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The Discovery and Properties of Avemar – Fermented Wheat Germ Extract: Carcinogenesis Suppressor

Posted in Anaerobic Glycolysis, Biomedical Measurement Science, Ca2+ triggered activation, CANCER BIOLOGY & Innovations in Cancer Therapy, Discovery process, Disease Biology, Small Molecules in Development of Therapeutic Drugs, Drug Toxicity, Experimental validation, FDA, CE Mark & Global Regulatory Affairs: process management and strategic planning - GCP, GLP, ISO 14155, Historical relevance, Intellectual Property, Innovations, Commercialization, Investment in technological breakthrough, International Global Work in Pharmaceutical, Interviews with Scientific Leaders, ISO 10993 for Product Registration: FDA & CE Mark for Development of Medical Devices and Diagnostics, Metabolomics, Nutrition, Oxidative phosphorylation, Phosphorylation, Population Health Management, Nutrition and Phytochemistry, Proteomics, Scientific & Biotech Conferences: Press Coverage, Signaling, Translational Science, Ubiquitinylation, tagged alternative medicine, Avemar, Chemotherapy, complementary medicine, Dietary supplement, experimental cancer research, fermented wheat germ extract, functional foods, gene expression, glucose consumption, pancreatic carcinoma, regulation of metabolism, RNA, tyrosine phosphorylation on June 7, 2014| Leave a Comment »

Larry H Bernstein, MD, FCAP, Contributor

Article ID #143: The Discovery and Properties of Avemar – Fermented Wheat Germ Extract: Carcinogenesis Suppressor. Published on 6/7/2014

WordCloud Image Produced by Adam Tubman

http://pharmaceuticalintelligence.com/5-6-2014/larryhbern/ The Discovery_and_Properties_of_Avemar – Fermented_ Wheat_Germ_Extract:_Carcinogenesis_Suppressor

The following discussion will be a review of the current interest in Avemar, a nontoxic, fermentation product of wheat germ extract, garnering interest with respect to alternative and complementary medicinal use.

Extracts from an interview by Sandra Cascio with Mate Hidvegi

Mate’s Transylvania Professor Lajos David was the organizer of the Department of Pharmacy of the University of Szeged in the 1920’s. He was elected as the Dean of the Faculty of Medicine, the first and only pharmacist who reached this high position at the University since. Dr. Hidvegy’s grandfather was a devout Roman catholic, who publicly opposed Nazi persecution of Jews during the Holocaust. One of his colleagues and, perhaps his best friend, was Albert Szent­Gyorgyi, the Nobel laureate who discovered vitaminC. Szent­Gyorgyi moved to the United States after World War II, where he turned to studies of muscle biochemistry. In his later years he turned to cancer research. He  theorized that a revolutionary anticancer drug could be based upon vitamin C combined with methoxy­substituted benzoquinones, the precursors of which can be found in wheat germ. After completion of the PhD, Dr. Hidvegi spent two years with the Wheat Grain Trust in Winnipeg, Canada, before returning to Hungary in 1990.  He decided to followthepathwaythat Szent­Gyorgyi was now engaged intocompletehisgoals.He contacted anoldfriend,GaborFodor, a brilliantchemist, also a collaborator withSzent­Gyorgyiincancerresearch.

He wasinvited by Hermann Esterbauer, the head of the Institute of Biochemistry at the University of Graz, to work in his laboratory. Thanks to the generosity of Professor Esterbauer,  he accomplished much at Graz  together with his student, Dr. Rita Farkas.  It was soon after Szent­-Gyorgyi’s death when, with the help of Dr. Fodor, they prepared the chemicals to make the drug Szent­-Gyorgyi had intended to make, with encouragement from the great quantum­ biochemist, Janos Ladik.  They made wheat germ extracts with the highest free benzoquinone content.This required a  fermentation process to liberate the benzoquinone moieties from the chemical bonds which keep them in natural forms: in glycosides. He recalls the purple colored active molecules in the fermentation liquid. Living cells with their exo­ and endo­enzymes are used to split bonds and make new molecules. This is also true for the manufacturing process of Avemar. This extract contains new molecules which cannot be found elsewhere.

“WhenAvemar was voted by the majority of the more than 50,000 professionals for NutrAward, it became obvious that this product is of biological efficacy  plus safety, and it is based on good science.” It received the financial support needed. From this, he was able to complete the experiments and get the approval for the registration. The time arrived when he really had to give a name to the product which had only had a code name. One late night it just came: Avemar, from the Latin prayer: Ave Maria.

Avemar with widely used chemotherapeutic drugs completely inhibited the development of metastases. Exploring its whole activity profile might even take a lifetime of research. So far he has supervised Avemar research done in Hungary, Israel, the United States, Austria, Italy, Spain, Slovakia, the Czech Republic, Germany,the United Kingdom, Russia, Australia, Korea, Vietnam. It has been a good experience to see the scientific interest it has generated worldwide. In 2009, Dr. Hidvegy received an invitation from the Nobel laureate, James Watson, co­discoverer of DNA’s double helix. It was a great honor. Avemar, he hopes,will be a significant cancer drug.

Mate Hidvegi was born in Budapest, Hungary, in 1955. He studied, then  taught at what is now Budapest University of Technology  and Economics.  After finishing university, he worked in the cereal industry and was co­developer of patented feed advisory system based on near infrared ingredient      data. In Hungary, Hidvegi was one of the pioneers in the development of           technologies for large ­scale production of instantized extracts for  therapeutic use.

 

Carcinogenesis vol.22 no.10 pp.1649–1652, 2001

Wheat germ extract inhibits experimental colon carcino-genesis in F-344 rats

Attila Zalatnai, Karoly Lapis, Bela Szende, Erzsebet Raso, Andros Telekes, Akos Resetar, and Mate Hidvegi

 

It has been demonstrated for the first time that a wheat germ extract prevents colonic cancer in laboratory animals. Four-week-old inbred male F-344 rats were used in the study. Colon carcinogenesis was induced by azoxy-methane (AOM). Ten rats served as untreated controls (group 1). For the treatment of the animals in group 2, AOM was dissolved in physiologic saline and the animals were given three weekly subcutaneous injections at 15 mg/kg body weight (b/w). In two additional groups Avemar (MSC), a fermented wheat germ extract standardized to 2,6-dimethoxy-p-benzoquinone was administered as a tentative chemo-preventive agent. MSC was dissolved in water and was given by gavage at a dose of 3 g/kg b/w once a day. In group 3, animals started to receive MSC 2 weeks prior to the first injection of AOM daily and continuously thereafter until they were killed 32 weeks later. In group 4 only the basal diet and MSC were administered. At the end of the experiment all the rats were exsanguinated under a light ether anesthesia and necropsied. Percentage of animals developing colon tumors and number of tumors per animals: group 1 – 0 and 0; group 2– 83.0 and 2.3; group 3 – 44.8 (P ≤ 0.001) and 1.3 (P ≤ 0.004); group 4 – 0 and 0. All the tumors were histologically neoplastic. The numbers of the aberrant crypt foci (ACF) per area (cm2) in group 2 were 4.85 while in group 3 the ACF numbers were 2.03 only (P ≤ 0.0001).

Table I. Macroscopic findings in the large intestines of F-344 rats treated with MSC or MSC +  AOM No. of animals     w/tumorw   Average # tumors Average diameter N 1 Untreated controls (10) 0/10 0/10 2.  AOM (47) 39/47 (83.0%) 2.3 ­+ 0.21 (range 1–8) 2.35 + 0.25 3.   MSC + AOM (29) 13/29 (44.8%) 1.3 + 0.17 (range 1–3) 2.21 + 0.12 4.  MSC (9) 0/9 0/9

Fig. 1. Experimental schedule. Colon carcinogenesis was induced by three consecutive s.c. doses of AOM 1 week apart in F-344 rats. Oral administration of MSC was started 2 weeks before the carcinogen treatments. All the animals were killed at the end of the experiment, e.g. on the 32nd week.  (not shown)

 

Summing up, although the chemoprevention of colon cancers (and their pre-neoplastic lesions) has well and long been established and could be achieved by totally different compounds, the mechanisms have still remained to be clarified. This is also true for MSC.

The exact mechanism by which the fermented wheat germ concentration can prevent colon cancer is still partly unknown. MSC did inhibit the AOM-induced ACF and colon neoplasm formation, the multiplicity of the tumors, apparently acting in the initiation phase. Regarding this, we can hypothesize that MSC acts as an immunomodulator.

 

Wheat Germ Extract Decreases Glucose Uptake and RNARibose Formation but Increases Fatty Acid Synthesis in MIAPancreatic Adenocarcinoma Cell

LG Boros, K Lapis, B Szende, R Tömösközi-Farkas, Ádám Balogh, …., and M Hidvégi

UCLA School of Medicine, Harbor-UCLA Research and Education Institute, Torrance, Ca.; First Institute of Pathology and Experimental Cancer Research, Semmelweis  Medical University, Budapest, Hungary; Central Food Research Institute, Budapest, Hungary; Department of Surgery, Albert Szent-Gyorgyi Medical and Pharmaceutical Center, School of General Medicine, University of Szeged, Szeged, Hungary; Department of Biochemistry and Molecular Biology, Institut d’Investigacions Biomediques August Pi i Sunyer, University of Barcelona, Barcelona, Spain; andDepartment of Biochemistryand Food Technology, Technical University of Budapest and Biromedicina Company, Budapest, Hungary

Pancreas 2001; 23 (2), pp. 141–147

Summary: The fermented wheat germ extract with standardized composition has potent tumor inhibitory properties. The fermented wheat germ extract controls tumor propagation. The authors show that this extract induces profound metabolic changes in cultured MIA pancreatic adenocarcinoma cells when the [1,2- ¹³C₂] glucose isotope is used as the single tracer with biologic gas chromatography–mass spectrometry.

MIA cells treated with 0.1, 1, and 10 mg/mL wheat  germ extract showed a dose-dependent decrease in cell glucose consumption, consumption, uptake of isotope into ribosomal RNA (2.4%, 9.4%, and 8.0%), and release of ¹³CO₂ . Conversely, direct glucose oxidation and ribose recycling in the pentose cycle showed a dose-dependent increase of 1.2%, 20.7%, and 93.4%. The newly synthesized fraction of cell palmitate and the ¹³C enrichment of acetyl units were also increased with all doses of wheat germ extract.

The fermented wheat germ extract controls tumor propagation primarily by regulating glucose carbon redistribution between cell proliferation–related and cell differentiation–related macromolecules. Wheat germ extract treatment is likely associated with the phosphor-ylation and transcriptional regulation of metabolic enzymes that are involved in glucose carbon redistribution between cell the direct oxidative degradation of glucose,proliferation–related structural and functional macromolecules(RNA, DNA) and the direct oxidative degradation and survival of pancreatic adenocarcinoma cells in culture.

Key Words: Pentose cycle—Ribose synthesis—Fermented wheat germ extract—Nonoxidative glucose metabolism—Cell proliferation—Avemar.

 

Fig 1 glu consumption of MIA pancreatic carcinoma cells in response to WGE

 

 

 

 

 

 

 

 

 

 

 

Figure 1. Glucose consumption of MIA pancreatic adenocarcinoma cells in response to increasing doses of fermented wheat germ extract (Avemar) treatment after 72 hours of culture. Glucose consumption (measured in milligrams) was estimated by the difference in media glucose content between Avemar-treated and control cultures. MIA cell glucose consumption was significantly inhibited in the presence of either 1 mg/mL (*p < 0.05) or 10 mg/mL (**p < 0.01) Avemar (x + SD;  n = 6).

 

fig-3-rna-syn-of-mia-pancreatic-carcinoma-cells-in-response-to-wge.jpg

 

 

 

 

 

 

 

 

 

 

 

Figure 3. Ribosomal RNA synthesis of MIA pancreatic adenocarcinoma cells in response to increasing doses of fermented wheat germ extract (Avemar) treatment after 72 hours of culture. Glucose carbon incorporation into ribose isolated from ribosomal RNA is expressed as molar enrichment. The dose-dependent decrease in of rRNA after Avemar treatment indicates that ribosomal RNA synthesis is the primary site significantly affected by all doses of Avemar treatment with a maximum decrease of 29% after 10 mg/mL treatment (x + SD; n = 9; *p < 0.05, **p < 0.01).

changes in metabolic activity indicate that Avemar treatment affects cell metabolism primarily by decreasing glucose uptake and nucleic acid ribose synthesis while increasing glucose oxidation through the oxidative reactions of the pentose cycle and fatty acid  synthesis from glucose carbon. The effect of Avemar treatment on lactate production and TCA cycle anapleurotic flux compared with glucose oxidation is less prominent

 

Fermented wheat germ extract induces apoptosis and downregulation of major histocompatibility complex class I proteins in tumor T and B cell lines

R FAJKA-BOJA, M HIDVÉGI, Y SHOENFELD, G  ION, D DEMYDENKO, R TÖMÖSKÖZI-FARKAS, et al.

INTL J ONCOLOGY 2002; 20: 563-570.

Lymphocyte Signal Transduction Laboratory, Institute of Genetics, and Cytokine Group, Institute of Biochemistry, Biological Research Center of the Hungarian Academy of Sciences, Szeged; Department of Biochemistry and Food Technology, Budapest University of Technology and Economics, Budapest, Hungary; Department of Medicine ‘B’, Center for Autoimmune Diseases, Sheba Medical Center, Tel-Hashomer, Israel; Central Food Research Institute; National Institute of Oncology; Biromedicina Co., Budapest, Hungary
Abstract. The fermented wheat germ extract (code name:  on cyto-fluorimeter using a monoclonal antibody to the  MSC, trade name: Avemar), with standardized benzoquinone non-polymorphic region of the human MHC class I. MSC  content has been shown to inhibit tumor propagation and stimulated tyrosine phosphorylation of intracellular proteins metastases formation in vivo. The aim of this study was to  understand the molecular and cellular mechanisms of the anti-tumor effect of MSC. Therefore, we have designed in vitro model experiments using T and B tumor lymphocytic cell lines. As a result of the MSC treatment, cell surface MHC class I proteins was downregulated by 70-85% compared to the non-stimulated control.

