When discussing the path that the industry has taken since the COVID-19 pandemic landed on the planet, industry experts frequently mention the opportunities along with the disruptions—and Joe DiMartino is no exception to that. The product manager with ACD/Labs recently spoke with Outsourcing-Pharma about the highs and lows over the past year and some of the ways in which drug development leaders adjusted to the challenges.
OSP: Could you please tell us what you feel were the biggest challenges faced by drug development and clinical research professionals?
JDM: Among the greatest challenges facing drug development organizations involve global, distributed supply chains. Certainly, the urgent need to distribute COVID-19 mRNA vaccines [Comirnaty] to billions around the world was the largest need in 2021 – and potentially for years to come. But these challenges persist for the entire therapeutic product portfolio.
Inefficient and inadequate scientific data management systems are an important contributor to this challenge. Supply chain quality data transparency – enabled via secure, facile data transfer between partner organizations is essential to building supply chain quality resilience.
OSP: What do you feel were some of the bright spots in 2021?
JDM: While the COVID-19 pandemic continued to impact both personal and work lives, many organizations have realized that lab activity did not have to be restricted to specific physical spaces. For organizations with digital transformation projects well underway, switching to remote work was made relatively easier. For others, it meant a concerted acceleration of these efforts. As a result, 2021 ushered in a refinement of tools and workflows to enable remote collaboration.
Digitalization and access to analytical and chemical data to retain context and veracity has always been central to ACD/Labs’ technologies. Over the last 12 months, we’ve continued to help our customers digitalize and manage complex, heterogeneous data.
We’ve also improved and expanded our technologies for remote and browser-based data access. This allows instrument data to be detached from the physical lab space and electronically marshaled from instruments to remote computers.
OSP: You mention that we’re seeing an uptick in the amount of collaboration among stakeholders. Could you please tell us your thoughts on that, and why (or why not) that’s a positive thing?
JDM: Collaboration between stakeholders is always a positive thing, and it’s essential to manage the life cycle of a drug product effectively. The data collected for the drug substance and drug product is cumulative – from early process development, through manufacturing over the patent lifetime. Access to, and sharing of, this data throughout ensures efficient commercialization, timely risk mitigation, and product quality.
The lack of tools for cross-supply chain, effective data management has made such a reality especially challenging, with scientists resorting to a variety of applications and systems to try to bridge specific gaps. Our customers report more effective collaboration and increased efficiency in preparing regulatory submissions using products such as Luminata. Successful deployment and positive results are leading to companies expanding the footprint of digitalization and knowledge management technologies in their organizations.
OSP: Specifically, data is being shared—please share your thoughts on collaboration on data management projects, open data sets, etc.
JDM: Historically, sharing data has always been difficult in drug development with different groups using different software packages. For example, process chemists store reaction information in an electronic lab notebook (ELN) or a lab reactor application (e.g., EasyMax), while the analytical chemists store and view analytical data from a chromatography data system (CDS), and the specification for each stage/step is found in the laboratory information management system (LIMS).
When a project nears completion, all the stakeholders look to consolidate all this chemical, structural, and analytical information into a central location accessible to everyone, typically Excel spreadsheets. There is a lot of stress associated with the administration of these spreadsheets—just imagine the anxiety of propagating errors through a project. Working with multiple contract manufacturing organizations (CMOs) furthers the data-sharing nightmare by adding more Excel documents and PDFs of disconnected data coming into the sponsor lab.
Excel was not designed to handle the analytical “proof” data collected by instruments, so sponsor organizations must spend time verifying the results of experiments. Without systems designed to handle chemical and analytical data, it becomes a significant problem to interpret the data, track it against batches/lots, and maintain its integrity.
OSP: Then, please share your thoughts on what might be the biggest problems and areas rife for optimism in 2022.
JDM: Continuing the digital evolution of workflows and expanding browser-based applications will remain important in 2022. One area of opportunity to note is the digitalization of data management in drug development and manufacturing to limit the risk of drug quality concerns. Too many scientists still rely on antiquated methods, such as managing and interpreting analytical and chemical data in Excel spreadsheets, which significantly reduces the integrity of data analysis.
While it is impossible to eliminate the risk of drug quality issues completely, it is possible to reduce the chance of negative outcomes with the proper procedures and tools. Digitalized data management solutions can help detect issues earlier and allow companies to respond to problems quickly and effectively. Modernizing data management and sharing is a significant project and undertaking, but it is essential for building an efficient and secure pharmaceutical supply chain.