Expert Details

Pharmaceutical Dosage Forms

ID: 737899 New Jersey, USA

Expert is the founder and the President and Founder of a pharmaceutical technology company since 1997, and Adjunct Professor of Pharmaceutical Sciences, Faculty of Pharmacy, since 2019. Prior to that he was as a faculty member at the Faculty of Pharmacy- Eastern Mediterranean University, Famagusta, Cyprus (2017-2020), Faculty of Pharmacy – Near East University (2014-2017), He also served as 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.

Expert 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. He 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.

He has organized over fifty national and international symposia and short courses and has edited a book on Pharmaceutical Powder Compaction Technology published by Informa Healthcare 2011). He also published several 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.

Expert's areas of expertise include: 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, 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, and nano-technology.

Expert has acted a consultant to the FDA and to over seventy-five pharmaceutical, nutraceutical, excipient, and equipment companies as well as law firms worldwide.

Expert has served as a member of the editorial board or a reviewer for numerous pharmaceutical journals: Pharm. Development & Technology, Int. Journal of Pharmaceutics, Pharmaceutical Technology, Tablets & Capsules, and European Journal of Pharmaceutical Sciences.

Expert has served at numerous scientific and organizational committees: Founder of Expert Systems Focus Group, AAPS; Founder of Excipients Focus Group, AAPS; Chairperson, Expert Systems Focus Group, AAPS; Chairperson, Excipients Focus Group, AAPS; Chairperson, Process Development Focus Group, AAPS; Steering Committee Member, Excipients Focus Group, AAPS; Steering Committee Member, Process Development Focus Group, AAPS; AAPS Program Committee Member; AAPS Short Course Committee Member; NJPhAST Program Committee Member; NJPhAST Program Committee Chair.

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

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Education

Year	Degree	Subject	Institution
Year: 1884	Degree: PhD	Subject: Pharmaceutical Technology	Institution: De Montfort University, Leicester, England
Year: 1979	Degree: BSc	Subject: Pharmacy	Institution: Hacettepe University, Ankara, Turkey

Work History

Years	Employer	Title	Department
Years: 1997 to Present	Employer: Undisclosed	Title: President	Department: R&D
Responsibilities: Founder of the company. Provide consultancy services to Pharmceutical Industry worldwide.
Years	Employer	Title	Department
Years: 2019 to Present	Employer: Undisclosed	Title: Adjunct Prof. of Pharmaceutical Sciences	Department: College of Pharmacy
Responsibilities: Acting as a co-advisor on a PhD project.
Years	Employer	Title	Department
Years: 2017 to 2020	Employer: Eastern Mediterranean University, Famagusta, TRNC	Title: Faculty member	Department: Faculty of Pharmacy
Responsibilities: Lecturing on Pharmaceutical Technology courses Advising Doctor of Pharmacy student projects
Years	Employer	Title	Department
Years: 2008 to 2017	Employer: Near East University, Nicosia, TRNT	Title: Faculty member	Department: Faculty of Pharmacy
Responsibilities: Lecturing on Pharmaceutical Technology courses Advising MPhil and PhD students
Years	Employer	Title	Department
Years: 2004 to 2008	Employer: Rutgers, The State University of New Jersey, USA	Title: Part-time faculty member	Department: Department of Industrial Engineering
Responsibilities: Lecturing on Pharmaceutical Engineering courses
Years	Employer	Title	Department
Years: 1988 to 1997	Employer: Rutgers, The State University of New Jersey, USA	Title: Faculty member	Department: College of Pharmacy
Responsibilities: Lecturing on pharmaceutics course Advising MPhil and PhD students Establishment of the second Compaction Simulator in the USA. Acting as the director of Pharmaceutical Compaction Research Center & Information Center
Years	Employer	Title	Department
Years: 1986 to 1988	Employer: SmithKline & French, PA, USA	Title: Post Doctoral Scientist	Department: Pharmaeutical Tecnology
Responsibilities: Establishment of the first Compaction Simulator in the USA.
Years	Employer	Title	Department
Years: 1985 to 1985	Employer: Novartis (Formerly known as Sandoz) Istanbul, Turkey	Title: Development Coordinator	Department: R&D
Responsibilities: Establishment of the R&D department Troubleshooting of the problematic products
Years	Employer	Title	Department
Years: 1984 to 1985	Employer: Novartis (Formerly known as Sandoz), Basel, Switzerland	Title: Trainee	Department: R&D
Responsibilities: Trained in R&D and manufacturing departments to lead the R&D activities in Turkey after the completion of training.

Additional Experience

Expert Witness Experience
Total of 26 Expert witness experience

Career Accomplishments

Associations / Societies
AAPS (American Association of Pharmaceutical Scientists), 1988 ISPE (International Society of Pharmaceutical Engineers), 2000

