If information and process digitisation is as positively disruptive as its proponents claim, then what is the potential for transforming the management of marketing authorisation? Assuming this is considerable, what is involved in enabling practical, large-scale data management, and how can RA departments build on product data to help advance the broader business agenda?
Even today there remains a lot of confusion around what companies mean by digital transformation. Talk of making content ‘digital’ often refers to plans for capturing documents and information in an electronic format, while transformation refers to the new possibilities that are created as a result. But real transformation can only take place once organisations have reliable, ready and precise access to information and the insights it contains. Here, data doesn’t simply exist electronically; it can also be intelligently and quickly called up – and used in new ways to support advanced decision-making; to complete tasks more swiftly and accurately; and to generally make people’s lives easier.
In general, when companies talk about digital transformation, they are referring to information accessibility and knowledge exchange and the potential that is unlocked once this is improved significantly. The implication – and hope – is that, once everyone can plug in to the fuller insights they need, on demand, this will drive substantial improvements to productivity, and to process accuracy and efficiency.
One of the obvious beneficiaries of improved information management in life sciences is regulatory affairs – a function which must collate, curate, quality-check and prepare data ad infinitum, to stay compliant with the latest industry specifications and keep products on the market. Here we consider the specific opportunities enabled by digital transformation of this department and its activities.
There have been some great advances in the way life sciences firms and regulating bodies capture, share and process important product-related data, as needed to get products into a given market, and to keep them there. Yet, although standards-based document templates and formats for electronic application submissions may have been an important step towards more efficient data exchange, any efficiency and productivity gains will remain limited unless the constituent data is easy to call up and verify as the definitive, correct information – to satisfy a given query, for instance, or enable a next action to be taken.
It is potentially of greater value still, if document compilation processes can be automated to some degree, from reliable, definitive, good-quality data about a product. It could also save human teams a lot of time and risk of error, if correct, up-to-date information contained in incoming submissions can be intelligently ‘read’ and filed by receiving systems, and automatically organised into databases where the same content can be readily extracted again in response to an authorised user’s search, or perhaps as part of broader analytics across a wider set of records.
With digitisation, as opposed to electronic data capture, the template of documents is no longer simply Word based; it is encoded with the XML formatting, allowing linked, live data to be lifted from or delivered to databases. This offers all sorts of advantages for everyone concerned, reducing repetitive manual data re-entry and the associated scope for human error and delay. Regulatory rigour now involves checks happening in one main place, for instance, while automation simplifies the task of extracting data, entering this into documents, and checking for information consistency.
And this opportunity extends beyond pharmaceutical and biotech products, now. With regulatory changes, extended data requirements will also apply to medical devices and combination products.
Holistic data management, at scale
As source data, rather than static documents, becomes the emphasis of regulatory information management, life sciences companies must ensure they have the means to manage and maintain the quality and currency of all of this data.
As regulators’ demands increase, so will the range and scope of the data that firms will need to have readily available to them. Building and maintaining a complete set of regulatory information for the authorisation or life-cycle management of a product is likely to involve data from multiple different databases – from clinical to toxicology and beyond. The regulatory agency, meanwhile, will continue to build global databases for the manufacturer, the marketing authorisation holder, for excipients, and for pharmacovigilance.
In addition, it will keep databases to cluster the various reports companies must file, including periodic safety update reports and risk management plans.
With the growing emphasis on drug, manufacturer and supply chain transparency, regulatory information now refers to almost all data about a marketed product. All of which has to be managed and maintained to a high level of detail and quality, and indexed and linked so it can be easily and accurately retrieved. All the data within these databases is linked and managed through metadata (ie the tags which help define, organise and locate data). Once the Identification of Medicinal Products (IDMP) set of data standards is in place, the regulatory authorities should be able to pull out any data relevant to a product.
These intentions shine a light on what’s possible, with implications for companies themselves. If regulatory authorities expect to enjoy greater insight from and ease in product data handling in future, why shouldn’t life sciences firms themselves also benefit from the ability to call up any information about any aspect of a product and its current status – at any time, to support any purpose? If that product information can be accessed and traced at any point in the manufacturing/regulatory continuum, so much the better. Functional information silos hold no benefit in the digital age.
As the likely data stewards, responsible not only for managing and finding data, but for understanding its broader purpose, regulatory affairs departments have an important facilitating role to play in all of this.
Delivering more than compliance
The days of companies delivering pure compliance projects ought to be behind us now: it is a costly and labour-intensive pursuit, so to restrict expectations to meeting the needs of regulators alone is shortsighted. Rather, digital transformation of RA offers a chance for regulatory teams to add unprecedented value for their businesses.
This might involve building a strong knowledge base of global regulations, timelines and opportunities for the portfolio: a comprehensive resource of the latest regulatory intelligence, built and harnessed using progressive technologies. Facilities could include data mining to extract data from websites; as well as natural language processing, artificial intelligence and machine learning, and rules-driven process automation, to expand the capacity and accuracy of regulatory intelligence.
Having these capabilities at hand will help regulatory affairs achieve and maintain a complete understanding of global regulatory trends and ensure all requirements are met for each product in the portfolio. Expanding internal regulatory intelligence will enable organisations not only to better respond to international demands, but also to position their products optimally for markets access, by quickly leveraging data that demonstrates the safety and efficacy of their products.
By providing the business with pivotal intelligence in this way, RA can create an opportunity to raise its profile and add a new and appealing dimension to the function and for the people who deliver it. Although the demands of regulators can seem unrelenting, especially currently, there is one way out of this negative spiral of costs and resource consumption – which is to frame the situation differently, and look for the internal advantage.
Erick Gaussens is chief scientific officer at Product Life Group