Company News & Updates

While most of America is locked down at home, in almost every case, pharmaceutical, medical device and equipment, and biotechnology companies (including operations, research and development, manufacture, and supply chain) organizations are considered essential workers and are facing this global challenge head on. Even with diminished staff and resources, the pharmaceutical and life sciences industry continues to work toward the development of diagnostics, vaccines and therapies for respiratory infection. The FDA (Food & Drug Administration) has taken action to streamline discovery, while many diagnostic tools and drug targets are starting to find their way into the greater conversation about how to handle SARS-CoV-2 and the COVID-19 disease itself. FDA Activity More Regulatory Relief: The FDA will provide regulatory relief during the outbreak. Foreign Inspections: In response to the COVID-19 outbreak, the FDA is postponing most foreign inspections. Authorization of Emergency Use: On the basis of this determination, the FDA Secretary declared that circumstances exist justifying the authorization of emergency use of personal respiratory protective devices during the COVID-19 outbreak. While regulatory issues are being managed, some companies are starting to make progress on diagnostic tools. Testing has been a significant challenge for the US and is essential for identifying people who have been infected and for understanding the true scope of the outbreak. A few companies are making strides in this space. Abbott: The FDA approved Abbott’s molecular test for the novel coronavirus that causes COVID-19 under an Emergency Use Authorization (EUA). The company indicates it is immediately shipping 150,000 Abbott RealTime SARS-CoV-2 EUA tests to current customers in the U.S. Biomerica has begun shipping samples of this COVID-19 test to multiple Ministries of Health and government agencies that have requested the product through the company’s distributors in the Middle East, throughout Europe, and other countries In the end, what will help get the global population back to life as we knew it will be healing and preventive measures. Here, companies are attempting to find therapies to treat the illness and eventually prevent infection. Failed clinical studies In adults with severe COVID-19 hospitalized in Wuhan, China, treatment using a combination of antiviral drugs – lopinavir–ritonavir (HIV/AIDS therapies) – provided no benefit. Vaccine candidates Two Phase I safety clinical trials on vaccine candidates were initiated: mRNA-1273: The US National Institute of Allergy and Infectious Disease (NIAID) collaborated with Moderna to develop an RNA vaccine matching a spike of the coronavirus surface. Ad5-nCoV: A Phase I safety trial of a recombinant adenovirus vaccine candidate manufactured by CanSino Biologics Inc. (Tianjin, China), called Ad5-nCoV, began recruiting 108 healthy adults in Wuhan, China in March. Several other vaccine candidates were being fast-tracked to begin first-in-human studies, as of March 2020. Post-exposure prevention Based on experience with antimicrobials, pre-exposure prophylaxis and post-exposure prophylaxis (PEP) with antiviral drugs may be effective procedures to minimize infection which causes COVID-19.  PEP using the antibiotic, rifampicin, is recommended by WHO for people at high risk of infection before or after exposure to pandemic influenza. Some experts speculate that antiviral drugs administered shortly after the onset of COVID-19 infection symptoms may reduce illness and lower the risk of infecting other people by reducing viral shedding in respiratory secretions. Repurposing approved drugs During the COVID-19 outbreak, drug repurposing (or “repositioning”) is the clinical research process of rapidly screening and defining the safety and efficacy of existing drugs already approved for other diseases to be used for people with COVID-19. Clinical trials using repurposed, generally safe, existing drugs for hospitalized COVID-19 patients may take less time and have lower overall costs to obtain endpoints proving safety (absence of serious side effects) and post-infection efficacy, and can rapidly access existing drug supply chains for manufacturing and worldwide distribution. Phase III trials Favipiravir: In people with COVID-19, favipiravir (marketed as Avigan and approved for use in Japan in 2014 for several viral diseases) was found to be safe and had preliminary efficacy in an early-stage trial in Shenzhen, China. Remdesivir: the Gilead Sciences antivirus drug candidate is in multiple clinical trials, with preliminary results expected in May 2020 ASC-09 + ritonavir (oral tablet): ASC-09 (product of the Chinese firm, Ascletis Pharma Inc.), a HIV-1 protease inhibitor in combination with ritonavir, was initiated in a Phase III trial in China during February 2020 to assess efficacy against COVID-19. Tocilizumab: a monoclonal antibody with activity against the interleukin-6...

