When the coronavirus pandemic broke out, Paul Aliu knew that he would have to act fast. His team at Novartis soon received a deluge of requests from physicians around the world. Doctors asked to access the company’s medicines more than 1 000 times during the first two months of the crisis to help patients with COVID-19 disease.
While vaccines for COVID-19 could be well over a year away, researchers are working to identify treatments for patients in the near term. This effort includes repurposing existing medicines for patients with COVID-19 disease. When physicians and investigators outside the company want to use or evaluate a Novartis compound or product for a new application, they contact Aliu’s group via the company’s medical teams.
Aliu’s group has been very busy the last few months. Even for a team used to rapidly responding to requests for Novartis medicines – in 2019 the team handled more than 10 000 requests, approving 96.8% of them – the workload is unprecedented. Aliu, who is Global Head of Medical Governance for Novartis Global Drug Development, rapidly created a streamlined, COVID-19-specific process to respond.
In general, the team receives two types of requests that are relevant to the coronavirus pandemic. First, a physician can ask to use a product that’s been approved for a different use or that is not yet approved or available in a country for a patient with a serious or life-threatening disease through a managed access program (MAP).1 Second, a physician-scientist can request drug supply or funding from Novartis for a clinical study to test a new application of a product through an investigator-initiated trial (IIT).
The workload of Aliu’s team has increased by 50% during the pandemic. Yet the group is working at warp speed.
The standard review timeline for a MAP request is approximately five business days. The team can now approve COVID-19 requests within three to four hours and ship drugs to epicenters of the pandemic within 12 to 24 hours. Review times for IITs have also been significantly reduced – from more than 30 days to 48 hours.