Friday, February 24, 2012

Immunogenicity For Biotherapeutics Sessions Spotlight: Interactive Update Panel on FDA Regulatory Guidelines

Leading up to Immunogenicity for Biotherapeutics this April 17-19, 2012 in Washington, DC, we'll be highlighting some of the key sessions at this year's conference.  Today, we're looking at Interactive Update Panel on FDA Regulatory Guidelines.

The industry is awaiting clarification on new draft guidelines concerning immunogenicity. This hour-long session will be strongly driven by audience priorities, as in addition to the normal Q&A elements, preregistrants will have the opportunity to submit questions in advance to the event management team to be selected for extra coverage during the session. We had something similar to this 2 years ago and it was a big hit!

If you'd like to know more about Immunogenicity for Biotherapeutics, download the brochure.  You may also join the LinkedIn Group to receive an exclusive code to save 25% off the standard rate.  If you have any further questions, feel free to email Jennifer Pereira.

Featured Session: Interactive Update Panel on FDA Regulatory Guidelines

Speakers:Darshana Jani, PhD, Scientific Manager – Clinical Science & Technology, BIOGEN IDEC
Susan Kirshner, PhD, Associate Chief, Laboratory of Immunology Therapeutic Proteins, Biotechnology, FDA
Laura Salazar-Fontana, PhD, Staff Fellow, CDER, FDA

About the Session:
This timely session will discuss the expected timetables and content changes for the draft guidelines on immunogenicity testing, as well as the chief “pain points” now facing your industry. Do you have questions about the regulatory criteria for cell-based NAb testing, or the expected methods of following-up after positive immunogenic results? Not sure how much more drug tolerance FDA wishes to see, or across which phenotypes? Bring your best questions and your notepad!

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