IND document preparation starts with the understanding that the application must be written in eCTD format which is comprised of five modules:
Module 1. Forms, cover letters, investigational labels, investigator brochure, and other region specific documents.
Module 2. Overall and tabulated summaries and an introduction.
Module 3. Information on chemistry, manufacturing, and controls (CMC).
Module 4. Non-clinical study reports.
Module 5. Clinical study reports, clinical protocol, and investigator information.
IND document preparation then is just a matter of assembling this information, right?
You could approach it that way. Or, you could work to make your document one that facilitates the regulators’ reviews and work and thereby helps speed your drug development path towards approval. We recommend the latter. Here are a few tips to get you started:
Create a Style Guide
Before you start to write even one IND module, create a style guide. That simple task will go a long way toward adding professionalism and order to your documents and overall application. It will address questions like which font should be used and how many spaces should be allowed between sentences. It will also help to make the work of numerous contributors look like the work of a single individual — one with good editorial skills.
Build and Maintain It Well
The IND is a living document, so you want to set that file up correctly at the outset and maintain it faithfully over time. Remember that when you change something in one document, it might impact 10 others. Check and update as necessary. Note that if you develop a well-organized, well-edited IND, you will have a much easier time turning it into a quality NDA or BLA or even an MAA.
Be judicious with what you include. If you go overboard with documents, throwing in everything multiple times, it will be a bigger challenge to ensure everything is consistent.
When an IND is unduly long, it makes for more challenging publishing, too.
Make It Easy for Your Reader
You don’t want your reviewers to struggle in any way while reading your document. You want them to be able to breeze through it and give you the green light to move ahead. Keep that in mind, too, as you consider how much content to include. Overkill is burdensome for your readers, and may slow down their response. Conversely, multiple reviewers of different disciplines will be reading your application, so too little information or summarization can make it challenging for the FDA Review Teams. A balance of the right amount of information is key!
Be careful and thoughtful about your hyperlinking. Don’t hyperlink to every data point. When you do hyperlink, be certain it’s to the correct location. These small things add up to a document that is either satisfying or irritating.
Leave Enough Time for Publishing
You know how it goes: Deadlines are missed. Timelines get revisited. And those tasks scheduled at the end of the line get squeezed. Don’t be tempted to compress the time for publishing too much. Errors in publishing is one of the easiest ways to end up with an invalid application.
Consider Your Long-Term Goals
Consider that you should probably approach your IND differently depending on what you plan to do with your development program. If yours is a company that wants to sell its intellectual property, you may wish to put a different emphasis on some of the components and messaging than if you are a company that is planning to take its drug to phase three. Working with an experienced consultant will give you an advantage in structuring your story to best support your objectives.
Think of the Regulator As Your Customer
Your ultimate customer may be the patient, but while you’re preparing your IND application, your customer is the regulator. You can gain critical good will by being thoughtful and data driven about the documents that you put in front of the regulator. In our experience, the FDA can be truly appreciative of a well prepared and data driven document. (Quotes include, “Wow, this is a really easy read” and “Thank you for organizing this so well.”) Strive to make quotes like these a reality for you and your team.
The IND is generally your first opportunity to make an impression on a regulator. Make it the best possible.