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Biotechnology and nanotechnology provide a growing number of innovator-driven complex drug products and their copy versions. Biologics exemplify one category of complex drugs, but there are also nonbiological complex drug products, including many nanomedicines, such as iron-carbohydrate complexes, drug-carrying liposomes or emulsions, and glatiramoids. In this white paper, which stems from a 1-day conference at the New York Academy of Sciences, we discuss regulatory frameworks in use worldwide (e.g., the U.S. Food and Drug Administration, the European Medicines Agency, the World Health Organization) to approve these complex drug products and their follow-on versions. One of the key questions remains how to assess equivalence of these complex products. We identify a number of points for which consensus was found among the stakeholders who were present: scientists from innovator and generic/follow-on companies, academia, and regulatory bodies from different parts of the world. A number of topics requiring follow-up were identified: (1) assessment of critical attributes to establish equivalence for follow-on versions, (2) the need to publish scientific findings in the public domain to further progress in the field, (3) the necessity to develop worldwide consensus regarding nomenclature and labeling of these complex products, and (4) regulatory actions when substandard complex drug products are identified.

This paper describes and compares methods and analyzers used to measure hemoglobin (Hb) in clinical laboratories and field settings. We conducted a literature review for methods used to measure Hb in clinical laboratories and field settings. We described methods to measure Hb and factors influencing results. Automated hematology analyzer (AHA) was reference for all Hb comparisons using evaluation criteria of ±7% set by College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA). Capillary fingerprick blood usually produces higher Hb concentrations compared with venous blood. Individual drops produced lower concentrations than pooled capillary blood. Compared with the AHA: (1) overall cyanmethemoglobin (1.0-8.0 g/L), WHO Colour Scale (0.5-10.0 g/L), paper-based devices (5.0-7.0 g/L), HemoCue® Hb-201 (1.0-16.0 g/L) and Hb-301 (0.5-6.0 g/L), and Masimo Pronto® (0.3-14.0 g/L) overestimated concentrations; (2) Masimo Radical®-7 both under- and overestimated concentrations (0.3-104.0 g/L); and (3) other methods underestimated concentrations (2.0-16.0 g/L). Most mean concentration comparisons varied less than ±7% of the reference. Hb measurements are influenced by several analytical factors. With few exceptions, mean concentration bias was within ±7%, suggesting acceptable performance. Appropriate, high-quality methods in all settings are necessary to ensure the accuracy of Hb measurements.This paper describes and compares methods and analyzers used to measure hemoglobin (Hb) in clinical laboratories and field settings. With few exceptions, mean concentration bias was within ±7%, suggesting acceptable performance. Appropriate, high-quality methods in all settings are necessary to ensure the accuracy of Hb measurements.

Anemia is an important public health problem that negatively affects health of individuals and economic potential of populations. An accurate case definition is critical for understanding burden and epidemiology of anemia, for planning public health interventions, and for clinical investigation and treatment of patients. The current threshold hemoglobin concentrations for diagnosis of anemia were proposed in 1968 and based on studies predominantly of Caucasian adult populations in Europe and North America. The World Health Organization is undertaking a project to review global guidelines for anemia. We describe the process of obtaining input from technical experts, researchers, blood bank experts, policy makers, and program implementers to identify key information or knowledge gaps for anemia diagnosis. From this scoping exercise, six priority areas were identified on diverse topics related to the use and interpretation of hemoglobin concentrations to diagnose anemia in individuals and populations. A call for authors was conducted to produce background, review, and research papers across priority topics. This paper summarizes the first technical meeting, which included commissioned papers as well as case studies, describes key data gaps identified, and describes the next steps in the guideline development process to assess available evidence and define knowledge gaps to improve anemia characterization.

Anemia is an important public health challenge and accurate prevalence estimates are needed for program planning and tracking progress. While venous blood assessed by automated hematology analyzers is considered gold standard, most population-based surveys use point-of-care diagnostics and capillary blood to estimate population prevalence of anemia. Several factors influence hemoglobin (Hb) concentration, including human and analytic error, analysis method, and type of instrument, but it is unclear whether biological variability exists between venous and capillary blood. The objective of this paper was to systematically review sources of Hb variability and the potential biological basis for venous and capillary differences. We use data from a recent survey in the state of Uttar Pradesh, India, to illustrate the implications on anemia prevalence estimates. Significant differences in Hb concentration between capillary and venous blood samples are common. Most but not all find capillary Hb concentration to be higher than venous. Instrument/method variability and human error play an important role, but cannot fully explain these differences. A normative guide to data collection, analysis, and anemia diagnosis is needed to ensure consistent and appropriate interpretation. Further research is needed to fully understand the biological implications of venous and capillary Hb variability.

