Pharmanet

PharmaNet has the expertise and hands-on experience to successfully conduct studies in infants, children, and adolescents. Our pediatric-specific services include:

Consulting on chemistry issues, including age-appropriate formulations
Interpretation of the FDA's Modernization Act (FDAMA) and Pediatric Rule
Attention to age-specific informed consent and assent issues
	Medical oversight of active clinical trials, with emphasis on patient eligibility and monitoring of efficacy and safety in pediatric populations
	Input into study reports and regulatory filings, including interpretation of age-dependent laboratory and other data
Identifying appropriate pediatric investigators from:
	our database
		ongoing relationships in academia (including investigators affiliated with Pediatric Pharmacology Research Units)
	community-based physicians
Monitoring by experienced CRAs, many with prior pediatric-trial experience
	Implementing strategies to boost enrollment, consistent with applicable ethical and age-based standards

Our experience in pediatric studies includes:

Drug/device for delivery of local anesthesia in children

Type II diabetes mellitus in children and adolescents

Cystic fibrosis

Juvenile rheumatoid arthritis

Oral yeast infection

Thomas J. Newman, MD

President, Late Stage Development

Dr. Newman trained in pediatrics and endocrinology and then served on the faculty at the University of Minnesota Medical School. In 1980, he joined Bristol-Myers Squibb where he worked on the development of a variety of cardiovascular, anti-infective, and diagnostic products and also served as Head of Drug Safety. Prior to joining PharmaNet, Dr. Newman was Vice President of Clinical Research at a major contract research organization.

Christine Rhoda

Senior Director, Clinical Research

Ms. Rhoda has more than 17 years of experience in drug development settings, including pharmaceutical, biotechnology, and contract research organizations. Her expertise spans a range of services in clinical research, project management and medical writing. Ms. Rhoda‘s experience in pediatric research includes serving as project director for an international enzyme replacement therapy program for boys.

Philippa Smit-Marshall, MD

Vice President, Medical Affairs, Europe and Asia Pacific

Dr. Smit-Marshall trained in pharmacology and internal medicine in the UK before joining the pharmaceutical industry nearly 20 years ago. During that time she has worked for both industry and CROs and she has been involved in the development of drugs in children across several indications including epilepsy; growth disorders associated with renal failure; intrauterine growth retardation and Turner Syndrome; cystic fibrosis, and schizophrenia. Philippa chairs the institute of Clinical Research’s Special Focus group on Pediatrics.

Margarete Traiser, PhD

Director, Clinical Research

Dr. Traiser manages PharmaNet’s clinical research team in Germany as well as mentoring clinical research managers in conducting clinical trials in children of all age groups, including pre-term neonates. Before joining PharmaNet, she worked for more than 9 years in many aspects of clinical R&D within the pharmaceutical industry, including paediatric drug development. Dr. Traiser has held positions including clinical research associate, global clinical trial manager, and interdisciplinary R&D project manager for an international drug development program for an orphan disease in oncology. She studied biology, pharmacology, and toxicology in Germany and holds a PhD in Natural Science.