Optimize Your Immunogenicity Strategy with Trusted Expert Advice

Immunogenicity is a critical factor in biologic drug development, with the potential to determine a therapy’s success or failure. Undesirable immune responses, including the formation of anti-drug antibodies (ADAs), can compromise drug efficacy, alter pharmacokinetics, and trigger hypersensitivity reactions. In severe cases, immunogenicity concerns have halted otherwise promising therapies in clinical trials or after approval. Given that 90% of clinical drug development programs fail before reaching FDA approval, proactively assessing immunogenicity risk is not just a formality – it’s essential for success. 

Regulatory agencies have increased their focus on immunogenicity strategies in preclinical development. FDA guidance emphasizes structured risk assessments and mitigation planning, which must be clearly outlined in the Investigational New Drug (IND) application. Sponsors are expected to present a well-reasoned approach to immunogenicity risk early in development to improve their chances of regulatory success. 

Navigating Immunogenicity Risk 

Immunogenicity risk is influenced by a complex interaction of factors: 

• Product-related: Amino acid sequence, glycosylation patterns, and formulation impact immunogenic potential. 

• Patient-related: Genetics, underlying health conditions, and concurrent medications introduce variability in immune responses. 

• Treatment-related: Dosing regimen, route of administration, and treatment duration can all influence ADA development and clinical consequences. 

With so many variables at play, navigating immunogenicity risk and evolving agency expectations requires deep scientific and regulatory expertise. The FDA and other agencies expect sponsors to provide a structured, well-supported immunogenicity risk assessment, but determining the right approach for a specific therapeutic can be daunting. Missteps can lead to delays, unexpected safety concerns, or costly program adjustments. 

As Dr. Amy Rosenberg, Senior Director of Immunology at EpiVax, explains: 

“To best ensure that drug development is not sabotaged by clinically relevant immune responses to the therapeutic, high-level expertise in immunogenicity risk assessment and mitigation strategies is critical. Knowledge of available regulatory actions and interactions with regulatory agencies that spur rather than delay development of novel therapeutics is essential.”  

With 33 years’ experience at the FDA overseeing the regulation of biologics, Dr. Rosenberg brings deep insights into the intersection of immunology and regulatory science. Having led key divisions within the agency, she understands how regulatory agencies evaluate immunogenicity risk and what they expect from sponsors.  

Trusted Expert Advice: Immunogenicity Guidance for Every Stage of Development 

Navigating immunogenicity risk requires more than just data; it takes experience, strategic thinking, and an understanding of evolving regulatory expectations. That’s where Trusted Expert Advice (TEA) comes in. 

EpiVax developed TEA to support biotech teams of all sizes and stages in confidently assessing and managing immunogenicity risk. Whether refining early-stage R&D strategies, preparing for an IND submission, planning clinical trials, or looking to mitigate clinical immunogenicity, TEA provides direct, one-on-one consulting tailored to each company’s unique needs. 

Our seasoned immunogenicity consultants don’t just interpret regulatory guidance – they help anticipate challenges, refine risk assessment and mitigation strategies, and ensure that immunogenicity evaluations are both scientifically sound and agency-ready. With deep expertise in both immunogenicity science and regulatory oversight, TEA helps sponsors align risk assessments with FDA expectations and make informed decisions at every stage of development. 

Beyond regulatory strategy, EpiVax’s TEA consultants deliver insights to give your pipeline a competitive edge at every step of the preclinical development journey: 

Simplify lead candidate selection: Receive guidance in ranking candidates, allowing you to prioritize the best options for further development. 

Focus deimmunization and optimization: Identify critical protein regions, enabling you to optimize therapeutic design and reduce immunogenicity risk. 

Maximize R&D efficiency: By minimizing the need for costly downstream studies, TEA consultants help you save resources in the future — on average, 20-fold. 

Support strategic planning and fundraising: Reliable immunogenicity data bolsters grant applications, publications, investor materials, internal product characterization discussions, and more.  

Whether you’re part of an emerging startup or a global pharmaceutical leader, TEA consultants will equip you with the expertise needed to reduce risk, ensure regulatory compliance, and accelerate development. 

“With her abundant experience guiding the development of biologics at FDA, Dr. Amy Rosenberg provided invaluable advice to our team when we encountered an unexpected issue in manufacturing. Dr. Rosenberg and the Epivax team provided guidance on strategies to resolve the situation and mitigate risks. It is the closest advice we could get before engaging with the Agency.” 

– Regulatory Affairs team, Mid-size clinical stage Biotech Company 

Meet A Featured Consultant: Amy Rosenberg, MD  

Amy Rosenberg, MD 

Sr. Director and Consultant, Immunology 

(Formerly FDA) 

Dr. Amy Rosenberg consults with biotechnology and pharmaceutical companies regarding immunogenicity considerations as they approach an IND filing or while strategizing immunogenicity mitigation and monitoring approaches for clinical trials. 

A physician-immunologist, Amy oversaw the regulation of biologics, including cellular and protein therapeutics and cell-device combination products at the FDA for 33 years. She directed the Division of Therapeutic Proteins in CBER/CDER and subsequently, the Division of Biotechnology Review and Research III in the Office of Biotechnology Products in CDER, FDA which regulates diverse protein therapeutics, including monoclonal antibodies, fusion proteins, enzyme replacement therapies, hematologic and somatic cell growth factors, and immunomodulatory agents. Dr. Rosenberg was a principal author of the 2014 FDA guidance titled “Immunogenicity Assessment for Therapeutic Protein Products” and served as an expert consultant to the National Institute of Health’s Immune Tolerance Network. 

Dr. Rosenberg and other EpiVax consultants are available to lend their expertise in pre-clinical and clinical immunogenicity risk strategies through Trusted Expert Advice. 

Want to ensure immunogenicity is never a roadblock? Get in touch today to discuss how personalized TEA consulting can help you navigate immunogenicity challenges before they arise. 

EpiVax offers a range of in silico immunogenicity assessments designed to support preclinical development at every stage. With industry-leading tools and expert-driven analyses, these fee-for-service and SaaS options provide critical data on T cell epitope content, helping drug developers refine and advance their pipelines with confidence. Learn more.