The excessive consumption of certain vitamins and minerals could have deleterious consequences on health and development of individuals and populations. Simultaneous micronutrient-delivery interventions could be challenging in terms of safety as the target populations may overlap, posing a risk of excessive intake of certain micronutrients. The Evidence and Programme Guidance Unit of the Department of Nutrition for Health and Development of the World Health Organization convened a technical consultation on the risk of excessive intake of vitamins and minerals delivered through public health interventions in October 2017. The technical consultation's working groups identified important and emerging technical issues, lessons learned, and research priorities related to (1) planning, implementing, monitoring, and evaluating nutrition programs for the detection and control of the risk of excessive intakes; (2) safety, quality control, and assurance considerations; (3) coordination between public health nutrition interventions and other interventions and sectors; and (4) the legislative framework and policy coherence needed for simultaneous nutrition interventions. This paper provides the background and rationale of the technical consultation, synopsizes the presentations, and provides a summary of the main considerations proposed by the working groups.

Biomarkers are biological characteristics that can be used to indicate health or disease. This paper reviews studies on biomarkers of low back pain (LBP) in human subjects. LBP is the leading cause of disability, caused by various spine-related disorders, including intervertebral disc degeneration, disc herniation, spinal stenosis, and facet arthritis. The focus of these studies is inflammatory mediators, because inflammation contributes to the pathogenesis of disc degeneration and associated pain mechanisms. Increasingly, studies suggest that the presence of inflammatory mediators can be measured systemically in the blood. These biomarkers may serve as novel tools for directing patient care. Currently, patient response to treatment is unpredictable with a significant rate of recurrence, and, while surgical treatments may provide anatomical correction and pain relief, they are invasive and costly. The review covers studies performed on populations with specific diagnoses and undefined origins of LBP. Since the natural history of LBP is progressive, the temporal nature of studies is categorized by duration of symptomology/disease. Related studies on changes in biomarkers with treatment are also reviewed. Ultimately, diagnostic biomarkers of LBP and spinal degeneration have the potential to shepherd an era of individualized spine medicine for personalized therapeutics in the treatment of LBP.

Staple diets that are deficient in thiamine can result in low body thiamine levels, which may be subclinical or may manifest as a thiamine-deficiency syndrome. In many communities in the developing countries of Africa, the staple diets of polished rice or processed cassava are deficient in thiamine, and thus the communities are at high risk for marginal or frank thiamine deficiency unless their diets are supplemented by other sources of thiamine, such as protein meals and vegetables. African communities with large numbers of individuals in low socioeconomic strata are more likely to subsist on a monotonous diet of rice or cassava with minimal or no protein supplementation and are therefore particularly at risk of thiamine-deficiency disorders. Indeed, there is evidence of widespread biochemical thiamine deficiency from community-based studies in Africa. The protean manifestations of thiamine deficiency disorders in the developing countries of Africa are presented in this paper. We present evidence supporting the contention that there is a diagnosis and treatment gap for thiamine-deficiency disorders in Africa. We discuss research and clinical options for bridging the putative diagnosis and treatment gap for thiamine-deficiency disorders in the developing countries of Africa.

Adolescent nutritional behaviors are assuming considerable importance in nutrition interventions given their important relationships with medium- and long-term outcomes. This is the period when young people undergo major anatomical and physiological maturational changes in preparation for adulthood. Nutritional requirements during puberty are higher during adolescence than during the prepubertal stage and during adulthood. A significant proportion of adolescents also become parents, and hence the importance of their health and nutritional status before as well as during pregnancy has its impact on their own health, fetal well-being, and newborn health. In this paper, we describe the evidence-based nutrition recommendations and the current global guidance for nutrition actions for adolescents. Despite the limitations of available information, we believe that a range of interventions are feasible to address outcomes in this age group, although some would need to start earlier in childhood. We propose packages of preventive care and management comprising nutrition-specific and nutrition-sensitive interventions to address adolescent undernutrition, overnutrition, and micronutrient deficiencies. We discuss potential delivery platforms and strategies relevant to low- and middle-income countries. Beyond the evidence synthesis, there is a clear need to translate evidence into policy and for implementation of key recommendations and addressing knowledge gaps through prioritized research.

