The PPAR archive preserves the historical record of past roundtable meetings and organizes available presentation and meeting materials by year. Materials may include agendas, topic-introduction decks, benchmarking surveys, discussion materials, photos, brochures, and other archive materials.
2025 — Recipharm Advanced Bio, Watertown, MA:
Summary:
The 2025 PPAR meeting at Recipharm Advanced Bio in Watertown, Massachusetts continued the roundtable’s focus on practical PAT implementation, benchmarking, emerging technologies, digital twins, bioprocess modeling, regulatory discussion, and new technology evaluation.
Discussion Focus:
- PAT benchmarking
- Emerging technologies
- Digital twins and bioprocess modeling
- Regulatory discussion
- New technology evaluation
- ICH guidance and regulatory references
Available Materials:
- Event Program / Agenda
- Benchmarking Survey
- Emerging Technology
- Digital Twins / Modeling
- Regulatory
- Regulatory References
- Prior-Year Summary
Key Topics:
PAT benchmarking, regulatory strategy, digital twins, bioprocessing, emerging technology, ICH guidance
Summary:
The 2024 PPAR meeting hosted by Takeda focused on practitioner discussion across new technologies, industry PAT survey findings, PAT for new modalities, business case development, adaptive sensor fusion, AI/ML and digital twins, PAT technology transfer to manufacturing, model validation, and laboratory-based PAT implementation.
Discussion Focus:
- New technologies
- Industry PAT survey findings
- PAT for new modalities
- Business case development
- Adaptive sensor fusion
- AI/ML and digital twins
- PAT technology transfer to manufacturing
- Model validation
- Laboratory-based PAT implementation
Available Materials:
- Event Brochure / Program
- New Technologies
- Technology Survey
- PAT Business Case
- Industry Forum / Emerging Technologies
- Reference / Roadmap
- Highlights
Key Topics:
new technologies, industry PAT survey, new modalities, business case development, adaptive sensor fusion, AI/ML, digital twins, PAT tech transfer, model validation, lab tours, automation
Summary:
The 2023 PPAR archive currently includes benchmarking survey material from the BMS-hosted meeting. This year remains part of the ongoing historical record of industry PAT practices, implementation trends, and benchmarking discussion.
Discussion Focus:
- PAT benchmarking
- Survey results
- Industry practices
- Implementation trends
Available Materials:
- Benchmarking Survey
Key Topics:
PAT benchmarking, survey results, industry practices, implementation trends
Button:
View Materials → /ppar-presentations/2023/
2022 — Duquesne University, Pittsburgh, PA
Summary:
The 2022 PPAR meeting remains part of the historical meeting record.
Discussion Focus:
Discussion topics are not currently available for this year.
Available Materials:
Materials are not currently available for this year.
Key Topics:
Not currently available.
Summary:
The 2021 PPAR meeting continued discussion around PAT benchmarking, real-time release testing, digital transformation, PAT talent development, regulatory and modeling topics, biopharmaceutical applications, advanced process control, MSPC case studies, and emerging technology needs.
Discussion Focus:
- PAT benchmarking
- Real-time release testing
- Digital transformation
- PAT talent development
- Regulatory and modeling topics
- Biopharmaceutical applications
- Advanced process control
- MSPC case studies
- Emerging technology needs
Available Materials:
- Program / Agenda
- Benchmarking Survey
Key Topics:
RTRT, PAT benchmarking, digital transformation, PAT talent, regulatory strategy, modeling, biopharmaceutics, APC, MSPC, technology needs
Summary:
The 2020 PPAR meeting was held virtually and focused on digital transformation, mechanistic and hybrid modeling, PAT in operational excellence, new technology needs, cell and gene therapy process analytics, real-time release testing, model lifecycle management, PPAR outreach, and technology benchmarking.
Discussion Focus:
- Digital transformation
- Mechanistic and hybrid modeling
- PAT in operational excellence
- New technology needs
- Cell and gene therapy process analytics
- Real-time release testing
- Model lifecycle management
- PPAR outreach
- Technology benchmarking
Available Materials:
- Program
- PPAR Outreach
- New Technology Slides
- PAT Benchmarking Survey
Key Topics:
digital transformation, mechanistic modeling, hybrid modeling, control strategy, operational excellence, cell and gene therapy, RTRT, model lifecycle management, PPAR outreach, technology benchmarking
2019 — AbbVie, North Chicago, IL
Summary:
The 2019 PPAR meeting hosted by AbbVie in North Chicago focused on PAT benchmarking, modeling and simulation, regulatory discussion, Industry 4.0 and data architecture, continuous manufacturing, new and disruptive technologies, MVDA, outsourcing, and academic/industrial outreach.
