ALS 401: Biotechnology-based Therapeutics
Course Number: ALS 401
Course Name: Biotechnology-based Therapeutics
No. Units: 3.0
Faculty/Instructor(s): Larry Grill
400-level Technical/Business Designations: Technical
Clinical and Regulatory Affairs: Elective
Pharmaceutical Discovery and Development: Required
Advances in genomics, proteomics, recombinant protein technology and structural biology have created opportunities and challenges for the biotech and pharmaceutical industries. This course will provide students with a background of the scientific basis of some key aspects of biotechnology based drug, biologic and vaccine design, discovery and development process. Students will learn about therapeutic and vaccine targets, and how the drugs and vaccines are designed, tested and produced. They will also learn about recently developed biological pharmaceuticals along with many of the current targets of pharmaceutical companies. The mechanism of many of the current biotechnology-based therapeutics will be discussed. In addition, the elements involved in the development a biotechnology company will be taught. A group project will be required in which each group will provide a short business plan for the development of a new drug. This course will consist of lectures, seminars and student presentations/group discussions. Environmental, ethical, regulatory, patent, economic and social issues related to biotechnology-based therapeutics will also be discussed.
Background knowledge in chemistry, biochemistry, and molecular biology.
- The likely future of medicine: patient-specific therapeutics.
- Drug design, discovery and development.
- Biotechnology-based therapeutics.
- Production methods for therapeutics and vaccines.
- Anticancer drugs and validation of cancer drugs.
- Vaccines and the immunological challenges.
- Vaccines for noninfectious diseases.
- Genomics and proteomics based drug discovery.
- Government regulatory oversight of vaccines and therapeutics.
- Intellectual Property Rights for drug development and discovery.
- How to develop a business plan for a new biotech-based therapeutic.
- Students will become familiar with biotechnology based therapeutics.
- Students will be able to understand the research and development processes for biologics and therapeutics.
- Students will become knowledgeable about elements of clinical trials for therapuetics.
- Students will understand the drug discovery, development and marketing process as well as learn about the biotech-drug industry.
- Students will learn the elements involved in the development of a business plan to develop a new biotech-based therapeutic.
Classroom attendance and participation in discussion. . . . 10%
Exams and Quizzes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40%
Group project on starting a company that produces
a biotechnology service or product. . . . . . . . . . . . . 25%
Written reports on projects and/or assignments. . . . . . . . . 25%