Saturday, 25 May 2019

How microbes in the human body swap genes

Bacteria in the human body are sharing genes with one another at a higher rate than is typically seen in nature, and some of those genes appear to be traveling -- independent of their microbial hosts -- from one part of the body to another.

The findings are the result of a molecular data-mining method initially conceptualized by Kyung Mo Kim, a senior research scientist at the Korea Polar Research Institute. This computationally challenging method allowed them to identify instances of "horizontal gene transfer," the direct transfer of genes between organisms outside of sexual or asexual reproduction. Horizontal gene transfer is a major force of exchange of genetic information on Earth, These exchanges allow microorganisms to adapt and thrive, but they are likely also important for human health. There are some bacteria that cannot live outside our bodies and some without which we cannot live.

For the new analysis, the scientists used genomic information to build tens of thousands of "family trees" of bacteria that colonize the human body. Reconciling those with trees of microbial genes allowed the team to tease out which genes had been inherited and which were the result of horizontal gene transfer.

The researchers studied human-associated microorganisms, since they are known to be key players in maintaining human health and metabolism and calculated gene-transfer rates and direction -- who transferred what to whom -- for more than 1,000 reference bacterial genomes sampled by the National Institutes of Health Human Microbiome Project.

The bacteria had been sampled from six human body sites: the gut, skin, oral cavity, blood, urogenital tract and airways. The researchers found evidence to support earlier findings that human-associated bacteria are quite promiscuous with their genes.

The horizontal exchange between microbes in our bodies is about 30 percent higher than what you'll find on the rest of the planet. This implies that our bodies provide a niche that is unique and facilitates innovation at the microbe level.

About 40 percent of gene swapping occurred among bacteria living in the same body sites. The other 60 percent involved gene sharing among bacteria in different tissues, for example between organisms in the gut and in blood.

In all cases, gene transfer was most common among closely related organisms, regardless of whether they occupied the same or different bodily tissues. In fact, the researchers report, gene sharing among organisms in different body sites occurred at a higher rate than gene sharing among distantly related bacteria living at the same sites.

The researchers say other scientists can use the tool they developed for this work, HGTree, to more accurately predict which genes were inherited "vertically," through the process of reproduction, and which were picked up from other microbes through horizontal gene transfer. This will lead to an improved understanding of microbial -- and human -- evolution.

See: Hyeonsoo Jeong, Bushra Arif, Gustavo Caetano-Anoll├ęs, Kyung Mo Kim, Arshan Nasir. Horizontal gene transfer in human-associated microorganisms inferred by phylogenetic reconstruction and reconciliation. Scientific Reports, 2019; 9 (1) DOI: 10.1038/s41598-019-42227-5

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Friday, 24 May 2019

New ‘interspecies communication’ strategy between gut bacteria and mammalian hosts

Bacteria in the gut do far more than help digest food in the stomachs of their hosts, they can also tell the genes in their mammalian hosts what to do.

A study published today in Cell describes a form of “interspecies communication” in which bacteria secrete a specific molecule–nitric oxide–that allows them to communicate with and control their hosts’ DNA, and suggests that the conversation between the two may broadly influence human health.

The researchers out of Case Western Reserve University School of Medicine, University Hospitals Cleveland Medical Center, and Harvard Medical School tracked nitric oxide secreted by gut bacteria inside tiny worms (C. elegans, a common mammalian laboratory model). Nitric oxide secreted by gut bacteria attached to thousands of host proteins, completely changing a worm’s ability to regulate its own gene expression.

The study is the first to show gut bacteria can tap into nitric oxide networks ubiquitous in mammals, including humans. Nitric oxide attaches to human proteins in a carefully regulated manner–a process known as S-nitrosylation–and disruptions are broadly implicated in diseases such as Alzheimer’s, Parkinson’s, asthma, diabetes, heart disease, and cancer.

The findings suggest nitric oxide is a general mechanism by which gut bacteria can communicate with mammalian hosts. Previous work to untangle communication lines to and from gut bacteria has primarily focused on rare molecules that bacteria secrete. The new findings are akin to uncovering a chemical language common across species, as opposed to single words, said senior author Jonathan Stamler, MD, director of the Institute for Transformative Molecular Medicine at Case Western Reserve University School of Medicine and president of the Harrington Discovery Institute at University Hospitals Cleveland Medical Center.

“There is tremendous complexity in the gut, and many researchers are after the next unusual substance produced by a bacterium that might affect human health,”

he says. With trillions of bacteria in the average gut, Stamler decided to look for a common language that all bacterial species might use.

