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Dr. Metin Çelik
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`Metin Çelik, Ph.D.
`
`22 Durham Road, Skillman, New Jersey 08558, USA
`Voice: + 1 908-864 0555 ; +90 548 853 0550
`e-mail: Metin.Celik@pt-int.com metin.celik@neu.edu.tr
`
`
`
`CURRICULUM VITAE
`
`
`Current/Recent Position(s) and Affiliation(s):
`
`9/97 - present:
`08/08 - present
`
`
`
`
`President, Pharmaceutical Technologies International, Inc. (PTI), Skillman, NJ.
`Part-time faculty member, Department of Pharmaceutical Technology, Faculty of
`Pharmacy, Near East University, Nicosia, Turkish Republic of Northern Cyprus
`
`
`Fields and Areas of Specialization:
`
`Dr. Çelik's recent areas of interests include:
` QbD and PAT;
` Development of solid dosage formulation and processing (including milling, mixing, granulation, tabletting,
`and film coating) using SUPAC guidelines, QbD and PAT approach
` Process assessment of pharmaceutical manufacturing process for solid dosage forms
` Evaluation of novel drug delivery technologies;
` Development of artificial intelligence based pharmaceutical expert systems, excipient databases (for
`tableting, spray drying, film coating, and novel dosage forms), and management tools for FDA inspection
`preparations (PAI, API, Validation, Technology Transfer, etc)
` Utilization of compaction simulators in the product development; pharmaceutical compaction; excipient
`functionality;
`
`Faculty of Pharmacy, Hacettepe University, Ankara, Turkey (1979).
`Department of Pharmaceutical Technology, School of Pharmacy, De Montfort
`University (formerly known as Leicester Polytechnic), UK (1984).
`
`
`Education:
`B.S. (Hons.):
`Ph.D.:
`
`
`
`
`Previous Positions Held:
`
`1/04 – 08/08
`
`
`
`
`
`Faculty, Department of Industrial & Systems Engineering, Rutgers University, Piscataway,
`NJ
`Part-time Faculty
`1/04 – 9/04
`
`
`(Visiting) Research Professor of Pharmaceutical Processing
`9/05 – 5/08
`
`
`9/1988 - 7/1997: Assistant Professor of Pharmaceutics, and Director of Pharmaceutical Compaction Research
`Laboratory & Information Center, College of Pharmacy, Rutgers University, Piscataway, NJ.
`6/1986 - 9/1988: Post Doctoral Scientist, Pharmaceutical Research & Technologies, SK & F Labs, Swedeland, PA.
`11/1985 - 3/1986: Military Service.
`5/1985 - 10/1985: Development Coordinator, Galenical R & D, Sandoz, Istanbul, Turkey.
`7/1984 - 5/1985: Special Trainee, Galenical R & D, Sandoz Ltd., Basel, Switzerland.
`
`Professional Licensure:
`
`Pharmacy License (Turkey)
`
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`Honors, Awards, Promotions, and Recognitions:
`
`Faculty Academic Service Increment Program Award (1991, 1993, 1994)
`Who is who in science and engineering (1995)
`Commission of Science & Technology of New Jersey Award (1996).
`
`
`
`THE PORTFOLIO OF ACCOMPLISHMENTS
`
`Publications:
`
`
`1.
`Book:
`
`M. Çelik “Pharmaceutical Powder Compaction Technology”, 2nd Edition, Informa Healthcare (2011).
`
`Book Chapters:
`
`M. Çelik*, M. Mollan and N. Chang, "The reworkability of microcrystalline cellulose formulations" in "Tableting
`technology Volume 2 (Compression), Edited by J.I. Wells and M.H. Rubinstein, Ellis Horwood, Chapter 5, 44-61
`(1993).
`
`M. Çelik, "Compaction of multiparticulate oral dosage forms", in "Multiparticulate oral drug delivery" (Edited by I.
`Ghebre-Sellassie), Marcel Dekker, Inc., Chapter 9, 181-216 (1994).
`
`M. Çelik* and L. Maganti, "An overview of the compaction of microspheres" in "Minutes: 9th Int. Symposium on
`
`Microencapsulation", 157-
`
`M.J. Mollan, Jr. and M. Çelik*, "Maltodextrin", in "Analytical profiles of drug substances and excipients", Edited by
`H.G. Brittain, Vol. 24, Chapter 8, 307-350, Academic Press (1996).
`
`M. Çelik and S.C. Wendel "Spray drying”, in “Handbook of Granulation Technology”, Edited by Dilip Parikh, 2nd
`Edition, Taylor & Francis, Chapter 5, 129-157 (2005).
