12 DRUG DISCOVERY & DEVELOPMENT
The outsourcing boom grows for non-core pharma activities
There’s no competitive advantage in submissions management, so why be dragged down by the process, asks Adam Sherlock. Let someone else do it ...
La gestion des demandes d’autorisation n’apporte aucun avantage concurrentiel, alors pourquoi se laisser envahir par ce processus, s’interroge Adam Sherlock. Laissons quelqu’un d’autre le faire…
Die eigene Abwicklung von Ausschreibungen bringt keine Wettbewerbsvorteile. Warum also sollte man sich davon lähmen lassen, fragt Adam Sherlock. Überlassen Sie es doch lieber anderen ...
T
here’s nothing like a darkening economic climate and rising competitive pressures to focus a business’s priorities. Like their
counterparts in other commercial sectors, pharmaceutical organisations are being forced to re-examine their core and non-core activities to determine where new efficiencies can be found, and to drive greater productivity and competitive agility into their operations. This is leading to a surge of interest in
outsourcing of non-core activities, as pharma organisations attempt to sharpen their practices and reduce time to market. There are other challenges they need
to address, too. The era of the blockbuster drug is over, competition from generic drug manufacturers is increasing, and drug development pipelines are slowing. Pharma organisations needs to respond by
re-evaluating and streamlining their business processes, removing redundancy and repetition to enhance efficiency and reduce internal costs, so that they can move more deftly and exploit opportunities more cost-effectively.
Breaking old habits
This is easier said than done, however. This is an industry where habits and legacy processes are ingrained and there is a resistance to change. Yet, for many,
particularly those worried about their agility and long-term competitive edge, or caught up in the complexities of mergers and acquisitions, it is clear that something must be done to make their operations slicker. As part of this
re-evaluation process, organisations are being forced to go back to basics and to differentiate between value-added business processes and non-core administrative activities that drain time and resources (Fig. 1).
Many companies have already been tightening
their operations around core activities such as R&D and marketing, relying on outside vendors to handle non-core activities such as clinical trials.
The submissions burden
The onerous burden of licence submissions is now going this way too. Growing adoption of electronic submissions, particularly eCTD- compliant submissions (based on the electronic Common Technical Document standard) means that managing all of the content and documentation has become a substantial job. This is especially true in Europe, where publishing requirements vary from one country to the next. As a result, there is now a growing interest in managed services, where an external specialist is enlisted to take over non-core activities, freeing up skills internally. Fortuitously, this growth in demand has coincided with an increasing availability of specialist managed services. ‘Strategic sourcing’ is proving particularly
popular. This is a more flexible form of outsourcing, which draws on the most appropriate combination of offshore, onshore, and onsite resources. It offers pharma organisations substantial cost benefits (derived from the service provider’s
Fig. 1. Re-evaluation involves differentiating between value-added business processes and non-core administrative activities that drain time and resources.
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