What to Expect

A clear, structured and collaborative process designed to deliver actionable insights

Introductions and Intake

We begin with an introductory conversation to understand your program, objectives, and key questions related to immunogenicity risk. Following initial project scoping, we establish a consulting agreement, including confidentiality protections, so that data and materials can be shared securely.

Data Collection & Review

Once agreements are in place, we initiate project onboarding and gather relevant background information, materials, and available data needed to support the engagement.

Project Planning

We refine the project scope, objectives, and approach based on the information provided, ensuring alignment on priorities, timelines, and expected outcomes.

Project Execution

We carry out the defined project activities in close collaboration with your team, applying relevant expertise and analyses aligned with your prioritized objectives.

Insights & Deliverables

We develop clear insights, recommendations, and deliverables based on the work performed, tailored to support your program's scientific and strategic needs.

Readout & Next Steps

We review findings and recommendations with your team, discuss implications for your program, and (if desired) align on potential next steps or follow-on activities.

Typical Timelines

Engagement duration varies based on scope, complexity, and data availability.

Shorter Focused Assessment: Targeted review of a narrow set of questions, scenarios or data sets
Longer Comprehensive IRA: Full risk assessment to support advancement through major development milestone
Ongoing Tactical Support: Active planning, execution and data analysis for a program/project

We work with you to define project scope and estimate timelines and effort, while keeping you informed of hours spent throughout the engagement.

What Determines Timeline?

Key factors that influence engagement duration:

Data Readiness: Availability and organization of existing data
Scope: Breadth and depth of assessment requested
Complexity: Novel modality, unique risk factors, or special populations
Your Needs: Program urgency and desired timelines

Typically Most Useful Information

Amino acid sequence (confidential)
Drug target and mechanism of action
Therapeutic modality and format descriptions
Clinical context (indication, co-medications, dosing)
Current development stage

Helpful Additional Data

In silico prediction results
Preclinical immunogenicity data
Product quality/analytical data
Clinical ADA data for comparators (if available)
Past internal experience with similar molecules

Client Involvement

We strive to work efficiently and respect your team's time. Typical client involvement includes: an initial kickoff call, availability for clarifying questions during project execution, and participation in the final readout session. We handle the heavy lifting while keeping you informed of progress.

How is confidentiality protected?

We take confidentiality seriously. All engagements begin with execution of an agreement that clearly defines confidentiality expectations (CDA/NDA/etc.). We never share client information externally and can work with your standard security protocols. For longer term engagements, some clients prefer we utilize a laptop provided by them.

How are fees structured?

Based on your preferences and the nature of the engagement, we can offer either project-based and/or hourly fee arrangements. For defined scope projects, fixed-fee proposals can be offered. For ongoing advisory relationships or variable-scope work, hourly arrangements may be more appropriate. We'll discuss options during our initial consultation and are happy to be flexible to meet your needs.

Can you support regulatory meetings?

Yes. We can assist with preparation of immunogenicity-related sections for regulatory briefing documents, help anticipate and prepare responses to potential questions, and participate in meeting preparation sessions. We do not typically attend regulatory meetings directly but can provide real-time support as needed.

Do you work with early-stage companies?

Absolutely. We work with organizations of all sizes, from emerging biotechs advancing their first program to large pharma companies with complex portfolios. For early-stage companies, we can help establish immunogenicity strategies that scale appropriately with your resources and development stage.

What modalities do you have experience with?

Our combined experience spans a wide range of biologic modalities, with work across antibody-based therapeutics, enzyme therapies, engineered microbes, de novo designed proteins and other emerging biologic platforms. If we don't have the specific experience you are looking for, someone in our combined extensive network very likely does.

Can you help with biosimilar development?

Yes. We have specific experience supporting biosimilar development programs, including comparative immunogenicity assessments, evaluation of product quality differences, and development of clinical immunogenicity testing strategies aligned with biosimilar regulatory guidance.

How do you stay current with immunobiology, technology and regulatory expectations?

We actively participate in industry working groups, attend and present at relevant scientific conferences, maintain close attention to evolving guidance documents, and continuously learn from our engagement experience across multiple programs and sponsors. Our network within the immunogenicity community helps us stay connected to emerging thinking and best practices.

Ready to Get Started?

Schedule a complimentary initial consultation to discuss your program and explore how we can help.