The Drug Development Process: An Intensive Seminar

Get a detailed picture of all aspects of the complex and highly interrelated activities involved in bringing a pharmaceutical discovery to approval and market. Although the focus is on pharmaceuticals, seminar discussions also integrate biologics, diagnostics and devices. This course is designed for executives, disciplinary experts who wish to broaden and advance their careers, nontechnical professionals, investors, and others interested in fully understanding the biopharmaceutical industry.

Class discussions are guided by experts with years of hands-on experience with large and small pharmaceutical, biotechnology and related companies. Seminar topics include industry environment, discovery and pharmacology, chemistry manufacturing and controls (CMC), toxicology, pharmacokinetics, program management, Food and Drug Administration (FDA) inspections, biologics, assays and devices, clinical trial design and conduct, clinical trial statistics, pharmacogenomics, FDA compliance regulations, patents and intellectual property, and commercial development.

How You Can Benefit From This Course

Understand the processes that are vital to successfully bringing a biotechnology product to market. Recognize the critical roles of each company unit, and gain insight into the integrated and multifunctional nature of drug development. Interact with experts and colleagues from a wide range of disciplines in the biopharmaceutical industry. Leave with knowledge of the entire process, enabling you to understand industry terminology and work more effectively in multidisciplinary teams.

Schedule (tentative)

Day 1: 8:30 am–5:30 pm

• Welcome and introductions
• Industry environment
• IND/NDA documents
• Introduction to case studies

Day 2: 8:30 am–5:30 pm

• Drug discovery
• CMC/pharmaceutical development
• Toxicology
• Regulatory affairs and approval process
• Case study presentation and discussion

Day 3: 8:30 am–5 pm

• Pharmacokinetics and metabolism
• Project management concepts
• Pharmacogenomics
• Assays, devices and diagnostics
• Case study presentation and discussion

Day 4: 8:30 am–5:30 pm

• QA/QC and compliance
• Clinical development
• Clinical trial design and statistics
• The FDA perspective on bioresearch monitoring (BIMO)
• Case study presentation and discussion

Day 5: 8:30 am–1:00 pm

• Biologics and biopharmaceuticals
• Commercial development
• Patents and intellectual property
• Business planning and commercial development
• Case study presentation and discussion