Biofortification of staple crops has been proposed as a strategy to address micronutrient malnutrition, particularly with respect to insufficient intake of vitamin A, iron, zinc, and folate. The World Health Organization, in collaboration with the Food and Agriculture Organization of the United Nations and the Sackler Institute for Nutrition Science at the New York Academy of Sciences, convened a technical consultation entitled "Staple Crops Biofortified with Vitamins and Minerals: Considerations for a Public Health Strategy" in April 2016. Participants of the consultation reviewed the definition of biofortification of staple crops, patterns of crops production, processing, consumption, seed varieties, and micronutrient stability and bioavailability, as well as farmers' adoption and acceptability of the modified crops. Also discussed were economic, environmental, safety, and equity aspects of biofortified crops, as well as legal, policy, regulatory, and ethical issues for the implementation of biofortification strategies in agriculture and nutrition. Consultation working groups identified important and emerging technical issues, lessons learned, and research priorities to better support the evidence of improved nutrition and unintended adverse effects of biofortification. This paper provides the background and rationale of the technical consultation, synopsizes the presentations, and provides a summary of the main considerations proposed by the working groups.

Randomized controlled trials can benefit from proactive assessment of how well their participant selection strategies during the design of eligibility criteria can influence the study generalizability. In this paper, we present a quantitative metric called generalizability index for study traits 2.0 (GIST 2.0) to assess the a priori generalizability (based on population representativeness) of a clinical trial by accounting for the dependencies among multiple eligibility criteria. The metric was evaluated on 16 sepsis trials identified from ClinicalTrials.gov, with their adverse event reports extracted from the trial results sections. The correlation between GIST scores and adverse events was analyzed. We found that the GIST 2.0 score was significantly correlated with total adverse events and serious adverse events (weighted correlation coefficients of 0.825 and 0.709, respectively, with P < 0.01). This study exemplifies the promising use of Big Data in electronic health records and ClinicalTrials.gov for optimizing eligibility criteria design for clinical studies.

This paper focuses on the relationship between the circadian system and glucose metabolism. Research across the translational spectrum confirms the importance of the circadian system for glucose metabolism and offers promising clues as to when and why these systems go awry. In particular, basic research has started to clarify the molecular and genetic mechanisms through which the circadian system regulates metabolism. The study of human behavior, especially in the context of psychiatric disorders, such as bipolar disorder and major depression, forces us to see how inextricably linked mental health and metabolic health are. We also emphasize the remarkable opportunities for advancing circadian science through big data and advanced analytics. Advances in circadian research have translated into environmental and pharmacological interventions with tremendous therapeutic potential.

Condiments and seasonings have been considered as potential vehicles for fortification in place of, or in addition to, fortifiable staple foods. Methodologies for establishing fortification programs focus primarily on use of staple foods, which are consumed in larger portions than condiments and seasonings. Some fortification models assume self-limiting consumption relative to the maximum energy consumed by target populations. However, this assumption may prove incorrect for estimating fortification concentrations of condiments and seasonings because they may only provide negligible energy. Although flavor or color may limit consumption, these limits would vary across each condiment or seasoning vehicle. In addition, the small volume of condiments and seasonings consumed relative to staple foods can lead to proportionally larger potential errors than with staple foods when measuring usual dietary intakes for establishing safe and effective fortification concentrations. This paper reviews available methods for setting fortification levels, whether or how available methods or conceptual frameworks could be adapted to condiments and seasonings, and gaps in knowledge for appropriately using condiments and seasonings as vehicles for fortification in public health.

