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Business & Regulation Business Practice, COVID-19

The Pandemic Diaries

David Underwood, founding CEO and Chairman at Quanticate

As a statistician, I closely watched the data that was being collected as the pandemic broke. For those in my age range (60-70), the statistics were not for the faint hearted. It quickly became clear that COVID-19 would be the biggest challenge the world has faced in decades. It has affected every aspect of daily life.

From a business perspective, the integrity and feasibility of ongoing clinical trials have been threatened by the outbreak. At Quanticate, we switched our entire workforce to remote working – and the industry as a whole is now showing huge interest in remote source data verification (rSDV) due to lockdown, travel restrictions, and social distancing.

But trial sponsors have no such flexibility and have been greatly hampered. The impact ranged from a marked slow-down in recruitment rates due to enforced social  distancing policies to a complete halt in drug development programs, as pharmaceutical companies rationalized their investments or pivoted focus to join the race for a vaccine. In this environment, it is unfeasible and often impossible to keep a trial running “as usual” for a variety of reasons. 

I’m lucky to work with an excellent team that quickly realized these challenges and focused on supporting our clients through the pandemic with the provision of “rescue support” for clinical trials. There are several statistical methodologies that can be applied to provide protection against issues, such as missing data, reduced patient visits and reductions in patient recruitment, that have the potential to impede the scientific integrity of a trial.

The pandemic’s impact over the coming years will be widespread and although the severity is still unknown, it is possible to examine core components of studies with centralized statistical monitoring on an individual basis, and identify the most affected areas. By putting mitigating strategies in place, it may be possible to salvage some of – if not all – a study’s potential.

On a personal level, as the outbreak began, I invited my mother who lived alone to live with me. If you had told me 30 years ago that I would be living with my elderly mother, abiding to a lockdown, and washing all deliveries to avoid a deadly virus, all while running a 250-employee strong global organization, I would never have believed it. But every cloud has a silver lining and I am grateful to be spending this time with my mother and family. 


Zahid Tharia, consultant at the Pistoia Alliance

The COVID-19 pandemic has meant that many conferences have been transformed into digitally accessible events – and this has affected the Pistoia Alliance too. A few months ago, we replaced a physical event with a series of virtual events that explored the implementation and adoption of digital technologies in pharma. Speakers from across the industry addressed themes including emerging science and technology, the lab of the future, and the impact of AI and its underlying disciplines on real world-data. The success of these events motivated us to replace our annual conference, with a digital one this October.

Fortunately, we have a lot of experience in this area and have actually been operating as a virtual organization for a long time! We’ve always been focused on ways to collaborate that aren’t hampered by geography. So, we’ve had the tools and platforms in place to host virtual events like this for a while.

Over the last few months, remote working has been implemented relatively smoothly across the industry. Even before the pandemic, we’d already seen many companies embracing digital and virtual technologies within the laboratory setting through our Lab of the Future (LotF) initiatives, and this has now picked up further pace. In areas like clinical trials, virtual and digital technology is proving invaluable as companies explore ways of keeping patients enrolled in trials despite social distancing barriers. Now, the challenge is to ensure new digital projects are interoperable, and that we do not end up with a surfeit of digital tools in a year’s time that only benefit a limited number of companies and patients. If we work together, we can ensure that innovations borne of COVID-19 have long-lasting positive effects.

 

We recently launched a new series of programs to help organizations collaborate on advancing the role of digital technology in life sciences R&D and healthcare – the first initiative will aim to define standards for collecting patient-centric data using digital tools. This theme was on our agenda long before COVID-19, but the pace at which digital solutions are adopted can only be accelerated. Social distancing will continue for some time, meaning organizations and researchers will need digital tools to change how, for instance, clinical trials are run, and how people can continue work within clinical settings and laboratories. This acceleration of digitalization against the backdrop of COVID-19 makes it even more crucial that the industry works together, shares its knowledge, and adopts industry-wide standards so that data can be shared and therapies identified much faster.

Looking forward, we can but wait and see what the future holds for physical events – and we look forward to being able to come together again to share expertise and network face to face. Our priority for now remains supporting collaboration. And it’s great to see our members doing so much to identify treatments and therapies for COVID-19 and to see examples of collaborative projects.


Kenneth Lee, Commercial Head and Director of Business Development at GenScript ProBio

Almost everyone in the world has been affected by COVID-19 and it’s clear that we must prepare for the long haul. This issue is not going to disappear in a few months. Fortunately, there are many outstanding drug development technologies available and I have seen many good therapeutic candidates. At my company, we see many projects related to COVID-19, including oral medicines, vaccines, antibodies, and antibody drug conjugates. Many scientists are putting a lot of effort into devising new ways to deal with the virus – and it’s my sincere hope that the industry has the development and manufacturing flexibility to bring treatments and vaccines to communities as soon as possible.

