Main Summit Sessions Agenda: Day 1

Thursday, September 12, 2019


7:45 AM - 8:30 AM


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.


  • Marla Phillips, Director, Xavier Health, Xavier University


  • 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:

  • Supplier Partnering

  • Post-Market Safety Reporting

  • Digital Health

  • EU MDRs


  • Marla Phillips, Director, Xavier Health, Xavier University

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

9:30 AM - 9:50 AM


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.


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


  • Thinh Nguyen, Director, Office of Combination Products, FDA

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

10:50 AM - 11:50 AM

Successful Practices and Challenges for Supplier Partnering

Suppliers to the combination products industry are faced with challenges that have historically not been experienced when supplying materials for use in traditional pharmaceutical, biological and medical device products. Our expert facilitators will share a real-world case study to demonstrate how to effectively engage your suppliers in the product development process, as well as improvements that still need to be made as combination product processes continue to mature. Since suppliers are experts of the materials they provide, they bring scientific understanding of how their materials impact each constituent component in your product. Additionally, suppliers have recognized that their critical components are being designated as “inactive” when these components are not part of the primary mode of action (PMOA). Don’t miss this opportunity to gain insight on risks that are predominantly unknown across the industry and regulatory agencies, and how you can improve your practices to reduce risk to your patients, products and business.


  • Fran DeGrazio, Vice President, Scientific Affairs & Technical Services, West Pharmaceutical Services


  • Heather Guerin, Ph.D., P.E., Associate Director, Global CMC Regulatory Affairs, Medical Devices and Combination Products, Janssen

  • Meera Raghuram, Director, Regulatory Strategy and Policy, Lubrizol Advanced Materials, Inc and Chair, Regulatory Affairs Committee, IPEC- Americas

11:50 AM - 12:50 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 Implementation

  • Premarket Submissions

  • Digital Health Technologies

12:50 PM - 1:40 PM

EU Medical Device Regulation: Preparing for Implementation

The EU Medical Device Regulation will come into effect in May 2020; however, there remain a number of uncertainties around how this new regulation will affect your combination products. Our expert speakers will provide a general overview of the EU MDRs, while specifically examining the provisions that impact combination products, including Article 117. Don’t miss this opportunity to gain a greater understanding of how changes to the EU medical device regulations impact the future role of Notified Bodies in the review of your products (including single integral combination products) and corresponding revisions to quality systems.


  • Fatemeh Razjouyan, Associate Director, Regulatory Policy, Corporate Regulatory Affairs, BD


  • Mike Barnett, Global Associate Director - Device Quality, AstraZeneca

  • Tim Chesworth, Senior Director Regulatory Affairs - Medical Devices & Combination Products, AstraZeneca

1:40 PM - 2:40 PM

Connected Digital Technologies: An FDA Update on the Evolving Regulatory Landscape

Digital health technologies are a requisite component of healthcare delivery and one that medical device and pharmaceutical companies must manage to be successful. At the same time, the regulatory landscape for how health authorities will regulate digital technologies is in a formative state. Hear directly from leading experts on critical aspects of digital health regulation for combination products, as well as proven practical advice for how to develop technologies in a time when regulatory guidance is still emerging. Walk away with facts and clear steps you can take to advance your organization.


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


  • Kristina Lauritsen, Combination Products Regulatory Advisor, FDA-CDER

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

  • Andrew Yeatts, Combination Product Policy Analyst, FDA-CDRH

2:40 PM - 3:00 PM


3:00 PM - 3:45 PM

SaMD - Software Quality Management Systems for Combination Products

The combination product industry has been largely successful in implementing streamlined quality management systems based on 21 CFR Part 4. However, as companies begin to develop digital health technologies and Software as a Medical Device (SaMD), they may find that their existing quality management system does not comply with applicable regulations. Participants will gain an understanding of software quality management systems and learn recommended methods for lean integration into existing medical device and pharmaceutical quality practices, including ISO 13485.


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


  • Kim Trautman, Executive Vice President, Medical Device International Services, NSF International

3:45 PM - 5:00 PM

Comparability Bridging Studies for Combination Products: Leveraging Current Knowledge

Participants will learn through case studies and panel discussion from FDA representatives about the importance of bridging studies in the development/delivery of new medications to patients. Testing methodologies and data packages will be discussed in providing a risk-based approach to ensure both the drug and device constituent parts are suitably evaluated in the finished combination product. The expert panel will further examine the opportunities for leveraging prior experience (including bench top, clinical studies, or market data) for an established drug or device constituent in combination with a new drug/device.


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


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

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

  • Alan Stevens, Assistant Director, Division of Drug Delivery, General Hospital, and Human Factors, FDA-CDRH

  • John Towns, Senior Research Fellow, Global Regulatory Affairs, Eli Lilly

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.