By Petter Moree, Industry Principal, OSIsoft
Long timelines and high costs have always been challenges pharmaceutical companies had to face while navigating the path of bringing a new drug to market, which is estimated to take an average of at least 10 years and $2.5 billion.1 Now, as the industry transitions from blockbuster drugs to niche drugs for smaller patient populations, competition is fiercer than ever. Manufacturers are in a high-stakes race to market with every step – and any delay – impacting their place at the finish line. This is compounded by the fact that only 1 in 5,000 molecules created actually get commercialized.2
To stack the odds in their favor, manufacturers are investing heavily in R&D to identify and pursue any drug candidates that show promise during the early stages of development. Moving to the next phase with those that do requires enough material for the clinical trial phases, which is often limited. For any company without the internal resources or capacity to produce these materials, working with a contract manufacturer (CDMO or CMO) may be the fastest and most economical option to get ahead. One may even decide to continue this relationship into commercial manufacturing. But what risks do manufacturers face when they put the future of their company in the hands of the partner, specifically when it comes to maintaining the data integrity required for quality and regulatory compliance? And more importantly, how do they safeguard it?
How Do You Ensure Data Integrity When You Outsource?
Pharmaceutical companies lose, on average, $1 million a day in potential revenue for every day spent in the development or regulatory approval process.3 Therefore, it is imperative manufacturers find ways to reduce timelines, avoid major capital investments, and maintain regulatory compliance. The latter can prove especially difficult, as doing so is the responsibility of the manufacturer, regardless of whether they are producing their drug in-house or through a CDMO. And meeting these requirements is not just about checking a box; ensuring compliance means you can be confident the drugs you deliver to patients are safe and efficacious, which requires supporting data for every single batch of a drug substance and drug product. That data must also be fully accessible and traceable going back several years. If the CDMO does not have a quality risk management program and a data solution to provide that support, you risk losing that information, along with the ability to successfully bring your product to market.
Avoiding this scenario requires two important steps. The first is proper vetting of your CDMO before you commit to a partnership. Make sure they have the expertise, experience, and equipment you need to support your product long term (or at least through the phase you anticipate needing them). Once you find a CDMO you feel is a fit for your needs, you must ensure there is clear communication and especially transparency. These qualities are essential for the success of any relationship but especially for one where millions of dollars and patients’ well-being hang in the balance.
Transparency extends into the data solution you rely on, as it should be one that establishes visibility into the manufacturing process and puts the information into a format all stakeholders can understand and trust. A system that offers real-time data sharing connects different systems and records commonly isolated as “islands of data” into a single source of truth. You can then understand the role of each machine and how they all work together, creating an opportunity to prevent major problems before they occur and, when necessary, facilitate investigations.
Accountability And Control Through Real-Time Data
As a leading manufacturer of insulin pens, Eli Lilly works with a network of contract manufacturers to produce the pens.4 Made up of four to five parts, each pen is built using a series of molds and machines, all of which are owned by Eli Lilly. While contract manufacturing organizations (CMOs) have enabled the company to scale pen production, the remote nature of these facilities means lack of visibility and control. However, with the help of real-time sensor data and the cloud, Eli Lilly was able to stream real-time data from its contract manufacturing sites through the cloud to ensure equipment is running to specification and identify any production issues. With the influx of real-time data, Eli Lilly’s engineers can ensure that custom machinery is properly built and set benchmarks around machine performance before it is delivered to the CMO.
Once delivered, they can see production data in near real time, while it would previously take at least a week to view data. With a digital twin of the production floor, engineers can visualize machine downtime and drill down to understand the root cause. Not only does access to real-time data give Eli Lilly confidence in remote operations, but these insights also allow the contract manufacturer to demonstrate accountability for quality and compliance as well as better control the supply chain—all while reducing production lead time and inventories.
Overall, real-time operational insights mean both pharmaceutical companies and contract manufacturers can meet regulatory requirements while ensuring high production standards. Therefore, it becomes not just about delivering product but what you can learn from the data you collect and how you use that infrastructure to overcome the challenges of drug development and manufacture in order to contribute to the long-term future of your company.
- PhRMA. (2015). Biopharmaceutical Research and Development: The Process Behind New Medicines. Retrieved from http://phrma-docs.phrma.org/sites/default/files/pdf/rd_brochure_022307.pdf
- Williams, Sean. (2018). The Motley Fool. The Drug Development Process: 9 Steps From the Laboratory to Your Medicine Cabinet. Retrieved from https://www.fool.com/investing/general/2015/01/03/the-drug-development-process-9-steps-from-the-labo.aspx
- Deloitte. (2020). Analysis: Ten Years On Measuring The Return From Pharmaceutical Innovation 2019. Retrieved from https://www2.deloitte.com/us/en/pages/life-sciences-and-health-care/articles/measuring-return-from-pharmaceutical-innovation.html
- OSIsoft. (2017) Breaking Down Barriers in Medicine with the PI System. Retrieved from https://www.osisoft.com/pi-system/case-studies-and-testimonials/all-case-studies/EliLillyUC2017story/