iBiomatics, the provider of private, secure web portals for biomedical research, has promoted Edward Helton, to vice president of regulatory and biomedical affairs.
In 1997, the US Food & Drug Administration issued guidance and regulations that require companies to use validated systems for submission of their electronic signatures and records. Helton will ensure that iBiomatics technology meets the requirements of the FDA.
“Ed’s appointment to this newly-created position will help make sure that we continue to develop technology solutions that conform to the FDA’s regulatory guidelines,” Scott Neuville, CEO of iBiomatics said.
“We know what it takes to develop systems that provide a documented structure,” said Helton. “A solution isn’t worthwhile if it doesn’t present data in a format that the FDA requires. iBiomatics’ goal is to become the de facto standard regulatory platform for the industry.”
He will serve as the liaison between the industry, iBiomatics and its parent company, SAS Institute. This collaboration will focus on creating an open framework that will integrate clinical, genomic and phenomic data in an end-to-end solution. iBiomatics will provide online access to the data through secure web portals and, with SAS, provide tools to analyze data.
“I’m looking forward to working with Ed to deploy SAS’ core technologies through the iBiomatics business model,” said Russ Wolfinger, senior research statistician at SAS. “Medical products companies have to warehouse and analyze massive amounts of data, and these tasks are only going to get harder as genomic data enters the clinical trials process. SAS and iBiomatics have the tools to meet this challenge.”
Helton, 55, has more than 25 years of experience in the design and FDA submission of several classes of drugs. Prior to his work at iBiomatics, he served as chief clinical scientist for PharmaHealth Technologies, a business unit of SAS. He was a senior clinical study director in the neuroclinical trial center at the Virginia Neurological Institute and vice president of regulatory affairs for both Quintiles and Sigma-Tau Pharmaceuticals.
Helton has extensive experience in working with domestic and international regulatory authorities, having served as director of the Drug Research & Evaluation Program and senior research chemist at the National Center for Toxicological Research.
iBiomatics, a subsidiary of SAS Institute, is a technology company that enables researchers in the life sciences industry to better understand and predict the safety and effectiveness of drugs and medical devices at Internet speed. Through private, secure iBiomatics websites, researchers can access, analyze and collaborate on information about particular medical products. This will benefit patients by saving time and money in medical products development.