FDA to Address Industry Questions about Biosimilar Regulations at the Pharma's IQ Immunogenicity Event

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Pharma IQ News
04/04/2011

This May, Joao Pedras-Vasconcelos, Visiting Associate, Therapeutic Proteins CBER from FDA will meet with European industry experts at Pharma IQ's Immunogenicity event to discuss FDA directives on Immunogenicity introduced in 2008.

Over the last two years, the regulations have been subject interpretation. Although the regulations were released in 2008, there has been some confusion within the industry as the regulation are subject to interpretation. The confusion arose around the what tests had to be developed in order to get approval and develop a drug with a suitable level of immunogenicty.

Joao will provide the attendees with the reviewed FDA regulations and an analysis of the FDA implementation policy. He will also discuss how new FDA guidelines will influence the product development and how companies could make the most out of the pending regulations.

During his presentation, he will also assess the changing regulatory landscape and the practicalities of regulatory approval establishing relationships between immunogenicity assay development studies.

FDA session, Regulatory Update: An FDA Guidance for Industry; Understand Policy and Ensure Assay Development Within the Guidelines, will be part of the 2nd Annual Immunogenicity: Prediction, Detection and Effective Assay Development event, taking part 30 May - 01 June 2011 in Munich.

Other key sessions include:

Implementing the correct immunogenicity assay for successful drug development with an A-Z of everything you need to know with Dan Sikkema, GlaxoSmithKline
Ensuring global regulatory compliance with key insights from Joao Pedras-Vasconcelos, FDA and Meenu Wadhwa, NIBSC
Discovering novel in vitro and in vivo assay techniques to improve immunogenicity prediction methods with Bruce Green, Pfizer

Effectively appling theory to practice with insights into comparative immunogenicity studies with Birgit Reipert, Baxter
Keeping up to date with industry advances with clinical updates on the role of compliment in nanomedicines and biologicals with Janos Szebeni, Nanomedicine Research and Education Center, Bay Zoltan Foundation
Case Study: Developing Safe and Efficacious Drugs: How immunogenicity is impacting clinical affects of drug development and safety by Andrew Yates Senior Group Leader, Drug Research & Development UCB
Case Study: Developing Standardised Assays to Allow Direct Comparisons of the Immunogenicity of Innovator Products and Biosimilars