Immunogenicity Case Studies and Clinical Management


As the immunogenicity field is moving forward, closing the gap between clinicians and assay developers is essential in the success of biologic development and accelerates the adoption of new biologic therapies in patient treatments. This year, CHI’s Immunogenicity Case Studies and Clinical Management conference will focus on new case studies of novel biologics and emphasize on closing this gap by providing multiple viewpoints from clinicians, technology developers and regulators on how to use immunogenicity data in clinical settings.

Final Agenda


Recommended Short Course(s)*

SC1: Preclinical and Clinical Assessment of Immunogenicity: Focus on New Modalities Including Bi- and Tri-Specific Antibodies, Oligonucleotides, Gene Therapy and CAR-T

Darshana Jani, MSc, Associate Director, Global Lead Biologics, Clinical Assay Group, Global Product Development, Pfizer, Inc.

SC5: In silico Immunogenicity Predictions (Hands-on) Workshop

Vinodh B. Kurella, PhD, Principal Scientist, Protein Engineering, Merrimack Pharmaceuticals

Daron Forman, PhD, Principal Scientist, Molecular Discovery Technologies, Bristol-Myers Squibb


*Separate registration required.


7:00 am Registration and Morning Coffee


8:30 Chairperson’s Opening Remarks

Sandra Garces, MD, PhD, Senior Medical Advisor for Immunogenicity, GPS Medical and Benefit-Risk Management, Eli Lilly

8:40 KEYNOTE PREESENTATION: How to Characterize ADA Responses and Assess Their Clinical Impact to Better Inform the Clinical Relevance of ADA Using a Risk-Based Approach

Garces_Sandra_SPB2Sandra Garces, MD, PhD, Senior Medical Advisor for Immunogenicity, GPS Medical and Benefit-Risk Management, Eli Lilly

Practical cases will be used to better illustrate the specific questions and some of the limitations we sometimes face and to discuss potential ways to overcome challenges in pre-clinical risk assessment of expected clinical consequences according to type of biologic, disease population, drug MoA. Study designs to incorporate specific immunogenicity questions, characterization of ADA responses, type of analyses to characterize the impact on PK, on PD, efficacy and safety and risk-benefit perspective to decide if further mitigation strategies are needed will also be discussed.

9:10 Relationship Between ADA and PK Assays: Is There an Impact?

Araya_MarcelaMarcela M. Araya, PhD, Principal Scientist, Group Leader, BioMedicine Design, Pfizer

The assessment of immunogenicity of therapeutics drugs is a requirement for regulatory filings. The ADA formation may have an impact on the efficacy, dosing schedules and sampling schedules. Current gaps include a limited knowledge of the effect of endogenous ADA on PK/PD profiles, and the inconsistency of reported types of ADA responses (e.g., titers, concentration, isotypes, etc). The presentation will cover the impact of immunogenicity induction on PK assays.

9:40 Applying Modeling Methodologies to Analyze the Impact of Immunogenicity on Exposure and Efficacy

Jawa_Vibha_SPB2Vibha Jawa, PhD, Director and Lead, Predictive and Clinical Immunogenicity, PPDM, Merck & Co Inc

Understanding immunogenicity’s effect on the PK and PD of a therapeutic protein is important during drug discovery, as it allows for the identification of clinically relevant anti-drug antibody reactions. The goal of this work is to use modeling methodologies to understand the effect of immunogenicity, streamlining the early drug discovery process and informing clinical decisions.

10:10 Networking Coffee Break


10:45 Chairperson’s Remarks

Vibha Jawa, PhD, Director and Lead, Predictive and Clinical Immunogenicity, PPDM, Merck & Co Inc

10:50 Increased Immunogenicity Associated with Combination Regimens with Immune Modulatory Biologics

Jad Maamary, PhD, Associate Principal Scientist, Predictive and Clinical Immunogenicity, PPDM, Merck & Co Inc

The use of immune modulatory biologics to augment functionality of immune cells can also augment the risk of immunogenicity. The quality of such an immune response and its clinical relevance will be explored through this talk. Whether the activation of immune cells can break tolerance to otherwise tolerant sequences will also be explored.

11:20 Current Risk Assessment of Immunogenicity: Best Practices and Regulatory Hurdles

Daniel Kramer, PhD, Global Scientific Advisor Clinical Immunogenicity, Sanofi, Munich Center, Germany

The main focus of this talk is the current challenges of risk assessment for immunogenicity including patient, process, and product-related risks. With the ever-changing landscape of regulatory requirements, it is difficult to grasp what is exactly needed when conduct risk assessment of immunogenicity for drug candidates. I will present a work flow and procedure that was recently developed in Sanofi to address this issue.

11:50 ADA Testing in Clinical Routine: Where Are We and Where Are We Heading?

Hahn_Anna_FogdellAnna Fogdell-Hahn, PhD, Associate Professor, Karolinska Institutet, Clinical Neuroscience, Clinical Neuroimmunology, Center for Molecular Medicine (CMM), Stockholm, Sweden

Whereas ADA testing is now a requirement for drugs to be approved, the use of them in clinical settings are only partially applied. This is unfortunate since it would enable identification of patients that have reacted and become tolerant against their treatment before clinical symptoms appear. In this talk I will present a feasible process for translating the ADA testing from the industry, through academy to applied clinical routine.

