Combination Products Summit Program & Agenda

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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.

September 11, 2017

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Time Description
2:00 PM - 4:00 PM Track 1

Office Hours with FDA

Thinh Nguyen and Barr Weiner are offering to host “Office Hours” with anyone who wants to meet with them.  You have the opportunity to meet with Thinh and Barr for a 15 minute scheduled session at the Xavier University Cintas Center.  They are interested in understanding your concerns and offering to help if possible, so they are making themselves available for you.  This opportunity is possible only for registered attendees of the Combination Products Summit, so after registering, please click here to schedule a time with them.  You may meet with them as an individual, or with other team members who are registered for the summit.  These sessions are based on a first come, first served basis.

8:00 AM - 5:00 PM Track 2

Pre-Conference Workshop: Foundations of Combination Products

In this foundational workshop, participants will be exposed to challenges, expectations and successful practices for management of combination products throughout the total product lifecycle.  Participants will be able to:

  • Understand the intricacies of the US and EU approaches to combination products.
  • Successfully develop combination products by understanding the similarities, differences, and areas of overlap from the key aspects of drug development and device development requirements.
  • Establish a framework to determine what types of post-market changes require what type of regulatory approval.
  • Successfully navigate Post-Market Safety reporting expectations through an understanding of challenges and best practices from across the industry.
8:00 AM - 8:30 AM Track 2

Check-in and Hot Breakfast

Participants will have an opportunity to enjoy a hot breakfast with workshop leaders and their colleagues from across the industry in our comfortable and collaborative setting.

8:30 AM - 8:45 AM Track 2

Welcome and Introductions

Welcome to Xavier University and welcome to the Combination Products Foundations Workshop.  Through our mission of inspiring collaboration, leading innovation, and making a difference, we look forward to making a difference in your life.  Thank you for joining us!

Speakers:

8:45 AM - 9:45 AM Track 2

Setting the Stage

As simple as it sounds, the question of “what is a combination product” is an intricate question filled with many complexities that the workshop leaders will explore with participants.  To set the stage, the US approach to combination products (lead center, role of the Office of Combination Products, Request for Designation, and meetings with FDA) will be compared to the EU approach to combination products (current directives, implications of the new medical device reports, scientific advice, and marketing authorization applications) such that participants will have a clear understanding of what is necessary for a successful global strategy.

9:45 AM - 10:00 AM Track 2

Break

10:00 AM - 11:30 AM Track 2

Combination Product Development

Key aspects of the drug development process and of the device development process will be shared with participants.  Workshop leaders will then examine with participants the areas of overlap that occur in the development process for a combination product, including similarities, differences, and challenges.  (This session will be continued after lunch).

11:30 AM - 12:15 PM Track 2

Lunch

Participants will have an opportunity to enjoy a wonderful lunch while discussing their questions and ideas with workshop leaders and their colleagues in our comfortable and collaborative setting.

12:15 PM - 1:30 PM Track 2

Combination Product Development (continued)

(This session from before lunch is continued here).  Key aspects of the drug development process and of the device development process will be shared with participants.  Workshop leaders will then examine with participants the areas of overlap that occur in the development process for a combination product, including similarities, differences, and challenges.

1:30 PM - 1:45 PM Track 2

Break

1:45 PM - 3:15 PM Track 2

Post-Market Changes for the Combination Product

The differences in post-market change approval requirements for drugs and devices will be assessed as various types of changes are examined.  A framework of understanding will be established that will allow participants to navigate uncertainties in post-market change approvals for combination products.

3:15 PM - 3:30 PM Track 2

Break

3:30 PM - 5:00 PM Track 2

Post-Market Safety Reporting

Expectations, challenges and best practices will be shared with participants related to the post-market safety reporting requirements and expectations related to drug primary mode of action (PMOA) and device PMOA combination products.  Participants will be armed with examples they can apply for successful practices in their organizations.

Speakers:

September 12, 2017

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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 - 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:

  • Formative Human Factor Design
  • Stability and Shelf-life
  • Part 4 System Readiness
  • Post-market Challenges
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: Susan Neadle

10:15 AM - 10:35 AM

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

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 betweeen Quality by Design and Design Controls so your organization can streamline your combination product development approach.

Moderator: Suzette Roan

Speakers:

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

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

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

Speakers:

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.

September 13, 2017

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Time Description
7:45 AM - 8:30 AM

Join us for Breakfast

Join your colleagues for a nice complimentary warm breakfast to jump start Day 2!

8:30 AM - 9:50 AM

Case Studies: Global Regulatory Strategies for Combination Product Registration and Change Management

The session will utilize pre-filled syringe and drug-eluting stent case studies to help participants work through learnings from Day 1 and apply them to real life scenarios. Case studies will come from the FDA cGMP guidance for combination products (Case Studies A and C) participants will work collaboratively to address new challenges related to those scenarios.

Moderator: Suzanne O’Shea

9:50 AM - 10:10 AM

Break

10:10 AM - 11:55 AM

Post-Market Reporting Challenges and Successful Practices for Combination Products

The speaker will simplify the complexities of the Final Rule as it applies to a combination product with a Device and a Drug/Biologic Primary Mode of Action. This deep dive, scenario based discussion will engage participants, leaving them with successful practices and a clear understanding of how to address the challenges facing their own products in the market.

Moderator: Lal Ninan

Speakers:

11:55 AM - 12:40 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:

  • Part 4 Inspection Readiness
  • Post-Market Challenges
  • Global Regulatory Strategies
12:40 PM - 1:55 PM

Inspection Readiness

A panel of FDA and industry experts will share their unique perspectives and experiences preparing for combination product regulatory inspections and associated outcomes. Speakers will discuss specifics on key considerations associated with Part 4 cGMP compliance, challenges encountered, implementation of changes to quality systems and lessons learned. Conference participants will engage in table discussions and share key challenges associated with cGMP Part 4 implementation at their facility.

Moderator: Francis Blacha

2:15 PM - 3:15 PM

Fireside Chat with FDA

In a world of uncertainty as it relates to combination product development, quality system readiness, product approval, evolving regulations and expectations, our FDA panel members will take your questions in an informal, collaborative setting that gets to the heart of your most pressing challenges. Don’t miss this opportunity to engage with FDA and your industry colleagues in a session to remember.

Moderator: Scott Thiel