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Combination Products Summit 2023

Combination Products Summit 2023

Agenda

November 28, 2023 @ 8:00 am

5:10 pm

Workshop

7:00 am – 8:00 am ————— Breakfast
8:00 am – 10:30 am ———— Notified Body Opinion Workshop – Experiences And Lessons For Combination Products In EU
10:00 am – 2:00 pm ———— FDA Office Hours
10:30 am – 10:50 am ———— Break
10:50 am – 2:20 pm ———— Combination Products Risk Management: Integration Of ICH Q9(R1) And ISO 14971:2019
11:50 am – 12:50 pm ———— Lunch
2:20 pm – 2:40 pm ————— Break
2:40 pm – 5:10 pm ————— Risk Management Application In Post-Market Safety & Other PMSR Hot Topics
5:10 pm – 5:30 pm ————— Q&A Session

For more details, check out session information by clicking this link!

November 29, 2023 @ 12:00 am

7:00 pm

Networking Reception

November 29, 2023 @ 7:00 am

8:00 am

Breakfast

Join your colleagues from around the globe as we kick off the Combination Products Summit with a complimentary hot breakfast!

November 29, 2023 @ 8:00 am

8:20 am

Let’s Make A Difference!

Welcome to the Combination Products Summit, and welcome to the Office of Combination Products, FDA! This purpose-driven conference will lead you to actionable learning and implementation plans.

Moderator

Timothy W. Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative

November 29, 2023 @ 8:20 am

9:05 am

The Solutions Exchange

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 various challenges that will be discussed throughout the Summit while tying your ideas to the hopes of a patient whose life is depending on YOU.

Moderators

Fran DeGrazio, Executive Advisor, Kymanox

Susan Neadle, Principal Consultant and President, Combination Products Consulting, LLC

November 29, 2023 @ 9:05 am

10:05 am

From The Desk Of The Office Of Combination Products: Strategic Priorities & 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.

Speakers

James Bertram, Director of the Office of Combination Products (OCP), FDA

John “Barr” Weiner, Associate Director for Policy in FDA’s Office of Combination Products (OCP), FDA

Moderator

Timothy W. Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative

November 29, 2023 @ 10:05 am

10:25 am

Break

November 29, 2023 @ 10:25 am

11:25 am

Global Harmonization Opportunities In Combination Products

As regulatory bodies around the globe increasingly recognize the need to establish regulatory frameworks for combination products and other combined use systems, the implemented regulations and practices can diverge. What is the path forward to harmonize combination products and combined use experience? This panel discussion will bring in the perspectives from convergence under IMDRF and pharmaceutical expectations under ICH.

Speakers

Stiina Aarum, Scientific Officer, Scientific Advice and Protocol Assistance, European Medicines Academy(EMA)

Theresa Jeary, Principal Technical Specialist, Medicinal & Biologics, BSI

Joo Hee Kim, Professor, Regulatory Strategy center for Combination Products (RSCP), Ajou University

Mike Wallenstein, Global Head Regulatory Medical Devices, Combination Products & Precision Medicine, Novartis

John “Barr” Weiner, Associate Director for Policy in FDA’s Office of Combination Products (OCP), FDA

Moderators

Susan Neadle, Principal Consultant and President, Combination Products Consulting, LLC

Khaudeja Bano, VP Combination Product Quality, Amgen

November 29, 2023 @ 11:00 am

12:25 pm

Platform Drug-Delivery Devices: Regulatory And Technical Considerations

Regulatory and technical perspectives for the following topics will be explored during this session: (a) definition of platform for drug-delivery devices, (b) set realistic expectation of “Device Platform” Approach, (c) approaches to develop these platforms, and (d) approaches to apply platform data (molecule-agnostic) and the need to create molecule-specific data. Join in the discussion and help us find a common understanding of what a “platform” means and the implications!