Prominent apoptosis of and the influx of extracellular Ca²⁺ resulted in elevation of the amount of the intracellular Ca²⁺ concentration. 20-40% was detected upon 24 h of MSC treatment of the cell lines. Apoptosis was measured with cytofluorimetry by staining the DNA with propidium iodide and detecting the ‘sub-G ’ cell population.

Tyrosine phosphorylation of intra-cellular proteins and elevation of the intracellular Ca²⁺ concentration were examined using immunoblotting with anti-phosphotyrosine antibody and cytofluorimetry by means of Ca²⁺ sensitive fluorescence dyes, Fluo-3AM and FuraRed-AM, respectively. MSC did not induce a similar degree of apoptosis in healthy peripheral blood mononuclear cells.

Inhibition of the cellular tyrosine phosphatase activity or Ca²⁺ influx resulted in the opposite effect – increasing or diminishing the Avemar induced apoptosis as well as the MHC class I downregulation. The level of the cell surface MHC class I molecules was analysed with indirect immunofluorescence. The benzoquinone component (2,6-dimethoxi-p-benzoquinone) in MSC induced similar apoptosis and downregulation of the MHC class I molecules in the tumor T and B cell lines to that of MSC. These results suggest that MSC acts on lymphoid tumor cells by reducing MHC class I expression and selectively promoting apoptosis of tumor cells on a tyrosine phosphorylation and Ca²⁺ influx dependent way.  One of the components in MSC, 2,6-dimethoxi-p-benzoquinone was shown to be an important factor in MSC mediated cell response.

 

Abbreviations:MHC, major histocompatibility complex;NK, natural killer;DMBQ, 2,6-dimethoxi-p-benzoquinone; FCS, fetal calf serum;PBMC, peripheral bloodmononuclear cells; TCR, T cell receptor;BCR, B cell receptor; mAb, monoclonal antibody;PMSF,phenylmethyl-sulfonylfluoride;pNPP, para-nitrophenyl-phosphate; PHA,phytohemagglutinineKey words: fermented wheat germ extract, Avemar, MSC, 2+ benzoquinone, tyrosine phosphorylation, intracellular Ca , CD45, tyrosine phosphatase, MHC class I downregulation, apoptosis

 

fig-4-apoptosis-of-t-cell-lines-induced-by-avamer.jpg

 

 

 

 

 

Figure 4. Apoptosis of tumor T cell lines and healthy lymphocytes upon MSC treatment. Jurkat cells were treated with 1 mg/ml MSC or .3 µg/ml DMBQ and PBMC were treated with 1 mg/ml
MSC for 24 h (A) or Jurkat cells were treated for 12 h (thick line in panel B). Control cells were left unstimulated (black bars in panel A or thin line on panel B). Apoptotic cells were enumerated
with the DNA analysis of the ‘sub-G ’ population (A) or with staining the cells with FITC1 labeled Annexin V
(B). Representative experiments are shown. The difference between the % of apoptosis in the case of treated and non-treated Jurkat cells was significant (MSC, p<0.001, n=14; DMBQ, p<0.05, n=3,
using  paired, two-tailed t-test). No difference was found for PBMC (n=2).

MSC treatment causes prominent apoptosis in lymphoid tumor cells but it does not induce apoptosis of healthy resting mononuclear cells. Moreover, although MSC blocks the proliferation of PBM cells stimulated with PHA, it does not induce apoptosis in PHA stimulated cells (data not shown).

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@Stanford University – Rapid Language Evolution in 19th-century Brazil: Data Mining, Literary Analysis and Evolutionary Biology – A Study of Six Centuries of Portuguese-language Texts

Posted in Academic Publishing, Genome Biology, Interviews with Scientific Leaders, Population Health Management, Genetics & Pharmaceutical, Population Health Management, Nutrition and Phytochemistry, Statistical Methods for Research Evaluation on June 5, 2014| Leave a Comment »

@Stanford University – Rapid Language Evolution in 19th-century Brazil: Data Mining, Literary Analysis and Evolutionary Biology – A Study of Six Centuries of Portuguese-language Texts

Reporter: Aviva Lev-Ari, PhD, RN

Article ID #142: @Stanford University – Rapid Language Evolution in 19th-century Brazil: Data Mining, Literary Analysis and Evolutionary Biology – A Study of Six Centuries of Portuguese-language Texts. Published on 6/5/2014

WordCloud Image Produced by Adam Tubman

Stanford Report, June 4, 2014

Stanford collaboration offers new perspectives on evolution of Brazilian language

Using a novel combination of data mining, literary analysis and evolutionary biology to study six centuries of Portuguese-language texts, Stanford scholars discover the literary roots of rapid language evolution in 19th-century Brazil.

BY TOM WINTERBOTTOM
The Humanities at Stanford

L.A. Cicero Stanford biology Professor Marcus Feldman, left, and Cuahtemoc Garcia-Garcia, a graduate student in Iberian and Latin American Cultures, combined forces to investigate the evolution of Portuguese as spoken in Brazil.

 

Literature and biology may not seem to overlap in their endeavors, but a Stanford project exploring the evolution of written language in Brazil is bringing the two disciplines together.

Over the last 18 months, Iberian and Latin American Cultures graduate student Cuauhtémoc García-García and biology Professor Marcus Feldman have been working together to trace the evolution of the  Brazilian Portuguese language through literature.

By combining Feldman’s expertise in mathematical analysis of cultural evolution with García-García’s knowledge of Latin American culture and computer programming, they have produced quantifiable evidence of rapid historical changes in written Brazilian Portuguese in the 19th and 20th centuries.

Specifically, Feldman and García-García are studying the changing use of words in tens of thousands of texts, with a focus on the personal pronouns that Brazilians used to address one another.

Their digital analysis of linguistics development in literary texts reflects Brazil’s complex colonial history.

The change in the use of personal pronouns, a daily part of social and cultural interaction, formed part of an evolving linguistic identity that was specific to Brazil, and not its Portuguese colonizers.

“We believe that this fast transition in the written language was due primarily to the approximately 300-year prohibition of both the introduction of the printing press and the foundation of universities in Brazil under Portuguese rule,” García-García said.

What Feldman and García-García found was that spoken language did in fact evolve during those 300 years, but little written evidence of that process exists because colonial restrictions on printing and literacy prevented language development in the written form.

A national sentiment of “write as we speak” arose in Brazil after Portuguese rule ended. García-García said their data shows an abrupt introduction in written texts of the spoken pronouns that were developed during the 300-year colonization period.

Drawing on Feldman’s experience with theoretical and statistical evolutionary models, García-García developed computer programs that count certain words to see how often they appear and how their use has changed over hundreds of years.

In Brazilian literary works produced in the post-colonial period, Feldman said, they have “found examples of written linguistic evolution over short time periods, contrary to the longer periods that are typical for changes in language.”

The findings will figure prominently in García-García’s dissertation, which addresses the transmission of written language across time and space.

The project’s source materials include about 70,000 digitized works in Portuguese from the 13th to the 21st century, ranging from literature and newspapers to technical manuals and pamphlets.

García-García, a member of The Digital Humanities Focal Group at Stanford, said their research “shows how written language changed, and through these changes in pronoun use, we now have a better understanding of how Brazilian writing evolved following the introduction of the printing press.”

Feldman, a population geneticist and one of the founders of the quantitative theory of cultural evolution, said he sees their project as a natural approach to linguistic evolution.

“I believe that evolutionary science and the humanities have a lot to offer each other in both theoretical and empirical explorations,” Feldman said.

Language by the numbers

García-García became interested in language evolution while studying Brazilian Portuguese under the instruction of Stanford lecturer Lyris Wiedemann. He approached Feldman, proposing an evolutionary study of Brazilian Portuguese, and Feldman agreed to help him analyze the data. García-García then enlisted Stanford lecturer Agripino Silveira, who provided linguistic expertise.

García-García worked with Stanford Library curators Glen Worthey, Adan Griego and Everardo Rodriguez for more than a year to develop the technical infrastructure and copyright clearance he needed to access Stanford’s entire digitized corpus of Portuguese language texts. After incorporating even more source material from the HathiTrust digital archive, García-García began the time-consuming task of “cleaning” the corpus, so data could be effectively mined from it.

“Sometimes there were duplicates, issues with the digitization, and works with multiple editions that created ‘noise’ in the corpus,” he said.

Following months of preparation, Feldman and García-García were able to begin data mining. Specifically, they counted the incidences of two pronouns, tu and você, which both mean the singular “you,” and how their incidence in literature changed over time.

“After running various searches, I could correlate results and see how and when certain words were used to build up a comprehensive image of this evolution,” he said.

“Tu was – and still is – used in Portugal as the typical way to say ‘you.’ But, in Brazil, você is the more normal way to say it, particularly in major cities like Rio de Janeiro and São Paulo where the majority of the population lives,” García-García explained.

However, that was not always the case. When Brazil was a Portuguese colony, and up until the arrival of the printing press in1808, tu was the canonical form in written language.

As part of the run-up to independence in 1822, universities and printing presses were established in Brazil for the first time in 1808, having been prohibited by the Portuguese colonizers in what García-García calls “cultural repression.”

By the late 19th century, você emerged as the way to address people, shedding part of the colonial legacy, and tu quickly became less prominent in written Brazilian Portuguese.

“Our findings quantifiably show how pronoun use developed. We have found that around 1840, vocêwas used about 10-15 percent of the time by authors to say ‘you.’ By the turn of the century, this had increased to about 70 percent,” García-García said.

“Our data suggest that você was rarely used in the late 17th and 18th centuries, but really appears and takes hold in the middle of the 19th century, a few decades after 1808. Thus, the late arrival of the printing press marks a critical point for understanding the evolution of written Portuguese in Brazil, ” he said.

From Romanticism to realism

Their research revealed an intriguing literary coincidence – the period of transition from tu to vocêcorrelated with the broad change in the dominant literary genre in Brazilian literature from European Romanticism to Latin American realism.

Interestingly, the researchers noticed that the rapid change was most evident several decades after Brazil’s independence in the 1820s because it took that long for Brazilian writers to develop their own voice and style.

For centuries Brazilian writers were forced to write in the style of the Portuguese, but as García-García said, “with their new freedom they wanted to write stories that reflected their national identity.”

“Machado de Assis, arguably Brazil’s greatest author, is a fine example. His early novels are archetypally Romanticist, and then his later novels are deeply Realist, and the use of the pronouns shift from one to the other,” García-García said.

Nonetheless, in Machado’s work there is sometimes a purposeful switch back to the tu form if, for example, the author wanted to evoke a certain sentiment or change the narrative voice.

“The data-mining project cannot ascertain subtle uses of words and how, in some works, the pronouns are ‘interchangeable,'” he added.

Computational expertise was no substitute for literary expertise, and García-García used the two disciplines in tandem to get a clearer picture in his data.

“I had to stop using the computer and go back to a close reading of a large sample of books, and the literary genre change reflects this period of post-colonial social and historical change,” he said.

Feldman and García-García hope to use their methodology to explore different languages.

“Next we hope to study the digitized Spanish language corpus, which currently comprises close to a quarter of a million works from the last 900 years,” García-García said.

Tom Winterbottom is a doctoral candidate in Iberian and Latin American Cultures at Stanford. For more news about the humanities at Stanford, visit the Human Experience.

Media Contact

Corrie Goldman, director of humanities communication: (650) 724-8156, corrieg@stanford.edu

 

SOURCE

http://news.stanford.edu/news/2014/june/evolution-language-brazil-060414.html

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Bristol-Myers Squibb: A global BioPharma leader – Tracing the innovative biotech core of $3.7 billion R&D Investment and $16.4 billion in Net Sales

Posted in Pharmaceutical Analytics, Pharmaceutical Industry Competitive Intelligence, Pharmaceutical R&D Investment, Pharmacogenomics, Population Health Management, Genetics & Pharmaceutical, Population Health Management, Nutrition and Phytochemistry, Regulated Clinical Trials: Design, Methods, Components and IRB related issues, Technology Transfer: Biotech and Pharmaceutical, Translational Science on May 12, 2014| Leave a Comment »

Bristol-Myers Squibb (BMS): A global BioPharma leader – Tracing the innovative biotech core of $3.7 billion R&D Investment and $16.4 billion in Net Sales

Reporter: Aviva Lev-Ari, PhD, RN

 

BMS’s  innovative biotech core represents +150 years of American leadership in Life Sciences and Pharmaceutics.

History

Our company has a strong legacy of innovation that began in New York in 1858 when Edward R. Squibb, M.D., founded a pharmaceutical company in Brooklyn, and in 1887 when two friends, William McLaren Bristol and John Ripley Myers purchased a struggling drug manufacturing firm in Clinton. Together, they laid the foundation for our company today — a global BioPharma leader that continues this legacy of innovation.

• 1858
• 1878
• 1898
• 1918
• 1938
• 1958
• 1978
• 1998
• 2009

As a young U.S. Navy doctor, Edward Robinson Squibb (1819-1900) was so unimpressed by the quality of medicines available on ships during the Mexican War that he pitched the unfit drugs overboard. In 1858, he founded his own pharmaceutical laboratory in Brooklyn, New York. E.R. Squibb, M.D. was dedicated to the production of consistently pure medicines.

