support. A series of facilitating measures are also proposed, including (1) developing customized on-site recycling equipment, (2) establishing a demand-supply information-sharing platform, (3) developing more thriving off-site recycling, and (4) providing more government support. This study probes into the real-life on- and off-site waste recycling practices in Hong Kong's prominent C&D management system. It can also provide useful references for others in developing their own C&D waste recycling strategies by rationally deploying on- and off-site recycling., Graphical abstract Unlabelled Image, Highlights • Identified five major barriers to on-site C&D waste recycling in Hong Kong; • Developed four facilitators to promote on-site C&D waste recycling in Hong Kong; • The facilitators discussed may serve as useful reference for other economies.

Summary Eroom’s law (Moore’s law spelled backwards), describes adverse trends towards declining innovation and rising costs of drug development over the last several decades. Therapeutics for cardiovascular diseases (CVD) appear to have been particularly sensitive to these trends. Thirty-three percent fewer CVD therapeutics were approved between 2000 and 2009 compared to the previous decade, and the number of CVD drugs starting all clinical trial stages declined in both absolute and relative numbers between 1990 and 2012. In the last 5 years, drugs to treat CVD disease comprised just 6% of all new drug launches. This review discusses the decline in CVD therapeutics, the reasons behind it, and ways in which this trend is being or might be addressed.

Summary Taking a solution for a clinical unmet need from a mere idea to a profitable medical device company is a long and complex process. After developing a prototype solution, the physician-inventor must quickly file a patent to protect his or her intellectual property. After the patent is secured, the first major business decision arrives: should the inventor sell the patent or maintain ownership? If the inventor decides to maintain ownership, he or she will face a series of hurdles from obtaining additional funding to device development, and ultimately, commercialization and marketing of the product. Although this process is daunting at first glance, and physicians certainly face unique challenges in this endeavor, clinicians are uniquely and strategically positioned to identify clinical unmet needs and, therefore, have the ability to fundamentally transform the way we treat our patients.

Highlights • In medicine, research is the search for scientific knowledge, which is crucial for the development of novel medications and techniques. • Conducting research provides a deeper understanding of several scientific topics of the specialty of each doctor. • Research through RCTs represents the principal methodological approach. • There are two main research processes; qualitative and quantitative studies. • It is important to develop Research Units in hospitals and medical centres. • Ethics and the high quality of research are ensured by committees (i.e., Internal Board Review, Ethics Research Committee). • Research sessions could be implemented in the job plans of doctors. • Research is not a waste of time, but a scientific investment., Objectives To answer the questions ‘Why should I do research? Is it a waste of time?’ and present relevant issues. Methods Medline was used to identify relevant articles published from 2000 to 2013, using the following keywords ‘medicine’, ‘research’, ‘purpose’, ‘study’, ‘trial’, ‘urology’. Results Research is the most important activity to achieve scientific progress. Although it is an easy process on a theoretical basis, practically it is a laborious process, and full commitment and dedication are of paramount importance. Currently, given that the financial crisis has a key influence in daily practice, the need to stress the real purpose of research is crucial. Conclusion Research is necessary and not a waste of time. Efforts to improving medical knowledge should be continuous.

This study analyses how public R&D financing impacts companies. Our main goal is to study whether public and private R&D financing are substitutes or complements, and whether this impact differs between financially constrained and unconstrained companies. Our company-level panel data cover the period from 1996 to 2002. The statistical method employed in the research takes into account the possibility that receiving public support may be an endogenous factor. Our results suggest that public R&D financing does not crowd out privately financed R&D. Instead, receiving a positive decision to obtain public R&D funds increases privately financed R&D. Furthermore, our results suggest that this additionality effect is bigger in large firms than in small firms. Tässä tutkimuksessa tarkastellaan julkisen tutkimus- ja tuotekehitysrahoituksen vaikutuksia yrityksiin ja millainen merkitys rahoitusrajoitteella on näihin vaikutuksiin. Tutkimuksen tavoitteena on siis selvittää lisääkö vai vähentääkö julkinen t&k-rahoitus yrityksen omarahoitteista t&k-toimintaa. Lisäksi selvitetään, onko tämä vaikutus erilainen rahoitusrajoitteisilla ja eirahoitusrajoitteisilla yrityksillä. Aineistona käytetään yritystason paneliaineistoa vuosilta 1996-2002. Tutkimusmenetelmässä otetaan huomioon, että julkisen t&k-rahoituksen saaminen on endogeeninen tekijä. Tutkimuksen mukaan julkinen t&k-rahoitus ei syrjäytä yritysrahoitteista t&k:ta vaan pikemminkin täydentää sitä. Tutkimuksen keskeisin tulos on, että julkisen t&k-rahoituksen lisäysvaikutus on suurempi suurilla yrityksillä kuin pienillä yrityksillä. Sen sijaan lisäysvaikutus on samansuuruinen sekä hyvän että huonon koronmaksukyvyn omaavilla yrityksillä