Life Science Business and Marketing: Their Integral Role

UC Berkeley Extension, Thursday and Friday, April 19-20, 2012

Belmont, CA

Course Description

The life science industry presents very different challenges found in other industries and requires specialized knowledge and skills to navigate the unique regulatory path requirements, lengthy development times, expensive clinical trial process, FDA control of advertising and labeling, and impact of managed care on reimbursement and pricing. This course conveys the foundational research and analysis skills needed on the job to make good marketing and business recommendations and decisions across company functions.

Course includes two days of intensive classroom work and mentoring by instructor available for balance of term while completing term project. Course will be offered in April and October of each year. Students will learn how to research and analyze markets and environments for making recommendations and decisions useful for all professional functions in bioscience companies. They will learn how to do typical business and marketing assignments common to the workplace and receive templates/outlines for documents. In the process students will develop a basic understanding of the role and benefits of various business and marketing functions involved in company’s success, underscoring their roles across all stages of company and product lifecycle. Participants will learn what makes the industry “tick,” identify challenges and opportunities critical to the success of a company and its products that might otherwise be overlooked until too late in the development process. Students will complete business investment analysis of a company and its technology/products of their choice for term project.

Students receive an extensive student reader with lecture slides for note taking, lists of Internet-accessible information resources and gratis access to otherwise paid subscription databases to assist in researching their term project. 

Experienced and newer business and marketing professionals--as well as scientific, clinical, regulatory, and legal professionals--can benefit from this introduction to the important business and marketing aspects of the life science industry and how to research and develop solutions to handle its challenges.

Course Director

Audrey Erbes, Ph.D., is a global life-science business development and marketing consul­tant, industry educator, organization leader and public speaker who originated several bioscience business development and marketing courses at the UCB and UCSC Extensions. She is known for her industry blog publications on Audreysnetwork.com. She has 25 years of managerial experience in the biopharmaceutical industry including Executive Vice President and Cofounder of Kowa Research Institute, a biopharmaceutical licensing and investment subsidiary of Kowa Company Ltd., Japan. Previously, she held both U.S. and international man­agement positions at Syntex Corp. in market research, product management, strategic marketing, and business development, with a special emphasis on Europe and Asia/Pacific/Canada.

Guest Speakers and Their Topics

Donald Holsten, Pharm D., a regulatory consultant and educator with over 20 years of national and international experience as a senior regulatory affairs and quality assurance executive, has expertise in food, drug/biopharmaceutical, medical device and cosmetic products. He has an intimate knowledge of the FDA approval cycle and has helped prepare numerous biotechnology and pharmaceutical companies for FDA interactions and panel reviews.  Don has held management positions at several companies, including Liposome Technology, Inc and Oclassen Pharmaceuticals, Inc. where he was Director of Regulatory Affairs/Quality Assurance and Director of Regulatory Affairs, respectively.  Earlier in his career he held a senior level position as Assistant Chief, Food and Drug Branch, Department of Health Services for the State of California. Topic: “Operating in the U.S. Regulatory Environment: Is Product Approvable”

Bev Hudson, MBA, is the Senior Vice President, Business Development, Omnicomm Systems, Inc., a Web-based electronic data capture (EDC) and eClinical (eClinical) software and services company with products that streamline the clinical research process. Previously, she was VP and General Manager of Clinical Research Services at MedPoint Communications, Inc. and earlier ran sales and operations for Mayo Clinical Trial Services. She spent eleven years at Genentech in sales and marketing management roles. Topic: "The Impact of U.S. Health Care System on Marketing Biotech Products"

Julie Tompkins, MBA, is Sr. Vice President at Timely Data Resources (TDR), a healthcare market research and consulting firm.  She has more than 30 years experience in the pharmaceutical and biotech arenas, including 12 years in industry and more than 20 years in market research consulting, and has worked with pharmaceuticals, diagnostics, and drug delivery systems.  At Syntex (now Roche), Julie worked in both R&D and Marketing, including positions as Analytical Chemist, Market Research Analyst, Manager of New Product Planning, and Manager of Market Analysis.  She spent most of her time in Marketing as the primary liaison between Marketing and R&D, serving as a key member on multi-disciplinary project teams and strategic planning committees.  After leaving Syntex, Julie was President and Founder of MedSearch, a primary market research company that merged with TDR in January 2000.  She holds a B.A. in Human Biology from Stanford University and an MBA from Santa Clara University. Topic: “The Role of Market Research in Product Planning, Development and Marketing"

Course Content Outline

The Discipline of Marketing in the Bioscience Industry

• Unique bioscience industry marketing characteristics
• The core marketing functions
• Pivotal documents associated with marketing functions
• The critical role of marketing at all stages of a product’s development

Marketing Research and Analysis

• Use of market research to optimize product planning, development and marketing
• Role of market research throughout development of company and product
• Defining the objectives, planning and implementation of the research
• Types of market research and methodologies

Impact of Managed Care System on Marketing Bioscience Products

• Review healthcare industry trends/data that impact cost and reimbursement
• Define “who/what is the U.S. healthcare system” and how it influences the commercialization process
• Define reimbursement from Managed Care perspective

Success Parameters for Products and Companies

Dealing with regulatory Environment and Product’s Approvability

The Role, Function, Objective of Selected Major Marketing Functions

• Business Development and Licensing Process, Contract and Terms
• Product/Technology Opportunity Assessment Research and Recommendation
• Strategic Planning and Strategic Plan
• Product Management and Product Marketing Plan
• Sales and Distribution

 Register at UC Berkeley Extension website:

    Life Sciences Business and Marketing: Their Integral Role for Success.