`
`M. Çelik and S.C. Wendel "Spray drying and pharmaceutical applications”, in “Handbook of Granulation Technology”,
`Edited by Dilip Parikh, 3nd Edition, Informa Healthcare, Chapter 5, 98-126 (2009).
`
`M. Çelik and S.C. Wendel "Expert systems and their pharmaceutical applications”, in “Handbook of Granulation
`Technology”, Edited by Dilip Parikh, 3nd Edition, Informa Healthcare, Chapter 5, 579-597 (2009).
`
`C. Ruegger and M. Çelik, "Advanced compaction research equipment, Compaction simulators", in Pharmaceutical
`Powder Technology, Edited by M. Çelik, 2nd Edition, Informa Healthcare, Chapter 6, (2011).
`
`M. Çelik, "Expert systems and their use in pharmaceutical applications", in Pharmaceutical Powder Technology,
`Edited by M. Çelik, 2nd Edition, Informa Healthcare, Chapter 13, (2011).
`
`
`
`Refereed Journal Articles:
`
`D.N. Travers*, M. Çelik and T.C. Buttery, "A computer aided investigation on strain movements in compacts under
`constant stress within the die", Drug Dev. & Ind. Pharm., 9, 139 - 157 (1983).
`
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`M. Çelik, D.N. Travers* and T.C. Buttery, "Computer logged changes of strain movements in compacts of direct
`compression bases and granules produced by wet massing techniques", Labo-Pharma, 32, 22 - 27 (1984).
`
`M. Çelik and D.N. Travers*, "The use of an elastic recovery index as a criterion of compactional behavior of some
`direct compression bases", Drug Dev. & Ind. Pharm., 11, 299 - 314 (1985).
`
`M. Çelik and K. Marshall, "Use of a compaction simulator system in tabletting research, I. Introduction to and initial
`experiments with the system", Drug Dev. & Ind. Pharm., 15(5), 759 - 800 (1989).
`
`M. Çelik* and N. G. Lordi, "The Pharmaceutical Compaction Research Laboratory & Information Center", Pharm.
`Technol., 15(3), 112 - 116 (1991).
`
`M. Çelik, "Overview of compaction data analysis techniques", Drug Dev. & Ind. Pharm., 18(6&7) 767 - 810 (1992).
`
`L. Maganti and M. Çelik* "Compaction studies on pellets Part I: Uncoated pellets", Int. J. Pharmaceutics, 95, 29 - 42
`(1993).
`
`M. Çelik* and C.E. Driscoll, "An overview of the effects of some physico-chemical and mechanical characteristics of
`particulates on the compaction and post-compaction properties of compacts", Drug Dev. & Ind Pharm., 19(17-18),
`2119 - 2141 (1993).
`
`M. Çelik* and E. Okutgen, "A feasibility study for the development of a perspective compaction functionality testing
`and the establishment of a compaction data bank", Drug Dev. & Ind Pharm., 19(17-18), 2309 - 2334 (1993).
`
`M.J. Mollan, Jr. and M. Çelik*, "Characterization of directly compressible maltodextrins manufactured by three
`different processes", Drug Dev. & Ind Pharm., 19(17-18), 2335 - 2358 (1993).
`
`L. Maganti and M. Çelik*, "Compaction studies on pellets Part II: Coated pellets", Int. J. Pharmaceutics, 103, 55 - 67
`(1994).
`
`M.J. Mollan, Jr., and M. Çelik*, "Tabletability of maltodextrins and acetaminophen mixtures", Drug Dev. & Ind. Pharm.
`20(20), 3139 - 3149 (1994).
`
`M. Çelik* and L. Maganti, "Formulation and compaction of microspheres", Drug Dev. & Ind. Pharm., 20(20), 3151 -
`3173 (1994).
`
`M.J. Mollan, Jr., and M. Çelik*, "The effects of humidity and storage time on the behavior of maltodextrins for direct
`compression", Int. J. Pharmaceutics, 114(1), 23-32 (1995).
`
`M.J. Mollan, Jr., N. Chang and M. Çelik*, "The effect of reworking on post-compaction properties of microcrystalline
`cellulose formulations", Pharm. Technol. 19(10), 2-14 (1995).
`
`M. Çelik, "The past, present and future of tableting technology", Drug Dev. & Ind. Pharm., 22(1), 1-10 (1996).
`
`M. Çelik* and M.E. Aulton, "The viscoelastic deformation of some tableting materials as assessed by indentation
`rheology", Drug Dev. & Ind. Pharm., 22(1), 67-75, (1996).
