Accenture’s Barry Heavey believes one positive from the pandemic is how biopharma companies have uncovered opportunities to improve how life-saving treatments are developed – and there’s no going back.
With the whole world looking forward to the way out of the pandemic, it’s safe to say that there has never been a time when so many people have been interested in biopharma development and manufacturing.
Creating vaccines for Covid-19 in less than a year was a spectacular achievement for science, but even more so for an industry that was mostly using longstanding processes and regulations.
Up until very recently, it took an average of 10 years to develop a new treatment or vaccine, but incredible developments in our understanding of and approaches to disease have compressed this timeline.
New science, the combination of advanced science and tech, is expected to drive 81pc biopharma revenue growth globally. New science is much more targeted, personalised, effective and can bring new treatments to market faster than ever. But it is also more expensive to develop and serves smaller patient populations because it is so targeted.
The complexity of these new products means that regulations and processes for verifying the quality of biopharma manufacturing are rightly rigorous but are extremely complex. This shift drives a new economic environment that is demanding change for biopharma, especially as new science grows in prominence.
In the manufacturing space in particular, biopharma companies are now under enormous pressure to develop their manufacturing processes for these new and often very complex treatments.
The complex manufacturing processes that produced AstraZeneca and Johnson & Johnson vaccines share some of the complex biology needed for the production of many cancer drugs. The mRNA manufacturing used by Moderna and Pfizer-BioNTech has applications in treating a variety of diseases.
Enabling rapid scale-up of production may be a positive and long-lasting outcome of Covid-19. The pandemic demonstrated just what is possible when there is collaboration, public-private partnerships and a common interest in progressing with pace and due care.
Much has already been written on how digital tool adoption has accelerated during the pandemic in enabling enhanced collaboration in an era of working from home. The adoption of digital in biopharma manufacturing may prove to be an even more profound change with life-saving impact as it will enable more effective and faster collaboration internally and better interaction between companies and regulators.
It’s time to rebalance the treatment-cost equation from old ways of operating to new ways of discovering, developing and supplying treatments.
The process is the product
In other R&D-intensive industries like aerospace and automotive, product design and production processes are based on well-understood principles of physics and engineering and can be modelled and optimised using computer-aided design. Changes or enhancements to the assembly process of the product can be done quite easily.
In contrast, biopharma companies work with complex chemical formulas and reactions that operate inside large reactors. A change in the process can cause an unforeseen change in the product – the process in this case literally is the product.
‘The pandemic may prove to be a tipping point for the biopharma industry in Ireland’
In developing and optimising these manufacturing processes, companies need to confirm scientifically that there are no unforeseen consequences on the quality of the product produced.
Any significant changes to a manufacturing process (such as transfer of production to a new site) must be reviewed by regulators in the various markets to ensure they are satisfied that the product remains safe and efficacious. Demonstrating this ability to achieve consistency can be more challenging when manufacturing a very complex biological drug or vaccines using a novel manufacturing process.
To continue the acceleration in bringing new treatments and vaccines to market in a compressed timeframe, the sector will have to undergo a type of digital transformation bridging R&D and manufacturing that it has been slow to adopt.
Better data management
When regulators seek information on biopharma companies’ manufacturing and quality processes, having fast access to relevant data from various internal teams becomes paramount. If the right digital tools are used early in the development process it will be much easier to retrieve old data and harness knowledge from previous work to address regulator queries.
The lesson we’ve learned from other industries is that data must be liberated from silos to deliver the most value. Barriers between R&D and manufacturing are particularly troublesome for pharma companies due to a heavy reliance on paper-based documentation and siloed systems.
A variety of software tools used by the various teams in biopharma companies to manage data in R&D and manufacturing are often poorly integrated between the silos in the companies. Utilising these systems in a more coordinated way by bringing R&D, manufacturing and quality closer together in shared processes, workflows, data and insights is a natural next step.
Ireland’s place in the global innovation continuum
What does this mean for the Irish biopharma sector? The announcement by Pfizer earlier this year that it is establishing production of the mRNA vaccine drug substance in its Grange Castle facility in Dublin is a great example of how Irish sites have shown the agility and innovation to take on responsibility for new products.
As the rate of new treatment and vaccine development continues to accelerate, it will be vital that Irish manufacturing sites collaborate ever more closely with their colleagues globally who are involved in developing the new therapies and associated manufacturing processes, to ensure they can keep pace with the latest developments in science and expectations from global regulatory authorities.
The pandemic may prove to be a tipping point for the biopharma industry in Ireland. It has learned some important lessons about using digital technology to bridge departmental silos, creating more agile organisations that can respond more quickly to scientific developments, regulatory concerns and market demand.
In short, the industry has unlocked faster time-to-market processes for life-saving products, and further digitalisation of the industry can help ensure this momentum can be maintained when the crisis abates.