Course listings | Case Western Reserve University

Term: Spring 2020

RGME 525: Current Topics in Regenerative Medicine (100/9832)

T 04:00-05:45 PM Jan 13-Apr 27

Bonfield, T

Current Topics in Regenerative Medicine, will be an elective course in the newly approved Master's Program in Regenerative Medicine and Entrepreneurship. The objective of this course is for each student to develop a general understanding of concepts and current topics related to Regenerative Medicine, Stem Cell research, entrepreneurship and product development. -To expose students to principles in Cell Biology and Tissue Engineering relevant to the field -To review the current landscape and spectrum of topics which makes up the field of regenerative medicine -To explore current and emerging technologies supporting regenerative medicine research -To discuss federal regulatory and compliance issues related to clinical research and the development of therapeutics -To explore cellular manufacturing approaches for regenerative medicine products -Discuss ethical and societal issues related to regenerative medicine research and technologies

RGME 545: Stem Product Biology, Bench to Bedside Development and Therapeutic Translation (100/10621)

TR 08:30-09:45 AM Jan 13-Apr 27

Bonfield, T

This course is a team - taught course using multiple faculty content experts. The objective of this course is for each student to understand the concept of stem cell biology from procurement to therapeutic development. This course will provide an overview of the regulatory framework, concepts, lab operations, and biologic techniques to support cell and regenerative medicine product manufacturing. To work in this emerging field, students must understand the scientific and regulatory development of biologic therapies as well as operational issues related to manufacturing in the cleanroom space under quality systems. The goals are to: 1) Develop an understanding of the infrastructure and compliance required to manufacture biologics for clinical use of stem cells. 2) Identify and critically analyze key operational issues related to clinical development and use of biologics from expansion to pre-clinical validation and therapeutic use. 3) Perform hands on activities using current techniques. 4) Discuss ethical and societal issues related to regenerative medicine research and technologies.