`
`M. Çelik*, J.T.H. Ong, Z.T. Chowhan and G.J. Samuels, "Compaction simulator studies of a new drug substance:
`Effect of particle size and shape, and its binary mixtures with microcrystalline cellulose", Pharmaceutical
`Development & Technology, 1(2), 119-126 (1996).
`
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`M. Çelik* and C.E. Ruegger, "An overview of tableting technology - Part I: Tablet presses and instrumentation",
`Pharm. Technol., Vol. 20, Suppl. 20-39(1996).
`
`M.J. Mollan, Jr. and M. Çelik*, "The effects of lubrication on the compaction and post-compaction properties of
`directly compressible maltodextrins". Int. J. Pharmaceutics, 144(1), 1-9 (1996).
`
`S. A. Sharpe, H. G. Brittain*, A. W. Newman, and M. Çelik, "Physical characterization of the polymorphic variations of
`magnesium stearate and magnesium palmitate species". Structural Chemistry, 8, 73-84 (1997).
`
`S.C. Wendel & M. Çelik*, “An overview of spray drying applications”, Pharm. Technol., 21(10), 124-156 (1997).
`
`C. E. Ruegger & M. Çelik*, “The effect of compression and decompression speed on the mechanical strength of the
`compacts”, Pharmaceutical Development & Technology, 5(4), 485-494 (2000).
`
`C. E. Ruegger & M. Çelik*, “The influence of varying pre- & main compaction profile parameters on the mechanical
`strength of the compacts”, Pharmaceutical Development & Technology, 5(4), 495-505 (2000).
`
`R. Sirihorachai, S.C. Wendel & M. Çelik*, “Evaluation of a novel portable instrumented punch system”, stp Pharma
`Pratiques, (10) 27-31, 2000
`
`M. Çelik, “Catching up with Expert Systems”, Pharm. Technol., 25(7), 122-124 (2001)
`
`M. Çelik, “Excipient selection: Practical advice on using SUPAC”, Tablets & Capsules, 6(6), PP. , 2008
`
`M. Çelik, Eye on Excipients: “Compactability testing of excipients”, Tablets & Capsules, 7(3), 37-40, 2009
`
`M. Çelik, Eye on excipients: “Compactability testing of excipients, Part 2”, Tablets & Capsules 7(4), 33-37, 2009
`
`M. Çelik, Eye on Excipients: “Tools for risk-based product development”, Tablets & Capsules, 7(6), 55-59, 2009
`.
`Non-Refereed Journal Articles:
`
`M. Çelik, "A new method for characterizing the compression process", IPP (Information for Pharmaceutical
`Production), 2(March), 23 - 29 (1985).
`
`Book Reviews:
`
`M. Çelik, "Excipient and delivery systems for pharmaceutical formulations", Journal of American Chemical Society,
`118(21), 5160 (1996).
`
`Abstracts:
`
`M. Çelik and D.N. Travers, "Tablet compression studies using a 5 channel computer linked data processor", Pharm.
`Research, 4(2), S69 (1987).
`
`E. Okutgen, P. Wray and M. Çelik, "The effect of crystal surface history on post- compaction properties of sodium
`chloride tablets", Pharm. Research, 9(10), S115 (1992).
`
`M. Çelik, D. Goldman, E. Okutgen, R. Pinal and A.W. Malick, "Simulation of an F-3 single station press using an
`integrated compaction research system", Pharm. Research, 9(10), S134 (1992).
`
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`M.J. Mollan, Jr. and M. Çelik, "Direct compression of maltodextrins and acetaminophen", Pharm. Research, 9(10),
`S134 (1992).
`
`M. Çelik, E. Okutgen and C. Driscoll, "Compaction functionality testing", Pharm. Research, 10(10), S138 (1993).
`
`E. Okutgen, C. Driscoll and M. Çelik, "Introduction to a compaction data bank", Pharm. Research, 10(10), S138
`(1993).
`
`M.J. Mollan, Jr. and M. Çelik, "Lubrication effects on the properties of maltodextrins", Pharm. Research, 10(10), S146
`(1993).
`
`M.J. Mollan, Jr. and M. Çelik, "The effect of humidity on the properties of maltodextrins", Pharm. Research, 10(10),
`S146 (1993).
`
`M. Çelik and M.E. Aulton, "The viscoelastic deformation of some tableting materials as assessed by indentation
`rheology", Pharm. Research, 11(10), S131 (1994).
