You are a Sr Manager of Regulatory Affairs at a small, emerging biotechnology company that is looking to develop a new treatment for people with bad cholesterol. The treatment is a drug/device combination product called "LOCOR" a lipid-lowering medication.  The treatment is a new type of statin.
A statin is a class of lipid-lowering medications that reduce illness and mortality in those who are at high risk of cardiovascular disease.
Describe the regulatory requirements for an Investigator's Brochure and examine the requirements of an Investigator's Brochure (IB) to pull out ensure we highlight key safety information to help guide the company in the development of the IB for LOCOR.
 
Your Executive Brief should have the following sections:
1. Title and purpose of the brief
· Briefly describe why you are developing this document and how you think it might help
in the creation of the IB for "LOCOR".

2. Intended audience  
· Based on our discussions in class, what members of your company should be sure to
read this brief?
3. Description of E6(R2) Section 7: Investigator's Brochure
 (ICH GCP - 7. INVESTIGATOR'S BROCHURE: ICH E6 (R2) Good clinical practice)
· What is E6(R2) and how does it relate to safety science application in drugs/biologics?
· What does E6(R2) say about the composition, audience, and lifecycle of the IB?
· What kinds of safety information is contained within the IB and what are some of the
key sections?
4. Analysis of the ZOCOR PRESCRIBING INFORMATION  
Nonclinical safety:
· What are some of the key nonclinical pharmacology findings of nonclinical studies of ZOCOR?
(Example: Effects of body weight?  Fat mass? Cardiovascular safety?)
· How many toxicity studies were conducted and in what species?
Clinical Safety (Effects in Humans)
· What is the intended indication of ZOCOR?
· Summarize the Absorption, Distribution, Metabolism, and Elimination of ZOCOR
· How many Phases 1, 2, and 3 studies of ZOCOR have been run so far?
· What kinds of drug-drug interactions have been observed with ZOCOR?
· What is the overall benefit-risk profile of ZOCOR at this stage of development?
· Summarize 1 or 2 expected AEs and describe why these AEs are considered expected for    
ZOCOR
5. Suggestions for the DIAB-320 IB writing team
· What recommendations do you have for your team in order to help them draft a compliant,
accurate IB for LOCOR?