Learn more at Booth #1718. View the full conference agenda:
https://aaps2024.eventscribe.net/
USP participation
Innovating Together: How Diversity Drives Team Science Success
Monday, October 21, 1:30 – 2:30 PM MT, Careers 360, Exhibit Hall
Allison Radwick, Senior Regulatory and Communications Manager
This presentation explores the vital intersection of diversity within the context of research teams and academic settings. This session will examine team science and research collaboration, emphasizing its significance in fostering diversity and inclusion within scientific communities. Through compelling narratives, real-world examples of diversity initiatives, data-driven insights, practical strategies including actionable steps, participants will gain a comprehensive understanding of why diversity is essential for driving innovation, fostering collaboration, achieving impactful outcomes, and promoting individual success in scientific endeavors. Drawing on best practices and expert insights, participants will be equipped with the knowledge and tools needed to champion diversity and equity in their own academic and professional spheres, cultivate successful research teams, and navigate potential pitfalls in collaborative environments.
Learning Objectives:
- Analyze the importance of diversity within research teams and academic settings
- Evaluate the benefits and challenges associated with fostering diversity and inclusion in scientific collaborations
- Demonstrate practical strategies for promoting diversity, fostering collaboration, and achieving impactful outcomes in research endeavors
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Risk in Pharmaceutical Quality: Role of the Documentary and Reference Standard. Case Studies.
Tuesday, October 22, 9:30 - 10:30 AM MT, 360 Stage #2, Exhibit Hall
Naiffer Romero, Principal Scientist, Science-Global Biologics
In the complex landscape of pharmaceutical development and compliance, ensuring the highest quality of products is paramount and accurate measurements are at the heart of pharmaceutical quality assessment. This presentation will cover the pivotal role that Reference Standards play in mitigating risks and will shed some light on practical cases in which inaccurate measurements can influence the reliability of analytical results and can lead to erroneous conclusions about product quality and safety.
Learning Objectives:
- Learn the risks to pharmaceutical quality and the impact of the use of non-fit for use RS and Analytical Procedures
- Gain insights into how inaccurate measurements can lead to erroneous conclusions about product quality and safety
- Understand the critical stages of Reference Standards development process: What is suitability for use and how to minimize Risks to Quality
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The Importance of Excipient Quality and Development: New Frontiers for Use in Medicines
Tuesday, October 22, 1:30 - 2:30 PM MT, 155 B, Salt Palace Convention Center
Keynote: Catherine Sheehan, Senior Director, Growth Programs, Excipients and Food, Science-Excipients
Moderator: Kenny Xie, Principal Scientist, Compendial Operations
The quality of excipients is important since they can make up to about 90% of the total mass/volume of drug products. Fatal consequences are linked to excipients at a higher risk of adulteration and contamination as well as product recalls and facility closures due to excipient quality/GMP violations.
Traditionally, excipient specifications were established with a focus on intended use in the drug product and less on excipient composition, however, the increasing demand for high quality excipients used in the development of advanced nanomedicines and novel delivery systems requires higher quality and purity, e.g., use of phospholipids in development of Covid-19 vaccine nanomedicine delivery systems. USP is collaborating with stakeholders to address the lack of standardized methods for complex polymeric type excipients (e.g., lipids/LG polymers), by expanding its offerings to be more flexible in its approaches introducing evolving, iterative approaches that address excipient compositional and variability issues. This presentation will highlight the recent updates to excipient monographs at risk for adulteration and contamination with DEG/EG and general chapters for excipient <1078> GMP and <1059> Excipient Performance, and introduction of excipient nomenclature guidelines and definitions. In addition, the presentation will provide an overview of evolving compendial approaches (e.g., standalone chapters) and expanded offerings through use of expanded non-compendial approaches (use of analytical reference materials (ARMs) and associated application (App) notes). Lastly, the presentation will provide an overview of the complexities surrounding the use of novel excipients in pharmaceutical formulations and safety assessments, USPs collaboration with stakeholder's, creation of a Novel Excipients Knowledge Hub, and the establishment of the Novel Excipients Expert Panel to revise General Chapter <1074> Excipient Biological Safety Evaluation Guidelines.
Learning Objectives:
- Understand the quality challenges in pharmaceutical science, the importance of excipient quality testing, and the availability of high quality USP-NF standards for testing excipients at risk of adulteration and contamination with DEG/EG.
- Gain insights into the application of USP's expanded and flexible approaches for complex type excipients and novel standards development that include stakeholder engagement in identifying the best pathway including standalone general chapters, iterative and emerging standards approaches, and possible pathways, such as analytical reference materials and application notes that may also help reduce the current barriers to using novel excipients in new therapeutics and advanced formulations.
- Learn about USP's efforts to develop standards for novel excipients, including the creation of the Novel excipient Information Hub, and the establishment of a Novel Excipients Expert Panel and revisions to General Chapter <1074> Excipient Biological Safety Evaluation Guidelines.
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Emerging Standards and Iterative Approaches to Novel Excipients
Tuesday, October 22, 2:30 - 3:30 PM MT, Spotlight Stage C, Aisle 2800, Exhibit Hall
Jenny Liu, Senior Principal Scientist, Science-Excipients
Novel excipients play a pivotal role in enhancing drug stability, bioavailability, and therapeutic efficacy in pharmaceutical formulations. However, their selection, characterization, and regulatory compliance present unique challenges for drug manufacturers. This session provides an in-depth exploration of the complexities surrounding novel excipients, equipping participants with the knowledge and tools necessary to navigate this evolving landscape.
