FOUNDATIONS OF BIOTECHNOLOGY 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. Date Topic Description Instructor 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. Kern 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” Kern Kern . J. May Ex-Pfizer 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. Kern Oct 2 Good Laboratory Practices & Principles for Lab Tech & Researchers. GXP, GLP, SOP, QSP. Good Laboratory Notebook Procedures. Methods, Procedures, Sampling, Handling. Storage and documentation. Out-of-Spec procedures & consequences. Homework on Regulatory/QC/GLP. Kern 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 Risk Management Broberg Attorney & Kern Genentech @ 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. Kern & TBA 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.” Class On your own Date/event is student’s discretion & obligation. 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. Kern Class Class Kern 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.