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Pharmaceutical Intellectual Property And Regulatory Practice
2007
Traversing the Legal Landscape
The Madison Hotel
Washington, DC
March 15, 2007 New Date!!
Who Should Attend
CEO's, administrators, lead researchers, compliance officers and counsel,
particularly patent and FDA/Regulatory counsel, of:
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Clinical Trials
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Academic Medical Research Centers
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Specialty Pharmaceutical Companies
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Pharmaceutical Manufacturers and Distributors
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University Research Tech Transfer and Intellectual Property Offices
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Contract Research Organizations
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Why You Should Attend
Pharmaceutical innovation knows few boundaries in research today. Scientists are
sharing ideas across disciplines, networking with colleagues from diverse
fields, and seeking collaborative pathways to develop new pharmaceuticals.
The legal landscape for the pharmaceutical industry is also continuously
changing. To successfully traverse that landscape requires strong intellectual
property and a pathway through the regulatory terrain, challenges faced in the
life of every new drug. Companies and universities now often combine efforts,
resources, and roles to bring a drug to market. These relationships add yet
another dimension to the legal landscape for pharmaceuticals. This seminar will
look across that landscape and give direction for charting a course. Focusing
on current issues, industry experts will address what is happening today and
look forward to what we can expect in the future.Innovation knows few
boundaries in pharmaceutical research today. Scientists are sharing ideas
across disciplines, networking with colleagues from diverse fields, and seeking
collaborative pathways to develop new pharmaceuticals.
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The Speakers
Jill Alvarez,* Esq.
Partner
Technology & Intellectual Property, Life Sciences
OPEB Task Force
Washington, DC
Meredyth Smith Andrus, Esq.
Assistant Attorney General
Antitrust Division
Office of the Attorney General
State of Maryland
MD
Eyal Barash, Esq.
General Counsel
SSCI Inc.
West Lafayette, IN
Fredric Cohen, M.D.
President
Pharma Growth Strategies LLC
Langhorne, PA
Niteesha Gupte, Esq.
Assistant Counsel
Daiichi Sankyo Company, LTD
Parsippany, NJ
Stuart Horowitz, Ph.D.
MBA
Director
Miami Children's Hospital Research Institute
Miami, FL
James J. Kelley, Esq.
Associate General Patent Counsel
Eli Lilly and Company
Indianapolis, IN
Raju Kucherlapati
Paul C. Cabot Professor of Genetics, Professor of Medicine
Harvard Medical School
Scientific Director
Harvard Medical School Partners Healthcare Center for Genetics and Genomics
Boston, MA
Jeffrey A. Lindeman, Esq. ** [
bio ]
Ph.D.
Partner
Technology & Intellectual Property
Life Sciences
Nixon Peabody LLP
Washington, DC
Gail Norris, Esq.
Senior Associate Counsel for Technology Transfer
University of Rochester
Rochester, NY
David S. Resnick, Esq. [
bio ]
Partner
Technology & Intellectual Property
Nixon Peabody LLP
Boston, MA
Adil E. Shamoo, Ph.D.
Editor-in-Chief
Accountability Research
University of Maryland School of Medicine
Baltimore, MD
Elizabeth Dana Smith, Esq. [
bio ]
Associate
Technology & Intellectual Property
Life Sciences
Nixon Peabody LLP
Washington, DC
Lawrence Sung, Esq. [
bio ]
Partner
Technology & Intellectual Property
Nixon Peabody LLP
Washington, DC
Melissa B. Tearney, Esq. [
bio ]
Partner
Business Litigation & Life Sciences
Nixon Peabody LLP
Boston, MA
**Planning Committee
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Agenda
Thursday, March 15, 2007
7:30 AM
Registration & Networking Breakfast
8:30 AM
Filling the Product Pipeline
Identifying promising new therapeutic agents is a continuing concern for
pharmaceutical companies. In addition to their own research and development
efforts, companies are partnering with universities and emerging companies to
expand their own platform and to gain new technologies. Hear from licensing and
transactional attorneys about how these relationships are structured and how
they accomplish their goals.
