Syneos Health Consulting REMS Leadership Summit Insights ...

Syneos Health Consulting

REMS Leadership Summit Insights Series

Part 1 of 3 Observer Status

On October 4, 2017, REMS executives from various organizations met in New Orleans for a programagnostic forum discussing emerging trends such as observer status, waiver-granted REMS programs and simultaneous shared REMS development and operations. This three-part series details these emerging trends in the REMS landscape.

Summary

Some shared Risk Evaluation and Mitigation Strategies (REMS) programs allow companies to "observe" in advance of joining as a program Participant. This Observer role can be helpful both to the current program Participants and to the companies with Observer status but is not without its complications. In this post, we define the Observer role, discuss considerations for potential Observers as well as program Participants, and conclude with some potential best practices that might be helpful to companies designing multiple sponsor REMS programs.

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Observers Defined

In a shared REMS program, a Participant is a program sponsor with an approved application (NDA or ANDA) who has executed a REMS Program Agreement (RPA) or Memorandum of Understanding (MOU) to become full member of a consortium of sponsors.

An "Observer" is a company with a pending application (NDA or ANDA) that is permitted access under a Confidential Disclosure Agreement (CDA) in order to follow the progress of the program through participation in meetings, access to documents, and inclusion in day-to-day correspondence. Observers are typically not permitted to vote in program decisions. While this definition is generally applicable, there is no current industry definition which applies across all shared REMS programs.

Part Observer 1 Status

Meeting Attendance and Program Correspondence

Observers might be permitted to attend all meetings and be copied on all correspondence or limited to a subset of meetings and communications that Participants determine are appropriate to the Observer role in that program.

Costs

In some cases, joining a program as an Observer may incur potentially refundable charges, associated with

gaining access to the program and associated materials.

Document Access

Observers may have access to the full host of program documentation

or only to a subset relevant to their role. For example, some documentation that contains the program's intellectual property may be restricted to Participants only.

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Considerations for Observers and Participants

Part Observer 1 Status

Onboarding

Whether joining a program first as an Observer or immediately as a Participant, all sponsors can benefit from participating in onboarding activities. Generally conducted by the Program Management Office (PMO), onboarding provides an overview of program background, structure, rules, and tools that enable the sponsor to understand how the REMS program functions, contribute appropriately to ongoing workstreams, keep up with program progress, and, in the Observer case, plan for eventual transition to Participant status. While effort to conduct these onboarding activities needs to be considered, it can be an investment that enables effective Observer contributions and supports them moving seamlessly into the Participant role when their application is approved.

Observer Contributions

Once onboarded, Observers can usually begin participating in the program. As the role name implies, this can take a purely passive form or Observer companies can begin to actively engage with program workstreams. While prior shared REMS experience may allow Observers to make immediate contributions, a combination of effective onboarding and ongoing Observer engagement is required to ensure that their involvement in the program is perceived as a positive contribution rather than a distracting burden on the Participants.

Limitations to Observer Access

When creating the Observer status, Participants will likely leave themselves the right to restrict Observer access. While not the only reason such a restriction might be exercised, one that merits particular focus is the protection of a program's intellectual property (IP). With full access, an Observer might be able to leverage program materials to create a separate REMS program that meets the same goals without paying a share of the costs that went into creating that IP in the first place. The same concern holds for knowledge gained through observing program activities. And, unlike program documents whose use is restricted by the CDA executed by Observers, knowledge cannot be returned when a company leaves the program. Thus, for some programs, Participants may restrict access to documents and meetings that contain program specific IP.

Costs

The financial cost of becoming an Observer varies from program to program. Three primary considerations for why Observers might be charged a share of program costs prior to becoming Participants include:

1

Costs associated with both Observer onboarding and

ongoing support for which the

Participants might feel the

Observer should be responsible.

2

Related to the discussion of IP above, program materials are

costly to develop. Paying into the

program prior to obtaining access

to those materials is an incentive for

Observers to stay with the program

rather than striking out on their own.

3

Having "skin in the game" might motivate Observers to

make more robust contributions to

aid in the progress of the program.

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Potential Best Practices

Part Observer 1 Status

Clear Definition of Observer Status

While each program has specific needs that may require a nuanced definition of the Observer role, there may be opportunities for standardization across programs. Specifically, definitions that do not change from one program to the next could be standardized. And, in areas that do vary, the spectrum of possibilities could be laid out for consistency between programs.

Onboarding

A key component of any shared REMS should be onboarding that is conducted in a way that minimizes disruptions to program flow, makes optimal use of PMO/Participant effort, and equips Observers to transition smoothly into the Participant role.

Observer Costs

While not necessarily appropriate for all programs, allocation of some costs to Observers is a tool that has the potential to allow more open information sharing while aligning the interests of Observers with those of Participants.

Contact

Jemma Contreras, PhD

Managing Director, Practice Area Lead Risk & Program Management Syneos Health Consulting jemma.contreras@

For more information about our REMS Leadership Summit, contact REMSLeadershipSummit@

About Syneos Health Consulting Syneos Health Consulting is an industry-leading consulting firm specializing in the biopharmaceutical industry and part of Syneos Health, the only fully integrated biopharmaceutical solutions organization. We provide services across a comprehensive range of key areas, including commercial strategy and planning, medical affairs, risk and program management and pricing and market access. Recognized by Forbes magazine as one of America's Best Management Consulting Firms for two years running, our industry focus and depth of functional expertise, combined with strong scientific and market knowledge, uniquely position us to tackle highly complex business and market challenges to develop actionable strategies for our clients. For more information, please visit solutions/consulting.

About Syneos HealthTM

Syneos Health (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies ? INC Research and inVentiv Health ? we bring together more than 21,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers' delivery of important therapies to patients. To learn more about how we are shortening the distance from lab to lifeTM visit .

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