1858

Squibb became the source of medicines for the Union Army during the Civil War. He invented the Squibb pannier—a compact wooden medicine chest used on the battlefield—filled with some 50 medicines to treat casualties. The chest sold for about $100, and included ether and chloroform for use as an anesthetic during amputations, quinine and whiskey to treat symptoms of malaria, and herbal treatments for dysentery and other diseases that ravaged the unsanitary military camps.

1860

August 2012

Bristol-Myers purchased Clairol, a company founded by the husband-and-wife team of Lawrence Gelb and Joan Clair. Clairol transformed hair coloring from a difficult-to-use specialty item into a highly successful mainstream consumer product.

1959

E.R. Squibb & Sons marketed the world’s first electronic toothbrush in 1961. By 1990 more than 150 other brands of automatic toothbrushes were introduced, most of which essentially imitated the original Squibb model invented by Professor Philippe G. Woog.

1961

1967

Bristol-Myers acquired Mead Johnson & Company, a leader in science-based infant and children’s nutrition. Mead Johnson introduced its first baby formula in 1910 and over the decades expanded into vitamins, pharmaceutical products and prenatal nutrition. The Enfamil® brand grew to be recognized worldwide for its leadership in pediatric nutrition.

1967

Squibb delved into cancer research, discovering and developing hydroxyurea for leukemia and advanced ovarian cancer.

For a time, Bristol-Myers was in show biz. In 1970, the company formed Palomar Pictures, which produced “The Taking of the Pelham One, Two, Three,” starring Walter Matthau and Robert Shaw, and “The Stepford Wives,” starring Katharine Ross and Paula Prentiss. Palomar was terminated in 1974.

1970

Squibb established worldwide headquarters in Princeton, New Jersey. It also expanded facilities for the Squibb Institute in Princeton, New Jersey. This expansion allowed Squibb to make more groundbreaking discoveries and advancements in medical research.

1971

In the 1970s Bristol-Myers introduced several early medicines, beginning in 1973 with BLENOXANE® (bleomycin sulfate) for squamous cell cancers, head and neck cancers, and non-Hodgkins lymphomas; followed in 1974 with MUTAMYCIN® (mitomycin) for bone cancer and stomach and pancreas tumors; in 1976 with CEENU® (lomustine), a chemotherapy product for brain cancer and Hodgkins lymphoma; in 1977 with BICNU (carmustine), for treatment of brain and lymphatic cancers; and in 1978 with anticancer agents PLATINOL and LYSODREN (mitotane).

1973

Squibb researchers Miguel A. Ondetti (on left) and David W. Cushman created CAPOTEN (captopril)®; the first in a new class of high blood pressure agents called ACE (angiotensin-converting enzyme) inhibitors. CAPOTEN was an important new medical discovery for the treatment of patients with high blood pressure.

1975

Squibb sold a dental bandage in the 1970s that maintained its stickiness on warm, moist surfaces. At the time, ostomy patients were forced to use irritating substances such as rubber cement and adhesive tape to secure their ostomy pouches to their bodies. Squibb formed ConvaTec as a separate division in 1978 to develop adhesive skin barriers and products that could give people with an ostomy new freedom. Headquartered in Skillman, New Jersey, ConvaTec grew into a global company with 3,000 employees in 100 countries.

1978

Bristol-Myers marketed VEPESID® (etoposide) for cancer.

1983

Bristol-Myers opened a state-of-the-art research complex in Wallingford, Connecticut, designed to house more than 800 scientists and support staff. In 1995, this facility was named the Richard L. Gelb Center for Pharmaceutical Research and Development after the former Bristol-Myers chairman and CEO.

1986

Bristol-Myers merged with Squibb, creating a global leader in the health care industry. The merger created Bristol-Myers Squibb company, which was then the world’s second-largest pharmaceutical enterprise.

1989

PARAPLATIN® (carboplatin) was approved for the treatment of recurrent ovarian cancer.

The U.S. Food and Drug Administration approved VIDEX® (didanosine).

VIDEX® (didanosine)
Prescribing Information including Boxed WARNINGS
Medication Guide

1991

Approvals in 1991 included two cardiovascular medicines, PRAVACHOL® (pravastin sodium) and MONOPRIL® (fosinopril sodium).

PRAVACHOL® (pravastatin sodium)
Prescribing Information

Bristol-Myers Squibb developed a new compound, TAXOL® (paclitaxel). The company invested hundreds of millions of dollars to supply TAXOL for clinical trials, prepare data for regulatory submission and develop alternative sources of TAXOL (which originally derived from the bark of the endangered Pacific Yew tree). TAXOL launched in 1993.

An antibiotic, CEFZIL® (cefprozil) was approved in 1992.

1992

The company completed its acquisition of Union Pharmacologique Scientifique Appliquee (UPSA), a leading manufacturer of pharmaceutical and consumer medicines, based in France. It acquired GLUCOPHAGE® (metformin hydroxchloride), from Lipha Pharmaceuticals, Inc. and received FDA approval of ZERIT® (stavudine).

GLUCOPHAGE® (metformin hydrochloride)
Prescribing Information

ZERIT® (stavudine)
Prescribing Information including Boxed WARNINGS
Medication Guide

1994

The company had more than 60 product lines with $50 million or more in annual sales worldwide. PRAVACHOL® (pravastatin sodium) granted expanded usage from the FDA.

PRAVACHOL® (pravastin sodium)
Prescribing Information including Boxed WARNINGS

1995

The company opened a 433-acre research campus in Hopewell, New Jersey. Two important new medicines codeveloped with Sanofi-Sythelabo received approvals: AVAPRO® (irbesartan) and PLAVIX® (clopidogrel bisulfate).PLAVIX® would become the company’s leading product.PLAVIX® (clopidogrel bisulfate)
Prescribing Information including Boxed WARNING Medication Guide
Product Website

1997

 

The FDA granted clearance to market EXCEDRIN® Migraine for the relief of migraine headache pain and associated symptoms. Excedrin became the first migraine headache medication available to consumers without a prescription.

1998

President Bill Clinton awarded the National Medal of Technology to Bristol-Myers Squibb —America’s highest honor for technological innovation—“for extending and enhancing human life through innovative pharmaceutical research and development, and for redefining the science of clinical study through groundbreaking and hugely complex clinical trials that are recognized models in the industry.”

Bristol-Myers Squibb announced SECURE THE FUTURE®, a $100 million commitment to advance HIV/AIDS research and community outreach programs in seven African countries: Botswana, Namibia, Lesotho, Swaziland, Uganda, Burkina Faso and Tanzania.

1999

Bristol-Myers Squibb, together with four other pharmaceutical companies and international agencies, joined the UNAIDS Drug ACCESS Initiative. The ACCESS program aimed to make antiretroviral medicines and therapies more widely available in African countries by reducing prices. The company offered to lower the prices of HIV/AIDS medicines in those countries by 90 percent.

2000

Bristol-Myers Squibb committed $15 million for extending SECURE THE FUTURE® to four Western African countries—Burkina Faso, Côte d’Ivoire, Mali and Senegal.

Bristol-Myers Squibb announced a new strategy that included a sharpened focus on medicines and an aggressive external development program. As part of this new strategy, the company sold its Clairol business.

The company launched GLUCOVANCE® (glyburide and metformin hydrochloride), a single-pill combination of metformin and glyburide. It also launched GLUCOPHAGE XR (metformin hydrochloride), a once-daily formulation of GLUCOPHAGE.

GLUCOVANCE® (glyburide and metformin hydrochloride)
Prescribing Information 

GLUCOPHAGE® (metformin hydrochloride)
Prescribing Information

GLUCOPHAGE® XR EXTENDED RELEASE (metformin hydrochloride)
Prescribing Information

Bristol-Myers Squibb was chosen “America’s Most Admired Pharmaceutical Company” by FORTUNE Magazine.

2001

The Bristol-Myers Squibb Children’s Hospital opened in March 2001 as part of the Robert Wood Johnson University Hospital in New Brunswick, New Jersey. The first freestanding children’s hospital in the state, the hospital offered care without regard to the family’s ability to pay and offered more than 45 pediatric specialties.

The company announced the purchase of DuPont Pharmaceuticals Company for $7.8 billion with the intention to further strengthen Bristol-Myers Squibb’s medicines business. With the DuPont acquisition, Bristol-Myers Squibb added SUSTIVA® (efavirenz) and COUMADIN® (warfarin sodium) to its portfolio. The company also acquired Bristol-Myers Squibb Medical Imaging.

SUSTIVA® (efavirenz)
Prescribing Information 
Product Website

COUMADIN® (warfarin sodium)
Prescribing Information including Boxed WARNING Medication Guide
Product Website

The U.S. FDA approved ABILIFY® (aripiprazole) in November. It was jointly marketed in the U.S. by Bristol-Myers Squibb and Otsuka America Pharmaceutical.

ABILIFY® (aripiprazole)
Prescribing Information including Boxed WARNINGS
Medication Guide
Product Website

2002

The company sponsored the Bristol-Myers Squibb TOUR OF HOPE™, an unprecedented week-long coast-to-coast cycling event. En route, the 26-member team of cancer survivors, caregivers, physicians, nurses and researchers raised awareness of cancer research and the importance of clinical trials in developing new treatments. Building on the success of the 2003 event, Bristol-Myers Squibb again to sponsored the 2004 Tour of Hope coast-to-coast cycling event.

2003

In July, REYATAZ® (atazanavir sulfate) was introduced in the U.S.

REYATAZ® (atazanavir sulfate)
Prescribing Information
Product Website

In February, the U.S. FDA approved ERBITUX® (cetuximab), co-developed and co-marketed with ImClone Systems Incorporated.

ERBITUX® (cetuximab)
Prescribing Information including Boxed WARNINGS
Product Website

2004

in March, the U.S. FDA approved BARACLUDE® (entecavir). In late December, the U.S. FDA approved ORENCIA® (abatacept).

BARACLUDE® (entecavir)
Prescribing Information including Boxed WARNINGS
Product Website

ORENCIA® (abatacept)
Prescribing Information 
Product Website

2005

The U.S. FDA approved SPRYCEL®(dasatinib) in June.

SPRYCEL®(dasatinib)
Prescribing Information
Product Website

2006

In July, Bristol-Myers Squibb and Gilead Sciences announced the U.S. FDA approval of ATRIPLA® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg).

ATRIPLA® (efavirenz/emtricitabine/tenofovir disoproxil fumarate)
Prescribing Information including Boxed WARNINGS
Product Website

Bristol-Myers Squibb announced a new strategy to transform itself from a midcap pharmaceutical company to a next-generation BioPharma company focused on the discovery and development of innovative medicines to fight serious diseases. To accelerate this transformation, the company introduced the String of Pearlsapproach to complement and enhance its internal capabilities with a suite of innovative alliances, partnerships and acquisitions with small and large companies.

2007

In October, Bristol-Myers Squibb announced U.S. FDA approval of IXEMPRA™(ixabepilone).

IXEMPRA™(ixabepilone)
Prescribing Information including Boxed WARNING
Product Website

Bristol-Myers Squibb acquired Adnexus Therapeutics, developer of a new class of biologics called Adnectins™. The acquisition helped advance Bristol-Myers Squibb’s biologics strategy across multiple therapeutic areas and included a Phase I oncology biologic, CT-322. Adnexus was the first acquisition in the company’s String of Pearls strategy, which aims to accelerate the discovery and development of new therapies with innovative alliances, partnerships and acquisitions.

Underscoring its worldwide commitment to children with HIV/AIDS, Bristol-Myers Squibb opened a new clinical center at the Bristol-Myers Squibb Children’s Hospital at Robert Wood Johnson University Hospital in New Brunswick, New Jersey. Dedicated to the research and treatment of children’s immune system disorders and infectious diseases, the Bristol-Myers Squibb Pediatric Infectious Disease and Immunology Center was made possible by a $5 million gift from the Bristol-Myers Squibb Foundation.

Bristol-Myers Squibb sold its Medical Imaging business to the private equity firm Avista Capital Partners for $525 million, as part of its effort to focus on its core pharmaceutical pipeline. Bristol-Myers Squibb also sold its ConvaTec business unit to Nordic Capital Fund VII and Avista Capital Partners for $4.1 billion. ConvaTec was a world leader in the development and marketing of innovative wound therapeutics and ostomy care products.

2008

Bristol-Myers Squibb announced in April 2008 its plan to sell approximately 10-20 percent of Mead Johnson Nutrition Company stock to the public through an IPO and to retain at least an 80 percent equity interest for the foreseeable future. This announcement, in addition to the Medical Imaging and ConvaTec sales, was part of the BioPharma transformation to better focus Bristol-Myers Squibb on its biopharmaceutical business.

Bristol-Myers Squibb entered into an exclusive agreement with KAI Pharmaceuticals, Inc., a privately held biotechnology company, to globally develop and commercialize a therapy for cardiovascular diseases.

Bristol-Myers Squibb purchased Kosan Biosciences, a cancer therapeutics company based in California, for approximately $190 million. This acquisition enhanced the company’s pipeline with compounds in two important classes of anticancer agents.

Bristol-Myers Squibb entered into an exclusive agreement with PDL BioPharma of Redwood City, California to develop and globally commercialize a therapy for multiple myeloma.

Bristol-Myers Squibb entered into a global collaboration with Exelixis, a biotechnology company based in San Francisco, California, to develop and commercialize two novel therapies: one for medullary thyroid cancer and the other as a treatment for advanced solid tumor malignancies.

 

Bristol-Myers Squibb entered into a global collaboration with ZymoGenetics of Seattle, Washington to develop and commercialize PEG-Interferon lambda, a new treatment for hepatitis C.

2009

Bristol-Myers Squibb entered into a global collaboration with Nissan Chemical Industries and Teijin Pharma for the development and commercialization of an oral atrial-selective antiarrhythmic medication.

