The Data Relationship

SunwArt - Stock.adobe.com

As the world becomes increasingly data-driven and the need for standardization and transparency between the various sectors of the bio/pharma industry heightens, Europe’s implementation of the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) continues to progress apace under the European Medicines Agency’s (EMA’s) substance, product, organization, and referential (SPOR) programme (1). To learn more about the ISO IDMP and the way that data and documents will need to be addressed in the future for bio/pharma companies, Pharmaceutical Technology Europe spoke with James Kelleher, CEO of Generis; and Frits Stulp, managing director, and Remco Munnik, associate director, both of Iperion Life Sciences, a Deloitte company.

Key details

PTE: Could you provide some key details about the ISO IDMP standards and how these will impact bio/pharma companies within Europe (as well as those seeking to do business in the region)?

Kelleher (Generis): The ISO IDMP standards were designed to allow structured data exchange on medicinal products. These standards will ensure consistency of data collected, enabling comparisons, traceability, and that updates to constituent parts are harmonized (for example, update on manufacturer or substance information).

As with any such standard, there is effort required by all companies, small and large, in meeting it. EMA has published an EU IDMP Implementation Guide (EU IG) (2), with several updates, to guide along this process, but while it might seem an easy task, and a goal that will provide a considerable benefit to companies, agencies, and, therefore, ultimately to patients, getting ready for IDMP is not straightforward.

Stulp (Iperion): It is expected that IDMP data standards will be implemented as part of the SPOR programme, which will be used directly by the Digital Application Dataset Integration (DADI) project. Existing electronic application forms (eAFs) will be replaced by this project. This will trigger a huge step forward in the submission of structured data within the regulatory processes.

This change requires companies to control their regulatory data in accordance with the ISO IDMP standards and controlled vocabularies.

Potential hurdles

PTE: What, in your opinion, could be significant bottlenecks for bio/pharma companies in the future in terms of data and documents?

Munnik (Iperion): ISO IDMP requires data from different departments. For this reason, data governance—clear rules on rights and accountabilities for the data—must be considered and provided for. Due to the tie-in of the submission of structured regulatory data and the regulatory process, companies need to have processes and systems in place to access structured data from the get-go. Authors contributing to the supporting documents for product registration will need direct access to the latest and agreed terms to ensure consistent use. Although this may sound challenging, this requirement provides an opportunity to control the regulatory data end-to-end—from development and across the regulatory process and pharmacovigilance—and achieve benefits (e.g., cross-divisional reporting), harnessing that data as the definitive source for authoring.

Kelleher (Generis): Much of the data required is, of course, already present within company databases—but frequently in multiple databases, which have different data owners and stewards, and are not linked or synchronised. Additionally, data [are] quite often in the wrong format—one key example being items such as dosage strength, where some companies might have a dosage strength as a single value (‘10 mg/100 mL’) and others might have four data items (‘10’, ‘milligrams’, ‘100’, ‘millilitres’). These data items might even be free text in some systems internally, leading to a need for a substantial exercise in data cleaning/consolidation.

As companies look to do business in Europe and meet these standards, they will also find two basic types of vendors on the market: those who provide a dedicated IDMP database (yet another database of separate information), meaning users have to enter data that is potentially duplicated in other systems, and potentially in different formats and not linked to the regulatory documents and applications/registrations; and those who provide regulatory systems where the data [are] captured and applied, in the right format, to documents and submissions as part of the regulatory operations processes, and can then be compiled/extracted to provide the required IDMP submissions, without duplication.

Increased digitalization

PTE: Do you believe there will be an increased demand for digital provisions post-pandemic, and if so, how might this impact the volume of data to be processed by companies?

Kelleher (Generis): The use of digital/virtual solutions will absolutely increase—having been forced to accelerate the implementation of such capabilities during the pandemic, companies are really seeing the benefits in both the speed with which they can perform business processes (and therefore being able to do more in the same time) as well as the consistency of data that it brings, improving compliance, reducing rework and errors.

