The eCTD summit

Today’s blog features a guest posting by Dr. Shannon Strom, Senior Regulatory Specialist at Cato Research.

Acceptance of electronic submissions by small to mid-size early-stage pharmaceutical companies has been characterized by a slow, but steady, conversion to the eCTD standard, and nowhere is that fact more evident than in the rate of IND conversions to eCTD format.  According to the FDA, 52% of original marketing applications and 83% of efficacy supplements are received in eCTD format, but only 12% of original IND submissions are in eCTD format.   However, the FDA’s numbers also offer positive signs for the future.  While the percentage of original INDs submitted in eCTD format remained stable from FY 2008 to FY 2009, the number of IND amendments in eCTD format nearly doubled, indicating that companies are beginning to understand the benefits of electronic submissions.   

Small to mid-size pharma companies most frequently cite infrastructure requirements as the reason to delay conversion to electronic submissions.  For a small or early?stage organization with limited budgets and internal resources, the expense of purchasing electronic submission software, including the implementation and validation effort, can be overwhelming enough to wait until the FDA or other global regulatory authorities require electronic-only submissions.  After the software is purchased, installed, and validated, a company must also make another investment in hiring a regulatory submission specialist with experience in electronic submissions or providing training to existing regulatory affairs resources to actually create and review the electronic submissions.  Additional infrastructure considerations may include implementation of an electronic document management system, on-going validation requirements for software updates, implementation of standardized document templates, and training of medical authors to write for electronic submissions.  It’s no wonder why electronic submissions can be so easily delayed by corporate management until strong convincing data justifies the investment.

But this “wait-and-see” type attitude ignores the very real benefits of electronic submissions for small firms.  The FDA has stated repeatedly that the eCTD is their preferred format for both INDs and marketing applications, and that the review process is significantly facilitated by the automatic processing of sequences through the Electronic Submission Gateway.  Large pharma companies have, for the most part, already made the transition to, or are actively engaged in, the transition process to electronic submissions.  A product portfolio that already contains an electronic regulatory submission can be more attractive to a large pharma company than a paper-based regulatory dossier because the time and effort to convert the submission to electronic format is saved.  Therefore, it’s within a smaller company’s best interest to develop electronic dossiers as soon as possible. 

Software providers have developed very cost- and time-effective solutions to minimize the impact of electronic submissions on existing corporate infrastructure and business goals.  The best solution for some companies may be to outsource some, if not all, of the components of the electronic submission process.  One of the more innovative solutions in the last few years has been to utilize Software as a Service.  In this business model, the submission software is “rented” as a hosted solution from the software vendor to minimize the internal infrastructure requirements and the validation effort and to maximize the time spent on creation of electronic submissions. 

In summary, the transition to electronic submissions for IND-phase submissions can be difficult, but represents a real economic and time-effective choice for innovative early-stage companies.  

Cato Research is a full-service CRO with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them.  One of Cato’s specialties is outsourced regulatory publishing, and they bring considerable expertise and experience to creating and maintaining NDAs, BLAs and INDs in the eCTD format.  For more information about Cato’s services, contact Christine Warrington at 919-368-5995.  Also check back for a URL to Cato’s new blog, which will be launched shortly.