Life Science Business Development

UC Berkeley Extension, Thursday and Friday, June 21-22, 2012

Downtown San Francisco Center

Course Description

This intensive course including two days of classroom and balance of term for individual research is designed to provide participants with an understanding of the critical role business development and licensing functions play in the commercialization of new products or technology and to the development of a successful life science company. The term assignment is designed to give students the opportunity to put the knowledge and materials from class to immediate and practical use with resulting document for inclusion in their portfolio.

Upon successful completion of the course, participants will:

• Understand the various aspects of the business development function in the life science industry and appreciate the skills required to be effective in business development and licensing roles
• Appreciate types of deals and their role in commercialization strategies and funding of a company
• Understand importance of IP status and patent life cycle planning

Who Will Benefit from This Course

This course is suitable for marketing and business development professionals as well as scientific professionals working in bioscience companies, especially those considering a career move into BD. Licensing, potential entrepreneurs, scientific, clinical, regulatory financial, legal and auxiliary personnel will also benefit from insights gained in the course. Although there are no format prerequisites, those who have been exposed to the life science industry and/or the Drug Development Process course will most benefit from the course.

Deliverables

Lectures, discussion, and guest expert lecturers will address business development topics and issues. Student will be exposed to templates and primers for major business development documents and offered mentoring by instructor in researching and developing their term project. They will have access to two major industry databases for use in researching their project during the term. An extensive reader, including lecture slides and a sizable online accessible reference list, will be prepared and distributed by the instructor for use by students during and after class.

Course Instructor

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

Thomas L. Gutshall, Chairman as well as Co-Founder of Cepheid in 1996, was the company’s first CEO.  He also served as President and COO for CV Therapeutics from 1994-96. Previously, he was the Executive Vice President for Syntex Corporation and a member of its Pharmaceutical Executive Committee.  Tom serves on the board of directors for PROFUSA. He graduated from the University of Delaware with a BS in Chemical Engineering and completed the Executive Marketing Program at Harvard University. He serves the University of Delaware as a member of the Chemical Engineering Advisory Council and was named to the Delaware Alumni Wall of Fame in 2001. Topic: “Cepheid: How to Build Your Own Biotech Company”

Harold (Hal) Etterman, MBA, CEO, Knight Financial Plans & Services, LLC has over twenty-five years experience in Finance, Operations and Information Technology, including over ten years serving as a CFO, COO and interim CEO. Hal’s extensive international and domestic experience includes medial devices, software development, medical information publishing, Internet/data security and Homeland security systems. Hal had earlier worked for Siemens Medical Systems for nearly 17 years in Manufacturing Operations, Divisional Sales and Service, Corporate Finance and Information Systems. After Siemens, Hal was the CFO/COO for a medical laser manufacturer and has served as a financial planning consultant for 3 medical device businesses. Most recently he has just completed four major Sarbanes-Oxley projects where he successfully helped his client firms through their internal audits resulting in SOX certified SEC filings. Topic: “Financial Planning and Funding for a Bioscience Venture: New, Emerging and Growing Entities”

Carolyn Feamster, MBA, a business strategy and analysis consultant, has over 25 years experience in the pharmaceutical and biotech therapeutics, diagnostics and drug delivery systems.  She has broad expertise across numerous therapeutic areas, including oncology, CNS, transplantation, autoimmune disease, women’s health and urology. Carolyn worked in R&D and pharmaceutical marketing at Syntex, where her responsibilities included the major brands Naprosyn and Cellcept. In 1995, Carolyn joined ALZA Corporation as Senior Director of New Product Marketing with commercial responsibility for building and managing the pipeline products. She shepherded three products onto the market and was instrumental in evolving the three ALZA therapeutic franchises: urology, CNS and oncology. Carolyn was VP of New Product Planning at Corixa Corporation and, most recently, Vice President of Business Strategy and Analysis at Clearview Projects. Topic: "Preparing for and Planning Deals for Maximum Strategic Impact"

Gilbert R. Mintz, Ph.D., President of GRM Associates, a biotechnology business development, licensing, strategic planning consulting firm, has expertise in building early-stage companies by focusing their strategic planning and licensing activities, and raising money through venture capitalists. His 20-plus years in the biotechnology industry include general and laboratory management and executive level business development roles. He has executed technology platform, corporate and academic collaborations; in/out licensing of late-stage products for partnerships in the US, Europe and Japan; as well as analyzed and managed intellectual property activities. He has consulted with Affymetrix and other biotechnology companies; served as the President and CEO, Director of an early-stage cancer company; and provided transactional and strategic planning advice to numerous pre-IPO biotechnology companies.  He has held senior management positions at Genelabs Technologies, Anergen (Corixa), Cygnus and Trega Biosciences. Topic: “Working Your Way through the Bioscience Licensing Process: Negotiating and Writing  Deal Contract”

Ginger Dreger, J.D., M.S., partner in Arnold & Porter LLP’s intellectual property practice group, concentrates her practice on counseling and providing strategic advice to emerging and established public companies in the biotechnology, medical device, and pharmaceutical industries. She advises clients on domestic and international patent matters, including worldwide patent protection and enforcement strategies; freedom-to-operate issues; intellectual property due diligence; and analysis of third-party patents. Corporate experience included role with Genentech’s in-house legal department. Topic: "What you Need to Know about Patents Working in Business Development"

Chris Dokomajilar serves as a senior Biopharma Analyst at Deloitte Recap LLC. He provides advisory services to clients in the Life Sciences, including Biotech and Pharmaceutical companies, and Legal and Venture Capital firms. His focus areas include alliances, M&A, financing, and pharmaceutical manufacturing. Prior to joining Recap, Chris managed international labs and clinical trials at the University of California San Francisco. His research on trends in infectious diseases has been published in medical and scientific journals. Before transitioning into science, Chris held finance positions at Bank of America. Chris holds a bachelor’s degrees from the University of California Berkeley in Molecular and Cell Biology and in Integrative Biology. Topic: “BioPharma Alliances: Trends in the Marketplace”

Course Content Outline

The Function of Business Development In A Bioscience Company

• How a discovery product becomes identified as potential commercial product
• Assessing commercial potential of a life science discovery product
• Development of business model and plan
• Typical activities of BD function

Financing The Development And Commercialization Process Of Life Science Products And Technologies

• Preparing financials and marketing company for getting funding from banks, individual investors, angel investors, VCs, bridge loans, and finance rounds
• Discuss various financial vehicles for funding and maintaining a company

Developing And Protecting The Product’s Intellectual Property Status

• Role of patents in business development function and alliances
• Filing for patents worldwide—the process
• Due diligence of developing IP estate needed to successfully commercialize the product
• Developing legal resources to protect the patent
• Life science IP life cycle planning: U.S. and international patent issues

Licensing Process

• Working through the licensing process
• Intellectual property as corporate assets
• Contractual terms and provisions
• Financial and strategic variables of contracts
• Specific collaborations and licenses
• Strategic alliance and alliance management
• Preparing for and planning deals for maximum strategic impact
• Academic licensing and offices of technology transfer

Business development from the entrepreneurial perspective

• Developing the business model and plan for a start up company
• Building the management team
• Financing and staffing to IPO
• Implementation of business plan
• Building valuation and meeting the payroll

Alliance Deals: Trends in the Marketplace

• Environment of dynamic macro level in which deals happen
• Status quo and trends
• Analysis of deals and what it tells us
• Changing business models as reflected in deals

Register at UC Berkeley Extension website: A link will be provided when Registration opens at UC Berkeley Extension.