Monday, 23 November 2020

Digital Transformation and Regulatory Considerations for Biopharmaceutical and Healthcare Manufacturers

Tim Sandle's new book is out: 'Digital Transformation and Regulatory Considerations for Biopharmaceutical and Healthcare Manufacturers, Volume 1: Digital Technologies for Automation and Process Improvement'.


For details, see the flyer below:

Digital transformation of pharmaceuticals (new book) by Tim Sandle on Scribd




Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

Discoveries reshape understanding of gut microbiome

Gut microbiome


The human gut is home to microorganisms that outnumber our cells by a factor of 10 to 1. Now, discoveries by scientists at the Oklahoma Medical Research Foundation have redefined how the so-called gut microbiome operates and how our bodies coexist with some of the 100 trillion bacteria that make it up.


The new findings appear in the journal Science and could lead to new therapies for inflammatory bowel disease and people who've had portions of their bowels removed due to conditions like colon cancer and ulcerative colitis. They also help explain why the use of antibiotics can create a multitude of problems in the digestive system.



Using research models, scientists found the microbiome controls the creation of a sticky layer of special forms of sugar-enriched mucus that encapsulates and travels with fecal matter. The mucus -- which the researchers showed not to be static as previously thought -- acts as a barrier between bacteria in feces and the thousands of immune cells in the colon. Without the mucus, the whole system gets thrown out of balance.


In the study, the researchers found that the fecal matter of mice treated with a broad-spectrum antibiotic had no trace of the mucus coating. And when mice without this protective barrier received a transplant of fecal matter with microbiome, their mucus production jump-started.


This may have significant treatment implications for patients whose microbiome is out of balance.




Kirk Bergstrom, Xindi Shan, David Casero, Proximal colon–derived O-glycosylated mucus encapsulates and modulates the microbiota. Science, 2020; 370 (6515): 467 DOI: 10.1126/science.aay7367


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

Sunday, 22 November 2020

Stop TB Partnership & “Hello Kitty” join forces to end TB in children


The Stop TB Partnership (STBP) and the famous Japanese icon Hello Kitty by Sanrio Co. Ltd are teaming up to raise global awareness to curb tuberculosis (TB) in children, #StopTBwithHelloKitty, at a virtual unveiling event. On a global scale, approximately 1.2 million children contract TB every year, with an estimated 200,000 children needlessly dying from the disease.  

Sanrio GmbH, a group company of Sanrio Co. Ltd, the global brand behind Hello Kitty, the  much-loved global character and Stop TB Partnership jointly launch a campaign to #EndTB aimed at raising awareness in children with TB and drug-resistant TB, the challenges they face in getting diagnosed and treated and the urgent need for increased investment and innovation in TB diagnosis and treatment. TB is a curable disease, but among infectious diseases, it has been the biggest killer globally for the past 8 years.

“We are very proud of becoming a TB Champion. I am happy to say that the good news is that there is a cure for TB and that she is looking forward to support children and their parents in seeking timely diagnosis, treatment and care for TB and prevent further spread,” said Silvia Figini, Chief Operating Officer Sanrio – EMEA, India and Oceania, Mr Men – Worldwide.

“Children, adolescents and families affected by TB and drug-resistant TB need special care and support throughout their TB journey and beyond. The Hello Kitty collaboration may add interest and incentives for small children and act as a message of support for older children and adolescent affected by TB. Child friendly, second line and all oral regimens make children’s TB treatment easier and free of painful injections,” said Dr. Farhana Amanullah (Pakistan), Chair Child and Adolescent TB, Stop TB.


Partnership Working Group. 

Tuberculosis is a disease that mainly infects the lungs and is transmitted through the air. Like COVID-19, it can spread when someone coughs, speaks, sings or laughs close to you.

