Biotech's perfect storm.

The global financial crisis has hit biotech companies hard both in the US and Europe as venture capital dries up. Finding new sources of long-term financing for translating research into new therapeutics will be essential for maintaining innovation and new drug development by biotech companies.

Venture capital investment in urology, 2011 to mid-2021.

INTRODUCTION: To characterize venture capital (VC) investments in urology in the past decade that represent promising innovations in early-stage companies. MATERIALS AND METHODS: A retrospective analysis of deals made between VC investors and urologic companies from January 1, 2011, through June 28, 2021, was conducted by using a financial database (PitchBook Platform, PitchBook Data Inc). Data on urologic company and investor names; company information and funding categories (surgical device, therapeutic device, drug discovery/pharmaceutical, and health care technology companies); and deal sizes (in US dollars) and dates were abstracted and aggregated. Descriptive and linear regression analyses were conducted. RESULTS: Urology-related VC funding fluctuated from 2011 through mid-2021, but no substantial change was observed in funding over time. In total, 191 distinct deals were made involving urologic companies, totaling $1.1 billion. The four largest funding categories together accounted for $848 million and comprised therapeutic devices ($373 million), surgical devices ($187 million), drug discovery/pharmaceuticals ($185 million), and health care technology ($102 million). At least $450 million (41% of total investments) was invested in companies developing minimally invasive surgical devices. CONCLUSIONS: Urologic VC investments did not increase in the past decade and were allocated more toward devices than pharmaceuticals or health care technology. Given relative patterns within urology, VC investments may shift toward health care technology and away from pharmaceuticals but remain stable for devices. Further investments in promising technologies may help urologists more effectively manage urologic disease while optimizing outcomes.

Conservation finance: What are we not doing? A review and research agenda.

Conservation finance embraces a series of innovative financing mechanisms aimed at raising and managing capital to be used for the conservation of biodiversity. The climate emergency and the pursuit of sustainable development underline the criticality of financial support for achieving this goal. Funding for the protection of biodiversity, in fact, has long been disbursed by governments in a residual form, only after they have dealt with social needs and political challenges. To date, the main challenge of conservation finance is to identify solutions that not only generate new revenue for biodiversity, but also effectively manage and allocate existing funding to provide a mix of social and community benefits as well. The paper, therefore, aims to act as a wake-up call, urging academics working in economics and finance to turn their attention to resolving the financial problems faced by conservation. Through a comparative bibliometric analysis, the study aims to outline the structure of scientific research on the topic of conservation finance, to understand the state of the art, and to identify open questions and new research trends. The results of the study show that the topic of conservation finance is currently a prerogative of scholars and journals of ecology, biology and environmental sciences. Finance scholars pay very little attention to the topic and yet there are many opportunities/needs for future research. The results are of interest to researchers in banking and finance, policy-makers and managers.

Saving lives through early diagnosis: the promise and role of point of care testing for sickle cell disease.

Sickle cell disease (SCD) is a devastating and under-recognised global child health issue affecting over 300,000 infants annually, with the highest prevalence in India and sub-Saharan Africa. Most affected infants born in low- and middle-income countries (LMIC) lack access to SCD testing and die from complications in the first years of life without a formal diagnosis. The majority of deaths are preventable with early diagnosis and provision of inexpensive interventions. Despite global recognition of the urgent need, expansion of SCD newborn screening (NBS) programmes beyond the pilot stage has been obstructed by a dependence on an expensive and logistically challenging centralised laboratory testing model. Recently, several point-of-care tests (POCT) for SCD have been developed with promising field validation studies. Here, we summarise the state of POCT for SCD, review barriers and unanswered questions, and discuss optimal strategies for utilising POCT to address the growing global burden of SCD. There is an urgent need to prospectively evaluate the ability of POCT to reduce the morbidity and high early mortality of SCD. To impact a sustainable reduction to this end, it is essential to link a diagnosis with comprehensive SCD care, including wide and affordable access to affordable hydroxycarbamide therapy.