“The enormity of the gut bacteria population and its relationship to the host predicts there will be general means to communicate that we humans can recognize.”

The researchers demonstrated the phenomenon by feeding developing worms bacteria that produce nitric oxide. They then selected one very important protein–argonaute protein, or ALG-1–that is highly conserved from worms to humans and silences unnecessary genes, including genes critical for development. When nitric oxide secreted by the bacteria attached to ALG-1, they developed malformed reproductive organs and died. Too much nitric oxide from bacteria commanded the worms’ DNA silencing proteins and impaired healthy development.

“Practically, animals will not let this happen,”

Stamler said. Instead, the authors speculate a mammalian host outside of a laboratory setting will adjust to accommodate changing nitric oxide levels. Said Stamler,

“The worm is going to be able to stop eating the bacteria that make the nitric oxide, or it will begin to eat different bacteria that makes less nitric oxide, or change its environment, or countless other adaptations. But by the same token, too much nitric oxide produced by our microbiome may cause disease or developmental problems in the fetus.”

The study adds to a growing body of evidence that bacteria living in the gut, determined by diet and environment, have a tremendous influence on mammalian health. Stamler imagines nitric oxide may represent an opportunity to manipulate this symbiotic relationship. Just as probiotics are designed to improve digestion, inoculating a person’s gut with bacteria to improve nitric oxide signaling is conceivable.

“I now think of this therapeutically, as a drug. There are tremendous opportunities to manipulate nitric oxide to improve human health.”

While nitric oxide and S-nitrosylation may be a general mode of interspecies communication with broad health implications, it will require additional future research. Will nitric oxide be the only chemical communication channel?

“We’re basically seeing a new field opening for general strategies of communication. There will be others.”


Stamler collaborated with several researchers from Case Western Reserve University School of Medicine on the new study, including first authors Puneet Seth, MD and Paishiun (Nelson) Hsieh, MD, PhD; Suhib Jamal; Liwen Wang, PhD; Mukesh Jain, MD; and Jeff Coller, PhD.

This research was supported in part by grants from the National Institutes of Health (R01-GM099921 to J.S.S., T32GM007250 and F30AG054237 to P.N.H, and R35HL135789 to M.J.).
Puneet, S., et al. “Regulation of microRNA machinery and development by interspecies s-nitrosylation.” Cell. DOI: 10.1016/j.cell.2019.01.037

Source: Microbiome Times

Thursday, 23 May 2019

FDA - Nonproprietary Naming of Biological Products

The FDA has issued a new draft guidance document – “Nonproprietary Naming of Biological Products:  Update”.

This draft guidance describes FDA’s current thinking on nonproprietary names of biological products licensed under section 351 of the Public Health Service Act (PHS Act) that do not include an FDA-designated suffix.  Specifically, the nonproprietary names of these products need not be revised in order to accomplish the objectives of the naming convention described in the Guidance for Industry: Nonproprietary Naming of Biological Products (Naming Guidance). 

Similarly, FDA does not intend to apply the naming convention described in the Naming Guidance to biological products that are the subject of an approved application under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as of March 23, 2020, when such an application is deemed to be a biologics license application (BLA) under section 351 of the PHS Act on March 23, 2020 (transition biological products).

In addition, this draft guidance describes FDA’s current thinking on the appropriate suffix format for the proper name of an interchangeable biological product licensed under section 351(k) of the PHS Act. For each interchangeable product, FDA intends to designate  a proper name that is 30 a combination of the core name and a distinguishing suffix that is devoid of meaning and 31 composed of four lowercase letters.

FDA is also reconsidering whether vaccines should be within the scope of the naming convention.

To access the document, see:

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Wednesday, 22 May 2019

Oral bacteria 'battle royale' helps explain how a pathogen causes hospital infections

Hundreds of different bacterial species are living inside your mouth. Some are highly abundant, while others are scarce. A few of these oral bacteria are known pathogens. Others are benign, or even beneficial.

Scientists know the genetic makeup of about 70 percent of oral bacteria. What they don't know is which species would live the longest without nutrients in a "battle royale" -- so they decided to find out. The results help explain how certain dangerous bacteria are able to persist in a sterile hospital environment and infect patients.

Researchers from the Forsyth Institute, the J. Craig Venter Institute, the University of Washington, and the University of California, Los Angeles, have described their discovery that three closely related species of bacteria belonging to the family Enterobacteriaceae outlived all other oral bacteria in long-term starvation or "doomsday" experiment.

