Subject: RGME

Term: Spring 2026

RGME 468: Commercialization and IP Management II (100/9813)

MW 04:50-06:05 PM Jan 12-Apr 27

Bonfield, T; Jankowski, J; Theofrastous, T

This course will concentrate on early-stage product development, with a focus on conventional approaches to venture financing, regulatory positioning and navigation, corporate licensing/partnering, and investment pitch methodologies. The content of the course will include specific innovations vetted by CWRU Technology Transfer and facilitation by the product Principal Investigator The course will culminate in a presentation for financing to a panel of investors, clinical thought leaders and/or economic development professionals; in a simple sense, students will learn how to position a qualified opportunity for early-stage development and financing towards ultimate clinical and market introduction. Offered as EBME 468, GENE 468, LAWS 5342, MGMT 468, and RGME 468.

RGME 525: Current Topics in Regenerative Medicine (800/2755)

T 04:00-05:45 PM Jan 12-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 529: FDA Regulation in Entrepreneurship and Clinical Research (800/2617)

T 04:00-06:00 PM Jan 12-Apr 27

Cola, P; Mangosh, T

The FDA Regulation in Entrepreneurship and Clinical Research course is designed to provide foundational knowledge in the FDA approval and regulatory process while highlighting scientific, clinical, ethical, and other related emergent factors for consideration. The course includes a series of lecture-based classes delivered by content experts and interdisciplinary team-based learning discussions of case studies designed for the application of lecture content. Students who elect to take the course for three credits as opposed to one credit will go through the process of reviewing an example Investigational New Drug (IND) or Investigational Drug Exemption (IDE) Application (midterm project) and preparing an IND or IDE for submission (final project) with the guidance of nationally renowned experts in FDA regulation and law. The primary goal of this course is that upon completion, students will be able to take the knowledge gained from content experts and apply it to facilitate the movement of their current or future technologies through the FDA approval process. Offered as CRSP 529 and MGRD 529 and PHRM 529 and RGME 529.

RGME 535: Foundations in Regenerative Medicine (100/10129)

MW 12:45-02:00 PM Jan 12-Apr 27

Bonfield, T

Foundations in Regenerative Medicine is a team-taught course using multiple faculty content experts. The objective of this course is for each student to develop a general understanding of the foundations and concepts related to Regenerative Medicine and Stem Cell research. -To expose students to foundational 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: Bench to Bedside Cell Therapy Innovation (100/2322)

TR 08:30-09:45 AM Jan 12-Apr 27

Bonfield, T

This 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.

RGME 549: Advanced Regenerative Medicine: Innovation and Applications (100/2627)

TR 01:00-02:15 PM Jan 12-Apr 27

Bonfield, T

This course is a literature based class. The review of regenerative medicine literature with presentations by students so that they learn how to interpret literature critically.

RGME 560: Regenerative Medicine Independent Study, Research Project (100/2543)

Bonfield, T

The RGME 560 Independent Study-Research Project allows students to explore a topic of interest under the close supervision of a RGME program director and mentor. The course may include directed readings, applied work, assisting a faculty member with a research project, carrying out an independent research project, or other activities deemed appropriate. Regardless of the activities, the work must culminate in a formal paper. The specific course requirements are described in the Independent Studies Proposal form to be completed by the student, project mentor and program director prior to enrollment in the course.

RGME 565: Regenerative Medicine Independent Study, Internship (100/2544)

Bonfield, T

The RGME 565 Independent Study-Industry Internship provides students with the opportunity to gain practical experience within an industry environment. Course objectives are: -Acquire knowledge of the industry sector in which the internship is completed. -Translate knowledge and skills learned in the classroom into a work environment. -Explore additional career options available with the designated industry sector. -Identify areas for future knowledge and skill development.