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The #1 Immunogenicity & Bioassay Event in the U.S.

Join leading experts from the FDA, industry, and academia at CHI’s 18th Annual Immunogenicity & Bioassay Summit, taking place October 19–22, 2026, in Alexandria, VA and virtually.

This premier meeting offers unmatched opportunities to connect with regulatory leaders and scientific peers while exploring the latest advances in immunogenicity risk assessment, bioassay development, and clinical strategies.

With strong FDA representation, interactive discussions, and a vibrant exhibit and poster hall, the summit provides the insights and high-value networking opportunities you need to move your programs forward.

We look forward to welcoming you this October in Alexandria, VA!

Programs Bringing Together Top Industry, Academia & Regulatory Authorities

STREAMS

OCTOBER 19

OCTOBER 20-21

OCTOBER 21-22

IMMUNOGENICITY

Symposium
Immunology for Biotherapeutics

Immunogenicity Assessment & Clinical Relevance

Immunogenicity Prediction
& Control

BIOASSAYS

Training Seminar:
Biostatistics for Beginners

Training Seminar:
A Guide to Statistical Methods for Bioassay

Optimizing Bioassays for Biologics

Past FDA Speakers Include:

Daniel Lagassé, PhD

Daniel Lagassé, PhD
CBER, FDA

Anurag Sharma, PhD

Anurag Sharma, PhD
CBER, FDA

Yow-Ming Wang, PhD

Yow-Ming Wang, PhD
CDER, FDA

Sojin Bing, PhD

Sojin Bing, PhD
CBER, FDA

Eric Brodsky, MD, PhD

Eric Brodsky, MD, PhD
CDER, FDA

Leslie Wagner

Leslie Wagner
CBER, FDA

Wojciech Jankowski, PhD

Wojciech Jankowski, PhD
CBER, FDA

Andrew Byrnes, PhD

Andrew Byrnes, PhD
CBER, FDA

Jennifer Kirk, PhD

Jennifer Kirk, PhD
CBER, FDA

VIEW PAST FDA SPEAKERS

VIEW ALL SPEAKERS

Network with Industry Titans from the FDA, Regeneron, AstraZeneca, Eli Lilly, Merck,, Johnson and Johnson, Bristol Myers Squibb, Genentech, Moderna, Novo Nordisk, Bayer & More!

View Photos & Videos

Top Reasons to Attend the 18th Annual
Immunogenicity & Bioassay Summit

VIEW MORE TESTIMONIALS

Engage directly with FDA and global regulatory leaders shaping expectations for immunogenicity risk assessment, ADA/NAb strategies, and bioanalytical validation, and gain clarity on evolving guidance impacting your development programs.
Gain practical insights from industry and academic experts advancing immunogenicity prediction, assay development, clinical immunogenicity assessment, and emerging therapeutic modalities, with real-world case studies and lessons learned.
Participate in interactive discussions and panels designed to address real-world scientific and regulatory challenges, allowing you to benchmark approaches, ask questions, and exchange perspectives with peers.

Explore a dynamic exhibit and poster hall featuring innovative technologies, solution providers, and cutting-edge research, and discover new tools and partners to support your work.
Expand your network with scientists and decision-makers working across biologics, cell and gene therapies, vaccines, and novel drug platforms, fostering meaningful connections that extend beyond the event.
Leave with actionable strategies and valuable connections — this premier meeting delivers the scientific depth, regulatory clarity, and peer network you need to confidently move your programs forward.

Thank You to Our 2026 Corporate Sponsors