To create a battle of bacteria, researchers placed hundreds of samples of oral bacteria from human saliva into test tubes. The bacteria, which are accustomed to living in the nutrient-rich mouth, were starved in their new environment. Each day, scientists checked the samples to see which bacteria were still alive.

Nearly every bacterial species died within the first couple of days. But three species -- Klebsiella pneumoniae, Klebsiella oxytoca, and Providencia alcalifaciens -- survived the longest, with Klebsiella pneumoniae and Klebsiella oxytoca surviving for more than 100 days.

Researchers were surprised to find that Klebsiella were among the champions of this bacterial combat. In their natural environment of the oral cavity, Klebsiella are considered an underdog. They account for only about 0.1 percent of all microbes in the mouth. But in an extreme environment deprived of all nutrients, Klebsiella reigned supreme while the bugs normally found in high abundance rapidly died off.

Scientists describe Klebsiella species as opportunistic pathogens. In healthy people, they live in the mouth peacefully, crowded by other microbes and unable to grow or cause trouble. But outside the mouth, where few other bacteria survive, Klebsiella is king. They persist on hospital surfaces, like sinks or tables. If a patient with a compromised immune system makes contact with Klebsiella, that patient could develop an infection.

Infections by Klebsiella can result in a number of dangerous conditions including pneumonia and meningitis. One of the reasons Klebsiella infections are so dangerous is that Klebsiella are particularly adept at developing resistance to antibiotics, as well as transferring this drug resistance to neighboring bacteria.

The finding that these Klebsiella species survive longer than their more benign neighbors in mixtures of saliva is likely to have a great deal of clinical significance, as multiple virulent outbreaks of antibiotic-resistant Klebsiella have been traced back to hospital sinks and drains. This research also helps illuminate a key ecological dynamic of bacterial communities.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Tuesday, 21 May 2019

20 years of sampling and testing programme for medicines

EMA and the European Directorate for the Quality of Medicines & Healthcare (EDQM) have reviewed EMA’s sampling and testing programme for centrally authorised medicines on the EU/EEA market, which has been organised yearly since 1998.

The number of centrally authorised medicines tested every year has steadily increased from nine in the 1997-1998 pilot project to 58 in 2017, totalling over 700 products. Most of the issues identified during the testing resulted in EMA requiring companies to amend the registered manufacturer’s control methods for their medicines. In a small number of cases, the tested samples were not compliant with the authorised quality specifications for the medicine and required other regulatory actions such as re-testing, inspections, recalls or suspension of supply. These are some of the key findings in a report summarising the sampling and testing activities and main achievements over the past 20 years.

The programme is an important part of the supervision of the quality of centrally authorised products (CAPs) for human and veterinary use in all parts of the distribution chain. The tests are aimed at verifying the compliance of medicines with their authorised specifications and ensuring that the manufacturer’s control methods are satisfactory.

To access the report, see:

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Monday, 20 May 2019

Bacterial factories to manufacture high-performance proteins for space missions

Scientists report on a new method that takes advantage of engineered bacteria to produce spider silk and other difficult-to-make proteins that could be useful during future space missions.

If produced in sufficient quantities, spider silk could be used for a variety of applications, ranging from bullet-proof fabric to surgical sutures. But spider silk isn't easy to farm -- spiders produce tiny quantities, and some species turn cannibalistic when kept in groups. Therefore, scientists have tried engineering bacteria, yeast, plants and even goats to produce spider silk, but they haven't yet been able to fully replicate the natural fiber's mechanical properties.

Part of the problem is that spider silk proteins are encoded by very long, highly repetitive sequences of DNA. Spiders have evolved ways to keep these sequences in their genome. But when scientists put this type of DNA into other organisms, the genes are very unstable, often getting snipped or otherwise altered by the host's cellular machinery. Zhang and colleagues at Washington University in St. Louis wondered if they could break the long, repetitive sequences into shorter blocks that bacteria could handle and make into proteins. Then, the researchers could assemble the shorter proteins into the longer spider silk fiber.

READ MORE: ISS is not causing bacteria to mutate into dangerous, antibiotic-resistant superbugs

The team introduced genes to bacteria that encoded two pieces of the spider silk protein, each flanked by a sequence called a split intein. Split inteins are naturally occurring protein sequences with enzymatic activity: Two split inteins on different protein fragments can join and then cut themselves out to yield an intact protein. After introducing the genes, the researchers broke open the bacteria and purified the short pieces of spider silk protein. Mixing the fragments caused them to join together through the "glue" of the split intein sequence, which then cut itself out to yield the full-length protein. When spun into fibers, the microbially produced spider silk had all of the properties of natural spider silk, including exceptional strength, toughness and stretchability. The researchers obtained more silk with this method than they could from spiders (as much as two grams of silk per liter of bacterial culture), and they are currently trying to increase the yield even more.

