Overview
When it comes to early phase research, the way a product is formulated and manufactured can significantly impact not just the quality of the data, but the success of the study itself. Many researchers and sponsors default to USP-based compounding due to speed or familiarity, without realising the risks this introduces in terms of consistency, regulatory compliance, and analytical depth. As regulatory expectations increase and the push for translational fidelity grows, the choice between USP compounding and GMP manufacturing becomes more than just a technical decision — it's a strategic one.
In this webinar we will explore the critical differences between these two approaches, and why starting with GMP — even in early phase development — can save both time and resources downstream.
Our experts will discuss:
- The differences between GMP and USP compounding in research: While USP can support certain research needs, it falls short when robust data integrity, reproducibility, and regulatory compliance are required — particularly in early phase clinical trials.
- Real world case studies: Where USP-based approaches missed critical analytical insights – and how GMP could have changed the outcome.
Optimised GMP facility design: Key considerations that support quality, compliance, and operational efficiency including:
- Cleanroom design & workflow segregation
- Environmental monitoring systems
- Quality assurance integration
- QC laboratory collaboration
- Equipment calibration and integration
Speakers:
Mindy Findlay
Mindy is a Pharmacy Manager with over 20 years of experience in clinical research, specialising in early phase trials and cGMP compliance for phase 1. She currently leads the pharmacy team in San Antonio, TX, overseeing sterile and non-sterile compounding, investigational product management, and regulatory readiness.
Corey Ohnmacht, PhD
Corey is the Director of Bioanalytical and Quality Control Laboratories at ICON, bringing over 20 years of experience in regulated CRO environments. He has led both bioanalytical and CMC operations for small molecules and biologics, with deep hands-on expertise in quantitative analysis, including LC-MS/MS and hybrid LBA-LCMS workflows. His work has supported PK/PD, toxicokinetic, and immunogenicity studies across all phases of drug development.
Jeffrey Hinchey, PharmD
Jeffrey is the Senior Manager of the Research Pharmacy at ICON in Lenexa, Kansas over-seeing the Good Manufacturing Practice (GMP) manufacturing services. He has over 20 years of experience in diverse clinical settings and more than 15 years of dedicated involvement in pharmaceutical research. His expertise spans across drug development, clinical trials and GMP.