Manage information

Recording detailed product and licence lifecycle information purely to meet regulatory requirements misses a significant opportunity. Competitively, it should be seen as a company's chance to plan its marketing activities more strategically and steal a lead over its rivals.

Tracking the licensing and marketing status of a broad variety of drugs across multiple markets globally is a significant and growing challenge for pharmaceutical organisations. As it is, companies are overwhelmed by the mass of information and, with so many products and territories to monitor, it is not surprising that senior marketing personnel feel they are losing control.

Fortunately, this missed opportunity is being resolved by the general drive to improve and standardise regulatory information management. This means organisations are capturing more data than ever before and, importantly, the kind of information that could be exploited for commercial advantage if properly handled.

Bigger picture
All too often, however, companies become so embroiled in the detail of regulatory information management (IM) requirements that they overlook the broader opportunity for improvement associated with having ready access to better information.

While regulatory compliance is clearly important, there are other areas that life sciences firms could be addressing with the information they are now collating, such as commercial planning, including the targeting of new markets, mergers and acquisitions and the pursuit of new types of industry partnership.

To achieve this, companies need to find ways to release and share content more readily, so as to achieve a single, meaningful version of the truth, which can inform insightful commercial decision-making.

Where the pharma industry is at an advantage is in its extensive use of enterprise applications. This gives companies a good starting point, in that they are already generating a lot of raw data. At the other end of the spectrum, the industry has been slow at adopting business intelligence solutions, meaning the plethora of data being collected is not fully exploited. The challenge is to integrate information more effectively so that more can be done with it. Process optimisation and behavioural changes across teams of users are also required, so that real benefits can be felt.

Marketing planning
A comprehensive regulatory IM solution is likely to include registration planning and tracking, submission planning, publishing and tracking, registration management (including activities beyond initial licence approval) and high-level portfolio management.

Few pharmaceutical companies, however, are even close to achieving anything resembling holistic reporting.

An independent survey conducted by Gens & Associates found that some 70 per cent of life sciences firms persist in using manual tracking and spreadsheets to generate reports. Most companies use a combination of tools to manage and track information, and these are applied in a disjointed way.

ISI's own focus groups have confirmed, too, that many life sciences companies struggle with even the most basic information, such as knowing which products are registered where.

In other cases, regulatory IM has been approached too discretely, driven by specific questions around submissions, obligations to do with scheduled items such as annual reports or manufacturing changes, or marketing authorisation status. While each is important, regulatory and commercial advantages stem from having an information strategy capable of creating something bigger than the sum of the parts.

The risks of falling short on both a regulatory and commercial front are significant. Poorly harnessed product status information could result in a breach of licence terms, falling foul of changing country-specific regulations and ultimately compromising patient safety. Commercially, it could mean protracted, inefficient and costly administrative processes, delays in getting to market and a failure to maximise revenue opportunities.

In some cases, it is easier for organisations to start from scratch with a new IT system for managing all of this regulatory and related data, rather than trying to fill in the cracks in an existing, fragmented legacy set-up. This provides an opportunity to ensure that the resulting tracking systems are managed logically for the users, with information categorised in a way that feels familiar to them and with data that is clean and consistent.

Post approval
Certainly, companies have been more progressive when it comes to regulatory requirements. Yet, where companies are beginning to get to grips with the information requirements of the fuller regulatory lifecycle, in many cases their vigilance does not yet extend to post-approval commitments, which also need to be tracked and managed.

This can add a further layer of complexity, since commitments may vary by market. On the manufacturing side, for example, companies can enhance the decision-making process by having actionable information on formulation and dosage, on manufacturing facilities and locations, and on when the product can be released to various regions.

Until now, most tracking tools in use among life sciences organisations have not incorporated planning. Nor have they facilitated the integration of various sources of data, limiting the potential impact of the information companies are monitoring. As the Gens survey showed, far too many companies are still relying on simple spreadsheets to manage their tracking and planning. However, as markets become increasingly global, the need to track and plan more strategically becomes paramount, going far beyond these simple solutions.

Encouragingly, there is a growing realisation of the need for change. Gens reports that many companies are preparing to make organisational and procedural changes to submission operations over the next two years, with significant investment being made by the 60 largest pharma firms globally in submission management and registration tracking projects. Among the top 30 companies, 88 per cent are now making substantial changes to their submission management activities, with the aim of benefiting from the ability to engage in more predictive planning.

Reasons cited include the need to support the electronic Common Technical Document (eCTD) submissions publishing standard, and the growing requirement to address emerging markets. Organisations now want an authoritative source of information concerning registrations and product files. Cost reduction, too, is a big driver; after all, efficient management of information reduces the need to take people away from the core functions to respond to a regulatory request. Another catalyst is the need for tools for data mining to ensure greater control of in-licensing and divestitures and to manage global capabilities more effectively and efficiently.

Crucially, the clear commercial advantages that new systems afford give the relevant departments greater leverage in securing a budget for their regulatory IM initiatives.

From a regulatory perspective, life sciences organisations have little choice but to sharpen their information recording and tracking capabilities, which means finding order where previously there was chaos.

The same applies if they want to expand their markets globally, maximise relationships with affiliates and minimise the disruptive impact of mergers and acquisitions, all of which are high priorities commercially.

As the pace of change in the industry continues to accelerate, a holistic regulatory IM strategy is what will separate the achievers from those left struggling to compete.

The Author
Adam Sherlock is managing director, ISI Europe

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