For this project management Assignment, You just received confirmation that your drug successfully met Phase 2 end points. Your presentation to senior leadership was endorsed and the budget was approved. As the Technical Leader for this drug development project you are now required to develop the project plan. Identify 3 major milestones (3 paragraphs, where a paragraph is 5 sentences) your team will have to accomplish in order to prepare for submission to FDA.

Provide your rationale on the criticality of each of these milestones to meeting the CMC (chemistry, manufacturing controls).

Textbook: New Drug Development: A Regulatory Overview ( Mathieu) 8th Revised Edition. Chapters 10, 11 & 14

ANSWER

Applying project management Assignment

Pre-clinical Research

After getting approved by the board and the idea being positively received, the next step before submitting to the FDA is finding out whether the drug can cause serious harm. This involves testing the drug on animals. There are two types of pre-clinical research; in vitro and in vivo (FDA). Pre-clinical research involves guinea pigs and arts as the research subject. It is not usually large, but the studies have to provide enough information on the dosing and the level of toxins in the drug. After this testing, the researchers review the findings and decide if the drug is safe to be tested on people.

Clinical Research

Pre-clinical research answers the basic questions about the safety of a drug. Clinical research involves trials involving human beings. It is meant to examine how the drug interacts with the human body. Clinical trials are more advanced than pre-clinical trials as they involve human beings (DiProspero, 2021). The processes in clinical trials involve finding the right candidates to take part in the trial, the number of people in the trial, and how long it will last. Clinical trials also have different phases. This is done to ensure that the drug is completely safe for human use.

FDA Drug Review

After the first two processes and the drug is proven to be safe for its intended use, the company then files for an application to market the drug. The FDA review team thoroughly reviews all the data submitted on the drug before deciding whether or not to approve it. The new drug application has all the information concerning the drug. The drug has to prove that it is safe for its intended population (Revive). The drug developer has to include everything about the drug. This includes pre-clinical data to phase 3 data trial. The FDA uses all this data to decide whether the drug is safe for use or not.

Applying project management Assignment: References

DiProspero, D. (2021). The basics and the process of drug approval. https://www.crbgroup.com/insights/pharmaceuticals/drug-approval-process

FDA. The Drug Development Process. https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process

Revive. Chemistry, manufacturing, and controls (CMC). https://revive.gardp.org/resource/chemistry-manufacturing-and-controls-cmc/?cf=encyclopaedia#:~:text=Definition%3A,quality%20and%20consistency%20during%20manufacturing.

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