Business of Biotechnology

Biot 201b

Spring 2017

Dr. Neil Simister, Biology Department

Tuesday, Thursday, 3.30-4.50 PM, in Shapiro Science Center GL14

Biotechnology includes many ways of using living organisms to provide products or services. In current usage, the term biotechnology usually refers to industries based upon recombinant DNA methods. These industries are diverse but most are in the areas of medicine, agriculture, and manufacturing. Business of Biotechnology gives an overview of these industry sectors and introduces their research and development models, regulation, financing and marketing.

Learning goals: Students who successfully complete Biot 201 Business of Biotechnology will be able to identify major sectors of the biotechnology industry and give examples of their marketed products. They will be able to recognize similarities and differences in the research and development timelines and regulatory processes of these sectors. They will be able to distinguish between different ways in which companies are financed and to describe the typical stages of financing of a company as is develops from start-up toward acquisition or IPO.

Prequirement: Biot 200a Biotechnology Proseminar, or instructor's permission.

Text: Building Biotechnology, 3rd edn., Yali Friedman, Logos Press 2008 (Not current edition).

Attendance is required.To get the most value from the course, students need to do a lot of work outside of class. I expect students to spend a minimum of 9 hours per week on readings and other information-gathering, and working on the individual and team assignments.

Office hours: Monday 1-2 PM and Wednesday 11 AM - noon in Bassine 203, ext. 64952,.

Electronic resources: the web site at contains class information, links and assignments. You can access the site with your UNET name and password.

Grading will be based on participation in discussion and activities in class and on the individual and team assignments (20% for attendance and participation;80% for assignments).

Learning/other disabilities: If you have a documented disability on record at Brandeis, please talk to me early about any special needs you have, or any reasonable accommodation you require. I am hearing-impaired; when you speak to me, you may need to talk more loudly than usual. You may notice that I look at your lips for clues to what you are saying.

Academic integrity: Students should be familiar with and must uphold Brandeis policies on academic honesty These include the requirement that all work submitted for credit must be the student's own except where the contributions of others are properly cited or where teamwork is explicitly allowed. Take care to use quote marks and cite direct quotes, and to cite sources of ideas and substantial paraphrasing. Work is checked for plagiarism including translation from other languages.

Biot 201b Business of Biotechnology, Spring 2017

TuesdayJan 17 / Industry development and sectors
ThursdayJan 19 / Industrial biotechnology: enzymes
TuesdayJan 24 / Medical biotechnology: small molecules
Thursday Jan26 / Medical biotechnology: biologics–therapeutic antibodies
Tuesday Jan31 / Medical biotechnology: biologics–therapeutic proteins
ThursdayFeb 2 / Siamab, JeffBehrens, Siamab
TuesdayFeb 7 / R & D: discovery
ThursdayFeb 9 / Agricultural biotechnology(snow day, MP4 on LATTE)
TuesdayFeb 14 / R & D: preclinical testing
ThursdayFeb 16 / Regulatory approval
Tuesday Feb 21 / Recess, no class
Thursday Feb 23 / Recess, no class
TuesdayFeb 28 / Intellectual property, Steve Bossone, Alnylam
Thursday Mar 2 / Labeling andadvertising
Tuesday Mar 7 / Label-driven drug development,Corinne Noyes, Biopharma Consultant
Thursday Mar 9 / Clinical trials,Ken Getz, Tufts Center for the Study of Drug Development
TuesdayMar 14 / Post-approval monitoring
ThursdayMar 16 / Gene therapy, Catherine O'Riordan, Genzyme
TuesdayMar 21 / Company structure
Thursday Mar 23 / Financing biotech
Tuesday Mar 28 / Manufacturing: production
Thursday Mar 30 / Manufacturing: purification and formulation
TuesdayApr 4 / Alliancemanagement,Jeremy Ahouse, Celgene
Thursday Apr 6 / Alliances and mergers,Sandra Glucksmann, Editas
Tuesday Apr 11 / Recess, no class
Thursday Apr 13 / Recess, no class
Tuesday Apr 18 / Recess, no class
Thursday Apr 20 / Analysis of biologics Elizabeth Higgins, GE
Tuesday Apr 25 / Marketing
Thursday Apr 27 / Student presentations
Tuesday May2 / Student presentations

Syllabus might change to accommodate the guest speakers' schedules.

Business of Biotechnologypage 1Dr. Neil Simister