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April 11, 2018 - April 12, 2018 PRINT PDF

2018 Annual International Neonatal Scientific Workshop

Bethesda North Marriott Hotel & Conference Center, Maryland

 

Agenda – Day 1, April 11, 2018

8:00 am – 12:00 pm

INC Hemodynamic Adaptation Workgroup Meeting

Heike Rabe and Janis Dionne, co-chairs

8:00 am – 12:00 pm

INC BPD Workgroup Meeting

Robin Steinhorn and Wolfgang Göpel, co-chairs

12:00 pm – 1:00 pm

 Lunch

1:00 pm – 5:00 pm

INC Communications Workgroup Meeting

Christina Bucci-Rechtweg and Jennifer Degl, co-chairs

1:00 pm – 5:00 pm

INC Clinical Pharmacology Workgroup Meeting

Karel Allegaert, Robert Ward and Jeffrey Barrett, co-chairs

6:00 pm – 9:00 pm

 DINNER at Pinstripes (near Marriott) for all Workshop Participants

 

Agenda – Day 2, April 12, 2018

Meeting Objectives:

  • Share regulatory perspectives on developing safe and effective therapies for neonates.
  • Develop a framework for applying real world evidence: how to standardize data elements and clinical methods, what types of data should be collected, how should quality assurance be addressed.
  • Discuss approaches for both simplifying and standardizing the evaluation and reporting of adverse events in neonatal trials.
  • Review the extent and nature of influences of parenteral nutrition on very low birth weight infants and identify ways to take nutrition into account during clinical trials.
  • Review the progress and plans of INC workgroups.

 

8:00 – 8:30 am

Welcome

Susan McCune (Director, Office of Pediatric Therapeutics, FDA)

 

Applying Innovative Approaches to Developing Neonatal Therapeutics

Gerald Dal Pan (Director, Office of Surveillance and Epidemiology, CDER/FDA)

8:30 – 10:15 am

Real World Evidence to Inform Regulatory Decision-Making on Neonatal Medicinal Products

Neena Modi (Imperial College, London) and Prakesh Shah (U-Toronto), co-chairs

  • Dominique Haumont (St-Pierre University Hospital, Brussels)
  • Michael Padula (Data Workgroup Co-Chair; Children’s Hospital of Pennsylvania)
  • Rebecca Kush (Founder, CDISC)
  • Nicole Thiele (EFCNI)
  • Kristjan Kahler (Novartis)
  • Jeffrey Barrett (Sanofi)
  • Lily Mulugeta (CDER/FDA)
  • Jacqueline Corrigan-Curay (CDER/FDA)
  • EMA/PDCO/Health Canada/PMDA

10:15 – 10:45 am

 Coffee Break

10:45 – 12:30 pm

Standardizing Safety Approaches for Neonatal Clinical Trials

Jon Davis (Tufts U and INC Co-Director) and Gerri Baer (OC/FDA), co-chairs

  • Danny Benjamin (Duke University) by Webex
  • Matt Laughon (UNC)
  • Karel Allegaert (University of Leuven)
  • Isamu Hokuto (St. Marianna University, Japan)
  • Hidefumi Nakamura (NCCHD, Tokyo)
  • Mary Short (Lilly)
  • Laura Fabbri (Chiesi) by Webex
  • Alexandra Mangili (Shire)
  • Jennifer Degl (Preemie Parent Alliance)
  • Carole Kenner (COINN)
  • Michael Blum (CDER/FDA)
  • Joseph Toerner (CDER/FDA)
  • Agnes Klein (Health Canada)
  • Barry Magnum (Paidion Research, Inc.)

12:30 – 1:30 pm

 Lunch

1:30 – 3:00 pm

Regulatory implications of nutritional influences on outcomes of preterm birth

Mark Turner (U. Liverpool and INC Co-Director) and Mary Hise Brown (Baxter), co-chairs

  • Brenda Poindexter (Cincinnati Children’s Hospital)
  • Thibault Senterre (University of Liege)
  • Satoshi Kusuda (Tokyo Women’s Medical University)
  • Thomas Miller (Bayer)
  • Andrea Lotze (CFSAN/FDA)
  • Suna Seo (CDER/FDA)
  • Cynthia Pellegrini (March of Dimes)

3:00 – 3:30 pm

 Coffee Break

3:30 – 4:45 pm

INC Workgroup Updates

Ronald Portman (Novartis, INC Co-Director), chair

  • Hemodynamic Adaptation (Heike Rabe, Janis Dionne)
  • Data (Thomas Diacovo, Michael Padula)
  • Bronchopulmonary Dysplasia (Robin Steinhorn, Wolfgang Göpel)
  • Clinical Pharmacology (Karel Allegaert, Robert Ward, Jeffrey Barrett)
  • Communications (Christina Bucci-Rechtweg, Jennifer Degl)

4:45 pm

Closing Remarks

Mark Turner (INC Co-Director)

5:00 pm

 Workshop Adjourns

 

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