Clinical trials are arguably the backbone of medical advancement. But the trials most worth doing are usually large, costly and time-intensive, demanding extensive resources and personnel. During the COVID-19 pandemic, there has been a marked uptick in the number of clinical trials, many of which are woefully flawed with issues ranging from insufficient sample size to bad design. The published research that follows is often redundant or inconclusive.
So how can scientists designing and running clinical trials streamline their efforts to reduce waste and achieve more useful outcomes? The answer could be adaptive clinical trials.
Small- and medium-sized companies are critical to the Spanish economy. During 2020 the COVID-19 pandemic made business difficult for many of these companies, yet they have demonstrated strength and resourcefulness and have led the pandemic recovery in Spain in many ways. Recently, Promega Biotech Ibérica was recognized with a Madrid Community SME (small- and medium-sized business) Award along with 15 other companies. The awards were presented by Manuel Giménez, Minister of Economy, Employment and Competitiveness of the Madrid Region, Andres Navarro delegate director of La Razón, and Francisco Marhuenda, director of La Razón. As part of the award, Promega Biotech Ibérica General Manager, Gijs Jochems, was interviewed about the award and Promega’s work in the region.
According to Gijs Jochems, General Manager of Promega Biotech Ibérica, while Promega Corporation is an American multinational company, it remains privately held, which offers a great deal of flexibility to the subsidiaries to adapt to local needs. It also allows the company to place increased emphasis on employee well-being (critical during the pandemic), reinvest profits in research and development, and work to mitigate the impact of company activities on the environment. All these business practices reflect a long-term vision of sustainable business growth.
The past year has been a challenge. Amidst the pandemic, we’re thankful for the tireless work of our dedicated employees. With their support, we have continuously stayed engaged and prepared during all stages of the COVID-19 pandemic so that we can serve our customers at the highest levels.
How We Got Here
The persistent work by our teams has made a great impact on the support we can provide for scientists and our community during the pandemic. From scaling up manufacturing to investing in new automation, every effort has helped.
Promega has a long history of manufacturing reagents, assays, and benchtop instruments for both researching and testing viruses. When the pandemic began in 2020, we responded quickly and efficiently to unprecedented demands. In the past year, we experienced an approximately 10-fold increase in demand for finished catalog and custom products for COVID-19 testing. In response to these demands, we increased production lines. One year ago, we ran one shift five days per week. Currently, we run three shifts seven days per week. This change has allowed 50 different Promega products to support SARS-CoV-2 testing globally in hospitals, clinical diagnostic laboratories, and molecular diagnostic manufacturers. Additionally, our clinical diagnostics materials make up about 2/3 of COVID-19 PCR tests on the global market today. Since January 2020, Promega has supplied enough reagents to enable testing an estimated 700 million samples for SARS-CoV-2 worldwide.
Developments and Advances
Promega products are used in viral and vaccine research. This year, our technologies have been leveraged for virtually every step of pandemic response from understanding SARS-CoV-2 to testing to research studies looking at vaccine response.
We are extremely grateful for our employees. In the past year, we hired over 100 people and still have positions open today. While welcoming newcomers, this challenging year also reinforced the importance of our collaborative culture. Relationships at Promega have been built over multiple years. The long history of our teams allows us to stay coordinated while prioritizing product distribution to customers across the globe. It also leads to effective communication with colleagues and vendors. Those leading our manufacturing operations team, for example, have an average tenure of 15 years. Their history in collaborating through challenging situations helps them quickly focus where needed most.
Our 600 on-site employees support product manufacturing, quality, and R&D. They do it all while remaining COVID-conscious by social distancing, wearing masks, working split shifts, and restricting movement between buildings. While we continue to practice physical safety precautions, we also prioritize our employees’ mental health and wellness. Promega provides a variety of wellness resources including phone and video mental health sessions, virtual fitness and nutrition classes, and stress and anxiety tools.
What’s to Come
While we acknowledge that the COVID-19 is not over, we are proud of the support we have been able to provide to customers working both on pandemic research and critical research not related to COVID-19. Our policies of long-term planning and investing in the future has allowed us to respond quickly and creatively and learn from the experience.
This post is written by Malynn Utzinger, Director of Integrative Practices at Promega.
Connection is intuitive. We’re wired for connection, hard wired. This need exists at a bone deep biological level. If that seems like poetry or hyperbole, imagine trying to do the smallest thing to accomplish the tiniest part of your day without the existence of others.
This realization has never been more apparent as we do our best to manage life in our current connection-restricted world. We find that when we lose this essential element of ourselves, we lose part of our human survival kit. We survive but to truly thrive, we need to make an intentional effort to reignite connection.
