26-27 - Biopharma transformed

As vaccine programmes roll out worldwide and the beginning of the end of the pandemic is hopefully in sight, now is a good time to consider how the events of the past 18 months are going to change biopharma in future.

The collaboration and innovation that has taken place in our industry in response to this global threat has been nothing short of remarkable. We have seen everyone from biopharma and biotechs, to global supply chains, to governments the world over working together to fight this pandemic – the result of which has been the creation, development and mass production of a raft of groundbreaking new vaccines in record time. And while this has been fuelled by significant amounts of government funding (in some cases) that would not be available in ‘normal’ times, it has proven that altering the dynamic of the business model can enable the biopharma industry to innovate and deliver at a speed and scale that no one ever thought possible.

As I reflect on this terrible yet remarkable period and my previous decades working in the biopharma industry, I believe there are five key lessons we must learn from the pandemic – lessons which will fundamentally transform the biopharma industry and bring about huge benefits for biopharma companies, their partners and, most importantly, the populations they serve.

The speed of the industry response – discovering, developing, manufacturing and distributing new vaccines and therapies at scale for this novel coronavirus – has challenged our assumptions of biopharma development and manufacturing timescales. For patients, the medical community and for shareholders, it is now simply no longer acceptable to wait 10-12 years for a new drug when people are suffering and dying. Something has to change in the biopharma industry to bring safe, effective drugs to market faster than the typical time-frame.

However, the achievements with COVID-19 vaccines were often delivered at the cost of diverting research and resources from drug development in some other therapy areas. To retain the accelerated timescales, the industry will need to define a new equilibrium between simultaneous development programmes and speed-to-market.

The COVID-19 crisis has been so acute that it has driven the biopharma industry – and, indeed, the world – to reconsider what had previously been thought to be the immovable rules of the game in biopharmaceutical development and manufacturing.

The ‘desequencing’ of clinical trials and manufacturing was one of the best examples of this during the pandemic. Danaher operating company Pall was charged with developing the large-scale manufacturing process for the Oxford/AstraZeneca vaccine – achieved, remarkably, in just eight weeks – which was then transferred to CDMOs (contract development and manufacturing organisation) to begin production of the vaccine before clinical trials were complete. It was of course the extraordinary support made available in the circumstances that made this possible, but it showed how partnerships between academia, biopharma and science and technology companies could yield significant benefits when the traditional rules of engagement did not apply.

Parallelisation of workflows is now occurring throughout all stages of drug development. Coupled with strategic outsourcing and partnerships, the efficiencies and economic of scale this can provide to biopharma will be vital to success in future.

Just as parallelisation of workflows is now occurring throughout all stages of drug development and bringing new efficiencies and economies of scale, a more strategic use of partnerships and outsourcing is transforming the way biopharma companies do business.

Tackling the COVID-19 vaccine challenge not only significantly increased biopharma companies’ reliance on their networks of partners across science and technology providers, CDMOs, academia and government, it highlighted just how important the synchronisation of these partners is. Indeed, what we have found at Danaher is that biopharma customers want our operating companies not just to be science and technology providers, but to act as a global coordinator or ‘matchmaker’ – helping them to coordinate this network of partners, standardise approaches and, most importantly, ensure the same exact product can be made to the same standard, anywhere in the world.

This, coupled with the adoption of single-use technologies, has also enabled biopharma companies to shift risk to the supplier and force all these partners to share information, speed up delivery, and work more closely together with unprecedented levels of transparency.

The pandemic and the need to manufacture billions of doses of vaccines has led to an unprecedented demand for everything from raw materials for the vaccines themselves to consumables used in the manufacturing process. As a result, ensuring resilience in the supply chain has quickly become the biggest challenge facing the industry.

The simple truth is, when you are faced with a challenge like this, it isn’t a quick fix to increase capacity many times over. It’s not a case of flicking a few switches and suddenly you can manufacture hundreds of millions of doses of a product overnight – you need to build this capacity and that takes time.

New investments will be vital to ensuring that biopharma companies have partners who can demonstrate consistency and ensure an unbroken, predictable supply chain, not just as we battle this pandemic but as we look to future global health challenges too

The COVID-19 crisis has accelerated the development, regulatory approval and relatively widespread public acceptance of genomic medicines. Many of the technologies that have come to prominence during the pandemic were there already and were relatively advanced – the pandemic has simply accelerated their scale up and adoption.

This third major drug modality – after small molecules and biologics – will undoubtedly see a huge acceleration beyond the pandemic. The precedent that has been set will catalyse the investment in and development, approval and application of other genetic medicines, including gene- and cell-based therapies, and help propel them into mainstream medicine.

Although understanding pathobiology will always continue to be a key component of drug discovery and development, now we clearly see in focus, that to deliver at scale advanced therapeutics, like genomic medicines, legacy expertise and the operational status quo could easily become a crutch. Biopharma needs to tear up the rule book and write a new one – and it cannot do this alone. Science and technology companies are relied on and will be even more so by biopharma to help them become more innovative, more efficient, more productive and more agile, and to ultimately be able to make high-quality biologic drugs more accessible to a broader population.

The COVID-19 pandemic is not the last major global health crisis we will face. Cancer remains the leading cause of death worldwide – even during the pandemic. Chronic disease is also rife, along with many other diseases that individuals worldwide experience every day. Because of the interconnectivity of the world in the 21st century, the likelihood of further infection pandemics and other worldwide threats to human health is extremely high. Antimicrobial resistance, for instance, is one that many are increasingly concerned about and could be the next big public health issue that we must tackle as an industry.

The pandemic has been terrible, but some important lessons have come into focus as we come out of this global tragedy. The way in which we’ve come together as an industry to develop groundbreaking new vaccines has demonstrated just how effective the biopharma industry can be when united behind a common cause and working cohesively with others, from science and technology companies to regulators to academia. It is hoped that these unprecedented achievements and collaborative ways of working will serve not only as a template for combating future pandemic threats, but also as a springboard for real transformation in the industry going forward. If we learn the lessons from this terrible pandemic, we will be in a position of real strength to boost drug discovery and development and tackle other looming health issues before they take hold. Medicines and vaccines have changed and saved the world many times over, now we have the basic road map to do it better and faster. This is a call to action to all of us.