Discussion Focus:
- PAT benchmarking
- Modeling and simulation
- Regulatory discussion
- Industry 4.0 and data architecture
- Continuous manufacturing
- New and disruptive technologies
- MVDA
- Outsourcing
- Academic/industrial outreach
Available Materials:
- 2019 Agenda
- PPAR Model Discussion
- PPAR PAT Benchmarking Survey
Key Topics:
PAT benchmarking, modeling, simulation, regulatory strategy, Industry 4.0, data architecture, continuous manufacturing, MVDA, outsourcing, new technologies
2018 — Hovione, East Windsor Township, NJ
Summary:
The 2018 PPAR meeting was hosted by Hovione in New Jersey and remains part of the historical PPAR meeting record.
Discussion Focus:
- Regulatory aspects
- Technology novelties
- People and organization
- Continuous manufacturing
- Process control
- Product release
- PAT implementation
Available Materials:
Materials are not currently available for this year.
Key Topics:
regulatory aspects, technology novelties, people and organization, continuous manufacturing, process control, product release, PAT implementation
2017 — Host/location to be confirmed
Summary:
The 2017 PPAR meeting remains part of the historical meeting record.
Discussion Focus:
Discussion topics are not currently available for this year.
Available Materials:
Materials are not currently available for this year.
Key Topics:
Not currently available.
2016 — Host/location to be confirmed
Summary:
The 2016 PPAR meeting remains part of the historical meeting record.
Discussion Focus:
Discussion topics are not currently available for this year.
Available Materials:
Materials are not currently available for this year.
Key Topics:
Not currently available.
2015 — Genentech, South San Francisco, CA
Summary:
The 2015 PPAR meeting hosted by Genentech included discussion around NIR calibration lifecycle management, rapid microbiological methods, raw material variability, academic consortium activity, PAT for continuous drug product manufacturing, PAT in ADC production, disposable sensors, and Genentech pilot plant tours.
Discussion Focus:
- NIR Calibration Life Cycle
- Strategic goals for Rapid Micro Methods: moving beyond technologies to solutions
- Key initiatives controlling raw material variability
- NIST Academic Consortium
- Applications of PAT to continuous drug product manufacturing
- PAT in ADC production
- Genentech Pilot Plant Tours
- Disposable sensors
Available Materials:
Materials are not currently available for this year.
Key Topics:
NIR calibration, rapid microbiological methods, raw material variability, academic consortium, continuous manufacturing, ADC production, pilot plant tours, disposable sensors, Genentech, PAT implementation
Summary:
The 2014 PPAR meeting hosted by GSK included discussion around model validation and maintenance, method transfer, standards preparation, parallel testing, regulatory interaction, big data and lifecycle management, rapid microbiological and biological methods, disposable sensor guidelines, electronic data exchange standardization, continuous drug product manufacturing, and software backward compatibility for PAT and modeling.
Discussion Focus:
- Model validation, maintenance, method transfer, and standards preparation
- Parallel testing
- Live meeting with Christine Moore, FDA
- Big data on lifecycle management
- Rapid microbiological and biological methods
- Disposable sensor guidelines
- Standardization of electronic data exchange formats between suppliers and pharma
- PAT considerations for continuous drug product manufacturing
- Backward compatibility of software for PAT and modeling, including regulatory implications
Available Materials:
Materials are not currently available for this year.
Key Topics:
model validation, method transfer, standards, FDA interaction, lifecycle management, rapid micro methods, biological methods, disposable sensors, data exchange, continuous manufacturing, software compatibility, regulatory implications
Summary:
The 2013 PPAR meeting was hosted by BMS on October 2–3 in New Brunswick, New Jersey. Discussions focused on raw material variability and global supply chain issues, rapid microbiological methods, disposable sensors and disposable processing equipment, drug product development and manufacturing operations, biopharmaceutical real-time analytical suites, RTRT and in-process method expectations, real-time analytics business strategies, PAT and contract manufacturing, and PAT data management software.
Discussion Focus:
- Raw Materials Variability / Global Supply Chain
- Rapid Micro Methods
- Disposable Sensors and Disposable Processing Equipment
- Drug product development and manufacturing operations
- Biopharmaceutical real-time analytical suite
- Regulatory expectations for RTRT and in-process methods
- Business strategies for applying real-time analytics
- PAT and contract manufacturing
- PAT data management software
Available Materials:
- Raw Materials Variability / Global Supply Chain
- Rapid Micro Methods
- Disposable Sensors and Disposable Processing Equipment
Key Topics:
raw material variability, global supply chain, rapid micro methods, disposable sensors, disposable processing, real-time analytics, RTRT, in-process methods, contract manufacturing, PAT data management
2012 — Eli Lilly, Indianapolis, IN
Summary:
The 2012 PPAR meeting was hosted by Eli Lilly in Indianapolis, Indiana. Discussion areas included raw material variability, raw material CQAs, global supply chain, the business case for PAT, collaborative instrument development, CRO/CMO challenges in a QbD environment, high-N specifications and statistics, recent regulatory experiences, industry standards sharing, new and emerging technologies, disposable sensing, and regulatory authority engagement.
