Our full-time students complete the 30-credit hour master's degree in two years while learning from internationally renowned faculty across the University. The core courses provide the foundational elements including stem-cell biology, biomaterial engineering, medical product development, federal regulations, bioethics, and how to take a discovery to market. In addition, students select an independent study in either hands-on laboratory research or an industry internship. Various science and business development electives, paired with seminars and career development opportunities, round out your tailored experience. In lieu of a thesis, students create public presentations and written scientific projects throughout the program.
Recommended Program of Study
|Semester||Course Code||Course Name||Credit|
|Fall||RGME 535||Foundations in Regenerative Medicine||3|
|BIOL 491||Contemporary Biology and Biotechnology for Innovation||3|
|-||Science or Business Development Elective(s)||1-6|
|Spring||RGME 545||Stem Cell Biology and Therapeutics||3|
|BIOL 492||Contemporary Biology and Biotechnology for Innovation||3|
|-||Science or Business Development Elective(s)||1-6|
|Semester||Course Code||Course Name||Credit|
|Fall||RGME 560 or RGME 565||Independent Study - Research Project or Internship||3|
|GENE 467||Commercialization and Intellectual Property Management||3|
|-||Science or Business Development Elective(s)||1-6|
|Spring||-||Science or Business Development Elective(s)||1-6|
15 Required Foundational Credits
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.
- 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.
- 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
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
- 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
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:
- Early-stage company organization, private financing fundamentals (i.e. angel and venture capital), business planning, organization building, and negotiation skills/approaches.
- 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.
3 Required Independent Study Credits (Students must complete one of two)
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.
Science Program Electives (Students must complete 6 credit hours)
Students will be evaluated by the faculty member in charge of that student's seminar with input from the students' own thesis committee. After each seminar, the student presenter will meet with other graduate students for peer-review of the content, delivery, and style of the seminar.
This course will explore numerous mechanisms utilized by pathogens to subvert the host and enhance their own survival. Topics covered include nuclear regulatory mechanisms, protein synthesis and stability, membrane-bound organelles, endocytosis and phagocytosis, and factors that influence cell behavior such as cytoskeleton rearrangements, cell-cell interactions, and cell migration. Additional topics include cell signaling and co-evolution of pathogens and host cell functions. Students are expected to come to class prepared to discuss pre-assigned readings consisting of brief reviews and seminal papers from the literature. Student assessment will be based on effective class participation (approximately 80%) and successful presentation of an independent research topic (approximately 20%).
This course familiarizes the students with human diseases resulting from aberrations in protein folding, processing, and turnover. Contribution of associated inflammation and heavy metal mis-metabolism will be discussed where appropriate. Specific examples include, but are not limited to, Alzheimer's Disease, Parkinson's Disease, Prion disorders multiple sclerosis, amyotrophic lateral sclerosis, Huntington's Disease, and others based on popular demand. The students will be expected to discuss relevant research publications in an interactive format. Grading will be based on class participation and an R21 grant proposal on the subject of their choice that does not overlap with their current area of research.
Written communication is a critical skill in clinical science. We disseminate our work to others through publications, and we obtain the resources to conduct research through grant proposals. The course focuses on writing grant proposals and, in particular, specific sections of an NIH-style grant. However, the principles discussed in the course apply to any type of proposal.
This course covers the important fundamentals and applications of polymers in medicine, and consists of three major components: (i) the blood and soft-tissue reactions to polymer implants; (ii) the structure, characterization and modification of biomedical polymers; and (iii) the application of polymers in a broad range of cardiovascular and extravascular devices. The chemical and physical characteristics of biomedical polymers and the properties required to meet the needs of the intended biological function will be presented. Clinical evaluation, including recent advances and current problems associated with different polymer implants.
The emphasis of this course is on the molecular and cellular mechanisms underlying physiological processes. Structure-function relationship will be addressed throughout the course. The primary goal of the course is to develop understanding of the principles of the physiological processes at molecular and cellular level and to promote independent thinking and ability to solve unfamiliar problems.
Introductory immunology providing an overview of the immune system, including activation, effector mechanisms, and regulation. Topics include antigen-antibody reactions, immunologically important cell surface receptors, cell-cell interactions, cell-mediated immunity, innate versus adaptive immunity, cytokines, and basic molecular biology and signal transduction in B and T lymphocytes, and immunopathology. Three weekly lectures emphasize experimental findings leading to the concepts of modern immunology. An additional recitation hour is required to integrate the core material with experimental data and known immune mediated diseases. Five mandatory 90 minute group problem sets per semester will be administered outside of lecture and recitation meeting times.
