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  • MDS Pharma Services

  • LOEB & LOEB

  • Wolf Block

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  • Pharmaceutical & Healthcare Insight

  • Scrip Reports

  • Generics bulletin

  • World Generic Markets (WGM)

  • Generic Companies Analysis (GCA)

  • Generics Web

  • Journal of Generic Medicines

  • Orange Book Blog

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8th Annual Generic Drugs Summit

when and where

September 17 - 19, 2007 | The Fairmont, Washington , DC

doc title

Agenda Day One

Agenda Day One

MAIN CONFERENCE DAY ONE: TUESDAY, SEPTEMBER 18, 2007

7:00Registration and Morning Coffee
8:00

Chairperson's Opening Remarks

Shashank Upadhye, Esq., Vice President - Head of Intellectual Property, Sandoz U.S., SANDOZ, INC.

CONGRESSIONAL ADDRESS
8:15

Update on Hatch-Waxman Reform

The Honorable Henry A. Waxman, MEMBER OF CONGRESS, UNITED STATES, CALIFORNIA DISTRICT 30

KEYNOTE ADDRESS
9:15

Regulatory Issues Impacting Generic Drugs

Scott Gottlieb, MD, Resident Fellow, AMERICAN ENTERPRISE INSTITUTE FOR PUBLIC POLICY RESEARCH; Former Deputy Commissioner for Medical and Scientific Affairs, FDA

9:45

Morning Refreshment and Networking Break

VIEW FROM THE HILL
10:15

The Future of Generic Drugs: What's Happening on Capitol Hill?

Panelists:
Scott Gottlieb, MD, Resident Fellow, AMERICAN ENTERPRISE INSTITUTE FOR PUBLIC POLICY RESEARCH; Former Deputy Commissioner for Medical and Scientific Affairs, FDA

Suzanne M. Sensabaugh, Vice President, Biopharmaceutical Development, MDS PHARMA SERVICES

Steven E. Irizarry, Vice President of Government Affairs, ML STRATEGIES, LLC; Former Senior Health Counsel to the Senate Special Committee on Aging and the Senate HELP Committee

Amy Muhlberg, PhD, Professional Staff Member, Committee on Health, Education, Labor, and Pensions, OFFICE OF US SENATOR MIKE ENZI (invited)

David Dorsey, Legislative Assistant, Office of US Senator, EDWARD KENNEDY (invited)

FTC ADDRESS

11:00

Federal Trade Commission Actions Involving Generic Drugs

Markus H. Meier, Assistant Director, Healthcare Division, FEDERAL TRADE COMMISSION, BUREAU OF COMPETITION INDUSTRY KEYNOTE

11:45

Building Upon A Global Vision and Aggressive Growth Strategy in Today's Competitive Marketplace

Douglas S. Boothe, Executive Vice President and Chief Operating Officer, Actavis US, ACTAVIS GROUP HF

12:30

Luncheon for Delegates and Speakers

 Concurrent Tracks Begin

Track A:
Intellectual Property & Legal Issues

Track B:
Business Trends & Strategy

1:45

To Go Ahead or Not: How to Make the Most of Due Diligence

Beverly W. Lubit, Esq., PhD, Partner, Intellectual Property/Information Technology Practice Group, WOLF, BLOCK, SCHORR & SOLIS-COHEN LLP

Brand-Generic Settlements: Deal or No Deal?
Meredyth Smith Andrus, Attorney, Health Care Services and Products Division, FEDERAL TRADE COMMISSION, BUREAU OF COMPETITION

Steven J. Lee, PhD, Partner, KENYON & KENYON

David Balto, ATTORNEY AT LAW


2:30

Trends in New Pharmaceutical Patent Claim Strategies

Shashank Upadhye, Esq., Vice President - Head of Intellectual Property, Sandoz U.S., SANDOZ, INC.

2007 US Strategic Management Review: Trends, Issues, Outlook

Douglas M. Long, Vice President, Industry Relations, IMS HEALTH, INC

3:15Refreshment and Networking Break


DEBATE 2007

3:45

Authorized Generics: Here to Stay?

William C. Kennally III, President, GREENSTONE

David Balto, ATTORNEY AT LAW, Former Assistant Director for Policy and Evaluation, FEDERAL TRADE COMMISSION, BUREAU OF COMPETITION

4:45

Day One Concludes; please join us for our networking reception, generously hosted by .



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