Take Your Medicine: Developing New Drug Products (edX)

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.

What you'll learn:

• 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"

Syllabus

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