Course Detail

This course will focus on the key aspects of the business and technical development of biologicals, drugs and combination products.  Customized case studies will be developed to cover the business background of the company of interest, technology involved, key preclinical studies for one product, pivotal clinical studies as well as marketing strategy, corporate alliances and intellectual property issues.  Students will be assigned to give group presentations as part of each case study.  A corporate representative from each company will be invited to provide a lecture for each topic.  In some cases, published case studies and/or scientific literature may be used as background reading for certain topics.  Business and science/manufacturing-related issues will be identified for active group discussion as part of each case study.

A schedule of different companies (up to six or seven) featuring one of each company’s key products will be selected and will include several of the following: small molecules, biologics, vaccine products, liposomal drug delivery products and combination drug-device products.  Case studies may also include issues related to the pharmaceutical industry in general.

Students will develop critical analytical skills for appreciating the challenges of bringing a pharmaceutical product through the pipeline and will understand the company’s critical management decisions for moving the product forward. The product information will be obtained from publicly accessible information and interviews with company personnel.  If available, a representative will then give a presentation on the company’s product.  By the end of the course, students should understand the challenges and successes/failures experienced in bringing a product to market and subsequent management of product life cycle after marketing approval has been granted.

Classroom arrendance and participation                                         20%
Oral presentations for the case studies and current events               40%
Written reports                                                                             40%