Book description
Case study details the right way and the wrong way to successfully
develop and market a new drug
Beginning with the untimely death of a young mother, A History of
a cGMP Medical Event Investigation unfolds a fictitious case
study that captures how unchecked human flaws during the development
and launch of a new drug can lead to disastrous consequences.
Moreover, it illustrates how and why Six Sigma principles and methods
should be applied to fully comply with FDA regulations at every stage
of drug development and commercialization.
From initial transgenic mouse studies to the FDA fatality
investigation, this case study introduces all the key regulations and
practices that govern the development, manufacture, and marketing of a
new drug, including:
- FDA Investigational and New Drug Application Processes
- FDA Code of Federal Regulations' current Good Manufacturing
Practice (cGMP)
- ISPE Good Automated Manufacturing Practice (GAMP)
Readers will also be introduced to a variety of managers and
researchers whose personal agendas conflict with best practices and
therefore compromise the safety and effectiveness of a new drug
product. Throughout the case study, the author offers tested and
proven practices and tips so that these human flaws are not translated
into drug product flaws. These practices and tips are critical and
typically can only be learned through years of experience working in
competitive drug development environments.
A History of a cGMP Medical Event Investigation is ideal for
students in biotechnology, pharmacology, engineering, and business
management as well as professionals in biomedical and drug
development. All readers will discover what can go wrong in developing
and bringing a new drug to market. Most importantly, they will also
learn how to apply Six Sigma principles and methods to ensure safe and
effective product design, development, and manufacturing.
MICHAEL A. BROWN, PhD, PE, is a Visiting Professor at the
University of Illinois at Chicago. Dr. Brown has twenty-five years'
experience in the biomedical industry in a product and process design
capacity with responsibilities for worldwide engineering and
management. He has served as a lead engineer on numerous products,
process, and equipment projects including design, implementation, and
qualifications. He is a registered Professional Engineer and a
certified Six Sigma Black Belt with considerable experience in team
leadership. The material presented in this case, including the FDA
regulations and Six Sigma concepts, was tested in an engineering
senior design course taught by Dr. Brown over a three-year period.
Student feedback noted that the difficult design principles were
explained in an easy-to-read story that introduced them to the Six
Sigma methodologies in an engaging manner.
