Responding to a Clinical Crisis - Media Communications in the First 24 Hours
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Click here for Handout 1 (Guide)
Click here for Handout 2 (Basic Characteristics)
Click here for Handout 3 (Seven Principles)
Date: August 6, 2003 at 7:00pm
Cost: $20 at the door.
Location: Wilson Sonsini Goodrich and Rosati
950 Page Mill Road, Palo Alto
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Your company is sponsoring a multicenter clinical trial of an inhaled insulin product in partnership with a large pharmaceutical company. Four deaths have occurred at three sites within the last month and ABC News has contacted you for comment on the deaths and your company's product. How do you respond?

Please join BioE2E as we simulate a company's response to this clinical crisis. Our panel of participants will take on the roles of CEO, legal counsel, regulatory and clinical representatives of a fictitious company and together formulate a response to such a crisis. Marcia Kean, CEO of Feinstein Kean Healthcare, and Jeremiah Hall, Vice President at Ogilvy PR/San Francisco, will guide the panel and the audience in the steps to appropriate crisis communications. Attendees will learn how to how to address the news media and what to say in response to such as crisis as well as how to respond to and work with pharmco partners, shareholders, clinical trial sites, regulators and employees. Attendees will also learn the six steps to crisis communications.

Networking session will follow.


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Presenters:

Marcia Kean, CEO, Feinstein Kean Healthcare

Marcia Kean has close to 30 years of health care industry experience, including senior positions with pharmaceutical, biotechnology and medical service firms, non-profit research organizations, and consulting firms. As one of the first senior-level practitioners of communications in the biotech industry, she has pioneered good practices in the field, and has been a prominent author and speaker on key communications and valuation issues facing senior management.

Prior to her recent appointment as Chief Executive Officer of Feinstein Kean Healthcare, Mrs. Kean had taken a .sabbatical. as the SVP-Commercialization at Ardais Corporation, a privately held clinical genomics firm. In that role, she led the initial commercialization of that company.s drug discovery technology.

From 1990 to 2001, Mrs. Kean served as founder and Managing Director of the Corporate Communications practice at Feinstein Kean Healthcare. In that role, she led a full-service U.S. and international corporate communications practice, with specialization in the definition and repositioning of corporate identities; planning and fulfillment of valuation potential; investor relations and media strategy and execution; and management of sensitive or challenging corporate issues. She assisted the CEOs and CFOs of numerous private companies in the process of preparing for and conducting successful IPOs. Mrs. Kean recruited, trained, and supervised a professional team that provided full services to dozens of private and public biotech and specialty pharmaceutical companies.

From 1982 to 1990, Mrs. Kean served simultaneously as vice president, corporate communications of Damon Corporation (NYSE) and of its subsidiary, Damon Biotech (Nasdaq), one of the first biotech companies in New England. She was the first and only female officer in the history of Damon Corporation.

Mrs. Kean was the only non-CEO to serve on the Emerging Companies Section Governing Board of BIO, the leading biotech industry organization, from 1998 to 2001. She was among the originating team that designed the successful BIO CEO and Investor Conference four years ago, which is now held annually. She served on the Steering Committee of BIO 2000 in Boston -- the largest convocation in the history of the biotech industry up to that time - and was appointed as the Chair of the Communications Committee for that event.

She has lectured at legal seminars as part of panels with attorneys from major law firms, and has often been the only speaker not holding a JD degree. She has been published in industry journals on the communications implications of conflicting regulatory demands from SEC and FDA, and has been a frequent speaker on strategic communications issues at industry seminars, including those at BIO 2000 and BIO 2001. Mrs. Kean holds an M.B.A. in finance from New York University and a B.A. from the University of California at Berkeley.

Jeremiah Hall, Vice President, Ogilvy Public Relations Worldwide/San Francisco

Vice President, Ogilvy Public Relations Worldwide Jeremiah Hall is a vice president and senior media specialist in the San Francisco office of Ogilvy Public Relations Worldwide. He joined Ogilvy PR in 1999 and plays a strategic role in planning the news and messaging for west coast biotech and bioinformatics clients.

