Providing Immunogenicity Risk Assessment (IRA) Expertise to Give Actionable Insights
Strategic guidance to help you navigate the complexities of unwanted immunogenicity. From discovery through clinical development.
Understanding Unwanted Immunogenicity
What Is Unwanted Immunogenicity?
Unwanted immunogenicity occurs when a patient's immune system recognizes a therapeutic biologic as foreign and mounts an immune response against it. This can lead to the formation of anti-drug antibodies (ADAs) that may neutralize the therapeutic effect or cause adverse reactions.
Why Does It Matter?
Immunogenicity risk can impact drug efficacy, patient safety, and regulatory approval timelines. Early and continuous risk assessment throughout discovery and development helps you anticipate challenges, design appropriate mitigation strategies, and build a robust clinical development plan.
Immunogenicity Risk Assessment (IRA) Services
Complementary expertise to provide comprehensive IRA support across your development program.
Discovery to IND Support
Strategic immunogenicity guidance from target or therapeutic modality exploration through IND-enabling activities, ensuring immunogenicity-related risks are well-characterized before you enter clinical development.
Risk Mitigation Planning
Proactive identification of immunogenicity risks with actionable mitigation strategies tailored to your therapeutic and the clinical context in which it will be deployed.
Program Troubleshooting
Rapid assessment and strategic recommendations for programs facing unexpected immunogenicity challenges or regulatory questions about existing data.
Clinical Strategy
Development of immunogenicity testing strategies, ADA assay design guidance, and clinical study protocols that address regulatory expectations.
Assay Oversight
Technical guidance for nonclinical and clinical assay development and fit-for-purpose validation to ensure robust and regulatory-compliant immunogenicity testing.
Comparability Assessments
Expert evaluation of immunogenicity implications from manufacturing changes, process modifications, or biosimilar development to support regulatory submissions.
When Should You Incorporate an IRA?
Key milestones and trigger points where immunogenicity risk assessment adds the most value
Program Inception
Inform decisions around therapeutic targets and modalities while elucidating opportunities for risk mitigation
Preclinical Development Milestones
Evaluate immunogenicity risk factors as your screen and commit to lead candidates
Pre-IND Planning
Develop comprehensive IRA before IND-enabling studies begin
Sequence & Manufacturing Changes
Re-assess whenever modifications are made to the molecule sequence, formulation or manufacturing processes
Clinical Phase Transitions
Update risk assessment with emerging clinical immunogenicity data
What to Expect
A fit-for-purpose, efficient process designed to deliver actionable insights
Our Process
Introductory Discussion
Initial conversation to understand your program and define project needs and potential scope
Project Onboarding & Data Sharing
After agreements are signed, share program background information and available data for evaluation
Project Execution
Execution of project activities in close collaboration with you and aligned with the defined objectives and scope
Insights & Deliverables
Recommendations, actionable outputs, and project artifacts delivered and refined to meet your needs
Example Deliverables
- Comprehensive immunogenicity risk assessment reports
- Customized nonclinical risk assessment strategies
- Immunogenicity mitigation strategy recommendations
- Clinical immune monitoring strategy guidance
- Study design and experimental planning support
- Data interpretation and integrated risk analyses
- Regulatory-ready documentation and supporting materials
Leverage Our Immunogenicity Expertise to Your Strategic Advantage
Two seasoned experts with complementary skills, united by a commitment to rigorous, actionable immunogenicity risk assessment
Daniel Leventhal, MS, PhD
Principal Consultant
Immunobiology, Platform Technologies and Immunogenicity
10+ years biologics R&D
Tim Hickling, PhD
Principal Consultant
Immunosafety, Immune Monitoring and QSP Modeling
19+ years industry experience
Why We Work Together
Diverse perspectives and close collaboration are key when facing complex challenges. We operate as independent experts but maintain a close working relationship, collaborating when projects benefit from complementary expertise. Clients can engage either of us individually while also accessing our broader combined range of experience when needed.
We believe that immunogenicity risk assessment should be proactive, not reactive. Our shared philosophy centers on integrating data-driven IRA throughout development, mitigating risks while helping teams appropriately weigh immunogenicity considerations alongside the many factors that determine a successful therapeutic.
Looking for Immunogenicity Expertise?
Let's talk about how we can support your immunogenicity risk assessment needs. Introductory discussions are complimentary.
Or email us directly:
dan@tactylteam.com |
tim@quasor.co.uk