10 drug discovery & development
➠
they provide a valuable catalyst for organisations to internal efficiencies they can glean from automating their
transform their productivity, and refocus their energies administrative activities internally, the ability to extend
and resources on more critical aspects of the business. the benefits on a global basis comes as good news.
As well as improving accuracy and ensuring that As well as the advantages of faster document retrieval,
the regulatory submissions process can be replicated review and transfer times compared to traditional paper
and tracked more easily, standardising and automating document handling methods, Web-based document
regulatory submissions administration activities frees up access allows for the simultaneous review and global
skilled people’s time which could be put to more strategic collaboration, and the ability to repurpose the same
use. If they can hone the submissions process so that clinical trial data and documents for various regional
they can hit more than one market quickly and cost- requirements. This in turn results in a more efficient
effectively, those gains quickly multiply. review process which could potentially result in faster
marketing approval timetables.
Speed to market
Automation also makes it much easier to outsource the
One shining example of an efficient, multi-region process to a specialist agency, potentially creating even
submission is provided by Alexion Pharmaceuticals, a greater internal efficiencies and accelerating the speed
biotech firm that recently launched its first commercial to market, as Alexion found. The larger the organisation,
product, Soliris. Soliris is the first and only FDA-approved and the larger the pipeline, the more complex the job
(March 2007) treatment for paroxysmal nocturnal becomes of bringing all drug development operations and
hemoglobinuria (PNH), a condition affecting fewer documentation under control.
than 10 000 people in the USA. Having developed a Whether managed internally, or via an external
groundbreaking treatment for a rare and debilitating agency, the best way of ensuring multi-regional
blood disorder, Alexion wanted to take full advantage by efficiencies is to embrace eCTD technology, even if target
submitting simultaneous licensing applications in the USA markets aren’t yet fully implementing the standard. The
and Europe in both electronic and paper formats. likelihood is that they soon will be; in the meantime,
It was vital, then, that Alexion got the submission it’s imperative to be able to address each country’s
process right first time. With the average eCTD requirements as they now stand, making it important to
submission to the FDA containing roughly six gigabytes buy in a solution that acknowledges and addresses this.
of data, thousands of files, hundreds of folders, hundreds Since some countries still use paper, or non-eCTD
of thousands of pages, at least a million hyperlinks, and electronic submissions (NeES) formats, any technology
hundreds of thousands of bookmarks, Alexion needed to solution must be able to cater for each method, while
optimise the operations of its relatively small regulatory being able to draw all of the information together so that
and medical writing staff to create a simultaneous eCTD it can be tracked and repurposed.
submission process for both target markets, while being
able to leverage external expertise for troubleshooting and
Staying ahead
eleventh hour issues that needed to be carefully managed Whatever their ambitions with regard to emerging
to ensure a quick and seamless submissions process. markets, with the drug discovery-to-market lifecycle
Alexion decided to include a specialist software and as long as 12 years, costing close to US$1 billion, life
services provider in both its submission and medical sciences companies have little choice but to seek creative
writing efforts. Behind the scenes, the granular nature and strategic solutions to stay competitive.
of the eCTD helped Alexion manage huge volumes of The benefits of improving submissions performance
data while ensuring the proper foundation to make are not just to do with speed, either. Pharma companies
filing updates. Leveraging this content granularity, need to ensure their submissions are tightly accurate. One
Alexion was able to submit variations of its paper and mistake in the overall process and approvals could be set
electronic submissions in both the USA and Europe back by months, if not years. While the costs to people in
within one month of each other. It has since submitted need of stalled remedies are immeasurable, the financial
an application to Australia, and is preparing to submit to losses for an average-performing drug can equate to
Japan taking advantage of the widest possible market for approximately US$1.1m daily in prescription revenues on
its niche drug. top of the US$1 billion to develop and market a new drug
As the months go by, the cases of other pharma or treatment.
companies seeking similar solutions can only increase. Adoption rates of electronic submission management
Global adoption of eCTD as the standard for submissions solutions can only increase as more countries adopt the
is accelerating. In July 2008, an annual report from the use of eCTD submissions. Those who invest early have
FDA showed that almost 31 000 eCTD transactions (over the most to gain, through both significant operational
3300 applications) had been processed over the previous efficiency improvements, and a substantial time-to-
year. The FDA in the US is the biggest champion of the market advantage. u
eCTD format to date, with other regions such as Europe
and Asia following quickly behind. Kate Wilber is Senior Regulatory Consultant at Image Solutions
As pharma companies begin to appreciate the Europe. www.imagesolutions.com
www.scientistlive.com
Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44