Early Bird Pricing Ends May 3rd, 2024
Venue: Convene Commerce Square, 2001 Market Street
Hotel: Sonesta Philadelphia Rittenhouse Square
AGENDA
12:00 ET
Exhibitor Showroom and Conference Registration
1:15 ET
Chairperson's Welcome and Opening Remarks
1:30 - 2:10 ET
Opening Session - (Compliance, Operations, Harmonization, Lab Optimization Topics)
Justin Pennington, Ph.D., Assistant Vice President, Merck; 2024 President, Eastern Analytical Symposium; Council of Experts, USP (Invited)
ANALYTICAL (Temple Track)
2:10 - 2:50 ET
Using Data Analytics to Effectively Manage the Laboratory
Kayla Woodlief, M.S., Director of Stability and Data Analytics, Vir Biotechnology, Inc
LAB MANAGEMENT (Temple Track)
- Define key performance indicators for Quality Control laboratories
- Establishing a robust trending program
- Power of controls in understanding assay performance and variability
- Learn how to leverage QC data to identify out of trend results
- Understand the importance of QC data for establishment of specifications and product expiry
2:50 - 3:30 ET
Streamlining Stability Studies for Clinical Trial Support
Tony Mazzeo, Ph.D., Associate Scientific Director, Product Development - ASO, Stability, Bristol Myers Squibb
3:30 ET
Exhibitor Showroom and Networking Refreshment Break
4:00 - 4:45 ET
"Analytical Procedure Development - The Impact of ICH Q14 Method Development Challenges, Setting Specifications, Method lifecycle, Validation, Transfer of Procedures"
Panelists: Jennifer Lewis, Ph.D., Director, University of Rhode Island; Leanna Pearson, Associate Director of Quality, Compliance, and Quality, CAI; Doug Brown, Ph.D., Stability Manager, Charles River Laboratories; Laura Pack, M.S., Senior Director, CMC Quantitative Science, Moderna; Yan Wu, M.S., Director, Analytical Chemistry in Development and Supply, Merck
- Establishing critical parameters for analytical procedures
- Determining acceptance criteria to monitor method performance
- How to establish changes to analytical methods
- Handling challenges of method transfer
4:00 - 4:45 ET
Establishing Product Performance - Establish Expiry, Impurity Profiles, Product Lifecycle, OOS Investigation, Sterility/Micro Testing, In-use testing, Excursions
Panelists: Kayla Woodlief, MS, Director of Stability and Data Analytics, Vir Biotechnology, Inc, , Inc; Robert Westney, PA Laboratory Director, FOCUS Laboratories; Tara Scherder, Principal, SynoloStats; Daniel Willingmyre, Associate Director, Stability and Data Analytics, Vir Biotechnology, Inc; Lori McCaig, Ph.D., Director, Global Stability Program Management, Pfizer Inc.
