9:30 am Virtual Networking & Morning Coffee

Device Leader Think Tank

9:50 am Chair’s Opening Remarks & Recap of Day 1

10:00 am How Should the Device Team Anticipate & Prepare for Emerging Pipeline to Accelerate Speed-to-Market with a Patient Centric Approach?

10:20 am Live Q&A – Ask Our Speakers Your Burning Questions

10:30 am Panel Discussion: How Customer Requirements Have Changed How We Package Biologics – From PFS to Autoinjector?

11:10 am Morning Speed Networking & Refreshment Break

11:40 am Jazz’s Journey in Developing a Novel Biologics Device – Thinking Ahead & Putting Patients’ Needs First

  • James Leamon Director, Biologics Device Development, Jazz Pharmaceuticals, Inc

12:00 pm Device Innovation & Challenges to Support Emerging Cell & Gene Therapy

  • Min Wei Former Associate Director, Janssen

12:20 pm Panel Discussion: Change Control to Drive QMRS & Product Progression

  • Alan Golden Principal, Design Quality Consultants, LLC
  • Min Wei Former Associate Director, Janssen
  • James Leamon Director, Biologics Device Development, Jazz Pharmaceuticals, Inc

1:00 pm Working Lunch & Action Groups

Synopsis

Join our action groups to share with your colleagues the challenges you face and be inspired of possible solutions!

Select the action group topic of choice where you can share your thoughts, questions and challenges with fellow participants following the morning presentations

Device Packaging Excellence  Design & Change Control for Combination Products

2:00 pm An Introduction to Microneedles – What, Why and Who?

2:20 pm From Device to Development – How Far Are We from a Commercial Needle-Free Injection?

2:40 pm A Collaborative Approach to Microneedle Development

3:00 pm Live Q&A – Ask Our Speakers Your Burning Questions

3:15 pm Chair’s Closing Remarks & End of Summit