Description: Discussions on the requirements for an initial IND allowing a first-in-man study always results in a wide array of opinion regarding the contents of the submission, specifically the quality (chemistry, manufacturing, and control) and toxicology (pre-clinical) sections of the submission. Thoughts range from providing extremely detailed information to providing somewhat general text, with little thought to the continuing quality and clinical development required in drug commercialization. Determining the right quality data, the correct pre-clinical studies, and an appropriate clinical protocol with key therapeutic endpoints will assure not only a submission that meets regulatory requirements for an initial clinical trial but will also assist in achieving the desired prescription label. Authoring an IND that meets regulatory requirements and industry standards provides assurance to regulators that the sponsor has a robust development plan and the right team to undertake that plan. This session will provide examples of the details required, the quality data necessary, required toxicology studies, and the development strategy to file an initial IND application. Included will be discussions on the initial molecule selection, pre-clinical development, requesting feedback from the FDA, a Briefing Document, meeting and communicating with the FDA, authoring an initial IND, and responding to FDA questions. Anyone who is new to regulatory, who is considering filing their first IND, or who would like to investigate other approaches to what data to include in an initial IND filing would find this session thought provoking. Everyone who leaves this session should have a better understanding of regulatory requirements and industry standards that, when utilized, result in a successful IND application.
Upon completion, participants should be able to describe the regulatory requirements and industry standards that are used in the authoring of an IND application.
Upon completion, participants should be able to describe at least three common sense points to remember while establishing a constructive working relationship with the FDA.
Upon completion, participants should be able to describe the details of the Quality and Preclinical sections of an initial IND.