The researchers can make various repetitive proteins simply by swapping out the spider silk DNA and putting other sequences into bacteria. For example, the researchers used the technique to make a protein from mussels that adheres strongly to surfaces. The protein could someday be applied as an underwater adhesive. Now, the researchers are working on streamlining the process so that the protein-joining reaction can occur inside bacterial cells. This would improve the efficiency and potential automation of the system because researchers wouldn't have to purify the two pieces of the protein and then incubate them together.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Sunday, 19 May 2019

Fast-changing genetics key to hospital superbug survival

A highly drug-resistant bacteria common in hospitals, Klebsiella pneumoniae, represents a significant antimicrobial resistance threat and should be monitored globally, say researchers. The warning follows new genetic analyses revealing how K. pneumoniae are able to quickly evolve to change their genetic makeup. This has implications for understanding how several species of bacteria -- called Enterobacteriaceae -- can rapidly adapt to essentially any antibiotic currently used in treatment.

By genetically analysing 100 strains of K. pneumoniae bacteria sampled from infected patients, carriers without symptoms and the hospital ward environment over a 14-month period, they found that the bacteria were highly transmissible and able to genetically adapt to any available antibiotic within very short periods of time.

The hospital outbreak strains of K. pneumoniae were found to be very highly drug-resistant, with all isolates analysed showing resistance to multiple drug classes, including to Carbapenems -- antibiotics used as a last resort in the treatment of severe infections.

With the number of deaths from drug-resistant infections predicted to rise from 700,000 to 10 million per year by 2050, Carbapenem-resistant Enterobacteriaceae are listed as one of three urgent threats by the Centers for Disease Control and Prevention and a key global 'critical-priority' by the World Health Organization.

READ MORE: Potential antibody treatment for multidrug-resistant K. pneumoniae

The team used whole genome DNA sequence data to reconstruct the evolution of the highly drug-resistant bacteria, including tracking their transmission within the hospital, spanning three campuses, 19 wards and two intensive care units. By using genome-wide genetic data the researchers could clearly follow their spread around the hospital. It's remarkable to see how easily these bacteria were moving between patients, particularly those in intensive care units, but we also found that they were transmitting across different hospital sites via ward equipment, including ward bed rails and medical devices.

The researchers found the bacteria were carrying many resistance plasmids, and in some cases these plasmids were present in multiple copies. We demonstrated that the number of copies helped to predict how successfully treatment was evaded by the bacteria. This means it isn't just the presence of a gene conferring resistance that is important, but also its abundance in an infecting strain.

Journal reference:

Lucy van Dorp, Qi Wang, Liam P. Shaw, Mislav Acman, Ola B. Brynildsrud, Vegard Eldholm, Ruobing Wang, Hua Gao, Yuyao Yin, Hongbin Chen, Chuling Ding, Rhys A. Farrer, Xavier Didelot, Francois Balloux, Hui Wang. Rapid phenotypic evolution in multidrug-resistant Klebsiella pneumoniae hospital outbreak strains. Microbial Genomics, 2019; DOI: 10.1099/mgen.0.000263
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Saturday, 18 May 2019

Global microbial signatures for colorectal cancer

Patients with colorectal cancer have the same consistent changes in the gut bacteria across continents, cultures, and diets -- a team of international researchers find in a new study. The hope is the results in the future can be used to develop a new method of diagnosing colorectal cancer. This is based on research from the University of Copenhagen The Faculty of Health and Medical Sciences.

Cancers have long been known to arise due to environmental exposures such as unhealthy diet or smoking. Lately, the microbes living in and on our body have entered the stage as key players. But the role that gut microbes play in the development of colorectal cancer -- the third most common cancer worldwide -- is unclear. To determine their influence, association studies have aimed to map how the microbes colonizing the gut of colorectal cancer patients are different from those that inhabit healthy subjects.

Now, researchers have analysed multiple existing microbiome association studies of colorectal cancer together with newly generated data. Their meta-analyses establish disease-specific microbiome changes, which are globally robust -- consistent across seven countries on three continents -- despite differences in environment, diet and life style.