Effects of chain ownership and private equity financing on quality in the English care home sector: retrospective observational study.

BACKGROUND: the structure of care homes markets in England is changing with the emergence of for-profit homes organised in chains and financed by private equity. Previous literature shows for-profit homes were rated lower quality than not-for-profit homes when inspected by the national regulator, but has not considered new forms of financing. OBJECTIVES: to examine whether financing and organisation of care homes is associated with regulator assessments of quality. METHODS: retrospective observational study of the Care Quality Commission's ratings of 10,803 care homes providing services to older people as of January 2020. We used generalised ordered logistic models to assess whether ratings differed between not-for-profit and for-profit homes categorised into three groups: (i) chained ownership, financed by private equity; (ii) chained ownership, not financed by private equity and (iii) independent ownership. We compared Overall and domain (caring, effective, responsive, safe, well-led) ratings adjusted for care home size, age and location. RESULTS: all three for-profit ownership types had lower average overall ratings than not-for-profit homes, especially independent (6.8% points (p.p.) more likely rated as 'Requires Improvement/Inadequate', 95% CI: 4.7-8.9) and private equity chains (6.6 p.p. more likely rated as 'Requires Improvement/Inadequate', 95% CI: 2.9-10.2). Independent homes scored better than private equity chains in the safe, effective and responsive domains but worst in the well-led domain. DISCUSSION: private equity financing and independent for-profit ownership are associated with lower quality. The consequences of the changing care homes market structure for quality of services should be monitored.

Venture Capital Investment in Orthopaedics: Has the Landscape Changed over the Past Two Decades (2000-2019)?

Background. Innovations in orthopaedic technologies often require significant funding. Although an increasing trend has been observed for third-party investments in other medical fields, no study has examined the influence of venture capital (VC) funding in orthopaedics. Therefore, this study analyzed trends in VC investments related to the field of orthopaedic surgery, as well as the characteristics of recipients of these investments. Methods. Venture capital investments into orthopaedic-related businesses were reviewed from 2000 to 2019 using Capital IQ, a proprietary intelligence platform documenting financial investments. Metrics categorized were investments by year, investment amount, and subspecialty domain as per the American Academy Orthopaedic Surgeons website. The compound annual growth rate (CAGR) for both quantity and dollar amount of investments was calculated over the study period and the two decade-long periods (2000-2009 and 2010-2019). Results. Over two decades, 673 VC investments took place, involving a total of US$3.5 billion. Both the number and dollar value of investments were greater in the second decade (440, US$1.9 billion), compared to the first decade (233, US$1.6 billion). Both quantity and dollar amount of VC investments grew over the first decade, with a CAGR 9.53% and 4.97%, respectively. However, investment growth declined in the latter decade. The largest and most frequent investments took place within spine surgery and adult reconstruction. Conclusion. An initially rising trend in VC investment in orthopaedic-related businesses may have plateaued over the past decade. These findings may have important implications for continued investment into orthopaedic innovations and collaboration between the surgical community and private sector.

The representation of public values in health technology assessment to inform funding decisions: the case of Australia's national funding bodies.

Over the past few years, there has been an increasing recognition of the value of public involvement in health technology assessment (HTA) to ensure the legitimacy and fairness of public funding decisions [Street J, Stafinski T, Lopes E, Menon D. Defining the role of the public in Health Technology Assessment (HTA) and HTA-informed decision-making processes. Int J Technol Assess Health Care. 2020;36:87-95]. However, important challenges remain, in particular, how to reorient HTA to reflect public priorities. In a recent international survey of thirty HTA agencies conducted by the International Network of Agencies for HTA (INAHTA), public engagement in HTA was listed as one of the "Top 10" challenges for HTA agencies [O'Rourke B, Werko SS, Merlin T, Huang LY, Schuller T. The "Top 10" challenges for health technology assessment: INAHTA viewpoint. Int J Technol Assess. 2020;36:1-4].Historically, Australia has been at the forefront of the application of HTA for assessing the effectiveness and cost-effectiveness of new health technologies to inform public funding decisions. However, current HTA processes in Australia lack meaningful public inputs. Using Australia as an example, we describe this important limitation and discuss the potential impact of this gap on the health system and future directions.

