| 9:00 |
Welcome Mara L Becker, MD, MSCE Duke Clinical Research Institute (DCRI) |
| 9:05 | Brief Overview of the Pediatric Trials Network Kanecia Zimmerman, MD, MPH DCRI |
| 9:15 | INCLUDE Project Overview Melissa Parisi, MD, PhD Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| 9:25 | Clinical Overview: Clinical variability and Therapeutic Challenges in individuals with Down syndrome Priya Kishnani, MD Duke University Medical Center |
| 9:40 | Q & A – Open discussion |
| Session | Community Engagement and Readiness |
| 9:45 |
Community Advocacy Perspective: Working with Advocacy Partners to Advance Clinical Trials in Individuals with Down syndrome Ashley Helsing Adrian Forsythe National Down Syndrome Society Tavrick Lawless Jacob Murasko Marla Murasko Carol Nye Sara Nye NDSS DS-AMBASSADORS ® |
| 10:05 | Individual/Family Perspective: How Can We Engage Families Meaningfully for Current and Future Research? Michelle Pfeiffer Matthew Schwab Michelle Schwab Emily Mondschein Gigi’s Playhouse |
| 10:25 | DS Connect: Connecting Families to Research Opportunities that INCLUDEs Them Sujata Bardhan, PhD NICHD |
| 10:45 | Moderated Q&A Session with stakeholders Moderator: Maria Stanley, MD University of Wisconsin-Madison Panelists: Julie Hajewski University of Wisconsin-Madison Sujata Bardhan, PhD NICHD NDSS DS-AMBASSADORS ® Gigi's Playhouse |
| 11:15-11:30 | BREAK |
| Session | Lessons Learned/ Best Practices from POP02 and PTN |
| 11:30 |
Lessons Learned/Best practices from the Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POP) study Elena Soler, MPH DCRI |
| 11:40 | POP02 Down syndrome Cohort: Lessons Learned and Looking Forward Kate Pawlowski Boston Children’s Hospital Jessica L. Van Bree, BS University of Wisconsin-Madison |
| 12:10 | Q & A – Open discussion |
| Session | Down syndrome Protocol and Future Considerations |
| 12:15 | ADHD in children with Down syndrome Anna Esbensen, PhD Cincinnati Children’s |
| 12:35 | Protocol Discussion: Guanfacine for Hyperactivity in Children with Down Syndrome (HYPEbeGONE_DS) Mara Becker, MD, MSCE DCRI |
| 12:55 | Q&A and Feedback on the protocol Moderator: Jenny Jackman DCRI Panelists: Mara Becker, MD, MSCE Kylie Opel, JD DCRI Ravinder Anand The Emmes Company |
| 1:15-1:30 | Wrap up/adjourn – Next Steps Mara Becker, MD, MSCE DCRI |
*BPCA=Best Pharmaceuticals for Children Act; DCC = Data Coordinating Center; PTN= Pediatric Trials Network