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Technological advances over the past few decades have been critical to improving global access to health practitioners and diagnostics. Even in rural areas and low-income countries, patients are often able to communicate with medical professionals through telemedicine, a previously unheard of resource. This makes health care more accessible, but usability challenges remain due to the inability to “download” the actual drug. According to the World Bank and the World Health Organization, half of the world Lack of access to essential health services.
Global pharmaceutical companies are meeting this challenge and are beginning to incorporate access to medicines into their business practices.For example, Pfizer just Announce It will sell its patented medicines at nonprofit prices in low-income countries.Moreover, according to the acquisition of the Medical Foundation Access to Drug Index 2021, progress is being made – other leaders such as GSK and Novartis have developed proven approaches to improve access – but more work needs to be done and it is up to pharma companies to act . According to the index, “pharmaceutical companies have a unique role to play here because of their ability to develop much-needed health products and increase product availability across socioeconomic divides.”
At the same time, pharmaceutical companies are embracing digital transformation, the FDA’s Advanced Manufacturing Initiative, and the International Society of Pharmaceutical Engineers (ISPE)’s Pharma 4.0 framework to increase efficiency and speed drug manufacturing. In fact, according to 2021 Research study, Reimagining Culture: How Pharma Can Confidently Use Data and AI, companies with more advanced digital cultures use data effectively in all aspects of pharmaceutical manufacturing. Eighty percent of such “digital cultural leaders” in the study said their vaccine manufacturing capabilities will be significantly impacted by future digital technologies.
There is, of course, no easy or “one-size-fits-all” solution to how pharmaceutical companies can better contribute to global access to medicines.But for those who have access to a drug strategy as a top business priority or plan United Nations Sustainable Development Goals, digitization is a feasible way to turn. Digitization is already increasing the efficiency and visibility of drug and vaccine production, and it can also help pharmaceutical companies improve their access strategies in remote parts of the world or in low- and middle-income countries.
Improve manufacturing efficiency
Digitization enables pharmaceutical companies to experience efficiencies that were simply not possible 10 years ago. Digital technologies are having a knock-on effect on everything from product quality and yield to on-time delivery. Digital transformation is optimizing outcomes across the pharmaceutical value chain and making traditional supply chains more resilient. The example of electronic batch records is just one example of digital transformation. Electronic batch records, combined with automated product releases, contain logic and rules to enforce manufacturing workflows, improve data integrity, minimize opportunities for errors, and limit held inventory pending release. In another example, predictive and prescriptive maintenance provides pharmaceutical companies with enough warning that equipment is deteriorating. They can act before costly failures occur, or avoid taking equipment offline for scheduled maintenance that may not be needed.
The higher the efficiency achieved, the faster and more cost-effective the drug can be commercialized. When production is leaner, there are fewer failed batches, faster time to market and lower overall production costs. According to McKinsey, the pharmaceutical company has shown a 70 percent increase in overall equipment efficiency through the use of artificial intelligence. Naturally, this has a trickle-down effect on pharma’s ability to make medicines more accessible and cheaper without sacrificing profits.
Optimize drug design
How new and mass-market medicines will be made available in underserved areas is not always considered in the up-front design of medicines, which often limits distribution. Once a drug is approved, reconfiguring the manufacturing process and subsequent revalidation is cumbersome and costly. This means, for example, that the specific distribution needs of vaccines in remote areas may not be easily met. We’re seeing this with Covid-19 vaccines that require cold chain storage. Cold chain storage is difficult in rural, tropical climates, creating challenges for Covid-19 vaccine distribution worldwide.
Data-driven digital workflows bring drug design considerations to the fore. Digitization has transformed the visibility and insight that drugmakers gain across the value chain. With more data that can be optimized through industrial AI and advanced analytics, drugmakers can learn from existing processes and improve drug design.
For example, modern Process Analysis Technology (PAT) is a powerful enabler of quality through design principles and process analysis. It allows manufacturers to monitor key quality and performance attributes to ensure final product quality in a compliant environment. Modern PAT ensures strict process design, monitoring and control, rather than identifying poor quality through post-mortem inspections.
Digital technologies such as PAT can improve drug design and mitigate problems before they arise, helping to accommodate and reduce distributional variables that add to the complexity of drug access globally. Thoughtful consideration of how new medicines, as well as commonly used medicines to treat chronic conditions such as diabetes, can be put into the hands of underserved communities can increase visibility and foresight into the entire drug design and manufacturing process. Decisions such as where a drug or vaccine is produced, cost, mode of transport, regulatory requirements and local clinic accessibility no longer need to be retrospective.
Unify efficiency and visibility in the pharmaceutical manufacturing process
For pharmaceutical companies struggling to improve their access strategies, they may consider starting with small batches of new drugs. When access is considered at the beginning of low-volume drug design and distribution, the resulting business risks are less and efficiencies are already embedded into the manufacturing process with the help of digital solutions. Then, with the successful move, the organization has a proven framework to scale as it builds and improves its access strategy.
As the population grows, so will the demand for medicines and the pressure on the pharmaceutical industry to meet the challenges of a more sustainable world. The operational efficiency and visibility brought about by digital transformation can help improve the way drugmakers play a key role in improving equitable access and supply of medicines globally.
Photo: MF3d, Getty Images
