About

What is the CPC?

A group of leading companies in the drug, device and biologics industries, the CPC works to improve the regulatory environment for combination products by developing and advocating policy positions on regulatory issues affecting combination products. The unique cross-industry membership of the CPC enables diverse thinking that leads to sound policies. This diversity distinguishes the CPC from other industry organizations.

Mission

The Coalition’s Mission is to improve the regulatory environment for combination products. To that end, the Coalition focuses on developing and advocating policy positions on issues affecting combination products.

Principles

With membership in the Coalition come 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:

  1. Membership control. The decisions and activities of the Coalition will be controlled by the members of the Coalition. No policy decisions will be made or activities undertaken without agreement of the Coalition.
  2. Operation by consensus. In most cases, we 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 Coalition members.
  3. Diverse viewpoints. The Coalition is 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 the Coalition from other industry organizations.
  4. Meetings. The Coalition typically will meet by teleconference to discuss issues and business pending before it. When appropriate, the Coalition may meet in person at a convenient location. Every effort will be made to schedule meetings during times when the majority of Coalition members are available to participate. Notice of teleconferences and in-person meetings typically will be provided by e-mail. Between such teleconferences and meetings, the Coalition will conduct its business through e-mail and oral communications, unless the Coalition agrees otherwise.
  5. Coordination. Bradley Thompson will be responsible for coordinating all Epstein Baker & Green, PC and EBG Advisor services involved in representing the Coalition, including all communications with members of the Coalition.
  6. Leaving the Coalition. Any Coalition member is free to leave the Coalition at anytime, for any reason. If at any point your company decides to leave the Coalition simply let us know. Your company will not be billed for the following month, or from that point forward.

Structure

The CPC Steering Committee, which includes representation from each CPC member company, serves as the governing body of the organization.

The Coalition’s advocacy work is driven by our working groups and their respective leadership (see detail below), which report to the CPC Steering Committee. These working groups are reviewed annually to ensure alignment with CPC member company priorities.

Bridging Working Group
Chair: Krystin Meidell, Biogen
Vice-Chair: Megan Doyle, Amgen

Description: 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.

Cross-Labeling and Combined Use Working Group
Chair: Anurag Patel, Merck

Description: 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.

Digital Health Working Group
Chair: Ryan McGowan, AstraZeneca
Vice-Chair: Chin-Wei Soo, Genentech/Roche

Description: 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.

Global Postmarket Safety Reporting Working Group
Chair: Khaudeja Bano, Amgen
Vice-Chair: Susan Neadle, Amgen

Description: By evaluating industry experiences, case studies and solutions, we seek to align on best practices regarding combination product post-marketing safety 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 Post-market 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.

Human Factors Working Group
Chair: Sherri Biondi, AstraZeneca
Vice-Chair: Karl Saldanha, Genentech/Roche

Description: 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.

International Working Group

Chair: Tim Chesworth, AstraZeneca
Vice-Chair: Stephanie Kelly, CSL Behring

Description: 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.

Submissions Working Group

Chair: Suzette Roan, Sanofi
Vice-Chair: Sue Holmes, GlaxoSmithKline

Description: 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.

History

In 2002, FDA established an Office of Combination Products (OCP) as required by SEC. 204 of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). Until that time, FDA had operated in a largely silo environment where the centers for drugs, biologics and medical devices operated very independently and with little coordination. Unfortunately, industry to was fairly silent in that any work done on combination products was done by a trade group for one particular type of therapeutic product, and combination products were simply an afterthought.

About that time, many in industry began to realize that the future of therapeutic interventions was not limited to narrow categories of medical devices and drugs and biological products.  True innovation, that opened up the doors to greatly enhanced therapeutic value, depended on combining those technical disciplines.  However, companies largely were also siloed, focusing on mainly one type of product.

The Combination Products Coalition was formed in 2003, to start breaking down those silos, and consider a more holistic vision of appropriate combination product regulation.  The goal was always to achieve balance, balance between innovation and public safety, and balance among importing the historical approaches of medical devices, pharmaceuticals and biological products.  The group was formed with very careful consideration of ensuring that all the different sectors of the combination product industry were represented in order to best ensure that balance.  In this way, the industry as a whole could offer unified input on policy issues being considered by the newly formed Office of Combination Products and FDA.

Over the years the coalition grew to the point where it started to include certain special areas of focus, particularly with regard to injector systems and companion diagnostics.  Today the coalition maintains its laser like focus on combination products, but works with many stakeholders at FDA from OCP to the three centers, Congress, and other policymaking arms of the government.