The 2016 ACI's 7th Annual Summit on Biosimilars is being finalized. Here's a sneak peak at some of the highlights of the hard hitting agenda and confirmed esteemed faculty speakers. Conference starts June 13-15 in NYC. We hope to see you soon.

1. BIOSIMILARSJUNE 13 - 15, 2016 | NEW YORK, NY
American Conference Institute's 7th Annual Summit on
Legal, Regulatory, Commercial, and Patent Strategies
for the Emerging U.S. Biosimilars Landscape
AMERICANCONFERENCE.COM/BIOSIMILARS

2. BIOSIMILARSJUNE 13 - 15, 2016 | NEW YORK, NY
American Conference Institute's 7th Annual Summit on
AGENDA
AT-A-GLANCE
AmericanConference.com/Biosimilars
The program agenda is being finalized so reserve
your seat early! This is the premier, CANNOT be
missed conference with an unparalleled faculty.

3. ADVISORY BOARD
AMERICANCONFERENCE.COM/BIOSIMILARS
Mark I. Bowditch, Vice President, Intellectual
Property and Litigation – Coherus BioSciences,
Inc.
Reza Green, Vice President, Intellectual
Property – Novo Nordisk, Inc.
Bruce A. Leicher, Senior Vice President and
General Counsel – Momenta Pharmaceuticals,
Inc.
Christian Smolizza, Assistant General Counsel
– Pfizer Inc.
Imaac (“Casey”) J. Thampoe, Ph.D., J.D.,
Managing Counsel, Biologics – Merck & Co., Inc.

4. DISTINGUISHED FACULTY
AMERICANCONFERENCE.COM/BIOSIMILARS
Mark I. Bowditch, Vice President, Intellectual Property and Litigation
– Coherus BioSciences, Inc.
Brynna Clark, Senior Director, State Affairs – Generic Pharmaceutical
Association (GPhA)
Thomas Felix, MD, Director, Regulatory Affairs, R&D Policy, Global
Regulatory Affairs and Safety – Amgen Inc.
Joseph P. Fuhr, Jr., Ph.D., Professor, Economics – Widener University
Gabriel Kleiman, Assistant General Counsel – Pfizer Inc.
Bruce A. Leicher, Senior Vice President and General Counsel –
Momenta Pharmaceuticals, Inc.
Julia Pike, Head Global IP Litigation – Sandoz Inc.
Kathleen Ranney, Senior Patent Counsel – Eisai, Inc.
Betty Ryberg, Vice President, IP Litigation – Novartis Services, Inc.

5. DAY 1: MONDAY, JUNE 13, 2016
AMERICANCONFERENCE.COM/BIOSIMILARS
Strengthening Your Regulatory Biosimilars Strategy for
Interchangeability, Naming, and More in an Uncertain
Landscape
Case Study: Amgen Inc. v. Sandoz Inc. and the Impact on the
Patent Dance and the Notice of Commercial Marketing
New Considerations for Practical Commercial Strategies
and Debating the Economic Viability of Biosimilars
Charting State Regulation: Sailing Through the Murky Waters
of State Laws Affecting Biosimilars
Demystifying IPRs for Effective Use in the Biosimilars
Landscape
Spotlight on the Judiciary: Lessons Learned in Biosimilars
Litigation

6. DAY 2: TUESDAY, JUNE 14, 2016
AMERICANCONFERENCE.COM/BIOSIMILARS
Mapping Out the BPCIA Process:A Cheat Sheet on Navigating the
Biosimilars Pathway
Open Floor Session:Exploring Strategies for Transitioning from an
NDA to a BLA and Understanding the Consequences
Evaluating the Strength of Patents Under New Section 101and 112
Patentability Case Law
Developing Real World Strategies for Marketing and Promoting a
Biosimilar:Distinguishing the Biosimilar From the Reference Product
Comparing and Contrasting the US and Global Biosimilars
Experience

7. BIOSIMILARSJUNE 13 - 15, 2016 | NEW YORK, NY
American Conference Institute's 7th Annual Summit on
POST-CONFERENCE WORKSHOP
WEDNESDAY, JUNE 15, 2016
AmericanConference.com/Biosimilars
Legal Ethics and Professional Responsibility:
Avoiding Conflicts of Interest, Maintaining
Confidentiality, and Other Special Concerns for
the Biosimilars Space

8. BIOSIMILARSJUNE 13 - 15, 2016 | NEW YORK, NY
American Conference Institute's 7th Annual Summit on
Legal, Regulatory, Commercial, and Patent Strategies
for the Emerging U.S. Biosimilars Landscape
AmericanConference.com/Biosimilars
888.224.2480
Registration is now open.
Join industry leaders from
innovator and biosimilar
companies as they discuss the
state of US biosimilars and
patent disputes.
For information on sponsoring or exhibiting at this event,
contact Esther Fleischhacker at e.fleischhacker@americanconference.com