In late July, Bristol-Myers Squibb announced the FDA approval of ONGLYZA™ (saxagliptin).

ONGLYZA™ (saxagliptin)
Prescribing Information
Product Website

Bristol-Myers Squibb acquired Medarex Inc., a biotech company and a partner since 2005. This acquisition was the largest String of Pearls transaction to date, and significantly expanded Bristol-Myers Squibb’s oncology and immunology pipeline, positioned the company for long-term leadership in biologics and allowed it to gain full rights for ipilimumab.

Bristol-Myers Squibb entered into a global collaboration with Alder Biopharmaceuticals Inc. of Bothell, Washington, to develop and commercialize a novel investigational biologic for the treatment of rheumatoid arthritis.

On December 23, the company completed its strategic split-off of its shares of Mead Johnson. The split-off focuses Bristol-Myers Squibb completely on its biopharmaceutical business, and completed the company’s transformation to a BioPharma leader.

Bristol-Myers Squibb and Allergan, Inc. announced a global agreement for the development and commercialization of an oral medication for the treatment of neuropathic pain.

2010

In November, KOMBIGLYZE™ XR (saxagliptin and metformin HCL extended release) approved in the U.S.

KOMBIGLYZE™ XR (saxagliptin and metformin HCL extended release)
Prescribing Information including Boxed WARNINGS

In December, Bristol-Myers Squibb acquired the worldwide rights from Oncolys BioPharma Inc. to manufacture, develop and commercialize festinavir, a once-a-day, orally available nucleoside reverse transcriptase inhibitor.

In March, YERVOY™ (ipilimumab) was approved by the U.S. FDA.

YERVOY™ (ipilimumab)
Prescribing Information including Boxed WARNING
Medication Guide
REMS Materials
Product Website

2011

In June, NULOJIX® (belatacept) was approved by the U.S. FDA.

NULOJIX® (belatacept)
Prescribing Information including Boxed WARNINGS 
Medication Guide
REMS Materials
Product Website

In July, Bristol-Myers Squibb and Innate Pharma announced a global agreement for the development and commercialization of an investigational immuno-oncology biologic.

In September, Bristol-Myers Squibb acquired Amira Pharmaceuticals, a small-molecule pharmaceutical company focused on the discovery and early development of new drugs to treat inflammatory and fibrotic diseases.

In September, Bristol-Myers Squibb and Ono Pharmaceutical Co., Ltd., entered into a strategic agreement to expand Bristol-Myers Squibb’s territorial rights to an investigational cancer immunotherapy, an anti-PD-1 antibody, and for the co-development and co-commercialization of Orencia in Japan.

ORENCIA® (abatacept)
Prescribing Information 
Product Website

In September, Bristol-Myers Squibb and Ambrx, Inc., announced a collaboration to research, develop and commercialize novel biologics programs in diabetes and heart failure.

In October, Bristol-Myers Squibb and Gilead Sciences, announced licensing agreement for development and commercialization of new fixed-dose combination pill for people living with HIV.

In November, Bristol-Myers Squibb and ASLAN Pharmaceuticals announced an innovative partnership to license and develop an investigational oncology compound.

In February 2012, Bristol-Myers Squibb acquired Inhibitex, Inc.

2012

In August 2012, Bristol-Myers Squibb acquired Amylin Pharmaceuticals, a biopharmaceutical company focused on the research, development and commercialization of a franchise of GLP-1 agonists for the treatment of type 2 diabetes.

In December, ELIQUIS® (apixaban) was approved by the U.S. FDA.

ELIQUIS® (apixaban)
Prescribing Information including Boxed WARNING
Medication Guide
REMS Materials
Product Website

In February 2014, Bristol-Myers Squibb sold its global diabetes business to AstraZeneca. The transaction includes the rights to Bristol-Myers Squibb’s global diabetes business that was part of its collaboration with AstraZeneca, the former Amylin manufacturing facility in West Chester, Ohio, and also covers the future purchase by AstraZeneca of Bristol-Myers Squibb’s Mount Vernon, Indiana, manufacturing facility approximately 18 months following the close of the deal.

2014

SOURCE

http://www.bms.com/ourcompany/Pages/history.aspx

 

Key Facts

Chief Executive Officer:	Lamberto Andreotti
Headquarters:	New York City
Business:	Biopharmaceuticals
Web Address:	www.bms.com
NYSE Listing:	BMY
Net Sales:	$16.4 billion in 2013
R&D Investment:	$3.7 billion in 2013
2013 Largest-Selling Products:	ABILIFY®, $2.3 billion SUSTIVA® franchise, $1.6 billion REYATAZ®, $1.6 billion BARACLUDE®, $1.5 billion ORENCIA® $1.4 billion SPRYCEL® $1.3 billion YERVOY® $960 million
Selected Key Products:	ABILIFY® (aripiprazole) ATRIPLA® (efavirenz / emtricitabine / tenofovir disoproxil fumarate) BARACLUDE® (entecavir) ELIQUIS® (apixaban) ERBITUX® (cetuximab) NULOJIX® (belatacept) ORENCIA® (abatacept) REYATAZ® (atazanavir sulfate) SPRYCEL® (dasatinib) SUSTIVA® (efavirenz) YERVOY® (ipilimumab)
Principal Locations:	Worldwide Facilities

 

Please click on the product links to see the Full Prescribing Information for ABILIFY®, ATRIPLA®,BARACLUDE®, ELIQUIS®, ERBITUX®, NULOJIX®, ORENCIA®, PLAVIX®, REYATAZ®, SPRYCEL®,SUSTIVA®, and YERVOY®, including Boxed WARNINGS for ABILIFY®, ATRIPLA®, BARACLUDE®,ELIQUIS®, NULOJIX®, and Boxed WARNINGS for YERVOY® regarding immune-mediated adverse reaction and Boxed WARNINGS for ERBITUX® regarding infusion reactions and cardiopulmonary arrest.

 

February, 2014

SOURCE

http://www.bms.com/ourcompany/Pages/keyfacts.aspx

Achievements What sets Bristol-Myers Squibb apart? It’s our commitment to patients with serious diseases, and our focus on finding innovative medicines to combat those diseases.Over the years, Bristol-Myers Squibb and its employees have received numerous distinguished awards and recognitions, including the National Medal of Technology, the Lasker Award for Medical Research and the Prix Galien Award. Also, we’ve been hailed year after year as one of the best companies for working mothers, a great place to work for scientists and an acknowledged industry leader in environment, health and safety. Below is a selection of awards and recognitions we have received. In April 2014, Bristol-Myers Squibb ranked first among health care companies on Corporate Responsibility magazine’s 2014 list of the 100 Best Corporate Citizens. Bristol-Myers Squibb is the only company to achieve the No. 1 ranking three times, including 2009 and 2012, and has ranked among the top 10 each of the last six years. In September 2013, Bristol-Myers Squibb was recognized as one of the 2013 Working Mother 100 Best Companies – marking the 16th consecutive year that our company has made the list. The company was recognized for its commitment to progressive workplace programs, such as child care, flexibility and paid family leave. In May, Bristol-Myers Squibb received a 2013 Environmental Tracking (ET) Carbon Ranking Leader Award as a result of being named a top 10 company in the 2013 ET North America 300 Carbon Ranking report, issued by the Environmental Investment Organization. Our company ranked in the top 30 in the 2013 ET Global 800 Carbon Ranking. In April, Bristol-Myers Squibb was chosen as one of the 2013 Top 50 Companies for Diversity by Diversity Inc. The ranking is based on a company’s answers to a detailed survey divided into four equally weighted areas: CEO Commitment, Human Capital, Corporate and Organizational Communications and Supplier Diversity. This year, 893 companies participated in the survey. For the eighth year in a row, Bristol-Myers Squibb received the top rating of 100 percent in the Corporate Equality Index. The report, released annually by theHuman Rights Campaign Foundation — the nation’s largest lesbian, gay, bisexual and transgender civil rights organization — provides an in-depth analysis and rating of large U.S. employers and their policies and practices. This year’s index rated 688 businesses. In February 2013, the National Association for Female Executives selected Bristol-Myers Squibb as one of the Top 50 Company for Executive Women, for the 11th consecutive year. Companies on this year’s list of 50 companies must have at least two women on the board of directors, a significant number of women in senior ranks and programs and policies that support women’s advancement. In July 2012, Ethisphere Institute, a leading international think-tank dedicated to the research and promotion of best practices in corporate ethics and compliance, awarded Bristol-Myers Squibb the Compliance Leader Verification Award. The award recognizes companies with best-in-industry ethics and compliance programs — those organizations that have made the decision to proactively invest resources in compliance, sending a clear signal to key stakeholders that compliance and ethics are an absolute organizational priority. In 2011, Bristol-Myers Squibb received a Prime Company rating for the fourth time in a row from oekom research, a leading European sustainability rating firm. Using social and environmental criteria, Prime Status is awarded to companies that are among the leaders in their industry. Bristol-Myers Squibb was recognized as 78th among 500 of America’s largest corporations in Newsweek’s 2012 Green Rankings. In January 2011, Bristol-Myers Squibb was recognized by R&D Directions magazine as having the “Most Innovative Pipeline” within the pharmaceutical industry. According to a report released by the Roberts Environmental Center at Claremont McKenna College, Bristol-Myers Squibb earned the highest score in the pharmaceutical sector for sustainability reporting. The report compiled Pacific Sustainability Index scores evaluating the environmental and social reporting of the 26 largest pharmaceutical companies worldwide. Bristol-Myers Squibb was recognized as the 2009 Trailblazer Company of the Yearby PM360 magazine. Among the criteria for selection were civic involvement, patient access, environmental consciousness, employee development and innovation. Our corporate website was recognized with the Best in Class award for a pharmaceutical company in 2009 by the Interactive Media Awards. Bristol-Myers Squibb was recognized in the 2009 Dow Jones Sustainability North America Index of leading sustainability-driven companies. Bristol-Myers Squibb’s Investor Relations department was rated the best in the pharmaceutical business by investors polled by Institutional Investor magazine, a leading international business-to-business publisher focused primarily on international finance. Bristol-Myers Squibb awarded the Allicense 2009 Breakthrough Alliance Award for collaboration with Exelixis. This is the second year in a row that the company has been presented with this prestigious recognition, which honors the world’s best and most innovative partnerships between biotechnology and pharmaceutical companies. FORTUNE China named Bristol-Myers Squibb China a Top Ten Green Company for 2009 in recognition of Bristol-Myers Squibb’s hepatitis awareness, prevention and care efforts in Asia. Since 2002, Bristol-Myers Squibb China has partnered with the Bristol-Myers Squibb Foundation and local non-profit organizations on 11 hepatitis prevention and control projects that have directly benefited seven million people. Barron’s 2009 Most Respected Companies Survey includes Bristol-Myers Squibb as theworld’s 40th most respected company. The survey reflects opinions of money managers for the 100 largest public companies in the world based on stock market capitalization. A variety of attributes contribute to the overall score, including strong management, sound business strategy, ethical practices and financial performance. Calvert, a leader in socially responsible investing, has created the Calvert Social Index®, a broad-based, rigorously constructed benchmark for measuring the performance of socially responsible companies. Calvert’s Social Research Department analyzes the top 1,000 largest U.S. companies annually. Bristol-Myers Squibb has been on its Social Index of companies since 2003. The Asian American Legal Defense and Education Fund honored Sandra Leung, senior vice president, general counsel and corporate secretary, as a recipient of its 2009 Justice in Action Award. The award, which recognizes exceptional individuals for their outstanding achievements and contributions in advancing justice and equality, was presented in March in New York. The Division of Medicinal Chemistry of the American Chemical Society will present John E. Macor, executive director, Neuroscience Discovery Chemistry, Research and Development, with the 2009 Robert M. Scarborough Memorial Award. This prestigious achievement recognizes scientists under the age of 50 who have documented success in the discovery of pharmaceutical compounds and who have made significant research contributions in medicinal chemistry. Macor was cited for the discovery of an anti-migraine medicine as well as a number of other clinical discoveries. The society will bestow the award at its annual meeting later this year.

