Written by Dr Hayley Kain, Pharmacokinetic Scientist at Agilex Biolabs
Since launching our in-house pharmacokinetic (PK) data analysis service, Agilex Biolabs has continued to invest in capability, people, and process optimisation to better support early-phase clinical development and later stage clinical trials across Australia and globally.
Over the past 12 months, we have expanded our PK team and built hands-on experience across multiple studies. This ongoing delivery has supported continuous refinement of our workflows, resulting in an efficient, scalable, and robust high-quality service for our clients.
As pharmaceutical and biotechnology sponsors increasingly seek integrated bioanalytical and pharmacokinetic support, the ability to generate, analyse, and interpret PK data within a single organisation can help reduce project complexity, improve communication, and accelerate decision-making throughout clinical development.
Expanding PK Capability: Growing Our Scientific Team
A key milestone in the growth of our PK data analysis service has been the expansion of our scientific team.
Eight months ago, Brodie Gregory joined the PK data analysis team, transitioning from a bioanalytical laboratory role to Pharmacokinetic Scientist. With a strong background in pharmaceutics and bioanalysis in the areas of liquid chromatography–mass spectrometry (LC-MS) and immunoassay, he brings valuable insight, supporting the interpretation and integration of complex analytical data within PK programs.
Brodie joins Dr Hayley Kain, Lead Pharmacokinetic Scientist, who first established the Agilex Biolabs TK data analysis service in 2024, followed by the PK data analysis service in 2025. With over ten years of experience working in pharmaceutical science, including over five years specialising in pharmacokinetics, Dr Kain’s experience allows her to combine cutting edge scientific advancements from academia with deep rooted regulatory expertise gained from industry.
With a dedicated team of PK scientists, Agilex Biolabs is well positioned to manage multiple studies in parallel while maintaining rapid turnaround times.
This growth enhances:
• Resourcing flexibility across concurrent satudies
• Continuity and redundancy in critical project timelines
Faster Turnaround Times, Same Scientific Rigor
With increased team capacity and refined internal workflows developed through delivery experience, we are now able to deliver PK analyses faster than ever, while maintaining high standards of scientific integrity and regulatory compliance.
Our PK data analysis service continues to support:
• Rapid interim PK analysis and reporting following each SAD or MAD cohort
• Timely decision-making for dose escalation committees
• Final, QA-audited PK reports suitable for regulatory submission
To date, we have delivered every interim and final report on time or ahead of schedule, 23 reports across 15 different projects, consistently meeting or exceeding client expectations. This performance reflects the flexibility and efficiency of our team, allowing us to respond effectively to challenges such as protocol changes, delayed sample deliveries, and unforeseen bioanalytical laboratory issues without compromising quality or timelines.
What differentiates Agilex Biolabs from many contract research organisations is our fully integrated bioanalysis and pharmacokinetic data analysis capability, delivered entirely in-house. By combining bioanalytical testing, data management, and PK interpretation within a single organisation, we reduce traditional handover points, improve communication between scientific teams, and enable faster access to decision-ready data. This integrated approach is particularly valuable for Phase I clinical trials, adaptive study designs, and programs requiring rapid cohort progression where timely PK insights can directly influence study decisions.
Supporting Complex and Adaptive Study Designs
As our capability has matured, we have expanded our ability to support more complex early-phase studies, including:
• Adaptive Phase I study designs
• Studies requiring rapid cohort turnaround
• Programs with complex sampling schedules or multiple analytes
• Dose expansion oncology trials
• Food effect cohorts
Our integrated model, linking bioanalysis and PK data analysis through in-house collaboration at Agilex Biolabs, remains central to enabling real-time insights and maintaining high-quality, efficient study data delivery.
Through continued experience across a growing range of study designs, Agilex Biolabs has developed practical expertise supporting sponsors navigating increasingly complex clinical development pathways. This experience enables our team to provide consistent PK support while maintaining the responsiveness required for modern adaptive and early-phase studies.
Looking Ahead
The first year of in-house PK data analysis at Agilex Biolabs has been defined by growth, learning, and continuous improvement. As we continue to build on this foundation, our focus remains on delivering timely, accurate, and decision-ready pharmacokinetic insights that support confident clinical development decisions across early-phase, adaptive, and later-stage programs.
Further details on our fully integrated bioanalysis and PK data analysis capabilities, including what clients can expect when working with Agilex Biolabs in Australia, are available in our original service announcement.
Partner with Agilex Biolabs
If you are planning an early-phase clinical study or preclinical program and require reliable, rapid PK or TK data analysis, our team is ready to support your program. Connect with our Business Development team at BD@AgilexBiolabs.com to discuss how our evolving analytical capabilities can support your next study.
Need TK Data Analysis for Your Toxicology Program?
Agilex Biolabs also provides in-house toxicokinetic (TK) data analysis services for both GLP and non-GLP preclinical toxicology studies.
Whether Agilex performs the bioanalysis for your toxicology studies or you’re collaborating with another partner, our TK data analysis services are available to support your programs. We apply the same integrated, in-house analytical approach used in our PK services, delivering consistent, rapid, and high-quality interpretation of TK data to support study evaluation and decision-making.
