![校友Dave Schultenover 83年]()
2020年1月初, the world started to hear reports out of China of a rapidly spreading virus as predictors warned of a global pandemic. 同时, inside the California-based offices of Thermo Fisher Scientific, Carroll alumnus Dave Schultenover ’83 and his colleagues mobilized their resources to fulfill what they anticipated would be a critical need. That foresight—the production of COVID-19 test kits—is proving vital to communities crippled by a growing number of coronavirus cases daily.
“In my lifetime, I never 虽然t I would actually see a global crisis such as COVID-19. You always saw it on the movies but that is fiction. 这 threat is real and has many unknown elements,舒尔特诺弗说, 监管高级总监, quality and compliance for clinical diagnostics—niche products at Thermo Fisher Scientific.
Schultenover and others at the company kept an eye on reports as pockets of coronavirus started to spread across the globe in the early days of the outbreak. “That’s when the conversation started around, ‘How can we do this?’”他说。. “We realized our ability to pull this together.”
回到卡罗时，他对 生物化学 作为学生的实施. Since then, he has worked during his career in food science and medical research. He expanded his skills to IT and rose through management ranks at various companies. His positions have gone from being a beer chemist for the G Heilman Brewery in La Crosse to plastics and then to medical devices and pharmaceutical manufacturing, 让他三年前来到弗里蒙特, 在加州与赛默飞世尔科技公司合作.
在他的作品中, Schultenover ensures that Thermo Fisher Scientific is compliant with FDA regulations in the U.S. before sending a product out to market but also must make sure that the company follows international standards when distributing products around the globe. The company has divisions on every continent except Antarctica, he said. He supervises 74 employees divided between regulatory affairs, 质量保证, and quality control for production of the COVID-19 kits.
“我在食物链的顶端. It’s my managers that oversee the people that take care of these activities and makes sure everything happens on schedule,他说. “If something goes wrong, that’s when they come to see me.”
Ensuring an effective product on a quick turnaround
Thermo Fisher Scienfitic knew with its previous experience of using its AcroMetrix line—assay control products —that it could support the type of testing that would be needed with COVID-19, Schultenover说. The company already had experience applying the technology to previous diseases to include H1N1 and the SARS virus.
这, 虽然, would require quick coordination between the company and federal authorities, particularly the FDA allowing an Emergency Use Authorization. The EAU bumped a typical approval of three months to five years up to a matter of days, but with assurance that the company would provide a safe and effective product, Schultenover说. After a week of calls between the regulatory and product development teams and FDA reviewers beginning the week of March 3, Thermo Fisher Scientific received its EAU approval on March 13.
“Under and EUA we can leverage a product used for another purpose and fast track it, 可以这么说, as we have data we can leverage for FDA to review and make the decision that the risk level is low enough compared to the benefit and they authorize its use for the immediate emergency,舒尔特诺弗说.
COVID-19检测试剂盒是如何工作的
The Thermo Fisher Scientific kit replaces the three-day test with a test that is four hours or less, 是自动的, and can process many patient samples at one time. It looks for specific molecules and protein sequences unique to this virus for confirmation of presence in a patient sample, Schultenover解释. It is being now distributed in hospital and clinical labs with the needed automated equipment or where the medical technologist can acquire the equipment and use it per U.S. requirements and will be shared around the globe.
“We are producing thousands of kits a week and it is literally all-hands on deck. Everyone that is properly trained is helping fill, label and kit,舒尔特诺弗说. “这其中也包括我，因为需求如此之高, the need is immediate and we have to keep the other IVD products for therapeutic drug monitoring supplied globally as well since these needs are also still emanate.”
赛默飞世尔是1.5 million test kits in stock but started producing 2 million per week after its EAU approval and planned to produce 5 million per week going into April, according to company CEO Marc Casper during an 他在3月份接受了《威尼斯彩票游戏》的采访.
Schultenover说: “这 will be our lives for the next several weeks as we do our part to help this country and the rest of the globe deal with diagnosing and treating those exposed.”