Patient Engagement Plan (PEP) Cat Mishalow April 14, 2022
If you can make it better...Do it
Bring the patient voice into your R&D organization.

Be faster. Be better. Deliver on what patients' need.

The Patient Engagement Plan is a roadmap for how, when, and why your team wants to engage with patients and care partners throughout an asset's lifecycle.

Be proactive, for the next budget cycle and develop high-quality insights to inform your team product development

Gain alignment across internal stakeholders, prioritize and

Focus on key areas where patient insights would be most valuable.

At the end of this process, you will have a Patient Engagement Plan developed collectively with input from your team, ready to implement

Deeper understanding of patient experience

Helps design decentralized trials with the combination of tools and flexibility needed by participants of a given trial.

Better plan design

Better Patient Experience Data to support regulatory decision-making

  • Understand if Patient Reported Outcome measure are measuring the symptoms that matter most to patients
  • Consider Patient Preference Information to support submission and label negations
  • Determine endpoints that matter to patients
Better business outcomes
  • Faster cycle times
  • Evidence generation needs to inform for regulators, payors, and providers but ultimately it is patients who are making the decisions on new therapies
  • Opportunities to co-create with patients from the ground up
What is it?

A refined and effective process to bring internal cross-functional teams together to develop a roadmap specifically focused on optimizing patient engagement opportunities for a given asset from R&D into commercialization, resulting in a Plan that can be incorporated into an asset’s overall strategy.

What problem does it address?

Many companies see opportunities to bring insights from patients living with a given condition to inform decisions on endpoint selection, informed consent language, adequacy of Patient-Reported Outcome measure in assessing what really matters to patients only weeks before the need arises. This is too late. Quality Patient Engagement requires planning to help ensure the right patient voices are represented, with various elements of diversity, whether geographic, age, sexual orientation, race/ethnicity, or stage of disease, for example. Planning and prioritizing when, why, and how insights from patients will be obtained allow for optimizing opportunities, budgeting, and maximizing insights for key internal and external decision-making (regulatory and payer) to best support clinical development and evidence generation.

What is our approach?

We form a core team with key leaders of a program or project team, and complete pre-work using existing source documents (e.g. asset strategy, Target Product Profile). A date for the 3-hour PEP Workshop mid-way through the six-to-eight-week process. This facilitated and highly interactive cross-function Workshop, live or virtual, focuses on the information the internal team needs to understand from patients or the patient community, by when, and for what purpose. The Workshop output is compiled and analyzed together with Legacy’s deep experience and understanding of the Patient Engagement landscape. Final outputs are discussed with the internal core and full team, and the plan is then integrated into the asset strategy.

What results do we see?

Many leaders and team members within organizations have concerns that “keep them up at night regarding what patients really need and what”. Often, they realize their teams may be making assumptions about patient perspectives. By bringing internal stakeholders together, we find that these concerns are not only validated across team members but concerted efforts to ensure patients’ voice as brought into the process of development is truly desired and needed and through the PEP process and resulting plan, teams now have an effective methodology and plan to address the issues that will help leaders feel confident that the products they are development will truly meet the needs of patients.

Discover how we can help you at every stage of R&D from discovery through clinical development and into commercialization

We can join as an extension of your team, to help integrate patient perspectives, speed cycle times and impact your company’s bottom line.