Assignment:
Based on the information provided below and discussed in class, prepare a 3 – 4 page report outlining recommendations for preparation and maintenance of an Investigational New Drug (IND) application.
Background Information:
Submission of an initial IND and ongoing IND maintenance, perhaps more so than most activities in drug development, require a high level of teamwork and collaboration. IND preparation is a prime example of how a diverse range of skill sets and expertise is necessary in drug development, as its contents include clinical, nonclinical, manufacturing, and administrative sections.
The IND allows a Sponsor to initiate and conduct clinical studies of investigational drugs in the United States. It allows a pharmaceutical company to negate a federal law set forth in the Federal Food, Drug, and Cosmetic Act, and ship an unapproved drug across state lines for clinical trials. Importantly, the IND should provide FDA the data necessary to decide if a new drug and clinical trial pose a reasonable risk to clinical trial participants. Getafix Pharmaceuticals is a small pharmaceutical company developing a compound it hopes to market someday for treating Alzheimer’s disease. With nonclinical studies completed, planned, and ongoing, GMP–compliant manufacturing underway, and a phase I clinical study protocol drafted, it is planning to submit an initial IND submission to FDA for its lead compound within a year. With limited resources and expertise, the company has requested your help as a Regulatory Affairs Consultant.
Prompt:
Outline operational and strategic considerations Getafix should take into account when preparing to submit its initial IND to the FDA. Within your plan, provide a brief introduction describing the indication and currently available treatment. Indicate whether you would recommend a Pre–IND meeting with FDA, and if so, describe the contents of required meeting material and potential goals of the meeting. Describe documentation required for initial IND submission and ensure Getafix understands the necessity of IND maintenance throughout drug development. Justify your recommendations by referencing applicable regulations from 21 CFR and advice from FDA Guidances and ICH Guidelines.
As the course proceeds, reflect on how what you learn in each class could be incorporated into a strategic regulatory plan that helps to guide a pharmaceutical company through various aspects of the drug development process.
