Instructors
Ed Elder
Credentials: PhD in Pharmacy
Position title: Director, Zeeh Pharmaceutical Experiment Station, UW-Madison
Zeeh Pharmaceutical Experiment Station
School of Pharmacy
Colleen Adams
Credentials: MTSC
Position title: Senior Director, Regulatory and Clinical Affairs, Waters Corporation
Adjunct Professor, M.S. in Biotechnology Program, UW-Madison
Nick Caruccio
Credentials: Ph.D.
Position title: Vice President and General Manager, Illumina-Madison (former)
Course Overview
crb820: Biotechnology Operations
Year 1, Spring Semester (4 credits)
To succeed, biotechnology companies must juggle a host of complex technological and managerial functions.
This course takes a close-up look at seven interdependent functional specialties key to developing products for human health: regulatory affairs, quality assurance, biomanufacturing, quality control, non-clinical development, clinical development and project management.
You’ll understand how companies plan, manage, coordinate and synchronize these disciplines to support a specific marketing plan—and how the underlying principals and practices are relevant to product development in other areas of biotechnology.
You’ll also learn how to design a development strategy, communicate objectives and lead a team through implementation.
Session Topics from Spring 2021
Session 1: Course Introduction; Overviews of Product Development; Project Management; Quality Systems – Introduction, Quality by Design, Risk Management; and Hallmarks of Quality Systems
Session 2: Quality Control — Specifications and Procedures; and Chemistry, Manufacturing, and Controls Introduction and Overview; From CMC to BioManufacturing
Session 3: Application of Quality Systems; BioManufacturing — Facilities, Equipment, and Utilities; and Overview of Regulatory Affairs — Roles and Responsibilities, Meeting with Agencies, Regulatory Submissions
Session 4: BioManufacturing — Process Design, Fermentation and Cell Culture; and Clinical Development – Clinical Research, Clinical Operations, and Good Clinical Practice
Session 5: BioManufacturing — Concentration and Purification, Aseptic Processing and Sterilization; and Introduction to Nonclinical Research — Pharmacology, Toxicology, Pharmacokinetics and Good Laboratory Practice
Session 6: BioManufacturing — Overview of Validation; Managing Non-FDA Compliance; Class Lectures – Current Issues in Biotechnology; Team Presentation Workshop
Session 7: Phase I Clinical Study Design and Implementation – A Case Study; Final Team Project Presentations (Location: MG&E, Irving Shain Conference Room)