Gleb Tsipursky’s picture

By: Gleb Tsipursky

Stakeholder engagement is one of the more critical aspects of leadership, whether you’re a team leader or a member of a cross-functional team trying to lead team members to focus on quality. Stakeholders can be anyone from your colleagues to suppliers to business partners, and your relationship with them is dynamic and can change over time.

There are many advantages to identifying and getting to know your stakeholders, and even more disadvantages to not engaging with them. Failing to understand their needs can lead to blind spots for managers and executives, which can have disastrous effects, such as low employee morale or a dismal bottom line.

On the other hand, effective engagement can result in increased productivity and stronger financials. We can use research-based strategies to notice such blind spots so we can overcome them.

Clare Naden’s picture

By: Clare Naden

Never have we been more acutely aware of the importance of reliability when it comes to laboratory testing. As the ongoing Covid-19 pandemic has highlighted, the development of accurate diagnostic tests plays an important role in outbreak management.

Whether a laboratory develops its own test methods or incorporates ones that already exist, there is a lot to be considered, and the task bequeathed to them is great. Apart from the general risks of contamination, inadequate equipment, or failings in processes that must be rigorously managed, the procedures and tools required for each test can potentially differ.

Since the beginning of the pandemic, ISO has been collaborating with experts in many fields to establish where standards can really make a difference. As a result, experts on ISO’s technical committee for laboratory testing and in vitro diagnostic (IVD) test systems are currently working on international best-practice guidelines to assist laboratories.

Multiple Authors
By: Stephen M. Hahn, Amy P. Abernethy

During a short period of time, our society has seen a rapid increase in the interest and availability of cannabidiol (CBD) products and other products derived from cannabis. However, we still have a limited understanding of the safety profile of CBD and many other cannabis-derived compounds, including potential safety risks for people and animals.

At the U.S. Food and Drug Administration, we see these knowledge gaps as an opportunity to develop new ways of building the science to inform public health decisions.

Richard Harpster’s picture

By: Richard Harpster

As someone who has helped companies in a wide variety of industries for the last 30 years solve many problems using risk-based thinking, I cannot think of an issue that I have worked on that is more important than preventing the spread of Covid-19. With three high-risk people in my home, I have spent considerable time studying Covid-19 since February 2020. By applying the risk-based thinking techniques I have used, I believe there is a method for saving 100,000 lives before we get the protection the new vaccines are going to provide during the next three or four months.

Jane Bianchi’s picture

By: Jane Bianchi

Let’s pretend, for a moment, that you’re a primary care physician and you refer one of your patients to another doctor for a colonoscopy. Will the patient follow through? If not, how will your team know to remind him or her? If the patient does receive a colonoscopy, will your team be alerted so you can evaluate and respond to the exam results?

High-performing healthcare teams that are organized and trained to do what’s best for the patient can shine in this type of scenario, while low-performing teams can inadvertently let patients fall between the cracks. How do you make sure your healthcare team is one of the effective ones?

New research co-authored by Sara Singer, professor of organizational behavior at Stanford Graduate School of Business and professor of medicine at Stanford University School of Medicine, provides answers.

Bahar Aliakbarian’s picture

By: Bahar Aliakbarian

The two major U.S. developers of the early Covid-19 vaccines are Pfizer/BioNTech and Moderna. They both developed mRNA vaccines, a relatively new type of vaccine. A major supply-chain issue is the temperature requirement for these vaccines.

The Pfizer vaccine needs to be stored at between –112° F (–80° C) and –94° F (–70° C), and the Moderna vaccine needs temperatures around –4° F (–20° C), which is close to the temperature of commercial-grade freezers. A third company developing vaccines, AstraZeneca, says it needs regular refrigeration temperature of 36° F to 46° F, or 2° to 8° C.

Sanjay Mishra’s picture

By: Sanjay Mishra

As the weather cools, the number of infections of the Covid-19 pandemic are rising sharply. Hamstrung by pandemic fatigue, economic constraints, and political discord, public health officials have struggled to control the surging pandemic. But now, a rush of interim analyses from pharmaceutical companies Moderna and Pfizer/BioNTech have spurred optimism that a novel type of vaccine made from messenger RNA, known as mRNA, can offer high levels of protection by preventing Covid-19 among people who are vaccinated.

Although unpublished, these preliminary reports have exceeded the expectations of many vaccine experts, including mine. Until early this year, I worked on developing vaccine candidates against Zika and dengue. Now I am coordinating an international effort to collect reports on adult patients with current or previous cancers who have also been diagnosed with Covid-19.

Nader Moayeri’s picture

By: Nader Moayeri

I am part of a grassroots effort at the National Institute of Standards and Technology (NIST) that is developing an exposure notification system for pandemics in general, though we hope it could be used in at least a limited fashion during the current Covid-19 pandemic. We are fortunate at NIST to have all the expertise required to tackle this multidisciplinary problem, solutions to which have the potential to save many lives and hasten economic recovery by helping to reopen our nation.

Contact tracing has been used to blunt the spread of pandemics since the 19th century. In its usual form, health workers conduct interviews with folks who have tested positive for the infectious disease to find out whom they have been in contact with during a certain period before testing. They also learn the length of time people were together and how close they got to one another. The health worker then traces those contacts to let them know they may have been exposed so that they can self-isolate or get tested. This process can be slow and labor-intensive and may not identify every contact. It relies on the infected person remembering all their contacts and the health worker being able to locate those individuals in a timely fashion to stop them from further spreading the disease.

Steve McCarthy’s picture

By: Steve McCarthy

The ideal of proactive quality has been the holy grail of chief quality officers in the life sciences industry for at least five years, but few, if any, have realized the vision. Industry has since set out a clear definition of the milestones a medical product manufacturer would need to meet in order to achieve proactive quality as a differentiator. Many of those are cultural, but the majority require quality technology and innovation to reach the disruptive levels they have today.

Quality 4.0 is defined as the application of Industry 4.0’s advanced digital technologies to enhance traditional best practices in quality management. With the advent of such innovations as AI and IoT in the quality management ecosystem, the promise of proactive quality is finally a reality. Today the industry faces unprecedented challenges but also opportunities to serve patients like never before; both require innovation in business and product as well as in how companies approach quality.

This article highlights just one of these key challenges and opportunities: the increasing complexity and diversity of the supply chain itself. It emphasizes the reasons why recognizing and embracing bimodality is so vitally important, and how quality technology is a critical enabler for life sciences companies under these unique pressures.

Rich Press’s picture

By: Rich Press

Researchers at the National Institute of Standards and Technology (NIST) have produced synthetic gene fragments from SARS-CoV-2, the virus that causes Covid-19. This material, which is noninfectious and safe to handle, can help manufacturers produce more accurate and reliable diagnostic tests for the disease.

Tests for an active infection—as opposed to antibody tests that indicate a past infection—work by detecting the virus’s genes on a nasal swab. But a negative result does not necessarily mean that a person is disease-free. It could be that the amount of virus is too low for the test to detect, which is especially possible during the first days after catching the virus.

“Having better data on test sensitivity will help us understand how often tests for Covid-19 produce a negative result for people who are actually infected,” says NIST research scientist Megan Cleveland.

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