An Open Forum on the Scientific and Regulatory Issues

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BIOGENERICS
2008
An Open Forum on the Scientific and
Regulatory Issues of Biosimilars and Follow-on
Biologics
March 2-4, 2008Boston, MA USA Copley Marriott
Hotel
www.barnett.neu.edu/biogenerics/
Address bySenator Edward Kennedy Chairman
of the Senate Health, Education, Labor and
Pensions Committee Plenary Lectures byDr.
Randall Lutter Deputy Commissioner for
Policy, US FDA Dr. Jean-Hugues Trouvin Head
of EMEA Biologics Working Party Organizing
ChairProf. Barry Karger Director, Barnett
Institute, and James L. Waters Chair, Hosted
by
A high level meeting of the international
biotechnology and generics industries, together
with government regulators and academic
laboratories, for an open forum and wide-ranging
debate on the scientific and regulatory issues in
the approval of biosimilar protein therapeutics.
For additional information or to receive updates,
email Biogenerics2008_at_neu.edu
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BIOGENERICS 2008
Confirmed Speakers (to date)
Stuart Builder, Consultant, Strategic
Biodevelopment Charles DiLiberti, Vice President
of Scientific Affairs, Barr Laboratories,
Inc. Stephen G. Dilly, Chief Executive Officer,
APT Pharmaceuticals, Inc. Robert Garnick, Senior
Vice President of Regulatory, Quality and
Compliance, Genentech, Inc. James D. Green,
Senior Vice President of Preclinical and Clinical
Development Sciences, Biogen Idec, Inc. William
S. Hancock, Professor of Chemistry and Chemical
Biology, Bradstreet Chair Barnett
Institute, Northeastern University. Takeo
Hayakawa, Senior Advisor, Pharmaceutical and
Medical Devices Agency, Japan (invited) Reed
Harris, Director of Analytical Development,
Genentech, Inc. Mathias Hukkelhoven, Senior Vice
President, Global Head of Drug Regulatory
Affairs, Novartis. Peter Hutt, Senior Counsel,
Covington Burling, LLP. Alison Lawton, Senior
Vice President, Regulatory Affairs and Quality
Systems, Genzyme Corporation. Tony Lubiniecki,
Vice President of Technology Transfer Project
Planning, Centocor, Inc. Amy Rosenberg, Director,
Division of Therapeutic Proteins, FDA. Ram
Sasisekharan, Professor of Biological
Engineering, MIT. Huub Schellekens, Professor,
Director of the Central Lab Animal Institute,
Utrecht University. Emily Shacter, Chief,
Laboratory of Biochemistry, Center for Drug
Evaluation and Research, FDA Meena Subramanyam,
Senior Director, Clinical Science Technology,
Biogen Idec, Inc. Steve Swanson, Director of
Clinical Immunology, Amgen, Inc. Ganesh
Venkataraman, Senior Vice President, Momenta
Pharmaceuticals.
www.barnett.neu.edu/biogenerics/