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)
Dianne Murphy, MD (FDA) (10 min)
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?
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)
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)
Susan Alpert, MD, PhD (Medtronic) (10 min)
Applying Preclinical Data from Adult Devices to Pediatric Device Development
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)
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)
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)
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)