One emerging trend is the desire to increase automations—having a system that acts as a ‘dump’ of data or documents is no longer sufficient, and companies are looking at systems that have capabilities to automate repetitive processes into a single button click. One great example is around the audits and inspections: previously, setting up an audit, requesting particular documents ahead of time, choosing dates, receiving pre-audit documents, and so on, was all done back and forth by emails. Now, a single audit object can be created which automates the process of notifications, uploads of documents, setting of meetings, and also generating a final audit report.

Stulp (Iperion): Digitalization is the future—to optimize existing processes and data flows. With increased demands as well as expectations around healthcare, the competent authorities will need to be able to do more with the same resources. It’s essential, then, to be able to leverage the potential of digital data/processes. This can only be achieved by adopting standards. The use of standardized and structured data will not only ensure data quality and consistency; it will also help accelerate regulatory processing and assessment by the health authorities. The sky is the limit, and the time is right to shape the future. What’s more, society will expect no less.

Available tools

PTE: What tools are currently available for companies to deal with this potential increased volume of data?

Munnik (Iperion): Most companies are still struggling with the legacy of data captured and held in documents. For large parts of the portfolio, consistency between the regulatory information and the data stored in documents needs to be checked, extracted, and aligned with ISO IDMP/SPOR data.

Tools exist that can alleviate the burden of the data extraction, and which make use of artificial intelligence (AI). However, experts in the interpretation of the regulatory data have an important role to play too, to assess the data extraction and data transformation requirements.

Biotech companies (with a smaller portfolio) have a potential advantage in being able to leverage processes and systems that work with structured data in a shorter timeframe.

Kelleher (Generis): There is a move towards ‘platforms’ which leverage technology such as Elasticsearch for very rapid searching in massive volumes of data. The concept of data lakes is being married to document/data repositories—for example, our platform can contain all enterprise data, documents, and business processes in a single ‘Information Lake’ to allow the enter-one-and-reuse that ensures data consistency for purposes such as IDMP and digital automations. There are two key aspects to this: to have a platform that does actually consist of a single data source—rather than the older-style platforms that are multiple silos built with the same technology and need connectors and even then, still duplicate data; and to have a platform that doesn’t just act as a data store but provides the place where users can do their entire business process, guided by wizards/automations, and where they have access to all supporting data required, regardless of its provenance or data owners within the company.

Accelerated uptake

PTE: Do you feel industry’s cautious approach to technology advances is changing?

Kelleher (Generis): Interestingly, we have seen a major change in this since the pandemic—the rate at which companies are reaching out for the kinds of automations, AI, single ‘Information Lake’ solutions has really accelerated, and the fear of newer technologies, moving to the cloud, and taking ‘out of the box’ pre-configured solutions has dramatically decreased—companies are looking for ready-made solutions (with pre-packaged validation thrown in) that can set them up for the coming five-year explosion in industry digital requirements and the faster pace of drug development that we have seen start during the pandemic.

Stulp (Iperion): Many bio/pharma companies are looking into ways in which AI might support and increase efficiency internally. Within the regulatory field, the administrative burden has only increased over the last few years, with fewer people having to do more work. We believe that the time is right to do things smarter, quicker… to optimize existing processes via a more data-driven way of working.

References

1. EMA, “Data on Medicines (ISO IDMP Standards): Overview,” ema.europa.eu [Accessed 2 Feb. 2022].
2. EMA, “Substance and Product Data Management Services,” ema.europa.eu [Accessed 4 Feb. 2022].

About the author

Felicity Thomas is the European editor for Pharmaceutical Technology Group.

Article details

Pharmaceutical Technology Europe
Vol. 34, No. 2
February 2022
Pages: 31–32

Citation

When referring to this article, please cite it as F. Thomas, “The Data Relationship,” Pharmaceutical Technology Europe 34 (2) 2022.