Participants at the The GLSA | FOCM Networking event that took place on November 16, 2022 were treated to a presentation from Chuck Bon with Biostudy Solutions. Chuck is a recognized industry expert in the area of pharmacokinetics and biostatistics. Chuck has served on FDA Expert and Blue Ribbon panels on Topical Corticosteroids and Population and Individual Bioequivalence. Biostudy Solutions has expertise in trial design of Phase 1 PK Bioequivalence (BE) studies as well as Therapeutic Equivalence Trials. The company specializes in the analysis of PK studies, bioequivalence studies and results from alternative in-vitro testing.
A discussion about the therapeutic equivalence of generic drugs to the original branded product took place. There is a tolerance range of bioavailability when comparing to the standard. The bioequivalence range for the Test-to-Reference ratio in both PK and clinical endpoint trials is 80% to 125%.
There was discussion over the ongoing mergers and acquisitions among small CROs to lift themselves into the mid-size CRO ranks.
Let’s continue to reinforce our collective goal to improve patients’ lives across the globe. If you would like to present on an educational life sciences topic and spur our discussions, please leave a comment below and I’ll reach out as soon as possible.
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Attendees (first time attendees in bold):
Dan Weddle, Senior Strategic Alliance Director, AltaSciences
Jill Curtis, Director of Project Management, Worldwide Clinical Trials
Duncan Shaw, President, DTS Translation Services
Ashley Clark, Regulatory Affairs Consultant
Ryan McCarthy, Government Markets Manager, Velocity BioGroup
David Holland, Senior Director of Business Development, cMed Clinical
Jim Lyon; Professor of Clinical Research; UNC – Wilmington
Nancy Zeleniak, Enterprise Strategic Partnerships and Participant Engagement, Atrium Health
Judy Carmody, Founder, Carmody Quality Solutions
Michael Young, Founder & Principal, biomedwoRx
Josh Lang, Associate Director, Business Development, Asymchem Group
Loretta Cipkus Dubray, Founder, Global Clinical Connections
Ravi Luthra, Clinical Research Coordinator
Mike O’Gorman, Founder, Life Science Marketplace
A few screenshots are below: