Applying Regulatory Science to Neonates: Third Annual Scientific Workshop
March 27 – 29, 2017
Bethesda North Marriott Hotel and Conference Center
5701 Marinelli Road, North Bethesda,
Maryland 20852 USA
Sponsors: Critical Path Institute and U.S. Food and Drug Administration
Agenda – Day 1, March 27, 2017
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8:00 am – 4:00 pm |
INC Severity Scale for Neonatal Adverse Events Workgroup Meeting |
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8:00 am – 4:30 pm |
INC Retinopathy of Prematurity Workgroup Meeting |
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9:00 am – 2:00 pm |
INC Seizures Workgroup Meeting |
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6:00 – 9:00 pm |
Workgroup Dinner at the Bethesda North Marriott Hotel |
Agenda – Day 2, March 28, 2017
Meeting Objectives:
- Share regulatory perspectives on developing safe and effective therapies for neonates.
- Review the progress of INC workgroups.
- Discuss challenges in conducting registration trials to prevent pre-term birth.
- Break out into smaller groups to tackle specific regulatory science issues, including developing 1) a severity scale for neonatal adverse events; 2) long-term outcome measures; 3) a neonatal common protocol template; 4) communications to promote a research culture; and 5) multiple enrollment in clinical trials.
- Receive updates on other partnership efforts related to INC: pediatric trial networks and nonclinical models of neonatal therapeutics.
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8:00 – 8:15 am |
Welcome – Jonathan Davis (Tufts University, INC Co-Director)A New Era for Developing Neonatal Therapeutics – Susan McCune (Director, Office of Pediatric Therapeutics, FDA) |
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8:15 – 9:00 am |
Panel for Workgroup Updates – Ronald Portman (Novartis, INC Co-Director)
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9:00 – 10:00 am |
Developing Endpoints for Use in Regulated Neonatal Trials – Gerri Baer (FDA) and Ralph Bax (EMA), co-chairs Gerri Baer (FDA) Junko Sato (PMDA) Agnes Klein (Health Canada) Ralph Bax (EMA) |
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10:00 – 10:30 am |
Coffee Break | |
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10:30 am – 12:30 pm |
Plenary Session on Challenges in Conducting Registration Trials to Prevent Pre-Term Birth – Mark Turner (University of Liverpool, INC Co-Director), chair Olof Rugarn (Ferring Pharmaceuticals) Yosuke Komatsu (GSK) Louise Kenny (University College Cork) Errol Norwitz (Tufts) Mehali Patel (BLISS) Deborah Discenza (PPA) Ralph Bax (EMA) Nicole Thiele (EFCNI) Barbara Wesley (FDA) |
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12:30 – 1:30 pm |
Lunch | |
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1:30 – 3:00 pm |
Concurrent Breakouts IMultiple Enrollment in Clinical Trials – Jonathan Davis and Gerri Baer, co-chairs (Brookside) |
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Communication Strategies to Promote a Research Culture – Christina Bucci-Rechtweg and Jennifer Degl, co- chairs (Seneca Boardroom) |
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Long-term Outcomes – Neil Marlow and Mark Turner, co-chairs (Cabin John Boardroom) |
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3:00 – 3:30 pm |
Coffee Break | |
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3:30 – 5:00 pm |
Concurrent Breakouts IIDeveloping a Neonatal Common Protocol Template – Ronald Portman and Anne Cropp (Echelon Pharma Solutions), co-chairs (Seneca Boardroom) |
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| Applying Generic Severity Grading Criteria to Persistent Pulmonary Insufficiency of Prematurity – Karel Allegaert and Thomas Salaets, co-chairs (Brookside) Wolfgang Göpel (University of Lübeck) Bob Ward (University of Utah) Ron Ariagno (Stanford) Jon Davis (Tufts University, INC Co-Director) Merran Thomson (Chiesi, Hillingdale Hospital NHS Trust) |
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| Regulatory Challenges in Conducting Trials to Prevent Pre-Term Birth – Mark Turner, chair (Cabin John Boardroom) Olof Rugarn (Ferring Pharmaceuticals) Yosuke Komatsu (GSK) Louise Kenny (University College Cork) Deborah Discenza (PPA) Ralph Bax (EMA) Barbara Wesley (FDA) Tonse Raju (NICHD/NIH) |
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5:00 – 5:30 pm |
Report out on Breakouts – Ronald Portman, chair 5-minute summary from each breakout group |
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5:30 – 5:45 pm |
Role of INC in Pediatric Trial NetworksI-ACT for Children – Edward Connor (PTC, I-ACT) |
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5:45 – 6:00 pm |
Nonclinical Models of Neonatal Therapeutics Susan McCune (FDA; DART committee of ILSI HESI) |
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6:00 pm |
Closing Remarks – Mark Turner (INC Co-Director) | |
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6:30 pm |
Networking Dinner at Bethesda North Marriott Hotel |
Agenda – Day 3, March 29, 2017
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8:00 am – 12:00 pm |
INC Bronchopulmonary Dysplasia Workgroup Meeting |
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8:30 am – 4:30 pm |
INC Data Workgroup Meeting |
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9:00 am – 4:30 pm |
INC Hemodynamic Adaptation Workgroup Meeting |
