Curriculum

The RGME is obtained under the Case Western Reserve University School of Graduate Studies’ graduate study Plan B. Beginning with the fall 2019 class, the degree will be completed with 30 credit hours, consisting of a combination of core courses, electives and seminars. The program can be earned full-time in two years. According to Graduate Studies, full-time status requires registration for a minimum of nine credit hours per semester.

Core Courses 

18 required core credits across disciplines

The RGME 535 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.

Learning objectives: 

  • Facilitate student critical review and foundational principles in Cell Biology and Tissue Engineering relevant to the field
  • Intricately explore the details of the current landscape and spectrum of topics which makes up the field of regenerative medicine
  • Overview and detail the current and emerging technologies supporting regenerative medicine research
  • Provide the foundation for understanding both federal regulatory and compliance issues related to clinical research and the development of therapeutics
  • Provide insight on cellular manufacturing approaches for regenerative medicine products including regulator and compliance regulations by the FDA
  • Discuss ethical and societal issues related to regenerative medicine research and technologies
  • Extend students capacity to read regenerative medicine literature critically from diverse perspectives from the fields of engineering, medicine, entrepreneurship and regulations.

RGME 545, Stem Cell Biology, Integrated Diagnostics and Therapeutics, 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.

Learning objectives: 

  • Develop an understanding of the infrastructure and compliance required to manufacture biologics for clinical use of stem cells
  • Identify and critically analyze key operational issues related to clinical development and use of biologics from expansion to pre-clinical validation and therapeutic use
  • Perform hands-on activities using current techniques
  • Discuss ethical and societal issues related to regenerative medicine research and technologies

This course 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 final, formal paper written by the student. The primary objective of the course is to provide students with research exploration of a specific topic related to regenerative medicine of interest to the student under the advisement of a program mentor who will monitor and evaluate the student’s progress. Students will log work hours by keeping, and submitting weekly, a reflection log. Entries will discuss an overview of the skills learned and focus for the week, and provide a detailed description of the next steps regarding research project activities and assignments. Students will be expected to submit an abstract to CWRU ShowCase for presentation to the University community and peers. Finally, students will be required to submit a final paper (20 pages). The final project must demonstrate a significant time of investment and research.

This internship course will provide students with the opportunity to gain practical experience within an industry environment. Course objectives include: 1) acquire knowledge of the industry sector in which the internship is completed, 2) translate knowledge and skills learned in the classroom into a work environment, 3) explore additional career options available with the designated industry sector, and 4) identify areas for future knowledge and skill development. Regardless of the activities, the internship must culminate in a final, formal paper written by the student. Students will log work hours by keeping, and submitting weekly, a reflection log. Entries will discuss an overview of the skills learned and focus for the week, and provide a detailed description of the next steps regarding internship activities and assignments. Students will be expected to submit an abstract to CWRU ShowCase for presentation to the University community and peers. Finally, students will be required to submit a final paper (20 pages). The final project must demonstrate a significant time of investment and research.

The first half of a two-semester sequence providing an understanding of biology as a basis for successfully launching new high- tech ventures. The course will examine physical limitations to present technologies, and the use of biology to identify potential opportunities for new venture creation. The course will provide experience in using biology for both identification of incremental improvements, and as the basis for alternative technologies. Case studies will be used to illustrate recent commercially successful (and unsuccessful) biotechnology-based venture creation, and will illustrate characteristics for success. Admission to this course requires consent of the instructor.

The purpose of the course is to provide an understanding of contemporary biology and biotechnology as a basis for successfully launching new high- tech ventures. The course will examine technical bases and limitations to present technologies, and the potential applications of extending existing technologies or developing novel methodologies for new venture creation. The course will provide experience in using all aspects of the natural sciences (physics, chemistry and biology) and relevant engineering approaches for both identification of incremental improvements and as the basis for alternative technologies. Case studies will be used to illustrate recent commercially successful (and unsuccessful) biotechnology-based venture creation, and will illustrate characteristics for success.