We all know that odd feeling of passing another masked person in the hallway at work or the aisles of a grocery store. We’ve been trained by now to step far to the side, moving apart from one another, and it feels like a contracture, a sinking inside. But we also know the feeling, when we encounter another person, even wearing a mask, and that person looks at you and smiles at you. You can see the warmth in their eyes and it’s real. You can both feel it, and even that small connection brings life to your day. And we remember those moments.
This past year has been a challenging one for most of us. The COVID-19 global pandemic has changed the way we live. We are working from home, our kids are learning online, we can’t gather with friends and family, we are wearing masks, we no longer attend in-person events. All of this change around us has profoundly affected us in many ways.
We asked our Promega colleagues how the pandemic changed their lives and how they adapted. How are they feeling? What keeps them going? What lessons have they learned? And what good has come out of it? Here’s what they said.
Adaptation: In biology and ecology, the process or state of adjusting or changing to become more suited to an environment.
Holiday traditions are certainly taking new forms this year as we all determine how to safely celebrate during a pandemic. It goes without saying that it’s been a tough year. Customs and rituals, large and small, bring peace and comfort. We need those more than ever now, so the challenge becomes finding new ways to honor valued traditions.
Today, we would like to share how one dearly held Promega Madison tradition was able to endure in our COVID-19 world. Adaptation is key. And butter and sugar help, too.
Promega employees this week were surprised and deeply moved to find that their beloved “Elaine Day” had not become yet another casualty of the pandemic.
“This has been such a difficult year,” says Senior QA Scientist Sue Wigdal. “I had assumed, sadly, that Elaine Day would be cancelled, but to be able to have it and all the thoughtfulness and deliciousness that it brings, was amazing.”
When the COVID-19 pandemic descended on New York in March 2020, Christopher Mason, PhD, knew he was in a unique position to contribute. The Mason Lab specializes in sequencing and computational methods in functional genomics – valuable expertise for addressing an emerging infectious disease. Within days, Chris and his team were helping to analyze patient data, as well as developing new tests and detection methods for the SARS-CoV-2 virus.
The Mason Lab developed protocols for a simple COVID-19 detection test that requires less time and equipment than common PCR methods. Their subsequent preprint detailing these methods quickly gained widespread attention, and Chris found himself fielding an endless stream of questions and requests.
During the frenzy, Chris received a call from his older brother. Cory Mason is the mayor of Racine, Wisconsin, the brothers’ hometown.
“He said he saw me tweeting about our new test,” Chris says. “Then he asked me, ‘What if we set it up here in Wisconsin?’’
Screen Media. Cell phones. Social media accounts. If you are a parent, you have probably discussed rules of engagement with your children about these things. All of our modern social media platforms are designed to keep us engaged with them by showing us the latest post, the next video or the people now online. Work emails give us notifications when something arrives in our Inbox. Business software platforms like Microsoft Teams send us notifications whenever someone comments in a conversation we have ever been part of. There are many siren signals pulling us toward our screens.
Enter COVID-19, the flu-like illness caused by the SARS-CoV-2 virus that has already claimed the lives of 210,000 people in the United States, and leaving countless others permanently affected by other long-term health consequences. Spread by aerosol, COVID-19 is most dangerous in places where lots of people congregate in a small area, particularly if they are talking to each other. Consequently, office buildings are empty as many of us work or go to school remotely.
Before COVID-19, if I had a day full of meetings at work, I was running from conference room to conference room, two miles, uphill, in the snow between buildings. Now, a day full of meetings means sitting in front of a computer monitor, trying to figure out how I will get any kind of break between calls. The average number of steps recorded by my pedometer has decreased markedly since March when our remote work started.
Technology has been an incredible blessing during this pandemic—allowing us to continue to work and stay connected with friends and family. Technology is the only way that some people can connect with loved ones in long-term care facilities. It allows students to continue learning through remote classrooms and chats.
But what has been the effect of the increased time spent on screens during this pandemic?
When the world is experiencing a viral pandemic, scientists and health officials quickly want data-driven answers to understand the situation and better formulate a public health response. Technology provides tools that researchers can use to develop a rapid sequencing protocol. With such a protocol, the data generated can help answer questions about disease epidemiology and understand the interaction between host and virus. Even better: If the protocol is freely available and based on cheap, mobile sequencing systems.
Many research labs around the world have temporarily closed their doors in response to the COVID-19 pandemic, while others are experiencing unprecedented need for reagents to perform viral testing. This urgency has led many scientists to make new connections and build creative, collaborative solutions.
“In labs that are still open for testing or other purposes, there’s certainly heightened anxiety,” says Tony Vanden Bush, Client Support Specialist. “I feel that right now, I need to help them deal with that stress however possible.”
Last week, Tony was contacted by a lab at the University of Minnesota that was preparing to serve as a secondary COVID-19 testing facility for a nearby hospital lab. The two labs needed to process up to 6,000 samples per day, and the university lab was far short of that capacity.
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