This course will be an introduction to evolving new advanced therapeutic technologies and cover some of the emerging technologies in the evolving therapeutic space. These include cell therapies, gene therapies, stem cells, genome editing, CRISPR technology, tissue engineering, regenerative biomaterials, and combination therapies. The course will also help the student describe the process of selection of an appropriate new therapeutic product for a given unmet clinical need.

This course will cover an introduction to industry standard methods, techniques and processes for preclinical product and process development for a new therapeutic agent or product. The industry has a well-established process by which desired product attributes meet specific endpoints and are developed. Oftentimes, new processes must be developed for the manufacture of these new modalities of treatment. The student will be exposed to these and other related concepts in new product design and manufacture.

This course will examine the process and ethical considerations that provide for the safe and humane clinical testing of new therapies in a preclinical and clinical setting with human subjects. It will cover topics such as clinical trial design and trial management and operations. It will also review the ties of clinical operations with science based and scientifically bourn marketing claims once approved by the authorized regulator in a given market.

This course will explore the different techniques and processes available to manufacture advanced therapeutic products. It is important to recognize that there are different types of cell, gene, and other advanced therapies that face very different manufacturing challenges. Additionally, biologically based and combination advanced therapies face their own processing requirements. Clinical trial design and ultimate commercial distribution goals of a new therapy will be one of the guideposts that determine a manufacturing strategy for a new therapy.

This course will provide an overview of both regulatory and quality aspects of the advanced therapies industry and allow the student to develop an understanding of pathways necessary for proper quality and regulatory compliance. The course will cover key topics such as the role of the patient in the overall regulatory strategy for a new product, the concept of total quality and risk management tools and techniques in the process of the development of new products, and the components of a quality management system.

Successful development and introduction of a new therapeutic agent requires solid mastery of project management and communications skills. This course will review basic project management skills, team leadership skills, and best practices in corporate communication and the ethical considerations therein. Additionally, the student will be introduced to a traditional organizational hierarchy in the biotech industry.

These courses are a two part series, Team Project I and Team Project II. The MBID-Therapeutics team project classes will mimic and involve the real-life process of selecting an underserved disease or unmet clinical need (or cycle of care), propose a solution, build a business case, and address reimbursement and regulatory paths. The final deliverable being the writing and presentation of the Business Report. Team Project Course I will cover items such as defining the unmet clinical need, mapping the regulatory and reimbursement landscape and building the required product specifications. In this two-course series, the groups will do everything through this process except develop a hands-on construct. The training through this curriculum will provide work on real life concepts, real-life experience, integrated project, and team work.

This course will review the background and history of medical ethics in the conduct of human clinical research and use that knowledge as a backdrop to understanding the importance of preclinical research in the development of new clinical therapies. Additionally, the course will review the ethical process of communicating clinical research to the broader clinical community and explore the process of marketing, selling, and clinical communications as a whole.

This course will provide an introduction to front and back end marketing processes, as well as an introduction to intellectual property and corporate law in their role in product development in the biotech industry. Students will be exposed to careers in these fields and opportunities for scientists to take a larger role in professional marketing efforts vis-à-vis traditional product development activities.

This course will expose the students to the importance of the regulatory and reimbursement environment and processes in the development of successful next generation advanced therapies. Understanding of the importance that these two subjects play is critical in the successful launch of a new product. Topics to be covered in this course include the importance of a reimbursement strategy as it affects the product development strategy and an understanding of the general US product reimbursement environment. Additionally, the student will be exposed to standard financial analysis tools that will allow them to explain the process of determining the financial value of a new product in the biotech space.