• ASSIGNMENT AVAILABLE: Week 3
• ASSIGNMENT DUE:
• ASSIGNMENT LENGTH:

o 5-7 written pages including references but NOT Including figures or tables, double- spaced

• DELIVERY TO INSTRUCTOR: Via Canvas link for Written Assignment #1

Assignment description:

In completing Writing Assignment #1 for RGA6212 students will have the opportunity to:

• Demonstrate an understanding of the basic principles of what encompasses safety science with respect to drug/biologics development
• Demonstrate an ability to extract and interpret safety-relevant information form the publicly available FDA Drug Approval Package Information
• Demonstrate an ability to describe/analyze safety information for an approved drug/biologic/device

For this assignment, you are a Sr Manager of Regulatory Affairs at a small, emerging biotechnology company that is looking to develop a new, inhaled treatment for Parkinson’s Disease. Your company is very small and inexperienced and so far, none of the nonclinical safety testing or clinical testing of this new drug has begun. As your team members prepare to start nonclinical safety testing and then clinical testing of the drug, it is your task to provide your colleagues with a summary of how nonclinical and clinical data is used to inform the development of safety information about your new Parkinson’s disease drug. You also need to provide your colleagues with background information on the regulatory aspects of safety monitoring, using the safety guidance provided by FDA and ICH.

During your research to learn more about drugs that treat Parkinson’s, you discover that there is already a marketed product for Parkinson’s that is also administered by inhaler. The already approved drug is called Inbrija (also known as CVT-301 – the research code name). This is great news! You can use this similar, already-approved drug as a comparison for your investigational inhaled therapeutic for Parkinson’s.

There is a lot of information your company can learn about how to safely develop your planned novel Parkinson’s therapeutic by studying the FDA’s published NDA approval information located on the FDA’s database of approved products: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/209184Orig1s000TOC.cfm (Links to an external site.). Specifically,

you can learn a lot about the safety information that was included in the NDA for Inbrija by reviewing information contained in the following FDA Application review Files:

Your task is to provide the following information to your colleagues (incorporation of figures and graphs HIGHLY encouraged):

1. Part 1: Background information:

1. Overview of Safety Basics: A description of the basic principles of generating safety information about drugs/biologics (see Module 2/Week 2 Lecture and related materials) from nonclinical and clinical studies that are relevant to a drug’s development. You may wish to include a description of why safety monitoring is a critical component of nonclinical and clinical development of a drug so that your colleagues fully understand the importance.
2. Regulatory information: Describe for your colleagues the different ICH and FDA guidance documents that are available to help you navigate the regulatory requirements with respect to safety monitoring from the nonclinical and clinical development perspectives. The ICH’s M3(R2) (Links to an external site.)(see week 1 reading) is a useful tool that you can describe for your colleagues to help them understand nonclinical safety requirements that must be completed prior to and during clinical testing of the drug. You can also navigate to the FDA’s Safety Reporting requirements for INDs (Links to an external site.)(see week 3 reading) and describe some of the requirements for clinical safety

2. Part II: Pulling out relevant examples from the Inbrija FDA approval package

1. Nonclinical safety information: Using the “Pharmacology Review” file for Inbrija’s NDA approval package, describe what kinds of safety pharmacology and general toxicology studies that were run. You can describe the number of studies in each nonclinical safety category as well as what species they were run in and the basic results/findings of these studies. You are encouraged to include tables and figures from the Pharmacology Review in your written summary, just be sure to include

1. Clinical safety information: Using the “Medical Review” file, describe some of the safety information that was generated as part of the clinical trials that were implemented when Inbrija was being developed. You should include a brief list/description of all the clinical trials that were

1. Part III: Conclusions: This section should be at least one paragraph and should work to summarize next steps for your company with respect to developing the nonclinical and clinical safety program for your novel Parkinson’s disease

We will review this assignment in weeks 1,2, and 3 and I am available by email to answer any questions you have regarding the assignment.

The entire assignment should be 5-7 pages of content (including references). Any graphs or figures that you choose to include must be properly cited and do not count against your page count. Please submit your assignment through the link provided in Canvas. Please remember that this assignment is worth 15.0% of your final grade for the course. Late submissions will not be accepted without prior permission of the Instructor.

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