READ MORE: Killer immune cells that halt malaria could hold key to new vaccines

The study led by UCPH and EMBL scientists focuses on a process in which certain gut bacteria turn bile acids that are part of our digestive juices into metabolites that can be carcinogenic. A related study from the University of Trento shows how certain classes of bacteria degrade choline, an essential nutrient contained in meat and other foods, and turn it into a potentially dangerous metabolite. This metabolite has previously been shown to increase cardiovascular disease risk, and can now also be linked to colorectal cancer.

One of the challenges of metagenomic studies, which are based on genetic material from microbes in environmental samples such as stool, is to link genetic fragments to the various microbial organisms they belong to. The goal of this so-called taxonomic profiling task is to identify and quantify the bacterial species present in the sample.

The role of gut microbes in colorectal cancer still needs to be established. If the changes in the microbiome play a role in developing the cancer, they could also be a therapeutic target. Therefore, Manimozhiyan Arumugam hopes that there will be more focus on the role of microbiome in diseases and that researchers will recognize the advantages of collecting microbiome samples, for example, in large cohorts.

Journal reference:

Meta-analysis of fecal metagenomes reveals global microbial signatures that are specific for colorectal cancer. Nature Medicine, 2019; DOI: 10.1038/s41591-019-0406-6
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Friday, 17 May 2019

Tackling challenge of antifungal resistance

New work is helping develop a better understanding of the growing threat posed by antifungal drug resistance. Invasive aspergillosis is a devastating disease caused by breathing in small airborne spores of the fungus Aspergillus fumigatus and it is a condition where drug resistance has been encountered. They have just released a paper revealing how they have been able to identify a previously uncharacterized genetic mutation in clinical isolates that leads to resistance.

Invasive aspergillosis is a devastating disease caused by breathing in small airborne spores of the fungus Aspergillus fumigatus and it is a condition where drug resistance has been encountered.

In a healthy person these spores are destroyed by the body's immune system but in those with a weakened immune system -- such as following organ transplantation or in someone with a lung condition such as asthma or cystic fibrosis -- they can trigger a range of problems including infections.

READ MORE: Fungal spore 'death clouds' key in gypsy moth fight

Every year aspergillosis leads to more than 200,000 life-threatening infections and increasingly resistance to vital antifungal drug treatments makes those infections harder to treat.

National Institutes of Health (USA) funding supported a collaboration between the University of Tennessee, the University of Texas and Swansea University as part of a $2 million, five-year research programme. This support enabled investigation of resistance to the triazole class of antifungal drugs used for treating the disease

A new paper shows how researchers have been able to identify a previously uncharacterised genetic mutation in clinical isolates that leads to resistance.

Journal reference:

Jeffrey M. Rybak, Wenbo Ge, Nathan P. Wiederhold, Josie E. Parker, Steven L. Kelly, P. David Rogers, Jarrod R. Fortwendel. Mutations in hmg1, Challenging the Paradigm of Clinical Triazole Resistance in Aspergillus fumigatus. mBio, 2019; 10 (2) DOI: 10.1128/mBio.00437-19
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Endotoxin and Pyrogen survey

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Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Thursday, 16 May 2019

probiotic could disrupt Crohn's disease biofilms

A probiotic has been found to help weaken stubborn microbial biofilm communities in the gut that can worsen symptoms. Researchers from Case Western Reserve University report.

Probiotics typically aim to rebalance bacteria populations in the gut, but new research suggests they may also help break apart stubborn biofilms. Biofilms are living microbial communities -- they provide a haven for microbes and are often resistant to antibiotics. A new study describes a specific probiotic mix that could help patients with gastrointestinal diseases avoid harmful biofilms that can worsen their symptoms.

The study evaluated the ability of a novel probiotic to prevent and treat biofilms containing yeast and bacteria -- in particular, species that thrive in damaged guts. Biofilms can contain an infectious polymicrobial mix of bacteria and fungi all living together underneath a thick protective slime. These polymicrobial communities are resistant to antibiotics, but can be antagonized by other microbes. Other microbes living in the gut -- or administered via probiotics -- can help break apart biofilms, according to the new study.

READ MORE: Probiotics Shown to Dramatically Improve IBS Gut Symptom

In a series of experiments researchers grew yeast (Candida species) and bacteria (Escherichia coli and Serratia marcescens) into biofilms. They then exposed the biofilms to a promising probiotic mix identified in a previous study -- one part yeast, three parts bacteria, and a small amount of amylase (an enzyme found in saliva). Microscope images showed biofilms exposed to the mix were looser-knit communities that were overall thinner and weaker than untreated biofilms.

