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Dalal S.,Harvard University | Beunza J.J.,Harvard University | Beunza J.J.,Public University of Navarra | Volmink J.,Stellenbosch University | And 10 more authors.
International Journal of Epidemiology | Year: 2011

Background: Sub-Saharan Africa (SSA) has a disproportionate burden of both infectious and chronic diseases compared with other world regions. Current disease estimates for SSA are based on sparse data, but projections indicate increases in non-communicable diseases (NCDs) caused by demographic and epidemiologic transitions. We review the literature on NCDs in SSA and summarize data from the World Health Organization and International Agency for Research on Cancer on the prevalence and incidence of cardiovascular diseases, diabetes mellitus Type 2, cancer and their risk factors. Methods: We searched the PubMed database for studies on each condition, and included those that were community based, conducted in any SSA country and reported on disease or risk factor prevalence, incidence or mortality. Results: We found few community-based studies and some countries (such as South Africa) were over-represented. The prevalence of NCDs and risk factors varied considerably between countries, urban/ rural location and other sub-populations. The prevalence of stroke ranged from 0.07 to 0.3%, diabetes mellitus from 0 to 16%, hypertension from 6 to 48%, obesity from 0.4 to 43% and current smoking from 0.4 to 71%. Hypertension prevalence was consistently similar among men and women, whereas women were more frequently obese and men were more frequently current smokers. Conclusions: The prevalence of NCDs and their risk factors is high in some SSA settings. With the lack of vital statistics systems, epidemiologic studies with a variety of designs (cross-sectional, longitudinal and interventional) capable of in-depth analyses of risk factors could provide a better understanding of NCDs in SSA, and inform health-care policy to mitigate the oncoming NCD epidemic. Published by Oxford University Press on behalf of the International Epidemiological Association © The Author 2011; all rights reserved.


News Article | March 2, 2017
Site: www.prweb.com

Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced that two leading analytical experts from Catalent Biologics will be presenting a workshop on the development and validation of bioassays, at the upcoming first BEBPA U.S. Bioassay Conference, to be held at the Sheraton Fisherman’s Wharf, San Francisco, on March 8 – 10, 2017. The workshop, starting at 9 a.m. on Wednesday, March 8, is entitled “The Course Awakens: Moving Bioassays from Development to Phase-Appropriate Validation,” and will be hosted by Mike Sadick, Ph.D., Principal Scientist, Biologics Analytical Services, Development; and Mike Merges, Director of Strategic Growth of Biologics Analytical Services. The day-long workshop will present a number of topics covering all aspects of phase-appropriate validations, from Investigational New Drug/Phase I through to Phase III/post-Biologic License Application, and will include both practical and theoretical approaches to development. Regulatory guidelines in the area, such as ICH Q2(R1) and USP 1033 will be addressed, compared, and contrasted as part of the session, which will be an interactive forum where advice, challenges and practical tips can be discussed openly. Dr. Sadick has an extensive background in cellular biology, cellular immunology, receptor signaling, molecular biology and biochemistry. He has more than thirty years of experience in research and industry, with prior positions at Genentech, Eli Lilly and Aptuit before joining Catalent in 2012. His current role sees him lead Catalent’s activities in potency assays, both cell-based and enzyme-linked immunosorbent assay (ELISA) based, as well as molecular biology (including cloning and quantitative polymerase chain reaction (qPCR)), and protein/protein binding assessment. He holds a bachelor’s in biology from John Hopkins University, and a master’s and doctorate, both in immunology, from the University of Washington. Mr. Merges joined Catalent in 2011 as Director of Catalent Biologics Analytical Services, focusing on the transfer, development, validation, and performance of bioassays, immunoassays, microbiological assays, and viral clearance assays. Prior to that, he was Associate Director of Bioservices for Lonza Biologics, and has also held positions at the University of Maryland’s Institute of Human Virology, the National Cancer Institute and Johns Hopkins University, where he conducted viral immunology research. He obtained his bachelor’s degree in microbiology from the Pennsylvania State University, and his master’s degree in microbiology/virology from Hood College. For more information on the conference, visit: http://www.bebpa.org/conferences/, and to arrange a meeting with any of the Catalent executives attending the event, contact Richard Kerns at NEPR - richard(at)nepr(dot)eu For more information on Catalent Biologics, visit http://www.catalentbiologics.com About Catalent Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 10,000 people, including over 1,400 scientists, at more than 30 facilities across five continents, and in fiscal 2016 generated $1.85 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit http://www.catalent.com


