Who is USP
The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,100 talented professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide. USP is committed to adopting more environmentally sustainable quality testing practices, manufacturing technologies, and health care actions across the pharmaceutical lifecycle.
Who are our Expert Volunteers?
A hallmark of USP’s standards is that they are determined by independent scientific experts. USP Expert Volunteers are selected based on their individual expertise and experience and use their best personal, professional, and scientific judgment to work collaboratively on setting standards. USP Expert Volunteers must agree to disclose conflicts of interest and to uphold standards of conduct that preserve the integrity of the standard setting process. USP Expert Volunteers work under a policy to foster a more sustainable environment, creating and revising standards toward reduction of energy consumption, minimization of toxic waste, reduction of animal testing, and water conservation.
Member Responsibilities
- Reads and abides by USP’s Bylaws, rules, and policies, including CoE Rules and the USP Code of Ethics
- Participates in meetings (reads briefing materials, attends meetings, reviews minutes and notes, etc.) and notifies USP staff of conflicts of interest
- Approves USP standards through balloting and voting (USP–NF, Reference Standards)
- Commits to understanding of USP’s Mission
- Advocates for and represents USP and its future
- Handles confidential information properly
- Considers regulatory framework
- Challenges constructively
- Commits time and effort to participate in EC activities
- Disposes of any confidential materials at the conclusion of service
- Commits to development of standards with positive impact on the environment.
FOCUS AREA - Personalized Medicines
2025-2030 FOCUS
Pharmacogenomics (PGx) Integration: Developing comprehensive standards for integrating pharmacogenomics into clinical practice, focusing on standards for genetic testing, result interpretation, and application in personalized drug therapy to improve patient outcomes.
Digital Therapeutics (DTx) and Digital Health Regulation: Establishing clear standards and regulatory frameworks for digital therapeutics and broader digital health applications, including labeling, categorization, version control, data privacy, security, and interoperability standards, to ensure these technologies are safely integrated into patient care.
Artificial Intelligence (AI) and Machine Learning (ML) in Healthcare: Formulating standards for the ethical development, validation, and implementation of AI and ML algorithms in healthcare, including standards for data quality, algorithm transparency, and ethical considerations to ensure patient safety and trust.
Bio simulation for Drug Development: Advancing standards for the use of bio simulation in drug development and personalized therapy, focusing on modeling and simulation techniques to predict drug interactions, efficacy, and safety in diverse patient populations.
Manufacturing and Quality Control of 3D Printed Medications: Creating standards for the manufacturing and quality control of 3D printed medications, emphasizing the unique challenges of producing personalized dosage forms.
Comprehensive Omics Approaches: Developing standards for the integration of genomics, transcriptomics, proteomics, metabolomics, and other omics technologies in personalized medicine. This includes data standardization, analysis, and interpretation to enable holistic approaches to patient treatment.
Ethical, Legal, and Social Implications (ELSI) of Personalized Medicine: Addressing ethical, legal, and social challenges related to personalized medicine, including patient consent, data privacy, and equitable access to innovative therapies, to ensure responsible and inclusive practices.
Interdisciplinary Collaboration and Education: Promoting interdisciplinary collaboration among scientists, clinicians, regulatory bodies, and patients to foster a comprehensive understanding of personalized medicine. This includes developing educational programs and resources to support healthcare professionals and patients in navigating the complexities of personalized treatments.
Global Standards and Harmonization: Working towards the harmonization of personalized medicine standards globally to facilitate international collaboration, data sharing, and the equitable distribution of personalized therapies, ensuring patients worldwide can benefit from advancements in personalized medicine.
2025-2030 KEY ISSUES
Integration of Pharmacogenomics into Clinical Practice: Developing frameworks that enable the widespread adoption of pharmacogenomics (PGx) in clinical settings, including standards for genetic testing, interpretation of results, and their application in personalized treatment plans. This includes addressing barriers related to cost, education, and infrastructure.
Standardization of Digital Health Technologies: Establishing standards for the development, validation, and clinical integration of digital therapeutics (DTx) and other digital health technologies. This encompasses data privacy, interoperability between different platforms and devices, and the effectiveness of digital interventions in diverse patient populations.
Ethical Use of AI and Machine Learning in Healthcare: Formulating standards to ensure the ethical development and use of AI and ML in healthcare, focusing on transparency, algorithmic bias, patient privacy, and the reliability of AI-driven diagnostic and treatment recommendations.
Regulatory and Ethical Frameworks for Personalized Medicine: Creating comprehensive regulatory and ethical frameworks that keep pace with the rapid advancements in personalized medicine, including new drug modalities like digital and 3D printed medications, as well as complex multi-omics data analysis. These frameworks must also address issues of patient consent, data security, and equitable access to personalized therapies.
Quality Control and Manufacturing of Personalized Therapies: Developing standards for the quality control and manufacturing processes of personalized therapies, such as 3D printed medications, to ensure they are safe, effective, and produced in a manner that meets regulatory requirements.
Interoperability and Standardization of Omics Data: Addressing the challenges related to the integration and standardization of multi-omics data (genomics, transcriptomics, proteomics, etc.) to facilitate their use in personalized medicine. This includes establishing standards for data formats, quality, and sharing protocols to enable interoperability across research and clinical care settings.
Economic and Access Issues in Personalized Medicine: Tackling the economic challenges and access issues associated with personalized medicine, ensuring that these innovative treatments are cost-effective and accessible to a broad range of patients, not just those in high-income regions.
Patient Engagement and Education: Enhancing patient engagement and education around personalized medicine, including understanding genetic testing, the implications of digital health technologies, and the role of AI in healthcare. Ensuring patients are informed and can actively participate in their treatment decisions is crucial.
Global Collaboration and Harmonization of Standards: Promoting global collaboration and the harmonization of standards for personalized medicine to ensure consistency and efficacy across different countries and healthcare systems. This includes working with international regulatory bodies, professional societies, and other stakeholders.
REQUIRED EXPERTISE
Pharmacogenomics and Genomic Sciences: Experts with deep knowledge in pharmacogenomics (PGx) and broader genomic sciences, including genomics, transcriptomics, proteomics, metabolomics, lipidomics, microbiomics, and epigenomics. Their expertise will be vital in understanding how genetic variations affect individual responses to medications, guiding personalized treatment plans.
Digital Health Technology: Specialists in digital therapeutics (DTx), digital medicine, and digital health technologies, with a strong background in developing, validating, and implementing software and devices designed to treat, manage, prevent, and/or monitor health conditions. This includes knowledge of regulatory standards and data privacy concerns.
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