EPM speaks to Abdullah Al-Hakimi, senior quality compliance specialist at Autolus and Robert Gaertner, strategy director for Veeva Vault Quality, about working during Covid-19 and why quality processes are so important in pharma.
Questions
To begin could you please introduce yourselves and the companies you work for?
Abdullah: Autolus is at the forefront of a revolution in cancer treatment. We focus on the development of precisely targeted, controlled and highly active T-cell therapies for the treatment of both haematological cancers and solid tumours. We work in partnership with physicians and other healthcare providers, we extract immune cells from patients, equip them with a receptor that targets the cancer cell and infuse them back into the patient in order to develop therapies.
Robert: Veeva Systems is the leader in cloud-based software dedicated to the global life sciences industry. Our Vault Quality Suite unifies quality processes, controlled content, and GxP training on a single digital platform. It enables life sciences companies to modernise quality management and drive compliance and operational innovation.
How has Covid-19 affected the day-to-day working of your companies?
Abdullah: As with most industries, we’ve had to rely much more heavily on working from home. Thankfully, Autolus has always had a heavy focus on cloud technology to ensure collaboration and visibility across different teams. The shift to home working hasn’t been too onerous, in fact our previously office-based teams have continued to operate effectively and it's even busier now than ever before.
Now, of course, as a company that manufactures drugs for patients, there are parts of our teams that are unable to work from home. Safety is paramount for our manufacturing teams. We have been providing transport, ensuring that sites are set up to allow social distancing, and providing masks and PPE. By following the government guidelines and putting the safety of our staff and the safety of our treatments first, we’ve been able to continue normal operations.
Robert: Being a native cloud company, we really believe in virtual ways of working. Most people at Veeva work remotely so in that sense, not much has changed in our day-to-day operations. What has been different is that Covid-19 caused a lot of life sciences companies to accelerate their move to remote and digital engagement with many needing to fast-track the implementation of enabling technologies.
Was the industry prepared for the necessity of home working situations because of Covid-19?
Robert: I'm afraid to say that the industry was largely not well prepared. There are younger companies, like Autolus, who took a very mature approach. Autolus already had a foundation of the right technology and right organisational mindset shift to remote working so have been able to do easily.
In comparison, some of the 'Big Pharma' have struggled, especially with working from home. Of course, they did manage to catch up after a while, but they had to invest in technology and workarounds in a very short time to keep their operations up and running.
Abdullah: Autolus was well prepared for the sudden need for more remote working. We had the technology in place and had invested in cloud solutions since our inception which was a huge help in keeping people online and working effectively.
I myself have been doing my role from home now, since the beginning of the UK’s lockdown. And I’ve found that I’m connecting with more people, more regularly than I used to. There is the loss of the social element but in terms of productivity and reaching our goals, we continue to do that rather effectively.
How is software such as Veeva’s Vault Quality applications helping companies with quality processes?
Abdullah: Before our implementation with Veeva, our document control system was paper based. This meant people would need to be in an office to access important documents.
Luckily, we completed our move to Veeva in the middle of last year, so our processes have been primarily cloud-based with people able to access documents virtually from anywhere in the world for some time now. We feel very fortunate that we were able to get ahead of the curve. It was a time just before a period of exponential growth and getting the right cloud technology in place was critical to that growth plan.
Importantly, when it comes to quality processes. We've also migrated all our change control processes to a virtual platform. If something goes wrong, it can be logged and processed electronically without the need for somebody to be there to sign a piece of paper or authorise in person.
Robert: Surprisingly, one of the biggest challenges that companies have experienced in going paperless was still the signature process. This was true even for companies that had invested in large, on-premise software, they were still circulating paper for wet ink signatures. Moving to a fully digital review and approval process has been a very well received part of Veeva’s Quality applications.
Another area has been around auditing, which is something that is carried out predominantly onsite. Remote auditing seems to have become a new normal in the industry, also with increasing adoption by regulatory agencies.
This is a hugely positive step and something that is only possible because of digital technologies available today. In general, remote collaboration could also lead to better and much richer and data-driven insights so we could see long lasting benefits from this change.
Do you think the pharmaceutical industry is welcoming of new technologies and willing to adopt? Or is uptake rather slow?
Robert: Nowadays if you ask across all segments of the industry, I would say that there's a cloud first policy. This hasn’t been a sudden change but rather a continuous evolution.
However, Covid-19 has exposed some major challenges and gaps within the industry which has in turn led to companies accelerating their adoption of industry specific cloud solutions.
How are quality processes being affected during Covid-19?
Abdullah: Personally, I think Covid-19 has had a positive impact on quality processes. Regarding electronic signatures. We had to move away from the mentality that somebody had to be on-site to sign a piece of paper. Lockdown really made remote signatures a necessity. This in turn makes the signing process more transparent and traceable.
Robert: Covid-19 has exposed an urgent need in the industry to implement an effective, unified risk management process. Risk management is something every company does in one way or another, but Covid-19 has shown that documenting risks isn’t enough. You need to have holistic mitigation and business continuity plans in place for a wide range of potential scenarios.
On top of this, if you look at how quality systems are designed today, they are quite rigid and strict. This turned out to be a weakness if pragmatic, yet compliant actions need to be taken Covid-19 has proven the need for flexibility and quick workarounds. There might be an opportunity here for people to change quality systems to become much more flexible and adaptable, as long as you're acting and operating in the spirit of strong quality and compliance. This could change the core of the quality systems across the pharmaceutical industry.
What lessons do you think the industry should learn from Covid-19?
Robert: Everyone I’ve spoken to says that we're not going back to the past. That means whatever we have achieved in terms of improvement, it should be sustained. This will also include more virtual collaboration even R&D and manufacturing sites and fully open back up.
Looking ahead, I think the industry will further strengthen collaboration and work in virtual networks in order to accelerate the development of critical treatments and vaccines. This will include sponsors, their partners, and also regulatory agencies because everyone has learnt what is possible if you share a common goal.
Abdullah: For us, for the foreseeable future, our teams in the office will probably continue to work from home. And similarly, those who are in the manufacturing facility would continue to adhere to the to the kind of social distancing and PPE requirements that we've implemented.
Looking forward, we need to work with a much greater partnership mindset. We need to make sure that not only what we do is right, but that we are looking outside of ourselves and ensuring that our partners are adhering to our standards.
For example, with every treatment, there is a supply chain that needs to be maintained, we need to consider our transport partners and the HCPs interacting with our patients.
We've managed to do well so far. But the bigger picture is that we can't just do our part alone, everybody else has to do their part too, ultimately for the benefit of the patient.