BIRS Blog: Stephen Byrn, Professor, discusses how the ABE 51100 Drug Development course plays a role in "getting things right the first time."

BIRS Blog: Stephen Byrn, Professor, discusses how the ABE 51100 Drug Development course plays a role in "getting things right the first time."

Purdue University Biotechnology Innovation and Regulatory Science (BIRS) Program ABE 51100 Drug Development Course Offered: Fall semesters

By: Dr. Stephen R. Byrn, a Charles B. Jordan Professor of Medicinal Chemistry in the College of Pharmacy, Purdue University, West Lafayette, Indiana.

The Biotechnology Innovation and Regulatory Science (BIRS) program at Purdue University represents an outstanding degree opportunity that can super-start your career. BIRS offers a four-course graduate certificate consisting of drug discovery, good regulatory practices, quality, audits and inspections, and the molecular basis of manufacturing. These four courses result in a Biotechnology Quality and Regulatory Compliance (BQRC) graduate certificate issued by Purdue University. These courses can also be used toward the Biotechnology Innovation and Regulatory Science (BIRS) master's degree. Students have commented:

 "These four courses expose me to many important areas. It would take me years to rotate through each of these areas in my company or regulatory agency. By taking these courses, I can learn valuable information rapidly."

ABE 51100 Drug Development Course Content

We offer the drug discovery course (ABE 51100) to a new cohort of students every fall semester. Drug discovery is a unique course developed almost 20 years ago by a collaboration between the medicinal chemistry department at Purdue University and scientists from Eli Lilly and Abbott. This course emphasizes the regulatory and innovation aspects of drug discovery. The course covers how drugs were discovered, screenings, the discovery of biologicals, and regulatory aspects of this area. The course also addresses animal preclinical research and human clinical research. In addition, the process for assembling an IND and NDA is discussed along with Phases (I,II,III) of human clinical trials. The CMC (chemistry manufacturing and control) aspects of drug development are presented along with ICH documents and manufacturing process analytical technologies. The course concludes with a brief review of international regulatory issues and patents.

Getting Things Right the First Time

This course also aims to provide education on the important aspects of Drug Development as it relates to biotechnology innovation, regulatory affairs, and quality control and quality assurance. Individuals completing this course will be able to describe information about biotechnology drug development and innovation and explain how this information relates to the discovery and registration of drugs. Modern biotechnology companies must conduct drug discovery, development, and sales in a highly regulated environment with competition and pricing pressures increasing. Integrated management systems for biotechnology innovation, discovery, development, quality control, quality assurance, compliance, and business improvement are critical elements for success in this complex and evolving environment. The cost of poor quality and non-compliance penalties are unacceptable in today's drug development business. Knowledge of effective manufacturing principles and practices is critical to getting things "right the first time".

Additional Information: The online course consists of 16 weeks of instruction interspersed with 3 to 4 synchronous sessions to facilitate the completion of the assignments. The instructors for the course are Professors Stephen Byrn and Kari Clase.

If you are interested in enrolling in this course or learning more about the BIRS/BQRC programs, contact Mary Speer at