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Wednesday, June 21 • 8:00am - 9:30am
#301: Progress in Pediatric Therapeutics

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Component Type: Session
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-17-564-L04-P; CME 1.50; IACET 1.50; RN 1.50

The availability of safe, effective therapies is critical to meet the needs of pediatric patients. FDA’s 2016 status report on the BPCA and PREA concluded that progress has been made in obtaining pediatric studies and new labeling but significant challenges remain in studies for neonate, infants, pediatric cancer, and international coordination of pediatric trials.

This DIAmond panel will discuss recent progress in global pediatric research and regulatory science and new developments in pediatric research networks such as the Pediatric Trials Consortium (C-Path Institute) and the International Neonatal Consortium.

Learning Objectives

Discuss recent legislative and regulatory developments in the US and EU related to pediatric studies and labeling and their expected impact on availability of safe and effective therapies for children; Identify regulatory and research approaches to address challenges that limit the availability of innovative medicines for infants, neonates, and children.

Chair

Ronald Portman, MD

Speaker

Panelist
Susan McCune, MD

Panelist
Mark Turner

Panelist
Robert M. Ward, MD

Panelist
Christoph Male, MD

Panelist
Marie-Helene Pinheiro, PharmD


Speakers
CM

Christoph Male

Associate Professor of Paediatrics, Medical University of Vienna
CM is associate professor of paediatrics at the Dept. of Paediatrics, Medical University of Vienna (MUW), Austria. He holds a degree in Health Research Methodology. His research is in paediatric coagulation, drug evaluation and clinical trials methodology in children. He leads th... Read More →
avatar for Susan McCune

Susan McCune

Director, Office of Pediatric Therapeutics, OSMP, OC, FDA
Dr. Susan McCune is the Director of the Office of Pediatric Therapeutics at FDA. She joined the Agency in 2003, and from 2/10 to 1/17 was Deputy Director, Office of Translational Sciences, CDER. She completed her undergraduate degree at Harvard, her MD at GWU, and training at Chi... Read More →
avatar for Marie-Helene Pinheiro

Marie-Helene Pinheiro

Industry Stakeholder Liaison, Corporate Stakeholders Division, European Medicines Agency, European Union
Graduated as Dr. of Pharmacy (1996, Paris). Worked 3 years in Pharma. Industry (Pfizer Central Research, UK) before joining EMA in 1996. Currently Principal Regulatory advisor to CHMP, CAT, VWP, CTWP, EMA ITF & Borderline activities, pandemic strategic group & vaccines & ATMPs RA... Read More →
avatar for Ronald Portman

Ronald Portman

Executive Director, Pediatric Therapeutic Area, Novartis Pharmaceuticals Corporation
Dr. Portman joined BMS 2007 & Novartis 2014 from Univ of Texas Med Sch (Houston)Professor/Director, Div of Pediatric Nephrology Training: MD (Dartmouth), Pediatrics (Fitzsimons/Univ of Colo), Ped Neph (St Louis Children's). Numerous national committees (BPCA ad com, PAS, Amer Boa... Read More →
MT

Mark Turner

Senior Lecturer in Neonatology; Co-Director, International Neonatal Consortium
Neonatologist with a special interest in early phase drug development and improving the availability of high quality medicines to children and babies. At present studying excipients, inotropes, postnatal steroids and surfactant. Current work also includes developing research infr... Read More →
avatar for Robert Ward

Robert Ward

Professor Emeritus of Pediatrics, Neonatology, Clinical Pharmacology, University of Utah
Dr. Ward received his MD from Johns Hopkins and trained in Pediatrics, Neonatology and Clinical Pharmacology at the Univ of Minn. Through the AAP, he helped develop FDAMA, PREA and BPCA. At the Univ of Utah, he started a pediatric clinical trials program that studied thousands of... Read More →

Wednesday June 21, 2017 8:00am - 9:30am
S105 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  12: DIAmond, Session
  • format json
  • Featured Topics Pediatrics,Patient Centric ,Academic Clinical Researcher,Global Regulatory,StudentProgramming
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session