Senior Manager of Global Regulatory Affairs for Wyeth discusses the implementation of eCTD and selecting the proper vendor.
After a roundtable discussion on eCTD implementation that brought together early implementors from around the industry, Applied Clinical Trials sat down with Valerie Mackner, senior manager of global regulatory affaris for Wyeth Research, to get her take on the discussion and the details of eCTD implementation at Wyeth.
Q:How long has Wyeth been submitting in eCTD format?
A: Wyeth has been submitting in eCTD format since 2003.
Q:You mentioned during the discussion that Wyeth is moving from an in-house eCTD software to an off the shelf one. Why is the company making this move?
A: Wyeth’s core business is drug development, not software development. When we started submitting in eCTD format, software options were limited so we had to develop our own tool. Now that there are options available that are competitive with or surpass our eCTD software in terms of publisher and viewer benefits, we can move toward an off the shelf solution. This will allow us to align our staff more to our core business.
Q:You noted flexibility as a benefit of using an in-house eCTD software, so why not just upgrade your in-house software?
A: Following on from my previous response, upgrading and supporting software takes a lot of time and energy. We will upgrade our tool until a suitable off the shelf replacement is identified, then refocus resources on supporting our core business.
Q:What benefits of using in-house software will the company be losing?
A: Almost instantaneous resolution to technical issues, and the customization to how Wyeth does business.
Q:What goals is the company hoping to achieve in making this transition?
A: To increase publishing efficiency and quality of our submissions; to allow users to have a better representation of what the health authorities see when they review a submission; to free up resources spent on in-house software upgrades in order to focus on software integration efforts.
Q: Other members of the discussion today mentioned they would have liked to involve the authors and publishers in the vendor selection process. With that in mind, who at Wyeth is involved in the selection process of an off the shelf eCTD software?
A: For Wyeth, our selection effort is being led by the Regulatory publishing group. Included in the requirements gathering are representatives from the Regulatory liaison, Information Technology, and Authoring communities. We are not at the point of selecting a vendor just yet, but intend to include these representatives during the assessment process prior to the final decision-making.
Q: A vendor’s history of hitting targets, plans for upgrades, and their level of experience in what they’re implementing were just a few types of criteria for selecting a vendor that discussion members contributed. What criteria will you and your company be considering in its selection process?
A: In addition to above, we will consider the level of customer service that is promised from technical and training support (during and after business hours)-the vendor’s reputation in the Industry for promptly responding to queries and resolving issues.
Q:Carol Rutkowski, senior director of global regulatory operations for Shire Pharmaceuticals mentioned today that certain vendors will sell a software and a completely different person will implement it. Considering that point, what particular characteristics are you looking for in the selected vendor?
A: I will be looking for constant(s)-at least one to two people from the vendor side to be involved with the whole process, who understand the requirements, configuration, implementation, and training and can link all of the parts together.
Q:How have the other companies’ experiences you heard today during the discussion influenced your selection criteria, if at all?
A: I think the panel discussion reinforced my criteria, and I am therefore more confident about narrowing my vendor list down to a few who have demonstrated experience in planning and implementing eCTD solutions.
Q: What challenges in the implementation process are you hoping to avoid and what steps are being taken to prevent them?
A: Performance issues (as Wyeth has multiple sites globally). Integration issues with our configuration of Documentum and other systems. In the past, we have seen these types of issues when deploying a solution globally. To prevent them, we will require that the vendor has done appropriate load testing (with documents, users, attributes, etc).
Q:What changes or effects are you anticipating on the internal processes already in tact once this transition in software takes place?
A: Best practices, publishing SOPs, and processes that specify our current in-house system will need to be revised, and rolled out in our training curriculum.
Q:Carol Rutkowski also had mentioned how critical it has been to have an in-house trainer at Shire. Has Wyeth discussed or considered having an in-house trainer?
A: Wyeth has an in-house trainer, who provides support for our current eCTD software, and whose resources will be utilized when it comes time to prepare a training process, materials, and exercises for an off the shelf software.
Q:Several discussion members noted that some countries still do not accept or pay mind to the eCTD format. What is your experience with the level in which eCTD is actually standardized?
A: eCTD is standardized for the most part according to ICH specifications across the countries that have adopted using it (US, EU, CA, Japan); and others that are in pilot phase (Switzerland, Australia) are starting to follow suit. By standardized, I am referring to the fact that the overall organization of the dossier is consistent throughout Modules 2–5. Module 1 is where most of the regional information is and therefore would not be standardized, but there are other regional requirements that make the content not standard (such as inclusion of CRFs, listings, and datasets).
Q:While Wyeth is in the beginning of a transition, it has submitted in eCTD for some time. What advice would you give to companies moving from paper to eCTD?
A: Realize that the skill sets needed to publish paper and eCTD are different. It is important to hire and train people with the right skill sets to manage eCTD-individuals who are not only technically savvy but also understand lifecycle in terms of the applications they are supporting, who are willing to accept change management, who will lead others in the organization who are unfamiliar with eCTD and champion them through the years of challenges that come with transition.