Mr. Hall leads the San Francisco media group which provides strategic support for media relations activities with a particular emphasis on generating continual coverage for clients as well as supporting events, tours and conferences. Mr. Hall maintains key relationships with reporters and editors at high-level business publications such as Business Week, Forbes, Fortune, the New York Times, the Wall Street Journal, Associated Press and Bloomberg News.

Prior to joining Ogilvy PR, Mr. Hall served as an account supervisor at Schwartz Communications. At Schwartz, his account assignments included a variety of health and technology accounts such as Internet health site WebMD, investment bank Volpe Brown Whelan, electronic catalog developer Requisite Technology and teleconferencing hardware provider Latitude Communications.

Prior to Schwartz, Mr. Hall worked for the Federal Emergency Management Agency (FEMA), where he gained extensive expertise in media relations and crisis communications skills. Prior to FEMA, Mr. Hall worked for Austin Taylor, a San Francisco public relations firm.

Mr. Hall's media placements include the Los Angeles Times, the New York Times, the Wall Street Journal, USA Today, the Rosie O'Donnell Show, the Oprah Winfrey Show, Today, Good Morning America, CNN, ABC News, 48 hours and many other news agencies. He earned a degree in journalism from San Francisco State University.

Carol Olson, Churchill Madison Group

Carol Olson is the Managing Partner at the Churchill Madison Group, a management-consulting firm that she founded with an emphasis on commercialization strategy and implementation for life sciences businesses. Prior to her current role, Carol was the Chief Commercial Officer and a Senior VP at Aviron, which she joined in 1998. There she was responsible for directing the commercialization activities, and drove the company.s strategy, corporate development, project management and marketing functions. Carol played a key role in the company.s acquisition by MedImmune in 2002. She was responsible for the establishment and management of strategic relationships, and headed up the partnership with Wyeth to commercialize and co-promote FluMist. The FDA recently approved FluMist, the first intranasal flu vaccine in the US, and the lead product developed by Aviron. Prior to joining Aviron, Carol ran a consulting business for 6 years where she worked with clients in the life sciences and information technology industries to develop new businesses. Early in her career, she spent 9 years at Hewlett-Packard.s commercial systems division in various product management, marketing and strategy roles.

Carol serves on the Board of Directors of the Palo Alto Institute for Research and Education (PAIRE), a non-profit corporation facilitating clinical research within the Palo Alto VA Health Care System and Stanford University.

She received her bachelor.s degree in economics cum laude from Yale, and an MBA from Stanford's Graduate School of Business.

Ralph Lin, BioE2E

Ralph Lin is currently a Technology Assessment Manager for Clearview Projects, a San Francisco-based firm specialized in assisting biotech clients execute partnership and other strategic transactions. Before joining Clearview, he worked in business development at Rinat Neuroscience as well as a management consultant for the Mitchell Madison Group.

Ralph completed his doctoral work at the MIT/Whitehead Institute for Biomedical Research. He has published papers focusing on the biochemical mechanisms underlying CD4 and TGF-beta receptor signaling. He received his undergraduate degree in biology from the California Institute of Technology.

David Michael Hoffmeister, WSGR

David Michael Hoffmeister is a Partner at the law firm of Wilson Sonsini Goodrich & Rosati (WSGR) and leads the firm's Drug and Device Regulatory and Healthcare Law practice within the Life Sciences Group. Mr. Hoffmeister brings 18 years of experience in drug and device Regulatory and Healthcare Law to WSGR. He represents pharmaceutical, biotechnology, dietary supplement, medical device and diagnostic clients and advises them on a variety of different healthcare and regulatory issues, including inspections, recalls, labeling, advertising and promotion, and strategies for obtaining FDA approval and clearance. Previously, Mr. Hoffmeister was Senior Counsel for Drug and Device Law at Syntex Corporation, where his primary focus was to advise senior management on all worldwide issues affecting the corporation and its affiliates ability to develop, manufacture and distribute pharmaceutical, device, diagnostics, and over-the-counter products in compliance with the Federal Food, Drug, and Cosmetics Act and implementing regulations and other state and federal healthcare laws. Mr. Hoffmeister received his B.S. degree from the University of the Pacific, and his J.D. degree from the San Francisco Law School. He is admitted to practice in the State of California and before various federal courts, including the United States Supreme Court.

 

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