Speaker

James Bertram, Director of the Office of Combination Products (OCP), FDA

Jiaying Shen, Distinguished Scientist, Merck

Kent Abrahamson, Director, Combination Product and Device Development, Abbvie

Patricia Love, Deputy Director, FDA’s Office of Combination Products (OCP), FDA (Invited)

Moderator

Chin-Wei Soo, Global Regulatory Head – CMC/Devices and Combination Products, Genentech

November 29, 2023 @ 1:25 pm

2:25 pm

Lunch

Sit with FDA officials, speakers, industry experts, and your colleagues at tables dedicated to topics that are important to you! Enjoy the discussion while sharing a meal together!

November 29, 2023 @ 1:25 pm

2:25 pm

Evolution Of Essential Performance Requirements

For the past several years, pharmaceutical and device constituent manufacturers have encountered FDA requests for Essential Performance Requirements (EPRs) in verification testing, clinical validation, manufacturing control strategies, and bridging strategies. Despite their prevalence and perceived importance, FDA has not issued a formal definition, and ISO 11608-1 released a competing concept called Primary Function. This panel will discuss the inception of EPRs, benefits, and their relationship with Primary Function.

Speakers

Matthew Ondeck, Senior Manager Regulatory Affairs, Regeneron Pharmaceuticals

Subhi Saadeh, Sr. Manager – Combination Products QA, Gilead Sciences

Ashley Boam, Director, Office of Policy, Center for Drug Evaluation and Research (CDER), FDA

Sarah Mollo, Combination Products Analyst, Center for Devices and Radiological Health (CDRH), FDA

Alan Stevens, Global Head of Complex Devices and Drug Delivery Systems, RA CMC Devices, AbbVie

Moderator

Rumi Young, Director, Regulatory Policy, BD

November 29, 2023 @ 2:25 pm

3:25 pm

Use Of Non-Integral Medical Devices In Medicinal Product Clinical Studies

Join us as we examine the challenging regulatory requirements for pursuing use of non-integral Medical Devices in global medicinal product clinical studies, including submission considerations and the different regulatory pathways. A Combination Products Coalition proposal for regulatory considerations that uses a risk-based framework will be presented. Then interact with an industry case study for an on-body delivery system that explores the global regulations and guidance driving the different regulatory submission strategies, while providing practical learnings based on the challenges encountered.

 

Speakers

Jonathan Amaya-Hodges, Director, Technical Services, Sutton Creek

Suzette Roan, Associate VP, Head of GRA Devices, Sanofi

Moderator

Jason Lipman, Senior Director, Global Regulatory Affairs, Device and Combination Products, Sanofi

November 29, 2023 @ 3:25 pm

3:45 pm

Break

November 29, 2023 @ 3:45 pm

4:45 pm

Use Of Emerging Digital Health Technologies For Combination Products

Digital health technologies (DHT) are increasingly deployed by combination product and medicine manufacturers for a range of uses in clinical programs and medicine development. Areas such as remote patient monitoring, digital endpoints, and use of artificial intelligence and machine learning (AI/ML) in medicine discovery and development are helping to provide patients with new technologies faster and with less burden both in clinical and commercial phases. In recent years, health authorities have begun to establish early frameworks for how they will oversee and assess these technologies. We will cover recent health authority guidance for digital health technologies and explore applicability to combination product and medicine development.

Speakers

Katie Chowdhury, Director, Global Regulatory Affair, Emerging Technologies, Digital Medical Devices, & Combination Products, AbbVie

MiRa Jacobs, Acting Assistant Director, Digital Health Policy, Digital Health Center of Excellence at FDA

Kristina Lauritsen, Combination Products Regulator, Center for Drug Evaluation and Research (CDER), FDA

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

Andrew Yeatts, Combination Product Policy Analyst, Center for Devices and Radiological Health (CDRH), FDA

Moderators

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

Ryan Hoshi, Director, Regulatory Policy and Intelligence at AbbVie

November 29, 2023 @ 4:45 pm

5:30 pm

Next-Generation Combination Products

Emerging innovations (like cell-gene therapy and regenerative medicine products) can provide cures for previously untreatable conditions, which will change the face of the industry. Join us as we look forward to these emerging technologies and discuss regulatory approaches to adapt to the fast-paced dynamics of technology evolution!

