2014 Meeting

• Model validation, maintenance, Method Transfer and standards preparation, Parallel Testing subtopic
• Live meeting with Christine Moore, FDA
• Big Data on lifecycle management
• Rapid micro and biological methods
• Disposable sensor guidelines
• Standardization of electronic data exchange formats between suppliers and Pharma
• PAT Considerations for Continuous DP Manufacturing
• Backward compatibility of software for PAT and Modeling and regulatory implications

The 2013 PPAR was hosted by BMS on October 2nd and 3rd in New Brunswick New Jersy

• 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
• Continuous manufacturing
• New technologies
• API - chemical development laboratory
• Clinical supplies manufacturing

The 2012 PPAR was hosted by Eli Lilly in Indianapolis, IN

• 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

The 2011 PPAR was hosted by Amgen on September 26-27 in West Greenwich Rhode Island

• 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 (online/offline, product lifecycle)
• Continuous Processing and Role of PAT
• PAT Hot Topics: Technology gaps, New technologies/applications: 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 (Sept. 12-13, 2011, PQRI meeting update)

The 2010 PPAR was hosted by Vertex on October 26-27 in Cambridge, MA

• Road map for using PAT as a technology/enabler for Process Understanding
• PAT IT infrastructure
• New Technologies
• Aimed at small molecules
• Aimed at large molecules
• Outstanding application opportunities/technology gaps
• Raw material characterization (verification and conformity)
• Recent regulatory activities/discussions/interactions
• What is happening in the ‘Rest of the World’; sharing learnings/information on guidances/filing experiences etc
• Regulatory submissions including RTR
• Continuous Processing

The 2009 PPAR was hosted by Novartis on October 13-14 in East Hanover, NJ and Suffern, NY

• Academia Presentation
• NIH Presentation
• Continous Applications Presentation
• PPAR MVDA Presentation
• Regulatory Presentation

The 2008 PPAR was hosted by Biogen Idec, on October 7-8 in the Research Triangle Park (RTP), NC.

The 2007 PPAR was hosted by Merck & Co., Inc., on October 9-11 in West Point, PA. Thirty-five PAT experts representing 20 pharmaceutical companies participated in two days of discussions.

For the agenda from the 2007 PPAR, click here. A selection of topics covered at the meeting include:

• What is the (current) definition of PAT? What is its role in/relationship to QbD?
• PAT/QbD: Review of selected current actively-pursued standards, white papers, and guidances (including ASTM E 55, ISPE white paper, PhRMA teams, etc.)
• Experiences from a PAT implementation example in the pharmaceutical environment
• Experiences from a PAT implementation example in the bio-pharm environment
• Experiences with PAT studies using multivariate process analysis and use of latent variables
• PAT implementation with contract manufacturers

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PPAR 2006 was hosted by Amgen from October 17-19 at the University Tower Hotel in Seattle,
Washington, USA. For the agenda of PPAR 2006, click here for the Word or PDF file.

PPAR 2006 delegates during the tour of the Amgen Helix facility.

2006 Benchmarking Survey
The 2006 Benchmarking Survey is being compiled and will be posted here.

2006 Discussions
There are no formal presentations at PPAR, but instead a series of discussion topics.
Here is a selection of slides used to kick off the conversations in 2006.

Status of PAT Today	Practical Approaches
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

 

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PPAR 2005 was held from September 27-29 on the Pfizer La Jolla campus in San Diego, California, U.S.A.


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For reference, here is a detailed schedule of activities at the 2005 meeting. Due to the interactive, informal nature of the roundtable discussion format, the schedule was subject to some on-the-fly modification.