As the COVID-19 pandemic continues, we continue to innovate to accommodate for the new situation and minimize the impact to operations. We closely follow local governmental measures and apply these as appropriate within our organization, guided and supported by our dedicated COVID-19 task force teams. All local and global task force teams meet regularly and make recommendations directly to the COO.
We report the following impacts for 2020:
We implemented strict measures to help prevent the spread of the virus and protect the health of our staff. We rolled out our global and site business continuity plans and took appropriate recommended precautions, including suspending almost all business travel. Over time, we learned most of the international travel could be replaced by virtual meetings resulting in improved cost efficiency, a better work-life balance, and a reduced carbon footprint. The positive impact of this forced way-of-working will therefore be retained in our future habits and updated work place strategy, called "To the Next Normal."
During lock-down periods, we arranged for essential tasks to be carried out within our facilities. Employees working on site needed an authorization letter signed by the line leader and site head. Consequently, approximately 70% of our Research staff continued working from the offices/labs, with periodic exceptions for local lockdowns during which no staff was allowed to come into the facilities. For those employees coming to the office, we have stringent cleaning and sanitation protocols in place, and we strictly respect social distancing policies at all times in order to minimize risk of exposure. Except for employees with laboratory operations and safety roles which require an on-site presence, over 95% of our staff systematically worked from home, supported by robust IT infrastructure and technologies that were rolled out globally to facilitate remote forms of work. For our employees working from home, we provided additional IT materials and a stipend to cover office expenses such as ink cartridges and paper.
It is in our culture to address what matters. During the COVID pandemic, we reached out to our employees to understand how they are coping with the new situation and understand what support they needed from the company. In May 2020, we carried out a “pulse check” employee survey. The results indicated that overall, employees felt that our company supported them well during the pandemic. Key highlights included:
- Appreciation for the support from the line leader and the business leadership
- Increased ability to adapt to home working, thanks to strong IT infrastructure and support
- Employees perceive themselves to have a greater focus on the job after working in isolation at home during the pandemic
The survey also underlined the continued need for our company to support our employees and to help them find the right work-life balance (e.g. sufficient physical exercise, information on how to set-up an ergonomic workstation at home, possibility to be ‘off-line’, more frequent short breaks). We helped them to stay connected as a team by organizing virtual coffee corners and using interactive applications during virtual meetings to increase engagement.
Four key areas of focus were identified as part of an overarching program called "To The Next Normal," with all its elements being fully linked to our workplace and digital strategies. This is a program intended to accelerate application of the learnings over the last year in our company’s operations, investing in:
- Enhanced approach to flexibility
- Future-proof, greener approach to mobility
- Employee well-being
- Integrated digital and connected virtual collaboration
By prioritizing the most advanced projects very early on, increasing the flexibility of our staff in the labs within projects, maintaining our hiring efforts as planned, and increasing our outsourcing, we sustained our research delivery, kept the compound management facility running at all times, and continued our early drug research and the implementation of new modalities for target or drug discovery.
The scorecard of the research department objectives shows a similar productivity compared to previous years, indicating that we were able to minimize the impact, at least on the short term.
We have a business continuity plan for our clinical development programs. We closely monitor each program in context of the current global and local situation of the pandemic and the associated specific regulatory, institutional, and government guidance and policies related to COVID-19. Within the boundaries of these guidances and policies, and in consultation with our CROs and clinical trial sites, we applied various measures to minimize the impact of the COVID-19 pandemic on our clinical development programs, with the primary aim to ensure the safety of our trial participants and to preserve the data integrity and scientific validity of the trials. These measures were implemented on a case-by-case basis, tailored to the specific study and country needs at any given time, with specific attention paid to vulnerable populations and the use of investigational medicines with immunosuppressive properties. The measures include, amongst others, increased, transparent communication to all stakeholders and the direct supply of investigational medicines to patients. For each clinical trial, we actively monitor and document the impact of COVID-19 to mitigate the study where necessary and to facilitate the interpretation and reporting of results.
Filgotinib filing process UC
As of publication of this report, our collaboration partner Gilead had not been informed by the regulatory agencies in Europe of approval timeline delays.
Manufacturing and supply chain
To date, there has been no COVID-19 impact to the commercial supply of filgotinib. Gilead also confirmed that all sites involved in the manufacturing of filgotinib are established sites that currently manufacture other Gilead marketed products and are in good standing with the FDA and are GMP certified. Under the binding term sheet that we entered into in December 2020 to amend our arrangement with Gilead for filgotinib in Europe, Galapagos plans to become the marketing authorization holder of filgotinib in Europe by year-end 2021, and then become responsible for manufacturing. We intend to work with the same manufacturing sites to ensure continuity.
The form of outreach of our commercial teams to physicians and hospitals was impacted by the COVID-19 pandemic and consequent travel restrictions, turning virtual instead. The teams invested in virtual channels as part of the overall commercial build strategy, and these channels are being utilized during our commercial launch today. We note as yet no material impact on our commercial operations due to travel restrictions, nor has there been an impact of COVID-19 on our ability to engage in market access discussions thus far.