Biotechnology and Basic Sciences

A to Z Course Index

Information Sessions

Certificate Programs

Transcripts

Course Locations

Concurrent Enrollment

Order a Catalog

Courses begin every month. A new edition of our catalog is published three times a year in early April, July and December.


Quick Enroll

Search

The Drug Development Process

(3.2 ceu)

MCLE credit: 32 hours

A recommended course in the Professional Sequence in Project Management for Biopharmaceuticals

This four-day intensive course provides a detailed picture of all aspects of the complex and highly interrelated activities involved in bringing a pharmaceutical discovery to approval and market. The focus is on drugs (small molecules), however, biologics, diagnostics, and devices will be integrated into the discussions. Provided by ten industry experts, this course is designed for executives, disciplinary experts, entry-level employees, investors, and all others interested in a full understanding of the biopharmaceutical industry. Topics include industry environment, discovery and pharmacology, chemistry manufacturing and controls, 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. Case studies will be presented for group discussion. There are no prerequisites other than interest. Attendees will be provided with a book containing slide printouts (handouts) in which they may take notes. Breakfast, refreshments, lunch, and social hours are included. Enrollment is limited to 45 in order to support a high degree of interaction between attendees and speakers.

This course is presented in April and October of each year. Check the Berkeley Extension catalog for upcoming dates.

Schedule and Outline*:
DAY ONE (Tuesday)
Check-in (8:00-8:30 am)
Welcome/Introductions/Overview
Industry Environment
IND/NDA Documents/Submissions
Drug Discovery

Pharmaceutical Development/CMC Toxicology
Social Gathering

DAY TWO (Wednesday)
Pharmacokinetics
Program Management
FDA Monitoring (BIMO)
Biologics
Case Studies Introduction

DAY THREE (Thursday)
Regulatory Affairs
Assays/Devices/Diagnostics
Clinical Development
Clinical Trial Design & Statistics
Social Gathering

DAY FOUR (Friday)
QA/QC/Compliance with Regs
Patents/Intellectual Property
Pharmacogenomics
Commercial Development


Case Studies will be presented and discussed as time permits.
* The exact schedule depends on guest speaker calendars and business commitments and may be subject to change at the last moment

Course Directors:
John M. Young, Ph.D. is a senior pharmaceutical executive with 40 years experience in all aspects of the pharmaceutical industry. He currently works with start-up companies in the areas of pharmaceuticals, biologics, diagnostics, and devices. His primary expertise is in the nonclinical and early clinical areas of pharmaceutical development.

Velimir M. Kuftinec, Ph.D., M.B.A., ia a business executive with extensive experience in the pharmaceutical, biotechnology, medical instrument, and medical diagnostics markets. His primary expertise is in the areas of business development and licensing, global commercial development, strategic product planning, and worldwide marketing.

Guest Speakers (subject to change):
P. Michael Dubinsky, with 24 years of experience at the FDA (through 1998), currently provides expert guidance to clients in GXP compliance.

David Ellis, M.D., Ph.D., is currently senior medical director with ARYx Therapeutics. His experience includes: Syntex, Alza, Neurex, and Elan.

Charles Du Mond, Ph.D., is senior VP, US Biometrics and Data Management, ICON Clinical Research. His experience includes: Syntex, Sequus, Pacific Research Associates.

Diane Gordon, Ph.D., is a global project manager with Roche Palo Alto. She joined Syntex in pharmaceutical research and has been a project manager since 1983.

Natalie McClure, Ph.D., is an independent contractor in the area of regulatory affairs and quality assurance. Experience includes: Syntex, Matrix, IntraBiotics, Tularik, Cerimon.

Tom Moran, J.D., currently consults in the area of pharmaceutical patents and intellectual property. Experience includes: Shell Oil, Syntex, Cooley Godward, Foley & Lardner.

Darwin Williams, M.S., has an active practice specializing in GMP/GLP compliance. He has previously held managerial positions in biologic and medical device companies.

Susan Wollowitz, Ph.D., is VP of chemistry and manufacturing at Medivation. Experience includes: Cerus, Dow Chemical, and independent contractor to the pharma industry.

Who should attend:
New and experienced individuals in pharmaceutical and health-related industries. A pharmaceutical or science background will be helpful, but is not essential for understanding of the main points: How you will benefit:


There are currently no sections open for enrollment.




Sections closed for enrollment

Tues. Oct. 13, San Francisco

Quick Enroll

Search