10:00 AM
Break
10:15 AM
Merck v. Integra - The § 271(e)(1) Safe Harbor
In its 2005 Merck v. Integra Life Sciences decision, the Supreme Court
held that § 271(e)(1), the safe harbor, exempted from infringement all uses of
patented compounds "reasonably related" to the process of developing
information for submission. In the wake of Merck, the practical
implications of the safe harbor are now being worked out. Questions of what
activity is within the safe harbor and what activities are outside, risking
patent infringement, are being asked. The real question is one of identifying
risk and managing it. Industry executives and legal experts will explore the
landscape of the statutory exemption.
11:45 AM
Complimentary Lunch
1:00 PM
Personalized Medicine: Implications for Pharmaceutical Companies Today and
Tomorrow (Sponsored by the Personalized Medicine Coalition)
Personalized medicine, healthcare using molecular analysis to diagnose and treat
disease, is becoming a reality with the potential to transform healthcare. A
panel of industry experts and pharmaceutical company executives will discuss
how genomics and personalized medicine have already changed their thinking and
their operations, and what further changes and implications they anticipate
over the next five years.
2:30 PM
Break
2:45 PM
Early Termination of Clinical Trials: Striking a Balance
For pharmaceutical companies and the FDA, whether or not to approve a drug or
keep it on the market, may present a legal, business, and ethical dilemma. A
drug may offer unique benefits to patients, yet at the same time expose them to
significant risks that may not be fully recognized or understood until
long-term data can be developed. When should a clinical trial be halted, a drug
receive FDA approval, or a drug be sold? How does one balance the need for
long-term data to better understand how a drug works with the need to get a
potentially beneficial drug to people with few or no other options? All of this
brings ethical, regulatory, and legal issues home to pharmaceutical companies
and regulatory agencies as they balance patient benefits with potential risks.
4:15 PM
Government Investigations from the Perspective of the Investigators
U.S. Attorneys and the Office of the Inspector General (OIG) are focused on the
pharmaceutical industry. Companies need to be vigilant in complying with
current regulations, and, if investigated, preparing for and participating in
investigations. Compliance is key, as an investigation can cause substantial
harm to a company through the imposition of significant fees and monetary
penalties, possible exclusion from Medicare, negative publicity, associated
reduction in a company's reputation for safety and efficacy of its products,
and ultimately decreased sales. Hear from the investigators themselves about
where they will focus next.
5:30 PM
Networking Cocktail Reception (Sponsored by
Nixon Peabody LLP)
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Sponsors
Sponsored by Nixon Peabody LLP
and the Personalized Medicine Coalition.
For sponsorship information, please send an e-mail to
hmaurer@ipedinc.net .
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Instructional Information
Teaching Methods: All sessions will be presented live, by on-site
speakers. The teaching modes will include individual presentations, panel
discussion, role playing and question and answer sessions.
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Registration Information
IPED, Inc. accepts the following forms of payment: Visa, Mastercard and check. American
Express is not accepted.
Fees and payment
General: $995.00
Early Bird-Register by October 2, 2006: $895.00
Payments must be made by check or credit card, in advance of the program.
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Group discounts
Group discounts are available. Group discounts cannot be combined with early
registration discounts. For three, four, or five attendees from the same
organization, deduct $50 per person from the applicable rate; for six or more
attendees, deduct $100 per person. To receive this rate, please register all
individuals together. If you have any questions, please call 202-331-9230.
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Cancellation Information
The fee is fully refundable if IPED is notified of a cancellation by 5:00 p.m.
EST November 2, 2006. $125 will be deducted from the refund after November 2,
2006, and no refund will be granted to any registrant who cancels after 5:00
p.m. on November 6, 2006.
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Conference Site and Hotel Information
IPED has secured a block of rooms at The Madison Hotel, 1177
15th St., NW, Washington, DC 20005, where the seminar will be held, at a room
rate of $225 per night. This block will be held exclusively
for IPED attendees through Friday, October 30, 2006, after
which reservations will be taken on a space-available basis only, and rates may
vary. To secure the special seminar rate, we highly recommend you book early.
For reservations, please contact the hotel directly at 1-800-424-8577 or
202-862-1600, or visit
the Madison Hotel website.
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| Price each: |
995.00 |
Total
|
995.00
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