Agenda | September 22, 2019

  • 8a - 8:30a

    Registration and Breakfast
  • 8:30a – 9a

    Welcome
    Kolaleh Eskandanian, PhD, MBA | Children's National Medical Center
    Janet Trunzo | AdvaMed
    David Wessel, MD | Children's National Medical Center
    Anthony Sandler, MD | Children's National Medical Center
  • 9a – 9:45a

    Opening Keynote
    Melinda Richter
    Global Head of JLABS, Johnson & Johnson Innovation
  • 10:a – 12:00p (Break at 11:00a)

    “Make Your Medical Device Pitch for Kids!” Competition
  • 12p – 1:15p

    Lunch and Startup Showcase
  • 1:15p-1:45p

    Legislative and Advocacy Updates
    Moderator: Tara Federici | AdvaMed
    Susan Sweat | Cornerstone Government Affairs
    Tonya Kinlow | Children's National Medical Center
  • 1:45p-2p

    The Amplatzer Piccolo™ Occluder Story
    Lisa Becker | Divisional Vice President, Regulatory Affairs, Abbott Structural Heart
  • 2p – 2:45p

    Device and Drug Trials: Apples and Oranges?
    Moderator: Pam Simpkins, MBA | Johnson & Johnson
    Laura Mauri, MD | Medtronic
    Eric Stone, MBA | Velano Vascular
    Christina VanderPluym, MD | Boston Children's Hospital
    Francesca Joseph, MD | Children's National Medical Center
    Sandi Siami, MPH | HealthCore/NERI
  • 2:45p – 3p

    Break
  • 3p – 3:45p

    Novel Methodologies and Alternatives to Clinical Trials in Small Populations
    Moderator: Tony Blank | Infinity Biomedical
    Martha Wang, PhD | University of Maryland A. J. Clark School of Engineering
    Sanket Dhruva, MD | UCSF
    Robbert Zusterzeel, MD, PhD, MPH | NESTcc
    Vasum Peiris, MD | FDA
    Susan Alpert, MD | SFA Consulting
  • 3:45p-4:30p

    Hope or Hype? Shining a Light on Digital Health and Software as a Medical Device for Kids
    Moderator: Lester Schultheis, MD, PhD | University of Maryland A. J. Clark School of Engineering
    Janene Fuerch, MD | Stanford University Medical Center
    Bakul Patel, MSEE, MBA | CDRH/FDA
    Zach Rothstein, JD | AdvaMed
    Hemant Virkar | Digital Infuzion
  • 4:30p – 5:15p

    Closing Keynote
    BioTalk with Rich Bendis
    Vasum Peiris, MD | Chief Medical Officer, Pediatrics and Special Populations, CDRH/FDA
  • 5:30p

    Closing Reception & Winner Announcement