In order to provide maximum flexibility for the target audience (the students in the new Entrepreneurship Track of the existing Master of Science in Biology Degree), the course is expected to be taught at night, and to meet once a week. Class time will include both formal lectures on the theory and implementation of contemporary methods in biotechnology, as well as weekly discussion of case studies. Experience in the application of molecular biological methods to the solution of problems will be provided through weekly problem sets. Guest speakers with particular expertise will be used where appropriate.

This course will provide an exposure to and good understanding of current methods (both laboratory and industrial scale) and their applications in the biotechnology arena. It is anticipated that this class (BIOL 491) will focus primarily on providing a good understanding of a set of core methodologies while the second course will emphasize applications and explore a broad range of possible areas that should extend beyond the current realm of biotechnology.

Review of biology, molecular biology and biotechnology principles and techniques relevant to problems of high tech innovation. These will be developed throughout the semester, and will include (but not be limited to):

  • Current DNA sequencing technologies – theory, practice, instrumentation, limitations
  • Methods for detection and analysis of variation without sequencing
  • High throughput methods, including automation and robotics
  • nucleic acid microarrays, protein microarrays, protein-protein interaction studies, protein-ligand interactions, antibodies
  • Proteonomics; various forms of mass spectrometry Computer-aided design of both large and small molecules
  • Fluorescence techniques
  • Combinatorial chemistry
  • Atomic force microscopy
  • Nanotechnology (perhaps join with physics)
  • Industrial bio-production – cells, proteins, antibiotics etc (with Chem. Eng)
  • Transgenics – cell, tissues, plants, animals.
  • Data management, data analysis, data mining. Review of existing world centers in bioinformatics, the types of data that they contain and the services that they offer. Examination of emerging trends in the types of data being generated, the way it is managed and possibilities for new directions.

Continuation of BIOL 491, with an emphasis on current and prospective opportunities for Biotechnology Entrepreneurship. Longer term opportunities for Biotechnology Entrepreneurship in emerging areas, including (but not be limited to) applications of DNA sequence information in medicine and agriculture; energy and the environment; biologically-inspired robots; Prerequisite: BIOL 491.

The purpose of the course is to explore the ways in which biology-based developments and inventions can impact society and thus provide an intellectual basis for successfully launching new high-tech ventures. The course will continue the themes of BIOL 491, but with an emphasis shifting from core methodologies and existing applications to extended or novel methodologies and new problems and applications.

In order to provide maximum flexibility for the target audience (the students in the new Entrepreneurship Track of the existing Master of Science in Biology Degree), the course will be taught at night, and will meet once a week. Class time will include both formal lectures on the biology content, as well as weekly discussion of case studies. Experience in the application of biology to the solution of problems will be provided through weekly problem sets. Guest speakers with particular expertise will be used where appropriate.

BIOL 492 will continue the integrated presentation of the themes introduced in BIOL 491, but with an emphasis on current and near-term opportunities for Biotechnology Entrepreneurship. In addition, longer-term opportunities for Biotechnology Entrepreneurship in emerging areas will be reviewed. These will include (but not be limited to):

