Chair: Desiree Crisolo, Biogen

Comparability studies for combination products, including the bridging of data from combination products that employ different device components for the same drug or biologic and the same device component across different drugs and biologics, is often required as manufacturers bring products through development to commercial market. The CPC Bridging Working Group seeks to understand the interactions between drug and device changes and develop industry positions on bridging topics to engage FDA, preferably through public forums, to clarify study designs in the establishing comparability of drug/device combination product presentation(s). These bridging study designs include identifying established like-drug attributes and/or delivery device platforms, where the leveraging of prior product experience and knowledge is appropriate in lieu of new studies needing to be performed.

Chair: Jill Lee, Novo Nordisk

There has been significant ambiguity in cross-labeling and what constitutes a cross-labeled combination product, which has affected industry’s ability to innovate in various areas where FDA-regulated products are used together (including “combined use”). The CPC Cross-Labeling Working Group is focused on developing an industry position on this topic and engaging FDA to facilitate clarity on the definition of cross-labeled combination products and the regulatory expectations for both these and “combined use” products.

Chair: Ryan McGowan, AstraZeneca

Vice-Chair: Karl Saldanha, Genentech/Roche

As the area of digital health grows, FDA is re-evaluating the appropriate level of oversight and regulation. It is important for industry to stay abreast of current FDA thinking. The CPC Digital Health Working Group seeks to advocate for consistent and predictable development and submission requirements for investigational and commercial digital health combination products and aims to present a unified industry position on combination product digital health-related topics.

Chair: Khaudeja Bano, Amgen

By evaluating industry experiences, case studies and solutions, we seek to align on best practices regarding combination product post-marketing safety and related global topics. We also seek to present a unified industry position to health authorities in response to evolving global post-marketing safety rules and guidance for combination products. The Postmarket Safety Reporting Working Group provides a balanced “Voice of Industry” with representation from pharma, biologics, vaccines and devices. Our scope includes: combination products PMSR strategy, regulations, processes and procedures, technology, methodology and best practices.

Chair: Sherri Biondi, AstraZeneca

The expectations for Human Factors work in combination product development has been evolving for many years. The Human Factors Working Group advocates for appropriately-scoped human factors programs along with well-timed and actionable FDA feedback. Specifically, we focus on clarity in summative study designs, early data-based feedback on instructions for use materials and a framework for platform validation.

Chair: Subhi Saadeh, Gilead

The global regulation of combination products is rapidly changing, therefore it is important for industry to monitor and maintain awareness of this evolving landscape – this is a key aspect of the International Working Group. In addition, as the CPC has a well-established track record of successful combination product advocacy, the International Working Group aims to use that CPC knowledge and experience to collaborate with and shape the regulatory environment via dialogue and exchange of information. The objective is to achieve global alignment that will benefit industry, regulators, and most importantly, patients.

Chair: Chelsea O’Connell, Amgen

Uncertainty and inconsistency around the content, structure, requirements and expectations for investigational, marketing and post-approval submissions creates a significant burden for industry. The CPC Submissions Working Group is a cross-industry group that collaborates to develop proposals for consistent and predictable submission requirements and seeks to engage with FDA to advocate for these positions.

Chair: Rumi Young, BD

The Design and Technical Requirements Working Group focuses on advocating for clarity and consistency around the underlying science and technical requirements required for submissions to FDA, including, for example, EPRs and needle safety expectations.