M.S. Technical Entrepreneurship and Management in Biomanufacturing & Therapeutic Development

The University of Rochester’s MS TEAM program has partnered with University’s School of Medicine and Dentistry to design a new and unique version of the traditional TEAM program called M.S. Technical Entrepreneurship and Management in Biomanufacturing & Therapeutic Development.

The goal of this program is to train the next generation of leaders in biomanufacturing and drug development. This will be achieved by providing training both in the principles of entrepreneurship and management, and in the techniques and methods used in biomanufacturing and therapeutic development.

The Department of Microbiology and Immunology, the Simon Business School and the Hajim School of Engineering and Applied Sciences have pooled their strengths in designing this vibrant curriculum that includes:

Required TEAM Courses

TEM 401: Economics, Marketing and Strategy Primer for Entrepreneurs (4 credits)

This course is designed to present fundamental concepts of microeconomics, marketing and strategy which will form the foundation for understanding the economic marketplace and to provide the basis for assessing entrepreneurial opportunities.

The course will begin with a study of consumer and firm behavior and the resulting demand and supply conditions in individual markets. Factors which affect market structure, prices, output levels, firm profitability and consumer welfare will be addressed in this context.

A critical question facing entrepreneurs and others developing new products or services is determining whether the market potential for a product justifies the investment. Building on the economic model, the course will explore marketing issues, in particular the value proposition for new products.

The course concludes with an examination of strategies for both the development and marketing of new products and services. Topics include strategies for market entry (stand alone, joint venture, licensing), distribution policies, pricing policies and product positioning.

TEM 402: Accounting and Finance Primer for Entrepreneurs (4 credits)

This course is designed to present the fundamentals of financial accounting and financial analysis that will serve as a foundation for concepts developed throughout subsequent courses in the entrepreneurship program. The objectives of this course are to enable participants to understand and productively use the principles of finance and accounting information to better structure business decisions.

The accounting module will present skills required to interpret and analyze common financial statements, and evaluate a company’s past performance and potential future performance. Specific topics of discussion will include transaction analysis, cash vs. accrual accounting, financial statements, financial statement analysis, development of budgets and pro-forma financial statements, depreciation methodologies, and inventory methodologies.

The financial module will present skills required to understand how companies make investment and financing decisions. Specific topics of discussion will include calculation of net present values, an introduction to financial instruments, the tradeoff between risk and return in financial markets, capital budgeting and investment decision-making, choosing an optimal capital structure, and using the weighted average cost of capital.

TEM 440: Screening Technical Opportunities (1 credit)

This course provides a process used to quickly assess the commercial merits of raw technologies. This course focuses on the very earliest stage of concepts where information is greatly lacking and the time and money to research such answers is also limited.
Students, in group format, will parse through approximately 150 technologies that are available for licensing.

These are provisional, pending, and issued patents based upon research conducted at the University of Rochester and held by the Office of Technology Transfer.
Teams will select and “thicken” two technologies of interest. Thickening will involve a cursory evaluation based upon technical merit, early market indicators, human resource availability, and business challenges. Teams will use a template to present the results of their investigation to a panel. Teams must state whether or not each technology is worthy to bring forward into TEM 441: Product Development and Technical Management.

TEM 411: General Management of New Ventures (4 credits)

This course provides an opportunity to examine the management practices associated with technical innovation and new business development. The analysis of entrepreneurship is evaluated primarily from the perspective of a start-up venture that requires equity capital investment. Management issues discussed include organizational development, analysis of market opportunities, market engagement, financial planning and control, capitalization, sources of funds, the due-diligence process and valuing the venture. Teams of three to four students will collaborate in the preparation of a business plan. The course will include time for students to share business ideas and identify possible team members. Each team will have a coach who is an experienced businessperson. The coach will be available to provide feedback to the team.

Required Biomanufacturing Courses

MBI 403: Drug Discovery (2 credits)

This course is designed to provide an introduction to current drug discovery processes, with special emphasis placed on antimicrobial development. The course will be taught by UR faculty with drug discovery research programs as well as internationally recognized leaders in requisite fields of pharmaceutical practices from biotechnology, pharmaceutical industry and the NIH. Topics to be covered include, but are not limited to: bioinformatics-based drug target identification, high throughput screening approaches (and pitfalls), medicinal chemistry, hit to lead optimization, clinical trial design and portfolio management.

MBI 406: Biomanufacturing (3 credits)

This course is designed to provide both undergraduate and graduate level students with an introduction to current aspects of the manufacturing and testing of materials produced through a variety of commercially relevant bioprocesses.

MBI 407: TEAM-BMTD Practicum (5-6 credits)

The practicum is an intensive, team-based, experiential learning experience, which is the cornerstone of the TEAM-BMTD program. The experience provides real-world, hands-on technical experience in either biomanufacturing or small molecule therapeutic development – with placement driven by the student’s career path objectives. The biomanufacturing practicum will take place in the University of Rochester’s Stem Cell cGMP Facility, which produces stem cell-based products and monoclonal antibodies under the FDA’s current Good Manufacturing Practices (cGMP). Students electing to participate in a small molecule therapeutic development practicum will have the opportunity to work in a research laboratory that is carrying out early phase drug development and screening. With permission of the director, other practicum experiences are possible that can be tailored to support the student’s career path. 1.0-6.0 credit hours.