  • Patents: what has worked in the past (Chakrabarty, Stanford Cloning, PCR, the Harvard Mouse, Recombinant Enzymes, Sequencing and Microarray Technologies).
  • The changing face of biological patents – shifts at the Patent Office.
  • Regulatory Issues
  • For human-targeted products, the role of the FDA and the time-scale of bringing products to market. For ag-bio products, not only USDA/FDA issues, but also the GMO debate.
  • Scope of Biotechnology
  • Whole genomes: – for every biological process in humans, mice, flies, Arabidopsis, yeast and some other fungi, many microbes – we now know the sequence (in principle) of every gene controlling every process. Most of the recent developments (and enterprises have been based either on applications of this kind of information or the development or refinement of appropriate enabling technologies (sequencing machines, microarray synthesizers and printers, Mass Spectrometers, etc)
  • Biotech medicine asks, “How can we use this information to derive therapeutic proteins, develop better diagnostic tools, provide more specific cures for disease etc.”
  • Biotech agriculture asks similar questions about the quality, safety, production efficiency etc of our food supply.
  • What about some quite different applications simply inspired by a deeper understating of biological phenomena:
  • Insect-inspired robots
  • Energy production: what are the biological models
  • Conservation and Remediation of the Environment
  • Learning
  • Nanotechnology – targeted medicines, DNA computers,
  • Materials: many natural materials have superior properties to any synthetic mimic – what can we learn from biology to make stronger, lighter, etc materials in energy-efficient ways – polymers, adhesives, plastics

 

Electives

6 credits of science electives

6 credits of business development electives (3 credits strongly recommended to be GENE 467: Commercialization and IP Management)

This course seeks to provide students with the ability to value a given technological advance or invention holistically, focusing on issues that extend beyond scientific efficacy and include consumer and practitioner value propositions; legal and intellectual property protection; potential market impacts; market competition; and ethical, social, and practitioner acceptance. These issues transcend disciplinary boundaries, requiring the integration of expertise in the fields of law, management, and science.

Students will learn that intellectual property strategy is implicit in technology-based business strategy, establishing strategic business assets that can be leveraged to create value in the marketplace. From this, students will learn to design an IP portfolio that aligns with a sophisticated business model, including market identification, value assessments, and a strong sense of the competitive landscape. This module exposes students to a range of issues related to the creation, management, and evolution of innovation and intellectual property estates. The focus of the course is to provide students the ability to discern value under multi-disciplinary lenses, leading to tactical approaches to commercial development and quantifiable value creation or go/no-go decision points. Primers in Intellectual Property Law, Finance and Scientific Substance will serve as the heart of the classroom-based curriculum. Meanwhile, the skills practicum will include risk analysis, modern approaches to valuing early-stage opportunities (i.e., decision tree analysis and application of Monte Carlo simulation techniques), and transactional approaches to collaboration/licensing.

New company formation and/or corporate partnering are two primary, although not exclusive, tools for bringing new innovations to market. In this skills-based course, students will learn the fundamentals of organizing a commercial development vehicle around a technology-based business model.

Multi-disciplinary focal points will include:

  • Management
    • Early-stage company organization, private financing fundamentals (i.e. angel and venture capital), business planning, organization building, and negotiation skills/approaches.
  • Law
    • Primers on corporate law and securities offerings (public and private) will be the focus. In addition, students will learn the impacts of industry-specific regulatory frameworks (e.g., FDA, EPA).
  • Science/Engineering (e.g. genomics, chemistry, energy, biomedical engineering)
    • The fundamentals of organizing product development in the company context will be a primary focus, with students developing decision skills for in-sourcing/outsourcing, corporate partnering, and portfolio scalability decision.
    • A secondary, but important tenet will be to impart to students an understanding of the ultimate customer/payor/practitioner framework that strongly impacts modern development in the global biomedical and energy industries.

Tangible outcomes/deliverables of this course will include the development of a formal business plan or partnering strategy that aligns to a tactical product development approach. When appropriate for a given technology opportunity, students will be exposed to implementation plans for commercializing a technology, leading to the creation of a securities offering for early-stage finance.

Sample Curriculum

Fall Semester 1

RGME 535

BIOL 491

Science Elective

Seminars

Spring Semester 2

RGME 545

BIOL 492

Science Elective

Fall Semester 3

RGME 560

Business Development Elective (Strongly Recommended - GENE 467: Commercialization and IP Management (3 credits])

Seminars

Spring Semester 4

RGME 565

Business Development Elective (Recommended - LAWS 5366: Venture Finance and Transaction [2 credits]; PHYS 491: Modern Physics for Innovation [1 credit])