12/10/2010: CSRC Pediatric CV Drug and Devices Safety Think Tank

12/10/2010: CSRC Pediatric CV Drug and Devices Safety Think Tank

Pediatric Thinktank

10 December, 2010

White Oak Facility, FDA Headquarters

Silver Springs, MD

07:30-08:00  Registration and Breakfast

08:00-08:15  Introductory Session:   

Welcome:  Norman Stockbridge, MD, PhD (FDA) (5 min)

Collaboration, Cardiac Safety and Children: The CSRC View: Mitchell Krucoff, MD (CSRC) (10 min)

08:15-09:00 Session I:  Plenary Session:  Pediatric Cardiovascular Safety in New Drug and Device Development

Moderators: Jennifer Li, MD (Duke), Matthew Killeen, PhD (Industry)

  

Drug Development, Surveillance and Pediatric Cardiovascular Safety:  Where Are We and Where Do We Need to Go?

Dianne Murphy, MD (FDA) (10 min)

 

Device Development, Surveillance and Pediatric Cardiovascular Safety:  Where Are We and Where Do We Need to Go?  

Susan Cummins, MD (FDA) (10 min)

Pediatric Therapeutics and Cardiovascular Safety- An Academic/Clinical Overview

Vicki Vetter, MD (Children’s Hospital of Philadelphia) (10 min)

Open Panel Discussion (20 min) : Speakers plus  John Finkle, MD (GSK), Lisa Mathis, MD (FDA), Jodi Lemacks (Patient Representative), Mitchell Krucoff, MD (CSRC)

09:00-10:30 Session II:  The Relevance of Preclinical & Adult Drug Safety Markers to Pediatric Cardiovascular Safety

      Moderator:  Rick Turner, PhD (Quintiles)

Early Preclinical Cardiac Safety Models:  Are They Relevant to Pediatric Safety?

Gary Gintant, PhD (Abbott) (10 min)

Preclinical ECG & Cardiac Biomarker in Adult Animals: Are They Relevant to Pediatric Safety?

Matthew Killeen, PhD (Industry) (10 min)

 

Regulatory Perspective in Assessing Pediatric Preclinical Cardiac Safety:  Pitfalls & Cardiac Safety Objectives for New Drugs

Elizabeth Hausner, DVM (FDA) (10 min)

 

Interpreting Adult Human Thorough QT Studies:  Are They Relevant to Pediatric Safety?

Hao Zhu, PhD (FDA) (10 min)

The Developmental Spectrum From Neonates to Adolescents:  Pitfalls & Cardiac Safety Objectives for New Drugs & Device

Melissa Tassinari, PhD (FDA) (10 min)

 

Open Panel Discussion (40 min) Lead Discussant:  Jennifer Li, MD (Duke)  Panel: Speakers Wrap Up (5 min): Brian Berridge, DVM, PhD, DACVP (HESI)

10:30-10:45         Break

10:45-12:15  Session III: Cardiovascular Safety in Non-Cardiac Drugs: Lessons Learned & Present Needs   

Moderator: John Finkle, MD (GSK)

 

An Overview of Pediatric Oncology: Clinical Trials Experience With Cardiac Safety

Peter Adamson, MD (Children’s Hospital of Philadelphia) (10 min)

Psychotropic & Stimulant Medications: Cardiovascular Drug Safety in Children

Josephine Elia, MD (Children’s Hospital of Philadelphia) (10 min)

 

A Tale of Two Profiles: The Hemodynamic Effects of Atomoxetine Under Clinical Observation vs. Intensive Monitoring

Charles M. Beasley, Jr. MD (Eli Lilly) (10 min)

 

Open Panel Discussion (50 min) Lead Discussant:  Anne Dubin, MD (Stanford) Panel:  Speakers plus TBA Wrap Up:   Daniel Bloomfield, MD (Merck) (5 min)                                                                                                               

 

12:15-13:15  Working Lunch:  Ethical Considerations of Pediatric Clinical Trials: An Open Roundtable

Moderator: Mitchell Krucoff, MD (CSRC)

Panelists:

 FDA OC View: Robert Nelson, MD, PhD

FDA CDER View: Norman Stockbridge, MD, PhD

FDA CDRH View: Ashley Boam, MSBE; Hina Pinto, MS

NIH View: Nancy Bridges, MD

Academic View: Vicki Vetter, MD

Academic View: Jennifer Li, MD

Patient Perspective: Jodi Lemacks

13:15-13:30: Special Address 

13:30-15:05  Session IV:  Pediatric Device Design: Preclinical & Clinical Safety Evaluation    

Moderators: Vicki Vetter, MD (Children’s Hospital of Philadelphia), Ashley Boam, MSBE (FDA)

An Overview of Pediatric Heart Failure, Dysrhythmias & Structural Heart Disease Device Trials Experience

Susan Alpert, MD, PhD (Medtronic) (10 min)

Applying Preclinical Data from Adult Devices to Pediatric Device Development

Fernando Aguel (FDA) (10 min)

Clinical Device Issues:

Anne Dubin, MD (Stanford) (10 min)

 

Pediatric Device Design: Preclinical & Clinical Safety Evaluation

Natalia Trayanova (John Hopkins) (10 min)

 

Open Panel Discussion (50 min) Lead Discussant:  Susan Cummins, MD (FDA) Panel:  Speakers plus Christopher Almond, MD, PhD (Boston Children’s) Wrap Up:  Susan Cummins, MD (FDA) (5 min)

 

15:05–15:15        Break

 

15:15-16:15  Session V:  Challenges of Clinical Trial Design   

Moderators: Mitchell Krucoff, MD (CSRC), Bram Zuckerman, MD (FDA)

An Overview of Pediatric Heart Failure, Dysrhythmias & Structural Heart Disease Clinical & Clinical Trials Experience

Jennifer Li, MD (Duke) (10 min)

 

Challenges of Designing Drug Trials & Comparing Adult and Pediatric Trials

Karen Kuehl, MD (Cardiocore) (10 min)

Developing Drugs for Pediatric Populations with Heart Failure, Dysrhythmias & Structural Heart Disease: An FDA View of Objectives & Pitfalls – Industry Perspective

Joseph Horrigan, MD (GSK) (10 min)

Developing Drugs for Pediatric Populations with Heart Failure, Dysrhythmias & Structural Heart Disease:  An FDA View of Objectives & Pitfalls

Lisa Mathis, MD (FDA) (10 min)

 

Open Panel Discussion  (20 min) Lead Discussant:  Brian McCrindle, MD (Sickkids) Panel:  Speakers plus Susan Alpert, MD, PhD (Medtronic), Kathy Jenkins (Children’s Hospital of Boston) Wrap Up:  Ashley Boam, MSBE (FDA) (5 min)  

 

16:15-17:15 Session VI: Post Market Surveillance of Cardiovascular Events Caused by Medical Products

Moderators:  Danica Marinac Dabic,MD, PhD (FDA), Theressa Wright, MD (Eli Lilly)

Key Challenges for Pediatric Cardiovascular Drug & Device Safety in Real World Practice

Ann McMahon, MD (FDA) (10 min)

 

Key Challenges for Pediatric Cardiovascular Drug & Device Safety in Real World Practice:  FDA Overview

Tom Gross (FDA) (10 min)

  

Open Panel Discussion (30 min) Lead Discussant:  TBA (Industry) Wrap Up:  Matthew Killeen, PhD (Industry)

 

17:15-18:00         Open Panel Roundtable:  Priorities & Next Steps

Moderators:  Mitchell Krucoff, MD (CSRC), Norman Stockbridge, MD, PhD (FDA)