The researchers found the probiotic worked in part by weakening yeast living in young biofilms. The yeast inside the biofilms were stunted in growth and did not form reproductive structures that help seed new biofilm growth and expansion. The researchers concluded their novel probiotic mix might help prevent harmful biofilms in people with inflammatory bowel disease or other gastrointestinal conditions.

Journal reference:

Christopher L. Hager, Nancy Isham, Kory P. Schrom, Jyotsna Chandra, Thomas McCormick, Masaru Miyagi, Mahmoud A. Ghannoum. Effects of a Novel Probiotic Combination on Pathogenic Bacterial-Fungal Polymicrobial Biofilms. mBio, 2019; DOI: 10.1128/mBio.00338-19
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Wednesday, 15 May 2019

Deep microbes' key contribution to Earth's carbon cycle

This new finding, from the Tokyo Institute of Technology, highlights the importance of microorganisms in the geochemistry of natural gas and petroleum.

Hydrocarbons play key roles in atmospheric and biogeochemistry, the energy economy, and climate change. Most hydrocarbons form in anaerobic environments through high temperature or microbial decomposition of organic matter. Subsurface microorganisms can also 'eat' hydrocarbons, preventing them from reaching the atmosphere. Using a new technique, scientists show that biological hydrocarbon degradation gives a unique biological signature. These findings could help detect subsurface biology and understand the carbon cycle and its impact on climate.

The researchers fed propane to microorganisms in the lab to measure the specific 12C/13C signature produced these organisms, and measured the non-biological changes that occurred when propane is broken down at high temperatures, a process known as "cracking." They then used these baseline measurements to interpret natural gas samples from the US, Canada and Australia, allowing them to detect the presence of microorganisms using propane as "food" in natural gas reservoirs, and to quantify the amount of hydrocarbons eaten by microorganisms.

READ MORE: Carbon monoxide improves effectiveness of antibiotic

When the researchers began analyzing samples from the bacterial simulation experiments, they matched perfectly what we observed in the field, suggesting the presence of propane degrading bacteria in the natural gas reservoirs.
Thus, this study revealed the presence of microorganisms that would have been difficult to detect using conventional methods, and opens a new window to understanding global hydrocarbon cycling.

Journal reference:

Intramolecular isotopic evidence for bacterial oxidation of propane in subsurface natural gas reservoirs. Proceedings of the National Academy of Sciences, 2019; 116 (14): 6653 DOI: 10.1073/pnas.1817784116

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Tuesday, 14 May 2019

Hospitals will be moving to digital pathology: Study

The take-up of digital pathology technology is expected to increase during the next decade and the main adopters of this technology will be healthcare organizations, such as hospitals and diagnostic laboratories, according to a new report.

As well as digital technologies in general, the healthcare sector will be enhancing digital images with artificial intelligence to help pathologists to detect key signs earlier or to help with greater accuracy.

Other advantages that will arise from such technology are centered on decreasing turnaround time, prioritizing critical cases, and improving overall patient outcomes. To do so will involve innovating and developing tools for primary and secondary analysis.

These are key highlights from a new report issued by Frost & Sullivan. The report is titled “Digital Pathology: Roadmap to the Future of Medical Diagnosis.” The types of technologies within this space are digital whole slide scanning, digital imaging solutions, and offering a digital data repository, which can be subject to big data analysis.
Many of these technologies will enable researchers to access databases from the cloud and for hospitals to collaborate together, in terms of sharing images. It is also possible to send an image around the world so that a second opinion can be given from a specialist consultant.

The report charts how the regulatory landscape has shifted and there is proven method qualification to show that digital systems are very effective, resulting in the barriers to technology take-up and implementation being lower.

As an example, the digital pathology system, and artificial intelligence platform, OsteoDetect has gained approval from the U.S. Food and Drug Administration (FDA). The technology is used for the detection of distal radius fracture.

Commenting on the report, Deepak Jayakumar, Senior Research Analyst, TechVision states: “Artificial intelligence has the potential to analyze big data and find patterns and insights that could enhance patient outcomes in the field of pathology. It can serve as a supplementary or a validation tool in imaging analytics for pathologists, and help process more slides in a shorter duration."

He goes on to assess how these technologies will appeal strongest to hospitals and diagnostic laboratories. A driver for this will be seeking cost optimization for end users. This can be realized via pay-per-use or Software-as-a-Service (SaaS) models. A side effect of this will be to disrupt traditional models within the healthcare system.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Monday, 13 May 2019

4 Cold Chain Logistics Trends Impacting Pharmaceuticals

When a drone is used for the first time to deliver an organ to a transplant recipient, you know big things are afoot in the pharmaceutical cold chain.