IND 426: Science Communication for Diverse Audiences (2 credits)

This course offers a hands-on based approach to improve science communication skills. Students will have the opportunity to work in small groups to learn basic presentation skills, distill their scientific message for a multitude of audiences, and become more comfortable presenting in front of groups. We will focus on improving communication with both scientific and non-scientific audiences. This course integrates some of the newest training techniques in the field including improv and story telling, which serve to help scientists better connect to audiences in the moment. The course will also offer brief sections on writing for non-scientific audiences. Participants should come ready to step outside of their comfort zone and dive into a variety of different training techniques from week to week.

MBI 492: Special Topics TEAM Career Catalyst (1 credit), fall semester

This course is designed to provide graduate-level students an introduction to professional development, network building skills and a guide to constructing unexpected career opportunities. The course uses lectures, discussion sections and independent-project work to investigate the following topics: career fate determination, prototyping your odyssey plans, the art of the information interview, and your job interview story kit. For the interview sessions, some of the stories will be recorded to provide instant feedback and help you see your performance as your audience and future interviewers will.

Several Electives

IND 439: Leadership and Management for Scientists (2 credits)

This 2 credit hour course is designed for graduate students and postdoctoral appointees who wish to enhance their leadership and management skills. It will cover a range of topics, including project management, communication, personality styles and budgeting skills, to help this unique group of leaders and managers. This course focuses on human-centered strategies for leading effective teams in biomedical and health science academic environments that can also be translated into research-related careers. Through a series of interactive activities, reflective writing, self-assessment instruments, and group discussions, you will develop a repertoire of techniques for addressing issues that commonly arise within and between research groups.

BST 465: Design of Clinical Trials (4 credits)

Introduction to the principles of clinical trials; clinical trial protocols; overview of the drug development process; hypotheses/objectives; specification of response variables; defining the study population; randomization; blinding; ethical issues; factorial designs; crossover designs; equivalence trials; trial monitoring and interim analyses; sample size and power; data collection and management; issues in data analysis and reporting; evaluating clinical trial reports.

PTH 571: Molecular Basis of Disease (3 credits)

This course provides translational medicine-oriented lectures to help students understand the utilization of molecular, cellular and genetic approaches to investigate human diseases and disease-related animal models. Significant emphasis will be placed on the current understanding of disease processes, limitations, and strategies for innovative experimentation that should lead to breakthrough discoveries and cures. Discussions will address various diseases including but not limited to cardiovascular, neurological and musculoskeletal abnormalities, autoimmunity, endocrine defects and cancer. The course is composed of lectures and journal club style paper presentations. Students will be assigned scientific papers of interest that they will present and discuss with their peers at the second session provided by each faculty.

PHP 404: Principles of Pharmacology (4 credits)

This course employs multidisciplinary knowledge in biochemistry, cell biology, chemistry, genetics, neuroscience, pathology, physiology, toxicology, and clinical medicine, to elucidate the mechanisms of action of drugs in treating human diseases. This course focuses on the fundamental principles of pharmacology (including dose-response relationships, receptors, pharmacokinetics, drug interactions, drug metabolism and pharmacogenomics), neuropharmacology, cardiovascular pharmacology, and contemporary approaches to drug discovery and design.

MBI 498: Biomanufacturing Internship (1 credit), summer semester only

Internship opportunities will be available to students who identify an authentic biomanufacturing internship experience in the private sector. Academic credit will be based upon a final paper or report and an evaluation from the on-site internship supervisor.

TEAM-BMTD Program faculty will provide advice and guidance to students who wish to pursue summer internships. Students seeking such internships must: (1) start their search at least 6 months before the planned internship start date; (2) have an excellent academic record; (3) have prior independent research experience (or outstanding performance in the bioGMP Project Team Practicum); and (4) a strong recommendation from a UR course director or research professor.

MBI 499: Drug Development Internship (1 credit), summer semester only

Internship opportunities will be available to students with interest in obtaining small molecule drug discovery internship experience in the industrial setting. Academic credit will be based upon a final paper or report and an evaluation from the on-site internship supervisor.

TEAM-BMTD Program faculty will provide advice and guidance to students who wish to take part in a summer internship experience. Students seeking such internships must: (1) start their search at least 6 months before the planned internship start date; (2) have an excellent academic record; (3) have prior independent research experience (our outstanding performance in the Drug Discovery Project Team Practicum); and (4) a strong recommendation from a UR course director or research professor.

For More Information Contact:
Office
Brenda Knorr, Graduate Program Coordinator, University of Rochester Medical Center
Email brenda_knorr@urmc.rochester.edu
Phone 585.275.3402