'Single author production' to an initial IND

I had convinced myself for a prolonged period of time that utilizing a single author system would be the superior approach for compiling an initial IND package, which required over 70 separate documents to be authored to ensure complete coverage.

Although confident in my ‘single author production’, I was not solitary. For several years, I had worked hard as a regulatory affairs manager or director to make progress in the initial IND applications in which expertise in three different areas (cmc, nonclinical and clinical studies) was demanded.

Engagement with the three different areas had begun with the readings of FDA guidance materials. I have to admit that the tireless history of understanding in multiple areas had cast a persistent doubt over my approach which had not been broken anyway.

My approach was reaffirmed (by myself) following the more IND packages made in success.

While I was there, no one in the regulatory service companies had any advertisers saying that we would certainly make progress by single author production on any IND packaging issue. Instead, all seemed to agree it could be done best by multiple writers system.

That might be correct, however, I would like to emphasize that single author production is bound to yield certain advantages.

A single author system has one experienced writer responsible for writing data to a document. The benefit of a single writer system is that it provides strong consistency guarantees, meaning that all readers see the same version of documents. Since there is only one writer, there is no possibility for conflicting updates, which simplifies the coordination and synchronization required for updates. I believe maintaining consistency is crucial when preparing an IND package, where multiple documents are compiled under a single topic to support.

On the other hand, multiple writers system can offer higher write throughput and better scalability, since multiple writers can write to the system in parallel. This approach is often used in mass production, where multiple IND packages need to be written within a shared time frame. Thus, ensuring consistency in a multiple writer system can be more challenging, and conflicts between concurrent writes must be carefully managed to prevent inconsistencies.

An additional benefit pertains to the costs. One of the most common ways to save costs in a business is by reducing the amount of labor required to perform a task. The single author system is designed to focus on one or two IND packages. From the user or sponsor's point of view, it can bring quality improvement at a rather low cost.

To sum up, opting for a single author production offers benefits rather than risks. I say this in a sincere heart, having acted as a single author for several initial IND projects.