`
`C.E. Driscoll, E. Okutgen and M. Çelik, "A new approach to the use of pre- & main compaction cycles", Pharm.
`Research, 11(10), S132 (1994).
`
`A. Ayman, M. Çelik, H. Brittain, A. Newman and G. Young, "Physicochemical properties of the pure magnesium
`stearate pseudopolymorphs", Pharm. Research, 11(10), S152 (1994).
`
`C. Driscoll-Ruegger and M. Çelik, "The effect of compression and decompression speed on the mechanical strength
`of compacts", Pharm. Research, 12(9), S179 (1995).
`
`M. Çelik, "The use of Force-Time Curves to evaluate the compaction behavior of pharmaceutical materials", Pharm.
`Research, 12(9), S185 (1995).
`
`M. Çelik and E. Okutgen, "An electronic tablet compaction data bank - I: Microcrystalline cellulose", Pharm.
`Research, 12(9), S185 (1995).
`
`M. Çelik and E. Okutgen, "An electronic tablet compaction data bank - I: Microcrystalline cellulose", European
`Journal of Pharmaceutics and Biopharmaceutics, Suppl. 5S (1996).
`
`M. Çelik, A.W. Newman, R. Mueller, C. Kiesnowski, I. Vitez, S.A. Sharpe, R.C. Moreton, "Pre-compaction and
`lubrication properties of Pruv", Pharm. Research, 13(9), S200 (1996).
`
`M. Çelik, R.C. Moreton, B.E. Sherwood, J.D. Cobb, D.J. Schaible, and J.A. Zeleznik, "The effects of moisture content
`and particle size on the functional properties of microcrystalline cellulose for use in direct compression", Pharm.
`Research, 13(9), S209 (1996).
`
`C. Driscoll-Ruegger, M. Çelik and S.D. Bateman, "Simulation of an instrumented manesty betapress using an
`integrated compaction research system", Pharm. Research, 13(9), S209 (1996).
`
`M. Çelik and R.L. Schmitt, “A Study on the compaction properties of three water soluble polymers”, Pharm.
`Research, 14(11), 1 (1997).
`
`S. Wendel and M. Çelik, “Limitations of applying artificial neural networks to a small spray drying data set and
`methods for overcoming limitations”, Pharm. Research, 14(11), 88 (1997).
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`Presentations:
`
`J. Engelhart and M. Çelik, “Feasibility of predicting lyophilization endpoint using artificial neural networks”, Pharm.
`Research, 14(11), 88 (1997).
`
`M. Çelik, R. Sirihorachai, and F. Spadaccini, “Artificial neural networks aided study on the comparison of the models
`193 and 197 of the quadro-comil milling equipment”, Pharm. Research, 14(11), 92 (1997).
`
`2.
`
`Invited Presentations/Plenary Lectures at Scientific Meetings:
`
`“Compaction simulators - A historical perspective”, New Jersey Pharmaceutical Discussion Group Meeting, New
`Brunswick, NJ (October 1988).
`
`“Potential applications of the compaction simulators in advanced tableting technology”, AAPS-Eastern Regional
`Meeting, East Brunswick, NJ (June 1989).
`
`“The role of the integrated tablet research systems in the drug development”, Johnson & Johnson's Annual
`Symposium on Drug Delivery, New Brunswick, NJ (October 1990).
`
`“Integrated tablet research systems: A case study”, 26th Annual Arden House Conference, Harriman, NY (January
`1991).
`
`“Overview of compaction data analysis techniques”, The First Symposium of the PCRL & IC on the physics of tablet
`compaction, Piscataway, NJ (March 1991).
`
`“Instrumented tablet machines and compaction simulators: What they are & what they can do?”, Pharm. Tech.
`Conference, New Brunswick, NJ (September 1991).
`
`“A Case Study: Compaction behavior of the pellets”, Pharm. Tech. Conference, New Brunswick, NJ (September
`1991).
`
`“The role of compaction studies on the design and development of tablet formulations”, Pharmaceutical & Cosmetic
`Engineering World Conference, Philadelphia, PA (October 1991).
`
`“The effects of physico-mechanical characteristics of particulates on the compaction and post-compaction properties
`of compacts”, The Second Symposium of the PCRL & IC on the compaction behavior of pharmaceutical materials,
`Piscataway, NJ (March 1992).
`
`“Integrated Compaction Research Systems: `”Compaction Simulators", Philadelphia Pharmaceutical Forum,
`Philadelphia, PA (September 1992).
