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The Drug Development Process: An Intensive Seminar

There are currently no sections open for enrollment.



(3.6 ceu)

MCLE credit: 36 hours

A required course in the Professional Program in the Life Sciences Business; a recommended course in the Professional Program in Project Management in the Life Science Industries

Get a detailed picture of all aspects of the complex and highly interrelated activities involved in bringing a pharmaceutical discovery to approval and market. While 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 career, 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, 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. The guest speakers use real-world case studies to promote lively group discussions.

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.

Breakfast, lunch and course materials are included in the course fee.

Course Directors
Velimir Kuftinec, Ph.D., M.B.A., has extensive experience in the pharmaceutical, biotechnology, medical instruction and medical diagnostic markets. He is an expert in business development and licensing, global strategic planning, and worldwide marketing.

Guest Speakers
P. Michael Dubinsky, has 24 years of experience working with the Food & Drug Administration (FDA) and 13 years of experience in private industry, focusing on GXP compliance.
Charles Du Mond, Ph.D., is senior vice president, biometrics, at ICON Clinical Research. He has published on interim analyses and speeding reports.
David Ellis, M.D., Ph.D., is senior medical director at ARYx Therapeutics. He has extensive experience in designing and conducting clinical trials for many companies.
Diane Gordon, Ph.D., has 28 years of experience as an expert project manager as an independent consultant for companies such as Syntex and Roche.
Natalie McClure, Ph.D., has 21 years of experience, in regulatory affairs, representing numerous companies before the FDA.
Tom Moran, has been active in patent law since 1973. He consults and teaches after recently retiring from Foley and Larner, LLP.
Darwin Williams, M.S., has more than 20 years of experience as a quality management consultant specializing in GMP/GLP compliance and training.
Susan Wollowitz, Ph.D., is vice president of chemistry and manufacturing at Medivation. She has more than 20 years of experience in the chemical and pharmaceutical industries.
Mary Alice Yund, Ph.D., Extension Honored Instructor, originated and leads the Bioscience Essentials for Industry Professionals course at UC Berkeley Extension.

Schedule (tentative)

Day 1: 1–5:30 pm

Day 2: 8:30 am–5:30 pm

Day 3: 8:30 am–5 pm

Social gathering after class from 5–7 pm

Day 4: 8:30 am–5:30 pm

Day 5: 8:30 am–5:30 pm


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We are upgrading our systems in July, so please enroll online in summer 2013 courses by July 8, 2013. After July 8, you must enroll in summer 2013 courses by phone, by mail or in person.

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expand San Francisco, Mon. April 22, 1 pm, 5 meetings