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Archive for the ‘Biomedical Measurement Science’ Category


June 4, 2018 – Department of Defense Medical Innovation and Biodefense Forum, BIO 2018! at Boston Convention & Exhibition Center

Announcement

Aviva Lev-Ari, PhD, RN,

https://mybio.org/profile/member/2029564?profile_tabs=profile

Founder and Director of LPBI Group will be in attendance covering the event in REAL TIME

https://pharmaceuticalintelligence.com/2018/05/26/bio-2018-june-4-7-2018-at-boston-convention-exhibition-center/

@pharma_BI

@AVIVA1950

for

#BIO2018

@BIOConvention

  • How DoD can assist Industry to commercialize technologies
  • How the coordination in the Infectious disease takes place
  • Manufacturing for DoD
  • Infrastructure to manage across Government RFP Process
  • Devices requires detailed engineering for use in Field hospitals
  • Regulatory, Scheduling and Engineering problems
  • Development is for all the Forces of the US and for all the Forces of US Allies — design for CIvilian first respnders as well
  • Some partners are commercial Partners, they need to approach DoD with novel product concept
  • FDA approved vs Right to Try – DoD uses both
  • Small business Program, success in bringing product to market
  • 20 years ago: Communities of interest – 20 orgs community common goals in Health Care, rehabilitation after coming home,
  • MROC – Conference in Florida DoD to explain the Public the process of engagement with Do
  • Interagency partnership
  • DoD starts with good ideas, concept studies – innovators
  • Collaborations with Academia, we are available to be approached
  • DoD will partner with small businesses to avoid the Regulatory process  – to save time and resources in the commercialization process
  • How a civilian concept FITS the needs of DoD
  • Sustaining an innovation along the years
  • Need for small business to approach DoD to make the contact
  • Where is a small business in the Development cycle? DoD can help calibrate
  • A System of Systems: Diagnostics drive decisions
  • develop partnerships in consortia
  • Six month to vaccinate 17,000 with a Vaccine for EBOLA
  • DoD of respective countries are collaborating with US DoD
  • Threat environment changes over time vs modify known threats
  • Monoclonal antibody – the Industry developed the manufacturing technology and DoD is user of Industry products
  • All research for the Joint Force, Chemical, Biological,
  • Short time to market solutions are of interest for DoD to identify
  • Military relevance: Key for funding
  • Announcements of DoD on WHAT PROBLEMS DoD tries to solve
  • DoD and HHS — aligned for common solution to avoid redundancy
  • Development of profilaxix is very expensive, DoD budget has competing goals: Next soldier suit,
  • FDA and DoD need to collaborate for DoDs needs
  • Order transaction authority,
  • Congress set aside a budget for small businesses to use accounting systems for Small business to interact with DoD
  • How to get a digital signal to the brain: Expertise in many disciplines: EE, Ethomology
  • Delivery, test , evaluation, develop sensors, IS to manage threats, Diagnostics,
  • How to do Business with Industry?
  • Congress asked for a Consorsium to engage with Industry in a different form than we engaged before
  • Partnerships for out of the box thinking and going quickly – the appetite for is greater then evr before
  • Successful area: Diagnostics – adoptation of existing diagnostics for military applications
  • Platform technologies: Metabolic, Vaccines,
  • Leverage existing technologies to solve DoD concerns
  • involved with MCS help Government to learn how to build their Office
  • Genomic, Proteomics, therapeutics candidates, Prophylaxis as Vaccines
  • In the event of an outbreak: clinicians, 1st responders
Panel 2: Clay Holloway, Director of Strategic Initiatives, Joint Project Manager, Medical Countermeasure Systems (JPM-MCS)
  • Partnering is key
  • capability requirements: broad spectrum capabilities
  • Decision tools to be used at studies for data analysis for decision making
  • Risks in partnership: DoD needs to evaluate ideas for next generation to SKIP one generation
  • How to used different agreement strategically? Streamline DoD Methods
  • Have continuous access to assets

 

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Top TEN Graduate School Search – Biological Sciences Programs

Reporter: Aviva Lev-Ari, PhD, RN

 

School Program Rank
Massachusetts Institute of Technology – Department of Biology

Cambridge, MA

#1Tie
Stanford University – Department of Biology

Stanford, CA

#1Tie
University of California–Berkeley – College of Letters and Science

Berkeley, CA

#1Tie
California Institute of Technology – Division of Biology

Pasadena, CA

#4Tie
Harvard University – Programs in Biological and Biomedical Sciences

Boston, MA

#4Tie
Johns Hopkins University – Biology Department

Baltimore, MD

#6Tie
Princeton University – Department of Molecular Biology

Princeton, NJ

#6Tie
University of California–San Francisco – Graduate Division

San Francisco, CA

#6Tie
Yale University – Combined Program in the Biological and Biomedical Sciences

New Haven, CT

#6Tie
Cornell University

Ithaca, NY

#10Tie

SOURCE

https://www.usnews.com/best-graduate-schools/search?program=top-biological-sciences-programs&name=&sort=program_rank&sortdir=asc

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Reporter and Curator: Dr. Sudipta Saha, Ph.D.