Speaker

Dan Groszmann, Director of Engineering, Amgen

Geoff Hamilton, Chief Executive Officer, Stemson Therapeutics

Steven Oh, Deputy Office Director, Office of Cellular Therapy and Human Tissue, Center for Biologics Evaluation and Research (CBER), FDA

James Wabby, Global Head, Regulatory Affairs (CoE) – Emerging Technologies, Devices, and Combination Products & Volwiler Senior Research Industry Fellow – Regulatory Science, Abbvie

Moderators

Susan Neadle, Principal Consultant and President, Combination Products Consulting, LLC

Sandy Boyd, Independent Consultant

November 30, 2023 @ 12:00 am

8:00 am

Breakfast

Join your colleagues from around the globe as we kick off the Combination Products Summit with a complimentary hot breakfast!

November 30, 2023 @ 8:00 am

8:15 am

Opening Day 2

Welcome and Summary of Highlights of Day Before

Moderator

Timothy W. Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative

November 30, 2023 @ 8:15 am

9:15 am

Navigating Combination Product Pathways: Industry Experiences And FDA’s Role

Depending on the primary mode of action (drug, device or biologic) a combination product is assigned to an FDA center (CDER, CBER and CDRH) for premarket review and regulation. FDA’s Office of Combination Product provides guidance to industry in the process but there are also Center liaisons known as product jurisdiction officers that play a role in combination product designation and policy.   For these products, industry experts will share real-world experiences and best practices associated with FDA engagement pathway(s) throughout the product life cycle. The roles of FDA jurisdiction officers play in the inter-center consult request (ICCR), policies and regulatory decision making will be explored.

Speakers

Chelsea O’Connell, Director, Global & Regulatory and R&D Policy at Amgen

Kristina Lauritsen, Combination Product Policy Advisor, Center for Drug Evaluation and Research (CDER) FDA

Sarah Mollo, Combination Products Analyst, Center for Devices and Radiological Health (CDRH), FDA

Winifred Wu, President and Principal Advisor, Strategic Regulatory Partners, LLC

Moderators

Chin-Wei Soo, Global Regulatory Head – CMC/Devices and Combination Products, Genentech

Rumi Young, Director, Regulatory Policy, BD

November 30, 2023 @ 9:15 am

10:05 am

Building Clarity To Address Regulatory Challenges Of On-Body Delivery

On-body delivery systems are an area of increasing interest and development. Over the last few years more of these combination products have been approved for use in the market. This has raised questions from various members in the industry about regulatory and technical challenges and best practice expectations going forward. This session will be an opportunity to level-set the audience on the basic technical and regulatory differences between injection and infusion versions and conduct an interactive panel session to answer industry questions on the subject.

Speakers

Carolyn Dorgan, Director, Technical Services, Suttons Creek

Sujith Kallur, Regulatory Affairs Lead, Wearable Injectors, BD Medical Pharmaceutical Systems

Juliane Lessard, Director, Division of Drug Delivery, General Hospital and Human Factors, Office of Gastro-Renal, ObGyn, General Hospital, and Urology Devices, Center for Devices and Radiological Health (CDRH), FDA

Krishna Venugopalan, Vice President – Combination Products, Drug Delivery and Sterile Packaging, AbbVie

Moderator

Fran DeGrazio, Executive Advisor, Kymanox

November 30, 2023 @ 10:05 am

10:24 am

Break

November 30, 2023 @ 10:25 am

11:40 am

Part 1 – Bridging And Leveraging Human Factors Data In Drug-Device Combination Products Development. Part 2 – Q&A And Discussion Of Final Guidance Of Application Of HF Engineering Principles For Combination Products

In recent years, we have witnessed a remarkable shift in global regulatory agencies and industries, recognizing the immense value and importance of Human Factors Engineering. This field, which focuses on understanding how people interact with products, systems, and environments, has become an integral part of ensuring the safety, effectiveness, and usability of various products and services. We have witnessed firsthand the increasing investment in this discipline. While the growth in Human Factors Engineering is undoubtedly positive, it also presents us with new challenges. With the rise in demand for efficiency and cost-effectiveness, there is a parallel need to strike a balance—a balance between conducting thorough studies and not overburdening our budgets. Part 1 of this session aims to explore the strategies for achieving effective and efficient human factors work – how to bridge and leverage human factors data in drug-led combination product development.

