• Welcome, Overview IFPAC-08
  Melvin V. Koch, Co-Chairman, CPAC, Seattle, WA and Moheb M. Nasr, Co-Chairman, CDER, FDA, Silver Spring, MD
  

• IFPAC: Soaring to New Heights - Perspective of Space Travel relating to Engineering and Science; Process Control and Pharmaceutical Development
  Dr. Lawrence J. Delucas, Director, Center for Biophysical Sciences and Engineering at the University of Alabama, Birmingham
  

• The FDA's Critical Path Initiative (TBA)
  Dr. Janet Woodcock, Deputy Commissioner, FDA, Rockville, MD
  

• QbD/PAT: Industry Perspective I (TBA)
  Raymond H. Scherzer, Senior Vice President, Engineering, Technology & Capital Management, GSK, UK
  

• Emerging Interest in Converting Feedstock to Bio-Feed Stock and the Importance of Process Intensification.
  Ray Stark, Jennifer Homegran, and Michelle Cohen, Honeywell
  

• IFPAC Achievement Award, sponsored by ExxonMobil
  Presenter: Jeff Gunnell, EssonMobil Chemical, Cowdenbeath, Fife, UK
  

• OnSite Determinants: Key Note Homeland Security, Forensics and Environmental Remediation
  Milt Statheropoulos, Natl. Technical University of Athens, Greece
  

• BioBase Sustainability Initiatives
  Randy Guschl, DuPont
  

• Process Analytical Technologies (PAT) - The Impact for Process Systems Engineering
  Julian Morris, Zeng-Ping Chen and David Littlejohn, Centre for Process Analytics and Control Technology,School of Chemical Engineering and Advanced Materials, Newcastle University, UK, Department of Pure and Applied Chemistry, Strathclyde University, Glasgow, Scotland.
  

• FDA Introduction: QbD
  Chi-wan Chen, FDA, Rockville, MD
  

• API Design Space (Novartis-Micronization)
  Author's TBA, Novartis, Suffern, NY
  

• QbD and Real-time Release in Year 2 After the First Approval
  Gert Thurau, Merck & Co., Inc., West Point, PA
  

• Physical and Chemical Characterization as a Strategy for Quality by Design
  E. Neil Lewis, Kenneth S. Haber, Frederick W. Koehler IV, Linda H. Kidder and Suzanne J. Hudak, Malvern Instruments, Columbia, MD
  

• Pharmaceutical Quality by Design - What is it and What are the Barriers for Implementation
  Prabir K Basu, NIPTE, West Lafayette, IN
  

• QbD Panel Discussion-AM
  All AM Presenters
  

• On-line Monitoring of Biodiesel Components with Raman Spectroscopy
  Michael J. Donahue, B&W Tek, Inc., Newark, DE
  

• The Use of PAT Tools in Biodiesel Production
  Jose C Menezes, Technical Univ Lisbon - Portugal, Dept Chemical & Biological Engineering, Lisbon, Portugal
  

• Optimizing fermentation systems in bio-pharmaceutical production using radio-frequency dielectric spectroscopy.
  J.P. Carvell & R.W. Todd, Aber Instruments Ltd., Aberystwyth, UK
  

• Automated Reactor Sampling - A PAT Enabling Technology
  George E. Barringer, Groton BioSystems, Boxborough, MA
  

• Monitoring Bioreactor Media Components and Products with On-Line LC
  Rick E. Cooley, Dionex Corporation, Bannockburn, IL
  

• PAT for Bio Processing
  Robert Mattes, Applications Scientist, Foss NIRSsystems, Inc., Laurel, MD
  

• In-Process Monitoring of Fermentation Processes
  Des O'Grady, Mettler Toledo AutoChem, Columbia MD
  

• Time-Domain Terahertz (THz) Measurements for Beta Gauge Replacement Applications
  Jeffrey White, Picometrix LLC, Ann Arbor, MI
  

• Reactive Spectrometers for Field Based Material Analysis
  Robert L. Green and Christopher D. Brown, Ahura Scientific, Wilmington, MA
  

• Using Quantum Cascade Lasers to Achieve Low-cost, In-line FTIR Capabilities in Process Control
  Miles J. Weida, Daylight Solutions, Poway, CA
  

• Widely Tunable DFB Laser Diodes for Gas Sensing Applications
  Wolfgang Zeller, Nanoplus GmbH, Gerbrunn, Germany
  

• Prism-based Cavity Ring-down Spectroscopy with Broadband Super-high
  Reflectivity
  Hongbing Chen, Yu Chen and Wen-Bin Yan, Tiger Optics, Warrington, PA
  

• Affordable Mini-Cavity Ring-Down Spectroscopy Gas Analyzer for Process Analysis
  Wen-Bin Yan, Tiger Optics, Warrington, PA
  

