Course Syllabus
Course Syllabus & Information |
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BIOT E-225: Biomedical Product Development Spring 2016, Mondays 5:30 pm – 7:30 pm Location: Pierce Hall 209
Instructor: Sujata K. Bhatia, MD, PhD – Assistant Director of Undergraduate Studies in Biomedical Engineering, Harvard School of Engineering and Applied Sciences Teaching Fellow: Dileep D. Monie – Associated Researcher, Broad Institute of MIT and Harvard; Neurosurgical Bioengineer, Brigham and Women’s Hospital Audience: Undergraduate Students, Graduate Students, Non-credit Students Prerequisites: Background in biology and chemistry is helpful Office Hours: The instructor is available by appointment to provide help and inspiration! Course Textbook: Students will be provided with recent literature each week.
Description: This course will examine the design and development of new therapeutic products. Students will learn through case-based studies of product development for pharmaceuticals, biologics, medical devices, and combination therapies. The course will describe the steps of biomedical product development, from conceptualization to design to manufacturing to regulatory approval and commercialization. The course will discuss both technical and business factors that contribute to the success or failure of new biomedical products. Appropriate design of preclinical and clinical trials will also be included in the course. Students will gain an appreciation for emerging technologies in stem cells, gene therapy, tissue regeneration, personalized medicine, and targeted therapies. Additionally, students will learn about the special challenges presented by emerging biomedical technologies. By the end of the course, each student will complete a project to propose a new biomedical device, and identify the regulatory strategy, technical milestones, and business milestones for the new device.
Learning Goals:
Lecture Schedule:
Week 1 (Jan 25th): Overview of Biomedical Product Development
Week 2 (Feb 1st): When Cell Therapy Isn’t Enough - Doris A. Taylor 4:15 pm at Knafel Center (or watch her on YouTube) 6:00 pm at Pierce Hall 209 for discussion
Week 3 (Feb 8th): SNOW DAY (review online materials in lieu of class) Clinical Trial Design and Good Clinical Practices FDA Advisory Committees
Week 4 (Feb 15th): University Holiday: President's Day (NO CLASS)
Week 5 (Feb 22nd): Biotechnology Entrepreneurship and Effective Altruism Guest Lecturer: Eric Gastfriend, MBA '15 (HUEA) Read: The Impact of Publicly Funded ... Research
Week 6 (Feb 29th): Patenting and Intellectual Property
Week 7 (Mar 7th): Good Clinical Practices and Clinical Trial Design Optional outside activity: Essential Elements of a Life Science Startup Johannes Fruehauf, MD, PhD, (LabCentral) 6:00 pm at the Harvard Innovation Lab IMPORTANT: Preregister as a Harvard Student here
Week 8 (Mar 14th): Spring Recess (NO CLASS)
Week 9 (Mar 21st): DIY Biomedical Products and Citizen Science Labs Guest Lecturer: Angela Kaczmarczyk, Ph.D. (BosLab) Read: Do-It-Yourself Medicine Zen and the Art of Microscope Maintenance A ... race to cure her fatal genetic disease Teen works to identify ... her own disease Governance: Learn from DIY biologists
Week 10 (Mar 28th): FDA Advisory Panels Optional outside activity: Tiling the Genome - Alexander Wait Zaranek 5:00 pm at Sheerr Room, Fay House 6:45 pm at Pierce Hall 209 for discussion
Week 11 (Apr 4th): Organs-On-A-Chip Optional after-class activity: Biotechnology and Small Business Innovation Research (SBIR) grants Guest Lecturer: Pei Zhang, Ph.D.
Week 12 (Apr 11th): Leveraging Prior Art for Drug Discovery Optional: students may contact Fanuel Muindi, Ph.D. at fmuindi@fas.harvard.edu and check out www.stemadvocacy.org to learn about Global STEM advocacy
Week 13 (Apr 18th): Case Study of Biologic Development: Penn Gene Therapy Trial Optional: students may contact Kris Ramadurai at kramadurai@g.harvard.edu and check out attached slides to learn more about global humanitarian work to address unmet needs in public health
Week 14 (Apr 25th): Case Studies of Pharmaceutical Development: Pfizer and Merck
Week 15 (May 2nd): Student Presentations DUE: Course Project Presentation Slide (April 30th)
Week 16 (May 9th): Student Presentations DUE: Course Project Paper
Course Policies and Expectations
Course Project: Students taking the course for credit are expected to complete a 5-10 page paper to propose a novel biomedical product. Students should accomplish the following goals:
Students will also complete a 2-minute final presentation on their proposed product.
Grading Procedures: Class Participation: 25% Student Report: 50% Student Presentation: 25%
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Course Summary:
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