Licenses / Certifications
Pharmacy License, 1979

Awards / Recognition
1. Faculty Academic Service Increment Program Award (3 years) 2. Who is who in science and engineering 3. Commission of Science & Technology of New Jersey Award 4. Received over fifty grants at Rutgers University in the total amount of more than $1,100.000 5. Establishment of the Pharmaceutical Compaction Research Lab. & Information Center 6. Berlex Laboratories Inc ($25,000); Ciba Geigy ($25,000); Eli Lilly ($25,000); Glaxo ($25,000); Hoffman LaRoche ($25,000); Johnson & Johnson Corporation ($7,000); Lederle ($25,000); McNeil Consumer Products Company ($6,000); McNeil Pharmaceuticals ($6,000); Merck Sharp & Dohme ($ 25,000); Ortho Pharmaceutical ($6,000); Park Davis ($15,000); Pfizer ($25,000); Sandoz ($25,000); Schering Plough ($25,000); Squibb ($25,000); Syntex ($25,000). 7. General Research: Hoffman La Roche: $7,500; RWJ-Pharmaceutical Research Institute: $4,000; Takeda USA: $3,000, $3,000, $1,000; Mendell: $12,000, $15,250, $ 16,000; Hoffman La Roche: $4,000; SmithKline Beecham: $5,000; McNeil Consumer Products Company: $7,500; Syntex $10,000. 8. Compaction studies on surelease coated pellets: Colorcon: $ 20,000; Sandoz: $10,000 9. Characterization of a roller compacted maltodextrin for direct compression: Mendell: $13,300, $13,860 10. Scale up studies in milling process using Model 193 and 197 Quadro-Comil: Quadro Engineering Inc. $5,000 . 11. A study on the dimensional changes of tablets as a factor causing internal stress development within film coating: RWJ-Pharm. Research Inst. $8,000 12. Development of a compaction data bank: Hoffman La Roche: $8,000 ; J & J Corporation $ 6,000; McNeil C.P. Company: $10,000 ; RWJRI Ortho Pharm: $6,000; Takeda USA: $5,000; Takeda Japan: $5,000; Mendell: $45,000, $22,500; $150,000. 13. Tableting Expert Systems: Bayer $50,000; Hoffman La Roche $5,000 14. Support for the Annual PCRI&IC symposia: Berlex $40,500, Registrations: $30,000; National Science Foundation: $10,000 15. Equipment Support: Sitco: $10,000; VanKel: $7,500; RWJ-PRI: $5,000; Quadro: $15,000 16. Direct fabrication and evaluation of orthopedic bone implants via 3-dimensional printed technology (A collaborative project with Therics): Commission of Science & Technology of NJ: $100,000 17. The Best Industrial Pharmacy Poster Prize - FIP Congress İstanbul (Student: Sena Erdil, Poster entitled “The Effect of Fluidized Bed Systems on Granule Flowability and Compaction Properties”)

Awards / Recognition

1. Faculty Academic Service Increment Program Award (3 years)
2. Who is who in science and engineering
3. Commission of Science & Technology of New Jersey Award
4. Received over fifty grants at Rutgers University in the total amount of more than $1,100.000
5. Establishment of the Pharmaceutical Compaction Research Lab. & Information Center
6. Berlex Laboratories Inc ($25,000); Ciba Geigy ($25,000); Eli Lilly ($25,000); Glaxo ($25,000); Hoffman LaRoche ($25,000); Johnson & Johnson Corporation ($7,000); Lederle ($25,000); McNeil Consumer Products Company ($6,000); McNeil Pharmaceuticals ($6,000); Merck Sharp & Dohme ($ 25,000); Ortho Pharmaceutical ($6,000); Park Davis ($15,000); Pfizer ($25,000); Sandoz ($25,000); Schering Plough ($25,000); Squibb ($25,000); Syntex ($25,000).
7. General Research: Hoffman La Roche: $7,500; RWJ-Pharmaceutical Research Institute: $4,000; Takeda USA: $3,000, $3,000, $1,000; Mendell: $12,000, $15,250, $ 16,000; Hoffman La Roche: $4,000; SmithKline Beecham: $5,000; McNeil Consumer Products Company: $7,500; Syntex $10,000.
8. Compaction studies on surelease coated pellets: Colorcon: $ 20,000; Sandoz: $10,000
9. Characterization of a roller compacted maltodextrin for direct compression: Mendell: $13,300, $13,860
10. Scale up studies in milling process using Model 193 and 197 Quadro-Comil: Quadro Engineering Inc. $5,000 .
11. A study on the dimensional changes of tablets as a factor causing internal stress development within film coating: RWJ-Pharm. Research Inst. $8,000
12. Development of a compaction data bank: Hoffman La Roche: $8,000 ; J & J Corporation $ 6,000; McNeil C.P. Company: $10,000 ; RWJRI Ortho Pharm: $6,000; Takeda USA: $5,000; Takeda Japan: $5,000; Mendell: $45,000, $22,500; $150,000.
13. Tableting Expert Systems: Bayer $50,000; Hoffman La Roche $5,000
14. Support for the Annual PCRI&IC symposia: Berlex $40,500, Registrations: $30,000; National Science Foundation: $10,000
15. Equipment Support: Sitco: $10,000; VanKel: $7,500; RWJ-PRI: $5,000; Quadro: $15,000
16. Direct fabrication and evaluation of orthopedic bone implants via 3-dimensional printed technology (A collaborative project with Therics): Commission of Science & Technology of NJ: $100,000
17. The Best Industrial Pharmacy Poster Prize - FIP Congress İstanbul (Student: Sena Erdil, Poster entitled “The Effect of Fluidized Bed Systems on Granule Flowability and Compaction Properties”)

Publications and Patents Summary
Publications: Book: 1 Book Chapters: 11 Refereed Journal Articles: 30

Fields of Expertise

Solid dosage forms, Tablets, Capsules, Formulation & Process Development, excipients, compaction simulators, novel dosage forms, QbD, PAT, process assesment, manufacturing of solid dosage forms

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Expert Details

Pharmaceutical Dosage Forms

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