FDA Becomes a Member of STRIPE, New Collaborative Community to Help Advance Pharmacogenomics (PGx) into Clinical Practice


HOUSTON, Aug. 25, 2020 /PRNewswire/ -- The American Society of Pharmacovigilance (ASP) today announced that the Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Initiative has developed a collaborative community with participation by the U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH). ASP is convening the STRIPE community to accelerate the development of personalized medicine practices as the standard of care by building a platform for stakeholders to resolve shared challenges in pharmacogenetics testing.

"We must keep raising our expectations of what is possible. STRIPE symbolizes an industry-wide commitment to our field, to each and every patient that deserves the safest and most effective medication, and to every patient seeking the promise of personalized medicine," states Benjamin Brown, Executive Director at the American Society of Pharmacovigilance. "The community aims to harmonize and optimize standards, practices, and resources related to pharmacogenetics testing that will improve access to safe, accurate, and reliable information about a patient's medication and drug-gene interactions." – Sara Rogers, Pharm.D., ASP Director of Clinical Affairs

The purpose of a collaborative community is to bring together medical device stakeholders in a continuing forum of private- and public-sector members, including the FDA, to achieve common outcomes, solve shared challenges, and leverage collective opportunities. CDRH sees participation in a community-based collaborative approach to the ongoing evaluation of the evolving science, as part of its commitment to continue engaging with health care professionals, guideline setting, patient and test developer groups. "CDRH is committed to engaging with stakeholders as we work to protect patients while fostering the development of new and innovative diagnostics," says Jeff Shuren, M.D., J.D., Director of the FDA's Center for Devices and Radiological Health. Ultimately, collaborative communities seek to contribute to the improvement of areas affecting U.S. patients and healthcare.

STRIPE aims to develop a common agenda for addressing challenges in personalized medicine to achieve its aim of large-scale change to bring pharmacogenomics into standard of care. Together, members will guide vision and strategy, support activities, establish shared measurement practices, build public will, advance policy and mobilize resources.

Stakeholders in personalized medicine interested in learning more and joining the STRIPE community are encouraged to visit the website: http://stopadr.org/stripe.  

About American Society of Pharmacovigilance

The American Society of Pharmacovigilance is a national biomedical and healthcare network with membership open to all healthcare professionals. Their mission is to reduce the high rate of suffering and morality due to adverse drug events. ASP represents the unity of different areas of expertise coming together to have a bigger impact on addressing the fourth leading cause of death in the U.S.

American Society of Pharmacovigilance
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SOURCE American Society of Pharmacovigilance


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