Course Description
Regenerative bioscience therapies and diagnostics, including cell therapies, biomaterials, biopharmaceuticals, gene therapies, and devices. In addition, the business of regenerative bioscience from concept development, pre-clinical and clinical testing, regulatory approval, and manufacturing will be covered. Students will learn about the key steps involved in bringing a product to market and how start-up companies are formed.
Athena Title
Senior Capst Regen Bioscience
Prerequisite
ADSC 4420
Semester Course Offered
Offered spring
Grading System
A - F (Traditional)
Course Objectives
In this course, students will learn about current regenerative bioscience therapies and diagnostics including cell therapies, biomaterials, biopharmaceuticals, gene therapies, and devices. Students will gain an understanding of the business of regenerative bioscience starting from product development at pre-clinical and clinical stages in academic and industry settings. Students will learn about the steps involved in bringing a product to market and how start-up companies are formed. Students will write a research proposal and apply regenerative bioscience approaches to develop a potential therapeutic or diagnostic that can be used to treat or evaluate a human or animal disease or injury. Students will utilize problem-solving and critical thinking skills and apply the scientific method to devise an experimental plan that encompasses diagnostics, pre-clinical, and clinical applications of a potential regenerative therapy. Students will be required to submit a written report and provide an oral presentation of their research proposal.
Topical Outline
I. Types of Regenerative Bioscience Products a. Therapeutics i. Cell Therapies ii. Biomaterials iii. Biopharmaceuticals iv. Gene Therapies b. Devices i. Simple Detection ii. Imaging iii. Therapeutic Devices II. Product Development a. Food and Drug Administration (FDA) Regulatory Pathway i. Investigational New Drug (IND) ii. Investigational Device Exemption (IDE) b. Preclinical Testing i. Cellular Assessments 1. Efficacy 2. Safety 3. Manufacturing Characteristics (Product consistency in physical characteristics, properties, and potency) ii. Preclinical Animal Testing 1. Efficacy a. Key Model Characteristics 2. Safety a. Toxicity i. Necropsy ii. Blood Chemistry and CBC b. Biodistribution c. Pharmacokinetics c. Clinical Trials i. Veterinary ii. Human 1. Phase I- Safety 2. Phase II- Efficacy 3. Phase III- Scaled Efficacy 4. Phase IV- Monitoring III. Business Development a. Product Market Fit b. Market Research i. Market Size ii. Market Risk and Mitigation iii. Potential for Success iv. Funding Sources IV. Develop your Own Product a. Write a Proposal b. Proposal Presentation
Syllabus