Fortification of staple foods with vitamins and minerals is an effective approach to increase micronutrient intake and improve nutritional status. The specific use of condiments and seasonings as vehicles in large-scale fortification programs is a relatively new public health strategy. This paper underscores equity considerations for the implementation of large-scale fortification of condiments and seasonings as a public health strategy by examining nonexhaustive examples of programmatic experiences and pilot projects in various settings. An overview of conceptual elements in implementation research and equity is presented, followed by an examination of equity considerations for five implementation strategies: (1) enhancing the capabilities of the public sector, (2) improving the performance of implementing agencies, (3) strengthening the capabilities and performance of frontline workers, (3) empowering communities and individuals, and (4) supporting multiple stakeholders engaged in improving health. Finally, specific considerations related to intersectoral action are considered. Large-scale fortification of condiments and seasonings cannot be a standalone strategy and needs to be implemented with concurrent and coordinated public health strategies, which should be informed by a health equity lens.

Esophageal cancer is the eighth most common cancer worldwide, and the incidence of esophageal carcinoma is rapidly increasing. With the advent of new staging and treatment techniques, esophageal cancer can now be managed through various strategies. A good understanding of the advances and limitations of new staging techniques and how these can guide in individualizing treatment is important to improve outcomes for esophageal cancer patients. This paper outlines the recent progress in staging and treatment of esophageal cancer, with particularly attention to endoscopic techniques for early-stage esophageal cancer, multimodality treatment for locally advanced esophageal cancer, assessment of response to neoadjuvant treatment, and the role of cervical lymph node dissection. Furthermore, advances in robot-assisted surgical techniques and postoperative recovery protocols that may further improve outcomes after esophagectomy are discussed.

The expansion in the geographical distribution of vector-borne diseases is a much emphasized consequence of climate change, as are the consequences of urbanization for diseases that are already endemic, which may be even more important for public health. In this paper, we focus on dengue, the most widespread urban vector-borne disease. Largely urban with a tropical/subtropical distribution and vectored by a domesticated mosquito, Aedes aegypti, dengue poses a serious public health threat. Temperature plays a determinant role in dengue epidemic potential, affecting crucial parts of the mosquito and viral life cycles. The urban predilection of the mosquito species will further exacerbate the impact of global temperature change because of the urban heat island effect. Even within a city, temperatures can vary by 10 °C according to urban land use, and diurnal temperature range (DTR) can be even greater. DTR has been shown to contribute significantly to dengue epidemic potential. Unraveling the importance of within-city temperature is as important for dengue as for the negative health consequences of high temperatures that have thus far been emphasized, for example, pollution and heat stroke. Urban and landscape planning designed to mitigate the non-infectious negative effects of temperature should additionally focus on dengue, which is currently spreading worldwide with no signs of respite.

Lysosomal storage diseases (LSDs) are a group of rare diseases in which the function of the lysosome is disrupted by the accumulation of macromolecules. The complexity underlying the pathogenesis of LSDs and the small, often pediatric, population of patients make the development of therapies for these diseases challenging. Current treatments are only available for a small subset of LSDs and have not been effective at treating neurological symptoms. Disease-relevant cellular and animal models with high clinical predictability are critical for the discovery and development of new treatments for LSDs. In this paper, we review how LSD patient primary cells and induced pluripotent stem cell-derived cellular models are providing novel assay systems in which phenotypes are more similar to those of the human LSD physiology. Furthermore, larger animal disease models are providing additional tools for evaluation of the efficacy of drug candidates. Early predictors of efficacy and better understanding of disease biology can significantly affect the translational process by focusing efforts on those therapies with the higher probability of success, thus decreasing overall time and cost spent in clinical development and increasing the overall positive outcomes in clinical trials.

Immune dysregulation, polyendocrinopathy, enteropathy, X-linked (IPEX) syndrome is a rare disorder that increasingly has gained attention as a model of genetic autoimmunity. Numerous papers documenting the key clinical and molecular characteristics of IPEX have provided a detailed understanding of this devastating disease. IPEX is a primary immunodeficiency caused by mutations in the gene FOXP3, which encodes an essential transcription factor required for maintenance of thymus-derived regulatory T (tTreg) cells. tTreg cell dysfunction is the main pathogenic event leading to multiorgan autoimmunity in IPEX. In addition to the traditional clinical presentation (i.e., severe enteropathy, type 1 diabetes, and eczema), IPEX may encompass other variable and distinct clinical manifestations. As IPEX awareness and characterization have increased, so has identification of FOXP3 mutations, with at least 70 to date. Thus, while FOXP3 is the unifying gene, IPEX is a complex and diverse clinical continuum of disorders. Despite understanding IPEX pathogenesis, new treatment options have remained elusive, although early diagnosis led to hematopoietic stem cell transplantation (HSCT) and immunosuppression treatment and improved patient outcomes. Here, we review current knowledge about IPEX syndrome and highlight findings that could lead to novel targeted treatments.

