As doctors struggle to treat patients suffering the illnesses caused by COVID-19, pharmaceutical companies race to find and test treatments and vaccines. A handful of promising drugs, like Gilead Sciences’ Remdesivir, are in clinical trials now. Big pharma leaders AstraZeneca and Johnson & Johnson are collaborating with government organizations and research labs to identify antibodies and develop vaccines to effectively treat and prevent outbreaks. It is the proverbial race against time.
That’s why these companies are investing in dual efforts – to develop pharmaceutical solutions in their labs, while also preparing their manufacturing facilities and suppliers for the mass production of medications and vaccines once testing is complete. Loftware’s Enterprise Labeling, Packaging Artwork Management and Clinical Trial Labeling Solutions help these customers eliminate time-consuming manual processes and support compliance with global regulations. This helps bring new vaccines and medications to market faster.
Supporting Global Collaboration and Vaccine Production
- Johnson & Johnson is teaming with the Biomedical Advanced Research and Development Authority (BARDA), part of the Health and Human Service (HHS) Office of the Assistant Secretary for Preparedness and Response, to develop a vaccine to Covid-19, committing more than $1 billion to research and development toward this effort.
- Janssen Pharmaceutical, a division of Johnson & Johnson, has identified a lead vaccine candidate for the COVID-19 virus and is working with researchers at Beth Israel Deaconess Medical Center on testing. The vaccine will use Janssen’s AdVac ® and Per.C6® technologies, which were used to develop Ebola Vaccine and build Zika, RSV and HIV vaccines currently in clinical development. The company expects to begin phase 1 human clinical studies by September 2020. The first batches of the Covid-19 vaccine could become available in early 2021 for emergency use authorization, reducing the process from years to months.
Reducing the Time Required to Deliver Advanced Treatments
After recently learning that patients treated with its blood cancer drug Calquence demonstrated positive results in a small group of COVID-19 patients at Walter Reed Army Medical Center, AstraZeneca (AZ) is scheduled to begin clinical trials on COVID-19 patients in intensive care units and on ventilators. The drug, which is already approved by the FDA for the treatment of certain blood cancers, blocks the Bruton’s tyrosine kinase (BTK) protein that signals white blood B cells of the human immune system to act. The overreaction of the immune system in COVID-19 patients can fill the lungs with thick fluid, causing acute respiratory distress syndrome (ARDS). Researchers and doctors hope the randomized, controlled clinical trial shows that Calquence both prevents coronavirus patients from requiring ventilation and also makes it possible to remove them from ventilators, where the mortality rate is 50% or higher.
AstraZeneca is also taking a multipronged approach to develop antibodies against the pandemic SARS-CoV-2 virus. As part of DARPA’s Pandemic Preparedness Platform program, AstraZeneca developed capabilities to discover antibodies against emerging viral threats. With the goal of targeting the spike protein the COVID-19 virus needs to enter cells, AstraZeneca is now screening antibodies from three different sources: patients who have recovered from COVID-19, humanized mice immunized with the SARS-Cov-2 spike protein, and laboratory techniques such as phage display. Theorizing that an antibody-based treatment could neutralize the SARS-CoV-2 virus, the company is betting on the antibody treatments it develops to be used as a preventative option for those exposed to the virus, as well as a treatment for those infected to prevent disease progression. AstraZeneca is partnering with the U.S. Army Medical Research Institute of Infectious Diseases and the University of Maryland School of Medicine to begin preclinical assessments and hope to begin clinical trials in three to five months.
Gilead Sciences’ antiviral drug, Remdesivir, is a leading drug among existing Covid-19 therapy projects and is currently used in a phase 3 trial on over 1,000 patients worldwide. First tested on Covid-19 patients in Wuhan, China, the investigative drug received approval from the National Institute of Allergy and Infectious Diseases (NIAID) to expand phase 3 trials. Gilead expects trial results from China as early as April and have expanded phase 3 trials to a global scale. They have also taken steps to be able to quickly ramp production should Remdesivir prove to be a safe and effective for the treatment of Covid-19.
Saving Lives by Shortening Time to Market
AstraZeneca, Gilead Sciences and Johnson & Johnson/Janssen Pharmaceutical are planning to accomplish the impossible, shortening the time to introduce new treatments and vaccines from many years to months. When planning clinical trials, labeling can create its own barrier to getting drugs to market sooner. Managing translations and keeping track of global regulations in a piecemeal fashion can slow the implementation of testing and the introduction of new medications. Loftware’s Enterprise Labeling, Packaging Artwork Management and Clinical Trial Labeling solutions streamline labeling, adding needed controls and audit tracking, supporting our customers as they achieve the impossible.
A Heartfelt Thank You
As the provider of Enterprise Labeling and Artwork Management Solutions to these impressive companies, Loftware is in awe of their work to defeat the novel coronavirus. We are proud to play our small role helping them bring their life-saving products to market. We wish them – and you – success and good health.