BioAgilytix 12:20 pm Presentation to be Announced

12:50 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:50 Session Break

2:20 Problem-Solving Breakout Discussions - Click here for details

3:20 Networking Refreshment Break


4:00 Chairperson’s Remarks

Rakesh Dixit, PhD, DABT, Vice President, R&D, Global Head, Biologics Safety Assessment, Translational Sciences, MedImmune


4:10 Vision for How Immunotherapy Will Shape Future of Cancer Care

Leena Gandhi, MD, PhD, Vice President, Immuno-Oncology Medical Development, Lilly Oncology

Immunotherapy is considered by many as a pillar of cancer care today, but in many ways we have only scratched the surface. Our knowledge and understanding of the complexities of immunotherapy and its mechanisms continue to evolve. The future of cancer care will be defined by our ability to systematically identify and implement opportunities for combination therapy to improve and standardize patient response.


4:55 The Lassa Virus Glycoprotein: Stopping a Moving Target

keynote-headshot-hastie-400x400Kathryn Hastie, PhD, Staff Scientist, Immunology and Microbiology, The Scripps Research Institute

Lassa virus causes ~5000 deaths from viral hemorrhagic fever every year in West Africa. The trimeric surface glycoprotein, termed GPC, is critical for infection, is the target for neutralizing antibodies, and a major component of vaccines. Structural analysis of Lassa GPC bound to antibodies from human survivors reveals a major Achilles heel for the virus and provides the needed template for development of immunotherapeutics and improved vaccines.

5:40 Welcome Reception in the Exhibit Hall with Poster Viewing

7:15 End of Day


8:00 am Registration and Morning Coffee


8:25 Chairperson’s Remarks

Darshana Jani, PhD, Associate Director & Global Lead Biologics, Pfizer Inc

8:30 Lessons Learned from Biologic Agents in Rheumatology – Immunogenicity

Vibeke Strand MD, MACR, FACP, Adjunct Clinical Professor, Immunology/Rheumatology, Stanford University

Many pathways influence the bioavailability of biologics – immunogenicity is an important part of the picture. Most tests for ADAbs only capture a fraction of the “truth” and all TNF inhibitors are immunogenic. This talk will discuss how MTX impact the bioavailability of TNFis along with clinical practice implications of immunogenicity and treatment survival.

9:00 Nonclinical and Clinical Immunogenicity Assessment of Bispecific Protein Therapeutics

Eric Wakshull, PhD, Principal Scientist/Group Leader, Bioanalytical Sciences, Genentech

The advent of increasingly complex and novel protein therapeutic modalities requires non-standard approaches to assessing immunogenic responses. Bispecific antibodies are one such novel modality in which two different target specificities are engineered into a single protein. This presentation will discuss our bioanalytical strategy and its implementation using two such molecule programs. These case studies will illustrate how these strategies were implemented, their outcome and impact on clinical development.

9:30 Case Study: Clinical Immunogenicity and Its Impact

Finco_DeborahDeborah Finco, PhD, President, Deborah Finco Consulting LLC

Multiple companies developed therapeutic monoclonal antibodies to the same target for lowering low-density lipoprotein (LDL). However, the immunogenicity profiles varied considerably between the different companies monoclonal antibodies. This talk will discuss the different therapeutic antibodies, the immunogenicity assays, clinical results, and the impact of immunogenicity and efficacy on one program.

10:00 Coffee Break in the Exhibit Hall with Poster Viewing


10:45 Chairperson’s Remarks

Darshana Jani, PhD, Associate Director & Global Lead Biologics, Pfizer Inc

10:50 Immunogenicity Assessment of an Enzyme Replacement Therapy Administered via the Intracerebroventricular Route in Patients with CLN2 Disease

Cherukuri_AnuAnu Cherukuri, PhD, Associate Director, Immunogenicity Assessment, BioMarin Pharmaceutical Inc.

We have characterized immunogenicity of a novel ERT directly delivered to the CNS in patients with a life-threatening neurodegenerative disease. The consequences of both a systemic and CNS-specific immune response on the safety and efficacy profiles of the drug will be presented. Implications of ADA impact on systemic and CSF PK will be included. Lastly, regulatory feedback on the risk assessment approach and learnings from the program that can be applied to assess immunogenicity risks of future ICV-delivered ERT therapeutics will be presented.

