BIOL 357
Thursdays ♦ 5:30~8:15 pm ♦ MARK 201
(Except Company Visit & Special Events)
BIOL 357 Foundations of Biotechnology (2). A review of biotechnology applications and product
development in the life science industry. Topics will include: 1) the process of bringing a product to market
from concept to sales; 2) laws, regulations, ethics, and social issues pertaining to the discovery, development,
testing, manufacturing and commercial distribution; 3) skills of technical writing, Standard Operating
Procedures and documentation for regulatory, quality assurance, and intellectual property; and 4) employment
opportunities. Prerequisites: BIOL 210 and BIOL 211.
Course Outline and General Thrust:
Overlying themes and exposure:
The course will be divided into four general
categories with subsets of each. The general
course outline will be:
 Biotechnology and the Science.
 The Industry and Issues.
 Commercial Technology.
 Preparing for a job/career.
Required reports, readings and presentations
will center on some common themes. These
will include:
 Current events.
 The San Diego & Biotech scene.
 Controversial issues.
 Preparation & readiness.
Topic Description
Introduction to the Course and Industry Overview.
Aug 28
Introduction to the course and course expectations.
San Diego life-science industry.
Review of biotechnology, history and trends.
Homework prior to next class – Introduction and Chapter 2 of
“Dynamics of California Biotechnology Industry” + Terms list +
Current Events reading.
R&D: Discovery to the Marketplace.
Sep 4
Sep 11
Sep 18
“Must know” terms and issues.
Discovery and the R&D Process.
Product Development to the Marketplace.
Timeline handout assignment + Current Events reading.
Ag Biotechnology, Food Safety and Perspectives.
Genetically Modified Organisms.
Food Safety & Perspectives: Risk vs. Benefit -- Green vs. Science
Beyond crops for food and fiber.
Regulation of Ag Biotech.
Homework prior to next class -- Chapters 5 & 6 of “Dynamics of
California Biotechnology Industry . . .”
Biopharmaceuticals: Discovery to the Marketplace and Beyond.
 Big Pharma and Bio Pharma.
 Industry operations and drug development strategies.
 Review with Senior Scientist/Executive with successful history.
 Review: pp 18 – 24 in “Guide to Biotechnology”
J. May
Sep 25
Test 1
Government and Regulatory Affairs.
 The agencies and their role.
 Laws, regulations, process, and compliance.
 Website locations for regulations and guidance.
 Pharma and Medical Devices
 Reminder: organize to attend BIOCOM or In the Executive Chair.
Oct 2
Good Laboratory Practices & Principles for Lab Tech & Researchers.
 Good Laboratory Notebook Procedures.
 Methods, Procedures, Sampling, Handling.
 Storage and documentation.
 Out-of-Spec procedures & consequences.
 Homework on Regulatory/QC/GLP.
Oct 9
Laboratory Safety and Materials Handling in the Lab Workplace.
 Reagents, spills, disposal, radioactivity, hazardous materials.
 Safety precautions and actions.
 Emergency actions and rules.
 Home Quiz.
 Homework prior to next class – Chapters 3 & 4.
Oct 16
Oct 23
Oct 30
Intellectual Property – Patents, Trademarks, Trade Secrets,
Confidentiality, Materials Transfer agreements & Processes.
 What you should know about working in an intellectually
competitive world and why.
 Case examples.
 Home Quiz
 Homework prior to next class – pp 111-114 of BIO “Guide . . .)
Company Visit
 Industry perspectives & what companies want in employees.
 Science, instruments and workplace in action.
 Test Review
R. Frasca
@ 5:20
Test 2
Effective Communications, Written/Oral Reports: Science & General.
 Effective presentations.
 Effective written reports and communications
 Prepare presentation on career interests and why.
Nov 6
Job Searches, Resumes & Interviews.
 Internships, jobs and careers.
 Looking for jobs.
 Prepare resumes and cover letters for review. Hand-in next week.
S. Punch
Nov 13
Network or Gain Insight from the Industry and/or Industry Leaders.
 Attend one BIOCOM event or “In the Executive Chair” session
offered by the Business School.
 See instructor for alternative options. Approval needed.
 Purpose of BIOCOM event is to network and learn about the
industry. “In the Executive Chair provides insight from leaders.”
On your own
Date/event is
discretion &
Nov 20
Examining Annual Reports/Financial Statements of companies and
what they mean.
 Student Presentations -- Career interests.
 1st Paper due – 1,600-word report on current topic.
 Hand-in prepared resumes.
 Homework prior to next class—Chapters 2, 5 & 6 of above.
Thanksgiving Holiday – No Class. Happy Thanksgiving.
Nov 27
Dec 4
Dec 11
Second Paper due – 400-word Executive Summary from
attending BIOCOM or “In Executive Chair” due.
Practical Experiment Design/Controlling Experimental Error.
Goal setting and performance appraisals.
Semester review and highlights.
Final Exam
Final Exam
READINGS: (Readings will be made available/accessible over the internet free of charge.)
Dynamics of California’s Biotechnology Industry. 2005. Junfu Zhang and Nikesh Patel.
Public Policy Institute of California. San Francisco, CA.
Guide to Biotechnology. 2007. Biotechnology Industry Association. Washington, D.C.
The Daily Transcript/San Diego Source. A daily business newspaper.
Fierce Biotech. National biotechnology industry news.
Related documents