Insights into the critical role of novel excipients in drug development, as well as the regulatory requirements and quality control practices essential for ensuring product compliance and patient safety. The presentation will also highlight emerging standards related to novel excipients development, focusing on USP's efforts to develop and refine these standards through the establishment of an Expert Panel and revisions to General Chapter <1074> Excipient Biological Safety Evaluation Guidelines.
Throughout the session, participants will discover the challenges and benefits of incorporating novel excipients into their formulations, while gaining insights into USP's iterative approaches and emerging standards and possible pathways, such as analytical reference materials, application notes, general chapters, etc., that may help remove the current barriers to using novel excipients in new therapeutics and advanced formulations.
By understanding the impact of these standards on elevating industry practices and ensuring the highest levels of quality, safety, and efficacy in pharmaceutical products, attendees will be better prepared to navigate the complexities of novel excipients and drive innovation in their organizations.
Learning Objectives:
- Analyze the regulatory and safety assessment barriers associated with novel excipients, emphasizing the potential impact on early-stage drug development.
- Learn about USP's efforts to develop standards for novel excipients, including the establishment of a Novel Excipients Expert Panel and revisions to General Chapter <1074> Excipient Biological Safety Evaluation Guidelines.
- Gain insights into USP's iterative approaches and emerging standards for novel standards development and stakeholder engagement, highlighting its role in addressing emerging quality challenges in pharmaceutical science.
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Women in PharmSci Breakfast
Wednesday, October 23, 7:30 AM – 8:30 AM MT, Salt Lake AB, Hyatt Regency Salt Lake City
Otilia Koo, Portfolio Vice President, Novo Nordisk
Join us at the Women in PharmSci Breakfast for lively conversations and networking. The Alice E. Till Advancement of Women in Pharmaceutical Sciences Recognition recipient will also be honored at the breakfast. All attendees are invited to participate, and you do not have to register for this event. This will be a fun gathering that you don’t want to miss!
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A Game-Changing Quality Control Strategy: The Multi-Attribute Method
Wednesday, October 23, 10:30 - 11:00 AM MT, 155 E, Salt Palace Convention Center
Kevin Carrick, Senior Director, Biologics Science and Standards
This presentation explores multi-attribute method (MAM) capabilities and offers a comprehensive overview of its application in characterizing and monitoring the quality attributes of therapeutic proteins. As protein-based drugs become increasingly complex, traditional analytical methods often struggle to provide a holistic understanding of product quality. MAM, however, emerges as a game-changer, offering a streamlined approach to simultaneously detect, identify, quantify, and monitor multiple product quality attributes (PQAs) and critical quality attributes (CQAs) in a single mass spectrometry run.
The technical intricacies of MAM will be examined, including its two distinct phases: characterization and monitoring. By leveraging the power of liquid chromatography and mass spectrometry (LC-MS), MAM enables the evaluation of quality attributes at the amino acid level, replacing multiple traditional methods and facilitating the detection of unexpected modifications. Moreover, participants will gain insights into the increasing adoption of MAM within the biopharmaceutical industry, supported by retrospective analyses of Biological License Applications illustrate how MAM enhances understanding of the product and process, accelerates development timelines, and refines control strategies focused on specific CQAs.
Practical implementation of MAM in various facets of pharmaceutical development and manufacturing will be assessed, including process development, batch release, and stability analysis. Additionally, the session will highlight MAM's potential as a process analytical technology tool to enhance analytical efficiency and ensure product quality throughout the lifecycle.
Learning Objectives:
- Apply the principles of the multi-attribute method (MAM) to characterize protein modifications and assess critical quality attributes using liquid chromatography and mass spectrometry
- Analyze the applications of MAM in process development, batch release, stability analysis, and as a process analytical technology (PAT) tool to streamline workflows and enhance analytical efficiency
- Evaluate the utilization of MAM results for improved product understanding and control strategy development, including the integration of amino acid-level insights into quality assessment and the optimization of process parameters
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Collaborative Training Initiatives for Strengthening Regulatory and Laboratory Systems
Wednesday, October 23, 10:30 - 11:00 AM MT, 150 DEFG, Salt Palace Convention Center
Chaitanya Kumar Koduri, International Government & Regulatory Director
This presentation explores the critical need for collaborative training initiatives to strengthen regulatory and laboratory systems in low- and middle-income countries (LMICs). It discusses the challenges faced by regulators, such as limited human, financial, and infrastructural resources, and highlights the importance of ongoing training for regulatory professionals. The presentation also examines the competency-based frameworks developed by organizations like the WHO and others to guide training activities, as well as the impact of combined laboratory and regulatory systems training offered to LMICs. Through case studies and a panel discussion, this session will highlight the benefits and challenges associated with collaborative training approaches and provide recommendations for enhancing regulatory and laboratory capacity in LMICs.
Learning Objectives:
- Evaluate the challenges faced by regulators in low- and middle-income countries (LMICs) to understand the barriers to strengthening regulatory and laboratory systems
- Assess the impact of collaborative training initiatives on regulatory professionals in LMICs
- Formulate recommendations for enhancing regulatory and laboratory capacity in LMICs based on insights gained from collaborative training approaches
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