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Tuesday, June 28 • 4:00pm - 5:15pm
#274: Statistical Issues in the Evaluation of Biosimilars

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Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-588-L04-P; CME 1.25; IACET 1.25; RN 1.25

The 2010 Affordable Care Act amended the Public Health Service Act to create a new abbreviated licensure pathway for biological products that are demonstrated to be biosimilar to or interchangeable with an FDA-licensed biological product. A biosimilar should be shown to be highly similar to and to have no clinically meaningful differences in terms of safety and effectiveness from the reference product. In this session, we will discuss important regulatory and statistical issues in the evaluation of biosimilars. A regulatory perspective will be provided on key concepts, and and industry representatives will describe approaches to critical aspects of biosimilar development such as the evaluation of immunogenicity and inference based on the totality of the clinical evidence.

Learning Objectives

Discuss key regulatory and statistical issues in the development and evaluation of biosimilars; Describe approaches to critical aspects of biosimilar development.

Chair

Gregory Levin, PhD

Speaker

A Novel Statistical Model of the Relationship Between Exposure to a Biopharmaceutical and Immunogenic Reactions
Marek Ancukiewicz, PhD

Statistical Methodology to Assess Biosimilarity Based on Totality of the Evidence
Zhiying "Jean" Pan, PhD



Chair
GL

Gregory Levin

Mathematical Statistician, Office of Translational Sciences, CDER, FDA
Greg Levin is a mathematical statistician at the Food and Drug Administration. He joined the FDA after receiving a PhD in biostatistics from the University of Washington in 2012. At FDA, Greg has helped review development programs and marketing applications for pulmonary, allergy, rheumatology, metabolism, and endocrinology products. He now leads a statistics team focused on rheumatology conditions.

Speakers
avatar for Marek Ancukiewicz

Marek Ancukiewicz

Principal Biostatistician, PAREXEL International
Biostatistician with 25+ years of experience in clinical research. Currently (3 years) at PAREXEL (Principal Biostatistician) Previously (16 years) at Harvard Medical School (Assistant Professor) and at Duke University (post-doc fellow) and also a private consultant for industry. Author/co-author of 100+ peer-reviewed papers. Broad experience from drug discovery, pre-clinical, translational research to Phase I/II/III/IV. Areas of interest... Read More →
ZQ

Zhiying "Jean" Pan

Senior Manager, Biostatistics, Amgen Inc.
Dr. Pan is a Biostatistics Senior Manager in Biosimilars Global Development at Amgen. As the global statistical lead, she provides strategic input to and is responsible for all statistical aspects of clinical development for multiple biosimilar products in oncology and inflammation therapeutic areas. She has previously worked in oncology therapeutic area and supportive care in Medical Affair and Global Clinical Development at Amgen. She... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm
108B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA