Virtual Workshop from 8:30 AM – 4:15 PM ET

Date: March 30, 2023

Clusters of immediate hypersensitivity reactions to specific lots of Immune Globulin (IG) products occur episodically and unpredictably.  This phenomenon has led to voluntary market withdrawals of IG product lots and adversely affects a proportion of patient recipients.  Symptoms range from urticaria, pruritis, and orofacial swelling to anaphylactic-like reactions.  Resulting withdrawals of product lots and quarantining of implicated manufacturing intermediates can adversely affect IG supply.  The biochemical cause of these reactions is unknown.  The goals of this workshop are to:

1. Describe clinical presentations and epidemiology of patients with hypersensitivity reactions
2. Review pathogenesis of immediate hypersensitivity reactions
3. Discuss results of manufacturer’s investigations – including plasma donor factors, and manufacturing and laboratory investigations of implicated plasma units and IG lots.
4. Seek opinions on:
   • Likely biological mechanism(s) for lot-specific clusters of immediate hypersensitivity reactions 
   • In vitro methods that could be used, or should be tried, that would identify plasma units or product lots that could cause excessive numbers of immediate hypersensitivity reactions 
   • How to minimize the number of patients affected by immediate hypersensitivity-inducing product lots

Workshop Registration

Immune Globulin Hypersensitivity Reactions: Root Causes and Mitigation; Public Workshop

WORKSHOP AGENDA

8:30 a.m.	Welcome FDA Immune Deficiency Foundation Plasma Protein Therapeutics Association Division
8:45 a.m.	Introduction and statement of problem Dorothy Scott, MD, Acting Division Director, Plasma Derivatives Branch, Office of Therapeutic Plasma Products, CBER/FDA
8:55 a.m.	Patient experience – IVIG-associated allergic reactions
9:05 a.m.	Clinical presentation of immediate hypersensitivity reactions reported during or after Immune Globulin infusion Meghna Alimchandani, MD, Deputy Director, Division of Pharmacovigilance/Office of Biostatistics and Pharmacovigilance, CBER/FDA
9:35 a.m.	Pathogenesis of immediate hypersensitivity reactions         Introduction to immediate hypersensitivity reactions Fred Finkelman, MD, McDonald Professor of Internal Medicine (Emeritus), Adjunct Professor of Pediatrics, University of Cincinnati and Cincinnati Children’s Hospital Medical Center
10:05	Role of antibodies and Fc Receptors in immediate Hypersensitivity Robert Anthony, PhD, Associate Professor, Harvard Medical School
10:35	Cellular mediators of immediate hypersensitivity reactions Laurent Reber, PhD, Immunology Researcher, Institute Pasteur
11:05	Speakers Panel - Questions/Comments from audience
11:35 a.m.	LUNCH
12:15 p.m.	Manufacturer Investigations of IG-mediated immediate hypersensitivity reactions   CSL Behring Nathan Roth, PhD, VP of Global CMC, Global Pathogen Safety, and Plasma Product Development
12:45 p.m.	Grifols Biotherapeutics Clark Zervos, MS, VP Quality Peter Vandeberg, PhD, Director, R&D Program
1:15 p.m.	Octapharma Juergen Roemisch, PhD, Senior VP, R&D Plasma Balazs Toth, MD, PhD, Head of Corporate Drug Safety Josef Weinberger, PhD, Corporate Quality and Compliance Officer
1:45 p.m.	Manufacturers Panel - Questions/Comments from audience
2:30 p.m.	BREAK
3:00 p.m.	Discussion of Workshop Questions - All Presenters and Additional Experts Audience Participation if Time Permits Don MacGlashan, MD, PhD, Professor of Medicine, Johns Hopkins University School of Medicine Charlotte Cunningham-Rundles, MD, PhD, Professor of Immunology, Icahn School of Medicine, Mount Sinai
4:00 p.m.	Brief summary of workshop Dorothy Scott, MD, Plasma Derivatives Branch Chief, FDA/CBER
4:15 p.m.	Workshop Concludes