Xavier Combination Products Summit 2017 Agenda Overview
Day 1: Tues., September 12


7:45AM - 8:30AM

Breakfast

Join your colleagues for a complimentary warm breakfast to jump start your day!


8:30 AM - 8:45 AM

Let's Make a Difference!

Welcome to the Summit and welcome to Xavier University.  This purpose-driven conference will lead you to actionable learning and implementation plans.

Moderator: 

  • Marla Phillips, Xavier University

Speakers: 

  • Thinh Nguyen, FDA
  • Marla Phillips

8:45 am - 9:30 am

The Solution Xchange

Start your day with solutions! This fast paced, engaging session draws out your experience and ideas by having you work collaboratively with your colleagues to address the challenges that will be discussed throughout the conference, while tying your ideas to the hopes of a patient whose life is depending on you. Topics will include successful practices related to:

  • Formative Human Factor Design
  • Stability and Shelf-life
  • Part 4 System Readiness
  • Post-Market Challenges

Speaker: 

  • Marla Phillips, Xavier University

9:30 AM - 10:15 AM

Office of Combination Products - Strategic Priorities and Action

FDA’s Office of Combination Products serves as a liaison between industry and the necessary FDA Centers on the most pressing challenges faced by the Combination Products Industry. Learn firsthand what is being addressed by FDA now, and what is planned for the future on traditional and complex products.

Moderator: 

  • Scott Thiel, Navigant Consulting

Speakers: 

  • Thinh Nguyen, FDA
  • John “Barr” Weiner, FDA

10:15AM - 10:35AM

Break


10:35 AM - 11:35 AM

Global Regulatory Strategies for Combination Product Registration and Change Management

In this informative session, the speakers will provide insight on global regulatory expectations and best practices for registration and post-approval changes to drug and device-led combination products.

Moderator:

  • Suzanne O’Shea, Navigant Consulting

Speakers: 

  • Rick Chapman, Biogen
  • Jason Lipman, Johnson & Johnson

11:35 AM - 12:35 PM

Lunch Networking by Topic

Sit with FDA officials, speakers, industry experts and your colleagues at tables dedicated to topics that are important to you. Enjoy the discussion with others who share your passion on the following topics:

  • Human Factor Studies
  • Stability and Shelf-Life Successful Practices
  • Verification and Validation

12:35 PM - 1:35 PM

Drug vs. Device vs. Combination Product Development: A Foundation

A level-set discussion on the differences between drug development and device development will provide the foundation for combination product development understanding. The speaker will then expand on the similarities and differences between Quality by Design and Design Controls so your organization can streamline your combination product development approach.

Moderator:

  • Suzette Roan, Biogen

Speaker:

  • Susan Neadle, Johnson & Johnson

1:35 PM - 2:20 PM

Practical Stability and Shelf-Life Successful Practices and Considerations

The panel of FDA and industry leaders across pharma and device will discuss and share insight on practical approaches to managing the challenges related to stability and shelf-life for a combination product.

Moderator:

  • Susan Neadle, Johnson & Johnson

Speakers:

  • Ashley Boam, FDA - CDER
  • Steve Holcroft, Johnson & Johnson
  • John McMichael, FDA – CDRH
  • Alberto Velez, Accelerated Product Convergence

2:20 PM - 2:40 PM

Break


2:40 PM - 3:55 PM

Risk Management and Formative Human Factor studies (ISO 14971)

Robust Human Factor study design based on sound risk management principals is the key to successful combination product development and approval. Participants will work through challenges at their tables and share successful practices in a discussion led by industry thought-leaders.

Moderator:

  • Francis Blacha, Eli Lilly

Speakers:

  • Valerie Fenster, Amgen
  • Sara Waxberg McNew, Eli Lilly

3:55 PM - 5:00 PM

Verification, Validation and Summative Human Factor Testing

Discussions on successful verification and validation practices, including formative and summative Human Factor testing, will be facilitated through round table discussions. Learn from FDA and industry thought-leaders on how to set your product up for success.

Moderator:

  • Scott Thiel, Navigant Consulting

Speaker:

  • Scott Thiel

5:00 PM - 7:00 PM

Networking Reception

After the summit sessions, benefit from open dialog while enjoying drinks and hors d’oeuvres. You and your colleagues can continue to share ideas with Strategic Committee Members, speakers and each other in a pleasant, informal setting.