Course Detail

Advances in genomics, proteomics, recombinant protein technology and structural biology have created unprecedented opportunities and challenges for both 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, as well as the discovery development process. Students will learn about therapeutic and vaccine targets, and how vaccines and small molecule drugs are designed, tested and produced to prevent and/or treat human diseases. They will also learn about clinical testing of biologically derived therapeutics, elements of clinical trials as well as real and perceived issues of vaccine safety and how markets for vaccines are made. This course will consist of lectures, seminars and student presentations/group discussions.

• Biotechnology based therapeutics:  design, discovery and development.
• Structure based drug design: different methods, successes and possible pitfalls.
• Comparative development of biologics and small molecule drugs.
• Biotechnology industry perspective on development of biologics.
• Genomics and proteomics based approaches.
• Novel approaches for vaccine design: peptide, conjugate and DNA vaccines.
• Preclinical assessment of therapeutic proteins and monoclonal antibodies.
• From candidate to commercial product.
• Clinical testing of biologically derived therapeutics.
• Special topics in the clinical development of biologically derived therapeutics: Cell therapy and gene therapy, immunogenicity, safety with chronic administration, regulatory processes and manufacturing changes during clinical development.
• Clinical trials, cGCP, responsibilities of the sponsor, responsibilities of the investigators, IRB, informed consent, adverse events monitoring, the protocol, study activities, and study documents.
• Clinical evaluation of preventive vaccines for infectious disease indications.
• Vaccine safety: real and perceived issues.
• Biologics and generic biologics.
• Applications of immunotherapeutics.
• The vaccine industry and economics of vaccines.
• Making markets for vaccines and introduction of new vaccines in the healthcare system.
• Product name development:  Nomenclature of biotechnology products; synonyms of trade, common and scientific names.

1. Students will become familiar with biotechnology based therapeutics.
2. Students will be able to understand the comparative development processes for biologics and small molecule therapeutics.
3. Students will become knowledgeable about elements of clinical trials for biologically derived therapeutics.
4. Students will understand the vaccine discovery, development and marketing process and be able to describe the vaccine industry and vaccines in common use.

Classroom attendance and participation in discussion                       20%
Oral Presentations of case studies                                                   40%
Written report on  final project                                                        40%