- Establishing expiry in accelerated product development
- Handling OOS investigation for stability program
- Designing stability studies to support in-use or distribution of products
- Applying Risk Management to support stability excursions
4:45 ET
Close of Day One and Networking Cocktail Reception
7:30 ET
Exhibitor Showroom and Continental Breakfast
8:00 - 8:40 ET
Develop, Implement and Maintain a Risk-Based Stability Program
Stephanie Ferrari, M.S., Senior Manager, Global Regulatory Affairs, Vaccines CMC, Pfizer
Stability (Temple Track)
- Understanding the product & CQAs
- Risk assessments & protocol development
- Predictive Modeling
- Applications & Considerations
- Industry perspective & regulatory acceptance
8:50 - 9:30 ET
Developing Change Control Strategies for Stability Program Post-Approval Changes
Jing Capucao, Ph.D., Stability Manager, GSK Biopharm Global QC
Stability
9:30 - 10:30 ET
Speed Training and Networking Refreshment Break
10:30 - 12:00 ET
"Focus Topics - A. Data Evaluation and Stability Program Development B. Establish Expiry with Accelerated Development"
Moderators: Laura Pack, M.S., Senior Director, CMC Quantitative Science, Moderna; Lori McCaig, Ph.D., Director, Global Stability Program Management, Pfizer Inc. Tara Scherder, Principal, SynoloStats; Jennifer Lewis, Ph.D., Director, University of Rhode Island; Daniel Willingmyre, Associate Director, Stability and Data Analytics, Vir Biotechnology, Inc
Stability Hot Topics
12:45 ET
Networking Luncheon
1:30 - 2:10 ET
Evaluation of Stability Data per ICH Q1E: Application of Guidance to Drive Statistical Strategies
Laura Pack, M.S., Senior Director, CMC Quantitative Science, Moderna
Stability
- Purpose of stability testing of pharmaceutical products – Let’s focus on expiry
- Using the Q1E decision tree to guide extrapolation and statistical analysis decisions
- Principles that underly statistical approaches explicitly defined in ICH Q1E
- Poolability considerations in model fitting
- Interpreting the regression output and making the retest/expiry claim
- Takeaway Tools
- Decision tree notes to aid in statistical analysis decisions
- Quick guide on poolability criteria and model fitting
2:20 - 3:00 ET
Stability Beyond ICH: In-Use and Excursion Studies
Kayla Woodlief, MS, Director of Stability and Data Analytics, Vir Biotechnology, Inc, and Kelly Forney-Stevens, Director of Formulation Development, Vir Biotechnology, Inc
Stability
- Define requirements and expectations for establishing in-use stability
- Understand considerations for designing and executing in-use stability studies
- Define design requirements for temperature excursion studies
- Understand global market considerations for excursion studies
- Learn how to leverage stability data to support temperature excursions during manufacture, shipment, and storage
- Takeaway Tools:
- List of regulations pertaining to stability excursion studies
- Best practices for designing and executing in-use stability studies
3:00 ET
Exhibitor Showroom and Networking Refreshment Break
3:30 - 5:00 ET
"Focus Topics C. Stability Trending, Excursions Studies, In-use Testing D. Data Integrity, Storage, and Electronic Documentation"
Moderators: Kayla Woodlief, MS, Director of Stability and Data Analytics, Vir Biotechnology, Inc; Yan Wu, M.S., Director, Analytical Chemistry in Development and Supply, Merck; Jing Capucao, Ph.D., Stability Manager, GSK Biopharm Global QC; Leanna Pearson, Associate Director of Quality, Compliance, and Quality, CAI; John O'Neill, PSDG Facilitator, Editor, StabilityHub.com
Stability Hot Topics
5:00 ET
Close of Day Two
7:30 ET
Exhibitor Showroom and Continental Breakfast
8:00 - 8:40 ET
Essential Statistics for Stabilitarians
Laura Pack, M.S., Head of CMC Quantitative Science, Moderna
Stability
• Why statistics for stability? Make objective data-driven decisions
• What is a “research question”? Learn how to articulate the analysis purpose
• Graphical practices to rigorous analysis – statistics that stabilitarians need
• Key elements of a statistical consultation: elevate collaboration to avoid rework
• Case study: Follow a research questions from elucidation through analysis to final results
Takeaway Tools
• Outline for a statistical consultation: what you (as a stabilitarian) need to bring to the table to ensure you ask for what you need
• Concept map for data collection
• Template excel file for statistical analysis of stability data
• References for statistical guidance and application methodology
8:50 - 10:20 ET
Challenges of Using Predictive Stability Concept - Case Studies
Yan Wu, Director, Analytical Chemistry in Development and Supply, MMD, Merck & Co.
