9:00 am Virtual Networking & Morning Coffee

9:30 am Chair’s Opening Remarks & Recap of Day 1

Device Leader Think Tank

9:40 am Timely Launch: What Does a World Class Device Engineering Team Need to Look Like & How Can We Ensure Speed-to-Patient?

  • Paul Roussel Senior Director – Combination Products , Kiniksa Pharmaceuticals

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

11:00 am Morning Refreshment Break

11:30 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

11:50 am Device Innovation & Challenges to Support Emerging Cell & Gene Therapy

  • Min Wei Former Associate Director, Janssen

12:10 pm Panel Discussion: Change Control to Drive QMRS & Product Progression

  • Alan Golden Principal, Design Quality Consultants, LLC

1:15 pm Lunch

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

3:30 pm Chair’s Closing Remarks & End of Summit