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.
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.
Chair Responsibilities
- Leads, listens, and builds consensus among committee members
- Elects Expert Committee (EC) Members through their Council of Experts (CoE) role
- Chairs and leads an EC
- Enforces standards of conduct as expressed in USP’s Bylaws, rules, and policies, including CoE Rules and the USP Code of Ethics
- Participates in Collaborative Group discussions
- Leads Chair succession planning and develops “next generation” of volunteers
- Serves as the face of the EC
- Administers the EC’s Work Plan
- Reviews disclosure statements and manages conflicts of interest
- Prepares for meetings by working with USP staff to develop meeting agenda and briefing materials; manages meeting agenda, including meeting closure, facilitates EC meeting and discussion; and focuses on and summarizes outcomes
- Adopts the Rules and Procedures of the 2025-2030 Council of Experts (CoE Rules)
- Approves General Notices and General Chapter <11> USP Reference Standards
- Participates in the adjudication of appeals
- Recommends the number and types of ECs for the next cycle
- Appoints new/replacement EC Chairs through CoE role
- Considers long-term implications of activities on USP
- Fulfills all duties of an EC Member
Chair Qualification
- Proven track record of effective leadership within the industry or related fields, demonstrating the ability to guide and inspire diverse teams towards achieving common objectives.
- Strong communication and interpersonal skills, essential for fostering collaboration, facilitating discussions, and building consensus among committee members.
- Experience in strategic planning and decision-making, with the capability to navigate complex challenges and drive initiatives aligned with USP's mission and goals.
- Commitment to upholding the highest standards of integrity, ethics, and professionalism, serving as a role model for ethical conduct and accountability within the committee and broader community.
- Ability to represent the EC’s interests and perspectives within USP's governance structure, advocating for the adoption of evidence-based standards and best practices.
- Capacity to effectively manage time and resources, ensuring the efficient operation of the committee and timely completion of assigned tasks and deliverables.
- Dedication to ongoing learning and professional development, staying abreast of relevant industry trends, regulatory requirements, and emerging technologies to inform the committee's work and recommendations.
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.
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