Research on the contagion effect of associated credit risk in supply chain based on dual-channel financing mechanism.

This paper considers a two-echelon supply chain with a supplier and a retailer both having capital constraints. The capital-constrained retailer first applies for loans from the commercial bank, and then applies for trade credit from the supplier. Compared with the single trade credit financing mechanism, what are the similarities and differences in the contagion and evolution of the associated credit risk in the supply chain when the retailer adopts both trade credit and bank credit (dual-channel financing) mechanism. Based on Stackelberg game analysis framework of the supplier and retailer, this paper clarifies the contagion mechanism of the associated credit risk in the supply chain and discusses the influences of financing structure, financing channel and financing costs on the contagion effect of the associated credit risk in the supply chain under dual-channel financing mechanism. Combined with the case simulation analysis, it is found that: Compared with the single trade credit financing mechanism, the contagion effect is weaker under the dual-channel financing mechanism. The financing structure significantly affects the contagion effect, which increases with the increase of the proportion of trade credit financing. Both bank credit and trade credit financing costs can positively affect the contagion effect. Our research can enrich the existing credit risk management and supply chain finance literature and provide decision support for the selection of financing methods and risk control of commercial banks and supply chain enterprises.

A scoping review examining funding trends in health care professions education research from Taiwan (2006-2017).

BACKGROUND: Traditionally health care professions education research (HCPER) is poorly funded, despite it being key to success. PURPOSE: This unique study maps HCPER evolution within a single country during a period when significant national governmental HCPER funding is introduced. METHODS: A scoping review method examined Taiwan's HCPER landscape across 12-years. Literature searches across four databases (OVID Medline; Scopus; Web of Science; the Airiti Library), a manual scan of HCPE journals and hand searches. Endnote and ATLAS.ti managed the data. Demographic and content codes were developed. PRISMA guidelines are used. DISCUSSION: One thousand four hundred and ten articles across 310 journals, with a steady rise in funded studies. Science/Social Science Citation Index and English language publications increased. Nursing Students/Nurses and Medical Students/Physicians are the most common populations. Significant associations with funding was found for indexed and English language publications. National funding influenced quality and local funding positively. CONCLUSION: Caution around local vs. global needs is highlighted and national funding policies for HCPER are advocated.

Partnerships between universities and nonprofit transition coaching organizations to increase student success.

AIMS: This study aims to understand the motivations and benefits for universities and nonprofit college access and success organizations to develop formal partnerships. METHODS: Participants in this study were staff from a major urban research university (n = 22) and four nonprofit organizations (n = 17) that promote college access and success among underrepresented, low-income, and first-generation college students. Participants engaged in an audio-recorded interview that was transcribed and analyzed using thematic analysis. RESULTS: Data suggested that staff from the universities and nonprofit organizations were both holistic in their understanding of college student success. In addition, they were both motivated to form partnerships in an effort to reduce barriers to success, although they, at times, identified different barriers that they wanted the partnership to address. Both university and nonprofit staff saw increased effectiveness of their practice as a result of partnering and university staff gained a better understanding of the greater nonprofit college access and success community. CONCLUSION: Given the intense support that nonprofit organizations are able to provide with their level of funding, partnerships with universities can increase the success of underrepresented, low-income, and first-generation college students.

The benefits and challenges of a rural community-based work-ready placement program for allied health students.

