Accelerating ADC Research with Analysis-Ready PK and Safety Datasets

Overview

This case study details how Excelra partnered with a US-based large pharma to build comprehensive, analysis-ready datasets for FDA-approved antibody-drug conjugates (ADCs). Covering clinical PK profiles, physicochemical properties, and safety endpoints including Neutropenia, the curated datasets enabled robust cross-ADC benchmarking and accelerated exposure–response analysis to support data-driven decision-making in ADC development.

Our client

A US-based large pharma focused on advancing oncology therapeutics was evaluating FDA-approved Antibody-Drug Conjugates (ADCs) to better understand clinical PK profiles, physicochemical properties, and exposure–response relationships. The client aimed to leverage data-driven approaches and curated datasets to enable robust comparative analysis and model-based insights, supporting informed decision-making in ADC development.

Client’s challenge

A US-based large pharma was actively evaluating FDA-approved antibody-drug conjugates (ADCs) to benchmark clinical pharmacokinetic (PK) profiles and physicochemical properties across therapies. Given the growing relevance of ADCs in oncology, the client aimed to establish a comprehensive, data-driven framework to better understand variability in exposure–response relationships and support informed decision-making in their development programs.

However, the required data was highly fragmented across public sources, with inconsistencies in reporting formats, study designs, and endpoints. This posed significant challenges in creating standardized, comparable datasets that could be reliably used for downstream modelling and analysis.

Client’s goals

To address these gaps, the client sought support in developing a comprehensive curated and analysis-ready datasets that would facilitate robust comparative evaluation of pharmacokinetic, physicochemical, and safety attributes across FDA-approved ADCs. Specifically, the goals included:

• Compiling compartmental and clinical PK profiles, along with key physicochemical properties, for all FDA-approved ADCs from publicly available sources.
• Curating data on hematological disorders specifically Neutropenia in Oncology patients treated with selected ADCs to support exposure–safety evaluations.

Through this initiative, the client aimed to strengthen their understanding of ADC pharmacology, improve risk–benefit assessment, and support data-driven optimization of future ADC candidates.

Our Approach

Excelra implemented a structured, data-driven approach to develop standardized and analysis-ready datasets for FDA-approved ADCs. Data was systematically identified and relevant data was curated from public data sources, including Clinicaltrials.gov, FDA Reviews, scientific journals, ensuring comprehensive coverage of PK, physicochemical, and safety parameters. Our data curation workflow included the following steps to achieve a harmonized and consistent data format:

Search strategy development

• Search strategy was defined with structured keywords with synonyms in multiple biomedical literatures.
• Established inclusion/exclusion criteria to ensure selection of relevant ADC studies.
• Refined search iteratively to improve data coverage and relevance.

Screening and data identification

• Search results were screened for relevant articles using predefined Inclusion/Exclusion criteria from public domains as mentioned above.

Data extraction

• Compartmental and clinical PK profiles, physicochemical properties, and safety endpoints for FDA-approved ADCs was extracted.
• Compiled hematological disorder, specifically Neutropenia data in Oncology patients treated with selected ADCs.

Data harmonization and QC

• By applying standard vocabulary, heterogeneous data was standardised into a consistent, analysis-ready format.
• Performed rigorous QC checks to ensure data accuracy, completeness, and consistency.
• This ensured a robust foundation for evaluating exposure–response relationships and generating actionable insights for ADC benchmarking and development.

Our solution

Excelra delivered a comprehensive, end-to-end data curation and harmonization solution tailored to ADC benchmarking and analysis. We built standardized, high-quality datasets integrating clinical PK profiles, physicochemical properties, and safety endpoints from diverse public sources. The solution ensured consistency across compounds, enabling reliable cross-study and cross-molecule comparisons.

By structuring the data to be analysis-ready, we empowered the client to perform robust exposure–response and safety analyses with minimal downstream preprocessing. Our approach combined domain expertise with rigorous quality control to deliver accurate, traceable, and analysis-ready datasets, providing a strong foundation for data-driven decision-making in ADC development. Our clinical data services ensure end-to-end coverage from raw source data through to publication-ready outputs.

Value adds by Excelra:

✅ 100% coverage of FDA-approved ADCs, enabling comprehensive benchmarking across therapies.

✅ 3–5x faster data aggregation compared to manual literature review through structured curation workflows

✅ >95% data consistency and completeness achieved via harmonization and QC processes

✅ Reduced downstream data preparation effort by ~60%, with analysis-ready datasets

Other Strategic Impacts for the client:

• Enabled robust exposure–response analysis to better understand efficacy–safety relationships
• Accelerated decisiokn-making in ADC development through readily accessible, analysis-ready data
• Improved cross-molecule comparability, supporting competitive benchmarking and portfolio strategy
• Strengthened risk–benefit assessment using integrated safety and PK insights
• Established a scalable data foundation for future ADC evaluations and advanced modelling approaches