Interventions that improve health are often associated with longevity. Reduced growth hormone signaling has been shown to increase life span in mice by over 50%. Similarly, reductions in dietary intake of methionine, in rats and mice, result in life-span extension. Many factors affect metabolic health, mitochondrial function, and resistance to stressors, each of which influence aging and life span. This paper presents a comparison of these two interventions, as well as the results of a study combining these interventions, to understand potential mechanisms underlying their effectiveness in enhancing healthy aging.

In Ghana, iodine deficiency was first reported in 1994 among 33% of the population. A nationwide Universal Salt Iodization (USI) program plus other complementary interventions were subsequently implemented as a response. Our paper reviews the current risks of excess iodine status in Ghana and identifies policy and research gaps. A mixed methods review of 12 policies and institutional reports and 13 peer‐reviewed articles was complemented with consultations with 23 key informants (salt producers and distributors, food processors, regulatory agency officials, and healthcare providers) purposively sampled between May and August 2017. The findings show a strong policy environment indicated by regulations on food and salt fortification (Act 851), including the USI regulation. However, currently, only a third of Ghanaian households use adequately iodized salt. Recent evidence shows that voluntarily fortified processed foods (including condiments) supply a considerable amount of iodine to the food system. Limited biological impact data suggest possible household exposure to excessive dietary iodine (>15 parts per million). Currently, there is no systematic tracking of iodine content from fortified foods and other sources. Cross‐sectoral actions are needed to understand this situation better. Key research gap is the lack of comprehensive data on iodine content and intake from other sources in Ghana.

Technological progress within the last 15–20 years has significantly increased our knowledge about the molecular basis of cancer development, tumor progression, and treatment response. As a consequence, a vast number of biomarkers have been proposed, but only a small fraction of them have found their way into clinical use. The aim of this paper is to describe the specific demands a clinically relevant biomarker should meet and how biomarkers can be tested stepwise. We name this procedure the “triple-R principle”: robustness, reproducibility, and relevance. The usefulness of this principle is illustrated with the marker TP53. Since it is mutated in a broad spectrum of cancer entities, TP53 can be considered a very promising marker. Thus, TP53 has been studied in detail but there is still no explicit consensus about its clinical value. By considering our own experience and reviewing the literature, we demonstrate that a major problem of current biomarker research is disregard of whether the biomarker is prognostic or predictive. As an example, it is demonstrated that TP53 is not a prognostic marker, but rather a purely predictive marker, and that disregard of this fact has made this otherwise strong biomarker appear as not being clinically useful so far.

Mouse B-1 cells are not only major producers of steady-state natural antibodies but also rapid responders to infections and inflammation. These discrete functions may be the outcomes of distinct environmental or developmental triggers that drive B-1 cells toward IgM production or an effector cell fate. Alternatively, distinct B-1 cell subsets may exist, which differ in their functional plasticity. In this paper, we summarize existing data suggesting that B-1 cells form a heterogeneous group of cells with distinct developmental requirements and nonoverlapping functions. Most spleen B-1 cells differ in development from that of bone marrow and peritoneal cavity B-1 cells, in that they develop in the absence of natural IgM. Functional heterogeneity is revealed by findings that B-1 cells in the bone marrow and spleen, but not the peritoneal cavity, generate natural serum IgM, while the latter are rapid responders to inflammatory and infectious insults, resulting in their relocation to secondary lymphoid tissues. A clearer understanding of the developmental and functional differences within the B-1 cell pool may reveal how they might be harnessed for prophylaxis or therapy.

This paper highlights recent human neuroimaging and cross-species developmental and genetic studies that examine how fear regulation varies by age and the individual, especially during the period of adolescence, when there is a peak in the prevalence of anxiety disorders. The findings have significant implications for understanding who may be at risk for anxiety disorders and for whom, and when, an exposure-based therapy may be most effective. We provide proof of concept for targeting treatment to the individual as a function of age and genetics, inferred from mouse and human studies, and suggest optimization of treatment for nonresponders.

