Pediatric Clinical Trials in Diabetes
Sponsored by: Covance
- Clinical Trials
Date: 8 May
Time: 4PM London/11AM New York
Challenges and Opportunities
Conducting effective pediatric trials in diabetes requires a thorough understanding of the regulatory agency requirements and the competitive landscape of current pediatric studies for diabetic programs. Sponsors also face many challenges in the process, such as the lack of research infrastructure in T1DM or determining inclusion/exclusion criteria to effectively advance both T1DM and T2DM programs.
Our educational webinar explores the current requirements and several common challenges that sponsors face in pediatric trials in diabetes. You’ll hear from Dr. William Tamborlane, Dr. Barry Goldstein and Dr. Mala Puri as they share their applicable research experiences and discuss strategies that can help address these barriers to execution.
Join us as they evaluate the utility of several considerations, such as expanding inclusion criteria, employing telemedicine, running multi-arm protocols and accessing collaborative research networks to improve results in this complex space for both T1DM and T2DM pediatric studies.
William Tamborlane, MD,
Chief of Yale Medicine Pediatric Endocrinology
Dr. William Tamborlane is a highly respected endocrinologist who cares for children, adolescents and young adults with type 1 diabetes (T1DM). His accomplishments, including pioneering studies in the development of insulin pump therapy in the late 1970s, have given him an international reputation as one of the most highly regarded clinical scientists in childhood diabetes and related disorders.
In addition to his own clinical practice, Dr. Tamborlane leads a multidisciplinary team of Yale Medicine physicians, diabetes nurse educators, dieticians and social workers that care for more than 1,000 children, adolescents and young adults with diabetes. His team approach utilizes advanced technology, including continuous glucose monitoring and insulin pumps.
A professor of pediatrics (endocrinology) at Yale School of Medicine, Dr. Tamborlane has also contributed to improving diabetes care in leadership roles on a national level.
Barry Goldstein, MD, PhD, FACE,
Vice President & Therapeutic Area Head, Metabolic & Endocrinology, Covance
Dr. Barry J. Goldstein is a board-certified endocrinologist who is an internationally-recognized authority on diabetes mellitus. Dr. Goldstein has over 25 years of broad experience in clinical and basic R&D in Academia and Industry. He was vice president and therapeutic area head for Diabetes and Endocrinology at Merck from 2008-2013 and his clinical development experience spans from small molecules, combination therapies, novel insulin analogs, biosimilars, incretin peptides and novel biologics. Dr. Goldstein joined Covance in 2013 as global therapeutic area head for cardiovascular, metabolic, endocrine and renal, and is based in Princeton, NJ.
Dr. Goldstein received his combined MD/PhD degrees from the University of Rochester School of Medicine and Dentistry. His postdoctoral research and clinical fellowships were at the Joslin Diabetes Center and Brigham and Women's Hospital, both of Harvard Medical School, where he also served on the medical faculty for several years.
Mala Puri, MD,
Medical Director, Cardiovascular, Metabolic, Endocrine and Renal, Covance
Dr. Mala Puri is a board-certified pediatric endocrinologist and diabetologist. She provides medical expertise, consultation, and leadership for project teams in the planning, advising and management of clinical research trials. Dr. Puri is responsible for design and review of clinical trial protocols, as well as providing medical and scientific consultation for sites and investigators during the course of the trial.
Dr. Puri obtained her medical degree from the University of Oklahoma. She completed both her pediatric and pediatric endocrinology training at the Children's Hospital at Montefiore, Albert Einstein College of Medicine in New York City where her research focus was on childhood diabetes and metabolic syndrome. She then joined the faculty of the University of North Carolina (UNC) in Chapel Hill, North Carolina as an assistant professor of Pediatrics. She served as the co-director of the pediatric diabetes clinic and the pediatric bone clinic. She cared for inpatients and outpatients with diabetes, growth disorders, thyroid diseases, pituitary diseases, pubertal disorders and various rare genetic diseases. She was also actively involved in medical student, resident and fellow education training.
Key Learning Objectives
- Get an overview on the competitive landscape for pediatric trials in diabetes
- Discuss the various challenges faced in trials with pediatrics
- Gain insights on strategies that can mitigate barriers to execution of pediatric clinical trials in diabetes
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