Digitalization in the pharmaceutical industry: Pfizer
With the advent of digitalization, the pharmaceutical industry is using information sharing to improve its manufacturing and supply chain efficiency. Pfizer’s creation of the PCMM plant is one way manufacturing may change in addition to gathering provider-level, and perhaps even patient-level, information. But can providers and patients trust Pfizer and other members of the pharmaceutical industry with their data?
Digitalization is the use of information shared through systems integration, connected devices, and more to understand and predict consumer demand, connect siloed businesses, and improve supply chain efficiency. Digitalization can provide enormous benefit for small and large businesses within the pharmaceutical industry.[1] Pharmaceutical companies need to be acutely aware of changes in global healthcare and focused on how to best utilize digitalization.
For example, the use of digitalization can help create counterfeit-proof medications with serial numbers that are trackable across the supply chain, ensuring quality while meeting upcoming serialization requirements.[2] Pharmaceutical companies can also use digitalization to meet the expected increased demands from markets across the globe. Digitalization can help them meet regulations, find manufacturing efficiencies to address cost pressures, and use cloud-based information sharing to quickly connect with suppliers and distributors. In addition, automation, smart sensors, social media, and health apps can help measure drug compliance and predict demand across regions to support real-time manufacturing.[3]
Currently, Pfizer is using digitalization to improve manufacturing, find supply chain weaknesses and efficiencies, and expand their reach. They introduced continuous manufacturing to pharmaceuticals with the portable, continuous, modular and miniature plant (PCMM). Through digitalization and standardization of processes, manufacturing has been streamlined, from the addition of raw materials, to continuous quality testing, to shipping. This has reduced temporary storage needs, time to transfer materials, and downtime. By enabling manufacturing to take place in a smaller footprint, the company can also expand to regions that do not allow the sale of certain drugs due to lack of local manufacturing.[4]
Pfizer’s long-term plan is to improve their supply chain by automating more sites, tracking the movements of raw materials, work-in-progress, and finished goods, and introducing more PCMMs worldwide. They are focused on connecting control networks in their supply chain to ensure that packages are verified upon delivery, goods are high quality, and cross-contamination is avoided. They also intend to track demand in real-time using health apps and other forms of information sharing to improve both supply chain and manufacturing efficiency.[5]
While I believe that Pfizer’s PCMMs are a step towards reaching new markets, digitalization can also aid the research and development process. This flexible, agile manufacturing solution could be applied to R&D by facilitating rapid production of certain medications. They should apply this solution in both the short and medium term to help move drugs undergoing clinical testing along Pfizer’s pipeline. By manufacturing in locations near large-scale clinical trials, PCMMs could save Pfizer valuable time and money while ensuring high quality testing. This would be of particular benefit for drugs requiring specialized distribution or transport, such as those requiring clean-rooms and “active” drugs for cancer.[6]
With drug portfolios continuing to grow and many niche drugs coming to market, PCMMs and data sharing across the supply chain can be leveraged to manufacture drugs without over- or under-production. Pfizer should try to engage in data sharing with providers, pharmacies, healthcare systems, and even patients to best gauge customer demand in the short and long term. While the bulk of costs in pharmaceutical industry lies in R&D, manufacturing remains expensive and the opportunity to run a more efficient process using digitalization must be taken seriously. However, Pfizer must be wary of the cybersecurity risks posed by digitalizing manufacturing processes and sharing patient data.[7]
Is this cybersecurity risk worth the potential manufacturing and supply chain efficiencies? How will it affect trust between pharmaceutical companies and patients? Given the recent introduction of the “smart pill,” which tracks and shares when patients take their medication, should Pfizer look to predict demand using this sensitive data or should access be restricted to healthcare systems and providers?[8] Are there reasonable alternatives to this data?
(795 words)
[1] Barbara Jonischkeit, “Industry 4.0: Pfizer opens continuous manufacturing plant in Freiburg.” BIOPRO Baden-Wurttemberg GmbH, July 7, 2017, https://www.gesundheitsindustrie-bw.de/en/article/news/industry-40-pfizer-opens-continuous-manufacturing-Jplant-in-freiburg, accessed November 2017.
