PREVIOUS MEETINGS

PDIF #4: Using Real-World Evidence to Accelerate Pediatric Device Development: Challenges and Future Directions

Hosted by The UCSF-Stanford Pediatric Device Consortium

Thursday, September 23rd, 2021 | 11:00am - 12:30pm PT (2:00pm - 3:30pm ET)

Speakers & Panelists:

  • Felipe Aguel, PhD -- Deputy Director, Office of Clinical Evidence & Analysis, Center for Devices and Radiological Health, U.S. Food and Drug Administration

  • Sanket Dhruva, MD -- Assistant Professor of Medicine, UC San Francisco and San Francisco Veterans Affairs Medical Center

  • Brandon Dottin-Haley -- Chief Business Development Officer, Sonavi Labs

  • Christian Howell -- Vice President and General Manager, Medical Devices & Diagnostics Group, Aetion

  • Anitha John, MD -- Medical Director of the Washington Adult Congenital Heart Program, Children’s National Hospital

  • Jonathan McElwee -- Senior Manager of Regulatory Affairs, AtriCure

  • Vasum Peiris, MD -- Chief Medical Officer and Director for Pediatrics and Special Populations, Center for Devices and Radiological Health, U.S. Food and Drug Administration

  • Erika Torjusen, MD -- Director of the Rare Pediatric Disease, Humanitarian Use Device, and Pediatric Device Consortia Grant programs, Office of Orphan Products Development, U.S. Food and Drug Administration

  • Nancy Yu -- CEO, AllStripes

Agenda:

  • Welcome and Introductory Remarks - Hanmin Lee, MD, Stefano Rensi, PhD & Elizabeth Gress, MPA (11:00am PT / 2pm ET)

  • FDA Perspective: Overview of RWE @ FDA - Felipe Aguel, PhD (11:08am PT / 2:08pm ET)

  • RWE in the Startup World: 3 Snapshots - Moderator: James Wall, MD (11:17am PT / 2:17pm ET)

  • Panel Discussion - Moderator: Stefano Rensi, PhD (11:48am PT / 2:48pm ET)

  • Audience Q&A - Moderator: Janene Fuerch, MD (12:13pm PT / 3:13pm ET)

  • Closing Remarks and PDIF #5 Announcement - Chester Koh, MD (12:28pm PT / 3:28pm ET)


View and download a detailed version of the agenda here.

Learn more about the event and speakers by viewing the event brochure.

PDIF #3: Focused Ultrasound for Pediatric Indications

Hosted by The National Capital Consortium for Pediatric Device Innovation

Thursday, July 22nd, 2021 | 2:00pm - 3:30pm ET

Hosted by The National Capital Consortium for Pediatric Device Innovation

Thursday, July 22nd, 2021 | 2:00pm - 3:30pm ET


Speakers:

  • Jessica Foley, PhD — Chief Scientific Officer, FUS Foundation

  • Michael Anderson, MBA, FAAP, FCCM, FAARC — Senior Advisor, Children's National Hospital and US Department of Health and Human Services

  • Roger Packer, MD — Senior Vice President of the Center for Neuroscience and Behavioral Medicine, Children’s National Hospital

  • Arjun Desai, MD — Chief Strategic Officer, Insighttec

  • Karun Sharma, MD — Director, Interventional Radiology, Children's National Hospital

  • Arun Menewat, MD — Chairman and CEO, Profound Medical

  • Francesca Joseph, MD — Co-investigator, National Capital Consortium for Pediatric Device Innovation, Children’s National Hospital

  • Gordon Schatz, JD — President, Schatz Reimbursement Strategies, LLC

  • Mary Daymont, MSN — Vice President of Revenue Cycle and Care Management, Children’s National Hospital

Agenda:

  • Welcome and Introductory Remarks (2:00pm - 2:05pm)

  • Keynote Fireside Chat - Jessica Foley and Michael Anderson (2:05pm - 2:15pm)

  • Case study #1: Osteoid Osteoma (panel discussion and Q&A) (2:15pm - 2:50pm)

  • Case Study #2: DIPG (panel discussion and Q&A) (2:50pm - 3:25pm)

  • Closing Remarks and date of the next Forum (3:25pm-3:30pm)

Learn more about the topic and speakers here.

PDIF #2: Health Equity Challenges in Pediatric Medical Device Development

Hosted by The West Coast Consortium for Technology & Innovation in Pediatrics

Thursday, May 20th, 2021 | 3:00pm - 4:30pm ET

Speakers:

  • Maurice Jones, JD, MA CEO, OneTen

  • Patti White, MBACEO, Hemex Health

  • Vasum Peiris, MD, MPH, FAAP, FACC, FASEChief Medical Officer and Director – Pediatrics and Special Populations, CDRH, FDA

  • Kate Garrett, BSManaging Partner, Sonder Capital

  • Hanna Song, PhDChief Diversity Officer, Children's Hospital Los Angeles

  • Gordon Schatz, JD — President, Schatz Reimbursement Strategies, LLC

  • Charisee Lamar, PhD, MPH - Director, Office of Health Equity, NICHD

Agenda:

  • Introductory Remarks — Juan Espinoza, MD (3:00pm-3:05pm)

  • Framing Health Equity - Maurice Jones, JD, MA (3:05pm-3:15pm)

  • Case Study: The Gazelle Sickle Cell Disease Diagnostic Device Patti White, MBA (3:15pm-3:25pm)

  • Moderated Panel Discussion (3:25pm-4:00pm)

  • Audience questions addressed to the panelists (4:00pm—4:25pm)

  • Closing Remarks and date of the next Forum (4:25pm-4:30pm)

PDIF #1: Biomaterial Challenges in Pediatric Prosthetic Heart Valves Development

Hosted by the Pennsylvania Pediatric Medical Device Consortium

Thursday, March 11th, 2021 | 3:00pm - 4:30pm EST

Speakers:

  • Pediatric heart valve prostheses: Addressing unmet needs — Jonathan Chen, MD (Chief, Cardiothoracic Surgery, CHOP)

  • New synthetic biomaterials for pediatric heart valves — William Wagner, PhD (Director, McGowan Institute, Univ. of Pittsburgh)

  • Preclinical development of a novel heart valve prosthesis for pediatrics — Narendra Vyavahare, PhD (Professor, Dept. of Bioengineering, Clemson University)

  • Pediatric prosthetic heart valve trials in the USMartijn Cox, PhD (Chief Technology Officer, Xeltis)

  • Materials regulation for pediatric heart valvesScott McNamee, PhD (Materials Engineer, Office of Product Evaluation and Quality, CDRH, FDA)

Agenda:

  • Introductory Remarks—Vasum Peiris, MD, CDRH, FDA (3pm-3:05pm)

  • Panelists Introductory Remarks (3:05pm-3:20pm)

  • Questions (pre-submitted) addressed to the panelists (3:20pm-4:00pm)

  • Audience questions addressed to the panelists (4:00pm—4:25pm)

  • Final remarks, Post Forum activities, and topic and date of the next Forum (4:25-4:30pm)