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) Fall 2025 schedule Day and Time Topics Guest Speaker(s) Monday, 8:30 am–5 pm Welcome and Introductions Regulatory Affairs Biologics/Biopharmaceuticals CMC/Pharmaceutical Development Toxicology Aditya Das, Ph.D.

M.B.A.

Shaily Garg, PMP CCRA RAC Tuesday, 8:30 am–5 pm Drug Discovery Drug Metabolism and Safety Pharmaco-omics Biomarkers Companion Diagnostics Case Study Discussion Aditya Das, Ph.D.

M.B.A.

John C.

Erve, Ph.D.

Wednesday, 8:30 am–4:40 pm Drug Delivery Technologies Financial Aspects of Drug Development QA/QC and Compliance Aditya Das, Ph.D.

M.B.A.

Dan Klassen, B.Sc.

Thursday, 8:30 am–5:10 pm Post Marketing Surveillance Patents/IP Pharmacokinetics Clinical Development Clinical Trial Monitoring Aditya Das, Ph.D.

M.B.A.

Alexandra Baran, Ph.D.

Werner Rubas, Ph.D.

Melanie Morrison, M.S., RAC Friday, 8:30 am–1 pm Medical Affairs Program Management Aditya Das, Ph.D.

M.B.A.

Melanie Morrison, M.S., RAC