Novartis has established a fully dedicated internal team, or coalition, to collaborate with top global experts to examine potential root causes, risk factors, mitigation and potential treatment protocols for adverse events associated with Beovu.
The coalition represents a collaboration between an international, multidisciplinary panel of Novartis experts and top global experts from leading universities, hospitals, medical centers and clinics around the world. The coalition is structured as follows:
- Program work streams. This consists of fully dedicated internal experts from across Novartis, organized around the four key questions related to potential root causes, patient characterization, treatment and risk mitigation.
- Think tank. An additional source of information for the work stream teams, providing access to external expert resources in the evaluation of data and validation of hypotheses.
- Crowdsourcing initiative. Designed to incorporate broad perspectives from external scientific and entrepreneurial communities into coalition activities, with an emphasis on injecting fresh thoughts and ideas.
The coalition are considering four key questions:
- What are the root causes of these events?
- Are there patients at higher risk and can we characterize them?
- What can be done to lower the incidence of these events?
- How should these events be treated?
Novartis is fully committed to transparently communicating all facts and findings to ensure that ophthalmologists have the latest data and understanding they need to appropriately make treatment decisions for their patients.