News Article | February 15, 2017
Site: www.prweb.com

Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced that Mr. Michael Merges, Director of Strategic Growth, Catalent Biologics Analytical Services, will be presenting at the upcoming WCBP Conference, to be held at the Mayflower Hotel, Washington DC, on Jan. 24 – 26, 2017. Mr. Merges’ presentation, on Tuesday, Jan. 24, at 1:30 p.m., is entitled “Benefits to Strategic Outsourcing,” and will discuss the underlying nature of growth in the biologics development market, which has led to bioassays being the most outsourced service by biomanufacturers, and the service expected to witness the highest future demand. The presentation will outline the principles, options and drivers for parties to create outsourcing partnerships, as well as demonstrating how such strategies can be effective through a case study. Mr. Merges joined Catalent in 2011 as Director of Catalent Biologics Analytical Services, focusing on the transfer, development, validation, and performance of bioassays, immunoassays, microbiological assays, and viral clearance assays. Prior to that, he was Associate Director of Bioservices for Lonza Biologics, and has also held positions at the University of Maryland’s Institute of Human Virology, the National Cancer Institute and Johns Hopkins University, where he conducted viral immunology research. He obtained his bachelor’s degree in microbiology from the Pennsylvania State University, and his master’s degree in microbiology/virology from Hood College. For more information on the Conference, visit: http://www.casss.org/page/WCBP1700 and to arrange a meeting with Mr. Merges at the event, contact Richard Kerns at NEPR - richard(at)nepr.eu. For more information on Catalent Biologics, visit http://www.catalentbiologics.com About Catalent Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 9,500 people, including over 1,400 scientists, at more than 30 facilities across five continents, and in fiscal 2016 generated $1.85 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit http://www.catalent.com


Background aims. Immunotherapy using γδ T cells capable of mediating antibody-dependent cellular cytotoxicity (ADCC) is a promising anti-human immunodeficiency virus (HIV) strategy. Approved aminobispohsphonate drugs, for example zoledronate (Zometa), stimulate γδ T cells in cancer patients, where they may promote direct tumor killing. Knowing that γδ T cells are modulated during HIV disease, documenting their responses and potential for controlling HIV is important. We investigated whether zoledronate/interleukin (IL)-2 could expand cytotoxic Vδ2 cells from HIV+ donors and whether these cells functioned in ADCC. Methods. Peripheral blood mononuclear cells from uninfected controls and HIV+ individuals receiving anti-retroviral therapy were treated with isopentenyl pyrophosphate (IPP) or zoledronate plus IL-2 to expand the Vδ2+ subset. Immunophenotyping and functional analyzes (cytotoxicity or cytokine expression) allowed us to compare cell properties from individual donors and to compare the responses to each stimulating agent. Results. Zoledronate stimulated a greater expansion of Vδ2 cells in HIV+ individuals compared with phosphoantigen IPP, and these cells expressed CD16. CD56 expression (a marker for cytotoxic cells) was lower on zoledronate-expanded cells, consistent with significantly lower cytotoxicity against the Daudi tumor cell line. Cells expanded with either zoledronate or IPP were active in ADCC, were similar in terms of interferon (IFN)-γ and tumor necrosis factor (TNF)-α expression, and degranulated in response to Fc receptor cross-linking. Conclusions. Zoledronate causes ex vivo expansion of Vδ2 cells from HIV+ individuals. Despite lower expression of CD56 and decreased direct cytotoxicity, these effectors were potent in ADCC. Zoledronate/IL-2- expanded cells have potential for immunotherapy to activate Vδ2 cells in HIV patients and enhance ADCC. © 2012 Informa Healthcare.


