1. INTRODUCING THE AIChE PROCESS DEVELOPMENT DIVISION (#12) New Jersey Section Meeting September 9, 2003 John F. Peragine Bristol-Myers Squibb

2. 2 Agenda Effective process development The “new” Process Development division Benefits to New Jersey section Strategies and key deliverables to members Important achievements Future programming Summary of benefits

3. 3 Effective Process Development New product or process ideas Superior process research and innovation Detailed pilot plant scale-up Thorough technology transfer Quality manufacturing leading to successful commercialization

4. 4 The “New” Process Development Division Benefits to New Jersey section History Current structure- Process Research and Innovation, Pilot Plants, Technology Transfer, Manufacturing sub-groups Vision/goals/leadership

5. 5 Benefits to New Jersey Section Small but growing division follows product/process development from initial research, through scale-up, transfer of technology, and into manufacturing Direct linkage to national AIChE events Networking with peers and students Co-sponsoring opportunities with many divisions (in particular, Division #15)

6. 6 Process Development Division Brief History PDD started in 1984 as Pilot Plant Committee/Area in the Engineering Group (Group 12) In 1996, the expansion of the Pilot Plant Area was agreed upon and the Group name was changed from “Engineering” to “Process Development” In 1997, a new structure of the group was established, consisting of 12a Process Research and Innovation, 12b Pilot Plants, 12c Technology Transfer, 12d Manufacturing In 2000, probational Division status was granted by CTOC In 2002, permanent Division status was granted by CTOC

7. 7 Process Development Division Vision and Goals Our vision is to provide leadership in the development of the next-generation technologies for process development Promote programming and presentations of process development topics at the Spring and Annual Meetings of the Institute, and at the Process Development Symposium (first one in 6/03) Promote the interchange of ideas, concepts and history of process development in various aspects, from theory to hardware Provide a continuous forum for communication, sharing ideas, learning new concepts and benchmarking Promote networking and communication among those involved in process development Promote the teaching of process development, thereby improving interactions between industry and academia

8. 8 Process Development Division Current Leadership Chair: John E. Corn (Consultant; Professor at Ohio State University) Chair-Elect: Christine Seymour (Pfizer) Treasurer: Jean Bender (Genentech) Programming Chair: Raymond Rooks (Dow) Membership Chair: Ramesh Rameswaran (Lyondell) Newsletter Editor: Nicolette Modes (Abbott) Webmaster: Jack Vinson (Pfizer) Awards Committee Chair: Glen Wheeler (Alkermes) International Liaison: Kamlesh Bhatia (DuPont) Process Development Symposium Chair: Cawas Cooper (Air Products) Special Projects: Ka M. Ng (Hong Kong UST) 12a Cheryl Teich (Rohm & Haas), Yinlun Huang (Wayne State), Lionel O’Young (CWB Technology) 12b A. (Bob) Duggal (Ethyl), David Edwards (Zeton), Joe Powell (Shell) 12c John F. Peragine (Bristol-Myers Squibb), Annette Johnston (Abbott), Osman Aboul-Nasr (Fluor) 12d John Battler (Consultant), Helen Lou (Lamar), Stephanie Sullivan (Merck)

9. 9 Advantages of Becoming a Division Increased credibility & visibility –Encourage more participation in the division –Easier to get management approvals for attendance –Improved recruitment of new members –Make it easier to present and share info at meetings Common ground - linkage between Academia and Industry

10. 10 Strategies and Key Deliverables to Members Technical/topical sessions at AIChE mtgs Process development focussed symposia/workshops/seminars/short courses Proc. Dev. Resources; latest news and info Professional development; networking; recognition Benchmarking opportunities Dialog among specialists; plant tours

11. 11 Professional Development Attend Division sponsored activities –Technical sessions at AIChE meetings –Process development symposia –Topical conferences –Short courses Develop leadership and organizational skills by participating in Division activities

12. 12 Networking Interact with peers from industry and academia at group dinners and mixers Develop relationships for mentoring and career development Access a comprehensive membership list of peers active in Process Technology - future

13. 13 Benchmarking Best practices in Process Technology –Round table & panel discussions on specific topics –Pilot plant benchmarking survey - results in 11/03 at SF mtg; technology transfer benchmarking survey anticipated for 2004 Plant, pilot plant & laboratory tours - future Consortia sponsorships Centers of excellence - future

14. 14 Recognition Annual Division sponsored awards for outstanding contributions to the field of Process Development and Technology Certificates/plaques recognizing service to the Division

15. 15 News and Information Division web-site (www.pd-aiche.com) –Members only area with enhanced features - future Discussion groups Links to key resources –Consultants, contract research/manufacturing, suppliers, related societies, etc. Membership list Resume/job postings Division newsletter

16. 16 Important Achievements Permanent divisional status Programming (topical and general sessions at Spring national and Fall annual mtgs) The First Process Development Symposium Web site & newsletter Increased membership Awards Division by-laws

17. 17 Programming F99 Dallas topical on research to development; S00 topical on technology transfer F00 LA & S01 Houston sessions F01 Reno topical on batch processing; S02 New Orleans topical on process improvement F02 Indianapolis & S03 New Orleans First PD Symposium (6/03) in Poconos 72 attendees F03 SF topicals on innovation & pilot plant Second PD Symposium - Summer 2004 Chicago area S04 New Orleans & F04 Austin

18. 18 Spring 2003 - New Orleans 12 a - Role of Innovation in extending the life of Mature Products 12 b - New Trends and Best Practices in Pilot Plants I and II 12 c – Analytical Technology Transfer: the Good, the Bad, and the Ugly 12 d - Case Studies and Lessons Learned

