Combination Products Summit Program & Agenda from 2016


Inspiring Collaboration…

•Feel the Purpose-Driven nature of this Summit as soon as you enter the room.
•Expect orchestrated engagement with your peers across the industry on topics you are passionate about.
•Find attendees openly sharing their expertise to help advance the industry in collaboration with regulators.
•Work side-by-side with regulators to deepen the understanding on both sides of challenges and opportunities.

Leading Innovation…
•Identify solutions that will protect your patients around the world, your company brand, and your business.
•Talk about the “elephant in the room” to get to the real pain that plagues our industry.
•Learn what you didn’t know you didn’t know!  Walk away with real solutions.
•Hear directly from speakers who passionately challenge the status quo.

Making a Difference…
•Work through real working models that can improve the reliability of your product…today.
•Learn how you can be part of the solution.
•Understand who your stakeholders are so you can implement meaningful and sustainable change.
•Leave the conference armed with action plans that are orchestrated throughout the Summit and solidified before you leave.

November 2, 2016

Time Description
7:45 AM - 8:30 AM

Join us for Breakfast!

Join your colleagues from around the country for a nice warm complimentary 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

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:

  • Navigating the Regulatory Approval Pathway
  • Clinical Trial Design to Bridge drug delivery systems
  • Managing Combination Product FDA Inspection Expectations
  • Gaining approval for Post-Market Changes
Moderator: Marla Phillips

9:30 AM - 9:50 AM


9:50 AM - 10:50 AM

Office of Combination Products - Strategic Priorities and Actions

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: Steve Binion

10:50 AM - 12:00 PM

Developing Successful Global Clinical Trials Strategies for your Product Approval

One of the Top 3 challenges identified by the Combination Products Coalition is determining the clinical and non-clinical data required to support the successful bridging of one drug delivery system to another.  Attendees will also gain insight on FDA data requirements and industry best practices as they explore options through the Summit Case Study scenario.

Moderator: Suzanne O’Shea

12:00 PM - 1:00 PM


1:00 PM - 2:15 PM

Cross-Labeling Challenges and Successful Practices

Cross-labeled combination products raise many unique issues, such as adverse event reporting, the need for mutually conforming labeling (and how to achieve it), and whether the two products comprise a combination product at all.  Although many cross-labeled products may not technically be combination products, such as companion diagnostics and related drugs, they share many of the same regulatory questions.  Challenges in achieving a consistent and transparent policy on the regulation of cross-labeled products have led to difficulties in developing products that may be cross-labeled or that raise similar regulatory questions to cross-labeled combination products.  Attendees will gain insight into these challenging issues, and hear the current thinking on how best to resolve them as they continue exploring the Summit Case Study.

Moderator: Steve Binion

2:15 PM - 2:30 PM


2:30 PM - 3:45 PM

Digital Health

As the world of health care innovation evolves at a staggering rate so as to give every person instant access to their own health information, FDA and industry work together to protect patient safety and security by unraveling what falls under regulatory authority and what doesn’t. This session explores the blurred lines of digital health regulation through real world examples and the continuation of the Summit Case Study in an interactive and engaging session.

Moderator: Scott Thiel


3:45 PM - 5:00 PM

Optimizing Your Inter-Center Combination Product Review.

FDA will provide insight on the current state and future state map from their “Lean Process Mapping” initiative, as well as the success experienced through the “Consensus Voice” work being done by the FDA Combination Products Policy Council.

As FDA shares examples of cases addressed through this work and resolution of those cases, attendees will have an opportunity to provide feedback.

Moderator: Suzanne O’Shea


5:00 PM - 7:00 PM

Networking Reception

Complimentary appetizers and refreshments will be served as attendees continue building new relationships with their colleagues from across the industry.

November 3, 2016

Time Description
7:45 AM - 8:30 AM

Join us for Breakfast!

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

8:30 AM - 10:00 AM

Industry Successful Practices for Navigating Post-Market Changes

FDA and the Combination Products Coalition will address successful practices related to establishing pathways for post-market changes related to the device constituent part of a combination product.  The attendees will work through examples in the advanced case study, discuss outcomes and establish next steps and action plans.

Moderator: Steve Binion

10:00 AM - 10:20 AM


10:20 AM - 11:45 AM

Post-Market Safety Reporting case examples for implementation

Successful practices developed by the industry related to “use cases” will be explored with the attendees, as well as progress made by FDA on Post-Market Safety reporting requirements.

Moderator: Steve Binion


11:45 AM - 12:45 PM


12:45 PM - 1:30 PM

Holistic Risk Profile Assessment

Through the use of a heat map, attendees will learn how to overlay the drug and device component risks to see the overall risk of the total combination product.  Attendees will apply their learnings to the case study product in a hands-on exercise that will enable them to implement this tool and methodology when they return to work.

Moderator: Marla Phillips

1:30 PM - 2:45 PM

Inspection Readiness/Expectations

Industry leaders will share how they prepare for combination product inspections against Part 4 regulations while managing the device and drug investigator expectations.  They will discuss how they have successfully bridged the device and pharma worlds, hurdles they have come across, and lessons learned.  Attendees will be engaged in table discussions to articulate the challenges they face for collaborative dialog with the industry and FDA representatives on the panel.

Moderator: Marla Phillips

2:45 PM - 3:00 PM

To Your Success!

Thank you for joining us, but we insist that you leave with action plans that will enable you to make a difference in your organization and for the patients you serve.  Work with your colleagues on turning your learning into a full action plan.

Moderator: Marla Phillips