Embrace the eCTD and Stay Ahead

As one door closes, businesses must look for their next opening. Today, the traditional strongholds of the pharmaceutical industry, the US and Europe, are witnessing a downturn in growth to around 6% a year. This is the result not only of problems in the broader economy, but also the loss of marketing exclusivity by products in a number of major therapeutic categories; lower contributions from new products because of increased scrutiny of their value; and slower take-up by doctors and healthcare systems.

This is causing life sciences organisations to look to emerging markets which currently boast higher (double-digit) growth rates, such as China, India, Brazil, Russia, Mexico, Turkey and South Korea, to supplement their existing revenue streams.

But targeting new markets presents a challenge. Each country varies in its regulatory requirements, multiplying the administration hurdles organisations have to jump to prepare licence submissions. The risk is time to market - firms looking to break into new markets need to be ahead of the game if they want to gain early ground over their rivals.

The growing standardisation of regulations around the world should help in the long term, making it easier for organisations to play across multiple markets without sending their costs out of control, but as each region responds to global standards at its own pace, the current disparity has the potential to create a lot of extra work for regulatory compliance managers and their colleagues.

Maximising ROI
The answer, many firms are discovering, is to identify technology solutions that give them a dual advantage - helping them to address domestic changes in submissions practices (and at the same time giving them lots of productivity and cost-efficiency gains in their own operations), while making it very easy to adapt these for other markets. (This then gives them maximum payback on their IT investment, too.)

If the regulatory submissions process was onerous before, it has appeared even more so since the introduction of the electronic Common Technical Document (eCTD) standard, which is gradually becoming mandatory in key markets around the world as the global industry attempts to sharpen up and standardise on the formats used to manage clinical and safety data.

Although these changes create another administrative burden for companies, however, they also provide a valuable catalyst for organisations to transform their productivity, and refocus their energies and resources on more critical aspects of the business.

As well as improving accuracy and ensuring that the regulatory submissions process can be replicated and tracked more easily, standardising and automating regulatory submissions administration activities frees up skilled people's time which could be put to more strategic use.

If they can hone the submissions process so that they can hit more than one market quickly and cost-effectively, those gains quickly multiply.

Speed to market
A great example of this is provided by American biotech firm, Alexion Pharmaceuticals, which recently launched its first commercial product, Soliris.

Having developed a groundbreaking treatment for a rare but debilitating blood disorder, which was recently approved for use by the FDA, Alexion wanted to take full advantage of this discovery by submitting simultaneous licensing applications in the US and Europe in both electronic and paper formats.

Soliris, approved by the FDA in March, is the first product developed to treat paroxysmal nocturnal hemoglobinuria (PNH), a condition affecting fewer than 200,000 people in the US. Because of this, the product Soliris is classified as an orphan drug, giving the manufacturer exclusive marketing rights for a seven-year period.

It was vital, then, that Alexion got the submission process right first time. With the average eCTD submission to the FDA containing about 6.61Gb, 1,868 files, 387 folders, 514,533 pages, 1M hyperlinks, and 311,623 bookmarks, it needed to optimise the operations of its relatively small regulatory and medical writing staff to create a simultaneous eCTD submission process for both target markets.

Alexion decided to outsource both its submission and medical writing services to a specialist software and services provider, to benefit from its extensive experience of international eCTD submissions. As a result, despite huge volumes of data, Alexion was able to submit variations of its paper and electronic submissions in both the US and Europe within one week of each other. It has since submitted an application to Australia, and will submit to Japan and Korea later this year, taking advantage of the widest possible market for its niche drug.

eCTD adoption accelerates
As the months go by, the cases of other pharma companies seeking similar solutions can only increase. Global adoption of eCTD as the standard for submissions is accelerating. In July 2008, an annual report from the FDA showed that almost 31,000 eCTD transactions (over 3,300 applications) had been processed over the previous year. The FDA in the US is the biggest champion of the eCTD format to date, with other regions such as Europe and Asia following quickly behind.

As pharma companies begin to appreciate the internal efficiencies that they themselves can glean from automating their administrative activities internally, the ability to extend the benefits on a global basis comes as good news.

As well as the advantages of faster document retrieval, review and transfer times compared to traditional paper document handling methods, Web-based document access allows for the simultaneous review and global collaboration, and the ability to repurpose the same clinical trial data and documents for various regional requirements. This in turn speeds up the marketing approval process, increasing the opportunity to bring in new revenue for the business as the firm achieves patent approval before its rivals.

Automation also makes it much easier to outsource the process to a specialist agency, potentially creating even greater internal efficiencies and accelerating the speed to market, as Alexion found. The larger the organisation, and the larger the pipeline, the more complex the job becomes of bringing all drug development operations and documentation under control.

Whether managed internally, or via an external agency, the best way of ensuring multi-regional efficiencies is to embrace eCTD technology, even if target markets aren't yet fully using the standard. The likelihood is that they soon will be; in the meantime, it's imperative to be able to address each country's requirements as they currently stand, making it important to buy in a solution that acknowledges and addresses this.

Since some countries still use paper, or hybrid submissions formats, any technology solution must be able to cater for each method, while being able to draw all of the information together so that it can be tracked and repurposed effortlessly and accurately. Submission tracking and licensing management must be a key feature, completing the information management requirements of the regulatory affairs department.

Staying ahead
Whatever their ambitions with regard to emerging markets, with the drug discovery-to-market lifecycle as long as 12 years, costing close to $1 billion, life sciences companies have little choice but to seek creative and strategic solutions to stay competitive.

The benefits of improving submissions performance are not just to do with speed, either. Pharma companies need to ensure their submissions are tightly accurate. One mistake in the overall process and approvals could be set back by months, if not years. While the costs to people in need of stalled remedies are immeasurable, the financial losses for an average-performing drug can equate to approximately $1.1M daily in prescription revenue?on top of the $1 billion to develop and market a new drug or treatment.

Adoption rates of electronic submission management solutions can only increase as more countries adopt and mandate use of eCTD submissions. Those who invest early have the most to gain, through both significant operational efficiency improvements, and a substantial time-to-market advantage. With submissions - across any region - completed at the push of a button, rather than after months of labour-intensive compilation, these firms will find themselves with plenty of capacity left over for forward planning, increasing their lead over their rivals.

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