Keeping tabs on Covid-19: First human antibody study, FDA approved at-home testing and new investments to protect local communities
From new drug designs and vaccines, to new investments announcements to protect front line workers, this week’s round up explores how the pharma industry is collaborating to improve treatment options and industry innovationAdd bookmark
As pharma companies continue the race to find a cure for Covid-19, this week Pharma IQ looks at innovation within the industry as it discovers new solutions and adapts existing resources within healthcare to fit the needs of the global health crisis.
Read on to dive into new vaccines developments, antivirals and other treatments developed to help those infected with the fast-spreading novel coronavirus.
Eli Lilly begins world’s first antibody treatment study in humans to treat Covid-19
Eli Lilly and Company has announced that patients with Covid-19 have been treated in the world's first study of a potential antibody treatment that fights coronavirus.
This investigational medicine, referred to as LY-CoV555, has been developed in collaboration with Lilly and AbCellera. Lilly claims its scientists rapidly developed the antibody in three months after AbCellera and the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID) identified the basis of the antibody treatment from a blood sample taken from one of the first US patients to recover from Covid-19.
Daniel Skovronsky, M.D., Ph.D., chief scientific officer and president of Lilly Research Laboratories, said: “We are grateful to collaborate with colleagues at AbCellera, NIAID and the many academic institutions who have helped us reach this milestone in humanity's fight against Covid-19.
“We are privileged to help usher in this new era of drug development with the first potential new medicine specifically designed to attack the virus. Antibody therapies such as LY-CoV555 may have potential for both prevention and treatment of Covid-19, and may be particularly important for groups hardest hit by the disease such as the elderly and those with compromised immune systems.”
Skovronsky also stated that Lilly intended to review the results of the first human study and would initiate broader efficacy trials. Lilly is also investigating safety and efficacy of LY-CoV555 in the event the company begins large-scale production of the therapy.
FDA takes steps to streamline development of tests with at-home sample collections
In an effort to support test development during Covid-19, the US Food and Drug Administration (FDA), has authorized several Covid-19 tests for use with at-home collection of samples – such as from the nose or saliva – that can then be sent to a lab for processing and test reporting.
To ensure all at-home collection tests are reliable and authorized, tests must receive an Emergence Use Authorization. Currently, Covid-19 tests for at-home self-collection may also be used as part of an Institutional Review Board approved study.
Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, said: “During this pandemic, the FDA has remained supportive of making accurate and reliable tests widely available.
“Home collection raises unique concerns about safety and accuracy. For example, can the sample be collected safely and properly by a layperson or can the sample be shipped in a way that’s stable to ensure an accurate result once it reaches the lab? This is why these tests require FDA review, to ensure they work as they should and are safe for all involved.
“An at-home test that returns false results could be harmful to an individual patient, and hinder broader public health efforts to mitigate the spread of Covid-19,” Shuren added.
"We’ll continue to support ways of making our review processes as streamlined as possible, while continuing to protect patients and the public health.”
Cambia Health commits to combat the impact of Covid-19 on local communities
Cambia Health Solutions and the Cambia Health Foundation are addressing urgent and immediate needs of local communities in the US by initiating new investments of up to $500,000 to care for families and front-line healthcare workers impacted by Covid-19.
In support of healthcare and support service providers on the front lines, Cambia Health has provided approximately $50,000 in funding to address urgent and immediate needs identified by their healthcare partners.
In response to the significant increase in barriers to food access, Cambia Health has also donated $50,000 to the Oregon Food Bank, in addition to matching employee donations of up to $100,000 to designated nonprofits working to ensure communities are staying healthy and fed during the crisis.
Peggy Maguire, president of Cambia Health Foundation and Corporate Responsibility, said: “We are proud to support the work of organizations on the front lines, and to evolve our grant-making in relationship with our partners as new needs become clear.
“I want to recognize and thank the healthcare and support services providers who are providing essential services during these challenging and uncertain times. Now is the time for all of us to lean in and take care of one another.”
For more on drug discovery and development to combat Covid-19, join your peers in this interactive webinar to explore how Dassault Systèmes is using molecular modeling for drug repurposing, detection of SARS-CoV-2 and vaccine design. Anne Goupil-Lamy, BIOVIA Science Council Fellow at Dassault Systèmes, will present solution-driven case studies to help maximize drug development profitability and team collaboration.
EMBALL’ISO is exploring the key advantages of reusability and global sea repositioning to tackle supply chain disruptions during the Covid-19 pandemic in this Pharma Logistics IQ webinar. Secure your free seat and learn from a panel of logistics specialists.