It can take anywhere from five to 15 years to develop and fully commercialize a biologic product – but we cannot wait that long for a drug to tackle COVID-19. Fortunately, regulatory authorities are working favourably with drug manufacturers to move projects along as quickly as possible – and, in some cases, there is room to bypass certain aspects of development and move faster (while of course still adhering to safety requirements). I’m seeing some projects benefiting from huge reductions in manufacturing turnaround times after discussions with regulatory agencies.

I encourage companies who are interested in this space to be creative, to work with their manufacturing partners to develop effective solutions, and to work with regulators to see how timelines can be shortened. Together, we can discover the best way of maximizing the chances of approval.


Mike Jagielski, CEO at KCR, UK

The first half of 2020 brought unexpected and unprecedented challenges – both personally and professionally. As a CRO organization, we felt the impact of COVID-19 immediately so our response had to be quick. We developed the KCR Task Force for COVID-19 to gather regional regulatory information for daily evaluation and to gauge the probability of impact on all our portfolio projects. This information kept our project teams fully informed and ensured the most optimal health and safety of all patients, employees, and healthcare professionals involved in our projects. Our leadership team also worked to understand how decentralized processes and technologies could be leveraged to alleviate risks.

Like many other R&D industry organizations, we experienced substantial site-level impacts on trial operations as the pandemic spread. Using methodologies such as remote monitoring allowed our organization to make it through Q2 – and brings me to one key point: these times, though difficult for many reasons, perfectly displayed our full potential as human beings and as research professionals.

Our teams not only proved that we are supportive and committed, but also capable of developing skills in remote management, communication, and time management with unprecedented speed and efficiency. This crisis brought us closer together and revealed that progress does not always necessarily need to be planned or methodically tested to be achieved when times are tough (though undoubtedly, a planned and methodical research process is essential to developing innovative and safe medicines – and processes in this regard must stay the same). Simply, sometimes extraordinary circumstances force deviations from the norm for the rapid advancement of new solutions.

For instance, when the COVID-19 pandemic began to intensify in late February, I had already recorded a podcast episode on the long-standing need for sustainability in the research industry. The episode discussed how more energy-conscious solutions could keep the clinical industry from adding to the climate crisis. When the pandemic began to intensify, it exaggerated the need for advanced trial technology and integration. Thus, when the podcast was released in May, the speed and uncertainty of the pandemic had already launched many of the topics discussed into reality. While remote monitoring, reduced business travel, and telehealth operations seemed like difficult tasks to implement industry-wide in January, the pandemic presented a dire situation and industry professionals across the globe implemented “green” solutions to ensure the survival of clinical studies.        

During this time, country borders, cultural differences, and competitive business were not important, but the health and safety of patients, employees, and healthcare professionals were. The industry has certainly banded together to support one another all while achieving extraordinary progress.

Ger Brophy, Executive Vice President – Biopharma Production at Avantor

A global pandemic is unique in its ability to affect every aspect of life, and right now, everyone is experiencing significant challenges in managing the disruption.

For me, COVID-19 has emphasized why business continuity planning is so crucial. Business continuity means considering, among other things, partnerships with global life sciences companies that provide chemicals and single-use products, and the breadth of their supply chains. Acute problems for chemicals and single-use providers in a specific region could affect the entire world’s production of a critical ingredient.

Quality, logistics, and supply chain have always been fundamental to our biopharmaceutical production business – even before the pandemic – but the pandemic has tested some of what we knew to be true but didn’t think about every day.

Our supply chain and our global distribution network have allowed us to maintain our ability to operate and move critical materials around the globe, while taking proactive safety measures to ensure business continuity. For example, having plants in different jurisdictions, potentially with different restrictions, has always been part of our business plan. Especially during this time, being global has given us the flexibility to maintain our operations continuously. Our distribution infrastructure has also allowed us to navigate our network and work around obstacles.

We have always known that our relationship with our partners is not simply transactional. A situation like this demonstrates how strong partnerships between manufacturers and suppliers not only helps to increase process efficiency but also can help minimize potential missteps in the development and scale-up of therapies.

Additionally, these relationships enable better monitoring and measuring of a raw material supplier’s quality management system to ensure consistency over time. Manufacturers may notice some vulnerabilities there ─ and address them. Breakdowns in QMS can be catastrophic, so the importance of collaborations, routine audits and quality agreements cannot be understated.

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About the Authors

Zahid Tharia

Zahid Tharia, consultant at the Pistoia Alliance


David Underwood

Founding CEO and Chairman at Quanticate


Kenneth Lee

Head of Commercial Division, Americas at GenScript ProBio


Mike Jagielski

Mike Jagielski, CEO at KCR, UK


Ger Brophy

Executive Vice President – Biopharma Production at Avantor

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