Beyond our core values – ownership, integrity, leadership, sustainability and entrepreneurship – we aspire to create a culture in which our employees feel inspired. Here are five snapshots of how our culture is taking shape.
Integrity is not something that you can just claim, but rather something that takes years to build through consistent action and honesty with those who depend on our products throughout their lives. It is the backbone to developing sustainable business and patient relationships that can last many years. Underlying this notion are both transparency and honesty, without which no relationship can last long.
When there are market supply disruptions, we at Octapharma have always been very transparent with our partners to protect them and their patients. It is this openness, this integrity, and the trust that comes with it, which makes us able to work with our distributor and end-user accounts in creative ways to ensure that patients still receive their therapies during times of supply disruption.
Working in clinical trials forces you to be creative under time pressure. We must embrace our entrepreneurship from the very beginning when we start building a protocol, through seeking interested and qualified physicians to join our study, and through managing the various challenging scenarios that arise as we collect data. A good example would be GAM10-08, a pivotal clinical trial into the use of octagam®10% in Dermatomyositis, for which I was the Clinical Study Manager.
In that trial, we developed creative and entrepreneurial processes to overcome traditional approaches and succeeded in connecting study patients with this rare disease to our important trial in a very short time period. One way we did this was through the use of remote start up and remote verification of data. At first, this was seen as a novel approach, but now, with COVID-19, remote visits are the norm. Overall, this change in strategic tactics helped us accelerate study enrolment from 0 patients to 27 patients, making the USA the country with the highest number of patients enrolled overall, and helping to ensure the trial met its timelines.
Octapharma took the lead and organised an advisory board with key opinion leaders to better understand the PANS/PANDAS disease and to develop a new study for it. Octapharma was the first to bring together different specialities, such as immunologists, psychiatrists, neurologists and paediatricians, to discuss this disease and the evidence for IVIG treatment. Following several discussions, the members of the advisory board unanimously recommended pursuing a study in PANS/PANDAS.
Before jumping into a full phase 3 study, Octapharma again showed leadership and funded another study by three immunologists to verify some of the findings in the literature – something no other company had done. Later, Octapharma took the lead yet again to work with top physicians to fund additional research. Our company, and our managers at all levels, take leadership seriously. We are curious – curious to experiment, curious to continuously learn new skills and curious to explore new or better ways to re-imagine medicine together. And we are always eager to take a step forward, ahead of the crowd. It is highly energising to be part of such a team.
One important project in which I was heavily involved was the replacement of in vivo pyrogen assays in rabbits with far more sustainable in vitro endotoxin assays on microtiter plates. The absence of pyrogenic substances is a prerequisite for all parenterals (sterile preparations prepared to be injected, infused or implanted into the body). The European Pharmacopoeia originally required in vivo pyrogen assays to verify this, but the requirement was later changed to allow in vitro endotoxin tests. Clearly, extensive validation studies were required to show that the new tests were equivalent to in vivo assays.
As part of the process, hygienic conditions throughout the production process were monitored over several years, accompanied by the preparation of a careful definition of risk mitigation measures and an evaluation of adverse side effects in patients. Ultimately, all Octapharma products lay in the scope of this project and nearly all corporate and quality control (QC) departments from our sites were involved. My part was to motivate, support and coordinate all stakeholders, as well as contributing to documents and proofreading them. Today, as a result of the success of our efforts, all our main products are now exclusively tested by in vitro assays, saving both valuable resources and the lives of tens of thousands of rabbits every year. This is what it means to be sustainable.
In 2020, our company value of ownership had great importance to me personally. Watching the global pandemic unfold in the UK, it was clear to see the impact the situation was having on our people and patients. With so many issues requiring attention and clarity of thought, I truly felt the responsibility to make the right decisions, some of which were difficult. Our priority was to ensure our life-saving medicines reached patients and that each team member remained safe, well and able to perform their roles effectively, which could sometimes seem like contradictions.
The only way in which we could resolve that and stay focused on our objectives was to give each employee ownership of their own work and well-being, and to rely on them to function as a team to find workable solutions. As always, our people responded brilliantly and showed their commitment throughout the crisis. I am proud to say our business is strong, and our people are performing productively with a shared sense of ownership of both the challenges and successes we are experiencing together.