Previous PPAR meetings:

2015

2014

2013

2012

2011

2010

2009

2008

2007

2006

2005

2004

2003

2015 Meeting

2015 Group Photo

  • NIR Calibration Life Cycle
  • Strategic goals for Rapid Micro Methods: Moving beyond technologies to solutions
  • Key initiatives controlling raw material variability
  • NIST Acedemic Consortium
  • Applications of PAT to continuous DP Manufacturing
  • PAT in ADC production
  • Genentech Pilot Plant Tours
  • Disposable sensors

2014 Meeting

2014 Group Photo

2014 Group Photo

  • 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

2013 Group Photo

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

2012 Group Photo

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

2011 Group Photo

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

2010 Group Photo

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

2009 Group Photo

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

2008 Group Photo

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.

PPAR 2005 Attendees
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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.

2005 Benchmarking Survey

The 2005 Benchmarking Survey is being compiled and will be posted here.

2005 Discussions
Here is a sample of slides used to kick off the conversations in 2005:

 

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PPAR 2004 was held at the Genentech facility in South San Francisco, California, U.S.A.


2004 Benchmarking Survey

A fundamental purpose of PPAR is the ability to share best practices and do benchmarking. Here are the results from 2004.
(Disclaimer: This is not a statistically rigorous study and should be viewed as a 'for information only' resource. Survey results are used for seeding discussion on current practices and trends.)

2004 Discussions

Here is a sample of slides used to kick off the conversations (and debates) in 2004:

 

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PPAR 2003 was held on the University of Michigan campus in Ann Arbor, Michigan, U.S.A.

PPAR 2003 Attendees
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2003 Discussions

 

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