Regulation of immune responses and differentiation of leukocytes is modulated by proteins (cytokines) secreted and/or expressed by both immune and non-immune cells. Course examines the function, expression, gene organization, structure, receptors, and intracellular signaling of cytokines. Topic include regulatory and inflammatory cytokines, colony stimulating factors, chemokines, cytokine and cytokine receptor gene families, intracellular signaling through STAT proteins and tyrosine phosphorylation, clinical potential, and genetic defects. Lecture format using texts, scientific reviews and research articles.
Introduces the basic principles that underlie all of Pharmacology. The first half of the course introduces, both conceptually and quantitatively, drug absorption, distribution, elimination and metabolism (pharmacokinetics) and general drug receptor theory and mechanism of action (pharmacodynamics). Genetic variation in response to drugs (pharmacogenetics) is integrated into these basic principles. The second half of the course covers selected drug classes chosen to illustrate these principles. Small group/recitation sessions use case histories to reinforce presentation of principles and to discuss public perceptions of therapeutic drug use. Students will be expected to critically evaluate articles from the literature and participate in a separate weekly discussion session.
Current topics of interest in the pharmacologist sciences.
This course will give students a broad overview of current basic cancer biology, highlight recent advances in cancer therapeutics, and provide a clinical perspective of the pathogenesis and treatment of common cancers. Classes will be of lecture and discussion format, and will also include student discussion of journal research articles to develop critical thinking in cancer research and experimental design as well as presentation/communication skills. About 1 to 3 students per class will be scheduled to lead the presentation and discussion of the selected journal articles. However, all students will be required to read the material in advance and be ready for discussion. Topics will cover growth factor action and signal transduction, oncogenes, tumor suppressor genes, DNA damage, apoptosis, cancer immunology, cancer stem cells, metastasis, angiogenesis, chemotherapy, radiation therapy, targeted therapeutics, photodynamic therapy, targeting cancer stem cells, chemoprevention, and clinical aspects of cancers of the breast, prostate, lymphatic tissue, and colon.
In this course, students lead research projects. Projects include molecular endocrinology, neuropharmacology, receptor activation and signal transduction, molecular mechanisms of enzyme action and metabolic regulation.
Business Development Program Electives (Students must complete 6 credit hours)
This course focuses on the key issues in starting and managing a successful startup through the critical phases of growth: Birth, Funding, Pre-Product Launch, Product Launch, Rapid Growth and Exit Strategy. Students will be exposed to prominent alumni who have multiple entrepreneurial experiences enabling future entrepreneurs to avoid pitfalls and communication mistakes that could doom their fledgling company.
Course features new product launch by students and new business idea competition judged by actual venture capitalists. Students will also learn how to acquire control of an existing company, including valuation methods, sources of funding, tactics for finding companies to buy, and how to negotiate the purchase of a business. Also includes actual student negotiation with sellers of a company. Course is designed to accelerate career success through bold entrepreneurial strategies.
This course introduces the area of international entrepreneurship by focusing on various aspects of this area. Topics to be covered include: conditions making small, medium-sized, and new ventures increasingly important in international business; information sources relevant to international entrepreneurship; critical steps in deciding on doing international entrepreneurship, strategic planning and methods in conducting international entrepreneurship; and benefits and problems of going international as a new venture.
This course examines how entrepreneurial firms can develop human resource practices and strategies to sustain their vision, grow their businesses, and create value for customers, shareholders, and employees. The first half of the course will be devoted to exploring the distinctive challenges entrepreneurial firms encounter in aligning organizational goals and human resource strategy and practices. Among those practices are staffing, recruitment and selection, compensation, and employee motivation. The second half of the course will explore these issues further in the context of key organizational phases ranging from firm foundings, the transition from entrepreneurial to professional management, the development of "intrepreneurship" in existing organizations, and the spin-off of the new corporate ventures.
The objective of this course is to introduce students to the issues of financial management and capital formation in new ventures. The course will address issues of estimation of cash requirements, development of pro forma financial plans, firm valuation and the process and tools used in raising debt and equity financing. Bootstrapping, angel investing, venture capital, strategic alliances and initial public offerings will be covered. The emphasis is on the entrepreneur and how he/she can assess financial needs and develop a sensible plan for acquiring financial resources in a manner that is consistent with their financial needs and other strategic goals.