[2] Evren Ozkaya, “Pharma’s Digital Supply Chain Transformation.” Pharmaceutical Manufacturing, April 4, 2017, https://www.pharmamanufacturing.com/articles/2017/pharmas-digital-supply-chain-transformation, accessed November 2017.
[3] Andreas Gmür, “Digitalization: Blessing or curse for compliance? 8th Pharma Management Radar.” CAMELOT Management Consultants AG, May 2017, https://www.camelot-mc.com/us/wp-content/uploads/2017/05/Digitalization_Blessing-or-curse-for-compliance_8th-Pharma-Management-Radar.pdf, accessed November 2017.
[4] Barbara Jonischkeit, “Industry 4.0: Pfizer opens continuous manufacturing plant in Freiburg.” BIOPRO Baden-Wurttemberg GmbH, July 7, 2017, https://www.gesundheitsindustrie-bw.de/en/article/news/industry-40-pfizer-opens-continuous-manufacturing-Jplant-in-freiburg, accessed November 2017.
[5] Borja, “Industry 4.0 and Pharmaceutical sector: The Case of Pfizer.” Arrizabalagauriarte Consulting, May 13, 2016, https://arrizabalagauriarte.com/en/industria-4-0-sector-farmaceutico-caso-practico-pfizer, accessed November 2017.
[6] Pfizer Press Release, “Pfizer announces collaboration with GSK on next-generation design of portable, continuous, miniature and modular (PCMM) oral solid dose development and manufacturing units.” Pfizer, October 29, 2015, https://www.pfizer.com/news/press-release/press-release-detail/pfizer_announces_collaboration_with_gsk_on_next_generation_design_of_portable_continuous_miniature_and_modular_pcmm_oral_solid_dose_development_and_manufacturing_units, accessed November 2017.
[7] Marcus Ehrhardt, Peter Behner, “Digitization in pharma: Gaining an edge in operations.” Strategy& – PricewaterhouseCoopers, October 19, 2016, https://www.strategyand.pwc.com/ reports/digitization-in-pharma, accessed November 2017.
[8] FDA News Release, “FDA approves pill with sensor that digitally tracks if patients have ingested their medication.” FDA News & Events, November 13, 2017, https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584933.htm, accessed November 2017.
You’re right to point out the obvious cybersecurity risk that exists in this case, particularly given the sensitivity of information and the high cost of failure of pharmaceutical products. However, I would think the opportunity to digitalize the supply side of the equation outweighs the cybersecurity threat. Automating and streamlining raw material sourcing, inventory flow and production would bring drug costs down. As you mention, R&D remains the biggest cost in the system, but drugs are expensive in general, particularly in the U.S., and both consumers and manufacturers will still benefit from more efficiency and lower costs on the manufacturing side. To prevent issues and maintain trust with patients and providers, significant investment in cybersecurity defenses will likely be required. As will robust quality assurance testing. If these safeguards can be put in place, I agree that digitalizing the manufacture of these drugs should benefit the entire ecosystem.
I think the demand side is a little trickier. Consumer drug usage data is highly sensitive information. Typically, this information is only shared with health care providers and insurers. Consumers generally trust their healthcare providers and provide information to insurers out of financial necessity. Consumers have little to no relationship with drug companies like Pfizer. Asking consumers to share sensitive demand information – health condition, drug usage data, etc. – with Pfizer and its competitors on a mass scale seems difficult. It’s sensible for Pfizer to seek to gather this information and produce drugs that match demand. But they likely lack trust with consumers, and consumers likely don’t care about Pfizer’s manufacturing costs when insurers are paying for the drugs anyway. Perhaps there is a middle ground where Pfizer could obtain anonymized patient data from providers. Even if a path like this is pursued, additional information safeguards will need to be erected throughout the information chain.
Either way, this is exciting innovation in the pharma space. Thanks for highlighting this ongoing trend.