INTRODUCTION: Rural and remote Australia has a shortage of allied health clinicians. The provision of quality rural placement experiences for allied health students has been a significant strategy to address these health workforce shortages. Service learning rural placements are providing allied health services in small rural towns where previously allied health services were limited or did not exist. Published literature has little detailed description of the origin or nature of particular placement programs. METHODS: An increase in Commonwealth funding for rural allied health clinical placements led to the development of an innovative service learning placement model in northern New South Wales, the Rural Community-Based Work-Ready Placement Program. During this placement, students were paired for 4-10 full-time weeks in a preschool, school or aged care facility. The program's fundamental properties included cultural and social equity education, providing continuous service throughout the year, and quality improvement initiatives in placement sites. The program was underpinned by an interdisciplinary approach that included interdisciplinary placements, interdisciplinary supervision and a structured interdisciplinary education program. RESULTS: The program required investment in stakeholder engagement and in the alignment of universities' requirements for student learning outcomes and the sites' specific needs. Clinical supervisors had to adapt to supervising students from various disciplines and universities across several sites, towns and services. The program provided students with opportunities to work autonomously, problem-solve and to initiate and implement quality improvement projects at each site. CONCLUSION: Careful selection of students, adequate preparation and management of students' expectations were important contributors to the success of the program. Providing a continuous service is an ongoing logistical challenge.

Prioritizing research challenges and funding for allergy and asthma and the need for translational research-The European Strategic Forum on Allergic Diseases.

The European Academy of Allergy and Clinical Immunology (EAACI) organized the first European Strategic Forum on Allergic Diseases and Asthma. The main aim was to bring together all relevant stakeholders and decision-makers in the field of allergy, asthma and clinical Immunology around an open debate on contemporary challenges and potential solutions for the next decade. The Strategic Forum was an upscaling of the EAACI White Paper aiming to integrate the Academy's output with the perspective offered by EAACI's partners. This collaboration is fundamental for adapting and integrating allergy and asthma care into the context of real-world problems. The Strategic Forum on Allergic Diseases brought together all partners who have the drive and the influence to make positive change: national and international societies, patients' organizations, regulatory bodies and industry representatives. An open debate with a special focus on drug development and biomedical engineering, big data and information technology and allergic diseases and asthma in the context of environmental health concluded that connecting science with the transformation of care and a joint agreement between all partners on priorities and needs are essential to ensure a better management of allergic diseases and asthma in the advent of precision medicine together with global access to innovative and affordable diagnostics and therapeutics.

Science policies: How should science funding be allocated? An evolutionary biologists' perspective.

In an ideal world, funding agencies could identify the best scientists and projects and provide them with the resources to undertake these projects. Most scientists would agree that in practice, how funding for scientific research is allocated is far from ideal and likely compromises research quality. We, nine evolutionary biologists from different countries and career stages, provide a comparative summary of our impressions on funding strategies for evolutionary biology across eleven different funding agencies. We also assess whether and how funding effectiveness might be improved. We focused this assessment on 14 elements within four broad categories: (a) topical shaping of science, (b) distribution of funds, (c) application and review procedures, and (d) incentives for mobility and diversity. These comparisons revealed striking among-country variation in those elements, including wide variation in funding rates, the effort and burden required for grant applications, and the extent of emphasis on societal relevance and individual mobility. We use these observations to provide constructive suggestions for the future and urge the need to further gather informed considerations from scientists on the effects of funding policies on science across countries and research fields.

Setting the scene and generating evidence for malaria elimination in Southern Mozambique.