19. 19 First PD Symposium - “Accelerating Process Development for Growth” 22 June 2003 (evening reception) - 25 June 2003 @ Split Rock, Poconos, PA Batch Process Development for Pharmaceuticals & Specialty/Fine Chemicals Continuous Process Development for Petro/Commodity Chemicals Visionary Talks and Panel Discussion Table-Top Displays

20. 20 Batch Session “ An Integrated Development Approach to API Process R&D ” “ Process Development for the 21st Century Pharmaceutical Industry ” “ Notes on Process Development: Pharmaceutical Intermediates and APIs ” - Ed Paul “ Pick the Best Route: We Need It Tomorrow ” ! “ Successful Chemical Process Development: Profitable Specialty Chemical Products Using Winning Work Practices ”

21. 21 Continuous Session “ Recent Advances in the Application of Molecular Sieve Catalysts for the Commercial Production of Aromatics ” “ Development of Catalyst Impregnation Processes ” “ Using Physical Property Models to Accelerate Process and Product Development ” “ Flow Visualization and Modeling of Opaque Multiphase Flow Reactors ” “ Accelerating Process Development for Growth ” “ Dinosaurs to Small Furry Animals- The Evolution of Process Development Methodology ”

22. 22 Visionary Talks Dr. Arthur Andrews VP Process R&D, Merck “ Chemical Process Development for Pharmaceuticals - Challenges, Opportunities, and Future Directions ” Dr. Kenneth Kem VP Chemicals Technology, Air Products “ Use Process Innovation to Remodel Performance Products Businesses ” Dr. Frits Dautzenberg VP Technology Development, ABB Lummus “ Accelerating Innovation in Process Development ”

23. 23 Table Top Displays (partial list) Chemstations, Inc. CWB Technology HEL Lasentec Mettler Toledo AutoChem Molecular Knowledge Systems, Inc. Remspec Corp. Xytel Corp. Zeton Inc.

24. 24 Website (www.pd-aiche.com)

25. 25 Membership Number of members 2000-2001: 138 Number of members 2001-2002: 353 Number of members 2002-2003: over 500

26. 26 Awards Process Development Practice Award (Spring) sponsored by Zeton Excellence in Process Development Research Award (Fall) sponsored by Pharmacia (Pfizer) The Process Development Division Student Paper Award (Fall) sponsored by Lilly

27. 27 Division Bylaws Article I – Name and Objectives Article II – Membership Article III – Organization Article IV – Meetings Article V – Elections Article VI – Dues and Finances Article VII – General Provisions Article VIII – Amendments

28. 28 Future Programming Sessions at San Francisco 11/03 annual mtg Sessions at New Orleans 3/04 spring mtg 2nd Process Development Symposium - “Working Right on the Right Thing” June 2004 in Chicago area Sessions at Austin 11/04 annual mtg Future topics

29. 29 Fall 2003 - San Francisco Two topicals –Process Research and Innovation –Pilot Plants Other Division Sessions Several co-sponsored sessions

30. 30 Fall 2003 - Process Research and Innovation Topical Innovation in Pharmaceutical Process Development Innovation in Green Chemistry and Sustainable Process Development Selling and Implementing Innovation in the Traditional CPI Process Innovation as a Route to Shorter Time to Market Process Innovation in High-Value Add Product Development

31. 31 Fall 2003 - Pilot Plant Topical The Role of Pilot Plants in Process Development Pilot Plants: The Uniqueness of Small Scale Traditional and Novel Pilot Plant Reactors Key Factors in Successful Pilot Plant Design and Operation Pharmaceutical Pilot Plants

32. 32 Fall 2003 - Supplemental Process Development for APIs and Pharmaceutical Dosage Formulation Challenges in the Pharmaceutical Industry in view of FDA Regulatory Issues (focussing on PAT)- Dr. Ajaz Hussain (FDA), invited speaker; others speakers from industry/academia; panel discussion Biopharmaceutical Separations

33. 33 Spring 2004 - New Orleans Innovation in Fuel Processing Mixing in Pilot Plants Barriers to effective technology transfer (external and internal) Environmental Challenges in Manufacturing Engineering Solutions to Facility Security Challenges Case Studies and Lessons Learned CFD of Multiphase Flows

34. 34 Fall 2004 - Austin “Tool Time”- process development tools From the University to the Factory - Successful Collaborations in Innovation Innovation in Consumer Products Industrial Preparative Chromatography Innovative Design Methodologies Bioreactor Pilot Plants Membrane Process Design and Scale-up Considerations

35. 35 Fall 2004 - Austin (cont’d) R&D Management Topical 3: Utilizing Six Sigma & Design for Six Sigma in R&D Process Analytical Technologies (PAT) for Pharmaceutical and Biopharmaceutical Applications “Spend Capital or Toll it” (efficient energy usage in manufacturing)

36. 36 Some Future Topics Fuel Cell and Gas to Liquid Fuels Pilot Plants Pilot Plant Economics Safety in Pilot Plant Design and Operation Pilot Plant Success Stories Unit Operations in Pilot Plants Chemists are from Mars / Engineers are from Venus Tech Transfer to/from Third Party Manufacturers Process/Equipment Standardization

37. 37 Some Future Topics (cont’d) Special Issues with International Tech Transfer Corporate Partnerships (University to Industry) Internal and External (or Outsourced) Process Development Government to Industry Tech Transfer Information Technology Tools Future Prospects for Tech Transfer

38. 38 Summary of Benefits Programming follows key steps of successful process development Opportunities for growth and exposure at national AIChE venues Dynamic division with co-sponsoring possibilities with several other AIChE divisions “Good fit” with NJ industry and academia