So what else drives growth in this field? And which technologies are coming to the forefront to make this critical industry safer and more efficient? Let's take a look at some answers.

A guest post from Megan Ray Nichols

1. Personalized Medicines

One of the greatest disruptions to medicine in recent memory — and the cold chain that powers the pharma industry — is personalized medicine. Also called "precision medicine," this is the practice of specifically tailoring (and even 3D-printing) medications and gene and cell therapies for use by smaller, more specific sets of patients. According to a 2017 report by the Personalized Medicine Coalition, the next five years will see a 69% increase in the number of precision drugs coming to market.

This is a huge opportunity for cold chain and logistics companies — but it also presents some roadblocks. These are small-batch medications that must be delivered within very tight deadlines. Compared with larger shipments and uniform temperature control requirements, the challenges speak for themselves. Some of these bespoke medications, including monoclonal antibodies, are more fragile than others and more susceptible to environmental hazards. Supply chain and logistics companies must stand ready with more efficient business models and more advanced thermal packaging. 

2. Blockchain and Traceability Requirements

Visibility and transparency are even more important in cold chain logistics than in any other supply chain. Various countries and emerging markets have different track-and-trace requirements, but technology can help cut through the noise and provide a standardized approach to supply chain transparency.

Blockchain presents a way for pharmaceutical companies to comply with increasingly and appropriately stringent government regulations concerning the transportation of pharmaceutical products. For example, the FDA's Drug Supply Chain Security Act lays out expectations for "electronic, interoperable systems" for recording and reporting information on drug shipments, with the goal of rooting out counterfeit products and streamlining the auditing and reporting processes. But these electronic systems require accurate and timely data to be of any use.

With that in mind, it will likely become the norm for logistics companies to employ blockchain and attach a cryptographically unique identifier to pharmaceutical shipments. This blockchain "token" collects information from origin to destination and cannot be altered once recorded. As a result, logistics companies can visualize their entire supply chain in the name of safety and authenticity. 

3. Data Everywhere and the IoT

Adoption of the Internet of Things is ramping up across the medical landscape. According to a DHL report entitled "The Future of Life Sciences and Healthcare Logistics," the health care IoT market will grow to $646 million in value by 2020. Cold chain and logistics companies drive a great deal of this growth.

As the demand for traditional and personalized medicine alike grows, companies must be more vigilant than ever about optimizing their manufacturing processes, insulating themselves against disruptions and forecasting demand. The IoT and Big Data are key allies in these challenges:

As an example, Bayer plans out its antihistamine supply chain roughly nine months in advance using analytics that incorporate information about climate patterns, customer demand and historical and geographical trends for conditions like hay fever. This ensures their products get to where they're needed most and stores don't run out during peak demand.

IoT-enabled manufacturing equipment can collect data all the way from production through to distribution and provide insights that lead to process optimizations. If there's a department creating a bottleneck, an inefficient vendor, or a not-quite-optimally-placed distribution hub, companies can find out about it and make timelier decisions and operational changes.

Pharmaceutical products must be kept at stable temperatures during storage and transit, or risk spoilage. Remote monitoring using the IoT and cloud-based intelligence platforms can track critical metrics for every shipment and every variable-temperature, ambient and freezer storage space, and alert personnel if conditions drop below or rise above optimal levels. It's not just about the 32- to 37-degree model anymore — facilities must be more flexible and we need technologies to support that flexibility.

Predicting demand, ironing out the kinks in manufacturing and having "eyes on" every shipment at every moment brings greater efficiency and safety to the cold chain than was ever possible before the IoT came to the fore. 

4. Mergers, Partnerships and Acquisitions

If there's an overriding mission across just about every industry, it's to reduce the time it takes for a customer to receive their order after they click "buy." The "on-demand" and "same-day" business models have already changed entertainment and eCommerce for good — and they're about to do the same for health care.

In 2018, Amazon, J.P. Morgan and Berkshire Hathaway announced a partnership called "Haven" and declared their intention to disrupt the health care industry. Immediately afterward, CVS, Walmart, Express Scripts and Cardinal Health stocks all plummeted. They lost billions of dollars in value overnight.

This isn't Amazon's only move that looks ready to shake up the cold chain industry. The retail giant also owns Whole Foods and more recently acquired PillPack — an online pharmacy — for a reported $1 billion.

