With the continued growth of the Pharma/Biotech sector in North Carolina, it’s getting harder to keep up with colleagues and companies. This Spotlight series is part of Veracity Logic’s ‘Howdy Neighbor!’ initiative –a program designed to help all of us who work in North Carolina’s clinical trial industry to get to know the folks in our own backyard!
Once upon a time, in the world of new drug development, the pharmaceutical industry made very little distinction between the conclusions reached in research with adults and the presumptive application of those findings to children. (Sandeep Bavdekar provides a historical perspective on this issue in his article, “Pediatric Clinical Trials” in the 2013 Jan-Mar issue of Perspectives in Clinical Research).
Then the FDA/EMA issued new directives. Children, it was officially set forth, are NOT small adults – not in so many ways – and definitely not when it comes to the potential effects of drugs. Major pieces of US regulation in the new millennium include the Best Pharmaceuticals for Children Act (BPCA), the Pediatric Research Equity Act (PREA), and the Food and Drug Administration Safety and Innovation Act (FDASIA). Essentially, regulatory authorities have mandated a pediatric component to drug studies for investigational products that are potentially applicable to children. Pediatric reformulations are on the ascendant; by 2020, the FDA requires more sophisticated data modeling approaches that can inform pediatric trial designs.
One of the Pharma/Biotech companies in the Research Triangle Park area of North Carolina is Paidion Research, a global CRO devoted exclusively to pediatric research. “It’s what we know, it’s all we do,” their website proclaims. Headquartered on Leigh Farm Road in Durham, Paidion’s walls are adorned with photos of adorable kids doing adorable things – it’s a nice place to be.
The company was founded in 2013 by Barry Mangum, CEO, and Betsy Reid, COO. Barry’s background includes turns as faculty and as a researcher in pediatrics and clinical pharmacology at Duke and UNC medical schools, and as Senior Director of Pediatric Clinical Development Services for Quintiles. Betsy previously served as Chief Operating Officer at Duke Clinical Research Institute (DCRI).
“Barry and I discussed creating a pediatric-specific CRO as early as 2005, and when regulations changed to further support pediatric research, we knew it was time,” Betsy says. “Both of us worked in the CRO industry and academia where pediatric trials were designed and operationalized with adult research methodologies. Paidion is an organization with a singular focus: changing the pediatric clinical research paradigm to improve the health of children globally.”
The company specializes in pediatric-specific protocol designs and operational strategies which include “identifying and mitigating many of the challenges inherent in researching medicines in children.” For example, certain protocols require that siblings in the same family be assigned to the same treatment group in a clinical trial – not something that tends to come along in adult research!
“We recognize that when you recruit children to participate in clinical trials, you are recruiting the whole family,” Betsy says. “We employ operational methods that minimize disruption to both the children and their families and the clinical practice at investigational sites, while maximizing the efficient collection of pediatric-specific safety and efficacy data.”
“In the world of scientific inquiry, we're doing something completely different,” the Paidion website notes. “Our name says it all: Paidion is the Greek word for children, little ones. They're why we're here…we live our mission of using clinical research to improve the health of children around the world by helping companies and organizations develop clinical trials for kids. That's it...our passion, our expertise, our business, are all about – and only for – children.”
Veracity Logic extends a big ‘Howdy Neighbor!’ to Paidion Research.
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