Who are the "customers" of the PPKC? Pharmaceutical or biotechnology sponsor companies who are developing new therapeutic agents destined for pediatric use or alternatively, who are re-purposing existing drugs for the treatment of conditions which afflict infants, children or adolescents.

How does the PPKC work? Potential sponsors initiate contact with the coordinating center for the Consortium. An initial assessment of the sponsor's needs is undertaken and a general framework for the intended scope of work is drafted. Based upon the needs of the sponsor, member units of the Consortium are "activated" and institution-specific point-of-contact is initiated so that the process of study activation can begin in a fashion that is virtually simultaneous and highly efficient.
What is the PPKC? The PPKC is an Academic Site Management Organization developed as a consortium between four pediatric medical centers.

The mission of the PPKC is to work cooperatively with pharmaceutical and biotechnology companies to design, execute, analyze and interpret information from early phase (ie. phase I and II) studies of drugs and biologics in pediatric patients ranging in age from infancy through adolescence.

Our Goals The goals of the PPKC reside with the establishment of highly effective and productive professional relationships with sponsors that facilitate the generation of data of the highest quality. This is done by availing them to experienced and capable investigators and study teams, experienced in conducting early phase clinical trials, and to state-of-the-art clinical study platforms. As well, our location in large pediatric medical centers with complete representation of pediatric medical subspecialties enables the conduct of trials in the vast majority of conditions affecting infants and children.
PPKC Members The Consortium is comprised of the Children's Mercy Hospital, the Arkansas Children's Hospital Research Institute, Cook Children's and the Children's Hospital of the Louisiana State University Medical Center in Shreveport. As reflected in the descriptive profiles, each of the institutions has developed state-of-the-art pediatric clinical pharmacology program and facilities capable of supporting early phase clinical trials of drugs and biologics across a wide spectrum of pediatric disease states and patient age groups.

Arkansas Children's Hospital Research Institute

Arkansas Children's Hospital is the only pediatric medical center in Arkansas and was named one of the Fortune 100 Best Companies to work for. It is one of the largest pediatric hospitals in the United States serving children from birth to age 21. The pediatric health care facility boasts an internationally renowned reputation for medical breakthroughs and intensive treatments, unique surgical procedures and forward-thinking medical research - all dedicated to fulfilling their mission of enhancing, sustaining and restoring children's health and development.

Since 1989, the Arkansas Children's Hospital Research Institute, a not-for-profit corporation owned by Arkansas Children's Hospital has maintained a dedicated pediatric clinical research unit that was developed to support phase I-II clinical trials. This six bed unit has the capacity to conduct a wide variety of studies and also has a dedicated isolation room and an infant room. It is staffed by research nurse coordinators with experience and training in pharmacokinetic studies done in accordance with GCP standards. It also contains a centralized nursing station and a wet laboratory suitable for the handling and preparation of biological samples. A dedicated playroom and conference room meet the needs of the subjects/families and research staff.

Unit Director: Laura P. James, MD

Children's Mercy Hospital

Children's Mercy Hospitals and Clinics is a comprehensive pediatric medical center which is the only free-standing children's hospital between St. Louis and Denver. It is consistently ranked among the leading children's hospitals in the nation, and was the first hospital in Missouri or Kansas to receive the prestigious Magnet designation for excellence in patient care from the American Nurses Credentialing Center. The facility provides state-of-the-art care for children from birth to age 18 who come from throughout Missouri and Kansas and beyond.

Established in 1998, the Children's Mercy Hospital has operated the Pediatric Clinical Research Unit. This 3200 ft2 facility contains 6 monitored research beds, a play room, a fully equipped research kitchen, a wet laboratory and a dedicated, centralized nursing station. The unit is staffed by a group of six clinical research coordinators, four of whom are pediatric nurses with experience ranging from intensive care medicine (NICU and PICU) to outpatient medicine. As well, the unit operates in strict compliance with GCP standards and those required for phase I and II clinical trial units.