This paper brings together different perspectives on the investigation and understanding of temporal processing and temporal expectations. We aim to bridge different temporal deficit hypotheses in dyslexia, dysphasia, or deafness in a larger framework, taking into account multiple nested temporal scales. We present data testing the hypothesis that temporal attention can be influenced by external rhythmic auditory stimulation (i.e., musical rhythm) and benefits subsequent language processing, including syntax processing and speech production. We also present data testing the hypothesis that phonological awareness can be influenced by several months of musical training and, more particularly, rhythmic training, which in turn improves reading skills. Together, our data support the hypothesis of a causal role of rhythm-based processing for language processing and acquisition. These results open new avenues for music-based remediation of language and hearing impairment.

Stroke remains to be a leading cause of disability. However, optimal strategies can prevent up to 80% of strokes. A large body of evidence supports many strategies for primary and secondary prevention of stroke. The purpose of this paper is to highlight recent major advances for management of modifiable medical and behavioral risk factors of stroke. Specific studies are highlighted, including those related to atrial fibrillation (AF), hypertension, revascularization, hyperlipidemia, antiplatelets, smoking, diet, and physical activity. Effective strategies include the use of novel oral anticoagulants for AF, antiplatelet therapy, and intensive lowering of atherosclerosis risk factors.

It has been established that there is a relationship between chronic inflammation and cancer development. The constant colonic inflammation typical of inflammatory bowel diseases is now considered a risk factor for colorectal carcinoma (CRC) development. The inflammatory network of signaling molecules is also required during the late phases of carcinogenesis, to enable cancer cells to survive and to metastasize. Oxidative reactions are an integral part of the inflammatory response, and are generally associated with CRC development. However, when the malignant phenotype is acquired, increased oxidative status induces antioxidant defenses in cancer cells, favoring their aggressiveness. This contradictory behavior of cancer cells toward redox status is of great significance for potential anticancer therapies. This paper summarizes the essential background information relating to the molecules involved in regulating oxidative stress and inflammation during carcinogenesis. Understanding more of their function in CRC stages might provide the foundation for future developments in CRC treatment.

Schizophrenia is a major mental disorder associated with core neurocognitive impairments. The ability to recreate these deficits in animal models is limited, hampering ongoing translational drug development efforts. This paper reviews the use of electroencephalography (EEG)-based neurophysiological measures, such as event-related potentials (ERPs) or event-related spectral perturbations (ERSPs), as novel translational biomarkers for both etiological and treatment development research in neuropsychiatry. In schizophrenia, cognitive impairments manifest as deficits not only in high-level processes, such as working memory or executive processing, but also as deficits in neurophysiological responses to simple auditory and visual stimuli. Moreover, neurophysiological responses can be assessed even in untrained animals and are therefore particularly amenable to translational, cross-species investigation. To date, several sensory-level ERP measures, including auditory mismatch negativity and N1, and visual P1 and steady-state responses, have been validated in both human clinical investigations and animal models. Deficits have been tied to impaired neurotransmission at N-methyl-d-aspartate-type glutamate receptors (NMDARs). Time-frequency analysis of ERSP permits further extension of these findings from physiological to circuit/cellular levels of analysis.

Bipolar disorders are common psychiatric disorders that affect 1-5% of the population worldwide. Major advances in the epidemiology, pathophysiology, and treatment of the disorders have recently occurred. The majority of published reports, however, originate from the Western hemisphere, mostly Europe and the United States. There is a shortage of data from the Arab world on bipolar disorders. In an era of globalization and rapid communication, it is not clear to what extent research findings pertaining to one part of the world are by necessity applicable to other parts. Psychiatric disorders are known to be affected by the culture in which they occur, and knowledge of variations in illness presentation in different ethnic groups is also increasing. However, knowledge of variations affecting Arab populations remains quite limited. This paper provides a critical review of the literature on bipolar affective disorders in the Arab world, pointing to major gaps in knowledge and future opportunities to fill these gaps.

