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Regulatory change is driving data-driven processes and there is increasing recognition that these data-based requirements are creating opportunities to transform processes along the pharma lifecycle. And the structured data that is at the heart of these transformations is the key to eliminating product shortages, and managing labelling change.
At Amplexor’s recent BE THE EXPERT 2023 global conference, Remco Munnik of Iperion - a Deloitte business, discussed how good-quality data can be put to work to enhance internal and external processes, identifying new markets and reducing time to market.
The fact that Life Sciences is now adopting and seeing value in structured data is a huge turning point for the industry, and this acceptance is becoming increasingly palpable. Once companies are able to see beyond the mandatory detail of the regulations that are helping to drive data-oriented process change, their opportunities for transformation of entire functions and their approaches to product tracking and management will broaden and multiply.
Certainly, harnessing structured data and using this for strategic advantage is about so much more than adhering to the specific requirements of IDMP, ePI, CTIS, ESMP, PQ/CMC and associated global implementation projects for their own sake. Access to good-quality data can help to significantly improve internal and external processes - with a view to identifying new market openings, optimising clinical trials, shortening time to market, eliminating product shortages, and managing labelling changes seamlessly and without fuss.
At a recent conference – Amplexor’s annual global BE THE EXPERT forum, in June, in Split, Croatia – participants were more acutely aware and enthusiastic about the potential than in previous years. Although there remained a clear appetite to learn and interpret the latest updates on EU IDMP and other data-based requirements with a bearing on key aspects of the R&D and marketing authorisation/post-marketing product lifecycle (including safety surveillance and licence maintenance), event participants were even keener to appreciate the broader opportunities that exist for companies to transform the way they operate. This includes the way they track products, tap new market potential, and connect with and add value for clinicians, caregivers, prescribers, payers, and - of course - patients.
Doing More with Data
Taken individually, the various mandates and required data capabilities and systems, can seem daunting. Take the new European Shortages Monitoring Platform, expected to go live within two years. This has been conceived by the European Medicines Agency (EMA) in the wake of COVID-19 related supply chain disruption and shortages - not just of immediate vaccines and treatments, but of other critical medicines as entire countries and regions went into lockdown.
The new data-driven platform is EMA’s response to the situation, intended to pre-empt and curb unexpected supply issues – whether these involve paracetamol, antibiotics, flu vaccines, or hormone replacement therapy products – through prompt reporting of emerging issues. (In the US, the FDA has even more granular guidance around supply precautions and contingencies.)
While functional managers and IT teams might baulk at the additional reporting requirements, once companies are generating regulatory data - as captured currently in documents - they have the opportunity to do so much more with it.
It makes sense, then, to make the best possible job of capturing and maintaining that data, to a consistently high standard.
Gathering Insights
Once companies have captured all of the data they want and need, the next step is to structure it in such a way that it can be exchanged reliably with other systems, both internally and externally. Instead of requiring that new manual processes are invoked to enter the latest relevant data into a new system or portal, that information should pre-exist and be readily re-directable to fulfil each additional emerging need – fulfilling a range of new use cases relatively easily. That is, once companies have reliable, consistent, good-quality, structured data organised and ready to go.
Take the shortage management use case. Ultimately, gaining visibility of potential product shortages requires simply that product data and supply chain information can be combined to provide, compile and report the relevant insight. In other words, once all of the contributing insights have been released from static PDFs (e.g. CMC manufacturing process and control information as submitted to regulators in Module 3) and exist as live intelligence that can inform other teams and fulfil new reporting demands. For instance, visibility of how many products have a certain excipient, and where a product is manufactured, could automatically flag up emerging supply issues out of China, India or any other country, if that country is in lockdown.
Time to Start the Groundwork
Whether in Europe or not, there is a need for Life Sciences companies to move forward with their data preparation plans with new intent. Certainly, given the broad opportunity for process transformation and the potential for crucial new actionable insights, it makes no sense for companies to wait for Regulators to issue final data formatting instructions, or for software vendors to have exactly the right fields defined, before teams start doing the real work.
There is a lot of groundwork regulatory, quality and safety functions could be doing today to get their data in shape, while the Is are still being dotted and Ts being crossed at a regulatory level. In other words, getting control of internal data is paramount, and relying on regulators or the software industry to trigger next internal data-related preparations is a passive and risky way to approach this.
It’s a bit like starting to get financial book-keeping in order only once the Tax Office has asked for an annual tax declaration – when really everything should have been recorded continuously throughout the year. In this case, there is a chance to avoid the 11th-hour panic of data-based regulatory compliance, given that reliable on-demand reporting is possible and holds great benefit today (assuming appropriate attention has been given to data capture and management.
In the pharma sector, underpinned by EMA’s agile approach, there is already clear buy-in to working towards a structure enabling data and documents to be exchanged seamlessly. Pharma companies that are well on the way to being able to connect and exchange information effortlessly are reaping the benefits of being able to address supply issues effectively and efficiently, keeping their product pipelines flowing.