DRUG DISCOVERY & DEVELOPMENT 13


superior economies of scale); faster time to market (through rapid access to the right skills and the latest technologies); and the ability to refocus internal energies to more pressing business activities. In many industries, including pharmaceuticals, take-


up of hosted software solutions (SaaS) is accelerating, offering fast, affordable access to the latest applications. This has led to the realisation that outsourcing needn’t


stop there. If pharma organisations are going to entrust the management of their software and hardware to a third party, why not go further and let a reputed expert look after some or all aspects of the broader operation? Nowhere does business


process outsourcing (BPO) have greater appeal than in the complex and time-consuming business of regulatory submissions management, where good experts are hard to find, and processes have become increasingly onerous, thanks to the mandate to submit electronically. The opportunity to let external experts host and even co-manage the submissions process offers significant value. Harnessing the familiar


interface of the web, yet with the reassurance of robust security, the outsourced solutions allow users to access, view, edit and share documentation from their office desks as usual. The big difference is that the company no longer needs to own the software, and is able to let go of many of the processes involved in managing a licence submission. What’s more, this also gives them the opportunity to quickly and easily scale operations up or down as market conditions and demand dictates.


Lighter means nimbler


Professional managed services are now available to support every function, from clinical trials to post- submission tracking. The list includes medical writing, regulatory consulting and training (Fig. 2). Letting someone else manage these supporting


administrative services could be the key to the dynamism and agility pharmaceutical companies now need to survive and prosper. As the pharmaceutical industry embraces the eCTD


standard for drug licence submissions, organisations with foresight are seizing this as an opportunity to streamline their internal submissions-related processes to achieve multiple gains. Being experts in the drug development business, but not necessarily in managing documents, pharma


companies are attracted to the outsourcing option because it releases them from unrewarding work which distracts them from what they’re good at. The more involved the document requirements become the more burdensome and off-putting the submissions process becomes.


Avoiding costly investment


The move to eCTD submissions demands new investment, too - in processes and solutions to manage the documents, and to ensure that the company gains efficiencies from lifecycle management. Many companies, regardless of their size, simply can’t afford to build the internal knowledge base and infrastructure to develop this type of competency.


A better option can be to take a ‘virtual company’ approach, using external partners for specialist activities, as Purdue Pharma has done. This has enabled the company to cope with the peaks and troughs that characterise the pharmaceutical industry - handling processes internally during leaner times, yet outsourcing when the workload expands, rather than hiring additional internal staff. As well as being able to


Fig. 2. Professional managed services


now support every function, from clinical trials to post-submission tracking.


offload the headache of electronic submissions, outsourcing has enabled Purdue to retain a technological edge by working with external vendors that continuously remain ahead of the technological curve. Keep the baby,


lose the bathwater While some aspects of the development process are


clearly proprietary (such as data that is specific to a chemical entity), organisations are not jeopardising their competitive edge by inviting in external parties to run their more run-of-the-mill functions. Indeed, many core processes are common to the whole industry. The past decade has brought much upheaval to the pharma industry, and the future will bring even greater change. Firms that have committed to adapt their operations accordingly will find a whole new set of opportunities to redefine business processes, refocus their energies, reduce their costs and sharpen their competitive edge. As for the rest, they may one day find they have to spend a lot of money playing catch-up – that’s if it’s not already too late. u


Adam Sherlock is Managing Director of Image Solutions Europe GmbH, Eschborn, Germany. www.imagesolutions.com


www.scientistlive.com


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