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April 2011

How to Avoid Common IND Submission Pitfalls

by Meredith Brown-Tuttle
RAC, Chairperson of the RAPS Publication Board

An Investigational New Drug Application (IND) is like an orchestra - it brings together many players with different specialties that need to work together in harmony to create a synchronous melody (in the case of the orchestra) or message about the compound (in the case of an IND). With one instrument out of tune or with one musician who does not play his or her part there will most certainly be a displeasing sound to the ear and a composition that is thrown off. The same can be said for a section of the IND that does not support the safety of the compound. Keeping the instruments tuned and working together in harmony is comparable to the job of the regulatory group who will, in concert with project management, conduct the IND orchestra. However, keeping everyone in tune, while playing at the same time, and keeping everyone moving toward the same goal of an IND submission can be a challenge with many "sour notes" hit along the way. However, these sour notes can be avoided if everyone is playing the same sheet music and everyone knows how to avoid common INC submission pitfalls.

Broadly, the IND requirements are divided into 11-12 sections, depending on whether or not you are using the traditional IND format described in 21 CRF 312.23 or if you are transferring the requirements to the CTD format. The ultimate goal is to demonstrate safety of the compound through conducting pharmacology, pharmacokinetic and toxicology studies and the judicious use of the compound in initial human studies via a well vetted study protocol.

Many disciplines contribute to the components of the IND. With each discipline there are certain challenges that consistently occur within each department—across all companies—big and small. Table 1 gives an overview of the challenges presented by each department based on their IND contributions while Table 2 goes into depth about the specific IND myths and challenges and the proposed solutions for a more harmonious IND process.

Arming the IND team with the information presented in this article will help each team member understand their personal "blind sides," shed light on common IND myths and help to eliminate discord in the planning stages of an IND. That way, the real focus is on an effective IND, and subsequently, the ability to to initiate human clinical trials and bring therapies to those in need.

Don't understand the importance of an overarching strategic document (e.g, a package insert)? Underestimating the resources and time needed to publish an IND? Finding it difficult to understand a regulatory Division's culture and the types of issues and question that will be asked? Refer to this article and find out more.

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