SOURCE

http://www.bms.com/responsibility/Pages/achievements.aspx

Other related articles published in this Open Access Online Scientific Journal include the following:

 

Coagulation Therapy: Leading New Drugs – Efficacy Comparison

Curator: Aviva Lev-Ari, PhD, RN

http://pharmaceuticalintelligence.com/2014/05/10/coagulation-therapy-leading-new-drugs-efficacy-comparison/

 

Apixaban (Eliquis): Mechanism of Action, Drug Comparison and Additional Indications

Curator: Aviva Lev-Ari, PhD, RN

http://pharmaceuticalintelligence.com/2014/05/10/apixaban-eliquis-mechanism-of-action-drug-comparison-and-additional-indications/

 

 

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Summary of Translational Medicine – e-Series A: Cardiovascular Diseases, Volume Four – Part 1

Posted in Academic Publishing, Acute Myocardial Infarction, Advanced Drug Manufacturing Technology, Alzheimer's Disease, Atherogenic Processes & Pathology, Autologous Cell Therapy, Automated Cell Processing, Bio Instrumentation in Experimental Life Sciences Research, Biological Networks, Gene Regulation and Evolution, Biomarkers & Medical Diagnostics, Biomedical Measurement Science, Bone Disease and Musculoskeletal Disease, Bone marrow derived cells, Ca2+ triggered activation, Ca2+ triggered activation, Cachexia, Calcium Signaling, Calmodulin, Calmodulin Kinase and Contraction, Cardiac & Vascular Repair Tools Subsegment, Cardiac and Cardiovascular Surgical Procedures, Cardiac muscle regeneration, Cardiomyopathy, Cardiovascular Pharmacogenomics, Cell Biology, Signaling & Cell Circuits, Chemical Biology and its relations to Metabolic Disease, Chemical Genetics, Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and Pulmonary Arterial Hypertension (PAH), Circulating Progenitor Cells, Coagulation Therapy and Internal Bleeding, Competition in regenerative stem cell science, Computational Biology/Systems and Bioinformatics, Curation, Cytoskeleton, Diabetes Mellitus, Disease Biology, Small Molecules in Development of Therapeutic Drugs, Drug Delivery Platform Technology, Drug Toxicity, Electrophysiology, Endothelial cells, Epigenetics and Cardiovascular Risks, Etiology, Evolutionary cognition, Frontiers in Cardiology and Cardiovascular Disorders, Genome Biology, Genomic Expression, Health Economics and Outcomes Research, Human Immune System in Health and in Disease, International Global Work in Pharmaceutical, Interviews with Scientific Leaders, Medical and Population Genetics, Medical Device Therapies for Altzheimer’s Disease, Medical Devices R&D Investment, Medical Imaging Technology, Image Processing/Computing, MRI, CT, Nuclear Medicine, Ultra Sound, Metabolomics, Molecular Genetics & Pharmaceutical, Myocardial metabolism, Myocardial ischemia, myocardial perfusion, Myocardial adenine nucleotide metabolism, Na-K transport, Na-K-ATPase, Neurohumoral Transmission, Nitric Oxide in Health and Disease, Nutrition, Nutritional Supplements: Atherogenesis, lipid metabolism, Origins of Cardiovascular Disease, Oxidative phosphorylation, Personalized and Precision Medicine & Genomic Research, Pharmaceutical Analytics, Pharmacologic toxicities, Pharmacotherapy of Cardiovascular Disease, Phosphorylation, PKC, Population Health Management, Genetics & Pharmaceutical, Population Health Management, Nutrition and Phytochemistry, Proteomics, Regenerative Biology and Medicine, S-nitrosylation, Signaling, Skeletal muscle regeneration, Statistical Methods for Research Evaluation, Stem Cells for Regenerative Medicine, Stents & Tools, Synaptic vesicle, Systemic Inflammatory Response Related Disorders, Technology Advance Assessment of, Translational Effectiveness, Translational Science, Ubiquitinylation, Water Transporters, tagged bioengineering, Cardiovascular Disorders, computational biology, Coronary artery disease, DNA Sequencing, functional proteomics, gene expression, gene silencing, genetic engineering, Heart Failure, Human Genome Project, Hypertension, MicroRNA, mtRNA, myocardial infarction, nitric oxide, Nitric oxide synthase, Personalized medicine, protein modifications, Proteomics, reverse engineering, RNA, signaling pathways, Stem cell, synbiology on April 28, 2014| Leave a Comment »

Summary of Translational Medicine – e-Series A: Cardiovascular Diseases, Volume Four – Part 1

Author and Curator: Larry H Bernstein, MD, FCAP

and

Curator: Aviva Lev-Ari, PhD, RN

Article ID #135: Summary of Translational Medicine – e-Series A: Cardiovascular Diseases, Volume Four – Part 1. Published on 4/28/2014

WordCloud Image Produced by Adam Tubman

 

Part 1 of Volume 4 in the e-series A: Cardiovascular Diseases and Translational Medicine, provides a foundation for grasping a rapidly developing surging scientific endeavor that is transcending laboratory hypothesis testing and providing guidelines to:

• Target genomes and multiple nucleotide sequences involved in either coding or in regulation that might have an impact on complex diseases, not necessarily genetic in nature.
• Target signaling pathways that are demonstrably maladjusted, activated or suppressed in many common and complex diseases, or in their progression.
• Enable a reduction in failure due to toxicities in the later stages of clinical drug trials as a result of this science-based understanding.
• Enable a reduction in complications from the improvement of machanical devices that have already had an impact on the practice of interventional procedures in cardiology, cardiac surgery, and radiological imaging, as well as improving laboratory diagnostics at the molecular level.
• Enable the discovery of new drugs in the continuing emergence of drug resistance.
• Enable the construction of critical pathways and better guidelines for patient management based on population outcomes data, that will be critically dependent on computational methods and large data-bases.

What has been presented can be essentially viewed in the following Table:

 

Summary Table for TM – Part 1

 

 

 

There are some developments that deserve additional development:

1. The importance of mitochondrial function in the activity state of the mitochondria in cellular work (combustion) is understood, and impairments of function are identified in diseases of muscle, cardiac contraction, nerve conduction, ion transport, water balance, and the cytoskeleton – beyond the disordered metabolism in cancer.  A more detailed explanation of the energetics that was elucidated based on the electron transport chain might also be in order.

2. The processes that are enabling a more full application of technology to a host of problems in the environment we live in and in disease modification is growing rapidly, and will change the face of medicine and its allied health sciences.

 

Electron Transport and Bioenergetics

Deferred for metabolomics topic

Synthetic Biology

Introduction to Synthetic Biology and Metabolic Engineering

Kristala L. J. Prather: Part-1    <iBiology > iBioSeminars > Biophysics & Chemical Biology >

http://www.ibiology.org Lecturers generously donate their time to prepare these lectures. The project is funded by NSF and NIGMS, and is supported by the ASCB and HHMI.
Dr. Prather explains that synthetic biology involves applying engineering principles to biological systems to build “biological machines”.

http://synthetic_biology/Introduction_to_Synthetic_Biology_and_Metabolic_Engineering/Kristala_ L.J._Prather/E2/iBiology.htm#/sthash.71kZ0ofr.dpuf

Dr. Prather has received numerous awards both for her innovative research and for excellence in teaching.  Learn more about how Kris became a scientist at

http://science360.gov/obj/video/753bb4fa-aafb-4315-848e-51066ed9799a/finding-way-kristala-l-jones-prather-phd 

Prather 1: Synthetic Biology and Metabolic Engineering  2/6/14IntroductionLecture Overview In the first part of her lecture, Dr. Prather explains that synthetic biology involves applying engineering principles to biological systems to build “biological machines”. The key material in building these machines is synthetic DNA. Synthetic DNA can be added in different combinations to biological hosts, such as bacteria, turning them into chemical factories that can produce small molecules of choice. In Part 2, Prather describes how her lab used design principles to engineer E. coli that produce glucaric acid from glucose. Glucaric acid is not naturally produced in bacteria, so Prather and her colleagues “bioprospected” enzymes from other organisms and expressed them in E. coli to build the needed enzymatic pathway. Prather walks us through the many steps of optimizing the timing, localization and levels of enzyme expression to produce the greatest yield. Speaker Bio: Kristala Jones Prather received her S.B. degree from the Massachusetts Institute of Technology and her PhD at the University of California, Berkeley both in chemical engineering. Upon graduation, Prather joined the Merck Research Labs for 4 years before returning to academia. Prather is now an Associate Professor of Chemical Engineering at MIT and an investigator with the multi-university Synthetic Biology Engineering Reseach Center (SynBERC). Her lab designs and constructs novel synthetic pathways in microorganisms converting them into tiny factories for the production of small molecules. Dr. Prather has received numerous awards both for her innovative research and for excellence in teaching.

VIEW VIDEOS

https://www.youtube.com/watch?feature=player_embedded&v=ndThuqVumAk#t=0

https://www.youtube.com/watch?feature=player_embedded&v=ndThuqVumAk#t=12

https://www.youtube.com/watch?feature=player_embedded&v=ndThuqVumAk#t=74

https://www.youtube.com/watch?feature=player_embedded&v=ndThuqVumAk#t=129

https://www.youtube.com/watch?feature=player_embedded&v=ndThuqVumAk#t=168

https://www.youtube.com/watch?feature=player_embedded&v=ndThuqVumAk

 

David Bartel: micro-RNAs

 

I. Introduction to microRNAs

https://www.youtube.com/watch?feature=player_embedded&v=dupzE66J8u4#t=0

– See more at: http://www.ibiology.org/ibioseminars/genetics-gene-regulation/david-bartel-part-1.html#sthash.nGGr1tIt.dpuf

II. Regulatory Effects of Mammalian microRNAs

https://www.youtube.com/watch?feature=player_embedded&v=TcZK_A_wcWQ#t=0

https://www.youtube.com/watch?feature=player_embedded&v=TcZK_A_wcWQ

Calcium Cycling in Synthetic and Contractile Phasic or Tonic Vascular Smooth Muscle Cells

in INTECH
Current Basic and Pathological Approaches to
the Function of Muscle Cells and Tissues – From Molecules to HumansLarissa Lipskaia, Isabelle Limon, Regis Bobe and Roger Hajjar
Additional information is available at the end of the chapter
http://dx.doi.org/10.5772/48240

1. Introduction
Calcium ions (Ca ) are present in low concentrations in the cytosol (~100 nM) and in high concentrations (in mM range) in both the extracellular medium and intracellular stores (mainly sarco/endo/plasmic reticulum, SR). This differential allows the calcium ion messenger that carries information
as diverse as contraction, metabolism, apoptosis, proliferation and/or hypertrophic growth. The mechanisms responsible for generating a Ca signal greatly differ from one cell type to another.

In the different types of vascular smooth muscle cells (VSMC), enormous variations do exist with regard to the mechanisms responsible for generating Ca signal. In each VSMC phenotype (synthetic/proliferating and contractile [1], tonic or phasic), the Ca signaling system is adapted to its particular function and is due to the specific patterns of expression and regulation of Ca.
For instance, in contractile VSMCs, the initiation of contractile events is driven by mem- brane depolarization; and the principal entry-point for extracellular Ca is the voltage-operated L-type calcium channel (LTCC). In contrast, in synthetic/proliferating VSMCs, the principal way-in for extracellular Ca is the store-operated calcium (SOC) channel.
Whatever the cell type, the calcium signal consists of  limited elevations of cytosolic free calcium ions in time and space. The calcium pump, sarco/endoplasmic reticulum Ca ATPase (SERCA), has a critical role in determining the frequency of SR Ca release by upload into the sarcoplasmic
sensitivity of  SR calcium channels, Ryanodin Receptor, RyR and Inositol tri-Phosphate Receptor, IP3R.
Synthetic VSMCs have a fibroblast appearance, proliferate readily, and synthesize increased levels of various extracellular matrix components, particularly fibronectin, collagen types I and III, and tropoelastin [1].
Contractile VSMCs have a muscle-like or spindle-shaped appearance and well-developed contractile apparatus resulting from the expression and intracellular accumulation of thick and thin muscle filaments [1].

Schematic representation of Calcium Cycling in Contractile and Proliferating VSMCs

 

Figure 1. Schematic representation of Calcium Cycling in Contractile and Proliferating VSMCs.

Left panel: schematic representation of calcium cycling in quiescent /contractile VSMCs. Contractile re-sponse is initiated by extracellular Ca influx due to activation of Receptor Operated Ca (through phosphoinositol-coupled receptor) or to activation of L-Type Calcium channels (through an increase in luminal pressure). Small increase of cytosolic due IP3 binding to IP3R (puff) or RyR activation by LTCC or ROC-dependent Ca influx leads to large SR Ca IP3R or RyR clusters (“Ca -induced Ca SR calcium pumps (both SERCA2a and SERCA2b are expressed in quiescent VSMCs), maintaining high concentration of cytosolic Ca and setting the sensitivity of RyR or IP3R for the next spike.
Contraction of VSMCs occurs during oscillatory Ca transient.
Middle panel: schematic representa tion of atherosclerotic vessel wall. Contractile VSMC are located in the media layer, synthetic VSMC are located in sub-endothelial intima.
Right panel: schematic representation of calcium cycling in quiescent /contractile VSMCs. Agonist binding to phosphoinositol-coupled receptor leads to the activation of IP3R resulting in large increase in cytosolic Ca calcium pumps (only SERCA2b, having low turnover and low affinity to Ca depletion leads to translocation of SR Ca sensor STIM1 towards PM, resulting in extracellular Ca influx though opening of Store Operated Channel (CRAC). Resulted steady state Ca transient is critical for activation of proliferation-related transcription factors ‘NFAT).
Abbreviations: PLC – phospholipase C; PM – plasma membrane; PP2B – Ca /calmodulin-activated protein phosphatase 2B (calcineurin); ROC- receptor activated channel; IP3 – inositol-1,4,5-trisphosphate, IP3R – inositol-1,4,5- trisphosphate receptor; RyR – ryanodine receptor; NFAT – nuclear factor of activated T-lymphocytes; VSMC – vascular smooth muscle cells; SERCA – sarco(endo)plasmic reticulum Ca sarcoplasmic reticulum.

 

Time for New DNA Synthesis and Sequencing Cost Curves

By Rob Carlson

I’ll start with the productivity plot, as this one isn’t new. For a discussion of the substantial performance increase in sequencing compared to Moore’s Law, as well as the difficulty of finding this data, please see this post. If nothing else, keep two features of the plot in mind: 1) the consistency of the pace of Moore’s Law and 2) the inconsistency and pace of sequencing productivity. Illumina appears to be the primary driver, and beneficiary, of improvements in productivity at the moment, especially if you are looking at share prices. It looks like the recently announced NextSeq and Hiseq instruments will provide substantially higher productivities (hand waving, I would say the next datum will come in another order of magnitude higher), but I think I need a bit more data before officially putting another point on the plot.

 

cost-of-oligo-and-gene-synthesis

Illumina’s instruments are now responsible for such a high percentage of sequencing output that the company is effectively setting prices for the entire industry. Illumina is being pushed by competition to increase performance, but this does not necessarily translate into lower prices. It doesn’t behoove Illumina to drop prices at this point, and we won’t see any substantial decrease until a serious competitor shows up and starts threatening Illumina’s market share. The absence of real competition is the primary reason sequencing prices have flattened out over the last couple of data points.

