OUR HISTORY
In 2003, the Combination Products Coalition (“CPC” or the “Coalition”) formed with the mission of improving the regulatory environment for combination products. For more than 20 years, the CPC has maintained this focus, leveraging its diverse, cross-industry membership to develop policy positions and engage in advocacy initiatives to address key regulatory issues impacting combination products.
our mission
CPC’s mission is to improve the regulatory environment for combination products. To that end, CPC focuses on developing policy positions and engaging in advocacy efforts on various combination product issues.
our principles
Membership in CPC comes with certain rights and privileges. Among them is the right to have a say in all decisions made by—and activities undertaken by—the Coalition. Specifically:
Membership Control. The decisions and activities of CPC are controlled by the members of CPC. No policy decisions will be made or activities undertaken without agreement of the CPC Steering Committee (“SC”). The SC includes representation from each CPC member company and serves as the governing body of the organization.
Operation by Consensus. In most cases, CPC will seek unanimous agreement on decisions and activities to be undertaken by the Coalition. Any move to allow decision-making by majority rule will require agreement of the Steering Committee.
Diverse Viewpoints. CPC was founded on the belief that development of sound policies on combination products requires the unique perspectives of each of the component areas: drug, device, and biologic. With that in mind, the Coalition includes a diverse group of member companies with diverse viewpoints. This diversity is encouraged and is what differentiates CPC from other industry organizations.
Meetings. CPC’s Steering Committee and Working Groups typically meet virtually to discuss issues and business pending before them. When appropriate, CPC members may meet in person at a convenient location. CPC makes every effort to schedule meetings during times when a majority of CPC members are available to participate. CPC provides notice of virtual and in-person meetings by e-mail. Between such meetings, CPC conducts its business through e-mail and oral communications, unless the Steering Committee agrees otherwise.
OUR WORKING GROUPS
AS OF 2024, CPC HAS 8 WORKING GROUPS THAT DRIVE ADVOCACY WORK IN DEFINED COMBINATION PRODUCT AREAS. THE CPC STEERING COMMITTEE (“SC”) REVIEWS THE WGS ANNUALLY TO ENSURE CONTINUED ALIGNMENT WITH CPC’S STRATEGIC GOALS/PRIORITIES.
· EACH WG IS LED BY A CHAIR WHO IS RESPONSIBLE FOR OPERATION OF THE WG AND REPORTING TO THE SC REGARDING THE WG’S ACTIVITIES.
· EACH WG ALSO HAS AN ASSIGNED ATTORNEY LIAISON FROM Epstein Becker & Green, P.C. WHO ATTENDS ALL WG MEETINGS AND PROVIDES LEGAL SUPPORT TO THE WG.
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Bridging
Chair: Desiree Crisolo, Genentech
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.
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Cross-Labeling and Combined Use
Chair: Jill Lee, Novo Nordisk
There has been significant ambiguity in cross-labeling and what constitutes a cross-labeled combination product, which has affected the 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.
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Digital Health
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.
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Global Postmarket Safety Reporting
Chair: Khaudeja Bano, Genentech
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 pharmacuetical companies, biologics, vaccines and devices. Our scope includes combination products PMSR strategy, regulations, processes and procedures, technology, methodology and best practices.
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Human Factors
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.
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International
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.
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Submissions
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.
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Design and Technical Requirements
Chair: Rumi Young, Novo Nordisk
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, EDDOs and needle safety expectations.
WANT TO see examples of CPC’S PAST ADVOCACY EFFORTS? CHECK OUT OUR ARCHIVES
FREQUENTLY ASKED QUESTIONS (FAQs)
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CPC is led by a Steering Committee (“SC”)—which is comprised of one representative from each CPC Member Company plus the Chairs of our CPC Working Groups ("WG"). As CPC’s governing body, the SC is responsible for establishing the Coalition’s overall strategy and priorities, and reviewing and approving CPC policy positions.
CPC’s WGs, which report to the SC, drive CPC’s advocacy efforts in alignment with the strategic goals/priorities set by the SC.
CPC’s counsel, Epstein Becker & Green, P.C., is responsible for coordination and support of CPC’s activities.
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Monthly Steering Committee Meetings (SC members only)
Working Group Meetings (schedule/cadence set by WG Chairs; typically held on a monthly basis)
Annual In-Person All-Member Meeting (generally in the spring)
Annual In-Person Steering Committee Meeting (held in conjunction with the Annual All-Member Meeting)
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To cover the Coalition’s costs, each member company is billed a monthly fee based on the size of the company:
Companies over one billion dollars in sales: $2,000 per month.
Companies between $50 million and one billion dollars in sales: $1,000 per month.
Companies under $50 million in sales: $300 per month.
Start-up companies: $100 per month.
In addition to fees, member companies may be responsible to pay a share of disbursements and certain other expenses incurred in support of the Coalition. Those expenses typically are allocated equally among member companies; they will only be charged to coalition members if agreed upon by the Coalition.
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For more information, or to join the Coalition, contact Bonnie Odom of Epstein, Becker & Green, P.C. (BOdom@ebglaw.com), who serves as CPC’s General Counsel.