Ogundiran T.O.,University of Ibadan | Ayandipo O.O.,University of Ibadan | Ademola A.F.,University of Ibadan | Adebamowo C.A.,Institute of Human Virology | Adebamowo C.A.,University of Maryland College Park
BMC Surgery | Year: 2013

Background: Modified radical mastectomy remains the standard therapeutic surgical operation for breast cancer in most parts of the world. This retrospective study reviews mastectomy for management of breast cancer in a surgical oncology division over a ten year period. Methods. We reviewed the case records of consecutive breast cancer patients who underwent mastectomy at the Surgical Oncology Division, University College Hospital (UCH) Ibadan between November 1999 and October 2009. Results: Of the 1226 newly diagnosed breast cancer patients over the study period, 431 (35.2%) patients underwent mastectomy making an average of 43 mastectomies per year. Most patients were young women, premenopausal, had invasive ductal carcinoma and underwent modified radical mastectomy as the definitive surgical treatment. Prior to mastectomy, locally advanced tumors were down staged in about half of the patients that received neo-adjuvant combination chemotherapy. Surgical complication rate was low. The most frequent operative complication was seroma collection in six percent of patients. The average hospital stay was ten days and most patients were followed up at the surgical outpatients department for about two years post-surgery. Conclusions: There was low rate of mastectomy in this cohort which could partly be attributable to late presentation of many patients with inoperable local or metastatic tumors necessitating only palliative or terminal care. Tumor down-staging with neo-adjuvant chemotherapy enhanced surgical loco-regional tumor control in some patients. The overall morbidity and the rates of postoperative events were minimal. Long-term post-operative out-patients follow-up was not achieved as many patients were lost to follow up after two years of mastectomy. © 2013 Ogundiran et al.; licensee BioMed Central Ltd.


Tebit D.M.,Case Western Reserve University | Ndembi N.,Institute of Human Virology | Weinberg A.,Case Western Reserve University | Quinones-Mateu M.E.,Case Western Reserve University
Current HIV Research | Year: 2012

Since the beginning of the AIDS pandemic, and following the discovery of the human immunodeficiency virus (HIV) as the etiological agent of the disease, it was clear that the virus gains access to the human host predominantly through the mucosal tissue after sexual exposure. As a consequence, the female genital tract (vaginal and cervical), as well as the rectal, penile, and oral mucosae have been extensively studied over the last thirty years towards a better understanding of - and to develop strategies to prevent - sexual HIV transmission. This review seeks to describe the biology of the events leading to HIV infection through the human mucosa and introduce some of the approaches attempted to prevent the sexual transmission of HIV. © 2012 Bentham Science Publishers.


Amoroso A.,Institute of Human Virology | Etienne-Mesubi M.,Institute of Human Virology | Edozien A.,Institute of Human Virology | Ojoo S.,Institute of Human Virology | And 5 more authors.
Journal of Acquired Immune Deficiency Syndromes | Year: 2012

Background: Although used globally, little data exist on the efficacy of nevirapine (NVP) used in combination with tenofovir (TDF)/emtricitabine or lamivudine (XTC), and no large randomized prospective control trials exists comparing this combination with efavirenz (EFV)/TDF/(XTC). Methods: As part of the AIDSRelief program, a retrospective review of patient medical chart information along with a cross-sectional viral load, and adherence measurement was conducted between 2004 and 2009. An on-treatment analysis excluded patients who died, transferred out of care, or were lost to follow-up. A switch of antiretrovirals for any reason was considered a failure in the intent-to-treat analysis. Patients with only clinically relevant reasons for switching such as toxicity, adverse effects, viral failure or clinical/immunological failure, lost to follow-up, and death were considered failures as part of the modified-intent-to-treat analysis. Step-wise multiple regression analysis was used to identify variables that were associated with viral suppression. Results: A random sample of 3862 patients met criteria and were included in this analysis. In the on-treatment analysis, older age (P < 0.004) and baseline CD4 <100 cells per cubic millimeter (P < 0.021) were the most significant variables impacting viral load. Patients on TDF/XTC/EFV achieved higher rates of viral suppression compared with patients on TDF/XTC/NVP or azidothymidine (AZT)/lamivudine (3TC)/NVP. Conclusion: Our data show that patients on TDF/XTC/EFV had better outcomes than patients on TDF/XTC/NVP, AZT/3TC/EFV, or AZT/3TC/NVP. High rates of virologic suppression seen in patients on this regimen are consistent with previous studies and indicate the need to increase use of this regimen in HIV programs to promote sustainable viral suppression over time. © 2012 Lippincott Williams & Wilkins.


