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Hyatt Regency Bethesda

Nov 13, 2013 7:15 AM - Nov 14, 2013 4:30 PM

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

DIA Biosimilars 2013

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Quality Considerations for Biosimilarity

Session Chair(s)

Sundar Ramanan, PhD

Sundar Ramanan, PhD

Director, Global Biosimilars R&D Policy

Amgen Inc., United States

Quality (chemistry, manufacturing and controls) plays a larger role in biosimilar development than traditional biologic medicine development. The challenges as well as opportunities are many. This session will cover diverse topics including analytical (physiochemical and functional) considerations, drug product development utilizing QbD and post-approval considerations. In addition, keeping with long-standing successful DIA tradition of bringing diverse perspectives these topics will be presented by various biosimilar developers. Attendees will be able to gain insights into various biosimilar development strategies, interact with peers from regulatory agencies and industry in sessions enabling cross-functional discussions.

Speaker(s)

Post Approval Regulatory Considerations for Biosimilars

Gustavo Grampp, PhD

Amgen Inc., United States

Executive Director Global Operations

Emily Shacter, PhD

Level of Physicochemical and Biological Similarity

Emily Shacter, PhD

ThinkFDA, LLC, United States

Independent Consultant

Role of Functional Assays in the Assessment of Similarity

Cornelius Fritsch, PhD

Novartis Pharma AG, Switzerland

Fellow, External Bioassay Support

Drug Product Development of Biosimilars: Quality by Design Considerations and Strategies

Krishnan Sampath, PhD

Hospira Inc., United States

Associate Director, Formulation and DP Process Development, Global Biologics R&D

Practical Considerations for Biosimilarity Development

Jim Anderson, PhD

Momenta Pharmaceuticals, United States

Vice President, Analytical Development

Panel Discussion

All Session Speakers, United States

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