Main Summit Sessions Agenda: Day 2

Friday, September 13, 2019

 

7:45 AM - 8:30 AM    

Breakfast

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


8:30 AM - 8:40 AM    

Day 2 Opening

Participants will feel the Xavier Difference at the purpose driven, action-oriented Combination Products Summit. We will start the day recapping the take away points from Day 1 through the Act-Change-Transfer process that will lead to the development of action plans for your key learnings. We insist that our content is meaningful and impactful, so you can’t help but walk away with practical applications to implement when you return to work!

Moderator:

  • Marla Phillips, Director, Xavier Health, Xavier University


8:40 AM - 9:40 AM    

Post Approval Changes: ICH Q12 and Latest FDA Guidance

Risk-based, predictable expectations regarding reporting requirements for changes to combination product constituents are critical to manage the lifecycle of such products. In this interactive session, participants will gain insights on ICH Q12 and latest FDA Guidance, how to answer the all-important question, “When is a change a design change?”, and how to best manage post-approval changes to your combination products.

Moderator:

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

Speakers:

  • Ashley Boam, Director, Office of Policy for Pharmaceutical Quality, FDA-CDER (invited)

  • Thinh Nguyen, Director, Office of Combination Products, FDA (invited)


9:40 AM - 10:00 AM    

Break


10:00 AM - 11:30 AM    

FDA Approval Pathways for Digital Health Combination Products: What Recent Regulatory Approvals and Rejections Mean for You

Software products are playing a critical role in transforming healthcare globally. Despite this trend, however, the application of software regulatory requirements for determining a viable regulatory pathway is particularly challenging and unclear. During a time when regulatory guidance on digital technologies is emerging for combination products, the best information can often be found by studying examples of recent regulatory approvals and rejections. In this session you will engage in interactive and collaborative exercises exploring case studies based on recent health authority decisions. You will gain an understanding of these recent regulatory decisions, and how you can apply this knowledge to advance your organization.

Moderator:

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

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

Speakers:

  • Krystin Meidell, Manager, Regulatory Affairs CMC Combination Products and Medical, Biogen

  • Chin-Wei Soo, DRSc, Global Regulatory Head, Combination Products, Devices, Digital Health, Genentech, a member of the Roche Group


11:30 AM - 12:30 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 these topics:

  • PostMarket Changes

  • PostMarket Safety Reporting

  • Filing Strategies for OUS



12:30 PM - 12:50 PM

To Your Success!

Advance your organization by preparing key action plans from the conference that will make a difference for you, your organization and the patients you serve.

Moderator:

  • Marla Phillips, Director, Xavier Health, Xavier University


12:50 PM - 1:20 PM

Essential Performance Requirements - Latest FDA and Industry Insights on Identification and Control Strategies

Identifying Essential Performance Requirements and their associated control strategies can be challenging. During this interactive session with FDA and industry experts, you will gain understanding and insight on current regulatory strategies, content requirements, recent health authority requests, and successful practices to help expedite approval of your combination product submission.

Moderators:

  • Francis Blacha, Global Quality Leader – Drug Delivery System Development, Eli Lilly

  • David Shore, Director of Quality, Eli Lilly

Speakers:

  • Jason Lipman, Associate Director, Global CMC Regulatory Affairs, Medical Devices and Combination Products, Janssen

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


1:20 PM - 2:20 PM

Post-Market Safety Reporting – Be Ready for the New Requirements

FDA’s Post-Market Safety Reporting Guidance for Combination Products is currently pending, with an industry-anticipated effective date of 2020. Learn from your colleagues how to proactively align with the general direction of the draft guideline.  These expert leaders will share with you the debates, concerns and opportunities related to industry input on the development of the guideline so you can be prepared for the intent and expectations of FDA. Importantly, learn practical advice on how to ensure your post-market safety program is robust, and you know when and how to effectively report product safety issues.   

Moderators:

  • Inta Buhr, Manager, Regulatory Affairs CMC, Alkermes

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

Speakers:

  • Khaudeja Bano, Head Of Medical Affairs, Abbott Molecular Inc.

  • Melissa Burns, Senior Program Manager, FDA (invited)

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


2:20 PM - 2:40 PM    

Break


2:40 PM - 3:50 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:

  • Susan Neadle, Head, Combination Products CoP and Sr. Director, Global Value Chain Quality Design, Johnson & Johnson

Speakers:

  • Ashley Boam, Director, Office of Policy for Pharmaceutical Quality, FDA-CDER (invited)

  • Melissa Burns, Senior Program Manager, FDA (invited)

  • Irene Chan, Deputy Director, Division of Medication Error Prevention and Analysis, FDA-CDER (invited)

  • Kristina Lauritsen, Combination Products Regulatory Advisor, CDER (invited)

  • Thinh Nguyen, Director, Office of Combination Products, FDA (invited)

  • Bakul Patel, MSEE, MBA, Director, Division of Digital Health, Office of Science of Technology, FDA-CDRH (invited)

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

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


3:50 PM - 4:00 PM    

Conference Close

Thank you for joining us! We look forward to advancing the industry with you throughout the year as you implement the successful practices you learned at the Xavier Combination Products Summit 2019!

Moderator:

  • Marla Phillips, Director, Xavier Health, Xavier University