Circulating Myeloid-Derived Suppressor Cells Predict Differentiated Thyroid Cancer Diagnosis and Extent.

Background: Establishing the preoperative diagnosis and long-term prognosis of differentiated thyroid cancer (DTC) remain challenging in some patients. Myeloid-derived suppressor cells (MDSC) are tumor-induced cells mediating immune tolerance that are detectable in the peripheral blood of cancer patients. The authors previously developed a novel clinical assay to detect the phenotypes of two human MDSC subsets in peripheral blood, and hypothesize that higher MDSC levels measured by this assay correlate positively with both malignancy and worse patient outcomes.

Clinical practice guidelines for hypothyroidism in adults: cosponsored by the American Association of Clinical Endocrinologists and the American Thyroid Association.

Objective: Hypothyroidism has multiple etiologies and manifestations. Appropriate treatment requires an accurate diagnosis and is influenced by coexisting medical conditions. This paper describes evidence-based clinical guidelines for the clinical management of hypothyroidism in ambulatory patients.

Clinical practice guidelines for hypothyroidism in adults: cosponsored by the American Association of Clinical Endocrinologists and the American Thyroid Association.

Background: Hypothyroidism has multiple etiologies and manifestations. Appropriate treatment requires an accurate diagnosis and is influenced by coexisting medical conditions. This paper describes evidence-based clinical guidelines for the clinical management of hypothyroidism in ambulatory patients.

Emergence of biopharmaceutical innovators in China, India, Brazil, and South Africa as global competitors and collaborators.

Biopharmaceutical innovation has had a profound health and economic impact globally. Developed countries have traditionally been the source of most innovations as well as the destination for the resulting economic and health benefits. As a result, most prior research on this sector has focused on developed countries.

The case for conducting first-in-human (phase 0 and phase 1) clinical trials in low and middle income countries.

Background: Despite the increase in the number of clinical trials in low and middle income countries (LMICs), there has been little serious discussion of whether First in Human (FIH; phase 0 and phase 1) clinical trials should be conducted in LMICs, and if so, under what conditions. Based on our own experience, studies and consultations, this paper aims to stimulate debate on our contention that for products meant primarily for conditions most prevalent in LMICs, FIH trials should preferably be done first in those countries.

Discussion: There are scientific and pragmatic arguments that support conducting FIH trials in LMIC.

What could infant and young child nutrition learn from sweatshops?

Background: Adequate infant and young child nutrition demands high rates of breastfeeding and good access to nutrient rich complementary foods, requiring public sector action to promote breastfeeding and home based complementary feeding, and private sector action to refrain from undermining breastfeeding and to provide affordable, nutrient rich complementary foods. Unfortunately, due to a lack of trust, the public and private sectors, from both the North and the South, do not work well together in achieving optimal infant and young child nutrition.

Discussion: As the current debate in infant and young child nutrition is reminiscent of the "sweatshop" debate fifteen years ago, we argue that lessons from the sweatshops debate regarding cooperation between public and private sectors - and specific organizational experiences such as the Ethical Trading Initiative in which companies, trade unions, and civil society organizations work together to enhance implementation of labour standards and address alleged allegations - could serve as a model for improving cooperation and trust between public, civil society and private groups, and ultimately health, in infant and young child nutrition.

Indian vaccine innovation: the case of Shantha Biotechnics.

Background: Although the World Health Organization had recommended that every child be vaccinated for Hepatitis B by the early 1980s, large multinational pharmaceutical companies held monopolies on the recombinant Hepatitis B vaccine. At a price as high as USD$23 a dose, most Indians families could not afford vaccination. Shantha Biotechnics, a pioneering Indian biotechnology company founded in 1993, saw an unmet need domestically, and developed novel processes for manufacturing Hepatitis B vaccine to reduce prices to less than $1/dose.

Access and use of human tissues from the developing world: ethical challenges and a way forward using a tissue trust.

Background: Scientists engaged in global health research are increasingly faced with barriers to access and use of human tissues from the developing world communities where much of their research is targeted. In part, the problem can be traced to distrust of researchers from affluent countries, given the history of 'scientific-imperialism' and 'biocolonialism' reflected in past well publicized cases of exploitation of research participants from low to middle income countries.

Discussion: To a considerable extent, the failure to adequately engage host communities, the opacity of informed consent, and the lack of fair benefit-sharing have played a significant role in eroding trust.

Harnessing biodiversity: the Malagasy Institute of Applied Research (IMRA).

Background: Biopiracy - the use of a people's long-established medical knowledge without acknowledgement or compensation - has been a disturbing historical reality and exacerbates the global rich-poor divide. Bioprospecting, however, describes the commercialization of indigenous medicines in a manner acceptable to the local populace. Challenges facing bioprospectors seeking to develop traditional medicines in a quality-controlled manner include a lack of skilled labor and high-tech infrastructure, adapting Northern R&D protocols to Southern settings, keeping products affordable for the local population, and managing the threat of biopiracy.

Venture capital on a shoestring: Bioventures' pioneering life sciences fund in South Africa.

Background: Since 2000, R&D financing for global health has increased significantly, with innovative proposals for further increases. However, although venture capital (VC) funding has fostered life sciences businesses across the developed world, its application in the developing world and particularly in Africa is relatively new. Is VC feasible in the African context, to foster the development and application of local health innovation?As the most industrially advanced African nation, South Africa serves as a test case for life sciences venture funding.

Can incubators work in Africa? Acorn Technologies and the entrepreneur-centric model.

Background: Incubators are organizations that support the growth of new and typically technology-based enterprises, by providing business support services that bring together human and financial capital. Although the traditional role of incubators has been for economic development, they may also be a useful policy lever to tackle global health, by fostering the development and delivery of local health innovation.Given its high disease burden, life sciences incubators hold particular potential for Africa.