Claudine Mangen’s picture

By: Claudine Mangen

Work has become an around-the-clock activity, courtesy of the pandemic and technology that makes us reachable anytime, anywhere. Throw in expectations to deliver fast and create faster, and it becomes hard to take a step back.

Not surprising, many of us are feeling burned out. Burnout—which often affects women more than men—happens everywhere. Particularly challenged during the pandemic, however, are teachers and healthcare workers.

So we know burnout happens and that a lot of us are experiencing it, but how can we get out of it?

Gregory Way’s picture

By: Gregory Way

Drugs don’t always behave exactly as expected. While researchers may develop a drug to perform one specific function that may be tailored to work for a specific genetic profile, sometimes the drug might perform several other functions outside of its intended purpose.

This concept of drugs having multiple functions, called polypharmacology, may lead to unintended consequences. This is a common occurrence for cancer drugs in clinical trials that can have harmful side effects and treatment toxicity.

But polypharmacology may, in fact, be the norm for most drugs, not the exception. So rather than seeing a drug’s ability to perform many functions as a flaw, biomedical data scientists like me and my lab colleagues believe that it can be used to our advantage in designing drugs that address the full complexity of biology.

Adam Zewe’s picture

By: Adam Zewe

Physicians often query a patient’s electronic health record for information that helps them make treatment decisions, but the cumbersome nature of these records hampers the process. Research has shown that even when a doctor has been trained to use an electronic health record (EHR), finding an answer to just one question can take, on average, more than eight minutes.

The more time physicians must spend navigating an oftentimes clunky EHR interface, the less time they have to interact with patients and provide treatment.

Researchers have begun developing machine-learning (ML) models that can streamline the process by automatically finding information physicians need in an EHR. However, training effective models requires huge datasets of relevant medical questions, which are often hard to come by due to privacy restrictions. Existing models struggle to generate authentic questions—those that would be asked by a human doctor—and are often unable to successfully find correct answers.

Karina Montoya’s picture

By: Karina Montoya

Close to 9 million people in India suffer from hepatitis C. If left untreated, the virus leads to cirrhosis or liver damage, which eventually causes death from organ failure or cancer. On average, a 50-year-old man in India with asymptomatic liver damage who doesn’t receive treatment is expected to live a little more than a decade longer.

Until recently, the typical treatment for chronic hepatitis C in India was a 24-week course of peginterferon injections combined with pills to combat side effects. The treatment’s efficacy was relatively low: It cured 40 percent to 80 percent of patients. There was a need for more effective treatments, not just in India but also for the 58 million people worldwide with chronic hepatitis C.

About a decade ago, Gilead Sciences developed Sovaldi and other drugs, which are antiviral pills that can cure most cases of hepatitis C. The California-based pharmaceutical company planned to expand access to the new medications in India through a combination of branded and generic versions.

Tom Rish’s picture

By: Tom Rish

Your design history file (DHF) is one of the most critical components of your QMS. That’s because the DHF should contain all the product development documentation for a specific medical device. Its purpose is to show regulatory bodies and internal stakeholders that you appropriately followed the design control process during product development. It’s also proof that your medical device was developed according to the design plan.

FDA inspectors are guaranteed to look through it during an inspection, and even a single missing signature can get you written up.

With so much riding on it, you need a plan in place to store and manage all of the documentation that goes into your DHF. It may feel like an overwhelming task to keep your design history file audit-ready at all times, but there are a few basic steps you can take to keep it organized and ready for inspection at any time.

Patricia Santos-Serrao’s picture

By: Patricia Santos-Serrao

The pharmaceutical industry has seen significant upheaval and disruption during the past several years. These changes are due in part to the impacts of Covid—for example, interruptions in the supply chain and overwhelming market demand for shortened production times.

They are also being driven by extensive shifts in emergent digital technologies, a need for deep predictive data insights, and a cultural demand for personal and system connectivity. Add to this list a shifting regulatory environment with an increased focus on personal responsibility for auditing and risk management. New opportunities and responsibilities can seem overwhelming.

However, the bright side of assuming personal responsibility is the self-determination it allows. Businesses that make innovative changes amidst upheavals and downturns actually gain momentum and outperform competitors upon recovery. What sets apart thriving pharma businesses is their willingness to spot the market shifts as they begin to crest, pivot to align with them, and then swim through deep waters to ultimately catch and ride the wave. Their adaptive autonomy allows them to absorb disruptions and modify in company-specific ways to move through them. 

Mike John’s picture

By: Mike John

This article has been republished with permission from Medical Plastics News.

While ISO 13485 sets the standard for quality management systems (QMS) in medical device manufacturing, metrology is often treated as an afterthought and used simply to validate products and detect defects at the end of production. The result? It becomes harder to prove consistent quality, and the validation process can become fragmented.

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By: Ann Brady

Safer food, better health: This was the theme of World Food Safety Day (June 7, 2022), and it’s obvious, is it not, that access to safe food is vital for life and health? The challenge in today’s world is how to achieve this. Global food systems, already under pressure before the pandemic, are now subject to supply chain bottlenecks, the impacts of accelerating climate change, and fluctuating geopolitical tensions.

According to the World Health Organization (WHO), the theme “safer food, better health” highlights the importance of safe, nutritional food in ensuring human health and well-being. We all have a part to play in achieving this. Whether we grow, process, transport, store, sell, buy, prepare, or serve food, food safety is in all our hands.

The need to tackle the challenge is pressing. The WHO says unsafe food causes 600 million cases of foodborne diseases worldwide and 420,000 deaths. Some 30 percent of foodborne deaths occur among children under five. These figures are likely to be an underestimation.

Jamie Steiner’s picture

By: Jamie Steiner

Ultra-low temperature freezers became popular due to the storage of Covid-19 vaccines, but they have been important components of laboratories for many years. There’s a lot, however, to think about—quality, productivity, maintenance, different types of technology, warranties, etc. And if you end up with the wrong unit, you could incur unnecessary expenses or delays.

In this guide, we’ll talk about some of the most important factors when purchasing an ultra-low temperature (ULT) freezer so you can end up with the right unit for your laboratory needs and budget.

Types of ultra-low temperature freezers

An ultra-low temperature freezer is a unit that preserves and stores biological samples within a temperature range of -50°C to -86°C. First, let’s quickly review the two different types of ultra-low temperature freezers:

Prashant Yadav’s picture

By: Prashant Yadav

During the past two and a half years, we’ve seen unparalleled innovation and private-public collaboration in the global fight against Covid-19. The rapid development and rollout of new vaccines, diagnostic tests, and therapeutics have saved millions of lives. 

However, these developments haven’t benefited everyone equally. Although more than 67 percent of the global population has received at least one dose of the Covid-19 vaccine, disparities between higher and lower income countries are wide. As of May 2022, 72 percent of people in high-income countries have received one dose, compared to 18 percent in low-income countries, according to the United Nations Development Programme’s Global Dashboard for Vaccine Equity.

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