Cybercriminals are focusing more on pharmaceutical entities as information is increasingly stored in digital form and on the cloud. Pharmaceutical companies should assume every part of their business is vulnerable and have a strategy in place to respond and shift to manual and paper operations if there is a breach.
A second wave of COVID-19 could disrupt the pharma supply chain in the UK, and the International Trade Committee is asking pharmaceutical companies and the government to be ready. Manufacturers in the country should have the capacity to produce 20% to 30% of required supplies but the ability to scale up to 80% to 90% in a crisis, according to the report.
Two studies reported in JAMA Cardiology suggest long-term damage to the heart is possible following COVID-19, even among patients who were not hospitalized. A analysis of cardiac MRIs found higher rates of inflammation and evidence of structural change in 100 COVID-19 survivors, and high levels of the novel coronavirus were found in the hearts of 24 out of 39 people who died early in the pandemic.
Pfizer and Moderna have initiated late-stage trials to assess the effectiveness of their experimental COVID-19 vaccines in 30,000 volunteers. Moderna's vaccine, co-developed with the National Institute of Allergy and Infectious Diseases, will be evaluated in almost 90 sites in the US, while the vaccine jointly developed by Pfizer and BioNTech, will be tested in about 120 sites in the US and overseas.
The COVID-19 pandemic is placing stress on pharmaceutical manufacturers and their employees as companies struggle with supply shortages, supplier audits and preparations for inspections, all while trying to accelerate research and development and manufacturing timelines as vaccines and treatments move through the pipeline, writes James Morris, who has held management roles at pharma companies. The changes made during the COVID-19 pandemic could improve efficiency in the future, Morris writes.
Pill Connect from Elucid Digital Health is being used to help companies track patient adherence during clinical trials. A special cap added to the pill bottle indicates when the drug has been dispensed from the bottle, and a reminder is sent via text or phone call if the patient doesn't follow the protocol.
The majority of research on COVID-19 infections, vaccines and treatments is centered in the US, China and Europe, leaving some countries without access to important data about the virus, writes Hannah Balfour. However, information-sharing resources are available to bridge gaps, including the COVID-19 Universal Resource gateway and the Global Open Access Portal.
Researchers at the Wake Forest Institute for Regenerative Medicine are testing the effects of experimental COVID-19 drugs on 3D printed organoids, which they say streamlines preclinical testing and could reduce the need for animal testing. The team has also used organoids to study the effects of treatments for Zika virus, diabetes drugs and other therapies.
A Phase I trial of Innovative Cellular Therapeutics' autologous anti-CD19 chimeric antigen receptor T-cell therapy and dominant-negative PD-1 molecule ICTCAR014 found a high response rate in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. The results were presented at a virtual meeting of the American Association for Cancer Research.
Focusing on quality indicators, training and recertifying operators, harnessing technology, and encouraging collaboration between trained point-of-care testing personnel and users are the keys to effective quality assurance of point-of-care testing, writes Pedro Castaneda, University of Minnesota Medical Center's point-of-care testing supervisor.