Raleigh, NC, Nov. 13, 2008 – INC Research ®, Inc., a therapeutically-focused contract research organization (CRO) with a process for delivering reliable results, today announced the addition of Dr. Renee Simar as the company’s principle pediatric strategist. In this role, Dr. Simar will be leading the INC Research pediatric team in developing program strategy and considerations for clinical trials in neonates, children and adolescents.
Dr. Simar has been involved with more than 100 clinical and consulting projects in the areas of infectious disease, psychiatry, neurology, gastroenterology and cardiovascular indications. She was instrumental in forming the INC Pediatrics division in 2001 in order to assist pharmaceutical and biotech customers with the complex world of pediatric drug development. Dr. Simar was appointed vice president of the division in 2004, and further developed INC Research Pediatrics as a premier provider of multi-therapeutic pediatric drug development services. She then started Simar & Associates, an independent consulting firm to provide guidance on regulatory obligations, program design, trial implementation and recruitment issues relevant to pediatric trials.
“We are pleased to welcome Renee back to our pediatric team. She is an incredibly valuable resource to guide customers through the intricacies involved with the design and conduct of pediatric trials,” said John Potthoff, PhD, COO at INC Research. “As pediatric trials continue to increase, we pride ourselves on attracting top talent to plan, prepare for and manage this unique patient population.”
Dr. Simar has been involved in various phases of pediatric research for 15 years during a career spanning more than 20 years in academic and industry research. Prior to industry, she was an assistant professor, Department of Pediatrics, Section on Clinical Pharmacology at Louisiana State University Medical Center. She directed phase I - II studies while serving as associate clinical pharmacologist for the NIH-supported Pediatric Pharmacology Research Unit and assistant director for the Children’s Research Center at LSU.
She is currently a pediatric consultant for IntegReview, an independent Institutional Review Board (IRB) in Austin, TX and serves on the Editorial Board of the Good Clinical Practice Journal (GCPJ). Dr. Simar has been a featured speaker at pediatric conferences and regularly contributes to industry publications on the regulatory, ethical, and practical aspects of pediatric studies. Most recently, she has authored chapters on consent and recruitment in pediatric trials for the textbook Pediatric Drug Development: Concepts and Applications (2009).
INC Research’s pediatric research team has conducted more than 50 pediatric trials covering indications such as ADHD, autism, diabetes type 2, epilepsy, GERD, pain, schizophrenia and ulcerative colitis. Studies have been conducted in North America, the UK and the across the European continent and included more than 14,000 patients and 950 investigative sites.
About INC Research®
INC Research is a therapeutically-focused contract research organization with an unrivaled reputation for conducting global clinical development programs of the highest integrity. Pharmaceutical and biotechnology companies look to INC Research for a complete range of customized Phase I through Phase IV programs in therapeutic areas of specialty, and in innovative pediatric and women’s health trials. The company’s Trusted Process® methodology and therapeutic foresight leads customers to more confident, better-informed drug and device development decisions. INC Research is headquartered in Raleigh, North Carolina, and now in 25 locations in 32 countries worldwide. For more information please visit www.incresearch.com.
