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.
Presenters:
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Marcia Kean, CEO, Feinstein Kean Healthcare
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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.
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Jeremiah Hall, Vice President, Ogilvy Public Relations Worldwide/San Francisco
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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.
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Carol Olson, Churchill Madison Group
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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.
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Ralph Lin, BioE2E
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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.
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David Michael Hoffmeister, WSGR
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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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