`
`“Compaction functionality testing of tableting excipients and introduction to a compaction data bank”, The Third
`Symposium of the PCRL & IC on the application of compaction techniques as prospective functionality tests for tablet
`excipients, Piscataway, NJ (March 1993).
`
`“Functionality testing for tableting excipients”, AAPS-Eastern Regional Meeting, New Brunswick, NJ (June 1993).
`
`Plenary Lecture: “Fundamentals of compaction”, Symposium on the Pharmaceutical Solid Technology at the First
`International Conference on Pharmaceutical Science and Technology in Conjunction with the 24th Annual Meeting of
`the Fine Particle Society, Chicago, IL (August 1993).
`
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`Plenary Lecture: “A functionality testing for tableting excipients and introduction to a compaction data bank”, FIP
`Post-Satellite Symposium'93 Seoul: Pharmaceutical Excipients, Seoul, Korea (September 1993).
`
`Plenary Lecture: “Compaction of microspheres and microcapsules”, 9th International Symposium on
`Microencapsulation, Ankara, Turkey (September, 1993).
`
`“Critical aspects to consider in the formulation and compaction of microspheres”, The Fourth Symposium of the
`PCRL & IC on the tabletability of multiparticulates: A new technology, Piscataway, NJ (March 1994).
`
`“Microcrystalline cellulose in tableting”, Mendell Symposium, Cedar Rapids, IO (April 1994).
`
`“Formulation and compaction of coated and uncoated microspheres”, Rhône-Poulenc Symposium on
`Biodegradability and Formulation, Research Triangle Park, NC (October 1994).
`
`“The past, present and future of tableting technology”, The Fifth Symposium of the PCRL & IC on tableting
`technology in the year 2001, Piscataway, NJ (March 1995).
`
`Plenary Lecture: “The past, present and future of tableting technology”, Symposium on the Pharmaceutical Solid
`Technology at the International Conference on Pharmaceutical Science and Technology in Conjunction with the 26th
`Annual Meeting of the Fine Particle Society, Chicago, IL (August 1995).
`
`“Functionality testing and batch to batch consistency of pharmaceutical excipients”, AAPS Process Development
`Focus Group Meeting, 10th Annual AAPS Meeting, Miami, FL (November 1995).
`
`“Is there an electronic database in your future? What you should and need to know”, Pharm. Tech. Conference,
`Philadelphia, PA (September 1997).
`
`“An overview of pharmaceutical expert systems”, 12th Annual AAPS Meeting, Boston, MA (November 1997).
`
`“How expert systems can enhance pharmaceutical process and development”, IIR Meeting on Pharmaceutical
`Dosage Forms, Orlando, FL (December 1997).
`
`“Pharmaceutical expert systems and databases”, 1998 Conference on Pharmaceutical Science & Technology,
`Dallas, TX (April 1998).
`
`Plenary lecture (Speaker of the month): “Formulation and processing expert systems”, NJPhAST Meeting, Somerset,
`NJ (April 1998).
`
`“Pharmaceutical Expert Systems”, Tablet Manufacturing Technology, Atlantic City, NJ (April 1998).
`
`“Use of compaction simulators in tableting technology”, Recent Advances in Pharmaceutical Tableting Technology,
`Las Vegas, NE (May 1998).
`
`“Pharmaceutical (formulation & process) expert systems”, Recent Advances in Pharmaceutical Tableting
`Technology, Las Vegas, NE (May 1998).
`
`“How expert systems can enhance pharmaceutical process and development”, IIR Meeting on Pharmaceutical
`Dosage Forms, Princeton, NJ (May 1998).
`
`“Application of artificial neural networks in pharmaceutical processing”, AAPS Eastern Regional Meeting, Parsippany,
`NJ (June 1998).
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`“Pharmaceutical formulation and processes expert systems”, Pharm. Tech. Puerto Rico Conference, Rio Grande, PR
`(June 1998).
`
`“Pharmaceutical formulation and processing expert systems and databases”, Second International Meeting on
`Pharmacy & Pharmaceutical Sciences, Istanbul, Turkey (September 1998).
`
`“The rational choice of excipients: Preformulation databases”, Pharm. Tech. Europe Conference, Dusseldorf,
`Germany (October 1998).
`
`“Pharmaceutical expert systems”, Tablet Manufacturing CANADA’98, Richmond Hill, Ontario, Canada (October
`1998).
`
`
`“Expert systems: The future of formulation & process development”, 13th AAPS Annual Meeting, San Francisco, CA
`(Nov 1998).
