Patient Insight to Impact

The life sciences industry has made real progress in patient engagement. Companies are investing in advocacy teams, conducting listening sessions, and building relationships with patient communities. The intent is genuine.

But intent is not enough.

Too often, patient insights are collected and never integrated into the decisions that matter — trial designs that don’t reflect patient realities, development priorities set without the patient perspective, advocacy teams working hard but without a seat at the table where strategy is made. The result is a gap between what companies believe they are doing for patients and what patients actually experience. That gap creates risk — regulatory, reputational, and operational.

The FDA’s evolving Patient-Focused Drug Development guidance is now making that gap impossible to ignore. The expectation is no longer that companies engage patients. The expectation is that patient insight demonstrably shapes development decisions.

Patient Strategy Group was built for this moment.

Our purpose is to help life sciences leaders build patient advocacy as a true enterprise function — one with governance, decision rights, and executive accountability — so that patient insight moves from the margins of development to the center of it. Because when patient voice informs real decisions, everyone wins: companies develop better therapies, regulators see credible evidence of patient partnership, and patients finally see their experience reflected in the development of treatments built for them.

Contact: susan@patientstrategygroup.com

Our Services

Patient Advocacy in Life Sciences is at an Inflection Point

And the stakes have never been higher.

  • Effective patient advocacy starts with strategy —not programs. PSG works with executive and cross-functional teams to develop enterprise-wide patient strategy frameworks and asset-level patient engagement plans that are aligned with development priorities, regulatory expectations, and long-term business objectives. We ensure patient insight informs the decisions that matter most — from early development through commercialization.

  • Understanding the patient advocacy group

    landscape is foundational to any credible engagement model. PSG conducts comprehensive PAG landscape assessments — mapping key organizations, evaluating alignment with your therapeutic priorities, and developing relationship strategies that are ethical, sustainable, and built on genuine partnership.

  • Patient advisory boards are only as valuable as the strategy behind them. PSG designs, facilitates, and manages patient advisory boards that generate actionable insight — and ensures that insight reaches the people and processes where it can influence decisions. We deliver structured summaries and integration roadmaps so that patient input drives real outcomes, not just conversation.

  • The FDA’s Patient-Focused Drug Development guidance has raised the bar for patient engagement across the industry. PSG helps organizations build engagement models that meet evolving regulatory expectations — ensuring patient voice is captured, documented, and integrated in ways that strengthen regulatory submissions and withstand scrutiny.

  • Some organizations need senior patient advocacy leadership — but are not yet ready for, or do not require, a full-time hire. Fractional leadership is the answer.

    As a fractional patient advocacy leader, Susan embeds directly into your organization on a part-time or interim basis — providing the strategic direction, executive presence, and operational accountability of a senior leader, without the commitment of a full-time role.

    Fractional leadership with PSG is right for you if:

    — You are building a patient advocacy function and need experienced leadership to stand it up correctly from the start

    — You have an existing team that would benefit from senior strategic guidance and executive alignment

    — You are between full-time hires and need continuity of leadership during a critical period

    — You want to strengthen your patient strategy before making a permanent leadership investment

    Engagements are scoped to your needs — from a defined project with a clear deliverable to an ongoing advisory relationship that grows with your organization.

Susan Stein, MPH

Founder & CEO

Susan is a senior biopharmaceutical leader with more than 25 years of global experience in commercialization, patient advocacy, and engagement strategy across multiple therapeutic areas, including oncology and rare diseases.

An entrepreneur and builder by nature, she specializes in standing up new functions, bringing structure to emerging disciplines, and helping organizations move from well-intentioned activity to strategic execution.

Contact: susan@patientstrategygroup.com

Why Patient Strategy Requires Leadership

Innovation

Patient insight helps shape development priorities and ensures therapies address the realities patients face.

Regulatory Alignment

Regulators increasingly expect patient perspectives to inform trial design and development decisions.

Woman talking to her doctor about medical records

Community Trust

Organizations that meaningfully engage patients build stronger relationships with the communities they serve.