Reaching vulnerable populations in low-resource settings with effective business solutions is critical, given the global nature of food and nutrition security. Over a third of deaths of children under 5 years of age are directly or indirectly caused by undernutrition. The Lancet series on malnutrition (2013) estimates that over 220,000 lives of children under 5 years of age can be saved through the implementation of an infant and young child feeding and care package. A unique project being undertaken in Ghana aims to bring in two elements of innovation in infant and young child feeding. The first involves a public-private partnership (PPP) to develop and test the efficacy and effectiveness of the delivery of a low-cost complementary food supplement in Ghana called KOKO Plus™. The second involves the testing of the concepts of social entrepreneurship and social business models in the distribution and delivery of the product. This paper shares information on the ongoing activities in the testing of concepts of PPPs, social business, social marketing, and demand creation using different delivery platforms to achieve optimal nutrition in Ghanaian infants and young children in the first 2 years of life. It also focuses on outlining the concept of using PPP and base-of-the-pyramid approaches toward achieving nutrition objectives.

All living organisms depend on homeostasis, the complex set of interacting metabolic chemical reactions for maintaining life and well-being. This is no less true for psychiatric well-being than for physical well-being. Indeed, a focus on homeostasis forces us to see how inextricably linked mental and physical well-being are. This paper focuses on these linkages. In particular, it addresses the ways in which understanding of disturbed homeostasis may aid in creating classes of patients with mood and anxiety disorders based on such phenotypes. At the cellular level, we may be able to compensate for the inability to study living brain tissue through the study of homeostatic mechanisms in fibroblasts, pluripotent human cells, and mitochondria and determine how homeostasis is disturbed at the level of these peripheral tissues through exogenous stress. We also emphasize the remarkable opportunities for enhancing knowledge in this area that are offered by advances in technology. The study of human behavior, especially when combined with our greatly improved capacity to study unique but isolated populations, offers particularly clear windows into the relationships among genetic, environmental, and behavioral contributions to homeostasis.

India has experienced a rising prevalence of cardiometabolic risk factors in the past 15 years: the prevalence of diabetes has increased from 5.9% to 9.1%, hypertension from 17.2% to 29.2%, and obesity from 4% to 15%. The increase is among all socioeconomic groups and in urban and rural populations, though the quantum of change varies. A concomitant increase in per capita consumption of sugar from 22 to 55.3 g/day and total fat from 21.2 to 54 g/day was observed, with significant differences between states of high and low human development index (HDI). Per capita consumption of sugar, salt, and fat is consistently and significantly associated with overweight and obesity but variably associated with the occurrence of hypertension and diabetes. Market research shows that approximately 50–60% of total salt, sugar, and fat in Indian markets is procured by bulk purchasers, generally for manufacturing processed food items. This sector of the Indian economy is among the fastest growing, with several policy incentives. It is not clear from most of the data sets whether available information on per capita sugar, salt, and fat consumption has considered the contribution of processed and ready-to-eat food items. The unprecedented changes of rapid urbanization, mechanization, and globalization demand close monitoring of social, developmental, and economic determinants. This paper provides pieces of evidence to justify a whole-of-society (WoS) framework for monitoring the inputs, processes, and behavioral components of the National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Disease and Stroke (NPCDCS) in India.

Fortification of staple foods and commonly used condiments with vitamins and minerals has been considered one of the most cost-effective interventions to prevent and control micronutrient deficiencies. Because of its wide local consumption, acceptability, reach, and quantum of consumption, rice (Oryza sativa) far exceeds the requirements of a staple food vehicle that can be considered for fortification purposes at a population-level intervention. The World Health Organization (WHO) has the mandate to develop evidence-informed guidelines for the fortification of staple foods as a public health intervention, including rice fortification with micronutrients. The WHO, in collaboration with the Global Alliance for Improved Nutrition (GAIN), convened a consultation on “Technical Considerations for Rice Fortification in Public Health” in Geneva, Switzerland on October 9–10, 2012 to provide technical inputs to the guideline development process, particularly with reference to feasibility and implementability. The industrial and regulatory technical considerations in rice fortification, as well as the considerations for implementing it as a public health strategy and assuring equitable access and universal coverage, were reviewed in this consultation. This paper summarizes the discussions and priority research areas for the forthcoming years.

Remarkable advances in the technological capacity of modern medicine now permit the use of mechanical organ failure support deployed primarily to save life. Such technology serves as a bridge to either recovery or, when feasible, organ transplantation. However, when effective treatment options are exhausted, technological advances can be burdensome bridges to death. This paper briefly reviews the principles of management of life-threatening critical illness and the corresponding biological aspects of life, death, and organ donation, which are both informed and complicated by these technological and scientific achievements.