“TB is a curable infectious disease that, unfortunately continues to affect 10 million people every year, including more than 1 million children worldwide. TB is difficult to diagnose and treat in children, and it becomes even harder when it is resistant to drugs. Unfortunately, up to 32,000 children develop drug-resistant TB each year and only 3 in 10 are diagnosed with only a very small portion, around 5000 kids receive treatment for it,” said Dr. Lucica Ditiu, Executive Director of the Stop TB Partnership.   ”Children with TB are the real victims – they get infected by adults, and they do not spread the diseases further. The story behind every child with TB or drug-resistant TB is heartbreaking.”

Two years ago, on 26 September 2018, the United Nations General Assembly held its first-ever high-level meeting on the fight against tuberculosis. Under the heading: “United to end tuberculosis: an urgent response to a global epidemic,” world leaders pledged their support to increase efforts to fight TB and to ensure that by 2022, 3.5 million children with TB would receive the treatment they need, including 115,000 children with drug-resistant TB.   

In 2019, the Global Drug Facility of Stop TB – with support from USAID and Government of Japan  launched an initiative to ensure that children with drug-resistant TB have access to child-friendly medicines, which dissolves in water, taste better and are easier for a child to swallow. These new drugs are now available in more than 50 countries.  

“Currently, the COVID-19 pandemic has devastated the world, but we should always think of the hazardous consequence that could emerge if we do not tackle TB and other global health issues. We continue to work to end TB in children and avoid undermining years of hard work due to this pandemic,” said Kazuho Taguchi, Director, Office of Global Health Cooperation, International Affairs Division, Ministry of Health, Labour and Welfare, Japan. 
As we draw closer to the looming 2022 deadline, it is essential that we step up our combined efforts and remind the world of the promises it made in New York to protect children and end TB for good.  

Together with Hello Kitty, Stop TB calls upon global leaders to fulfil their promises and accelerate action needed by providing the necessary support, investment, research and innovation to end the disease by 2030 as part of achieving the Sustainable Development Goals (SDG 3, target 3.3).

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

Saturday, 21 November 2020

ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities


The EMA has published a listed of responses received in relation to the draft guidance on DNA reactive (mutagenic) impurities. The full title of the document is “Overview of comments received on ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - questions & answers (EMA/CHMP/ICH/321999/2020).”


In relation to the document, mutagenic potential refers to the ability of a compound to induce point mutations (i.e., bacterial reverse mutation assay), while genotoxic potential refers to both mutagenic and clastogenic potential.


The document can be accessed here:


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

Friday, 20 November 2020

Drug resistance linked to antibiotic use and patient transfers in hospitals


Understanding the role of antibiotic use patterns and patient transfers in the emergence of drug-resistant microbes is essential to crafting effective prevention strategies.


Antimicrobial resistance is a growing global health threat, but preventing it takes smart choices at the local level. The current findings, provide insights on how antibiotic use patterns and patient transfers in hospitals drive the emergence of resistance, and suggest a new approach for tailoring prevention strategies to an individual hospital or ward.


To help hospitals assess the best strategies for preventing the emergence of resistance, Shapiro and her colleagues employed a technique typically used in ecology to study the effect of antibiotic use and patient transfers on infections. They developed a computer model based on a year's worth of data around seven species of infection-causing bacteria, including drug-resistant strains, in 357 hospital wards in France.


The scientists found that the use of the penicillin antibiotic, piperacillin-tazobactam, was the strongest predictor of the emergence of bacteria that are resistant to the standard treatments for life-threatening blood infections. If this is confirmed in further studies, the authors suggest that the strategy of using piperacillin-tazobactam instead of carbapenems to prevent antimicrobial resistance may need to be reconsidered.


In fact, the study showed that the effects of antibiotic prescription and patient transfer patterns on the emergence of drug resistance varied among different microbes and types of infections, suggesting that a more individualised approach to preventing resistance is necessary.




Julie Teresa Shapiro, Gilles Leboucher, Anne-Florence Myard-Dury, et al Metapopulation ecology links antibiotic resistance, consumption, and patient transfers in a network of hospital wards. eLife, 2020; 9 DOI: 10.7554/eLife.54795


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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