Every business, and often every department, has its own way of doing things. In the life sciences industry this is true of the way companies and individual business functions record and manage information about drugs, making it difficult to gain a clear line of sight across a product’s lifecycle and its performance in the market. This has implications for the business as well as public safety.
It’s something that is now being addressed by the new international Identification of Medicinal Products (IDMP) ISO standards and pending regional implementation guidance, which seek to introduce a rigour and consistency to product data which has been lacking until now.
IDMP aims to harmonise the way products are identified, along with information about how products should be used, consumed and packaged, and create a standard way of linking related data. All of this will make it easier to track drugs and their effects in the market, with associated benefits right across pharma organisations due to a new uniformity in the way information is collated and managed.
Currently each part of a life sciences business - from early research, formulation, clinical trials and registration, to manufacturing and quality assurance, to marketing, sales and Pharmacovigilance - has its own priorities and systems for recording information. IDMP challenges this scenario, imposing the need for a central repository for lots of detailed, interlinked product information that must now be recorded using consistent product identification. It means that, finally, the different parts of the business must start speaking the same language.
Once the standards become mandatory (deadlines may keep shifting, but it’s only a matter of time before compliance becomes compulsory) companies will need to file IDMP data almost simultaneously when filing for a new marketing authorisation.
And it all begins in R&D. Get product information management right from the beginning, and there will be opportunities to streamline and improve a wide range of data-related processes.
Set the Pattern Early
Long before a medicinal product enters the market, it is created in more rudimentary forms, and it is here that the product information trail needs to begin as organisations develop and move that product through its lifecycle.
This is the role of the ‘product identifier’, assigned once proposed combinations of chemical entities have been studied for their medicinal and commercial potential but before the compound is chosen to evolve through pre-clinical and clinical testing.
Having a unique, consistent identifier throughout the research and development process allows an information trail to be gathered which will play an important role in the marketing authorisation process and, in due course, in IDMP compliance. Any gaps in this thread of knowledge could lead to delays in getting the eventual product to market, with associated commercial and competitive implications.
The testing processes and each round of results must be easily traceable, through the different stages of trials and as the optimum route of administration and dosage levels are set.
Marketing approvals are very specific concerning agreed dosages and methods of application for specific populations and possible demographics for use, and the eventual marketed product name may vary from country to country. So it makes sense that life sciences companies have everything documented in a way that tells the complete story and can be easily accessed, shared and understood – within and beyond the organisation.
Traditionally, this is where data capture and management have become very complex. Should companies define and track products by name and country, or by the chemical compound/active ingredient? In the pharmaceutical industry, products have a large number of variants and are challenging to define in a consistent, holistic way. Yet, the need to do this from a regulatory perspective is acute because of the health implications and companies’ exposure to financial and reputational risk if anything goes wrong once a product is in the public domain.
Once in use in the real world, products are subject to new rounds of tracking as individual customers respond to the drugs in discrete ways. The requirements for monitoring and reporting adverse events (pharmacovigilance), along with the effort to discover cause and concomitant drug interactions, needs to tie back in with the R&D information management, to build up the complete picture of the product’s performance.
The sponsor is responsible for ascertaining any need to revise labelling or even voluntarily withdraw a drug from markets, if the analytics indicate that this is needed. (Ultimately, this intelligence will be fed back into future development processes.) It’s essential to have a global view too, not only for actions relating to drug recall, but also to follow up on regulatory requests from any or all markets, and for general reporting.
Preparing for the unknown
It is because of the implications of information governance for customer safety and market confidence that international authorities are raising the bar for data collection and reporting. The onus is on life sciences companies to have all of the answers at their fingertips and ready to submit at short notice.
Five new standards around IDMP have been approved by ISO which have an impact on regulatory reporting. Although the major regions are still preparing guidance on when and how to implement these standards, there is no time to lose in preparing for compliance.
A consistent data profile that can be easily enhanced and amended as needs evolve and change means that companies can react with greater speed and ease to new events and emerging regulatory demands, and provide a better service to the public.
Even in the initial phase of the pending IDMP guidance, more than 90 different pieces of information are required. This considerably exceeds the current requirements for XEVMPD (by a factor of three) – and the figure will rise to over 450 different elements once the new standards reach the later phases.
Preparation should not be delayed. Companies will want to avoid rushing - which may prevent them delivering a scalable solution that allows for agile ways to meet broader and future needs.
Compliance, and the ability to gain an accurate overview of a product at a glance, relies on having a consistent ID from its origins and a consistent dictionary-driven model of data collection – across R&D, manufacturing, packaging, labelling, safety and beyond, and for all markets.
