1st Annual Symposium on PROCESS ANALYTICAL TECHNOLOGY (PAT) Monday, March 14, 2005 Core Building Auditorium, Bush Campus, Rutgers University, Piscataway, New Jersey ...Speakers:  Ajaz Hussain...Alan Royce...Reinhard Sievert...Ronald Miller...Metin Çelik...Tayfur Altiok... Organized by The Logistics Initiative Department of Industrial & Systems Engineering Rutgers, The State University of New Jersey   in collaboration with Pharmaceutical Technologies International, Inc.
PROGRAM	SPEAKERS	ABSTRACTS	DIRECTIONS	FURTHER INFO	REGISTRATION
PAT Logistics Initiative, Department of Industrial and Systems Engineering at Rutgers University is offering a one day symposium on Process Analytical Technology (PAT) Initiative. that will have its inaugural session on Monday, March 14, 2005.
PROGRAM
08:00 - 08:40   Registration and Breakfast
08:40 - 09:00   Opening Statement and Introduction				Prof. Tayfur Altiok & Dr. Metin Çelik
09:00 - 10:15   Engineering a Proactive Decision System for Pharmaceutical Quality				Dr. Ajaz S. Hussain
10:15 - 10:30   Break
10:30 - 11:15   Novartis PAT Experience: Alternate Analytical Method Development through PAT Manufacturing Processes				Dr. Alan Royce
11:45 - 12:15   Practical PAT Experience for Pharmaceutical Process Equipment				Reinhard Sievert
12:15 - 01:30   Lunch Break
01:30 - 02:15   What does PAT mean for the formulation Scientist?				Dr. Metin Çelik
02:15 - 03:00   The Industrial Perspective on the Implementation of PAT				Dr. Ronald Miller
03:00 - 03:15   Break
03:15 - 04:00   Risk Analysis: A critical component of PAT				Prof. Tayfur Altiok
04:00 - 04:45   Panel Discussion
PROGRAM DIRECTORS
Dr. Tayfur Altiok Professor Tayfur Altiok is the Department Chair of the Department of Industrial and Systems Engineering at Rutgers University.			Dr. Metin Çelik   Dr. Metin Çelik is a Research Professor of Pharmaceutical Processing at the Department of Industrial Engineering at Rutgers University.His responsibilities at Rutgers include PAT Logistics Initiative. Dr. Çelik is also  the founder and the President of Pharmaceutical Technologies International, Inc.
SPEAKERS
Dr. Ajaz S. Hussain  Deputy Director of the Office of Pharmaceutical Science (OPS) in CDER, FDA Dr. Ajaz Hussain is the Deputy Director of the Office of Pharmaceutical Science (OPS) in CDER, FDA  The OPS has oversight responsibilities for the development of science-based regulatory policies and the management of both review and research activities in the offices of New Drug Chemisty, Generic Drugs, Clinical Pharmacology & Biopharmaceutics and Testing & Research. Prior to this appointment he served as the Director, Office of Testing & Research.  Dr. Hussain currently holds adjunct faculty appointments at the School of Pharmacy, Purdue University (Adjunct Professor of Industrial Pharmacy) and School of Engineering, University of Michigan (Adjunct Professor of Pharmaceutical Engineering).  He is a Fellow of the American Association of Pharmaceutical Scientists and has received several FDA and CDER level awards including the Commendable Service Award and the Scientific Achievement Award for Excellence in Review Science. Prior to joining the FDA, Dr. Hussain served as Associate Professor of Pharmaceutics at the University of Cincinnati.  He trained at the Bombay College of Pharmacy (B.Pharm) and received his Ph.D. degree in Biopharmaceutics from the University of Cincinnati.  During his graduate education, he was awarded the Merrel-Dow Scholarship to acquire Industrial Pharmacy training at the Merrel-Dow Research Institute.  Dr. Hussain's research interests include prediction of quality and performance attributes of pharmaceutical dosage forms, computer-aided. Dr. Alan Royce Executive Director of Pharmaceutical Development Novartis Pharmaceuticals Corporation Alan E. Royce received a B.S. in Chemistry from Saint John’s University and a Ph.D. in Pharmaceutics from Temple University.  He has 20 years of experience in pharmaceutical development including products for animal and human health.  