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Role of Immune Tolerance Induction Public Workshop

The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research, in co-sponsorship with the National Organization for Rare Disorders (NORD), is announcing a one-day public workshop entitled “Immune Responses to Enzyme Replacement Therapies: Role of Immune Tolerance Induction.” Partners and stakeholders planning the workshop also include representatives from academia, industry and patients. The purpose of this workshop is to provide a forum to discuss the role of immune tolerance induction in patients receiving replacement biological products.

The workshop will be available via webcast at: https://collaboration.fda.gov/immuneresponse/.

Register for the meeting.

Location

FOOD AND DRUG ADMINISTRATION (FDA)

Center for Drug Evaluation and Research (CDER)

FDA White Oak Campus, Building 31, the Great Room

White Oak Conference Center, Silver Spring, Maryland

Program Details

View the agenda

Amy S. Rosenberg, MD, Immune Responses and the Role of Immune Tolerance Induction in Enzyme ReplacementTherapies for Lysosomal Storage Diseases:the FDA Perspective

Barbara K. Burton, MD, Anti-Drug Antibodies in Patients with Lysosomal Storage Disorders (LSD’s): Clinician’s Perspective

Rekha Abichandani, MD, Assessing immunogenicity during clinical development: – An Industry Perspective

Laurence A. Turka, Pharmacologic Approaches for Immune Tolerance

Jeanine R Utz, PharmD BCOP BCPS, Non-Cytotoxic, Non-Immunosuppressing Approach to Tolerance Induction During ERT Treatment

Priya Kishnani, MD, Immune tolerance induction in ERT to treat infantile-onset Pompe disease: Current Practice

 

 
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