Assignment:Based on the information provided below and discussed in class, prepare a 3 – 4 page reportoutlining 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 activitiesin drug development, require a high level of teamwork and collaboration. IND preparation is a primeexample of how a diverse range of skill sets and expertise is necessary in drug development, as itscontents include clinical, nonclinical, manufacturing, and administrative sections.The IND allows a Sponsor to initiate and conduct clinical studies of investigational drugs in theUnited 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 areasonable risk to clinical trial participants.Getafix Pharmaceuticals is a small pharmaceutical company developing a compound it hopes tomarket someday for treating Alzheimer’s disease. With nonclinical studies completed, planned, andongoing, GMP-compliant manufacturing underway, and a phase I clinical study protocol drafted, it isplanning to submit an initial IND submission to FDA for its lead compound within a year. With limitedresources 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 preparingto submit its initial IND to the FDA. Within your plan, provide a brief introduction describing theindication and currently available treatment. Indicate whether you would recommend a Pre-IND meetingwith FDA, and if so, describe the contents of required meeting material and potential goals of themeeting. Describe documentation required for initial IND submission and ensure Getafix understands thenecessity of IND maintenance throughout drug development. Justify your recommendations byreferencing 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 astrategic regulatory plan that helps to guide a pharmaceutical company through various aspects of thedrug development process.

Although business letter format is appropriate for Writing Assignment 3, please include a list of references that matches numerical or parenthetical citations provided within the letter- just as you have done for the previous two writing assignments.

For Writing Assignment , imagine you are a Regulatory Affairs Consultant recently hired by a small pharmaceutical company developing a compound it hopes to market someday for treating Alzheimer’s disease. With several nonclinical studies completed, planned, and ongoing, GMP-compliant drug substance and drug product manufacturing underway, and a phase I clinical study protocol drafted, the company is planning to submit an initial IND to FDA within the upcoming year. Construct a business letter to a representative from this organization that outlines strategic and operational considerations the company should take into account when preparing its initial IND.

In the introduction, indicate your enthusiasm and excitement for working with the organization towards this exciting milestone. Consider providing a few sentences on the indication and currently available treatment to highlight the importance of this particular development program, and congratulate the organization on its admirable work in this challenging therapeutic area. Following the opening paragraph, I would recommend dedicating each of the following paragraphs to a particular aspect of product development (e.g. nonclinical, clinical, CMC, safety, pre-IND meeting with FDA).

For the nonclinical section of your letter, explain which studies you would expect to have been completed at this point in development, and which ones you would have expected to be GLP-compliant. Indicate which ones may be conducted later in clinical development with an effective IND already in place. Describe which nonclinical documents you will help the company to incorporate into an initial IND, and where these documents would be included within the submission.

For the clinical section of the IND, I would recommend covering important documents like the Form 1572, CV, medical license, informed consent form, and clinical study protocol. You may want to ask the organization if it had completed any clinical studies on its product outside the US, so that available clinical study reports could be incorporated into the initial IND.

Although the pre-IND meeting was not detailed specifically during the IND lecture, please feel free to explain to the reader the purpose and objectives of this meeting. In doing so, you may describe the processes for securing the pre-IND meeting with FDA and ensuring the meeting is as productive and informative as possible.

In the manufacturing section of the letter, consider explaining the importance of demonstrating drug substance and drug product quality. Indicate the characteristics of product quality (e.g. identity, purity, stability) and explain which information and documents would be needed in the initial IND to help FDA evaluate whether the manufacturing processes and controls are fit for reliable production of quality API and drug product. Concepts like specifications, analytical procedures, and stability studies should be incorporated into the letter. Critical application of course material to the assigned topic (e.g. describing the relationships between stability data, nonclinical study results, and clinical study protocol) would be demonstrated in a strong letter.

In the conclusion, I would recommend reiterating the purpose and importance of the initial IND submission, as well as explaining the necessity of IND maintenance throughout clinical development. Reinforce to the reader how you are well-qualified to lead the organization not only through the process of an initial IND submission, but also continued IND maintenance through a wide range of IND amendments. Throughout your letter, justify your advice by referencing applicable regulations from 21 CFR and suggestions from FDA Guidances and ICH Guidelines. As the audience for this letter is a client you will be collaborating with closely on an important project, the writing must be professional, courteous, and clear.