 

Anti-Müllerian Hormone (AMH), is secreted by growing follicles that contains the egg or ovum. According to regular practice low AMH and high Follicle Stimulating Hormone (FSH) are generally considered as indicators of diminished egg quantity in a female. But, there are several cases the female conceived absolutely normally without any support even after low AMH was reported.

 

Therefore, a new research published in the Journal of the American Medical Association declares that AMH doesn’t dictate a woman’s reproductive potential. Although AMH testing is one of the most common ways that doctors assess a woman’s fertility. Present research says that all it takes is one egg each cycle and AMH is not a marker of whether a female can or cannot become pregnant. So, for women who haven’t yet tried to get pregnant and who are wondering whether they are fertile, an AMH value isn’t going to be helpful in that context. In addition, AMH is not necessarily a good marker to predict that whether one has to cryopreserve her eggs. So, practically doctors don’t yet have a way to definitively predict egg quality or a woman’s long-term ability to conceive, but age is obviously one of the most important factors.

 

The above mentioned study followed 750 women between the ages of 30 and 44 who had been trying to conceive for three months or less. During the 12-month observation period, those with low AMH values of less than 0.7 were not less likely to conceive than those who had normal AMH values. The study had various limitations, however, that are worth noting. The researchers only included women who did not have a history of infertility. Women who sought fertility treatments (about 6 percent) were withdrawn. And only 12 percent of the women were in the 38-to-44 age range. In addition, the number of live births was unavailable.

 

Among women aged 30 to 44 years without a history of infertility who had been trying to conceive for 3 months or less, biomarkers indicating diminished ovarian reserve compared with normal ovarian reserve were not associated with reduced fertility. These findings do not support the use of urinary or blood FSH tests or AMH levels to assess natural fertility for women with these characteristics. The researchers’ next want to see whether low AMH is associated with a higher risk of miscarriage among the women who conceived.

 

Although AMH testing isn’t designed to be an overall gauge of a woman’s fertility, it can still provide valuable information, especially for women who are infertile and seeking treatment. It can assist in diagnosing polycystic ovarian syndrome, and identify when a woman is getting closer to menopause. Previous research also showed that AMH is good predictor of a woman’s response to ovarian stimulation for in vitro fertilization and therefore it can predict the probability of conceiving via in vitro fertilization (I.V.F.).

 

References:

 

https://jamanetwork.com/journals/jama/article-abstract/2656811?JamaNetworkReader=True

 

https://www.nytimes.com/2017/10/16/health/fertility-test-ovarian-reserve.html

 

https://academic.oup.com/humrep/article/26/11/2925/656065

 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3339896/

 

https://www.ncbi.nlm.nih.gov/pubmed/27179263

 

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Reporter and Curator: Dr. Sudipta Saha, Ph.D.

 

Scientists at the Stanford University School of Medicine have completed the first-ever characterization of the meticulously timed immune system changes in women that occur during pregnancy. The findings were published in Science Immunology revealed that there is an immune clock of pregnancy and suggest it may help doctors predict preterm birth.

 

The timing of immune system changes follows a precise and predictable pattern in normal pregnancy. Although physicians have long known that the expectant mother’s immune system adjusts to prevent her body from rejecting the fetus, no one had investigated the full scope of these changes, nor asked if their timing was tightly controlled.

 

Nearly 10 percent of U.S. infants are born prematurely, arriving three or more weeks early, but physicians lack a reliable way to predict premature deliveries. Previous research at Stanford and other places suggested that inflammatory immune responses may help in triggering early labor. It suggested that if scientists identify an immune signature of impending preterm birth, they should be able to design a blood test to detect it.

 

The researchers used mass cytometry, a technique developed at Stanford, to simultaneously measure up to 50 properties of each immune cell in the blood samples. They counted the types of immune cells, assessed what signaling pathways were most active in each cell, and determined how the cells reacted to being stimulated with compounds that mimic infection with viruses and bacteria.