Our office-based colleagues have been directed to work from home since mid-March, while the ClinLab Staffing service remains fully operational and ready to meet rapidly changing life sciences, biotechnology and pharmaceutical temporary, contract and full-time staffing needs. Have questions? Call us (508)907.6222 Our team is ready, 24/7 to meet the staffing needs for everything from highly specialized positions to day-to-day roles with integrity, ClinLab is here and ready to exceed expectations.

Each year we vote to award the “Rising Star Award” to a top performer who has really grown and excelled in their position.  The winner of this award has always been someone that management sees a lot of future potential in and many of the past winners remain top performers today.  Some of the attributes that exemplify what it means to be a “Rising Star” are a Positive Attitude, Leadership Skills, Teamwork, Hard-Work and Dedication. This year we are proud to present this award to Rory Siy, an account manager in our North Carolina Division.  Rory joined ClinLab Staffing as an entry level scientific recruiter in 2017, shortly after graduating from Boston College. He rapidly progressed to an account manager role taking over for his predecessor and led the North Carolina division to their most successful year ever! We are thrilled to have him as part of our hard working team and excited to see his career soar! I was very happy to hear that Rory was the recipient of the Rising Star Award this year. Earning this award goes to show that he is well respected by his colleagues.Having grown the North Carolina division to where it is now is quite the accomplishment! I am very proud that he has kept his head down, pushed through, and has built a team around him with the same mindset. I am very excited to see what is in store for the NC team in 2020! – Sean Reilly, 2018 Rising Star Award Recipient. Congratulations Rory on your Rising Star Achievement!

ClinLab Staffing continues to be recognized as one of the fastest growing companies in MA by both Inc 5000 and the Boston Business Journal. We are thrilled to be experiencing tremendous growth as a company and wanted to take a moment to shine some light on our top biller in 2019, Caitlin McNamara who not only met but exceeded all of her goals. Caitlin receives this honor for the second year in a row and we couldn’t be more proud of her! Caitlin joined us in 2016 as an entry level recruiter after graduating from University of New Hampshire with a degree in Neuroscience. She has played an instrumental part of growing the Massachusetts division by making numerous successful placements. Over the past year she has transitioned into a new role as a group manager taking on new responsibilities as a team leader, helping her group soar and grow in ways we have never seen before. It is very exciting to see! “Caitlin has repeatedly shown that she is a valuable team member to everyone here at ClinLab Staffing.  She goes above and beyond in all aspects of her career, she is a true leader, and she is a great ambassador to all of her clients in the Pharmaceutical market space for ClinLab Staffing.  I really look forward to being a part of her growth for years to come!” – Andrius Congratulations Caitlin, keep up the great work!

As U.S. businesses brace and prepare for the Coronavirus (Covid-19) pandemic, ClinLab Staffing is working with biotech and pharma companies to create backup plans and strategize for emergency biotech labor in anticipation of work product shortages due to interruptions in foreign CRO, lab and technical availability. The impact of COVID-19 is beginning to extend into the American Biotech space as the outbreak expands into the new regions. Executives say they face both increases in their labor requirements and service shortages in general but as reliance on Chinese contract research organizations strategies falter, companies face real capacity challenges to meet deadlines and goals. C&EN recently reported on challenges faced by Massachusetts biotech startups who rely on Chinese contract research organizations (CROs) — the virus impact in China is forcing these companies to build in backup strategies and employ alternate service providers as well as engaging companies like ClinLab staffing to bring temporary contract CRO services in-house. While the exact consequences of COVID-19 are difficult to predict, recent disruptions in the supply chain, as well as fragility in the financial markets, are causing many organizations to plan for labor supply issues due to quarantine procedures or illness. On top of supply chain concern, the possibility of travel restrictions to certain areas may cause businesses to seek alternative sources of supply. If your biotech, lab, or drug development and discovery organization is facing staffing challenges, please contact us at ClinLab Staffing 508.907.6222 to work with one of our knowledgeable specialists to help keep your company on time, on target, and ready to handle the potential staffing and work product shortages.

ClinLab Staffing offers an exciting annual incentive trip to sales and recruiting staff who meet and exceed their goals over the course of the year. This year our top performers visited Puerto Rico for some sunshine and celebration of 2019 success, our greatest year yet! Looking for a career in Sales and Recruiting? Apply...