Master in Clincl Transln Mgmt

Continuation of MCTM Internship into subsequent semester

The course will draw from diverse academic science and business disciplines to explore the evolving landscape of biotechnology from the standpoint of entrepreneurial ventures. The course will focus on changes and challenges in the industry, as well as opportunities for startups and new entrants. Students will learn about the different stages and processes associated with the translation of life science research into applied products/services and the commercialization of technologies.

The practicum is an experiential learning opportunity, which allows students to gain experiences in the different phases of clinical translation and the commercialization of the life sciences discoveries. The duration of this practicum will be a least one academic semester.

Introduction to biological principles, concepts and mechanisms relevant in current biomedical research. Content: The course will be address four general topics: 1..Cellular structure and function 2..Gene and genome structure and function 3..Overview of organ systems and metabolism 4..Molecular techniques used in biomedical research

This course is designed to provide the student with a background and fundamental working knowledge in applied statistics for use in health, science, government, and technology based research. The course will emphasize the statistical tools required to analyze and test the quality and integrity of research data. Students will also learn how this analysis integrates with the steps involved in conducting clinical research. The course will review and evaluate the main study designs used in clinical research: case-control, cohort, clinical trials, and practical examples of statistical analyses of clinical research studies. Time permitting students will prepare and review a research project. Introduction to Statistics and Clinical Research

Moving a compound from pre-clinical studies into humans is a necessary step in the translational process. The current system of demonstrating safety and efficacy in animals, then first-in-human phase I trials, to larger cohorts and multi-center trials has many scientific and ethical decision points and challenges that investigators, review boards, and regulatory agencies must address in readying a novel therapeutic for wide- spread use. Importtant consideration will be given to conflicts of interest that involve both clinical issues of ethics, existing guarantees for clinical trials participants , and how anticipated risks are weighed against predicted benefits to society. Students will evaluate case studies of actual clinical trials to see wht contributed to the outcome.

The goal of the course is to provide the student with a basic understanding of the uses of accounting information in business. This is done in three segments: 1) Financial accounting and reporting; 2) Budgeting and Pro Forma financial statements; and 3) Decision making and control. The successful student will be able to use data to plan, implement, and measure the performance of projects, departments and firms at a basic level

This course integrates the tools of financial analysis with real-world problems in the technology industries. Topics include company valuation modeling, costs and benefits, and ratio and break-even analysis. Students will read, prepare, and analyze financial statements. The difference between management financial and tax financial statements will also be covered.

This course introduces students to concepts, models, and methods of marketing, focused on biotechnological products and services. Topics include segmentation and market evaluation, positioning, market intelligence, consumer behavior, and developing the marketing mix. There is also a strong focus on ethics and social issues.

Good ideas often fail because the art of organizing people, information, and decision making do not get considered. Therefore, this course surveys management skills including project and people management; organizational designs used in healthcare to balance the often competing interests of medicine, business, and care; and strategic approaches to reaching organizational effectiveness including change as a factor of people, control systems, and technology.

This course will describe what constitutes intellectual property, how to determine what patents or intellectual property currently exist, the process for application, and different mechanisms for patent approval. Students will learn different aspects of patent portfolio management in the global market. Students will be introduced to the process of technology licensing that gives the private sector the opportunity to control the intellectual asset for development. Finally, students will learn how regulations differ depending on the type of intellectual property under review.

This course will cover: 1) Financing strategies for basic and translational research in academe and the start- up companies (biotech models). 2) Financial dynamics of research (indirect costs, "subsidies", matching funds). 3) Intellectual property management at the academic-industry interface: Bayh-Dole, IP revenue cycle, the strategic chokepoints. 4) Differentials between research and medical product development. 5) Preparing for regulatory admission to clinical trials; current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP) en route to submission of Investigational New Drug (IND) and Investigational Device Exemption (IDE) for Premarket Approval (PMA). 6) Special regulatory classes: Cell therapy; Nanomedicine; Biomaterials. 7) Funding strategies to cross the preclinical Valley of Death.

The course will cover Clinical trials: Phase 0 through IV; utilizing special regulatory considerations as: Regenerative Medicine; Biomarkers; In Vitro Diagnostics; Contrast Agents. The students will learn about funding strategies for clinical trials and begin work on a new model: The Translational Research Initiative. This type of study will enhance the students' strategic perspectives on clinical trials from the point of view of the academic, major corporate, and biotech spin-off worlds. Students will learn about the profiles of key personnel roles in all phases of the Idea-to-Clinic transition; as well as the options for entrepreneurship and leadership in translational management.

