Until life sciences companies are able to manage product lifecycle information holistically, their ability to seize new market opportunities will be limited, warns Mark Evenepoel, Group CEO at AMPLEXOR Life Sciences
In 2016, the life sciences industry faces increasingly complex regulatory challenges and operational risks: the result of technology advances, clinician and patient expectations, and a globally-connected healthcare market. But unless organisations tackle the association product data management challenges holistically, they could be running up high levels of expense without reaping the full benefits. Worse, disjointed data management could compromise business agility, detracting from companies’ commercial goals for the year ahead.
EU legislation requires the implementation of new data standards (Identification of Medicinal Products or IDMP), enabling the unique identification of medicinal products at an international level. To comply, life sciences organisations must develop a method and process for generating global product identifiers, which can then be used for product reconciliation and linking across the entire product supply chain.
The specifics of IDMP compliance requirements will evolve over the next two years. Significant investment will be required not only to align key product data across a wide range of functions, from R&D and manufacturing to the supply chain but also to pursue operational excellence in R&D and customer safety: the ultimate goal of the new standards.
From a regulatory and risk perspective, these requirements absolutely must be met. But companies need to do this in a way that is both efficient and adaptable – as new regulatory requirements will continue to appear, and not all of these can be predicted in advance.
There are commercial implications too. If laborious internal processes are needed to collate and file detailed product lifecycle data in the mandated format, this could cost companies dearly in time to market – a serious consideration in today’s aggressively global playing field.
Customer centricity demands a different approach
The last year has seen a lot of strategic change in the life sciences industry, as pharma organisations have sought to realign their value propositions with target customer groups such as hospitals or over-the-counter pharmacies. Selling customer solutions rather than product features is not only more appealing to customers, it also presents additional cross-selling opportunities. Yet behind the scenes, operations aren’t conducive to enabling this readily - due to the numerous different information systems and processes, dispersed across multiple geographies. This fragmentation inhibits progress, preventing new types of collaboration for example. Mergers and acquisitions further add to the complexity.
This situation is unsustainable. The aim must be to simplify and streamline processes, and lower operating costs and administrative barriers, so that companies can seize opportunities and extract value.
Becoming more agile
It is for all of these reasons that in 2016 agility - the ability to adapt and take advantage of emerging opportunities - will top the life sciences agenda.
New strategies must involve strengthening collaboration and information-sharing - both among internal functions and with external partners - to create a global supply ecosystem that is more closely integrated, responsive and focused on the patient. And this must begin with a single, centralised approach to product lifecycle data management.
Each time companies approach a new information management project as a distinct entity, to meet a specific new need, they are creating a new data and process silo that adds to rather than alleviates their current challenges – and limiting their ROI.
Practical steps for 2016
By the end of this year companies should aim to have a clear roadmap for transformation, and be ready to start. Even where legacy systems must be taken into account, it is important to establish some kind of centralised strategy for master data and product lifecycle information management (this could be achieved virtually) as a first step. ‘Middleware’ can help with integration between jarring systems, but companies can leave the detail to external experts; internal IT teams have enough on their plates. The good news is that the life sciences industry already has most of the data it will need to become more agile (albeit currently in an unstructured format) , thanks to the rigour demanded for regulatory compliance. The challenge now is to unlock it - so that it is all accessible in a structured format - combine it and channel it for the wider benefit of the business.
About the author
Mark Evenepoel is Group CEO at AMPLEXOR Life Sciences, a digital solutions company offering global compliance, digital experience and content solutions. www.amplexor.com
Last updated on: 15/01/2016 14:01:59
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