When the World Called for Help with COVID-19, We Were Ready
Daniel Skovronsky, M.D., Ph.D. | November 10, 2020
Yesterday, 10 months after the world learned of COVID-19, the U.S. Food and Drug Administration (FDA) granted Lilly’s request for emergency use of our antibody therapy, a custom-designed treatment for the virus.
Creating a medicine from scratch and guiding it successfully through the clinical trial process often takes 10 years. In the case of this antibody therapy, it took less than one.
This is astonishing speed and a history-making achievement.
For perspective, the first therapy for HIV/AIDS arrived in six years. In the face of a global pandemic, pharmaceutical innovation has shortened what once took years into months.
Such speed was possible because when the world called, scientists and drug developers across our industry answered. Companies collaborated with one another in extraordinary ways. And the government, including regulators, partnered with industry, engaging in near-constant dialogue to share learnings and make critical decisions with less bureaucracy. It’s thanks to this unprecedented collective effort that we are now seeing more therapies become available to fight COVID-19.
When the coronavirus arrived, our innovators worked with incredible urgency and creativity to repurpose existing medicines to treat COVID-19 and design new drugs to fight it.
Creating a new treatment from scratch for a little-understood and rapidly spreading virus, which the world had learned of only months before, was a formidable task. But beginning in February, this is the challenge Lilly’s scientists and drug developers took on. Lilly was not in the business of producing vaccines or fighting viruses, but we had long been in the business of innovation.
We had invested in the right technology, we had studied the right data, cultivated the best talent, and were willing to take the right risks. And with little time to plan or act, we willingly disrupted the typical drug-making process for the sake of speed and creativity, all while remaining committed to our rigorous standards for patient safety and product quality.
We sought and worked with partners, including a Canadian biotech firm called AbCellera, to develop an entirely new treatment based on blood samples from an early COVID-19 survivor.
In February, the scientists at AbCellera and the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center took the blood sample and quickly identified antibodies – the part of the blood that likely helped the patient recover. Lilly then developed and mass-produced an engineered version of the antibody that could fight off the disease in other patients.
The process presented new challenges and compressed deadlines, requiring novel solutions.
For example, we worked with the FDA to quickly move the treatment into human testing. We set up mobile labs staffed with pharmacists in Lilly’s parking lots dedicated solely to the manufacture of this antibody. It usually takes three years for a new drug to begin the process of human testing. In this case, it took three months.
Faced with new challenges, we were ready to think anew. By doing so we were able to not just develop a new medicine, but discover new ways to work, to collaborate, to fight disease.
Finding a therapy for COVID does not represent the end of our fight. It does prove though that building the capacity to innovate is a powerful asset to improve public health.
Lilly has played a part in fighting other public health crises before. We were one of the largest producers of penicillin during World War II and the Salk vaccine in the following decade. Because of progress within our industry, and thanks to the unprecedented collaboration of scientists, companies and regulators, we’re proud to once again play our part to help society emerge from this pandemic.