Course Title and Number: IST 455 Commercialization of Drugs, Biologics and Medical
Devices
Instructor: Dr. Elizabeth Murray
Course Description, Credits, and Prerequisites.
This online course will introduce students to the key components of the drug discovery
process and the steps leading to full regulatory approval. These are necessary steps to obtain
legal permission to market the drug. The examples used will include historical as well as current
examples of small molecule drugs, large molecule drugs, live and subunit vaccines including
recent products of the biotechnology/molecular biology revolution. The very important role of
preclinical and clinical trials will be stressed. Medical devices and biological
Credit Hours: 3
Prerequisites: IST 340 or BSC 322 or BSC 302 or instructor’s permission
Required Texts: Drugs: From Discovery to Approval by Rick Ng Wiley-Blackwell; 2 edition
(December 3, 2008) ISBN-10: 047019510X
Instructor Assigned readings and videos
Computer Requirements:
Access to a computer with Microsoft Office 2003 or higher, a web browser and high-speed
internet access and WebCT Vista.
Desired Learner Outcomes/Objectives:



Describe how new drugs and devices are taken from the laboratory to the marketplace
in the U.S.
Differentiate Phase I, II, III, and IV studies.
Understand the balance between medical benefit, medical risk, economic reward, and
economic risk in the decision making process as it relates to drugs and devices in
development.
After completion of this class, students will have demonstrated the following skills:


Knowledge of drug target identification and development.
A familiarity with the FDA regulatory requirements for medicinal products and relevant
online information resources. Production of assay data of the necessary standards to
allow creation of compliant documents will be stressed. The requisite production steps,
assay procedures, and inspection/audit procedures involved will be discussed and


critically assessed. The complexities of Product License Applications (PLAs) and the
hoped for Marketing Approval will be discussed.
Familiarity with research ethics, including human experimentation, conflict of interest
and Biosafety regulations.
Students will demonstrate competency in these skills through practice, case studies,
discussion, written assignments, and exams.
Evaluation/Measurement of Learner Outcomes:
The mid-term and final exams will cover all the online lecture content from designated weeks’
lecture notes and the required reading materials. They will consist of approximately 20 multiple
choice and true/false questions and three short essay questions.
Class will be presented online at times TBA or with formal class room lectures. Questions
submitted by the class online will be answered at a time/schedule TBA or in classroom.
Grading Policy:
A = 91-100 %
B = 81-90 %
C = 71-80 %
D = 61-70 %
E < 60 %
Weekly Topic Participation
Book Review
Drug/Biologics/Device Case Studies
Midterm Exam
Final Exam
10%
10%
30%
25%
25%
Class Policies:
Each week, you will be expected to:
•
Review the week's learning objectives
•
Complete all assigned readings
•
Read, listen to the instructor online or attend class lectures, and comprehend all lecture
materials for the week
•
Perform the weekly assignments for class participation in a timely manner.
•
For credit to be received work must be submitted by the assigned date or an extension
can be negotiated with the instructor under exceptional circumstances.
Attendance Policy:
Attendance at class is expected. Students will sign in or if online, participation will be date
stamped. Poor attendance will result in lowered grades.
Course Outline:
The schedule below is intended to give you a guide to the course.
Course Topic
Week 1 Introduction, FDA
History
Week 2 Identification of
Targets
Week 3 Small Molecule Drugs
Week 4 Rational Drug Design
Week 5 Large Molecule Drugs
Week 6 Preclinical Studies
Week 7 Clinical Trials
Week 8 Regulatory Agencies
Week 9 Working with the FDA
Week 10 cGMP Regulation
Week 11 cGMP
Manufacturing
Week 12 Future Issues
Week 13
Week 14
Week 15
Week 16
Drugs: From Discovery to
Approval
Chapter 1
Chapter 2
Chapter 3
Chapter 3
Chapter 4
Chapter 5
Chapter 6 Mid Term Exam
(Through PreClinicals)
Chapter 7
Chapter 8
Chapter 9
Chapter 10
Chapter 11
Devices and Diagnostics
Thanksgiving Break
Devices and Diagnostics
Final Exam