Precision Medicine Enablement via Advanced Diagnostics
Advances in diagnostics—including pharmacogenomics, emerging tumor markers, the importance of individual variability of drug response, the influence of the microbiome, complementary and companion diagnostics—are rapidly changing our approach to medication therapy from a “shot gun” trial-and error-approach to personalized/precision medication and gene therapy choices. Increasingly, a larger percentage of existing guideline recommended testing (hereditary cancer, oncology mutations, companion diagnostics prior to prescribing) is not being offered or utilized to inform care/treatment decisions while emerging diagnostics aided by an explosion of scientific discovery fails to have a pathway to rapid deployment in the market. This Workgroup will focus on two of our core belief statements:
- A personalized, patient-centered, systematic and coordinated approach to medication use will vastly improve outcomes and reduce overall cost of care.
- Appropriate diagnosis and access to advanced diagnostics with companion/complementary and pharmacogenetic (PGx) testing is essential to target correct therapy.
Chair: Steve Goldberg, MD, MBA, Vice President, Medical Affairs, Population Health and Chief Health Officer, Health & Wellness, Quest Diagnostics
Co-Lead: Brian Caveney, MD, JD, MPH, President, Enterprise-Wide Chief Medical Officer, LabCorp
Co-Lead: Jill Bates, PharmD, MS, BCOP, FASHP, PHASER Pharmacy Program Manager, Durham VA Health Care System; Associate Professor of Clinical Education, UNC Eshelman School of Pharmacy
- Marcia Eisenberg, PhD, Chief Scientific Officer, Senior Vice President, LabCorp
- Steve Anderson, PhD, Chief Scientific Officer-Covance, Senior Vice President, LabCorp
- Tom Kraus, JD, MHS, Vice President, Office of Government Relations, American Society of Health-System Pharmacists
- Jacques Turgeon, BPharm, PhD, Chief Scientific Officer, Tabula Rasa; CEO, Precision Pharmacotherapy Research and Development Institute
- Dorothy (Dot) Adcock, MD, Chief Medical Officer and Senior Vice President, LabCorp
- Anthony Morreale, PharmD, MBA, BCPS, FASHP, Associate Chief Consultant for Clinical Pharmacy Services & Policy, Pharmacy Benefits Management VACO
- Chet Robson, DO, MHCDS, FAAFP, Medical Director, Walgreens Co.
- Philip Empey, PharmD, PhD, Director, PGx Center of Excellence; Associate Director, Institute for Precision Medicine; Associate Professor, Dept. of Pharmacy and Therapeutics, Center for Clinical Pharmaceutical Sciences
and the Clinical and Translational Science Institute
- Jane Gilbert, CPA, Director, Retiree Health Care, Kentucky Teachers’ Retirement System
Areas of Further Work
- Regulation: Strengthen the relationship of the FDA with laboratories that provide pharmacogenomic testing to optimize its usefulness to patients and providers
- HIT and AI: Develop tools that enable the practice of precision medicine and advanced diagnostics?
- Marketplace Strategy: Create and implement a plan that promotes precision medicine literacy and application to clinical care
- Education and Public Awareness: Standardize a process for precision medicine care and support providers in its delivery and adoption
- Evidence-Based Process: Create an evidence-based process that supports precision medicine data and enables effective understanding, awareness and interpretation