Course Syllabus

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:

• Students will learn the product development process for pharmaceuticals, biologics, devices, and combination therapies involving drugs and devices.
• Students will learn the regulatory approval process and key regulatory agencies for new drugs, biologics, devices, and drug-device combinations.
• Students will understand the roles of preclinical development, clinical development, and manufacturing scale-up processes in product development.
• Students will appreciate the technical factors and business factors that are necessary for successful product development in the biomedical sector.
• Students will appreciate ethical, social, and cultural considerations for novel biomedical products.
• Students will understand emerging biomedical product categories.
• Students will learn to analyze and critique contemporary real-world cases of biomedical product development.
• By the end of the course, students will generate visionary concepts and commercialization strategies for new biomedical products.

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 Links to an external site. (or watch her on YouTube Links to an external site.)

                                      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 Links to an external site. (HUEA Links to an external site.)

                                       Read: The Impact of Publicly Funded ... Research Links to an external site.

                                                 The Million-Life Idea Links to an external site.

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 Links to an external site.)

                                    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 Links to an external site.)

                                      Read: Do-It-Yourself Medicine Links to an external site.

                                                Biology Hacklabs Links to an external site.

                                                Zen and the Art of Microscope Maintenance Links to an external site.

                                                A ... race to cure her fatal genetic disease Links to an external site.

                                                Teen works to identify ... her own disease Links to an external site.

                                                Governance: Learn from DIY biologists Links to an external site.

Week 10 (Mar 28th):     FDA Advisory Panels

Optional outside activity: Tiling the Genome - Alexander Wait Zaranek

                                      5:00 pm at Sheerr Room, Fay House Links to an external site.

                                      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

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 Download attached slides

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

• Students are expected to attend and actively participate in every class session.
• Any material submitted to meet course requirements is expected to be a student’s own work. Details on academic integrity are included below.

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:

• Propose a new biomedical product (a drug, device or diagnostic), and explain the clinical need that it fulfills.  Why is there a need for this product?
• Explain the competitive landscape for your product.  What commercial products will compete with your proposed product in the marketplace?  How is your new product better?
• Describe the technical hurdles that must be overcome.  Are there new technologies that must be developed to make the product a success?
• Describe the regulatory pathway for the product. Will you need to conduct pre-clinical studies or a clinical trial?
• Explain the pricing for the new product.  How do you justify the price, and how will it compare in pricing to competitive products?

Students will also complete a 2-minute final presentation on their proposed product.

Grading Procedures:

Class Participation: 25%

Student Report: 50%

Student Presentation: 25%