Pediatric Safety Monitoring: Role of IRBs and DSMBs

Drug Safety, Life Sciences, Pharmaceutical, Pharmaceutical Regulation ,
  • July 18, 2013

With patient safety at the forefront of clinical research, critically so for pediatric populations, sponsor companies are leveraging multiple stakeholders in the development and execution of their data & safety monitoring plans. There are numerous groups that have pivotal insight and responsibility in this process including sponsors, CROs, DSMBs, IRBs and sites, just to mention a few. How can these groups best be leveraged to harvest their expertise and ensure a cohesive and effective safety monitoring strategy?

This webinar will explore the roles of DSMBs and IRBs in particular and examine how they are involved in ensuring patient safety in pediatric trials, the unique considerations in developing DSMBs for pediatric populations, how regulatory guidance is driving change for DSMBs and IRBs and how to best work with each other and sponsors to ensure the highest degree of safety for patients and the best quality of research and data. Join speakers Jeffrey Cooper (Copernicus WIRB) and Dr. Phil Walson (independent DSMB member) as they explore these issues and answer your questions.

This webinar is part of a series on Pediatric Clinical Trials

Part 1
November 8/11
Navigating Pediatric Regulations in the United States and European Union
Part 2
December 13/11
Pediatric Clinical Trials – Lessons Learned the Hard Way
Part 3
February 14/12
Perspectives on Pediatric Trials from Investigative Sites
Part 4
September 11/12
Regulatory Authorities and Ethics Committees: Perspectives from Europe for Pediatric Drug Development
Part 6
July 18/13
The Pediatric Safety Monitoring: Role of IRBs and DSMBs

Speakers

Jeffrey Cooper, Vice President Global Consulting at WIRB, Copernicus Group IRB

Jeffrey A. Cooper, MD, MMM, Vice President of Global Consulting, has 25 years of experience in the field of human research subject protection and oversees consulting and outsourcing services to institutions conducting or managing human research. A medical doctor, he is an accomplished basic and clinical investigator and an experienced IRB chair and director.

Dr. Cooper left an academic career in 2002 to help start the Association for Accreditation of Human Research Protection Programs Inc. (AAHRPP) where he was responsible for the development and operation of the accreditation process from 2002 to 2009. From 2009 until joining the WIRB-Copernicus Group in November 2012, Dr. Cooper was a director with the Huron Consulting Group, advising institutions and industry on human research protections and clinical research operations.

Dr. Cooper earned a Bachelor’s Degree in Science from Rensselaer Polytechnic Institute, his Medical Degree from Albany Medical College and a Master’s in Medical Management from Carnegie Mellon University.

Professor Philip Walson, MD, Board Certified in Pediatrics, Clinical Pharmacology and Medical Toxicology; Visiting Professor, Department of Laboratory Medicine at Georg-August-University Medical School, Goettingen, Germany

For 19 years, he was Professor of Pediatrics, Pharmacology and Pharmacy at the Ohio State University/Children’s Hospital, Columbus. During this time he was also co-founder, Medical Director and Chief Scientific Officer of Pediatric Clinical Trials International, a for-profit subsidiary of the hospital dedicated to the development of pediatric therapeutics. He was a member and chair of the Children’s IRB, Medical Director of the Central Ohio Poison Control Center, Director of the Therapeutic Drug Monitoring (TDM) and Toxicology Laboratory and principal investigator of the National Institute of Child Health and Human Development (NICHD) supported Pediatric Pharmacology Research Unit (PPRU) and Pediatric Clinical Pharmacologist for the National Institute of Mental Health (NIMH) supported Research Unit for Pediatric Psychopharmacology (RUPP) in Columbus.

In 2000, he moved to Cincinnati Children’s Hospital to set up the Clinical Trials Office and be Director of the Clinical Pharmacology Division. He was also the co-principal investigator for the University of Cincinnati PPRU, taught clinical study design, conducted clinical trials, and served on a number of academic and Pharmaceutical company sponsored DSMB’s/DMC’s.

In August 2008 he retired from the University of Cincinnati to move to Europe where he works part-time as a researcher and teacher at the University Medical Center in Goettingen, as well as a medical journal editor and consultant to industry, CRO’s, and government (NICHD and EU) on pediatric clinical trial design. He continues to serve as a member or chair of a numerous academic and Pharmaceutical company DSMB’s/DMC’s including the DMC he chairs that monitors NICHD/FDA sponsored studies of off-patent drugs studied as part of the Best Pharmaceuticals for Children Act (BPCA).

He completed his undergraduate studies in Chemistry at the University of California, Berkeley and obtained his MD at the University of California, School of Medicine, San Francisco (UCSF). He trained in pediatrics in the Pritzker School of Medicine at the University of Chicago and afterwards returned to UCSF to complete a two-year fellowship in clinical pharmacology at the Cardiovascular Research Institute in the UCSF Department of Internal Medicine.

Kathy Bohannon, Principal Strategist, Pediatrics, INC Research

Ms. Bohannon provides global operational and strategic leadership for INC Pediatrics. She has 16 years of diverse operational and therapeutic experience within Pharmaceutical research and development; including Phase I-IV clinical research, laboratory R&D, US and global project management, and sales & marketing. Ms. Bohannon has over 9 years of pediatric research experience including 5 years of pediatric study and program management within the Best Pharmaceuticals for Children Act – Coordinating Center (BPCA-CC) under the purview of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

Ms. Bohannon has supported development and management of pediatric projects across multiple therapeutic areas (analgesia, cardiovascular, CNS, dermatology, infectious disease, hematology, metabolic disease and respiratory) and clinical settings (inpatient, outpatient, ICU, OR and ER), including rare diseases/orphan indications. Her pediatric experience includes protocol and program development in compliance with FDA PREA and BPCA legislation, and the European Paediatric Regulation; internal team training and management from project initiation through completion; recent presentations examining pediatric research practices and opportunities for further training and education; and strategy development for navigating the challenges of pediatric research.

Who Should Attend?

Clinical development executives, chief medical officers and other professionals involved in drug development who have interest in further insights in pediatric clinical research.

The webinar will be particularly useful for attendees from biotechnology or pharmaceutical companies worldwide that are seeking to conduct pediatric trials.

Xtalks Partners

INC Research

INC Research is a therapeutically focused contract research organization with a high performance 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 The 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. For more information please visit http://www.incresearch.com/

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