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Department of Health Informatics

Clinical Research Management

BPHE5200 - Medicines Development

Course Description

The Medicines Development course provides students with knowledge of research and development from conceptualization to commercialization. Students in this course will follow the translational science model, beginning with basic research, assessment in humans, translation to patients, delivery into practice and adoption in communities. The focus of the course provides knowledge of product from research discovery, stages of development, methodological approaches, and intellectual property. Throughout applied critical thinking students will understand from bench to bedside.

Credits/Modes of Instruction

Credits: 3

This course is a graduate level course provided via the Internet using the Canvas Platform (a Learning Management System (LMS)).

Prerequisites

None

Course Goals and Outcomes:

Goals

To familiarize students with the knowledge of product development related to the novel idea, facets pre-clinical testing, research methodological design, multidisciplinary collaboration, consideration intellectual property, marketability, and commercialization.

Outcomes

Upon completion of this course, the student will have the ability to:

Articulate deep insight into the phases of drug development and commercialization process (i.e. pricing & market access).

Apply team science strategies and critically examine processes related to the development of medical interventions (i.e. precision medicine).

Identify, analyze and apply modalities of therapeutic intervention (i.e. Target identification, lead optimization, cell/ gene therapy), driven by regulatory oversight, revolutionary changes in the business models, scientific advances and technology application.