A Seminar Series: This course will give students the opportunity to learn how to identify a new idea (either technology, service or business model), define and evaluate a business model for taking the idea to market, and how to design appropriate funding processes such as positioning for a company or seeking risk capital execute the plan. From CEOs of startups to the researchers that have developed game-changing advances, invited lecturers will give first-hand accounts of their successes (and some failures) that have changed the biotechnology landscape and established Texas as the "third coast" in biotechnology.

Students will learn the nature of the entrepreneurial business process for emerging company formation as well as the strategic planning process for a biotechnology enterprise. Students will continue to work in teams with faculty and HMRI researchers on a current project from HMRI. The student teams will be required to prepare and present the findings and next steps for their project as part of this course.

This course provides a basic understanding of the clinical translation process and the business competencies required to support and manage the process. Guest lecturers who are experts in the field will familiarize students with the intricacies of the process. Students will also learn the responsibilities and day to day functions of various positions in different industry, private, and government settings. This course provides a context for the in-depth discussion in the following courses.

This course will explore the scientific, regulatory and financial hurdles involved in translating laboratory breakthroughs into treatments that can improve human health. Students will learn about the pre-clinical development process, including pre-clinical modeling and other tests a potential therapeutic undergoes prior to human trials. Students will also learn about the clinical research trials process, including the requirements for first-in-human trials, through the phase II and III trials that are required to bring a drug, biologic, or device to market.

This course is the first of a two-part series that will explore the scientific, regulatory and financial hurdles involved in translating laboratory breakthroughs into treatments that can improve human health. Students will follow an Investigational New Drug as it is taken through the pre-clinical development process, including localization studies using advanced imaging technologies, toxicology, kinetics, pre-clinical modeling and other tests a potential therapeutic undergoes prior to human trials.

This course is the second of a two-part series where students will learn about the clinical research trials process, including the requirements for first-in-human trials, through the phase II and III trials that are required to bring a drug, biologic, or device to market.

This course will start with an overview of Health Informatics and cover the following topics: Electronic Health Records, Clinical Data Warehouse and RedCap, Standards in Interoperability, Text Mining and Natural Language Processing, Decision Making, and Data Analytics/Machine Learning.

This course introduces students to the development and interpretation of accounting records and the use of accounting information as a managerial tool for reporting and decision-making. Major topics covered in the course are double-entry bookkeeping, the accounting cycle, individual assets and liabilities, interpretation of financial statements, and ethical issues of financial reporting.

In this course, students will learn and apply economic principles to understand the nature of health care markets and systems. Students will learn how the principles of health economics can improve decision making in the complex health care environment. Students will consider assessment approaches to determine the effectiveness of medical treatments, interventions and technologies.

This course introduces students to concepts, models, and methods of marketing. Topics include segmentation and market evaluation, positioning, market intelligence, consumer behavior, and developing the marketing mix.

This course introduces students to the analysis of the life sciences industry and provides key inputs into strategic marketing planning and decision-making. Students learn the process, concepts, and techniques commonly used in the identification, assessment, and forecasting of market opportunities for biotech innovations.

Moving a compound from preclinical studies into humans has many scientific and ethical decision points and challenges that investigators, review boards, and regulatory agencies must address in readying a novel therapeutic for widespread use. Important considerations will be given to conflicts of interest that involve both clinical investigators and institutions that conduct clinical studies. This course will overview the system of checkpoints, and address the larger issue of ethics.

The course aims at introducing students to the ethics and morality of business management and to the corporation as a social system. Topics include the difference between ethical integrity and moral compliance, the role of leadership, types of moral theories, and the moral foundations of the market, consumerism, and sustainability.

This courses focuses on various ways of estimating value of a new technology. New technology valuation is a part of technology assessment that focuses on determining the economic value of a new technology, with consideration for the uncertainties and risks.

This course will describe what constitutes intellectual property, how to determine what patents or intellectual property currently exist, the process for application, and different mechanisms for patent approval. Students will learn different aspects of patent portfolio management in the global market. Students will be introduced to the process of technology licensing that gives the private sector the opportunity to control the intellectual asset for development.

This course will give students the opportunity to learn how to identify a new idea (either technology, service or business mode), define and evaluate a business model for taking the idea to market, and how to design appropriate funding

The course provides a survey and overview of the key tasks and challenges typically faced by biotech entrepreneurs, their management team, and directors. Students will receive training and the tools required to form a business plan.

This course is an overview of the strategic planning process of a biotechnology enterprise. The course focuses on creating value through strategy formulation and implantation.