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 realizing 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, the featured speakers 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.
Register for this webinar to learn about the advantages of GMP over USP in early phase development.
Speakers
Mindy Findlay, Research Pharmacy Manager, ICON
Mindy is a Pharmacy Manager with over 20 years of experience in clinical research, specializing in early phase trials and cGMP compliance for Phase I. She currently leads the pharmacy team in San Antonio, TX, overseeing sterile and non-sterile compounding, investigational product management and regulatory readiness.
Message Presenter
Corey Ohnmacht, PhD, Director of Bioanalytical and Quality Control Lab Services, ICON
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.
Message Presenter
Jeffrey Hinchey, PharmD, Senior Research Pharmacy Manager, ICON
Jeffrey is the Senior Manager of the Research Pharmacy at ICON in Lenexa, Kansas, overseeing 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.
Message PresenterWho Should Attend?
This session will benefit senior professionals within the following areas:
- CMC (Chemistry, Manufacturing, and Controls)
- Regulatory Affairs
- Quality / Compliance
- Clinical & Program Leadership
- Strategic & Executive Roles (Decision Makers)
What You Will Learn
Attendees will gain insights into:
- 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
- Optimized 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
Xtalks Partner
ICON
ICON plc is a world-leading clinical research organization powered by healthcare intelligence. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. We develop new innovations, drive emerging therapies forward and improve patient lives. With headquarters in Dublin, Ireland, ICON employed approximately 39,900 employees in 95 locations in 55 countries as of June 30, 2025. For further information about ICON, visit: www.iconplc.com.
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