Dr. Royce’s current responsibilities at Novartis Pharmaceutical Corporation include formulation, process development, scale-up and transfer of new solid and liquid dosage forms for oral and parenteral delivery. Included in these responsibilities is leading a team within the Pharmaceutical and Analytical Development Department at Novartis implementing the FDA’s PAT initiative.  He is a member of AAPS and IFPAC Reinhard Siewert Mr. Reinhard Sievert Vice President & General Manager, L. B. Bohle, LLC 700 Veterans Circle, Suite 100 Warminster, PA 18974 Tel.:  (215) 957-1240  Born and raised in a German farming community, Mr. Sievert absolved an apprenticeship as a tool and die cast mechanic after graduation from the German school system.  He attended a technical college and after serving the required time in the German military studied Mechanical Engineering at the University of Kassel, Germany. Mr. Sievert found employment with Leybold GmbH in Cologne, Germany, with major activities in product management and technical sales of vacuum components and vacuum process equipment. Mr. Sievert came to the United States the first time in 1984 for two years, working for Leybold’s US subsidiary, Leybold Vacuum Products, in Pittsburgh, PA . Major activities involved the introduction of new, closed loop cryogenic refrigeration systems to the electronics -, space simulation -, and NMR scanning industries.. In 1986, Mr. Sievert joined the weighing systems division (electronic balances sales) of Sartorius GmbH in Goettingen, Germany, and was responsible for sales and marketing activities in North America and parts of Europe. In 1990, Mr. Sievert was transferred for one year to Chicago to set up a new joint venture company (Sartorius Instruments) between Satorius GmbH and Baxter Corporation. In 1996, Mr. Sievert took on a new challenge and started his employment as Vice President and General Manager with L. B. Bohle at their US operation in Philadelphia, PA. L. B. Bohle is specialized in supplying process equipment (blending, granulation, tablet coating and milling) and handling equipment to the pharmaceutical industry. Dr. Tayfur Altiok Professor Tayfur Altiok is the Department Chair of the Department of Industrial and Systems Engineering at Rutgers University. He holds a Ph.D. degree from the Department of Industrial Engineering at North Carolina State University at Raleigh. He is involved in mathematical and computer simulation modeling of manufacturing and distribution systems, marine port operations and distributed computing systems with an emphasis on transaction processing middleware. He has numerous publications including the two books in the areas of performance analysis of manufacturing systems and simulation. Dr. Altiok is a Fulbright Fellowship awardee and a recipient of numerous grants from the National Science Foundation, The United Nations, and NATO.			Dr. Ronald Miller Director of New Technology in Global Pharmaceutical Technologies at Bristol-Myers Squibb,   Dr. Miller is Director of New Technology in Global Pharmaceutical Technologies at Bristol-Myers Squibb, New Brunswick, NJ.  He is responsible for developing Process Analytical Technology applications in Technical Operations and key leader of the Corporate PAT Steering Committee. He was selected by the FDA as an industry expert in 2002 to serve as a PAT Subcommittee advisory member. Dr. Miller has over 30 year’s experience and leadership in manufacturing, formulation development and process technology solid dosage OTC and Rx drugs. He has spearheading technology launches of beta lactams and non-beta lactams, development of immediate release and sustained release products and directing problem solving process technology teams at US and international BMS sites worldwide for seventeen years. Dr. Miller has authored 25 journal articles and 3 book chapters about pharmaceutical roller compaction technology and applications. “Roller Compaction Technology” in The Handbook of Pharmaceutical Granulation Technology, Marcel Dekker, (MD) 1997. In 1999, he authored articles in Pharmaceutical Technology USA and Europe about  “Roller Compaction Technology Optimization – NIR In-Process Mapping”.  