Poonia B.,Institute of Human Virology | Kijak G.H.,United States Military HIV Research Program | Pauza C.D.,Institute of Human Virology
PLoS ONE | Year: 2010

Background:We investigated the genetics of Fc receptors, which function as activating receptors on immune cells and help to control HIV through antibody-mediated cellular cytotoxicity. Thus, Fc receptors may be important for virus immunity but might also promote immune hyperactivation that would enhance infection. Methodology/Principal Findings: We measured abundance of low and high activity alleles in two Fc receptor genes, FCGR2A and FCGR3A, for persons with HIV disease, natural virus suppressors (HIV+, without disease) and healthy controls to show whether genotypes were associated with infection and disease. Individuals homozygous for the high activity allele of FCGR3A (158VV) were predominantly found among HIV progressors and this group was also skewed toward higher allele frequencies for the V158 variant. Both of the HIV positive groups (progressors and natural virus suppressors) had significantly higher frequencies of the V158 allele compared with uninfected controls. There were no apparent associations among FCGR2A alleles and HIV status. Conclusions/Significance:Our results indicate that high activity alleles of FCGR3A may be risk factors for HIV infection or progression and we need to understand how allelic variants affect the balance between virus control and immune activation. © 2010 Poonia et al.


Gupta R.K.,University College London | Jordan M.R.,Tufts University | Sultan B.J.,Mortimer Market Center | Hill A.,University of Liverpool | And 7 more authors.
The Lancet | Year: 2012

Background The emergence and spread of high levels of HIV-1 drug resistance in resource-limited settings where combination antiretroviral treatment has been scaled up could compromise the eff ectiveness of national HIV treatment programmes. We aimed to estimate changes in the prevalence of HIV-1 drug resistance in treatment-naïve individuals with HIV since initiation of rollout in resource-limited settings. Methods We did a systematic search for studies and conference abstracts published between January, 2001, and July, 2011, and included additional data from the WHO HIV drug resistance surveillance programme. We assessed the prevalence of drug-resistance mutations in untreated individuals with respect to time since rollout in a series of random-eff ects meta-regression models. Findings Study-level data were available for 26 102 patients from sub-Saharan Africa, Asia, and Latin America . We recorded no diff erence between chronic and recent infection on the prevalence of one or more drug-resistance mutations for any region. East Africa had the highest estimated rate of increase at 29% per year (95% CI 15 to 45; p=0·0001) since rollout, with an estimated prevalence of HIV-1 drug resistance at 8 years after rollout of 7·4% (4·3 to 12·7). We recorded an annual increase of 14% (0% to 29%; p=0·054) in southern Africa and a non-signifi cant increase of 3% (-0·9 to 16; p=0·618) in west and central Africa. There was no change in resistance over time in Latin America, and because of much country-level heterogeneity the meta-regression analysis was not appropriate for Asia. With respect to class of antiretroviral, there were substantial increases in resistance to non-nucleoside reverse transcriptase inhibitors (NNRTI) in east Africa (36% per year [21 to 52]; p<0·0001) and southern Africa (23% per year [7 to 42]; p=0·0049). No increase was noted for the other drug classes in any region. Interpretation Our fi ndings suggest a signifi cant increase in prevalence of drug resistance over time since antiretroviral rollout in regions of sub-Saharan Africa; this rise is driven by NNRTI resistance in studies from east and southern Africa. The fi ndings are of concern and draw attention to the need for enhanced surveillance and drug-resistance prevention eff orts by national HIV treatment programmes. Nevertheless, estimated levels, although increasing, are not unexpected in view of the large expansion of antiretroviral treatment coverage seen in low-income and middleincome countries-no changes in antiretroviral treatment guidelines are warranted at the moment.


Kaye J.,University of Oxford | Meslin E.M.,Indiana University Bloomington | Knoppers B.M.,McGill University | Juengst E.T.,University of North Carolina at Chapel Hill | And 12 more authors.
Science | Year: 2012

We need an international infrastructure for the ethical, legal, and social implications of genomic research.

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