In September 2023, FDA issued the final guidance of Application of Human Factors Engineering Principles for Combination Products. In part 2, we will be engaging in questions and answers during this session. This guidance finalizes the February 2016 draft version entitled Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development.

Speakers

Irene Chan, Deputy Director, Division of Medication Error Prevention and Analysis, Center for Drug Evaluation and Research (CDER), FDA

Carrie O’Donel, Principal Device Engineer, Teva Pharmaceuticals

Jen Soosaar, Director of Human Factors, Core Human Factors, Inc

Colin Roscoe, Principal Human Factors Scientist, Teva Pharmaceuticals

Moderator

Jiaying Shen, Distinguished Scientist, Merk

November 30, 2023 @ 11:40 am

12:40 pm

Navigating The New Frontier In Cybersecurity: Technical And Regulatory Considerations For Managing Cybersecurity Risks For Combination Products

This session will discuss FDA’s current thinking and expectations on addressing cybersecurity risks and also provide industry perspectives on the technical and regulatory cybersecurity considerations for combination products.

As combination products become increasingly integrated with device technologies that are connected to the internet, hospital networks, and mobile applications, they can become more vulnerable to cybersecurity threats. A 2022 report by the FBI indicated that 53% of connected medical devices had critical cybersecurity vulnerabilities. In addition, according to the FDA, cybersecurity threats to the healthcare sector have become more frequent and more severe, carrying increased potential for clinical impact. To address these emerging cybersecurity threats, the recently passed Consolidated Appropriations Act of 2023 includes several cybersecurity provisions, including new premarket requirements for manufacturers of cyber devices and related systems.

Speakers

Edison Alvarez, Sr. Director, Regulatory Strategic Planning for Cybersecurity,

Aftin Ross, Acting Deputy Director – Division of All Hazards Response, Science & Strategic Partnerships, Center for Devices and Radiological Health (CDRH), FDA

Fubin Wu, Co-founder and President, GessNet Safety Engineering

Moderator

Ryan Hoshi, Director, Regulatory Policy and Intelligence at AbbVie

November 30, 2023 @ 12:40 pm

1:40 pm

Lunch

November 30, 2023 @ 1:40 pm

2:45 pm

FDA & Health Authority Fireside Chat

What is at the top of your mind regarding combination products? Join our FDA Fireside Chat to address your questions! In a world of uncertainty as it relates to combination product development, quality systems readiness, product approval, post-market requirements, evolving regulations and expectations, our FDA panel will address your questions anonymously or in real time in an informal, collaborative setting to get to the heart of your most pressing challenges. Don’t miss the opportunity to engage with FDA to hear their comments during the 2023 Combination Products Summit Fireside Chat!

We want to hear from you!

Submit your non-confidential questions here

All submitted questions will be compiled and asked anonymously of the FDA during the Summit. Questions will also be collected throughout the Summit, and there will be an opportunity to ask questions real-time as well.

Speakers

James Bertram, Director, Office of Combination Products

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

Ashley Boam, Director, Office of Policy, Center for Drug Evaluation and Research (CDER), FDA

Kristina Lauritsen, Combination Products Regulator, Center for Drug Evaluation and Research (CDER), FDA

Juliane Lessard, Director, Division of Drug Delivery, General Hospital and Human Factors, Office of Gastro-Renal, ObGyn, General Hospital, and Urology Devices, Center for Devices and Radiological Health (CDRH), FDA

Andrew Yeatts, Combination Product Policy Analyst, Center for Devices and Radiological Health (CDRH), FDA

Stephanie Shapley, Senior Advisor, Office of Combination Products, FDA

Sarah Mollo, Combination Products Analyst, Center for Devices and Radiological Health (CDRH), FDA

Moderators

Susan Neadle, Principal Consultant and President, Combination Products Consulting, LLC

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

November 30, 2023 @ 2:45 pm

3:00 pm

Summit 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 Combination Products Summit 2023!

Speaker

Timothy W. Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative

This conference IS co-sponsored by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services. The contents are those of the presenters and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. government.

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.

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