This course is designed to help students to identify, evaluate, and obtain control over technology opportunities that they can successfully exploit by starting new companies. The course focuses on four themes: (1) the source, discovery, and evaluation of technological opportunities, (2) the process of organizing innovation to produce new technology that satisfies the needs of customers, (3) the different mechanisms available to appropriate the returns from the exploitation of technological opportunities, and (4) the differences between opportunities and approaches that are valuable and sustainable for independent entrepreneurs and large firms.
The nature and importance of entrepreneurship is an area of importance to business leaders, educators, politicians, and individual members of the society. It is a driver of economic development and wealth creation in organization units ranging in size from the individual company to entire nations. Technology-based entrepreneurship is particularly important to this economic development due to its impact on productivity and its potential for exponential growth. To create something new and of value to both the organization and the market requires a technical individual who is willing to assume the social, psychic, and financial risks involved and achieve the resulting rewards whether these be monetary, personal satisfaction, or independence. This can occur while starting an enterprise (i.e., entrepreneurship) or while driving innovation in an existing organization (intrapreneurship). This course will also take students through a variety of issues related to enhancing innovation in the context of a technology-based organization. This is sometimes termed intrapreneurship and includes innovating new products and services within an organization. This is a very complex field and relatively young. Students will learn that there are not many "absolute truths," but there are numerous best practices and benchmarks that can assist the intrapreneur.
Entrepreneurship is an area of importance to business leaders, educators, politicians, and individual members of the society. It is a driver of economic development and wealth creation in organizational units ranging in size from the individual company to entire nations. Technology-based entrepreneurship is particularly important to economic development due to its impact on productivity (innovations in action) and its potential for exponential growth. This course will emphasize and explore a variety of issues related to innovation and entrepreneurship, demonstrating that there are not many "absolute truths," but there are numerous best practices. Successful students will conclude this course with new knowledge about opportunity analysis and insight on entrepreneurship & innovation, as well as having demonstrated measurable improvement in their critical thinking skills.
Basic concepts of patent law as property considered primarily in its substantive aspects, including the relationship to other forms of protection and intellectual property, infringement, and statutory requirements for patents.
Patent preparation, drafting, and filing of a patent application are the fundamental aspects of patent practice. Students will learn how to conduct a client-inventor interview, what questions to ask the client-inventor and what information is most important to obtain prior to commencing the patent drafting process. Technical aspects of patentability searching will also be explored. In addition, the student will learn the various parts of the patent application and best practices associated with drafting each part. Before the drafting takes place, the class will cover relevant case law. Also, nonlegal, practical aspects such as organization, various grammatical concerns, and other concepts related to patent drafting will be covered. Ultimately, students will take the information provided in the class and draft an actual patent application based upon a simple hypothetical invention. Emphasis will be placed on specification drafting and claim drafting, and how to claim around prior art.
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.
This course is designed to provide students with the fundamentals of creating, offering and closing a technology venture transaction. In each case, the goal is to imbue students with both the legal and compliance requirements of the given strategic scenario, as well as the business and technical drivers behind the transaction. Key points of emphasis include: 1) Corporate Structure and Governance: structure of an early stage tech venture, including form and charter documents; shareholder agreements; management contracts; advisory and board conventions. 2) Private Securities Offerings: state and federal securities laws, including investor requirements; disclosure regimes and private placement memoranda. This section also includes an emphasis on the process of due diligence, road shows, and subscription documents. 3) Equity Agreements: venture capital equity and governance terms; stock purchase agreements; incentive stock and other forms of contingent participation. 4) Ongoing Company Evolution: successive capital rounds; cram downs; resolving investor disputes; and management scenarios. 5) Acquisition and IPO Fundamentals: preparing for acquisition; the M&A process; preparing for public securities offerings; fundamental registration mechanics.
High technology products and services are unique in the levels of ambiguity and risk that challenge a manager's ability to craft a marketing strategy. Understanding the customer, reading market trends, creating a compelling vision of value, and launching marketing programs (already foreboding tasks in traditional marketing situations) have a heightened sense of uncertainty in the context of high technology platforms such as nanotechnology and regulated medical devices. This course draws on contemporary ideas in literature by thought leaders in technology marketing. We work though several marketing models and methods in practice today to assist students synthesize and build appropriate conceptual and managerial frameworks for technology marketing practice.