For your convenience, the Xavier Combination Products Summit presentations are loaded onto this page as they are received from the presenters, unless a presenter has requested that their presentation not be posted. In keeping with Xavier’s conservation commitment, printed versions of presentations will not be available at the conference. If you have any questions, please contact Heather Harwood, Director, Art & Communications, at harwoodh@xavier.edu.


Digital Health Technologies for Combination Products

Presenters:

  • Steven W. Badelt, Ph.D., Managing Partner and Founder, Suttons Creek, Inc.

  • Ryan McGowan, Director, Digital Devices and Combination Products, AstraZeneca

  • Gretchen Vandal, Director, Device Regulatory Affairs - Digital Health / Software, Sanofi


Global Regulatory Strategies for Combination Products

Presenters:

  • Tim Chesworth, Senior Director Regulatory Affairs, AstraZeneca

  • Girish Kumar, Ph.D., Product Specialist & Medical Device Auditor, MHS, TÜV SÜD America

  • Demetra Macheras, Director, Regulatory Policy and Intelligence, AbbVie


GMP and Control Strategies

Presenters:

  • Melissa Burns, Senior Program Manager, Office of Combination Products

  • Susan Neadle, Head, Combination Products CoE and Sr. Director, Design-to-Value and Product Quality Management, Johnson & Johnson

  • Rahul Patil, Reliability Engineering, Eli Lilly and Company

  • David Shore, Site Quality Director - Devices, Eli Lilly

  • Alan Stevens, Captain, Branch Chief, General Hospital Devices Branch, DAGHICD, ODE, CDRH


Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development

Presenters: 

  • Bjorg K. Hunter, Device Engineering Manager, GSK


Interactive Premarket Submission Solutions – Content, Strategies, Health Authority Requests, and Challenges

Presenters:

  • Irene Chan, Commander, Deputy Director, DMEPA, OSE, CDER

  • Laurie Graham, Acting Director, Division of Internal Policies and Procedures, OPPQ, OPQ, CDER

  • Suzette Roan, Senior Director, Global Regulatory Affairs, Sanofi

  • Alan Stevens, Captain, Branch Chief, General Hospital Devices Branch, DAGHICD, ODE, CDRH


Office of Combination Products - Strategic Priorities and Action

Presenters:

  • Thinh Nguyen, Director, Office of Combination Products, FDA

  • John “Barr” Weiner, Associate Director for Policy, Office of Combination Products, FDA


Post-Approval Change Management, Part 1

Presenters:

  • Ashley Boam, Director, Office of Policy for Pharmaceutical Quality, CDER

  • Chelsea O'Connell, Regulatory Affairs Manager, Amgen

  • Alan Stevens, Branch Chief General Hospital Device Branch, FDA-CDRH


Post-Approval Change Management, Part 2

Presenters:

  • Ashley Boam, Director, Office of Policy for Pharmaceutical Quality, CDER

  • Chelsea O'Connell, Regulatory Affairs Manager, Amgen

  • Alan Stevens, Branch Chief General Hospital Device Branch, FDA-CDRH


Post-Market Safety Reporting for Combination Products – Past, Present and Future

Presenters:

  • Khaudeja Bano, Head Of Medical Affairs at Abbott Molecular

  • Melissa Burns, Senior Program Manager, Office of Combination Products

  • John “Barr” Weiner, Associate Director for Policy, Office of Combination Products, FDA