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 six per cent 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 operations 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 Common Technical Document (CTD) and its electronic version (which includes an XML backbone) called the electronic Common Technical Document (eCTD). This standard is gradually becoming the preferred format for electronic submissions in key markets around the world as the global industry attempts to sharpen up and harmonise on the formats, making it possible to share and reuse data and thereby simplifying submissions to multiple regulators.
Although these changes may appear to create another administrative burden for companies, they 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
One shining example of an efficient, multi-region submission is provided by Alexion Pharmaceuticals, a biotech firm that recently launched its first commercial product, Soliris. Soliris is the first and only FDA-approved (March 2007) treatment for paroxysmal nocturnal hemoglobinuria (PNH), a condition affecting fewer than 10000 people in the USA. Having developed a groundbreaking treatment for a rare and debilitating blood disorder, Alexion wanted to take full advantage by submitting simultaneous licensing applications in the USA and Europe in both electronic and paper formats.
It was vital, then, that Alexion got the submission process right first time. With the average eCTD submission to the FDA containing roughly six gigabytes of data, thousands of files, hundreds of folders, hundreds of thousands of pages, at least a million hyperlinks, and hundreds of thousands of bookmarks, Alexion 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, while being able to leverage external expertise for troubleshooting and eleventh hour issues that needed to be carefully managed to ensure a quick and seamless submissions process.
Alexion decided to include a specialist software and services provider in both its submission and medical writing efforts. Behind the scenes, the granular nature of the eCTD helped Alexion manage huge volumes of data while ensuring the proper foundation to make filing updates. Leveraging this content granularity, Alexion was able to submit variations of its paper and electronic submissions in both the USA and Europe within one month of each other. It has since submitted an application to Australia, and is preparing to submit to Japan taking advantage of the widest possible market for its niche drug.
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 31000 eCTD transactions (over 3300 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 they 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 results in a more efficient review process which could potentially result in faster marketing approval timetables.
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 implementing 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 now stand, making it important to buy in a solution that acknowledges and addresses this.
Since some countries still use paper, or non-eCTD electronic submissions (NeES) 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.
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 US$1billion, 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 US$1.1m daily in prescription revenues on top of the US$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 the 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.
- Kate Wilber is Senior Regulatory Consultant at Image Solutions Europe. www.imagesolutions.com.
