Overview of drug development, approval and marketing processes
Understand the role of research in the development of new drugs
Identify key stakeholders and issues concerning pharmaceuticals
Discuss the issues and considerations of manufacturing pharmaceuticals
Discuss the role of the FDA in regulations and product approvals
Understand the financial investment necessary to “bring a drug to market"
Medicine has eradicated or eased the symptoms of many diseases. This course reveals how new drugs go from research innovation to a medicine that can be prescribed to patients. You’ll learn the process, challenges and issues in developing pharmaceutical products. Drug development is a dynamic field where innovation and entrepreneurship are necessary to keep up with health care expectations, strict regulations and tightening development budgets. An overview of drug development, approval, and consumer issues will be presented and discussed in the context of research practices, science, marketing, public welfare and business.
Participants from all backgrounds and interest, including scientists, healthcare professionals, entrepreneurs and the general public, are encouraged to participate.
Week 1: Drug Development Overview
An overview of the various phases of the drug development pathway, highlights of medical innovations and discussion of the changing landscape for new products
Week 2: Discovery & Preclinical Phases
Greater detail on the discovery and preclinical development, drug repurposing, formulating & testing drug products and how an academic researchers contributed to finding an antidote to anthrax
Week 3: Clinical Trials & Regulations
The clinical trial phases and challenges, how cancer therapies are developed, FDA’s perspective on new product approvals
Week 4: Patient Safety, Manufacturing & University Innovations
FDA role to ensure patient safety, how manufacturers assure the medicine you take is what it is supposed to be, the importance of university research to develop novel medicines
Basic understanding of science concepts