Mozambique has historically been one of the countries with the highest malaria burden in the world. Starting in the 1960s, malaria control efforts were intensified in the southern region of the country, especially in Maputo city and Maputo province, to aid regional initiatives aimed to eliminate malaria in South Africa and eSwatini. Despite significant reductions in malaria prevalence, elimination was never achieved. Following the World Health Organization's renewed vision of a malaria-free-world, and considering the achievements from the past, the Mozambican National Malaria Control Programme (NMCP) embarked on the development and implementation of a strategic plan to accelerate from malaria control to malaria elimination in southern Mozambique. An initial partnership, supported by the Bill and Melinda Gates Foundation and the La Caixa Foundation, led to the creation of the Mozambican Alliance Towards the Elimination of Malaria (MALTEM) and the Malaria Technical and Advisory Committee (MTAC) to promote national ownership and partner coordination to work towards the goal of malaria elimination in local and cross-border initiatives. Surveillance systems to generate epidemiological and entomological intelligence to inform the malaria control strategies were strengthened, and an impact and feasibility assessment of various interventions aimed to interrupt malaria transmission were conducted in Magude district (Maputo Province) through the "Magude Project". The primary aim of this project was to generate evidence to inform malaria elimination strategies for southern Mozambique. The goal of malaria elimination in areas of low transmission intensity is now included in the national malaria strategic plan for 2017-22 and the NMCP and its partners have started to work towards this goal while evidence continues to be generated to move the national elimination agenda forward.

[Health innovation in Mexico: important challenges and a long road to walk]. / Innovación en salud en México: retos importantes y un largo camino que recorrer.

The transfer of technology from health research institutions to businesses that develop new medical treatments has generated great benefits for public health at a global level. Mexico however, is lagging in innovation indicators. There are important cultural, regulatory, and financial barriers that limit innovation in Mexico. However recent years have seen the appearance of several useful initiatives that constitute progress in the right direction. This work provides a brief overview of the current situation of innovation in Mexico, describes the main barriers and gives recommendations that can promote health innovation in Mexico, which can contribute to improvements in public health.

La transferencia de tecnología de instituciones de investigación en salud a empresas que generen nuevos tratamientos médicos ha generado grandes beneficios para la salud pública a nivel mundial. Sin embargo, en México existen importantes rezagos en los indicadores de innovación. Hay barreras culturales, regulatorias y financieras que obstaculizan la innovación en México. Al mismo tiempo, los últimos años han visto la aparición de varias iniciativas útiles que avanzan en la dirección correcta. El presente trabajo describe la situación actual y las principales barreras y oportunidades para promover la innovación en salud y la contribución de ésta a mejoras en salud pública.

[Funding for national ethics committees for health research in Member States of the Economic Community of West African States]. / Le financement des Comités nationaux d'éthique de la recherche pour la santé dans les États membres de la communauté économique des États de l'Afrique de l'Ouest.

BACKGROUND: The financing of national research ethics committees for health is a decisive factor in their proper functioning and independence. Little information is available concerning the funding of these committees in West Africa. AIM: To analyze the funding of national research ethic committees for health in the Member States of the Economic Community of West African States. METHODS: A review of the documents from two regional workshops with the participation of the representatives of the national ethics committees of each ECOWAS Member State was carried out. These workshops enabled the collection and validation of data on the status of national ethics committees. These data were used to conduct a descriptive analysis of the funding sources of the committees. RESULTS: Three sources of funding for national ethics committees were identified. The first source was the support of the state or a national structure. The second source was the fee for reviewing the submitted protocols and the last source was the support of external donors. The collection of audit fees and the support of external donors were the main sources of funding for most of the national committees. In only one state, there were no fees for review of submitted protocols and all the ethic committee member were motivated by the government. CONCLUSION: In order to ensure the autonomy and independence of the national committees, state support for the funding of these committees should improve. The establishment of a regional network and its recognition by the Assembly of Ministers of Health of ECOWAS allowed for advocacy by WAHO, which should help achieve better results in the future.

Maternal, Infant, and Early Childhood Home Visiting: A Call for a Paradigm Shift in States' Approaches to Funding.