Discussion Focus:
- Raw Materials Variability / RM CQAs / Global Supply Chain
- Business Case for PAT
- Approaches to Collaborative Instrument Development
- Issues associated with CRO/CMO in a QbD world
- Specs and Statistics for High N
- Recent Regulatory Experiences and Industry Standards Sharing
- Discussion of New/Emerging Technologies, including disposable sensing
- Discussions with Regulatory Authorities
Available Materials:
Materials are not currently available for this year.
Key Topics:
raw material variability, RM CQAs, global supply chain, business case, collaborative instrument development, CRO/CMO, QbD, high-N statistics, regulatory experience, industry standards, emerging technologies, disposable sensing
2011 — Amgen, West Greenwich, RI
Summary:
The 2011 PPAR meeting was hosted by Amgen on September 26–27 in West Greenwich, Rhode Island. The meeting focused on raw material variability, QbD-PAT control strategy, regulatory updates, PAT data management, IT infrastructure, MVDA across the product lifecycle, continuous processing, technology gaps, new applications for small and large molecules, PAT benefits, PAT at contract manufacturing organizations, technology development strategies, process development lab tours, PAT demos, and sample-size determination.
Discussion Focus:
- Raw Materials Variability / RM CQAs / Global Supply Chain
- QbD-PAT: PAT tools enabling control strategy for CQAs
- Regulatory updates
- Data management for PAT
- IT infrastructure
- MVDA across online/offline and product lifecycle use cases
- Continuous processing and role of PAT
- Technology gaps
- New technologies and applications for small and large molecules
- PAT Benefits Case
- PAT at Contract Manufacturing Organizations
- Technology Development Strategies
- Tour of Process Development Labs and PAT demos
- Sample Size Determination / PQRI meeting update
Available Materials:
- Continuous Processing / RTRT
- New Technologies — Small Molecules
- New Technologies — Large Molecules
- Control Strategy / CQAs / Regulatory
- Raw Material Variability / Supply Chain
- Data Management / IT Infrastructure / MVDA
- Business Case / PAT Benefits
Key Topics:
raw material variability, CQAs, QbD-PAT, control strategy, regulatory updates, data management, IT infrastructure, MVDA, continuous processing, technology gaps, small molecules, large molecules, PAT benefits, contract manufacturing, process development labs, sample-size determination
Summary:
The 2010 PPAR meeting was hosted by Vertex on October 26–27 in Cambridge, Massachusetts. The meeting focused on using PAT as an enabler for process understanding, PAT IT infrastructure, new technologies for small and large molecules, application opportunities and technology gaps, raw material characterization, regulatory activity and filing experiences, international guidance learnings, regulatory submissions including RTR, and continuous processing.
Discussion Focus:
- Road map for using PAT as a technology/enabler for process understanding
- PAT IT infrastructure
- New technologies aimed at small molecules
- New technologies aimed at large molecules
- Outstanding application opportunities and technology gaps
- Raw material characterization, verification, and conformity
- Recent regulatory activities, discussions, and interactions
- Rest-of-world guidance and filing experience sharing
- Regulatory submissions including RTR
- Continuous Processing
Available Materials:
Materials are not currently available for this year.
Key Topics:
process understanding, PAT IT infrastructure, new technologies, small molecules, large molecules, technology gaps, raw material characterization, regulatory activities, global guidance, filing experience, RTR, continuous processing
2009 — Novartis, East Hanover, NJ and Suffern, NY
Summary:
The 2009 PPAR meeting was hosted by Novartis on October 13–14 in East Hanover, New Jersey and Suffern, New York. Available materials reflect discussion around academia collaboration, NIH perspectives, continuous applications, MVDA, regulatory topics, biologics, advanced process control, process validation, and continuous processing.
Discussion Focus:
- Academia collaboration
- NIH perspectives
- Continuous applications
- MVDA
- Regulatory topics
- Biologics
- Advanced process control
- Process validation
- Continuous processing
Available Materials:
- Academia Presentation
- NIH Presentation
- Continuous Applications Presentation
- PPAR MVDA Presentation
- Regulatory Presentation
Key Topics:
academia, NIH, continuous applications, MVDA, advanced process control, biologics, regulatory guidance, process validation, continuous processing, NIR
2008 — Biogen Idec, Research Triangle Park, NC
Summary:
The 2008 PPAR meeting was hosted by Biogen Idec on October 7–8 in Research Triangle Park, North Carolina.
