Pfizer to outsource more production as it prepares for COVID-19 vaccine

Pfizer is turning to its 200-strong network of outside contractors to make more of its existing medicines as it prepares for a potential COVID-19 vaccine., according to media reports.

The New York–based pharmaceutical giant said May 5 that it will invest at-risk to produce millions of doses of a coronavirus vaccine in 2020, boosting production to hundreds of millions of doses in 2021. Pfizer sites in Massachusetts, Michigan, Missouri and Puurs, Belgium will serve as vaccine manufacturing centers — with more sites expected to be added to the list.

BioNTech — Pfizers’s partner in developing a COVID-19 vaccine — plans to ramp up production sites in Mainz and Idar-Oberstein, Germany,

The first participants in Pfizer and BioNTech’s Phase 1/2 clinical trial for the BNT162 vaccine program have already been dosed in Germany and the U.S.

“The short, less than four-month timeframe in which we’ve been able to move from pre-clinical studies …

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Selux Diagnostics receives BARDA funding to speed development of rapid AST platform

[Image courtesy of Selux Diagnostics]

The Biomedical Advanced Research and Development Authority (BARDA) has awarded Selux Diagnostics $9.6 million to fund its development of a next-generation phenotyping (NGP) platform to treat superbug infections and combat antibiotic resistance.

The $9.6 million is the third funding tranche the company has received from BARDA as part of the company’s milestone-based contract. BARDA has provided Selux $30.4 million in funding to date.

“BARDA has offered strong support in the development of the Selux NGP platform and has led the way in the successful government-private sector collaboration to solve one of the world’s toughest health challenges — antibiotic resistance,” said Selux CEO Steve Lufkin. “This leadership is especially vital now, as new data indicate the antibiotic resistance crisis is even more threatening than previously understood. BARDA is leveraged…

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Plastic Sample Kits touts its molded material sample kits

A San Jose, Calif.–based outfit called Plastic Sample Kits is selling material-to-material comparisons of 20 different types of injection molding plastic.

The 20 Material Base Kit is available now, and the 6 High-Performance Material Kit is coming in June, with pre-orders taken now. Co-founders Brian Eastman and Stefan McClelland — both mechanical engineers — plan to release more.

“We made this product specifically so the engineers and designers can gain valuable experience and intuition about the materials they are expected to design with. I keep one of these kits on my own desk and people are constantly asking to borrow or reference it,” Eastman said in a news release.

Eastman noted to Medical Design & Outsourcing that the specific material grades in the 20 Material Base Kit are not medical grade materials, but several have FDA compliance certifications. The  6 High-Performance Material Kit, however, has several Solvay materials that ar…

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Could AI predict COVID-19 without testing?

Researchers in England and Massachusetts have developed an artificial intelligence diagnostic that can predict the likelihood of someone having COVID-19 based on symptoms.

King’s College London, Massachusetts General Hospital and health science company Zoe have developed an AI model that uses data from the COVID Symptom Study app to help predict COVID-19 infection. It compares symptoms and the results of traditional COVID tests to help populations that have limited access to testing.

According to the researchers, more than 3.3 million people around the world have downloaded the app and are reporting daily health status.

The researchers have analyzed data from 2.5 million people in the U.S. and the U.K who have regularly been logging their health in the app. About one-third of the people logged COVID-19 related symptoms. Of the one-third, 18,374 have had a coronavirus test and 7,178 tested positive.

Symptoms associated with COVID-19 were anal…

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Ultimate Guide to a Digitized Shop Floor

As Industry 4.0 initiatives and digital transformation efforts get off the ground, ongoing advances in Industrial Internet of Things, artificial intelligence and robotic process automation are making their mark on everything from product assembly to quality inspection to equipment maintenance and even good manufacturing practice (GMP) documentation. It’s no wonder that leading manufacturing companies today are focusing heavily on fully digitizing and integrating information technology and operational technology capabilities. The biggest change in manufacturing is taking place right on your shop floor.

Download our Ultimate Guide and see the exciting results offered by new innovations and how digitizing your shop floor can revolutionize your manufacturing operations.

Email* Name* …

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PTI Engineered Plastics donating thousands of face shields against COVID-19

PTI Engineered Plastics has a goal of manufacturing 100,000 face shields. [Image courtesy of PTI Engineered Plastics]

PTI Engineered Plastics has collaborated with industrial designers at PTI Design to create a protective face shield that can be quickly produced using injection molding manufacturing — helping to boost the supply of protective equipment for health providers treating people with COVID-19.

The Macomb, Mich.–based company says production of the shields started last week, with a goal of manufacturing 100,000 pieces in total.

PTI Engineered Plastics is coordinating donations with hospitals, skilled nursing facilities, hospice care and dental offices. Once more critical requests are met, donations could go to first responders and law enforcement personnel, followed by grocery stores and other essential workers.

PTI turned to existing designs or reference — but also made improvements:

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Webinar: How to manage medtech regulatory and financial compliance risk when diversifying production

Thursday, June 11, 2020 11:30 a.m. eastern time / 8:30 a.m. pacific time

 

 

In the wake of the COVID-19 pandemic, it has become increasingly clear that medical device and other healthcare companies need to diversify suppliers and vendors in an effort to minimize future supply chain disruptions. New diverse partnerships can expose organizations to hidden vulnerabilities, if not properly vetted.

After attending this webinar, you will be able to:

Discuss the key trends that are occurring worldwide that are creating the need for a diversified supply chain Identify potential risks associated with bringing on new partners Define a strategy for properly vetting those organizations by answering key questions such as: Is it a real business? Is the business representative associated with that business? Is the business on any government watchlists?

Attend this webinar to learn insights to protect against fraudulent supplie…

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India-led research effort asks the question: How do we keep a potential COVID-19 vaccine cold?

[Image courtesy of University of Birmingham]

U.K. scientists have joined a research effort in India to help solve distribution problems around whatever COVID-19 vaccine hopefully emerges from global efforts, according to a recent news release from the University of Birmingham.

Backed by the Shakti Sustainable Energy Foundation, experts from the University of Birmingham and Heriot-Watt University, Edinburgh are investigating the challenge involved in distributing a potentially temperature-sensitive COVID–19 vaccine.

The Centre for Environment Education (CEE) in India is leading the overall research, with support from commercial partners such as Zanotti (a part of the Daikin Group), Sure Chill and Nexleaf Analytics. The British researchers are exploring how integrated “Community Cooling Hubs’” can integrate food cold chains with other cold-dependent services such as community health fac…

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DeviceTalks Weekly: Ep. 9 – What’s the state of the medtech job market?

In this week’s episode of DeviceTalks Weekly, Tom Salemi speaks with two executive recruiters about what they see in the medtech market. Over the past month, we’ve seen several medtech companies – big and small – cutting jobs and reducing hours but what does this mean long-term.

In this podcast we’ll identify a few companies that are hiring, but we’ll talk in-depth with the recruiters about…

How bad is the current market? What’s the likelihood for recovery? What skills are in greater demand? What can people do to strengthen their hand?

Guests are:

David L. Vied, global sector leader, Global Sector Leader, Medical Devices and Diagnostics, Korn Ferry Giovanni Lauricella, VP, medtech practice-lead, The Mullings Group

Don’t miss an episode! Subscribe to DeviceTalks Weekly on your podcast players.

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