Early home visiting is a vital health promotion strategy that is widely associated with positive outcomes for vulnerable families. To expand access to these services, the Maternal, Infant, and Early Childhood Home Visiting (MIECHV) program was established under the Affordable Care Act, and over $2 billion have been distributed from the Health Resources and Services Administration to states, territories, and tribal entities to support funding for early home visiting programs serving pregnant women and families with young children (birth to 5 years of age). As of October 2018, 20 programs met Department of Health and Human Services criteria for evidence of effectiveness and were approved to receive MIECHV funding. However, the same few eligible programs receive MIECHV funding in almost all states, likely due to previously established infrastructure prior to establishment of the MIECHV program. Fully capitalizing on this federal investment will require all state policymakers and bureaucrats to reevaluate services currently offered and systematically and transparently develop a menu of home visiting services that will best match the specific needs of the vulnerable families in their communities. Federal incentives and strategies may also improve states' abilities to successfully implement a comprehensive and diverse menu of home visiting service options. By offering a menu of home visiting program models with varying levels of service delivery, home visitor education backgrounds, and targeted domains for improvement, state agencies serving children and families have an opportunity to expand their reach of services, improve cost-effectiveness, and promote optimal outcomes for vulnerable families. Nurses and nursing organizations can play a key role in advocating for this approach.

[The evaluation of efficiency of medical organizations providing primary medical sanitary care in conditions of capitation financing].

The article analyzes the results of implementing per capita financing mechanism in medical organizations providing primary medical sanitary care. The comprehensive methodology was applied, including analysis and generalization of experience, statistical, analytical, sociological, monographic description, economic, comparative analysis, organizational experiment. The analysis demonstrated that in actual conditions number of subjects of the Russian Federation, being able to include in per capita standard only those volumes of additional medical care that can be directly impacted by primary health care unit decreased significantly.

Role of industry funders in oncology RCTs published in high-impact journals and its association with trial conclusions and time to publication.

Background: Previous studies have shown that industry funded trials are associated with pro-industry conclusions and publication bias. Less is known about the role of industry funders and their influence on trial conclusions and time to publication. Methods: We identified all industry funded RCTs published in six high-impact clinical journals between 2014 and 2016 to estimate the prevalence of the role of industry funders in trial design, data collection, data analyses, data interpretation and manuscript writing. Ordinal logistic regression was used to assess the association between the role of industry funders and trial conclusions, which was classified on a five-point scale. Cox proportional-hazards were used to examine the effect of role of funder on time to publication. Results: Of the 255 eligible RCTs, industry funders had a role in trial design in 179 (70.2%) trials, data collection in 160 (62.7%) trials, data analyses in 173 (67.8%) trials, data interpretation in 135 (52.9%) trials and manuscript writing in 168 (65.9%) trials. Trials with any role of industry funders had 3.6 times (95% CI 2.0-6.6) higher odds of having positive conclusions compared with those without role of industry funders. In trials with any role of industry funders, positive trials were published more rapidly than negative trials (hazard ratio = 4.3; 95% CI 2.7-6.7, P < 0.001), while for trials without role of industry funders, there was no association (hazard ratio = 1.07; 95% CI 0.57-1.99, P = 0.84). Conclusion: The involvement of industry funders is common in all stages of clinical trials and was associated with more positive conclusions and more rapid publication of RCTs with positive results.

A proposed approach to accelerate evidence generation for genomic-based technologies in the context of a learning health system.

Genomic technologies should demonstrate analytical and clinical validity and clinical utility prior to wider adoption in clinical practice. However, the question of clinical utility remains unanswered for many genomic technologies. In this paper, we propose three building blocks for rapid generation of evidence on clinical utility of promising genomic technologies that underpin clinical and policy decisions. We define promising genomic tests as those that have proven analytical and clinical validity. First, risk-sharing agreements could be implemented between payers and manufacturers to enable temporary coverage that would help incorporate promising technologies into routine clinical care. Second, existing data networks, such as the Sentinel Initiative and the National Patient-Centered Clinical Research Network (PCORnet) could be leveraged, augmented with genomic information to track the use of genomic technologies and monitor clinical outcomes in millions of people. Third, endorsement and engagement from key stakeholders will be needed to establish this collaborative model for rapid evidence generation; all stakeholders will benefit from better information regarding the clinical utility of these technologies. This collaborative model can create a multipurpose and reusable national resource that generates knowledge from data gathered as part of routine care to drive evidence-based clinical practice and health system changes.