Discussion Focus:
Discussion topics are not currently available for this year.
Available Materials:
Materials are not currently available for this year.
Key Topics:
Not currently available.
Summary:
The 2007 PPAR meeting was hosted by Merck & Co. on October 9–11 in West Point, Pennsylvania. Thirty-five PAT experts representing 20 pharmaceutical companies participated in two days of discussion. Topics included the evolving definition of PAT, PAT’s relationship to QbD, standards and guidance work, pharmaceutical and biopharmaceutical implementation examples, multivariate process analysis, latent variable modeling, and PAT implementation with contract manufacturers.
Discussion Focus:
- Current definition of PAT and its relationship to QbD
- PAT/QbD standards, white papers, and guidances
- Pharmaceutical PAT implementation examples
- Biopharmaceutical PAT implementation examples
- Multivariate process analysis and latent variables
- PAT implementation with contract manufacturers
Available Materials:
- Agenda / Meeting Program
Key Topics:
PAT definition, QbD, standards, white papers, guidance, pharmaceutical implementation, biopharmaceutical implementation, MVDA, latent variables, contract manufacturing
Summary:
PPAR 2006 was hosted by Amgen from October 17–19 at the University Tower Hotel in Seattle, Washington. The meeting included agenda and regulatory status discussion, statistical treatment for large sample sizes, standards development, biologics versus small molecules, international aspects of PAT, business case development, and ISPE Community of Practice activity.
Discussion Focus:
- Status of PAT Today
- Agenda and Regulatory Status
- Statistical Treatment for Large Sample Sizes
- Developing Standards
- Biologics vs. Small Molecules
- International Aspects
- Business Case for PAT
- ISPE Community of Practice
Available Materials:
- Agenda and Regulatory Status
- Statistical Treatment for Large Sample Sizes
- Developing Standards
- Biologics vs. Small Molecules
- International Aspects
- Business Case for PAT
- ISPE Community of Practice
Key Topics:
PAT status, regulatory status, statistics, large sample sizes, standards, biologics, small molecules, international regulatory perspectives, business case, ISPE Community of Practice
Summary:
PPAR 2005 was held September 27–29 on the Pfizer La Jolla campus in San Diego, California. The meeting followed an interactive and informal roundtable format, with schedule adjustments made during the meeting. Materials included the 2005 schedule, benchmarking survey activity, and discussion-starter slides used to kick off conversations.
Discussion Focus:
- Detailed schedule of activities
- Interactive roundtable discussion format
- Benchmarking survey activity
- Discussion starters used to kick off conversations
- Practical approaches
- PAT infrastructure
- Development versus manufacturing applications
- Bioprocess sensing
- Specification setting
- FDA questions
- Lessons from process analytics practices in the chemical industry
Available Materials:
- 2005 Schedule
- 2005 Benchmarking Survey
- Discussion Materials
Key Topics:
interactive roundtable, benchmarking survey, discussion starters, practical approaches, Pfizer La Jolla, PAT implementation, infrastructure, FDA questions, bioprocess sensors, specifications, development vs. manufacturing, informal technical exchange
2004 — Genentech, South San Francisco, CA
Summary:
The 2004 PPAR materials reflect a formative period of PAT definition, regulatory development, and organizational benchmarking. Discussion areas included FDA PAT Guidance, international regulatory perspectives, benchmarking of PAT/PAC organizations, biotech manufacturing technologies, student training, and vendor audit practices.
Discussion Focus:
- Benchmarking
- Regulatory / FDA
- Biotech / Process Monitoring
- Workforce / Training
- Vendor / Standards
- FDA PAT Guidance
- International regulatory perspectives
- PAT/PAC organization benchmarking
- Biotech manufacturing technologies
- Student training
- Vendor audit practices
Available Materials:
- Benchmarking
- Regulatory / FDA
- Biotech / Process Monitoring
- Workforce / Training
- Vendor / Standards
Key Topics:
FDA PAT Guidance, benchmarking, biotech manufacturing, regulatory strategy, vendor audits, student training, PAT organization
2003 — University of Michigan, Ann Arbor, Michigan
Summary:
The 2003 PPAR meeting captured early industry discussion around PAT organizational structures, benchmarking, vendor auditing, FDA and industry engagement, and the formation of working sub-teams. This year represents one of the earliest archive points for the roundtable’s role in connecting PAT practitioners across pharmaceutical companies, academia, and related organizations.
Discussion Focus:
- PAT organizational structures
- Benchmarking
- Vendor auditing
- FDA and industry engagement
- Formation of working sub-teams
- Early PAT community-building
Available Materials:
- Meeting Summary
Key Topics:
PAT foundations, benchmarking, vendor auditing, FDA engagement, steering committee, industry collaboration