• Optimizing Biofuel Processes Using Online Process Mass Spectrometry
  Robert G. Wright (presenting author), Thermo Fisher Scientific, Process Instruments Division, Winsford, UK, Peter J. Traynor, Thermo Fisher Scientific, Process Instruments Division, Sugar Land, TX
  

• PAT - driven developments in Process Mass Spectrometry
  Tony Slapikas, Ametek Process & Analytical Instruments, Pittsburgh, PA and Rafael Arguelles, Joseph Ocando, Pfizer, Brooklyn, NY
  

• MS work and new developments in portable MS/MS systems
  Dr. Garth Patterson, Griffin Analytical Technologies, West Lafayette, Indiana
  

• Process Development with In-situ Mass Spectrometry
  Mark LaPack - Eli Lilly
  

• Petrochemical Gas Analyses - A New Frontier for On-Line Raman Spectroscopy
  Phillip Human, Project Manager, Analyzer Projects, Sasol Synfuels, Secunda, South Africa, and Peter van Vuuren, Process Analytics Consultant, Kingwood, TX
  

• Authentication of Incoming Raw Materials by Handheld Raman: Selectivity Studies within Groups of Similar Compounds
  Robert C. Brush, Robert L. Green, Wayne Jalenak and Christopher D. Brown, Ahura Scientific, Wilmington, MA
  

• Enhanced Raman Spectroscopy by Means of Multiple Pass Laser Excitation
  W. Michael Doyle, Axiom Analytical, Inc., Irvine, CA
  

• Petrochemical Applications of In-Situ Raman Spectroscopy
  George H. Vickers and Allen B. Mossman, BP America, Naperville, IL
  

• Raman Process Monitoring: Instrumental Solutions for On-line and At-line Analysis
  Norman Wright, Hamilton Sundstrand AIT, Pomona, CA
  

• Raman Spectroscopy (TBA)
  Ian Lewis, Kaiser Optical, Ann Arbor, MI
  

• Raman Imaging - Fast Enough for Process and Quality Control?
  Andrew Whitley, Horiba Jobin-Yvon
  

• Raman Gas Analysis and Control of Biomass Conversion Systems
  Ronald R. Rich, Atmosphere Recovery, Inc., Plymouth, MN
  

• Raman imaging - fast enough for process and quality control?
  Eunah Lee, HORIBA Jobin Yvon, Edison, NJ
  

• Borrowing from the Laboratory for Process Informatics
  Gregory Banik, Bio-Rad Laboratories, Infomatics Division, Philadelphia, PA
  

• Advanced Analyzer Control & Information Software: A 3rd Party Approach
  Jon S. Gethner, Adaptive Analyzer Technologies, New York, NY
  

• Deployment of a Multi-user Web-based Chemometric Prediction Engine
  Richard P. Gill, John J. O'Neill and Sadia Abid, Sun Chemical Security, Centerbrook, CT
  

• Moving Towards a Data Rich COPA Environment
  Carl Rechsteiner, Chevron ETC, Richmond, CA
  

• The Development of Chemometrics for PAT in Pharmaceutical Manufacturing
  Mark R. Smith, Pfizer, UK
  

• Beyond Octane Number: Predicting Numerous Fuel Properties from Raman
  Spectra using Chemometrics
  Wayne Smith, Carl Brouillette, and Stuart Farquharson, Real-Time Analyzers, Inc.,
  Middletown, CT
  

• PAT & Chemometrics
  Busolo Wabuyele, Novartis
  

The goal of this brainstorming session is to identify a long-term (10-yr) vision for biomanufacturing and outline the critical scientific and technical hurdles to implementation. This will be important for coordinating research priorities for the industry and designing federal and academic programs to help address the major technical roadblocks. There will be three brief overviews:

• Future Biomanufacturing: Possible Directions and Tools for Change
  Duncan Low, Amgen
• Where PAT Fits into the FDAÕs 21st Century Initiative
  Keith Webber, FDA/CDER
• The Path Forward
  Albert Lee, NIH/NIBIB

An audience session will follow, where we will focus on two questions:
1. What is the desired state of biomanufacturing technology in the long term (2018) and what scientific and technological roadblocks must be overcome?
2. What are the near term (1-2 years) priorities in terms of technological needs for the successful implementation of PAT?

This session is organized by NIH, FDA, NIST and MIT.

• PAT Training Tools: What can be learned from Petrochem's 60 years of Experience
  Walter Henslee, Editor-in-Chief (J. Process An. Chem.); Scientist, Dow Chemical (retired);
  Jeff Gunnel, ExxonMobil Chemical, Cowdenbeath, Fife, UK
  

• Plus
  Designing a PAT Curriculum
  Anthony J. Arturi, Stevens Institute of Technology
  

  This paper describes the architecture of the PAT course offerings in the graduate PME curriculum at Stevens Institute of Technology; design and content of individual courses; and correlates this to current and perceived needs of students, industry and academia. Experience and student reactions will also be described.