Note that the oligo prices above are for column-based synthesis, and that oligos synthesized on arrays are much less expensive. However, array synthesis comes with the usual caveat that the quality is generally lower, unless you are getting your DNA from Agilent, which probably means you are getting your dsDNA from Gen9.

Note also that the distinction between the price of oligos and the price of double-stranded sDNA is becoming less useful. Whether you are ordering from Life/Thermo or from your local academic facility, the cost of producing oligos is now, in most cases, independent of their length. That’s because the cost of capital (including rent, insurance, labor, etc) is now more significant than the cost of goods. Consequently, the price reflects the cost of capital rather than the cost of goods. Moreover, the cost of the columns, reagents, and shipping tubes is certainly more than the cost of the atoms in the sDNA you are ostensibly paying for. Once you get into longer oligos (substantially larger than 50-mers) this relationship breaks down and the sDNA is more expensive. But, at this point in time, most people aren’t going to use longer oligos to assemble genes unless they have a tricky job that doesn’t work using short oligos.

Looking forward, I suspect oligos aren’t going to get much cheaper unless someone sorts out how to either 1) replace the requisite human labor and thereby reduce the cost of capital, or 2) finally replace the phosphoramidite chemistry that the industry relies upon.

IDT’s gBlocks come at prices that are constant across quite substantial ranges in length. Moreover, part of the decrease in price for these products is embedded in the fact that you are buying smaller chunks of DNA that you then must assemble and integrate into your organism of choice.

Someone who has purchased and assembled an absolutely enormous amount of sDNA over the last decade, suggested that if prices fell by another order of magnitude, he could switch completely to outsourced assembly. This is a potentially interesting “tipping point”. However, what this person really needs is sDNA integrated in a particular way into a particular genome operating in a particular host. The integration and testing of the new genome in the host organism is where most of the cost is. Given the wide variety of emerging applications, and the growing array of hosts/chassis, it isn’t clear that any given technology or firm will be able to provide arbitrary synthetic sequences incorporated into arbitrary hosts.

 TrackBack URL: http://www.synthesis.cc/cgi-bin/mt/mt-t.cgi/397

 

Startup to Strengthen Synthetic Biology and Regenerative Medicine Industries with Cutting Edge Cell Products

28 Nov 2013 | PR Web

Dr. Jon Rowley and Dr. Uplaksh Kumar, Co-Founders of RoosterBio, Inc., a newly formed biotech startup located in Frederick, are paving the way for even more innovation in the rapidly growing fields of Synthetic Biology and Regenerative Medicine. Synthetic Biology combines engineering principles with basic science to build biological products, including regenerative medicines and cellular therapies. Regenerative medicine is a broad definition for innovative medical therapies that will enable the body to repair, replace, restore and regenerate damaged or diseased cells, tissues and organs. Regenerative therapies that are in clinical trials today may enable repair of damaged heart muscle following heart attack, replacement of skin for burn victims, restoration of movement after spinal cord injury, regeneration of pancreatic tissue for insulin production in diabetics and provide new treatments for Parkinson’s and Alzheimer’s diseases, to name just a few applications.

While the potential of the field is promising, the pace of development has been slow. One main reason for this is that the living cells required for these therapies are cost-prohibitive and not supplied at volumes that support many research and product development efforts. RoosterBio will manufacture large quantities of standardized primary cells at high quality and low cost, which will quicken the pace of scientific discovery and translation to the clinic. “Our goal is to accelerate the development of products that incorporate living cells by providing abundant, affordable and high quality materials to researchers that are developing and commercializing these regenerative technologies” says Dr. Rowley

 

Life at the Speed of Light

http://kcpw.org/?powerpress_pinw=92027-podcast

NHMU Lecture featuring – J. Craig Venter, Ph.D.
Founder, Chairman, and CEO – J. Craig Venter Institute; Co-Founder and CEO, Synthetic Genomics Inc.

J. Craig Venter, Ph.D., is Founder, Chairman, and CEO of the J. Craig Venter Institute (JVCI), a not-for-profit, research organization dedicated to human, microbial, plant, synthetic and environmental research. He is also Co-Founder and CEO of Synthetic Genomics Inc. (SGI), a privately-held company dedicated to commercializing genomic-driven solutions to address global needs.

In 1998, Dr. Venter founded Celera Genomics to sequence the human genome using new tools and techniques he and his team developed.  This research culminated with the February 2001 publication of the human genome in the journal, Science. Dr. Venter and his team at JVCI continue to blaze new trails in genomics.  They have sequenced and a created a bacterial cell constructed with synthetic DNA,  putting humankind at the threshold of a new phase of biological research.  Whereas, we could  previously read the genetic code (sequencing genomes), we can now write the genetic code for designing new species.

The science of synthetic genomics will have a profound impact on society, including new methods for chemical and energy production, human health and medical advances, clean water, and new food and nutritional products. One of the most prolific scientists of the 21st century for his numerous pioneering advances in genomics,  he  guides us through this emerging field, detailing its origins, current challenges, and the potential positive advances.

His work on synthetic biology truly embodies the theme of “pushing the boundaries of life.”  Essentially, Venter is seeking to “write the software of life” to create microbes designed by humans rather than only through evolution. The potential benefits and risks of this new technology are enormous. It also requires us to examine, both scientifically and philosophically, the question of “What is life?”

J Craig Venter wants to digitize DNA and transmit the signal to teleport organisms

http://pharmaceuticalintelligence.com/2013/11/01/j-craig-venter-wants-to-digitize-dna-and-transmit-the-signal-to-teleport-organisms/

2013 Genomics: The Era Beyond the Sequencing of the Human Genome: Francis Collins, Craig Venter, Eric Lander, et al.

http://pharmaceuticalintelligence.com/2013/02/11/2013-genomics-the-era-beyond-the-sequencing-human-genome-francis-collins-craig-venter-eric-lander-et-al/

Human Longevity Inc (HLI) – $70M in Financing of Venter’s New Integrative Omics and Clinical Bioinformatics

http://pharmaceuticalintelligence.com/2014/03/05/human-longevity-inc-hli-70m-in-financing-of-venters-new-integrative-omics-and-clinical-bioinformatics/

 

 

Where Will the Century of Biology Lead Us?

By Randall Mayes

A technology trend analyst offers an overview of synthetic biology, its potential applications, obstacles to its development, and prospects for public approval.

• In addition to boosting the economy, synthetic biology projects currently in development could have profound implications for the future of manufacturing, sustainability, and medicine.
• Before society can fully reap the benefits of synthetic biology, however, the field requires development and faces a series of hurdles in the process. Do researchers have the scientific know-how and technical capabilities to develop the field?

Biology + Engineering = Synthetic Biology

Bioengineers aim to build synthetic biological systems using compatible standardized parts that behave predictably. Bioengineers synthesize DNA parts—oligonucleotides composed of 50–100 base pairs—which make specialized components that ultimately make a biological system. As biology becomes a true engineering discipline, bioengineers will create genomes using mass-produced modular units similar to the microelectronics and computer industries.

Currently, bioengineering projects cost millions of dollars and take years to develop products. For synthetic biology to become a Schumpeterian revolution, smaller companies will need to be able to afford to use bioengineering concepts for industrial applications. This will require standardized and automated processes.

A major challenge to developing synthetic biology is the complexity of biological systems. When bioengineers assemble synthetic parts, they must prevent cross talk between signals in other biological pathways. Until researchers better understand these undesired interactions that nature has already worked out, applications such as gene therapy will have unwanted side effects. Scientists do not fully understand the effects of environmental and developmental interaction on gene expression. Currently, bioengineers must repeatedly use trial and error to create predictable systems.

Similar to physics, synthetic biology requires the ability to model systems and quantify relationships between variables in biological systems at the molecular level.

The second major challenge to ensuring the success of synthetic biology is the development of enabling technologies. With genomes having billions of nucleotides, this requires fast, powerful, and cost-efficient computers. Moore’s law, named for Intel co-founder Gordon Moore, posits that computing power progresses at a predictable rate and that the number of components in integrated circuits doubles each year until its limits are reached. Since Moore’s prediction, computer power has increased at an exponential rate while pricing has declined.

DNA sequencers and synthesizers are necessary to identify genes and make synthetic DNA sequences. Bioengineer Robert Carlson calculated that the capabilities of DNA sequencers and synthesizers have followed a pattern similar to computing. This pattern, referred to as the Carlson Curve, projects that scientists are approaching the ability to sequence a human genome for $1,000, perhaps in 2020. Carlson calculated that the costs of reading and writing new genes and genomes are falling by a factor of two every 18–24 months. (see recent Carlson comment on requirement to read and write for a variety of limiting  conditions).

Startup to Strengthen Synthetic Biology and Regenerative Medicine Industries with Cutting Edge Cell Products

http://pharmaceuticalintelligence.com/2013/11/28/startup-to-strengthen-synthetic-biology-and-regenerative-medicine-industries-with-cutting-edge-cell-products/

Synthetic Biology: On Advanced Genome Interpretation for Gene Variants and Pathways: What is the Genetic Base of Atherosclerosis and Loss of Arterial Elasticity with Aging

http://pharmaceuticalintelligence.com/2013/05/17/synthetic-biology-on-advanced-genome-interpretation-for-gene-variants-and-pathways-what-is-the-genetic-base-of-atherosclerosis-and-loss-of-arterial-elasticity-with-aging/

Synthesizing Synthetic Biology: PLOS Collections

http://pharmaceuticalintelligence.com/2012/08/17/synthesizing-synthetic-biology-plos-collections/

Capturing ten-color ultrasharp images of synthetic DNA structures resembling numerals 0 to 9

http://pharmaceuticalintelligence.com/2014/02/05/capturing-ten-color-ultrasharp-images-of-synthetic-dna-structures-resembling-numerals-0-to-9/

Silencing Cancers with Synthetic siRNAs

http://pharmaceuticalintelligence.com/2013/12/09/silencing-cancers-with-synthetic-sirnas/

Genomics Now—and Beyond the Bubble

Futurists have touted the twenty-first century as the century of biology based primarily on the promise of genomics. Medical researchers aim to use variations within genes as biomarkers for diseases, personalized treatments, and drug responses. Currently, we are experiencing a genomics bubble, but with advances in understanding biological complexity and the development of enabling technologies, synthetic biology is reviving optimism in many fields, particularly medicine.

BY MICHAEL BROOKS    17 APR, 2014     http://www.newstatesman.com/

Michael Brooks holds a PhD in quantum physics. He writes a weekly science column for the New Statesman, and his most recent book is The Secret Anarchy of Science.

The basic idea is that we take an organism – a bacterium, say – and re-engineer its genome so that it does something different. You might, for instance, make it ingest carbon dioxide from the atmosphere, process it and excrete crude oil.

That project is still under construction, but others, such as using synthesised DNA for data storage, have already been achieved. As evolution has proved, DNA is an extraordinarily stable medium that can preserve information for millions of years. In 2012, the Harvard geneticist George Church proved its potential by taking a book he had written, encoding it in a synthesised strand of DNA, and then making DNA sequencing machines read it back to him.

When we first started achieving such things it was costly and time-consuming and demanded extraordinary resources, such as those available to the millionaire biologist Craig Venter. Venter’s team spent most of the past two decades and tens of millions of dollars creating the first artificial organism, nicknamed “Synthia”. Using computer programs and robots that process the necessary chemicals, the team rebuilt the genome of the bacterium Mycoplasma mycoides from scratch. They also inserted a few watermarks and puzzles into the DNA sequence, partly as an identifying measure for safety’s sake, but mostly as a publicity stunt.

What they didn’t do was redesign the genome to do anything interesting. When the synthetic genome was inserted into an eviscerated bacterial cell, the new organism behaved exactly the same as its natural counterpart. Nevertheless, that Synthia, as Venter put it at the press conference to announce the research in 2010, was “the first self-replicating species we’ve had on the planet whose parent is a computer” made it a standout achievement.

Today, however, we have entered another era in synthetic biology and Venter faces stiff competition. The Steve Jobs to Venter’s Bill Gates is Jef Boeke, who researches yeast genetics at New York University.

Boeke wanted to redesign the yeast genome so that he could strip out various parts to see what they did. Because it took a private company a year to complete just a small part of the task, at a cost of $50,000, he realised he should go open-source. By teaching an undergraduate course on how to build a genome and teaming up with institutions all over the world, he has assembled a skilled workforce that, tinkering together, has made a synthetic chromosome for baker’s yeast.

 

Stepping into DIYbio and Synthetic Biology at ScienceHack

Posted April 22, 2014 by Heather McGaw and Kyrie Vala-Webb

We got a crash course on genetics and protein pathways, and then set out to design and build our own pathways using both the “Genomikon: Violacein Factory” kit and Synbiota platform. With Synbiota’s software, we dragged and dropped the enzymes to create the sequence that we were then going to build out. After a process of sketching ideas, mocking up pathways, and writing hypotheses, we were ready to start building!

The night stretched long, and at midnight we were forced to vacate the school. Not quite finished, we loaded our delicate bacteria, incubator, and boxes of gloves onto the bus and headed back to complete our bacterial transformation in one of our hotel rooms. Jammed in between the beds and the mini-fridge, we heat-shocked our bacteria in the hotel ice bucket. It was a surreal moment.

While waiting for our bacteria, we held an “unconference” where we explored bioethics, security and risk related to synthetic biology, 3D printing on Mars, patterns in juggling (with live demonstration!), and even did a Google Hangout with Rob Carlson. Every few hours, we would excitedly check in on our bacteria, looking for bacterial colonies and the purple hue characteristic of violacein.

Most impressive was the wildly successful and seamless integration of a diverse set of people: in a matter of hours, we were transformed from individual experts and practitioners in assorted fields into cohesive and passionate teams of DIY biologists and science hackers. The ability of everyone to connect and learn was a powerful experience, and over the course of just one weekend we were able to challenge each other and grow.

