Combination Products Summit Agenda: Day 1
Wednesday, September 12, 2018

 

7:45 AM - 8:30 AM

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 summit will lead you to actionable learning and implementation plans.

Moderator:

  • Marla Phillips, Director, Xavier Health, Xavier University

Speakers: 

  • Thinh Nguyen, Director, Office of Combination Products, FDA
  • Marla Phillips, Director, Xavier Health, Xavier University

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 summit, while tying your ideas to the hopes of a patient whose life is depending on you. Topics will include successful practices related to:

  • cGMP & Control Strategy
  • Post-Market Safety Reporting
  • Global Regulatory Landscape (beyond FDA)
  • Submissions

Moderator:

  • Marla Phillips, Director, Xavier Health, Xavier University

Speakers: 

  • Phil Harris, Senior Quality Associate, Alkermes
  • Marla Phillips, Director, Xavier Health, Xavier University

9:30 AM - 9:50 AM

Break


9:50 AM - 10:50 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: 

  • Steve Binion, Director Regulatory Policy and Technology Corporate Regulatory Affairs, BD

Speakers:

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

10:50 AM - 12:20 PM

Global Regulatory Strategies for Combination Products

International regulatory requirements are demanding increased attention from combination product developers and manufacturers. There are also a number of emerging markets that are increasing their regulatory expectations for medical devices and combination products. The European Union Medical Device Regulation (EU MDR) is requiring significant resources to interpret and implement.  This session will provide insight into this evolving global landscape and additionally, what actions should be considered to prepare for the EU MDR’s impact on combination products.

Moderators: 

  • Demetra Macheras, Director, Regulatory Policy and Intelligence, AbbVie
  • Kirsten Paulson, Senior Director, Global CMC - Medical Device Lead, Pfizer

Speakers:

  • 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

    12:20 AM - 1:20 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:

    • EU MDR Impact
    • Premarket Submissions
    • Digital Health Technologies

    1:20 PM - 2:20 PM

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

    Combination product premarket submission content requirements are continuously evolving. This session will focus on current regulatory strategies, content requirements, recent health authority requests, and challenges to help expedite approval of your CP submission. This will be an interactive session with FDA perspectives provided.

    Moderator: 

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

    Speakers:

    • Irene Chan, Commander, Deputy Director, DMEPA, OSE, CDER
    • Laurie Graham, Acting Director, Division of Internal Policies and Procedures, OPPQ, OPQ, CDER (invited)
    • Suzette Roan, Senior Director, Global Regulatory Affairs, Sanofi
    • Alan Stevens, Captain, Branch Chief, General Hospital Devices Branch, DAGHICD, ODE, CDRH (invited)

    2:20 PM - 2:40 PM

    Break


    2:40 PM - 3:40 PM

    Digital Health Technologies for Combination Products

    Digital heath products hold significant promise for improving both the investigation and commercial use of combination products, however the regulatory classification of and quality system requirements applicable to digital health technologies can be unclear and often change dramatically across marketing regions. This session will provide an overview of global digital health regulation as well as opportunities to benchmark regulatory and quality practices with fellow manufacturers.

    Moderator: 

    • Ryan McGowan, Associate Director, Combination Products, AstraZeneca

    Speakers:

    • Steven W. Badelt, Ph.D., Managing Partner and Founder, Suttons Creek, Inc.
    • Ryan McGowan, Associate Director, Combination Products, AstraZeneca
    • Gretchen Vandal, Director, Device Regulatory Affairs - Digital Health / Software, Sanofi

    3:40 PM - 5:00 PM

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

    This session will include interactive dialog with FDA regarding the intent and expectations outlined in the guidance, followed by an industry perspective on best practices implemented across the industry to comply with the Final Rule as it applies to a combination product approved as a Device and a Drug/Biologic. This scenario based discussion will give participants a clear understanding of how to address the challenges facing their product in the market. The industry speaker will decipher the guidance as proposed, and will include a walk through the organizational, infrastructure setup, and process updates using an example each for a device product and a drug/biologic.

    Moderator: 

    • Khaudeja Bano, Head Of Medical Affairs at Abbott Molecular

    Speakers:

    • 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

    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 FDA, committee members, speakers and each other in a pleasant, informal setting.