Industry landscape is evolving rapidly and successful partnerships are shaping the new terrain. Steffen Lang from Novartis explains how collaboration is changing pharma for the better
The pandemic affected conversations about pharma in two major ways.
Firstly, it brought them to the kitchen tables of families who normally had little involvement with pharma, outside picking up the odd prescription. But in 2020 suddenly everywhere we went (or rather, on every Zoom and phone call) it was a hot topic because it became so central to our common experience. Family and friends took a sudden interest in my job and my expertise because I had a unique insight into an industry that could ultimately hold the answers we were so desperately seeking.
Secondly, it changed the tone of those conversations. For years, pharma often made headlines only when accompanied with negative connotations. Competitive. Expensive. Complex. Different organisations’ priorities may vary, but the ultimate goal of pharma is preventing and treating diseases, easing suffering and improving quality of life for people worldwide.
The speed with which pharma companies safely brought COVID vaccines and treatments to patients around the globe emphasised this goal and the positive potential of our industry.
Many perceive pharma’s journey to producing safe and effective treatments – such as the COVID vaccines – as a competitive race between organisations. But this narrative ignores an ongoing paradigm shift in the way the pharma industry works.
Collaboration, data-transparency, resource-sharing and partnerships with governments, public health systems and other organisations are now defining pharma’s ‘Information age’. These are critical, not just to address COVID, but also to treat and cure other diseases.
One of the ways collaborations have enabled vaccine production specifically, is in the manufacturing process. The urgent need to rapidly spin-up production for a new vaccine, where billions of doses would be required, presented a challenge of unique scale. Once the vaccines were researched and approved by regulators, the bottlenecks in the journey to the end patient were largely due to a simple lack of manufacturing and shipping capacity.
Novartis doesn’t have a vaccine business anymore, but we recognised that our manufacturing capabilities and capacity could still prove useful to the vaccine production efforts of our competitors. In 2021, we signed contract manufacturing agreements to support the production of the Pfizer-BioNTech vaccine, using our facilities in Switzerland and Slovenia.
The nature of the agreements are ‘fill and finish’, the final step in vaccine production. This entails precisely filling the vaccination vials under strict aseptic conditions for shipment back to BioNTech for distribution. In the near future, it’s possible we could also collaborate with our competitors on other aspects of manufacturing, such as mRNA production, therapeutic protein production and raw materials production – all necessary steps in manufacturing a vaccine.
That initial agreement in 2021 with Pfizer-BioNTech was one of the first of its kind, and we knew we needed to build, not only on the success of that partnership, but also on the rationale of collaborative working to meet patient needs that lay behind it. Projections also showed that external demand for biotechnology, aseptic fill and finish, and cell & gene therapies will grow significantly in the coming years.
Later in 2021 we launched our own contract manufacturing organisation (CMO) within the Novartis Technical Operations business. The aim of the new unit is to provide both biotech and cell & gene products to other companies that need to scale up their operations, by leveraging our own manufacturing assets and teams.
By working with competitors through outsourcing manufacturing and teams, pharma businesses can get closer to that ultimate goal of reaching more patients in need worldwide.
The patient journey never starts and ends with pharma – it winds along a road dotted with all kinds of healthcare systems, businesses, insurers, charities and hospitals. Public health systems are one of the major players in this ecosystem, acting as the primary interface with many patients. The more that these disparate organisations can communicate and collaborate to prioritise the patient, the smoother that journey becomes.
This is particularly true when it comes to tackling treatable, but widespread, diseases. For example, the number one cause of human mortality is cardiovascular disease. The disease causes more than one in four deaths across the UK and costs the NHS an enormous amount of money, and there are an estimated 7.6 million people living with it in the UK alone. It’s the single biggest area where lives can be saved in the next decade, but clinicians still see many patients with insufficiently controlled cholesterol levels versus their risk.
In a first for the industry, last year we signed a population health agreement with the NHS to proactively identify, treat and monitor high-risk patients in the UK. Hopefully, we will see similar collaborative agreements between pharma companies and public health systems emerge around the world, taking pressure off these organisations and addressing some of the biggest health challenges of our time.
Particularly during a pandemic, the healthcare and pharma ecosystems have a common goal to develop new treatments as quickly as possible, while upholding the expected effectiveness, safety and quality. A lot of that boils down to collaborating to share knowledge on an ongoing basis – or to be more specific, sharing data. Pooling knowledge and data so that there is a clear, holistic picture of a particular situation means experts can reach the best treatments and solutions much more quickly.
For example, feedback from health authorities during the pandemic showed that the design of clinical trials was varying significantly from place to place around the world. This resulted in a much slower initiation and execution of cross-border clinical trials. To combat this, 29 key global health authorities within the International Coalition of Medical Regulatory Authorities collaborated on developing co-ordinated clinical trial design and committed to regular, rapid feedback.
A collaboration like this isn’t unique – many of the health authorities had previously relied on one another’s assessment or shared review workload in the past. But it is a model that should be encouraged and built upon to overcome other challenges to efficiency and patient access.
Pharma is having a moment in the spotlight, and now that discussions around our goals, processes and challenges have transcended the industry echo chamber, it’s a chance to prove that we can set a good example. It is thanks to collaborative initiatives in pharma that we are closer than ever to overcoming COVID-19.
By applying the same collaborative principles – leveraging each other’s resources, sharing knowledge, and forming partnerships with different players in the patient journey – we will create opportunities to come closer to beating many more of the most challenging diseases of our time.
Steffen Lang is Global Head of Novartis Technical Operations. Go to novartis.co.uk