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Main Conference Day Two

7:00 AM - NaN:NaN AM Registration and Coffee

7:45 AM - 8:00 AM Chairperson Opening Remarks

8:00 AM - 9:30 AM Comparative Immunogenicity: Clinical Trial Design and Data Assessment for Biosimilar Development

Patrick Liu , Vice President of Global Biologics R&D and Head of Global Bioassays and Technology, Teva Pharmaceuticals

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Patrick Liu

Vice President of Global Biologics R&D and Head of Global Bioassays and Technology
Teva Pharmaceuticals

9:30 AM - 10:15 AM Keynote: Overseeing the Development of a Biosimilar from Conception to Launch: Incorporating Unique Perspectives and Out of the Box Ideas

Joseph McClellan, Vice President Biosimilars Development, Pfizer

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Joseph McClellan

Vice President Biosimilars Development
Pfizer

11:30 AM - 12:15 PM Flexible Statistical Approaches for Biosimilar Development

Pantelis Vlachos, Director, Strategic Consulting, Cytel

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Pantelis Vlachos

Director, Strategic Consulting
Cytel

10:15 AM - NaN:NaN AM Morning Networking Break

10:45 AM - 11:30 AM Panel Discussion: Addressing All Aspects of the Regulatory Obligations, Considerations and Implementations that Could Affect the Development of a Biosimilar

Bruce Leicher, SVP and General Counsel, Momenta Pharmaceuticals Molly Burich, Associate Director, Public Policy- Biosimilars, Pipeline, Reimbursement, Boehringer Ingelheim Kay Holcombe, SVP Science Policy, Biotechnology Innovation Organization

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Bruce Leicher

SVP and General Counsel
Momenta Pharmaceuticals
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Molly Burich

Associate Director, Public Policy- Biosimilars, Pipeline, Reimbursement
Boehringer Ingelheim
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Kay Holcombe

SVP Science Policy
Biotechnology Innovation Organization

12:15 PM - 1:15 PM Networking Lunch

1:15 PM - 2:00 PM Progression vs Progressing: Is Evolving the Originator as a Biobetter Rather than Developing a Biosimilar the Best Case Scenario?

Rakesh Dixit, Vice President, R&D Global Head Biologics Safety Assessment, Pathology and , MedImmune

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Rakesh Dixit

Vice President, R&D Global Head Biologics Safety Assessment, Pathology and
MedImmune

2:00 PM - 2:45 PM Case Study : Biosimilar Development at Samsung Bioepis

Dr. Paul H. Song , Vice President Business Development Team , Samsung Bioepis

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Dr. Paul H. Song

Vice President Business Development Team
Samsung Bioepis

2:45 PM - NaN:NaN AM Afternoon Networking Break

Interactive Roundtables

4:15 PM - NaN:NaN AM Table1: Maintaining Efficacy and Safety While Streamlining Production to Keep Up with Inventory

Interactive Roundtables

4:15 PM - NaN:NaN AM Table 2: Educating the Market: Where do physicians fall and what are their concerns?

John Coelho, Global Medical Strategy Leader, Merck & Co

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John Coelho

Global Medical Strategy Leader
Merck & Co

4:00 PM - 4:45 PM Comparing One vs Two Assays: Clarifying the Assay Requirements for Comparative Immunogenicity Testing

Linglon Zou, Director of Experimental Immunology, Teva Parmaceuticals

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Linglon Zou

Director of Experimental Immunology
Teva Parmaceuticals

4:45 PM - 4:50 PM Closing Remarks: End of Biosimilars Summit