2019 Annual INC Neonatal Scientific Workshop
May 1-3, 2019
Hyatt Regency Bethesda, Maryland
Meeting Objectives:
- Share regulatory perspectives on developing safe and effective therapies for neonates.
- Provide foundational knowledge on innovative, regulated medicines development and factors influencing Go/No-Go decisions throughout the development pipeline.
- Discuss endpoints for clinical trials to evaluate pain medications.
- Address neonatal opioid issues through optimizing trial design for Neonatal Opioid Withdrawal Syndrome (NOWS) and Neonatal Abstinence Syndrome (NAS).
- Apply digital technologies to developing endpoints for neonatal trials.
- Review the progress and plans of INC workstreams, including 1) validating the neonatal adverse event scale; 2) developing neonatal terminology; 3) standardizing safety reporting; 4) constructing a communications toolkit for use in NICUs; 5) establishing blood pressure values and methodologies.
Day 1, May 1, 2019
| Morning Sessions for Individual Workgroups | ||
|
8:00 am – 12:00 pm |
INC Hemodynamic Adaptation Workgroup Meeting Heike Rabe & Janis Dionne, Co-chairs Room – Old Georgetown |
|
|
8:00 am – 12:00 pm |
INC Communications Workgroup Meeting Christina Bucci-Rechtweg & Jennifer Degl, Co-chairs Room – Congressional |
|
|
12:00 – 1:00 pm |
Lunch | |
| Full Workshop Commences – Room Regency I & II | ||
|
1:00 – 1:05 pm |
Welcome Joseph Scheeren, President and CEO, Critical Path Institute |
Slide presentations
|
|
1:05 – 1:15 pm |
INC at Four Years: Neonatal Growth and Predicted Long-Term Outcomes Susan McCune, Director, Office of Pediatric Therapeutics, FDA |
|
|
1:15 pm – 2:30 pm |
Educating the Neonatology Community on the Drug Development Process Ron Portman (Novartis, INC Co-Director) Session I: Setting the Scene Robert Ward (U-Utah) |
|
|
2:30 – 3:00 pm |
Coffee Break | |
|
3:00 – 4:25 pm |
Session II: Harnessing the Science Christina Bucci-Rechtweg (Novartis), Chair Norman Barton (Takeda) |
|
|
4:25 – 5:30 pm |
Session III: Addressing Neonatal Needs within the Current Environment Ed Connor (I-ACT for Children), Chair Panel Discussants to include: |
|
| Networking Dinner | ||
|
6:00 – 9:00 pm |
DINNER at Bacchus of Lebanon for all Workshop Participants 7945 Norfolk Ave., Bethesda |
|
Day 2, May 2, 2019
| Regency I & II | ||
|
8:00 – 8:15 am |
Challenges of Developing Analgesics and Treatments for NOWS in the Setting of the Opioid Crisis Sharon Hertz, Director of Anesthesia, Analgesia, and Addiction Products (CDER/FDA) |
Slide presentations
|
|
8:15 – 10:00 am |
Endpoints for Evaluating Pain Treatments for Neonates John Van den Anker (Children’s National Medical Center and University of Basel Children’s Hospital) and Lily Mulugeta (CDER/FDA), Co-chairs Lisa Wiltrout (CDER/FDA) |
|
|
10:00 – 10:30 am |
Coffee Break | |
|
10:30 am – 12:30 pm |
Optimizing Clinical Trials for Neonatal Opioid Withdrawal Syndrome (NOWS) and Neonatal Abstinence Syndrome (NAS) Gerri Baer (OC/FDA) and Jon Davis (Tufts U and INC Co-Director), Co-chairs Hendree Jones (U-North Carolina) |
Slide presentations
|
|
12:30 – 1:30 pm |
Lunch | |
|
1:30 – 3:00 pm |
Applying Digital Technologies to Developing Endpoints for Neonatal Trials Mark Turner (U-Liverpool and INC Co-Director) and Prakesh Shah (Mt. Sinai and U-Toronto), Co-chairs Joseph Frassica (Philips) |
Slide presentationsJoseph Frassica presentation
|
|
3:00 – 3:30 pm |
Coffee Break | |
|
3:30 – 4:45 pm |
INC Workstream Updates Ronald Portman (Novartis, INC Co-Director), Chair Hemodynamic Adaptation (Stephen Bremner – Brighton Sussex Medical School, Simin Baygani – Eli Lilly and Company) Data: Terminology (Michael Padula, Children’s Hospital of Pennsylvania) Adverse Event Severity Scale (Karel Allegaert – University of Leuven) Standardizing Safety Reporting (Gerri Baer – FDA, Jon Davis – Tufts U) Communications (Christina Bucci-Rechtweg – Novartis, Jennifer Degl – Speaking for Moms and Babies) |
|
|
4:45 – 5:00 pm |
Closing Remarks Jon Davis (Tufts U and INC Co-Director) |
|
|
5:00 pm |
Full Workshop Adjourns | |
Day 3, May 3, 2019 – for Individual Workstreams
|
8:00 am – 12:00 pm |
Safety Jon Davis, Karel Allegaert, Robert Ward, and Gerri Baer, Co-Chairs Room – Old Georgetown
|
|
8:00 am – 12:00 pm |
Neonatal Terminology Mike Padula & Mark Turner, Co-chairs Room – Congressional |