11:20 Immunogenicity Testing – The Next Frontier: Gene Therapies, Nanoparticles and Beyond

Pillutla_RenukaRenuka Pillutla, PhD, Executive Director, Lead, Bioanalytical Sciences, Bristol-Myers Squibb

Advances in molecular engineering and our understanding of biological mechanisms are resulting in increasingly novel therapeutics. In the realm of large molecules, we have gone beyond the traditional antibody and protein therapeutics to unique modalities with innovative delivery systems. Increasing complexity of novel modalities has led to increases in the complexity of immunogenicity testing strategies. This presentation will discuss the challenges of assessing immunogenicity risk and developing appropriate testing strategies as we move into this next frontier. Two case studies will be used to illustrate some of the challenges. In one example, the therapeutic is a lipid nanoparticle that encapsulates siRNA as the active pharmaceutical ingredient. Based on a thorough assessment and careful consideration, an immunogenicity assay development strategy was developed and implemented for this complex molecule. In another example, immunogenicity considerations in gene therapy and the potential impact of pre-existing antibodies to the vector will be discussed.


11:50 PANEL DISCUSSION: Characterization and Impact of Post Marketing Commitment Requirements for New Biologics Approved by the FDA

Moderator: Susan Richards, PhD, Presidential Scientific Fellow, Translational Medicine Early Development, Sanofi R&D

Panelists: Adrienne Clements Egan, PhD, Scientific Director, Janssen Biotherapeutics, Johnson and Johnson

Eric Wakshull, PhD, Principal Scientist/Group Leader, Bioanalytical Sciences, Genentech

Jack A. Ragheb, MD, PhD, Co-Chair, Immunogenicity/Immunosafety Working Group, Senior Medical Fellow for Immunogenicity, Global Patient Safety, Eli Lilly and Company, Lilly Corporate Center

Darshana Jani, PhD, Associate Director & Global Lead Biologics, Pfizer Inc

  • Gain an awareness of postmarketing requirements and commitments, how they differ and what gaps are generally addressed?
  • Discuss the various immunogenicity-related commitments that have been issued by the FDA. Are there common themes? Will they provide learnings for future biologics development?
  • How will the newer guidances and incorporating a risk-based immunogenic assessment approach in programs impact future PMR/PMCs?

12:20 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on your Own

1:20 Ice Cream Break in the Exhibit Hall with Poster Viewing


2:00 Chairperson’s Remarks

Sophie Tourdot, PhD, Senior Principal Scientist, Immunogenicity, Pfizer

2:05 Pre-Existing Antibody: Biotherapeutic Modalities

Clements-egan_AdrienneAdrienne Clements Egan, PhD, Scientific Director, Janssen Biotherapeutics, Johnson and Johnson

The relationships between biotherapeutic modalities to the nature, prevalence, and clinical consequences of pre-existing antibodies are reviewed. Initial evidence for pre-existing antibody is often identified during anti-drug antibody (ADA) assay development. Other interfering factors known to cause false ADA positive signal, including circulating multimeric drug target, rheumatoid factors, and heterophilic antibodies, are discussed.

2:35 Impact of Presence of Pre-Existing Antibodies on Immunogenicity Assessment Strategy

Goletz_TheresaTheresa J Goletz, PhD, Global Head NBE DMPK, BIOPHARMA, R&D, Global Early Development, EMD Serono Research & Development Institute Inc.

While all biotherapeutics have the potential to induce an antidrug antibody response (ADA), for some, pre-existing ADAs are observed in drug-naïve matrix. The presence of pre-existing ADAs may influence the bioanalytical approach and data analysis, both preclinically and clinically. Clinical case studies of biotherapeutic candidates in development for Oncology or non-Oncology indications for which pre-existing ADA were detected will be presented.

3:05 Sponsored Presentation (Opportunity Available)

3:35 Refreshment Break in the Exhibit Hall with Poster Viewing


4:25 New Updates on the Use of Low Dose Transient Methotrexate

Stephanie DeArmey, MHS, PA-C, Physician Assistant, Pediatrics, Medical Genetics, Duke University Medical Center

Prophylactic immune tolerance induction (ITI) has been standard of care in CRIM-negative infantile Pompe disease (IPD) patients. However, the side effects and cost of rituximab has resulted in its use on in CRIM-negative IPD. We have developed an immune modulation protocol using transient low-dose methotrexate. We will present data on our experience with transient low-dose methotrexate in infantile Pompe disease.

4:55 Immune Tolerance Induction Approaches for Immunogenicity Mitigation

Tourdot_SophieSophie Tourdot, PhD, Senior Principal Scientist, Immunogenicity, Pfizer

I will talk about rationale for mitigating immunogenicity through tolerance induction (the case of ERT and gene therapy, and beyond). Current practice in the clinic (ITI, methotrexate, … ) and new approaches such as antigen- specific and non-antigen specific (nanoparticles, proteasome inhibitors, anti-CD20, …) will also be discussed.

5:25 End of Immunogenicity Case Studies and Clinical Management

5:30 Registration for Dinner Short Courses

Recommended Dinner Short Course*

SC14: Subvisible Protein Particles in Immunogenicity: Measurement, Characterization and Impact

Björn Boll, PhD, Head, Particle Lab and Higher Order Structure Protein Analytics, Physical Chemical Analytics, Novartis Pharma AG

Antonio Iglesias, PhD, Expert Scientist, Pharma Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche, Ltd. Basel


*Separate registration required.

* The program is subject to change without notice, due to unforeseen reason.

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