September 2022 • PharmaTimes Magazine • 10-11
// COVER STORY //
Medicine access is at the summit of the global agenda and its future is inseparable from digitalisation
Over the past few decades, technology advancements have radically improved global access to health practitioners and diagnoses.
Even in rural areas and lower-income countries, patients are frequently now able to communicate with medical professionals via telemedicine – a resource that was previously unheard of. This has made healthcare more accessible, but without a way to ‘download’ actual medicine, availability challenges remain. According to the World Health Organization, two billion people across the globe still don’t have access to basic medicine.
The big pharmaceuticals companies, however, increasingly understand the need to address this issue urgently. The recent decision by US pharma giant, Pfizer – to offer all its patented drugs on a not-for-profit basis to 45 lower-income countries – points to a new trend for the sector’s leading players. A trend that will ultimately make their products more affordable and accessible to the world’s poorest people.
We have already seen AstraZeneca and Johnson & Johnson choosing to price their coronavirus vaccines at cost during the pandemic. The Access to Medicine Foundation’s 2021 Access to Medicine Index, shows progress is being made more broadly, with other pharmaceuticals giants like GSK and Novartis already having innovative approaches in place to improve access.
Yet, there is more to be done, and pharmaceutical companies have a responsibility to take action. According to the Index, ‘Pharmaceutical companies have a unique role to play here, as they have the capacity to develop urgently needed health products and to improve products’ availability across socioeconomic divides.’
For the kinds of approaches outlined above to be sustainable, they must be backed up by a focus on digitalisation aimed at driving long-term efficiencies. There is a major challenge to address here.
The good news is that global pharma companies are now rising to the challenge and starting to embrace digital transformation, with the FDA’s Advanced Manufacturing initiative and the International Society of Pharmaceutical Engineers’ (ISPE) Pharma 4.0 framework to improve efficiencies and drive faster drug manufacture.
The links between digitalisation and delivering pharmaceuticals to market more quickly and providing better access to those drugs are becoming ever clearer. According to a 2021 research study, Culture Reimagined: How Pharmaceutical Firms Can Use Data and AI with Confidence, companies that have a more advanced digital culture which uses data effectively across all aspects of drug manufacturing.
Indeed, 80% of these digital culture leaders say their vaccine manufacturing capacity will be significantly impacted by digital technologies in the future.
There is certainly no straightforward ‘one-size-fits-all’ solution in terms of how companies can better contribute to global medicine access. But for those prioritising access-to-medicine strategies as a top business priority or initiative for the UN’s Sustainable Development goals, digitalisation is clearly a viable path on which to turn.
Digitalisation is enabling pharma to experience efficiencies that were simply not possible just a decade ago. Today, digital technologies are having a ripple effect on everything from product quality to on-time delivery. Digital transformation is optimising outcomes across the entire pharma value chain and evolving traditional supply chains to be more resilient.
‘The recent decision by US pharma giant, Pfizer – to offer all its patented drugs on a not-for-profit basis to 45 lower-income countries – points to a new trend’
Take electronic batch records as just one example of this evolution. Electronic batch records, together with automated product release, contain the logic and rules that enforce manufacturing workflows, improve data integrity, minimise opportunities for error and limit held inventory waiting to be released.
In another example, predictive and prescriptive maintenance provide pharma companies with sufficient prior warning that a piece of equipment is degrading. They can then take action before a costly breakdown occurs or avoid taking equipment offline for scheduled maintenance that may not be required.
The more efficiencies gained, the quicker and more cost-effectively a drug can be commercialised. When production is leaner, there are fewer faulty batches, reduced product costs and faster time to market.
According to consultancy McKinsey, pharmaceutical companies demonstrate an estimated 70% improvement in overall equipment effectiveness with the use of artificial intelligence. Naturally, this can have a trickle-down effect on pharma’s ability to make medicine more available and less expensive, without sacrificing margins.
Despite these positive indicators, the access challenge remains a difficult hurdle to overcome. One of the issues is that considerations for how novel and mass-market drugs will be made available in underserved areas are not always factored into the up-front design of the medicine and this often limits distribution.
Once a drug is approved, it is cumbersome and expensive to re-configure manufacturing processes and subsequent revalidation. This means specific distribution needs that may be required for vaccines in remote areas, for example, are not easily accommodated.
We witnessed this with the COVID-19 vaccine, which required cold chain storage that proved challenging in rural, tropical climates and has made global COVID-19 vaccine distribution challenging.
Consequently, digital workflows powered by data are bringing drug design considerations to the fore. Digitalisation has been transformative in the visibility and insights pharma manufacturers have gained across the value chain. With more data, which can be optimised with industrial AI and advanced analytics, pharma manufacturers can learn from existing processes and improve drug design.
For instance, modern process analytical technology (PAT) is a powerful enabler of quality by design principles and process analytics. It allows manufacturers to monitor critical quality and performance attributes to ensure final product quality in a compliant environment. Modern PAT ensures stringent process design, monitoring and control, rather than resorting to identifying poor quality by inspection after the fact.
Digital technologies like PAT that improve drug design and mitigate issues before they arise, can help de-risk distribution variables that add complexity to global medicine access. Critical decisions on how to get new drugs – as well as common drugs for chronic conditions like diabetes – into the hands of underserved communities can be thoughtfully considered with more visibility and foresight into the entire drug design and manufacture process.
Decisions such as where a drug or vaccine will be manufactured, the cost, how it will be shipped, requirements to administer and local clinic accessibility, no longer need to be made retrospectively.
Any pharmaceutical company looking to improve its access strategies, should consider starting early in the pipeline with small batches of new drugs. The incurred business risk is smaller when access is considered at the onset of small batch drug design and distribution, and efficiencies are already embedded into the manufacturing process with the help of digital solutions.
Then, with a successful initiative under its belt, the organisation has a proven framework to scale going forward as it hones its access strategy.
As the world’s population continues to grow, so will the demand for medicine and the pressure on the pharma industry to meet the challenge of a more sustainable world. Operational efficiency and visibility brought about by digital transformation can help strengthen the role of manufacturers but – most importantly – unites pharma in boosting the availability of medicine to the global community irrespective of location.
Raman Bhatnagar is Vice President and General Manager Pharma at AspenTech. Go to aspentech.com/en