Amazon doesn't have a monopoly on eCommerce, but they do enjoy a huge share of the pie. Just as importantly, their business model ushered in huge changes in customer expectations and omnichannel sales strategies when it comes to online selection and speed of delivery. All of the clues we mentioned seem to suggest that Amazon wants to use its influence to make significant changes to how pharmaceutical products are distributed, too.

When we try to catch a glimpse of the future of the pharmaceutical supply chain, it looks more and more like direct-to-patient and direct-to-hospital delivery will be the order of the day, for diagnostic tools and medical devices as well as for more time-sensitive medication purchases. Supply chain companies aren't going anywhere — indeed, the explosion in popularity of online pharmacies and even subscription-based business models likely means they'll be busier than ever — but wholesalers might slowly be squeezed out of the equation as tech giants like Amazon and others consolidate industry resources and reinvent consumer expectations.

No matter what, the cold chain will keep doing what it does best — getting pharmaceutical products into the hands of people who need them. But how it does so, and the tools it uses, are shaking up before our eyes.

Sunday, 12 May 2019

Why Is Fire Safety Training Important For Your Health?

Fire safety training seems like something that is just done because it’s a part of office protocol or even your home protocol, but fires are no joke and your health matters at the end of the day. Fire safety training can protect you and your health, and here, we’ll discuss why it matters, and some other elements that you may not even think about.

Guest post by Emily Bartels.

They Are Dangerous

Fires are incredibly dangerous, because they are hot, and the smoke in them can actually cause lung issues later on, including asthma and other breathing problems. they’re not just something that you overlook either, they can potentially put you and the entire office at risk. they’re more dangerous than you think, and the thing is, you want to make sure that you recognize these dangers. Fire safety training teaches you how to do this, and also how to tell when fires are occurring.  You could potentially save a life or lives by knowing the protocol, so think about that next time.

People Don’t Recognize Fire Hazards Usually

All fires begin with some source of heat mixing with a fuel, and for a fire to occur, you need to have oxygen. If you're working with anything related to heat, or even fuel, you’ll want fire safety training, because people usually don’t realize how simple it is to cause a fire.  For example, if you have a gas stove, you’re at risk for a household fire.  It’s that small, but it’s super important to understand this since it can be potentially dangerous.

You Need to Know How to Leave the Building Quickly

The reason why you need a fire safety plan and training is because you need to know how to leave a building in the event of a fire.  For example, if you're up on the fourth floor, what’s the quickest way down? what’s the alternate route in the event that you can’t use the mains stairwell? Where are the stairs? Where should you go if they’re blocked? Understanding this will help in the event that there is a fire because you can actually leave the building quickly.

In this as well, you can also identify any fire fighting gear, including a fire extinguisher, which, while it isn’t the ideal way to fight a fire, ti can shave off precious time if you have one so that you can escape. This can put your safety at the forefront, and save your life.

If you Work with Others, you Need to Know

It isn’t just the health and safety of yourself, but it’s of others too.  you’ll want to know of the best way to handle these fires, especially with other people. If you work in a hospital or nursing home for example, you’ll want to know how to get these people out of there, any risks associated with their bodies that may pose a problem, such as oxygen tanks, and how to get someone who is in a wheelchair out.  This, in turn, will help to protect others, and it will help make it much better for you as well. You can save the lives of others if you’re careful, and you’ll be able to get others out of here quickly.
Allows you to Be Proactive

With a fire safety plan, you’ll be able to become more proactive in the home or workplace. For example, you’ll want to keep the spaces cleaner, and from there, only smoke in designated areas, and always make sure everything that is flammable is kept away from work areas.  you’ll also want to perform regular maintenance on your machinery too, which is very important, and you’ll want to read the different sheets that improve the way that you handle your fire safety and any flammable equipment. It puts you more in charge, and that can help a lot.

Prevents Damages from Chemicals

One of the biggest causes of fires especially in the workplace is chemical fires. that’s because they’re not properly restored. But, with the right kind of training, you’ll be able to prevent this from getting worse and you’ll be able to, with the right fire safety training, keep everything out of the way, and make sure that these chemicals are properly stored in places where there isn’t any heat being generated to these chemicals, which can act as a fuel. This also prevents other workplace accidents too.

When it comes to fire safety training, the right tactics are so important, so make sure that you always have these in place when you’re working on fire safety training, for it can help to make a change in the overall state of your office, and in turn, you’ll be able to prevent these fires and the like from getting worse, and also allow for you to have a better, more proactive plan of action.

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