Returning to work on Monday, we were hungry for more. We wanted to find a way to bring the excitement and energy from the weekend into the studio and into the projects we’re working on. It struck us that there are strong parallels between design and DIYbio, and we knew there was an opportunity to bring some of the scientific approaches and curiosity into our studio.

 

 

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Introduction to e-Series A: Cardiovascular Diseases, Volume Four Part 2: Regenerative Medicine

Posted in Acute Myocardial Infarction, Biological Networks, Gene Regulation and Evolution, Ca2+ triggered activation, Calcium Signaling, Calmodulin Kinase and Contraction, Cardiac & Vascular Repair Tools Subsegment, Cardiac muscle regeneration, Cardiomyopathy, Cardiovascular Pharmacogenomics, Cardiovascular Research, Cell Biology, Signaling & Cell Circuits, Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and Pulmonary Arterial Hypertension (PAH), Circulating Progenitor Cells, Coagulation Therapy and Internal Bleeding, Competition in regenerative stem cell science, Computational Biology/Systems and Bioinformatics, Curation, De novo synthesis, Diabetes Mellitus, Discovery process, Disease Biology, Small Molecules in Development of Therapeutic Drugs, Drug Delivery Platform Technology, Endothelial cells, Epigenetics and Cardiovascular Risks, Experimental validation, Frontiers in Cardiology and Cardiovascular Disorders, Genome Biology, Genomic Testing: Methodology for Diagnosis, HTN, Medical Devices R&D and Inventions, Molecular Genetics & Pharmaceutical, Na-K transport, Na-K-ATPase, Nitric Oxide in Health and Disease, Nutrition, Origins of Cardiovascular Disease, PCI, Personalized and Precision Medicine & Genomic Research, Pharmaceutical Analytics, Pharmacotherapy of Cardiovascular Disease, Population Health Management, Genetics & Pharmaceutical, Population Health Management, Nutrition and Phytochemistry, Proteomics, Regenerative Biology and Medicine, Resident-cell-based, Stem Cells for Regenerative Medicine, tagged Absorb™ Bioresorbable Vascular Scaffold, Acute coronary syndrome, Acute decompensated heart failure, Angioplasty, Array-comparative genomic hybridization, Ca2+/calmodulin-dependent protein kinase, Cardiac & Vascular Repair, cardiac arrhythmias, cardiac biomarkers, cardiac myocyte regeneration, cardiomyocyte transformation, cardiovascular complications, Cardiovascular Risk Reduction, cEPC as Biomarker, Circulating Progenitor Endothelial Cells, comparative genomic hybridization, complement activation, endothelial cell, Endothelial Cell Coagulation Activation, functional genomics, Genome Biology, Genome engineering, Human Umbilical Vein Endothelial Cells (HUVECS), Induced pluripotent stem cells (iPS), regenerative medicine, Therapeutic Potential of cEPCs on April 27, 2014| Leave a Comment »

Introduction to e-Series A: Cardiovascular Diseases, Volume Four Part 2: Regenerative Medicine

Author and Curator: Larry H Bernstein, MD, FCAP

and

Curator: Aviva Lev-Ari, PhD, RN

This document is entirely devoted to medical and surgical therapies that have made huge strides in

• simplification of interventional procedures,
• reduced complexity, resulting in procedures previously requiring surgery are now done, circumstances permitting, by medical intervention.

This revolution in cardiovascular interventional therapy is regenerative medicine.  It is regenerative because it is largely driven by

• the introduction into the impaired vasculature of an induced pleuripotent cell, called a stem cell, although
• the level of differentiation may not be a most primitive cell line.

There is also a very closely aligned development in cell biology that extends beyond and including vascular regeneration that is called synthetic biology.  These developments have occurred at an accelerated rate in the last 15 years. The methods of interventional cardiology were already well developed in the mid 1980s.  This was at the peak of cardiothoracic bypass surgery.

Research on the endothelial cell,

• endothelial cell proliferation,
• shear flow in small arteries, especially at branch points, and
• endothelial-platelet interactions

led to insights about plaque formation and vessel thrombosis.

Much was learned in biomechanics about the shear flow stresses on the luminal surface of the vasculature, and there was also

• the concomitant discovery of nitric oxide,
• oxidative stress, and
• the isoenzymes of nitric oxide synthase (eNOS, iNOS, and nNOS).

It became a fundamental tenet of vascular biology that

• atherogenesis is a maladjustment to oxidative stress not only through genetic, but also
• non-genetic nutritional factors that could be related to the balance of omega (ω)-3 and omega (ω)-6 fatty acids,
• a pro-inflammatory state that elicits inflammatory cytokines, such as, interleukin-6 (IL6) and c-reactive protein(CRP),
• insulin resistance with excess carbohydrate associated with type 2 diabetes and beta (β) cell stress,
• excess trans- and saturated fats, and perhaps
• the now plausible colonic microbial population of the gastrointestinal tract (GIT).

There is also an association of abdominal adiposity,

• including the visceral peritoneum, with both T2DM and with arteriosclerotic vessel disease,
• which is presenting at a young age, and has ties to
• the effects of an adipokine, adiponectin.

Much important work has already been discussed in the domain of cardiac catheterization and research done to

• prevent atheroembolization.and beyond that,
• research done to implant an endothelial growth matrix.

Even then, dramatic work had already been done on

• the platelet structure and metabolism, and
• this has transformed our knowledge of platelet biology.

The coagulation process has been discussed in detailed in a previous document.  The result was the development of a

• new class of platelet aggregation inhibitors designed to block the activation of protein on the platelet surface that
• is critical in the coagulation cascade.

In addition, the term long used to describe atherosclerosis, atheroma notwithstanding, is “hardening of the arteries”.  This is particularly notable with respect to mid-size arteries and arterioles that feed the heart and kidneys. Whether it is preceded by or develops concurrently with chronic renal insufficiency and lowered glomerular filtration rate is perhaps arguable.  However, there is now a body of evidence that points to

• a change in the vascular muscularis and vessel stiffness, in addition to the endothelial features already mentioned.

This has provided a basis for

• targeted pharmaceutical intervention, and
• reduction in salt intake.

So we have a  group of metabolic disorders, which may alone or in combination,

• lead to and be associated with the long term effects of cardiovascular disease, including
• congestive heart failure.

This has been classically broken down into forward and backward failure,

• depending on decrease outflow through the aorta (ejection fraction), or
• decreased venous return through the vena cava,

which involves increased pulmonary vascular resistance and decreased return into the left atrium.

This also has ties to several causes, which may be cardiac or vascular. This document, as the previous, has four pats.  They are broadly:

1. Stem Cells in Cardiovascular Diseases
2. Regenerative Cell and Molecular Biology
3. Therapeutics Levels In Molecular Cardiology
4. Research Proposals for Endogenous Augmentation of circulating Endothelial Progenitor Cells (cEPCs)

As in the previous section, we start with the biology of the stem cell and the degeneration in cardiovascular diseases, then proceed to regeneration, then therapeutics, and finally – proposals for augmenting therapy with circulating endogenous endothelial progenitor cells (cEPCs).

 

stem cells

 

regeneration

 

 

 

 

Therapeutics

 

augmentation

 

 

 

 

 

 

 

 

 

 

Key pathways involving NO

 

 

 

 

stem cellLlin28

Tranlational Research -Lab to Bedside

 

 

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Introduction to Translational Medicine (TM) – Part 1: Translational Medicine

Posted in Affordable Care Act, Atherogenic Processes & Pathology, Biological Networks, Gene Regulation and Evolution, Biomarkers & Medical Diagnostics, Ca2+ triggered activation, Cachexia, Calcium Signaling, Cardiac & Vascular Repair Tools Subsegment, Cardiac and Cardiovascular Surgical Procedures, Cardiovascular Pharmacogenomics, Cardiovascular Research, Cell Biology, Signaling & Cell Circuits, Computational Biology/Systems and Bioinformatics, Curation, Diabetes Mellitus, Diagnostic Immunology, Disease Biology, Small Molecules in Development of Therapeutic Drugs, Drug Toxicity, Epigenetics and Cardiovascular Risks, Experimental validation, Explanatory, Genome Biology, Genomic Expression, Genomic Testing: Methodology for Diagnosis, Health Economics and Outcomes Research, HealthCare IT, Immunodiagnostics, Interviews with Scientific Leaders, Medicare and Medicaid, Metabolomics, Methylation, Molecular Genetics & Pharmaceutical, mtDNA, Nutrition, Origins of Cardiovascular Disease, Personalized and Precision Medicine & Genomic Research, Pharmaceutical Analytics, Pharmacotherapy of Cardiovascular Disease, Population Health Management, Genetics & Pharmaceutical, Population Health Management, Nutrition and Phytochemistry, Proteomics, Regenerative Biology and Medicine, tagged cardiovascular biomarkers, epigenetic signatures, genetic expression, genomics, interventio, Interventional radiology, isoforms, mass spectrometry, Mass spectrometry imaging, Metabolomics, mtDNA, protein translational modifications, Proteomics, PTMs, transcriptome on April 25, 2014| Leave a Comment »

Introduction to Translational Medicine (TM) – Part 1: Translational Medicine

Author and Curator: Larry H Bernstein, MD, FCAP

and

Curator: Aviva Lev-Ari, PhD, RN 

Article ID #134: Introduction to Translational Medicine (TM) – Part 1: Translational Medicine. Published on 4/25/2014

WordCloud Image Produced by Adam Tubman

 

This document in the Series A: Cardiovascular Diseases e-Series Volume 4: Translational and Regenerative Medicine,  is a measure of the postgenomic and proteomic advances in the laboratory to the practice of clinical medicine.  The Chapters are preceded by several videos by prominent figures in the emergence of this transformative change.  When I was a medical student, a large body of the current language and technology that has extended the practice of medicine did not exist, but a new foundation, predicated on the principles of modern medical education set forth by Abraham Flexner, was sprouting.  The highlights of this evolution were:

• Requirement for premedical education in biology, organic chemistry, physics, and genetics.
• Medical education included two years of basic science education in anatomy, physiology, pharmacology, and pathology prior to introduction into the clinical course sequence of the last two years.
• Post medical graduate education was an internship year followed by residency in pediatrics, OBGyn, internal medicine, general surgery, psychiatry, neurology, neurosurgery, pathology, radiology, and anesthesiology, emergency medicine.
• Academic teaching centers were developing subspecialty centers in ophthalmology, ENT and head and neck surgery, cardiology and cardiothoracic surgery, and hematology, hematology/oncology, and neurology.
• The expansion of postgraduate medical programs included significant postgraduate funding for programs by the National Institutes of Health, and the NIH had faculty development support in a system of peer-reviewed research grant programs in medical and allied sciences.

The period after the late 1980s saw a rapid expansion of research in genomics and drug development to treat emerging threats of infectious diseases as US had a large worldwide involvement after the end of the Vietnam War, and drug resistance was increasingly encountered (malaria, tick borne diseases, salmonellosis, pseudomonas aeruginosa, staphylococcus aureus, etc.).

Moreover, the post-millenium found a large, dwindling population of veterans who had served in WWII and Vietnam, and cardiovascular, musculoskeletal,  dementias, and cancer were now more common.  The Human Genome Project was undertaken to realign the existing knowledge of gene structure and genetic regulation with the needs for drug development, which was languishing in development failures due to unexpected toxicities.

A substantial disconnect existed between diagnostics and pharmaceutical development, which had been over-reliant on modification of known organic structures to increase potency and reduce toxicity.  This was about to change with changes in medical curricula, changes in residency programs and physicians cross-training in disciplines, and the emergence of bio-pharma, based on the emerging knowledge of the cell function, and at the same time, the medical profession was developing an evidence-base for therapeutics, and more pressure was placed on informed decision-making.

The great improvement in proteomics came from GCLC/MS-MS and is described in the video interview with Dr. Gyorgy Marko-Varga, Sweden, in video 1 of 3 (Advancing Translational Medicine).  This is a discussion that is focused on functional proteomics role in future diagnostics and therapy, involving a greater degree of accuracy in mass spectrometry (MS) than can be obtained by antibody-ligand binding, and is illustrated below, the last emphasizing the importance of information technology and predictive analytics

Thermo ScientificImmunoassays and LC–MS/MS have emerged as the two main approaches for quantifying peptides and proteins in biological samples. ELISA kits are available for quantification, but inherently lack the discriminative power to resolve isoforms and PTMs.

To address this issue we have developed and applied a mass spectrometry immunoassay–selected reaction monitoring (Thermo Scientific™ MSIA™ SRM technology) research method to quantify PCSK9 (and PTMs), a key player in the regulation of circulating low density lipoprotein cholesterol (LDL-C).

A Day in the (Future) Life of a Predictive Analytics Scientist

 

By Lars Rinnan, CEO, NextBridge   April 22, 2014

A look into a normal day in the near future, where predictive analytics is everywhere, incorporated in everything from household appliances to wearable computing devices.

During the test drive (of an automobile), the extreme acceleration makes your heart beat so fast that your personal health data sensor triggers an alarm. The health data sensor is integrated into the strap of your wrist watch. This data is transferred to your health insurance company, so you say a prayer that their data scientists are clever enough to exclude these abnormal values from your otherwise impressive health data. Based on such data, your health insurance company’s consulting unit regularly gives you advice about diet, exercise, and sleep. You have followed their advice in the past, and your performance has increased, which automatically reduced your insurance premiums. Win-win, you think to yourself, as you park the car, and decide to buy it.

