PTI TEAM


President

        


Dr. Paul E. Wray

Dr. Metin Çelik

        

Dr. Paul E. Wray

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DR. METIN ÇELIK

President
 Phone : 1-908-864 0555  Fax: 1-908-864 0556  Email:    Metin.Celik@pt-int.com
 
 Biography and Clients 

Curriculum Vitae

Portfolio of Accomplishment
 

  1. Main Expertise Areas

  2. Biography

  3. Dr Çelik's Clients for:

Main Expertise Areas:

  • Pharmaceutical Expert Systems

  • Utilization of Artificial Intelligence for PAT Applications

  • Quality by Design

  • Solid Dosage Formulation & Process Development

  • Process Assessment

  • Validation of Solid Dosage Formulation & Processes

  • Pharmaceutical Compaction

  • Compaction Simulators

Dr. Çelik's Biography

Dr. Çelik is the founder and the President of Pharmaceutical Technologies International, Inc., (1997 - ) and is also a Research  Professor of Pharmaceutical Technology at the College of Pharmacy, Near East University in Cyprus (2008 - ).  Prior to that he was a Pharmaceutical Processing Research Professor at the Department of Industrial Engineering (2004-2008) and a faculty at the College of Pharmacy (1988-1997) at 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 fifty national and international symposia and short courses, and has published a book, nine book chapters, and over thirty articles relating to pharmaceutical formulation and processing issues, along with numerous abstracts and papers presented at scientific conferences and made over two hundred presentations (mostly invited) at the industry, academia and national and international meetings. 

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.

Dr. Çelik has acted a consultant to the FDA and to over fifty 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 also, the founder and the past chair of the AAPS Excipients Focus Group.  

Dr. Çelik is  listed in "Who is who in science and engineering (1995)".

Dr Çelik's Clients: Customized Software Development

Compaction Simulator Data Analysis:

  1. SK&F Labs (1989 - 1991)

Pharmaceutical Expert Systems:

  1. Bayer (1998 - 2001)
    SPRAYex- Spray Drying Expert System

  2. Therics (1997 - 2003)
    TheriSys - Flash Dose (Immediate Drug Release)
    TheriSys - Controlled Release  
    Expert Manager -  A Virtual Project Manager

  3. Novartis
    BILAYERex -  Bilayer Tablet Press Simulation Expert System

  4. Boehringer-Ingelheim (USA)
     INFOMex - Interactive Preformulation/Formulation/Analytical Data Analysis and Data Management System

  5. Novartis Pharmaceuticals Corporation (USA)
     INFOMex - Interactive Preformulation/Formulation/Analytical Data Analysis and Data Management System

Dr Çelik's Clients: Preformulation, Formulation & Process Development, Trouble Shooting, and Compaction Studies:

Pharmaceutical Companies:

  1. Advanced Care Products (1997-1998)

  2. Bayer (1996)

  3. Berlex Laboratories, Inc. (1993)

  4. Biogen Idec Corporation (2010-2011)

  5. Carter-Wallace (1992)

  6. Chelsea Laboratories (1995 - 1996)

  7. CoCensys (1996 -1998)

  8. Cyanamid (1992)

  9. G.D. Searle & Co. (1993)

  10. Gilead Sciences (2001)

  11. Glaxo (1990 - 1991)

  12. Merck Sharp & Dohme (1990 - 1991)

  13. Pain Therapeutics (2001)

  14. SKB (1997)

Excipient Companies:

  1. Colorcon (1996)

  2. Leprino Foods (1996 - 1997)

  3. Mendell, USA (1990 -1996)

  4. Mendell, UK (1993 - 1995)

  5. Sitco (1992 - 1993)

  6. Union Carbide (1995 - 1996)

Nutritional and Food Companies:

  1. American Nutritional Laboratories, Inc. (1994 -1996)

  2. Best Foods (1996)

  3. Nabisco (1990 - 1992)

Contract Research Companies:

  1. Chela  (2001)

  2. IPS (1998-2000)

  3. SMI (2001)

  4. University of Maryland Pharmaceuticals (1997)

Dr Çelik's Clients: Training Programs

Off-Site:

  1. FDA (1990 - 1991, 1995)

  2. IIR - PTI -  Educational Program (2001)

  3. Technomic - Educational Program (1998-2000)

  4. University of Wisconsin - Educational Program (1998)

  5. PTI Training Courses on Solid Dosage Forms (2004 - Present)

On Site:

  1. Janssen Ortho LLC (2000) 

  2. Oread (1998)

Dr Çelik's Clients: Expert Witness - Legal consultation in the field of solid dosage forms

  1. FDA (1993)

  2. Bryan Cave (1998-1999)

  3. Chadbourne & Parke LLP, (2001- 2002)

  4. Darby & Darby (2004, 2006-2007),

  5. Darby & Darby Professional Corporation (1998)

  6. Eckhaus & Olson Law Firm (1996 - 1997)

  7. Fish & Richardson (2005)

  8. Hazzard & Hore (2005 - 2008)

  9. Heenan Blaikie (2003-2007)

  10. Hitchman & Sprigings (2009- present)

  11. Jones Day (2004 - 2006)

  12. Kirkland & Ellis (2002)

  13. Knobbe, Mortens, Olson & Beer, LLP (2005)

  14. Latham & Watkins, LLP (2004)

  15. Lerner, David, Littenberg, Krumholz & Mentlik, LLP (2004-2006)

  16. Lord Bissel & Brook (2001 -  2002)

  17. Osler, Hoskin & Harcourt LLP (2006-2007)

  18. Price, Heneveld, Cooper, DeWitt & Litton (2001- 2007)

  19. Sterne, Kessler, Goldstein & Fox PLLC (2006)

  20. Quinn Emanuel (2009 - present)

  21. Wargo & French LLP (2006-2008)

  22. Wishart, Norris, Hennnger & Pittman, PA (2001-2002)

  23. Woodcock Washburn Kurts Mackiewicz & Norris Law Firm (1997)

Dr Çelik's Clients: Miscellaneous

  1. Nicolet Instruments (1990)

  2. Burroughs Welcome (1993)


 

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