INTRODUCING THE AIChE PROCESS DEVELOPMENT DIVISION (#12)

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

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

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

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

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

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. 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. 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. 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. 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. 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. 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. 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. 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