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Speeding the path to FDA approval in the era of electronic submissions
An Investigational New Drug (IND) Application submitted to the U.S. Food & Drug Administration (FDA) can easily run 10 or more volumes, largely consisting of reviews and copies of published studies of the drug in question. Many of the documents required come from published literature sources, mainly in the form of scientific articles. Obtaining, assembling, transmitting and managing this volume of materials is a major task for any pharmaceutical company, whether it submits traditional paper documents to the regulatory agency or opts for electronic submission—and let 's face it, it can be time-consuming, expensive and downright exhausting.
In 2008, the FDA mandated that all electronic submissions adhere to the electronic Common Technical Document (eCTD) format. This eCTD standard poses additional distinct challenges as the scientific literature is not published in this format, but needs to be reformatted to fit the FDA's standard. Even though it has been two years since the electronic system was implemented, many pharmaceutical companies are still struggling to navigate the approval process efficiently.
There is help. Acquiring the necessary published literature for the regulatory approval process can be effectively standardized and facilitated by a dedicated professional document preparation service.
The eCTD format: Advantages and pitfalls
First, a bit about the eCTD format itself. Designed by the International Conference on Harmonization, it represents a common organization structure for the submission of regulatory information to worldwide health authorities such as the FDA. An eCTD document is comprised of five modules: Administrative Information and Prescribing Information; Common Technical Document Summaries; Quality; Nonclinical Study Reports; and Clinical Study Reports. The reason this format was chosen is because it is optimized for copying/pasting, viewing/printing, annotating, facilitating the export of information to databases, searching within and across applications and navigating through the document.
Additionally, the eCTD format offers an important opportunity to make your company globally relevant, as it is standard across all markets worldwide. A successful pharmaceutical company is a global pharmaceutical company.
As with all electronic submissions, delays can arise when last-minute requests for FDA-quality documents are made. It is no longer acceptable to have documents with anything but clean text. Making sure these documents are acceptable can be a complex process that involves a number of parties. Currently, workflow at many companies is decentralized with multiple insourcing and outsourcing providers. A pharmaceutical company's Information Center might bear responsibility for the task of removing any stray marks, while regulatory affairs professionals might ensure that the documents are formatted, modified and assembled in a manner consistent with a regulatory agency's specifications. It involves a great deal of management and juggling before, during and after any submissions are made.
Companies need a centralized workflow system with standards in place. The eCTD format requires enhanced and specific digital document formatting and the inclusion of key navigation aids, making last-minute requests even more problematic and delaying the drug approval process even further. When the authorities reading a submittal encounter non-compliant PDF files, they can stop the review until the pharmaceutical company supplies them with corrected versions—a situation that can cost you and your company huge sums in lost revenue by impacting the time to market and the stock price. As the adage goes, time is money, and this is particularly applicable when it comes to getting a drug through the regulatory approval process and successfully to market.
How a dedicated professional document service can help
There are services out there dedicated specifically to helping you avoid the pitfalls and hold-ups associated with the approval process. If a company's expertise lies in drug development, the company should find a professional document repurposing company to manage the approval process.
A dedicated eCTD document service can provide valuable aid to global pharmaceutical companies facing the challenges of regulatory submissions. Such a service is capable of processing orders for documents either singly or in batches and procuring them—in as little time as a couple of hours. It can ensure that the retrieved documents are digitally formatted to internal and local regulatory specifications, and will oversee quality control and assurance processing. The service can also be set up to report on the details of usage for every document requested by the pharmaceutical company. And while the latter's Information Center may be overburdened, an independent service can provide a dedicated project manager to oversee the entire process.
It is perhaps easier to envision how this alternative system works by imagining what happens when Company X requires a set of, say, 12 documents on drug Y. First, Company X contacts the document service and specifies the documents on drug Y that it needs. The document service then retrieves those documents and pays copyright royalties to the documents' publishers. It then formats the document PDFs according to the specifications of both the client and regulatory agencies such as the FDA.
One of the most striking differences between this arrangement and the traditional submission process involves the timing of document preparation. Traditionally, when paper versions of documents were used, the preparation was undertaken immediately prior to submission. With electronic submission, documents can be prepared continuously from the start of clinical trials, potentially saving considerable time and money later on.
Anyone skeptical of taking what has traditionally been an activity overseen by the pharmaceutical companies themselves and assigning it to an outside service need only consider the advantages the latter can provide. An independent document service will not only have specialized expertise in managing information and electronic resources but also will have a thorough familiarity with both the eCTD format and current copyright laws. The opinions of some of those familiar with the electronic submission process are worth quoting.
"Invariably, [a] submission is held up waiting for that last journal article or monograph," notes Antoinette Azevedo, president of e-SubmissionsSolutions.com. "It is better to collect them starting at the IND phase rather than waiting [until a later stage of the application process]."
Robin Holmes, an information services and content management consultant who formerly worked for Johnson & Johnson and Jazz Pharmaceuticals, observes, "An eCTD solution should be an information center expertise and deliverable. With this, the center can enhance document delivery by leveraging existing purchases and removing a cause of submission delays."
Given the perspectives reviewed above, the advantages come clear to a pharmaceutical company sharing the eCTD challenge of regulatory submission with a scholarly document service. The best step you can take to speed your company's way through the regulatory approval process is to have your regulatory affairs personnel or contract research organization contact a supplier for a content workflow analysis to find a solution that will benefit you, your financing and ultimately, the people who will reap the benefits of your drug.
Peter V. Derycz is the founding partner and president of Derycz Scientific, a marketing services conglomerate focused on content repurposing tools and services, in Los Angeles.
From 2003 to 2004, he was CEO of the Puerto Luperon Co., a luxury resort real estate development company. From 1990 to 2003, he was president, chairman and CEO of Infotrieve Inc., a global provider of content management technology and information services. He has also served as an advisor to various organizations in the United States, Europe and Australia. He holds nine Internet technology patents.