 

The researchers developed an algorithm that captures the immunological timeline during pregnancy that both validates previous findings and sheds new light on immune cell interaction during gestation. By defining this immunological chronology during normal term pregnancy, they can now begin to determine which alterations associate with pregnancy-related pathologies.

 

With an advanced statistical modeling technique, introduced for the first time in this study, the scientists then described in detail how the immune system changes throughout pregnancy. Instead of grouping the women’s blood samples by trimester for analysis, the model treated gestational age as a continuous variable, allowing the researchers to account for the exact time during pregnancy at which each sample was taken. The mathematical model also incorporated knowledge from the existing scientific literature of how immune cells behave in nonpregnant individuals to help determine which findings were most likely to be important.

 

The study confirmed immune features of pregnancy that were already known. Such as the scientists saw that natural killer cells and neutrophils have enhanced action during pregnancy. The researchers also uncovered several previously unappreciated features of how the immune system changes, such as the finding that activity of the STAT5 signaling pathway in CD4+T cells progressively increases throughout pregnancy on a precise schedule, ultimately reaching levels much higher than in nonpregnant individuals. The STAT5 pathway is involved in helping another group of immune cells, regulatory T cells, to differentiate. Interestingly, prior research in animals has indicated that regulatory T cells are important for maintaining pregnancy.

 

The next step will be to conduct similar research using blood samples from women who deliver their babies prematurely to see where their trajectories of immune function differ from normal.

 

This study revealed a precisely timed chronology of immune adaptations in peripheral blood over the course of a term pregnancy. This finding was enabled by high-content, single-cell mass cytometry coupled with a csEN algorithm accounting for the modular structure of the immune system and previous knowledge. The study provided the conceptual backbone and the analytical framework to examine whether disruption of this chronology is a diagnostically useful characteristic of preterm birth and other pregnancy-related pathologies.

 

References:

 

http://immunology.sciencemag.org/content/2/15/eaan2946.full

 

http://med.stanford.edu/news/all-news/2017/09/immune-system-changes-during-pregnancy-are-precisely-timed.html

 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3078586/

 

http://www.nature.com/nm/journal/v19/n5/full/nm.3160.html?foxtrotcallback=true

 

https://www.ncbi.nlm.nih.gov/pubmed/14758358

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Trends in Sperm Count

Reporter and Curator: Dr. Sudipta Saha, Ph.D.

 

There has been a genuine decline in semen quality over the past 50 years. There is lot of controversy about this as there are limitations in studies that have attempted to address it. Sperm count is of considerable public health importance for several reasons. First, sperm count is closely linked to male fecundity and is a crucial component of semen analysis, the first step to identify male factor infertility.

Reduced sperm count is associated with cryptorchidism, hypospadias and testicular cancer. It may be associated with multiple environmental influences, including endocrine disrupting chemicals, pesticides, heat and lifestyle factors, including diet, stress, smoking and BMI. Therefore, sperm count may sensitively reflect the impacts of the modern environment on male health throughout the life span.

This study provided a systematic review and meta-regression analysis of recent trends in sperm counts as measured by sperm concentration (SC) and total sperm count (TSC), and their modification by fertility and geographic group. Analyzing trends by birth cohorts instead of year of sample collection may aid in assessing the causes of the decline (prenatal or in adult life) but was not feasible owing to lack of information.

This rigorous and comprehensive analysis found that SC declined 52.4% between 1973 and 2011 among unselected men from western countries, with no evidence of a ‘leveling off’ in recent years. Declining mean SC implies that an increasing proportion of men have sperm counts below any given threshold for sub-fertility or infertility. The high proportion of men from western countries with concentration below 40 million/ml is particularly concerning given the evidence that SC below this threshold is associated with a decreased monthly probability of conception.

Declines in sperm count have implications beyond fertility and reproduction. The decline reported in this study is consistent with reported trends in other male reproductive health indicators, such as testicular germ cell tumors, cryptorchidism, onset of male puberty and total testosterone levels. The public health implications are even wider. Recent studies have shown that poor sperm count is associated with overall morbidity and mortality. While the current study is not designed to provide direct information on the causes of the observed declines, sperm count has been plausibly associated with multiple environmental and lifestyle influences, both prenatally and in adult life. In particular, endocrine disruption from chemical exposures or maternal smoking during critical windows of male reproductive development may play a role in prenatal life, while lifestyle changes and exposure to pesticides may play a role in adult life.

These findings strongly suggest a significant decline in male reproductive health, which has serious implications beyond fertility concerns. Research on causes and implications of this decline is urgently needed.

