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

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.

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.

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.

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.

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!

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!

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.

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.

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.

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!

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

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.

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.

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.

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.

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

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!