Unit Director: Gregory L. Kearns, PharmD, PhD

Cook Children's

Cook Children's is one of the country's leading integrated pediatric health care delivery systems. Based in Fort Worth, Texas, the non-profit organization includes a nationally recognized Medical Center, Physician Network, Home Health Company, Health Plan, Health Foundation and Health Care System. Cook Children's includes more than 35 pediatric primary care offices and specialty clinics throughout Texas.

Cook Children's has proven its ability to fulfill the enrollment goals of Phase I-IV pediatric and young-adult clinical investigations involving inpatient or outpatient populations in strict accordance with GCP standards. All research activity and project-specific staffing is managed through a single, centralized Research Administration Office, offering our industrial partners a fully responsive, "one-stop" shop for the life of every clinical trial. The Cook Children's IRB meets twice each month and expedited review is available daily. A fully-electronic, web-based records system links every patient's medical information across the entire system, and we employ the iMedRIS system as the backbone of communications between investigative staff and the IRB. Uniquely, Cook Children's has developed a state-of-the-art primary care research network, including a fully-staffed Clinical Research Center, by linking its pediatric practices with mobile-flexible research staffing and instant communications tools. Inpatient beds for clinical trials are available, and a dedicated GCRC staffed by experienced clinical research nurse coordinators is under development.

Unit Director: James D. Marshall, MD

LSU Health Sciences Center - Shreveport

Louisiana State University Health Sciences Center at Shreveport is an academic health sciences center, including three health professions schools--medicine, allied health professions and graduate studies—and three teaching hospitals across North Louisiana. The university teaching hospital includes a Children’s Hospital which cares for children from throughout the North Louisiana, East Texas and Southwest Arkansas region. Assets of the LSU Health Sciences Center include a level III regional NICU, a regional Burn Center, a Level One Trauma Center, and two state-designated centers of excellence: the Feist-Weiller Cancer Center and the Center of Excellence for Arthritis and Rheumatology. Our Department of Pediatrics holds one of only six affiliations in the nation with the world-famous St. Jude Children’s Research Hospital. Translational and clinical research are signature programs of the LSU Health Sciences Center at Shreveport.

The Children's Hospital of the LSU Health Sciences Center at Shreveport maintains and operates a state-of-the-art, GCP-compliant pediatric research unit. This dedicated facility, established more than 10 years ago as part of the institution’s aggressive clinical trials program, contains three beds and can be immediately configured for studies involving children of any age. As well, it contains an "in-unit" laboratory for specimen handling / preparation. The unit is staffed by experienced pediatric nurses and trained research coordinators who have successfully performed both phase II and III clinical drug trials.

Unit Director: John T. Wilson, MD

What is the value proposition of the PPKC to its customers? The PPKC offers a "turn-key" platform for the conduct of phase I and II clinical trials over the entire age spectrum that comprises pediatrics and in the vast majority of pediatric subspecialty areas. This is accomplished by use of established intra-institutional collaboration between dedicated pediatric clinical pharmacology units and highly trained pediatric medical subspecialists who have critical knowledge of the patients and diseases that they treat. Through effective collaboration, the PPKC can significantly reduce the time and resources required for site identification, training and study initiation.

What are the value-added dimensions provided by the PPKC? In addition to study conduct, the PPKC member institutions have a wealth of experience in the design of early phase clinical trials, the conduct of pharmacokinetic/pharmacodynamic data analysis in support of New Drug Applications, the performance and integration of pharmacogenomic data in the context of phase I-II clinical trials and the interpretation of study data with regard to the potential impact of disease and development on drug disposition and effect. Additionally, the directors of each program in the Consortium have extensive experience with regulatory processes pertaining to pediatric drug development.
Contact Us Please use the following information to contact us:

Talita M. Hill, RN, MSN, MBA-HCM, CCRC
The Children's Mercy Hospital
(816) 234-3073