“But can providers and patients trust Pfizer and other members of the pharmaceutical industry with their data?”
Data privacy and cynicism/caution on sharing health data is a great topic, but while the question you pose is THE one on almost everyone’s minds, I’d like to pose a somewhat edited form of that question: Can society afford NOT to give over their data? Personalized medicine is the goal of many people nowadays, including being highlighted by former President Barack Obama in his SOTU address. It’s a buzzword used by people throughout society and mentioned in an almost reverent and inevitable tone – the idea that a drug can be developed and prescribed based on your unique characteristics and disease profile. But let’s take a minute and go one step further than the mantras – what, exactly, is personalized medicine and how do we get there.
The first step is to understand the patient – that’s the “personal” part of personalized medicine. So how do you understand the patient? This is not how human beings understand other human beings. It’s not about the person’s name, background, or emotions. Neither the disease nor the drug cares about the occupation of the patient, the number of siblings, nor his/her aspirations. You have to understand the biology of the patient and the body’s interaction with the disease. This requires data; it requires personalized data. That data can then be used at the basic science level and the drug development level, both to understand the fundamentals of the disease as well as to understand how best to intervene in the pathophysiology of that disease in the context of the specific patient burdened with that disease. This is impossible to do without that data.
There’s been quite a bit of backlash on biopharma R&D productivity lately. Basically, it has been more and more expensive (both in terms of time and $$$) to develop a drug, and a lot of these drugs have marginal incremental benefits. The consensus blame is that the low-hanging fruit has all been picked, and so the remaining diseases are just that difficult to tackle. But this doesn’t have to be that way. The difficulty of a problem is relative, and here specifically, it’s relative, in part, to our understanding of the disease-human interactions. But this obstacle can be overcome with the data from patients, resulting in drugs that are safer and more effective, have a higher response rate once given to a patient, and takes less time and money to reach the market. I believe that all of these are worthwhile results to pursue, and the first step of attaining that process is to start the widespread sharing of data.
And so I will pose once more – can patients and physicians afford not to share data?
PCMMs, if implemented effectively, have the potential to completely transform the drug distribution model as it exists today. My first inclination was that the regulatory headache and risk for Pfizer would be too immense to operate a distributed manufacturing model, given varying standards across geographies and the internal controls necessary to monitor a large number of facilities. However, in many regards a manufacturing model such as this could in fact de-risk the process. Not only does Pfizer realize the benefits of producing goods close to the demand centers, but to the extent that regulatory issues do arise, they can be nimble in switching manufacturing sites. I do wonder, though, at the changes they will need to make to their contracts with both the large distributors as well as end customers such as hospitals.
Additionally, I found the PCMM model interesting in regards to clinical trials as you state in your essay. Acurian, with the increasing prevalence of rare disease treatments and trials, is important in seeking out clinical trial participants and bringing the trial sites to the people. Pfizer, in the same way, is bringing the drugs to the people, rather than attempting to bring the people to the drug.
The opportunities that digitalization of the pharmaceutical supply chain provides are theoretically clear. However, I take issue with the notion that patients will be comfortable giving pharmaceutical companies their data; this will be an onerous task, and will need to be tackled sensitively and differently by geography and customer segment. For example, in the UK, the National Health Service (NHS) stores a vast amount of patient data. The majority of patients are comfortable with this as the NHS provides free care at the point of service. Nevertheless, earlier this year the NHS’s information technology systems suffered a system-wide cyber-security attack [1], hugely undermining patient confidence in the robustness of these integrated information technology systems. In environments such as the US where individuals pay directly for their healthcare, and therefore the costs of such a data breach are much higher, pharmaceutical companies will undoubtedly have a tough time convincing patients that the benefits of sharing their data outweigh the risks. A potential solution is for pharmaceutical companies to gather patient data indirectly – piecing together implied patient healthcare information from other public sources such as spending patterns and geolocation data.
[1] NHS seeks to recover from global cyber-attack as security concerns resurface: https://www.theguardian.com/society/2017/may/12/hospitals-across-england-hit-by-large-scale-cyber-attack