Many of the development activities leading up to the submission of an Investigational New Drug Application (IND) run concurrently.
Purification, analytical testing, characterization and formulation, for instance, are all moving forward at the same time as synthesis (small mol)/fermentation and cell culture (biologics). Sponsors frequently approach these activities in this order — perform experiments, develop processes and assays, followed by preparation and testing of clinical supplies, and finally the writing tasks.
A sequential approach, on the other hand, makes preparing an IND more difficult and is frequently the cause of filing delays or worse.
Based on experience operating with smaller emerging biotechs and the FDA, it was discovered that adhering to the following principles can greatly increase the chances of submitting an IND on time and successfully.
Image Credit: DS InPharmatics LLC
Construct from the start
Investigate the relevant FDA regulations/guidances and forms for an IND submission, which can be found on the FDA’s website, even before the start of the research phase, to analyze how the organization can best meet those requirements.
Companies that devote disciplined, systematic attention from the start are far more efficient in their approach to trial opening than those that choose to wait.
The science behind the drug, as well as its records, should be meticulous. It is not uncommon for products developed in discovery environments to lack a detailed, well-documented historical chain of events, and hazy origins can cause serious problems and fail to satisfy FDA reviewers.
Failure to plan, execute and produce the correct data from the start can cause problems and unnecessary delays.
Writing and document preparation should be consolidated with other development activities and organized by experienced technical writers and editors to reduce the time required for the chemistry, manufacturing and controls (CMC) section of the IND in particular.
The documentation should be new and, most importantly, accurate. There will be ample time to double-check if it is scientifically sound and meets a requirement.
Ensure sufficient documentation
Regulatory agencies will raise concerns if appropriate content items are missing or inconsistent all through the documentation. The same applies to insufficient details or data on the manufacturing method, container stability or sample testing.
When some companies find themselves in front of the FDA with insufficient data, they go into survival mode and uphold the product, asserting that the IND should be approved regardless. This runs the risk of losing all credibility with the agency.
Some sponsors wait until the very last minute to start working on the IND application. List the milestones as each of them is completed.
If the company has never written an IND before, it is better to find a professional contractor who is familiar with the issues that the FDA frequently raises.
This will be money well spent, as the IND document will be professionally prepared in accordance with FDA guidelines.
How to FILE the IND Application
About DS InPharmatics LLC
DS InPharmatics (DSI) provides regulatory, technical, and project management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.
Since 2007 we have provided our clients with innovative strategies and exceptional quality work products intended to enhance product development, approval, and marketing presence. Whether advocating CMC strategy, directing CMC operations or developing CMC submission content that represent the best interests of emerging biotech, we focus on the critical CMC issues and build programs that enhance development.
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