`
`“Integrated compaction research systems: Compaction Simulators”, 34th Annual Pharmaceutical Technologies
`Section Conference at Arden House, Harriman, NY (January 1999)
`
`“Use of instrumented tablet presses in formulation studies”, 34th Annual Pharmaceutical Technologies Section
`Conference at Arden House, Harriman, NY (January 1999)
`
`“How to make most of the compaction simulators”, Arden House 4th European Conference, Cambridge, UK
`(February-March 1999).
`
`“Use of expert systems & databases in the development of pharmaceutical formulation & processes”, 12th Powrex
`Symposium, Tokyo, Japan (July 1999).
`
`“Utilization of expert systems technology to troubleshoot pharmaceutical processes”, Troubleshooting’99, Atlantic
`City, NJ (October 1999).
`
`“Expert Systems: Use of predictive science in pharmaceutical applications”, Tablet Manufacturing Technology’2000
`Atlantic City, NJ (April 2000).
`
`“Theory and Practice of Compaction”, Formulations Forum 2000, Orlando, FL (September 2000)
`
`Plenary Lecture: “The use of expert systems in pharmaceutical applications”, Second workshop on physical
`characterization of pharmaceutical solids”, Lancaster, PA (September 2000).
`
`“Theory and practice of compaction”, Second workshop on physical characterization of pharmaceutical solids”,
`Lancaster, PA (September 2000).
`
`Plenary Lecture: “Use of Artificial Intelligence in the preparation of FDA inspections: PAI, QSIT, API, Solid Dosage
`Form Validation”, NJPhAST Meeting, Mahwah, NJ (October 2001).
`
`“Compaction Simulator: Its role in characterizing pharmaceutical solids”, AAPS Drug Delivery Conference 2002,
`Arlington, VA (April 2002).
`
`“The rational choice of excipients utilizing a preformulation database”, Barnett International’s 2nd Pharmaceutical
`Excipients Conference, Philadelphia, PA (June 2002).
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`“The rational choice of excipients utilizing a preformulation database”, Barnett International’s Raw Materials
`Conference, Philadelphia, PA (October 2002).
`
`“Critical Overview of the Proposed USP Compaction Functionality Test”, 17th AAPS Annual Meeting, Toronto,
`Ontario, Canada (November 2002).
`
` “Use of AI in Formulation & Process Development and FDA Inspection Preparations”, AAPS – PT Section
`Conference, Advances in Pharmaceutical Processing, Parsippany, NJ (June 2003).
`
`“Practical and Regulatory Considerations for Utilizing a Preformulation Database in the Characterization of
`Excipients”, Pharmaceutical Excipients Conference, Philadelphia, PA (June 2003).
`
`
`"Tools for Knowledge Management: Neural Networks and Expert Systems", 39th Arden House Conference on
`"Quality by Design in Pharmaceutical Development and Manufacturing: Principles, Applications and Scientific Risk-
`Based Regulatory Decisions", Harriman, NY (January 2004).
`
`
`“Theory and practice of compaction”, Advanced Practices in pharmaceutical tablet and capsule technology”, Las
`Vegas, NE (May 2004).
`
`“Practical and regulatory considerations for utilizing a preformulation database in the characterization of excipients”,
`Barnett International’s 4th Annual Pharmaceutical Excipients Conference” Philadelphia, PA (May 2004).
`
`“What does PAT mean for the formulation scientist?”, 1st Annual Symposium on Process Analytical Technology
`(PAT), Piscataway, NJ (March 2005): Acted the program co-chair and a speaker.
`
`“Theory and practice of compaction”, Advanced Practices in pharmaceutical tablet and capsule technology”, Las
`Vegas, NE (May 2005).
`
`“Practical and regulatory considerations for utilizing a preformulation database in the characterization of excipients”,
`Barnett International’s 5th Annual Pharmaceutical Excipients Conference” Philadelphia, PA (June 2005).
`
`“Selecting Optimal Excipients for Direct Compression: Considering the SUPAC and PAT Guidelines”, Advances in
`Direct Compression” Philadelphia, PA (June 2005).
`
`“The use of Artificial Intelligence ‘Expert Systems’ as formulation and process tools to overcome the PAT
`challenges”, 18th Powrex Symposium, Osaka, Japan (July 2005).
`
`“The use of Artificial Intelligence ‘Expert Systems’ as formulation and process tools to overcome the PAT
`challenges”, 3rd Annual Garnet E. Peck Symposium in Industrial Pharmacy, Lafayette, IN (October 2005).
`
`“FDA’s Process Analytical Technology (PA) initiative and formulation & processing related challenges” Las Vegas,
`NE (May 2006).
`
`“Theory and practice of compaction”, Advanced Practices in pharmaceutical tablet and capsule technology” Las
`Vegas, NE (May 2006).
`
`“Use of new technologies/tools in the development and manufacturing of novel dosage forms”, ISPE Washington
`Conference, Arlington, VA (June 2006).
`
`“Turning the results of preformulation studies into robust formulation and process development”, PharmTech
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`Conference, Somerset, NJ (June 2006).
`
`“FDA’s Process Analytical Technology (PA) initiative and formulation & processing related challenges”, Las Vegas,
`NE (May 2007).
`
`“Theory and practice of compaction”, Advanced practices in pharmaceutical tablet and capsule technology”, Las
`Vegas, NE (May 2007).
`
`“Use of artificial intelligence [expert systems]in pharmaceutical applications”, Pharmaceutical Technology Seminar
`2011 – “Advances in Tablet Production”, Singapore, Singapore (May 2011).
`
`“Theory and Practice of pharmaceutical compaction I”, Pharmaceutical Technology Seminar 2011 – “Advances in
`Tablet Production”, Singapore, Singapore (May 2011).
`
`“Theory and Practice of pharmaceutical compaction II”, Pharmaceutical Technology Seminar 2011 - Pharmaceutical
`Technology Seminar 2011, Singapore, Singapore (May 2011)
`
`“Use of artificial intelligence [expert systems]in pharmaceutical applications”, Pharmaceutical Technology Seminar
`2011 – “Advances in Tablet Production”, Ho Chi Minh City, Vietnam (May 2011).
`
`“Theory and Practice of pharmaceutical compaction I”, Pharmaceutical Technology Seminar 2011 – “Advances in
`Tablet Production”, Ho Chi Minh City, Vietnam (May 2011).
`
`“Theory and Practice of pharmaceutical compaction II”, Pharmaceutical Technology Seminar 2011 - Pharmaceutical
`Technology Seminar 2011, Ho Chi Minh City, Vietnam (May 2011).
`
`“Use of artificial intelligence [expert systems]in pharmaceutical applications”, Pharmaceutical Technology Seminar
`2011 – “Advances in Tablet Production”, Suwon, South Korea (June 2011).
`
`“Theory and Practice of pharmaceutical compaction I”, Pharmaceutical Technology Seminar 2011 – “Advances in
`Tablet Production”, Ho Chi Minh City, Suwon, South Korea (June 2011).
`
`Plenary Lecture: “Theory and Practice of pharmaceutical compaction”, XIII Argentinean Congress of Industrial
`Pharmacy and Biochemistry and II Latin American Congress of Industrial Pharmacy and Biochemistry,
`Buenos Aires, Argentine (November 2011).
`
`Plenary Lecture: “Advanced formulation development strategies and expert systems“, XIII Argentinean Congress of
`Industrial Pharmacy and Biochemistry and II Latin American Congress of Industrial Pharmacy and Biochemistry,
`Buenos Aires, Argentine (November 2011).
`
`Plenary Lecture: “Impact of pharmaceutical science for the pharmaceutical industry”, Asian Federation for
`Pharmaceutical Sciences Conference, Kuala Lumpur, Malaysia (December 2011).
`.
`Plenary Lecture: “Intelligent and Risk-based approaches to formulation and process development”, Asian Federation
`for Pharmaceutical Sciences Conference, Kuala Lumpur, Malaysia (December 2011).
`
`Plenary Lecture: “The past, present and the future of pharmaceutical industry: Impact of Pharmaceutical Sciences”,
`Conference on Recent Advances in Pharmaceutical Science: Transferring Knowledge From Education To Sceince,
`Kathmandu, Nepal (February 2012).
`
`Plenary Lecture: “The PAT challenge for the formulation and process development scientist”, Symposium on
`
`DRL - EXHIBIT 1034
`DRL010
`
`

`
`Dr. Metin Çelik
`
`
`
`Page 11 of 27
`
`“Simulator Aided Tablet Formulation Development Technique”, Nicosia, (May 2012).
`
`“Introduction to tableting”, GEA-NUS Pharmaceutical Processing Research Laboratory, Pharmaceutical Tablet
`Technology Seminar & “Hands-on” Workshop , Singapore (December 2013).
`
`“Physics of compaction”, GEA-NUS Pharmaceutical Processing Research Laboratory, Pharmaceutical Tablet
`Technology Seminar & “Hands-on” Workshop , Singapore (December 2013).
`
`“Theory and practice of compaction, Part I, and Part II”, GEA-NUS Pharmaceutical Processing Research Laboratory,
`Pharmaceutical Tablet Technology Seminar & “Hands-on” Workshop , Singapore (December 2013).