 

REFERENCES

Temporal trends in sperm count: a systematic review and meta-regression analysis 

Hagai Levine, Niels Jørgensen, Anderson Martino‐Andrade, Jaime Mendiola, Dan Weksler-Derri, Irina Mindlis, Rachel Pinotti, Shanna H Swan. Human Reproduction Update, July 25, 2017, doi:10.1093/humupd/dmx022.

Link: https://academic.oup.com/humupd/article-lookup/doi/10.1093/humupd/dmx022.

Sperm Counts Are Declining Among Western Men – Interview with Dr. Hagai Levine

https://news.afhu.org/news/sperm-counts-are-declining-among-western-men?utm_source=Master+List&utm_campaign=dca529d919-EMAIL_CAMPAIGN_2017_07_27&utm_medium=email&utm_term=0_343e19a421-dca529d919-92801633

J Urol. 1983 Sep;130(3):467-75.

A critical method of evaluating tests for male infertility.

https://www.ncbi.nlm.nih.gov/pubmed/6688444

Hum Reprod. 1993 Jan;8(1):65-70.

Estimating fertility potential via semen analysis data.

https://www.ncbi.nlm.nih.gov/pubmed/8458929

Lancet. 1998 Oct 10;352(9135):1172-7.

Relation between semen quality and fertility: a population-based study of 430 first-pregnancy planners.

https://www.ncbi.nlm.nih.gov/pubmed/9777833

Hum Reprod Update. 2010 May-Jun;16(3):231-45. doi: 10.1093/humupd/dmp048. Epub 2009 Nov 24.

World Health Organization reference values for human semen characteristics.

https://www.ncbi.nlm.nih.gov/pubmed/19934213

J Nutr. 2016 May;146(5):1084-92. doi: 10.3945/jn.115.226563. Epub 2016 Apr 13.

Intake of Fruits and Vegetables with Low-to-Moderate Pesticide Residues Is Positively Associated with Semen-Quality Parameters among Young Healthy Men.

https://www.ncbi.nlm.nih.gov/pubmed/27075904

Reprod Toxicol. 2003 Jul-Aug;17(4):451-6.

Semen quality of Indian welders occupationally exposed to nickel and chromium.

https://www.ncbi.nlm.nih.gov/pubmed/12849857

Fertil Steril. 1996 May;65(5):1009-14.

Semen analyses in 1,283 men from the United States over a 25-year period: no decline in quality.

https://www.ncbi.nlm.nih.gov/pubmed/8612826

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Genomic Diagnostics: Three Techniques to Perform Single Cell Gene Expression and Genome Sequencing Single Molecule DNA Sequencing

Curator: Aviva Lev-Ari, PhD, RN

 

This article presents Three Techniques to Perform Single Cell Gene Expression and Genome Sequencing Single molecule DNA sequencing

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The BioPharma Industry’s Unrealized Wealth of Data, by Ben Szekely, Vice President, Cambridge Semantics

Reporter: Aviva Lev-Ari, PhD, RN

 

 

The BioPharma Industry’s Unrealized Wealth of Data

by Ben Szekely, Vice President of Solutions and Pre-sales, Cambridge Semantics

 

Solving the great medical challenges of our time reside within patient data. Clinical trial data, real-world evidence, patient feedback, genetic data, wearables data and adverse event reports contain signals to target medicines at the right patient populations, improve overall safety, and uncover the next blockbuster therapy for unmet medical needs.

However, data sources are large, diverse, multi-structured, messy and highly regulated presenting numerous challenges. As result, extracting value from data are slow to come and require manual work or long-poll dependencies on IT and Data Science teams.

Fortunately, there are new ways being adopted to take better advantage of the ever-growing volumes of patient data.  Called ‘Smart’ Patient Data Lakes (SPDL), these tools create an Enterprise Knowledge Graph built upon foundational and open Semantic Web technology standards, providing rich descriptions of data and flexibility end-to-end.  With the SPDL, biopharma researchers can:

  • Quickly on-board new data without requiring up-front modeling or mapping, ingesting data from any source versus months or weeks of preparation
  • Dynamically map and prepare data at analytics time
  • Horizontally scale in cloud or on-prem infrastructure to 100’s of nodes – allowing billions of facts to be analyzed, queried and explored in real-time   

The world’s BioPharma and research institutions are sitting on a wealth of highly differentiating and life-saving data and should begin to realize its value via Smart Patient Data Lakes (SPDL).

 

 

CONTACT: Nadia Haidar

Global Results Communications ∙ 949-278-7328 ∙ nhaidar@globalresultspr.com

 

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