He co-authored “A Survey of Current Industrial Practices and Preferences of Roller Compaction Technology and Excipients Year 2000”, also in 2002, he wrote an article on “Statistical Process Capability Analysis” both in the American Pharmaceutical Review (APR). During 2002, he authored the first in a series of PAT articles titled “PAT Part 1” and in 2003; authored “PAT Part 2” both in APR. In 2003, he was the lead co-author of a chapter in the Encyclopedia of Pharmaceutical Technology, “Roller Compaction Technology for the Pharmaceutical Industry”, MD. In 2003 and 2004, Dr. Miller teamed with Purdue University pharmacy professors and graduate student in co-authoring referred articles about particle size characterization of sized roller compacts using NIR in-line, Journal of Pharmaceutical Sciences. In 2004, he completed a new chapter “Roller Compaction Technology” for the Second Edition of the Handbook of Pharmaceutical Granulation Technology, MD.  He is the lead co-author for a new chapter in the second edition of Pharmaceutical Process Scale-Up “Pharmaceutical Roller Compaction Scale-Up” scheduled MD publishing 2005. He is completing a textbook titled “Pharmaceutical Roller Compaction Technology” scheduled MD publishing 2005. He earned his B. S. in Chemistry from Lebanon Valley College 1970, MBA from Temple University Business School 1977, and Ph.D. from Temple University Pharmacy School 1988. He was awarded the1995 Neal Rice Award from the Institute for Briquetting and Agglomeration Society. He was an editorial advisory board member to the American Pharmaceutical Review 2000-2004 and is now editorial advisory board member of the PAT journal. In 2003, he was appointed adjunct professor in the Department of Industrial and Physical Pharmacy Purdue University and served on one doctorate thesis committee 2004. Dr. Miller has earned several process patents. Member of the American Association of Pharmaceutical Scientists, American Chemical Society, Board of Director and member of the Institute for Briquetting and Agglomeration and listed in the Who’s Who in Science and Engineering. Dr. Metin Çelik President, Pharmaceutical Technologies International, Inc. Dr. Çelik is the founder and the President of Pharmaceutical Technologies International, Inc.,  and is also a  Research Professor of Pharmaceutical Processing at the Department of Industrial Engineering, Rutgers University.  Prior to that, he was a faculty at the College of Pharmacy, Rutgers University. Dr. Çelik received his B.Sc.(Hons.) degree in Pharmacy from Hacettepe University-Turkey and was awarded a Ph.D. degree in Pharmaceutical Technology from Leicester Polytechnic-UK. Dr. Çelik worked at Sandoz-Switzerland and Sandoz-Turkey before he joined Smith Kline & French Laboratories to establish the first state-of-art Compaction Simulator System in the western hemisphere. He developed the second unit at Rutgers as the first such a unit in the academia in the U.S.A. and established an internationally recognized research center. Dr. Çelik has organized over forty national and international symposia and short courses, and has published over thirty publications including book chapters, and refereed research articles and made over hundred and fifty presentations (mostly invited) at the industry, academia and national and international meetings.  Dr. Çelik's recent areas of interests include: PAT (Process Analytical Technology);  development of pharmaceutical expert systems, excipient databases, and management tools in the area of drug delivery technologies;  use of compaction simulators in the prefomulationn and formulation of solid dosage forms;  theory and practice of pharmaceutical compaction; excipient functionality testing; and pharmaceutical processing (including milling, mixing, granulation, tableting, and coating). Dr. Çelik has acted a consultant to the FDA and to over forty-five pharmaceutical, nutraceutical, excipient, and equipment companies as well as law firms worldwide.   Dr. Çelik is currently is serving as a member of the editorial board or a reviewer for a numerous pharmaceutical journals. He is the past chair of the AAPS Process Development Focus Group. Dr. Çelik is the founder and the past chair of the AAPS Expert Systems Focus Group, and the founder and the present chair of the AAPS Excipients Focus Group.   Dr. Çelik is  listed in "Who is who in science and engineering (1995)".