In the clinical presentation at Harlan Krumholtz’ Yale Symposium, Prof. Robert Califf, Director of the Duke University Translational medicine Clinical Research Institute, defines translational medicine as effective translation of science to clinical medicine in two segments:

1. Adherence to current standards
2. Improving the enterprise by translating knowledge

He says that discrepancies between outcomes and medical science will bridge a gap in translation by traversing two parallel systems.

1. Physician-health organization
2. Personalized medicine

He emphasizes that the new basis for physician standards will be legitimized in the following:

1. Comparative effectiveness (Krumholtz)
2. Accountability

Some of these points are repeated below:

WATCH VIDEOS ON YOUTUBE

https://www.youtube.com/watch?v=JFdJRh9ZPps#t=678  Harlan Krumholtz

https://www.youtube.com/watch?v=JFdJRh9ZPps#t=678  complexity

https://www.youtube.com/watch?v=JFdJRh9ZPps#t=678  integration map

https://www.youtube.com/watch?v=JFdJRh9ZPps#t=678  progression

https://www.youtube.com/watch?v=JFdJRh9ZPps#t=678  informatics

An interesting sidebar to the scientific medical advances is the huge shift in pressure on an insurance system that has coexisted with a public system in Medicare and Medicaid, initially introduced by the health insurance industry for worker benefits (Kaiser, IBM, Rockefeller), and we are undertaking a formidable change in the ACA.

The current reality is that actuarially, the twin system that has existed was unsustainable in the long term because it is necessary to have a very large pool of the population to spread the costs, and in addition, the cost of pharmaceutical development has driven consolidation in the industry, and has relied on the successes from public and privately funded research.

https://www.youtube.com/watch?v=X6J_7PvWoMw#t=57  Corbett Report Nov 2013

(1979 ER Brown)  UCPress  Rockefeller Medicine Men

https://www.youtube.com/watch?v=X6J_7PvWoMw#t=57   Liz Fowler VP of Wellpoint (designed ACA)

I shall digress for a moment and insert a video history of DNA, that hits the high points very well, and is quite explanatory of the genomic revolution in medical science, biology, infectious disease and microbial antibiotic resistance, virology, stem cell biology, and the undeniability of evolution.

DNA History

https://www.youtube.com/watch?v=UUDzN4w8mKI&list=UUoHRSQ0ahscV14hlmPabkVQ

As I have noted above, genomics is necessary, but not sufficient.  The story began as replication of the genetic code, which accounted for variation, but the accounting for regulation of the cell and for metabolic processes was, and remains in the domain of an essential library of proteins. Moreover, the functional activity of proteins, at least but not only if they are catalytic, shows structural variants that is characterized by small differences in some amino acids that allow for separation by net charge and have an effect on protein-protein and other interactions.

Protein chemistry is so different from DNA chemistry that it is quite safe to consider that DNA in the nucleotide sequence does no more than establish the order of amino acids in proteins. On the other hand, proteins that we know so little about their function and regulation, do everything that matters including to set what and when to read something in the DNA.

Jose Eduardo de Salles Roselino

Chapters 2, 3, and 4 sequentially examine:

• The causes and etiologies of cardiovascular diseases
• The diagnosis, prognosis and risks determined by – biomarkers in serum, circulating cells, and solid tissue by contrast radiography
• Treatment of cardiovascular diseases by translation of science from bench to bedside, including interventional cardiology and surgical repair

These are systematically examined within a framework of:

• Genomics
• Proteomics
• Cardiac and Vascular Signaling
• Platelet and Endothelial Signaling
• Cell-protein interactions
• Protein-protein interactions
• Post-Translational Modifications (PTMs)
• Epigenetics
• Noncoding RNAs and regulatory considerations
• Metabolomics (the metabolome)
• Mitochondria and oxidative stress

 

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China, India, and Russia account for 46% of all new cancer cases globally, as well as 52% of cancer-related mortality per 4/2014 Lancet Oncology article

Posted in CANCER BIOLOGY & Innovations in Cancer Therapy, Population Health Management, Genetics & Pharmaceutical, Population Health Management, Nutrition and Phytochemistry on April 24, 2014| Leave a Comment »

China, India, and Russia account for 46% of all new cancer cases globally, as well as 52% of cancer-related mortality per 4/2014 Lancet Oncology article

 

Reporter: Aviva Lev-Ari, PhD, RN

 

Summary

Cancer is one of the major non-communicable diseases posing a threat to world health. Unfortunately, improvements in socioeconomic conditions are usually associated with increased cancer incidence. In this Commission, we focus on China, India, and Russia, which share rapidly rising cancer incidence and have cancer mortality rates that are nearly twice as high as in the UK or the USA, vast geographies, growing economies, ageing populations, increasingly westernised lifestyles, relatively disenfranchised subpopulations, serious contamination of the environment, and uncontrolled cancer-causing communicable infections. We describe the overall state of health and cancer control in each country and additional specific issues for consideration: for China, access to care, contamination of the environment, and cancer fatalism and traditional medicine; for India, affordability of care, provision of adequate health personnel, and sociocultural barriers to cancer control; and for Russia, monitoring of the burden of cancer, societal attitudes towards cancer prevention, effects of inequitable treatment and access to medicine, and a need for improved international engagement.

SOURCE

Challenges to effective cancer control in China, India, and Russia Paul E Goss, Kathrin Strasser-Weippl, Brittany L Lee-Bychkovsky, Lei Fan, Junjie Li, Yanin Chavarri-Guerra, Pedro E R Liedke, C S Pramesh, Tanja Badovinac-Crnjevic, Yuri Sheikine, Zhu Chen, You-lin Qiao, Zhiming Shao, Yi-Long Wu, Daiming Fan, Louis W C Chow, Jun Wang, Qiong Zhang, Shiying Yu, Gordon Shen, Jie He, Arnie Purushotham, Richard Sullivan, Rajendra Badwe, Shripad D Banavali, Reena Nair, Lalit Kumar, Purvish Parikh, Somasundarum Subramanian, Pankaj Chaturvedi, Subramania Iyer, Surendra Srinivas Shastri, Raghunadhrao Digumarti, Enrique Soto-Perez-de-Celis, Dauren Adilbay, Vladimir Semiglazov, Sergey Orlov, Dilyara Kaidarova, Ilya Tsimafeyeu, Sergei Tatishchev, Kirill D Danishevskiy, Marc Hurlbert, Caroline Vail, Jessica St Louis, Arlene Chan

The Lancet Oncology 1 April 2014 (Volume 15 Issue 5 Pages 489-538 DOI: 10.1016/S1470-2045(14)70029-4)

The Lancet Oncology, Volume 15, Issue 5, Pages 489 – 538, April 2014

doi:10.1016/S1470-2045(14)70029-4Cite or Link Using DOI

Three Countries Account for Half of All New Cancers

Roxanne Nelson

April 24, 2014

China, India, and Russia account for 46% of all new cancer cases globally, as well as 52% of cancer-related mortality. The populations in these regions are large and diverse, and the obstacles to providing effective cancer care are complex and idiosyncratic, according to a report published in the April issue of the Lancet Oncology.

Effective cancer control in China, India, and Russia is a burgeoning problem, but paying attention to the issue now will have “tremendous socioeconomic benefits in the future,” write the authors, led by Paul E. Goss, MB BCh, PhD, professor of medicine at Harvard Medical School and director of breast cancer research at the Massachusetts General Cancer Center in Boston.

“It is impossible to understand the issues that affect delivery of cancer care in China, India, and Russia without first understanding the social, economic, and attitudinal factors that influence the way cancer care is delivered and received in these countries,” Dr. Goss said in a statement.

The report is the result of a collaboration of more than 40 leading cancer experts from around the world, including China, India, and Russia.

Data from the report were presented earlier this month at the 6th Asian Oncology Summit and 10th Annual Conference of the Organisation for Oncology and Translational Research, held in Kuala Lumpur, Malaysia,

High Mortality Burden

The incidence of most cancers in China, India, and Russia is low, but the mortality burden is much higher than in the United States or the United Kingdom (whereas the financial burden per patient is much lower).

Table. Mortality and Financial Burden of Cancer

Region	Mortality to Incidence Ratio	Financial Burden per Patient ($)
United States	0.33	86,758
United Kingdom	0.40	37,836
Russia	0.60	3784
India	0.69	641
China	0.70	2202

 

The populations of China (1.35 billion), India (1.24 billion), and Russia (144 million) account for almost 40% of the world’s population.

Although diverse, these regions have much in common with each other, such as their vast geographies, rapidly improving economies, increasing population of elderly people, adoption of Westernized lifestyles (e.g., changes in diet and decreased physical activity), suboptimum healthcare for people in rural regions and of low socioeconomic status, serious environmental contamination, and a rising incidence of oncogenic communicable infections, the report notes.

Common Threads

In addition, in all 3 countries, there has been inadequate data on cancer. The lack of information on demographics and outcomes makes it difficult for policymakers to clearly see the size and trajectory of the problem they are dealing with, and therefore unable to devise a forward-looking modern national cancer plan.

In all 3 countries, financial and human resources need to be improved and equitably allocated to reduce the high mortality rates from cancer.

Policymakers need to be encouraged to invest more of their resources into healthcare, and specifically cancer care, so that they can study current and future trends of cancer and change policy and investment toward cancer prevention, early detection, and treatment.

“Active political engagement is absolutely necessary to ensure that effective policies to fight cancer are embedded in all government departments, not just health ministries,” said David Collingridge, MD, editor of the Lancet Oncology. “Departments charged with protecting the environment, provision of social services, and the delivery of education, science, and technology, all have key roles in these challenges,” he said in a statement.

The “magnitudes of the cancer burden and problems facing these 3 huge countries drive home many messages for smaller low- to middle-income countries: adequate and representative cancer data are required through investment in cancer registries.”

In addition, the development of a “forward-looking prospective national cancer plan is inexpensive and mandatory.”

The report evaluates the situation in each of the 3 countries and offers country-specific recommendations to improve cancer care.

China

In China, cancer accounts for about 20% of all-cause mortality, and the burden of this disease — driven by socioeconomic growth, an aging population, and environmental pollution — is increasing.

To address this issue, China urgently needs ongoing methods of combating air, water, and soil pollution, according to the report.

There is also a shortage of healthcare workers, especially in rural areas, which limits availability of optimum care. Training more healthcare workers would address this shortage, and could improve prevention and screening education.

Although traditional medical practices are widespread, cancer programs need to integrate traditional Chinese medicine to create acceptance and compliance.

China has had some success in cancer control. The country has built more than 200 cancer hospitals, 30 of which are tertiary-level hospitals for cancer that provide the highest level of care. In addition, many general facilities have established oncology departments, and the number of beds for cancer care doubled from 2005 to 2010. However, these hospitals are unevenly distributed, with twice as many in urban as in rural areas.

Russia

The dissolution of the Soviet Union in 1991 created social and economic instability, but since 2000, the economy has improved because of key economic reforms in several sectors. Russia is classified as a high-income nation and an emerging economy. Although expenditure on healthcare has dramatically increased over the past 2 decades, substantial socioeconomic disparities remain. Healthcare expenditure on the poorer population is very low, compared with other high-income countries.

Life expectancies, which have not risen along with increasing wealth, are much lower in men than in women. Cancer is responsible for 15% of all deaths. The risk of dying from cancer in Russia is nearly double that of the risk in the United States. An increase in the percentage of the healthcare budget directed toward cancer care is needed, according to the report.

The risk of dying from cancer in Russia is nearly double that of the risk in the United States.

Also needed are improvements in the quality of the data, a national cancer plan, a national cancer screening program that takes local needs and resources into account, and a comprehensive national prevention plan that includes campaigns to reduce tobacco and alcohol consumption.

Currently, an estimated 44 million Russians smoke (60.2% of men and 21.7% of women).

On the positive side, new forward-looking anticancer policies have been implemented to reduce the incidence of the disease and improve outcomes. Examples include public health initiatives directed at alcohol and tobacco control and at disease prevention, with the goal of lowering cancer mortality. Unfortunately, the effects of these strategies have been limited by inadequate enforcement and monitoring, according to the report.

India

Cancer now accounts for approximately 6% of all deaths (55 million) in India. This number is expected to grow substantially because of changing population demographics and lifestyle factors. There are significant socioeconomic disparities in India, and about 55% of the population (660 million) lacks sufficient resources for basic survival. Conversely, about 15% (180 million) of the population is wealthy and can afford the best healthcare. India is therefore considered a lower- to middle-income nation; as in China, it has a growing economy and environmental pollution.

India is also highly diverse, with a broad range of cultural and social traditions throughout the separate states and regions of the country. There are several major sociocultural issues that affect approaches to healthcare, including social taboos, castes, gender inequality, healthcare not being a priority, nihilistic approaches to cancer diagnosis (i.e., cancer fatalism), and religious dynamics.

Affordability and an extreme shortage of doctors and other healthcare workers are major obstacles to progress in cancer care, according to the report. Simple, affordable, and safe approaches that require minimal monitoring are needed to improve cancer outcomes for a large subset of the population.

Also needed are prevention and screening programs and the integration of traditional medicine into cancer care.

As in China and Russia, headway has been made in cancer care. A National Cancer Control Programme was launched in India in 1975. It led to the development of a cancer registry program, which enabled government policymakers to recognize the effect of cancer on the nation’s health, and to the development of 27 regional cancer centers.

More than 80 public hospitals have received funding to establish oncology services, and programs for cancer control are now operational in 21 Indian states.

Coauthor Pedro E.R. Liedke, MD, from Clínicas de Porto Alegre, Instituto do Câncer Hospital Mãe de Deus, in Brazil, reports receiving travel grants from Roche, sanofi-aventis, and Novartis, and consulting for Novartis.

Lancet Oncol. 2014;15:489-538. Abstract

SOURCE

http://www.medscape.com/viewarticle/824074#1

 

 

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