Research Ethics and Policy Series (REPS): "Regulatory Pearls and Pitfalls of Early Phase, High-Risk Clinical Trials in Pediatrics" led by Amanda DiNofia, MD, MSCE
12:00pm - 1:00pm • Hybrid: RCH B102AB, Richards Bldg., 3700 Hamilton Walk (and virtual via Zoom)
2025-01-14 12:00:00 2025-01-14 13:00:00 America/New_York Research Ethics and Policy Series (REPS): "Regulatory Pearls and Pitfalls of Early Phase, High-Risk Clinical Trials in Pediatrics" led by Amanda DiNofia, MD, MSCE Regulatory Pearls and Pitfalls of Early Phase, High-Risk Clinical Trials in Pediatrics Amanda DiNofia, MD, MSCE Attending Physician, Cancer Center Children’s Hospital of Philadelphia Amanda DiNofia, MD, is an Attending Physician in the Cancer Center and a member of the Center Childhood Cancer Research at Children's Hospital of Philadelphia. Talk Objectives: - Review rationale for and mechanism of CAR T cell therapy - Review early efficacy of CAR T cell therapy in pediatric B ALL - Discuss the regulatory burden of serving as sponsor for early phase, high-risk clinical trials - Understand differences in regulatory expectations between adult and pediatric and academic and industry clinical trials - Describe the regulatory approaches to a New Drug Application with the FDA for a pediatric indication Lunch provided. Streaming available via Zoom. Hybrid: RCH B102AB, Richards Bldg., 3700 Hamilton Walk (and virtual via Zoom) Penn Medical EthicsRegulatory Pearls and Pitfalls of Early Phase, High-Risk Clinical Trials in Pediatrics
Attending Physician, Cancer Center
Children’s Hospital of Philadelphia
Amanda DiNofia, MD, is an Attending Physician in the Cancer Center and a member of the Center Childhood Cancer Research at Children's Hospital of Philadelphia.
Talk Objectives:
- Review rationale for and mechanism of CAR T cell therapy
- Review early efficacy of CAR T cell therapy in pediatric B ALL
- Discuss the regulatory burden of serving as sponsor for early phase, high-risk clinical trials
- Understand differences in regulatory expectations between adult and pediatric and academic and industry clinical trials
- Describe the regulatory approaches to a New Drug Application with the FDA for a pediatric
indication
Lunch provided. Streaming available via Zoom.