ABSTRACTS
DIRECTIONS
CORE Building Busch Campus, Piscataway, NJ 08855 For detailed direction information, either contact Cindy Ielmini at 732-445 3654 or click on one of the following links:    Written Directions      Campus Map - Coarse    Campus Map - Detailed			Campus Map
From Route 287 (North or South) Turn off at Exit 9 (formerly Exit 5) "River Road, Bound Brook, Highland Park.".  Proceed East on River Road toward Highland Park. For specific campuses follow the directions below. Continue on River Road and you will pass under the overpass for Route 18. Make the next left onto Route 18 North. Take the first exit for Campus Road. Follow the exit until you reach a Circle. Once on the circle, take the first immediate exit off the circle and continue down Bartholomew Rd. At the first 4 way intersection, make a left turn on to Brett Road. Stay on Brett road and bear left until you see CoRe Building, There will be two parking lots, Lot 60 and Lot 64.   From New Jersey Turnpike (North or South) Turn off at Exit 9, bear right after the tollbooths and follow signs for "Route 18 North - New Brunswick. Stay to the left to continue on Route 18 North.  Proceed along Route 18 North, crossing the Raritan River (approximately 3.7 miles). Continue on Route 18 North. Take the first exit for Campus Road Follow the exit until you reach a Circle and follow the directions above from the Circle. From Route 1 ( North or South) Turn off at exit marked "Route 18 North-New Brunswick". Proceed along Route 18 North, crossing the Raritan River (approximately 3.7 miles). Continue on Route 18 North.. For the Busch campus - take the first exit for Campus Road. Take the first exit for Campus Road Follow the exit until you reach a Circle and follow the directions above from the Circle.
FURTHER INFORMATION
For Further Information or comments on the symposium please contact:      E-MAIL PHONE FAX Dr. Tayfur Altiok (Regarding Program) altiok@rci.rutgers.edu 1-732-445 2829 1-732-445 5467 Dr. Metin Çelik (Regarding Program) Metin.Celik@pt-int.com 1-609-936 8133 1-609-936 8134 Cindy Ielmini (Regarding Registration) Ielmini@rci.rutgers.edu 1-732-445 3654 1-732-445 5467 Mailing Address Regular Mail  Department of Industrial & Systems Engineering Rutgers, The State University of New Jersey PO Box 909, Piscataway, NJ 08855-0909 Overnight Mail Department of Industrial & Systems Engineering Rutgers, The State University of New Jersey 96 Frelinghuysen Road, Core Building, Room 201 Piscataway, NJ 08854-8018
REGISTRATION
PAT-2005   Personal Information       Mr.   Ms   Mrs.   Dr.   Prof. Full Name:    Job Title:    Organization:    Department:    Address : Street-1:      Street-2:      City:    State:    Zip Code:    E-Mail:    Phone:    Fax:    Dietary Restrictions:    I have dietary restrictions :    Additional Comments:      Registration Fee: $ 125.00 $ 175.00: On-Site Registration Fee - IMPORTANT UPDATE: PLEASE NOTE THAT ONLY LIMITED NUMBER OF SEATS AVAILABLE AS OF MARCH 9, 2005. Therefore, we reserve the right to limit On-Site registration. Please make check payable to PAT Symposium at Rutgers. Mail to:  Ms. Cindy Ielmini, Department of Industrial and Systems Engineering, Rutgers University 96 Frelinghuysen Road, CoRE Building, Room 201, Piscataway, NJ 08854 Phone (732) 445 - 3654 Fax: (732) 445 - 5467 Email: Ielmini@rci.rutgers.edu
Number of Visitors: