Get to know the newest ACT Editorial Advisory Board member.
Aaron F. Bartlone, MS, is vice president, preclinical and clinical quality assurance at UCB Pharma, Smyrna, GA. In this role, he leads a global organization of quality professionals based in the United States, Europe, and Japan. Aaron partners with UCB's Development and Medical Affairs organizations to establish robust Quality Systems that ensure GXP compliance while streamlining business processes and maximizing efficiencies. In addition, Aaron's organization executes field surveillance for safety and efficacy studies to ensure trial subjects' safety and rights are protected and that data generated from these studies are accurate and reproducible.
Aaron F. Bartlone, MS, vice president, preclinical and clinical quality assurance, UCB Pharma
Prior to joining UCB, Aaron was head of quality operations-product research & development, with Eli Lilly & Company, Indianapolis, IN, responsible for developing the strategy and framework for Lilly's product research & development quality system.
Aaron's earlier positions with Eli Lilly include European quality director-global product development in Mont-Saint Guibert, Belgium (2001–2004), where he led the delivery of quality assurance services across European drug development sites. Aaron had a staff of quality professionals located in Belgium and Germany, and worked closely with his U.S. counterparts to institute global processes and quality systems commensurate with international regulations and industry-best practices.
Prior to working at Lilly's Mont-Saint Guibert, Belgium, location, Aaron held numerous positions with Lilly in Indianapolis, IN: quality control manager-global product development (1999–2001); head of quality-biotechnology quality control and quality control laboratories (1998–1999); quality control team leader-oral and parenteral clinical products (1997–1998); senior compliance auditor-corporate quality assurance (1996–1997); and laboratory group leader-quality control laboratories (1994–1996).
From 1992 to 1995, Aaron was an associate professor at Ivy Tech State College, Indianapolis, IN, where he taught chemistry, physics, and mathematics, and participated in the design of a new laboratory teaching facility. Earlier, he was a clinical toxicologist with South Bend Medical Foundation, South Bend, IN, performing laboratory procedures for substances of abuse and forensic investigations.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Oveporexton Shows Superior Efficacy in Phase II Narcolepsy Type 1 Trial Without Hepatotoxicity
May 16th 2025In the TAK-861-2001 Phase IIb study, oveporexton significantly improved wakefulness, daytime sleepiness, and cataplexy frequency in patients with narcolepsy type 1, outperforming current therapies and avoiding liver toxicity seen with earlier OX2R agonists, according to results published in The New England Journal of Medicine.