Good Manufacturing Practices and Regulatory Affairs for Engineers

Course: Good Manufacturing Practices and Regulatory Affairs for Engineers
Core Bioengineering course for juniors, 1 credit

In this jigsaw activity, students learn the FDA requirements for an Investigational New Drug (IND) application for a biologic drug. (IND approval is needed for a company to initiate clinical studies in humans, and is a key milestone in the drug development process.) The topics covered in this activity include: (1) Clinical study requirements and protocols, (2) Chemistry, Manufacturing, and Controls (CMC) for early-phase clinical products, (3) Current Good Manufacturing Practices for early-phase clinical products, and (4) Basics of pharmacology and toxicology.

One 50-min was given prior to the assignment to provide students with an introduction to clinical trials and the chemistry, manufacturing, and controls (CMC) aspects of drug development. Just after the assignment was given to the students, a 5-10 min overview lecture of key unit operations in biologics manufacture was provided. The assignment itself included references (links to websites) for FDA regulations and guidances, which the students would need to read to answer the questions.

For this jigsaw, the students work for a hypothetical biotech company called "TherAmaze", which is developing "WonderDrug", a potential biologic treatment for pancreatic cancer. The students are told that TherAmaze has a team of crackerjack scientists and engineers who know a lot about bioprocessing, but very little about FDA submissions. They have hired their student team (the “home group”, consisting of 4-5 students) of regulations experts at "RegExp Inc". to ensure that TherAmaze completes all the work needed for the IND. The team at RegExp has at least one subject matter expert (SME) in one of the “expert groups”, each of which covers the four topics listed above.

The key steps of the exercise, as given to the students, are as follows:
Step 1 (in-class): Meet with your assigned home group. Assign SME’s in your home group.
Step 2 (Start in-class. Finish out of class.): Meet with your expert group. Answer the questions assigned to your expert group.
Step 3 (in-class): Reconvene with your home group. Each SME will do a “teach back” on the relevant sections of the IND. Begin to answer the home group questions.
Step 4 (out of class): Each home group will write a report that answers all the Expert Group and Home Group questions listed in the assignment.

Each home group submitted a report with answers to the expert group questions and home group questions. The expert group questions were used to evaluate the students’ knowledge and understanding of FDA guidances. (Examples: What is an IRB? What is the function of an IRB?) In the home group questions, the students had to apply the information in the guidances and write mock IND sections. (Example: Design a hypothetical Phase I clinical study. Be sure to include the number of patients, patient criteria, who the investigators are, and IRB requirements.)

This assignment was worth 30% of the overall grade in this 1-credit class. Students were given two 50-min class periods to work on this assignment. The rest of the assignment needed to be completed on their own time.