The way regulatory information is managed and used in pharmaceutical organisations today is far from optimum, posing a business risk of losing valuable insights and missing out on commercial advantages, To turn this situation around, life sciences organisations need to take a more strategic approach to how they manage the critical regulatory information that lies within their systems.
In just about every other aspect of business, the key to cost-justifying and maximising the return on an information-based initiative is transforming this into valuable business intelligence that can be acted upon to deliver tangible, broad-ranging benefits. The same could be true of regulatory information, if only life sciences organisations were set up to recognise and exploit the opportunities.
The reality, however, is that the wider purpose of and opportunities resulting from information recording and management are lost in the pursuit of a specific goal, such as regulatory compliance. Here, processes and systems are put in place and data accurately and securely recorded to meet agency requirements, for example by supporting e-discovery. And while responding to the regulators is imperative, this need not be done at the expense of enhancing the interrogation of valuable data for commercial advantage.
There is no doubt that regulatory compliance - whether relating to product information management (PIM) requirements, pharmacovigilance, or meeting new health authority submissions standards (especially around eCTD) - poses a significant challenge to life sciences organisations today, Equally, though, companies must respond to intensifying competition, pursue new markets and support growing merger and acquisition activity, for example.
Knowledge is power
Approached strategically, regulatory information management (IM) can help address all of these issues. Holistic IM involves unlocking segregated data, achieving true and trusted data, being able to release and share content more readily, and ultimately driving more efficient processes, workforce enablement and decision support. Without a proper IM strategy and discipline, on the other hand, organisations risk 'information friction', as analyst firm Ovum terms it - a situation where the value of captured information is compromised by its poor quality, duplication or inaccessibility.
For the pharma organisation, the implications of this could be costly. Poorly harnessed product status information could result in a significant risk of breaching licence terms, falling foul of changing country-specific regulations, and, in the worst-case scenarios, compromising patient safety. Commercially, it could mean protracted, inefficient and costly administrative processes, delays in getting to market and missed revenue opportunities.
Recent focus groups carried out independently for regulatory IM software and services consultancy Image Solutions Inc (ISI) found that, although pharmaceutical organisations may well have a lot of valuable information stored in enterprise information systems and document management systems, what's lacking is any integration that would enable -all of this content to be brought together as the basis for higher decision-making. In fact, many pharma organisations are struggling with even the most basic information - such as knowing which products are registered where.
Tracking the whole product lifecycle
Modern regulatory IM practices seek to reverse that situation. Holistic regulatory IM is designed to consolidate and manage all of the information related to global product licensing, marketing and maintenance - everything required to keep track of the requirements and product status for every drug sold in every market, across the entire product lifecycle.
Where many pharmaceutical organisations fall down is in failing to maintain their tracking vigilance beyond the initial drug application or marketing authorisation application (MAA). These should simply be the first steps in the regulatory affairs lifecycle. A more substantial part of the task is maintaining the licence in the market, for example as changes are made to manufacturing specifications and the impact is assessed, and as the licence has to be updated.
These ongoing and widely spread changes result in the accumulation of reams of diverse and ever-changing information, which in turn has an impact on other areas or locations of the business. Without reliable systems to collect data, and ensure the accuracy of that data, companies face a costly and cumbersome administration burden.
With true IM individual regulatory requirements and processes are not treated separately, but are all served from a single point of integration. The advantage of this approach is it enables business leaders to see high-level information which allows them to identify how and where the business can expand, thereby focusing the direction of the company and mapping out commercial plans for the years ahead.
The importance of planning
Companies still have a long way to go to exploit these benefits. An independent survey conducted in 2009 by healthcare consulting firm Gens and Associates found gaps in regulatory IM within most companies in the areas of tracking and reporting, to the extent that more than 70 per cent of respondents continue to use 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.
Change, however, is in the air. While the majority of tracking tools in use among life sciences organisations today have not incorporated planning, Gens reports that among the top 30 companies, globally by revenue, as many as 88 per cent are now making significant changes to their submission management activities, with the aim of boosting their predictive planning capabilities.
Champions of regulatory IM will need to determine how best to build the business case. For example, some regulatory leaders have argued that in today's more stringent climate a new IT system or an integration project should be considered as integral to a company's needs as an SAP system is to planning finances. This is because regulatory information represents the company's intellectual property, with significant value right across the enterprise.
A consolidated, global regulatory IM solution benefits multiple departments. It would enable the regulatory affairs team to see which products are registered where, respond to queries, and be confident that the information registered is consistent with what's actually being manufactured and is current. The compliance team would be able to see where individual products are, and the impact of any changes globally, while the regulatory operations team would be able to use planning and tracking to better manage resource allocation for submissions compilation. The commercial side of the business, meanwhile, would be able to see whether and when a product has been approved and verify that there is a licence number, enabling them to initiate their marketing plans.
From an IT perspective, having a single, consolidated system would not only mean that everyone in the business has access to the same accurate and up-to-date data, but that budgetary savings can be made through the retirement of older, hard-to-maintain systems, reducing the cost of ownership. Continuing with inadequate regulatory IM, on the other hand, could leave a company open to deficiencies that may be exposed during a regulatory authority inspection.
In an unforgiving market, life sciences organisations have no choice but to sharpen their information recording and tracking capabilities if they want to maintain and improve their competitive position. Agile, connected systems populated with accurate, up-to-date information are critical to companies' ability to respond to new market opportunities, adapt to changes, and comply with increasingly stringent regulations, while maintaining their competitive edge. Staying ahead demands more intelligence, not more information.
Don't forget that one company's threat is another organisation's opportunity. On one hand, becoming bogged down in the detail may leave organisations unable to see the bigger prize. On the other, those that keep their eye on the broader needs of the business can reap the rewards of streamlined regulatory IM. The difference is simply a matter of vision, strategy and positive organisational attitude.
James Hendry is an EU Regulatory Process Specialist at ISI Europe, Manchester, UK. www.imagesolutions.com.