`
`“Tablet simulators”, GEA-NUS Pharmaceutical Processing Research Laboratory, Pharmaceutical Tablet Technology
`Seminar & “Hands-on” Workshop , Singapore (December 2013).
`
`“Use of artificial intelligence in pharmaceutical applications: Expert Systems”, GEA-NUS Pharmaceutical Processing
`Research Laboratory, Pharmaceutical Tablet Technology Seminar & “Hands-on” Workshop , Singapore (December
`2013).
`
`Presentations/Invited Lectures at Scientific Short Courses:
`
`”Theory and practice of compaction”, Tablet Technology Update, College of Pharmacy, Rutgers University,
`Piscataway, NJ (March 1989).
`
`”Computer technology in pharmaceutical manufacturing”, FDA Course in Industrial Pharmacy, St. John's University,
`Jamaica, NY (June 1990).
`
`”Theory and practice of compaction”, Tablet Technology Update, College of Pharmacy, Rutgers University,
`Piscataway, NJ (September 1990).
`
`”Theory and practice of compaction”, Merck Sharp & Dohme, West Point, PA (December 1990).
`
`“Theory and practice of compaction”, Takeda Tablet Technology Update, Toronto, Canada, (February, 1991).
`
`“Formulation aspects of solid dosage forms”, Advanced courses for FDA inspectors, North Brunswick, NJ (November
`1991).
`
`“Tablet and capsule machine instrumentation A, The Institute for Applied Pharmaceutical Sciences, East Brunswick,
`NJ (July 1992).
`
`“Compaction, functionality testing and compaction data bank”, 1st Tablet technology update symposium: Tableting
`technology in the year 2000, Istanbul, Turkey (April 1994).
`
`“Dissolution and bioavailability”, 1st Tablet technology update symposium: Tableting technology in the year 2000,
`Istanbul, Turkey (April 1994).
`
`“Contract research: Pros & cons”, 1st Tablet technology update symposium: Tableting technology in the year 2000,
`Istanbul, Turkey (April 1994).
`
`“Tableting technology”, FDA Field Investigators Short Course in Pharmaceutical Science, Rutgers University,
`Piscataway, NJ (June 1995).
`
`
`DRL - EXHIBIT 1034
`DRL011
`
`

`
`Dr. Metin Çelik
`
`
`
`Page 12 of 27
`
`“The rational choice of Excipients”, PTI’s 1st Training Program on the formulation and process development for oral
`dosage forms, Nassau Inn, Princeton, NJ (April 2004).
`
`“Theory and practice of pharmaceutical compaction”, PTI’s 1st Training Program on the formulation and process
`development for oral dosage forms, Nassau Inn, Princeton, NJ (April 2004).
`
`“Evaluation and critical parameter of spray-drying and their impact on the stability of the resulting products”, PTI’s 1st
`Training Program on the formulation and process development for oral dosage forms, Nassau Inn, Princeton, NJ
`(April 2004).
`
`“The rational choice of Excipients”, PTI’s 2nd Training Program on the formulation and process development for oral
`dosage forms, Nassau Inn, Princeton, NJ (April 2005).
`
`“Theory and practice of pharmaceutical compaction”, PTI’s 2nd Training Program on the formulation and process
`development for oral dosage forms, Nassau Inn, Princeton, NJ (April 2005).
`
`“Current challenges and suggested solutions in formulation & process development”, PTI’s 3rd Training Program on
`the formulation and process development for oral dosage forms, Nassau Inn, Princeton, NJ (April 2006).
`
`“Use of AI based expert systems as PAT tools”, PTI’s 3rd Training Program on the formulation and process
`development for oral dosage forms, Nassau Inn, Princeton, NJ (April 2006).
`
`“Theory and practice of pharmaceutical compaction”, PTI’s 3rd Training Program on the formulation and process
`development for oral dosage forms, Nassau Inn, Princeton, NJ (April 2006).
`
`“Current challenges and suggested solutions in formulation & process development”, PTI’s 4rd Training Program on
`the formulation and process development for oral dosage forms, Nassau Inn, Princeton, NJ (April 2007).
`
`“Use of AI based expert systems as PAT tools”, PTI’s 4rd Training Program on the formulation and process
`development for oral dosage forms, Nassau Inn, Princeton, NJ (April 2007).
`
`“Theory and practice of pharmaceutical compaction”, PTI’s 4rd Training Program on the formulation and process
`development for oral dosage fo

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