As biotechnology and pharmaceutical companies seek innovative solutions to expedite their timelines, efficient management of a clinical trial starts with strategic planning. Submission of an Investigational New Drug (IND) application is a major milestone in new drug development. It marks the transition from bench research to clinical studies in human participants. While awaiting the FDA Safe to Proceed letter for their IND, companies are able to take advantage of a Pre-IND labelling and packaging strategy for their clinical study by working with a CDMO operating out of Canada, such as PCI Pharma Services. In this article, we share insights into the IND application process, the benefits of applying a Pre-IND strategy utilising a Canadian-based CDMO, and how this approach can deliver reduced First Patient-In (FPI) timelines by 6–8 weeks.
Understanding the IND application process
Successful IND submissions require careful planning and compliance with FDA regulatory requirements and although not required, a Pre-IND meeting with the FDA is valuable. It is the company’s first opportunity to ask specific questions of an FDA review panel pertaining to their specific product, reducing the risk of a clinical hold and delaying time of product delivery to clinic. Pre-IND meetings provide early FDA feedback on regulatory and scientific issues relating to clinical trial design, non-clinical research, and product related CMC questions. The specific feedback will assist in future drug development plans and preparation for submitting a complete IND application.
For companies entering the Pre-IND phase for the first time, seeking support from an experienced CDMO with a specialist regulatory consulting team can prove to be beneficial. Not only can the CDMO team represent the sponsor company at FDA meetings, but they can also provide valuable insight and assist in preparing the meeting package to ensure it contains appropriate information, such as clear focused questions for the review panel to answer, product overview information, design of preclinical and/or initial IND studies, and appropriate clinical / manufacturing and quality control data.
In terms of the process, following IND submission the FDA will review the application within 30 days for safety and assess whether the human subjects are incurring an unreasonable risk. At the end of the review cycle, the agency will either issue a Safe to Proceed letter or inform the sponsor that the study is on clinical hold. If placed on hold, the FDA will provide an explanation within 30 days and the sponsor will need to address the noted deficiencies. Submitted responses will then be reviewed and the FDA will determine whether the hold can be lifted. If the sponsor does not hear from the FDA within 30 calendar days after the initial submission, the IND goes into effect or becomes active on day 31. At that point, the study may proceed as submitted once it has been approved by an Institutional Review Board (IRB) whose purpose is to ensure the protection of the rights and welfare of the clinical trial participants.