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Renaissance Washington DC Dupont Circle Hotel

Oct 27, 2016 8:15 AM - Oct 28, 2016 5:00 PM

Formerly Renaissance M Street Hotel, 1143 New Hampshire Avenue, NW, , Washington, DC 20037 , USA

Biosimilars 2016

Preview the New Agenda for DIA Biosimilars 2016, the Premier Global Biosimilars Conference.

Session 1: Determining Biosimilarity: By Use of Totality of the Evidence

Session Chair(s)

Bruce P. Babbitt, PhD

Bruce P. Babbitt, PhD

Vice President - Technical (Drug Development and Regulatory Affairs)

PAREXEL Consulting, United States

In the US, Europe, and other regions, biosimilarity is demonstrated through a totality of evidence approach. This session will examine the picture of biosimilarity presented by the components of evidence, including the foundations laid by CMC/analytics, non-clinical data, analysis of critical quality attributes (CQAs), and clinical data to address the clinical relevance of differences, from the perspectives of the regulator and of industry. What is the regulator’s view of the organizing framework and how the data work together to demonstrate biosimilarity, especially for complex biologics? From the industry view, when is stepwise development preferable to a parallel development process, and how is decision making, about residual uncertainty or risk for example, influenced by each of these paradigms? What does the totality of evidence mean for development versus marketing applications? Global regulators will join the session speakers in an interactive panel discussion to address audience questions.

Speaker(s)

Leah  Christl, PhD

Regulators’ Perspective

Leah Christl, PhD

Amgen, United States

Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy

Lisa  Bell, DrSc, PhD

Industry Perspective: Application of Regulation to Development

Lisa Bell, DrSc, PhD

Coherus BioSciences, United States

SVP Global Regulatory

Panel  Discussion

Panel Discussion

All Session Speakers, United States

Jian  Wang, MD, PhD

Panelist

Jian Wang, MD, PhD

Health Canada, Canada

Division Manager, Clinical Review Division – Heamatology/Oncology

Hubert C Chen, MD

Panelist

Hubert C Chen, MD

PFEnex Inc, United States

Chief Medical Officer

Martina  Weise, DrMed, MD

Panelist

Martina Weise, DrMed, MD

Bfarm, Germany

Head, Licensing Division 2, BfArM; German CHMP Alternate

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