A positive side effect of IDMP, internally to organisations, is that it fosters a consistency in data management that hasn’t existed before in life sciences – where information governance has tended to be confined to departmental/application-specific silos. With mergers and acquisitions taking place on a regular basis in the sector, the diversity of systems and approaches to information management has reached unmanageable excess. Unravelling that complexity has seemed beyond daunting.
Setting the stage for holistic data management
As companies realise the urgency of bringing order to their product information, not only for regulatory reasons but also to safeguard their competitive position in the market, they are finding that the only practical way forward is to create a holistic content repository – a master data resource, where all product-related information is consolidated, so that all departments and parties along the supply chain are talking the same language and referring to the same source data. A resource that meets the needs of IDMP reporting requirements, safety evaluation and new marketing authorisation demands simultaneously.
Currently, that central repository (one that serves the whole organisation) is a rarity in life sciences -if it exists at all. But it must, and there is no time to lose. Putting R&D at the centre of those plans makes perfect sense, because of the wealth of product data it collects from the point of inception of a new drug (and receives back in the form of adverse reaction data).
Because of the large disparity that exists today in the way most life sciences organisations hold and manage data, an important initial exercise will be to assess the various current product information sources on which the master data repository will be built.
Some will exist only on paper, other content in electronic format – but conceivably not in a format or in sufficient detail for the purposes of IDMP compliance. Identifying the latest versions of information, or the quality of the information may prove a challenge too, so this is something else that needs to be planned into the transition. The goal must be to identify the steps that need to be taken to create a single, authoritative source of complete, accurate, reliable, up-to-date product data - which can be adapted, added to and brought in line with emerging and future requirements.
The initial challenge of defining a master data repository will become easier as identified best practices are distilled into standard, easily configurable solutions – those that can be applied to any life sciences company with relative speed (rather than each company doing its own thing in isolation). Emerging data and document management models, such as the DIA Reference Models for EDM, Labelling, TMF and GMP, offer organisations a good starting point for collating and storing content in the same standard format from one end of the product lifecycle to the other.
Although the regulatory affairs function has typically acted as a collection point for compliance-related data up to now, organisations cannot leave the responsibility at this department’s door - particularly as there remains quite a bit of data that doesn’t pass through the regulatory team.
Holistic product data management is much bigger than a single department, and needs its own champion – a responsible party who oversees the whole flow of data from R&D to eventual product withdrawal, and can help enforce consistency and provide governance from cradle to grave. It may be advisable to form a governance body that combines the interests of each department but speaks for the whole.
Improved response to regulatory and business changes will be a key capability that organisations will need for the future, for reasons of compliance and competitive advantage. The first draft of guidance on IDMP specifies that companies will have just 30 days to meet their IDMP data obligations once a marketing authorisation application has been submitted, so these submissions are not something that can be cobbled together in an ad-hoc fashion.
In the absence of a fixed deadline or released guidance for bringing systems and processes in line with IDMP requirements, the degree of current preparation is largely down to companies’ respective cultural make-up and strategic priorities. Do they want to be ahead of the game and exploit all of the associated efficiency benefits of a streamlined data management set-up, or is there something they stand to gain by waiting and watching what their peers do?
Of course, IDMP is just one of many new or improved regulations that are coming down the line. This is another reason why firms cannot afford to be too inert or rigid in their information management plans – and why it makes sense to get started sooner rather than later.
Bespoke, single-purpose systems lock companies in and are the enemy of agility. They are expensive to create and maintain, cannot be readily adapted to new requirements, and are usually inflexible in their ability to support additional data input (e.g. following a company merger). The more companies that move to consistent models for capturing, storing and managing content, and open interfaces between systems, the easier it will be to combine and blend different data sources and create a (secure) flow of content.
Preparing for IDMP and more holistic product data management isn’t a one-time exercise either. Identified data sources will also need to be kept up to date, by way of a continuous quality assurance process, and companies will need to find a way to do this that is as painless, straightforward and reliable as possible. That demands good governance.
As the need for speed intensifies, having a uniform architecture and centralised master data architecture, and configurable/adaptable systems, is the only way organisations can prepare themselves for whatever the future holds. The more they aim for a consistent content management model, the easier they will find it to absorb and adjust to - or outsource - related requirements.
One final piece of advice is to get involved proactively with standards bodies and industry organisations. This will allow you to gain an influence over, and have early insight to, upcoming or changing regulatory requirements. Knowing what’s coming might not reduce the workload, but it can help companies avoid being off balance, and offers them maximum opportunity to make any changes that will work positively for the business.