Pharmacogenomics Consulting

Eliminating barriers to
pharmacogenomic program
implementation

For health systems, payers, and labs

Access a team of regulatory, clinical, and laboratory experts to unlock the benefits of pharmacogenomics (PGx) for your organization — from policy development to lab workflows to sustainable clinical integration.

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35+ combined years in PGx
15+ PGx programs launched
End-to-End lab · clinical · regulatory

What We Do

Comprehensive services, tailored to your organization

We meet you where you are in your organization's PGx journey. Whether starting from scratch or scaling an existing program, we have the experience you need to be successful.

We help health systems, integrated delivery networks, and ambulatory clinics design, implement, and grow PGx programs that support positive patient outcomes.

PGx Program Design & Implementation

Build or grow a high-impact, clinically rigorous PGx program: clinical workflow development, EHR integration strategy, patient and provider communication frameworks, provider education, and governance structure.

Policy & Protocol Development

Keep your PGx program compliant, defensible, and aligned with CPIC guidelines: institution-specific PGx policies, clinical decision support design, formulary integration, and medication management protocols.

Outcomes Measurement & Reporting

Support quality improvement metrics, payer negotiations, and institutional value demonstration with a program metrics framework, data infrastructure guidance, and outcomes reporting.

From objective laboratory evaluation and validation to regulatory strategy and commercial development, we support labs as they navigate the complex PGx testing landscape.

Commercial Development

From vendor evaluation through go-to-market: objective assessment of PGx testing platforms and reference labs, in-house build vs. buy evaluation, go-to-market strategy, KOL engagement, and health system partnership frameworks.

Regulatory Strategy & Compliance

Access deep regulatory expertise across governing bodies and jurisdictions: FDA regulatory pathway navigation for PGx tests and devices, CLIA/CAP compliance support, LDT guidance, and 510(k) or De Novo strategy development.

Research & Publication Support

Comprehensive support for your research study: study design consultation, IRB strategy, biomarker validation frameworks, and translational research support.

We help payers and pharmacy benefit managers develop evidence-based PGx coverage policies and build the operational infrastructure to implement them effectively.

Coverage Policy Development

Evidence review and coverage determination frameworks for PGx testing — grounded in clinical utility data, CPIC/DPWG guidelines, and real-world outcomes literature.

Prior Authorization Strategy

Prior authorization criteria design that aligns with clinical evidence, minimizes unnecessary burden on providers, and supports appropriate test utilization.

Value & ROI Analysis

Pharmacoeconomic modeling, population health impact assessment, and ROI frameworks to support the business case for PGx coverage expansion.

We also support independent pharmacies, clinicians, and academic institutions with PGx strategy, interpretation, and more. Want to learn more about how we can help you? →

Our Approach

End-to-end means
no gaps

Most PGx implementations stall because expertise is siloed — the lab team doesn't understand clinical workflows, the clinical team can't navigate billing, and nobody connects the regulatory requirements to day-to-day operations.

We don't apply generic templates. Every engagement follows a structured path from assessment to sustainability, built around your infrastructure, patient population, and organizational goals.

01

Assess

Current-state analysis of your workflows, systems, staff capacity, and organizational readiness for PGx.

02

Design

A tailored implementation roadmap: clinical protocols, education plans, technology requirements, and governance structure.

03

Implement

Hands-on support through launch — training, workflow testing, stakeholder alignment, and real-time problem-solving.

04

Sustain

Post-launch evaluation, outcomes tracking, and ongoing optimization so your program grows rather than stalls.

Our Commitment

PGx should work for every patient

Pharmacogenomics has the potential to reduce health disparities — but only if testing is accurate, accessible, and implemented equitably. We are committed to building PGx programs that serve all patient populations: designing for diverse ancestral backgrounds in gene-drug interaction databases, advocating for inclusive research enrollment, and ensuring implementation plans account for the populations a health system actually serves.

The Team

End-to-end expertise, built from real-world experience

We launched E2E PGx to advance pharmacogenomics across the healthcare ecosystem. Our team brings deep, complementary experience across pharmacology, clinical practice, regulatory strategy, and laboratory science.

Bronwyn Ramey

Bronwyn Ramey, PhD

MB(ASCP)CM, HCLD(ABB)

Co-Founder · Pharmacogenomics & Laboratory Science

Dr. Ramey brings over 20 years of experience in pharmacogenomics, serving on expert committees and in advisory roles across industry and academia. She is the founder of Phoenix Laboratory Consulting, a specialist PGx laboratory consulting firm, with deep expertise in laboratory validation, assay development, and the translational science of PGx implementation.

Wrenda Teeple

Wrenda Teeple, PharmD, BCPS

 

Co-Founder · Clinical & Regulatory Strategy

Dr. Teeple is a board-certified pharmacotherapy specialist and FDA regulatory consultant with direct PGx experience from her tenure as Clinical Development Pharmacist at OneOme. As President of Arbit Consulting, she has led regulatory strategy across pharmaceutical, device, and academic medical center clients, achieving a zero-observation record across FDA inspections. She holds ASHP Pharmacogenetics Certification and co-chairs the FDA-partnered STRIPE Study Designs Task Force.

Work With Us

Ready to move your
PGx program forward?

Tell us where you are and where you want to go. We'll scope an engagement that fits your timeline and budget.

Email info@e2epgx.com
Contact Us