Stability
• Industry trend in using science risk-based predictive stability approaches
• Challenges of using predictive stability tools at various stages in drug development and life cycle
• Case studies during new drug development stage
• Case studies during post-approval stage
Takeaway Tools
• White papers
• Example of predictive stability tools
• Case Studies publications
10:30-10:50 ET
Exhibitor Showroom
11:00 - 11:40 ET
Different Approaches to Addressing Cumulative Stability Requirements
Jing Capucao, Ph.D., Stability Manager, GSK Biopharm Global QC
Stability
11:45 - 12:25 ET
Planes, Trains, and Automobiles-Developing an Effective Protocol for Transportation Studies
Chris Latoz, Manager of Stability Services, Hollister Incorporated
Stability
- Purpose of transportation studies
- Planning
- ISO 11607 requirements
- Protocol design for medical devices
- Sample selection
- Stress conditions – (ASTM D4169)-shock and vibration, compression, pressure changes, temperature, humidity
- Test selection-ASTM F88, ASTM F2096, ASTM F1929
- Test acceptance criteria
- Considerations for sensitive drug products or biologics
- Takeaway Tools
- Sample Distribution/Transportation Protocol for a Medical Device
- Sample selection
- Stress conditions – (ASTM D4169)-shock and vibration, compression, pressure changes, temperature, humidity
- Test selection-ASTM F88, ASTM F2096, ASTM F1929
- Test acceptance criteria
12:30 ET
Networking Luncheon
1:30 - 2:10 ET
Telling the Stability Story - Reporting for Product Teams, Management, and Health Authorities
Lori McCaig, Ph.D., Director, Global Stability Program Management, Pfizer Inc.
- Identifying reporting needs for different stability stakeholders (internal and external)
- The regulatory foundations – Stability reporting in the ctd
- Reporting product changes, reporting product issues
- Stability in the Annual Product Quality Review
- Efficiency tools for routine reporting
- The future in the cloud
- Takeaway Tools
- Outline and checklist to create formal stability report templates
- Sample table templates
- Useful references and links
2:20 - 3:00 ET
Stability Chambers – An Overlooked but Critically Important Element of the Stability Program
Chris Latoz, Manager of Stability Services, Hollister Incorporated
- Considerations for stability chamber selection and purchase
- Calibration
- Review qualification (IQ, OQ, and PQ) of stability chambers
- Learn the importance of chamber re-qualification
- Key SOPs for stability chambers
- Takeaway Tools:
- Sample SOP for Qualification, Calibration, and Maintenance of Stability Chambers
- Article on “How to Investigate Temperature and Humidity Excursions of Stability Chambers”
3:00 ET
Networking Refreshment Break
3:20 - 4:00 ET
Understand Statistical Modelling and Evaluation of Stability Data
Tara Scherder, Principal, SynoloStats
4:10 - 4:50 ET
Post Conference Summary Report - Emerging Trends and Takeaways
John O'Neill, PSDG Facilitator, Editor, StabilityHub.com
5:30 ET
Close of Conference
Stability Testing & Program Management
- Challenges of Using Predictive Stability Concept – Case Studies
- Stability Beyond ICH: In-Use and Excursion studies
- Develop, Implement and Maintain a Risk-Based Stability Program
- Different Approaches to Addressing Cumulative Stability Requirements
- Effectively Apply Q1E Guidance to Evaluation of Stability Data
- Developing Change Control Strategies for Stability Program Post-Approval Changes
- Develop an Effective Protocol for Conducting Transportation Studies
- Stability Reports: What to do and how to explain your Stability Data effectively
- Challenges with Vaccine Stability Program – Case Studies
- Prepare the Stability Area for Regulatory Inspection
- Understand Statistical Modelling and Evaluation of Stability Data
- Stability Chambers Selection, Validation, and Calibration
Create Your Own Event! This Event is co-located with:
Analytical Procedures & Methods Validation | QC Excellence and Laboratory Management
For An Additional $995, You Can Earn 1.5 Graduate Credit Hours Towards Temple’s RAQA Graduate Program! For More Information, Email INFO@KENX.ORG, Call 856-281-7134 or Register Above.
Personnel in the Following Environments Should Attend:
Validation
QA/QC
Scientist
Chemist
Laboratory Management
Regulatory Affairs
Data Integrity
This event is also appropriate to business development and sales managers that offer innovative solutions for QC laboratory management, validation departments, data collection and statistics.
Faculty
