3rd Annual Meeting on
FORMULATION & PROCESS DEVELOPMENT FOR ORAL DOSAGE FORMS
April 23 - 28, 2006, Nassau Inn, Princeton, New Jersey
Historical Location, Reputable Speakers & Innovative Program
Dr. Metin «elik
Dr. Metin «elik is the founder and the President of Pharmaceutical Technologies International, Inc. He is also a Research Professor of Pharmaceutical Processing at the Department of Industrial Engineering at Rutgers, The State University of New Jersey.
Dr. «elik has organized over thirty-five national and international symposia and short courses, and has published about thirty publications including book chapters, and refereed research articles and made more than hundred and fifty presentations (mostly invited) at the industry, academia and national and international meetings. His 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 prefomulation 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. Stuart C. Porter
Dr. Stuart Porter is the founder of Porter Pharmaceutical Technologies (PPT), which provides extensive consulting services to the pharmaceutical industry.
Dr. Porter holds several patents relating to film coating, and is a renowned speaker at technical symposia and conferences around the world. He is a member of the Royal Pharmaceutical Society of Great Britain, the American Association of Pharmaceutical Scientists, the American Pharmaceutical Association, and the Controlled Release Society, He is also a visiting adjunct faculty at several Schools of Pharmacy in the United States
Research Leader, Pharmaceutical and Analytical R&D, Hoffmann-La Roche
Graduated in 1982 from Khartoum (Sudan) University, Faculty of Pharmacy (Honor, Degree in Pharmacy). During 1982-1985 worked with the Faculty of Pharmacy, Khartoum University, WHO (world Health Organization), Ministry of Health in the Essential Drug Program for North Africa. Awarded a WHO fellowship in 1985 and went to the UK for MPhil, Ph.D. program in Pharmaceutical Technology. In 1990 awarded a Ph.D. in Pharmaceutical Technology from the University of Bath, UK. He joined Hoffmann-La Roche Inc. Nutley, NJ in 1992 and currently working as a Research Leader. During his career he was awarded several prestigious awards. Research interests have included pre-formulation and formulation testing of pharmaceutical products. Physical stability of pharmaceutical powder mixes. Physico-mechanical and physicochemical interactions encountered in the course of drug product design. Aspects of pharmaceutical technology including powder technology, tablet design and compaction, drug formulation and medicine design. He published extensively in the areas of powder mixing/segregation, powder technology, and tablets. In addition to development of solid dosage forms, current interests include formulation of low solubility drugs to improve bioavailability, discovery support through galenical disciplines.
President, Center for Pharmaceutical Physics
Prior to forming the Center for Pharmaceutical Physics, Dr. Brittain was Vice President for Pharmaceutical Development of Discovery Laboratories, Inc. Before that, he served as Director of Pharmaceutical Development at Ohmeda, Inc., and also led a variety of groups within the Analytical R&D department at Bristol-Myers Squibb. Dr. Brittain is a graduate of Queens College (B.S., 1970; M.S. 1972), and of the City University of New York (Ph.D. in physical chemistry, 1975). He was a postdoctoral fellow at the University of Virginia, and has held faculty positions at Ferrum College (Assistant Professor of Chemistry) and Seton Hall University (Associate Professor of Physical and Inorganic Chemistry). He has been Adjunct Professor of Pharmaceutics at Rutgers University and Visiting Research Scientist at Lehigh University.
Dr. Brittain has authored approximately 245 research publications and book chapters, and has presented over 70 invited lectures in the pharmaceutical field. He has edited the monographs Physical Characterization of Pharmaceutical Solids, Polymorphism in Pharmaceutical Solids, and Analytical Applications of Circular Dichroism. Dr. Brittain is a member of the editorial boards of Pharmaceutical Research, Journal of Pharmaceutical Sciences, Pharmaceutical Development and Technology, PharmSci, Pharmaceutical Technology, Journal of Pharmaceutical and Biomedical Analysis, Chirality, and Instrumentation Science and Technology. He is also the Editor for the book series Analytical Profiles of Drug Substances and Excipients, and is Chairman of the United States Pharmacopeia Expert Committee on Excipient Monograph Content.
Dr. Brittain was elected as a Fellow of the American Association of Pharmaceutical Sciences (AAPS) in 1991, a Member-At-Large of the AAPS Publications Board in 2001, and received the AAPS Research Achievement Award in Analysis and Pharmaceutical Quality in 1998. He was also elected as a member of the International Centre for Diffraction Data in 2001.
Gary Bubb is Vice President and the Director of Engineering of Specialty Measurements
Gary Bubb is Vice President and the Director of Engineering of Specialty Measurements in Whitehouse N.J.
Gary graduated with an undergraduate degree in mechanical engineering from Northeastern University in 1966. His work experience started as an engineer with the Department of Defense where he was assigned the task of standardizing the measurement systems at the various Army Proving Grounds in order to better correlate the data. While in that position Gary pursued a Graduate program in Measurements Engineering and Mechanical Vibrations during which he attended a variety of schools including Stevens, Arizona State, Trenton State, Tuffs, and UCLA.
In 1982 Gary was one of the co-founders of SMI, Specialty Measurements Inc., with a focus on developing specialized transducers and instrumentation systems for Industry. SMI grew to become the largest independent testing laboratories on the East Coast, with major projects including all of the East and Hudson River Bridges in New York and the Delaware River Bridges in Philadelphia. In 1984 SMI developed the first PC based system for instrumented tablet presses that was the precursor for the SMI 3600, a computer-based data acquisition system designed and manufactured by SMI. Ultimately, the SMI 3620 and evolved into the SMI 3620, 3630, and 3640 using Motorola processors and a unique operating system called OS-9. When the IBM series of computers proved to be powerful enough, SMI introduced a PC based system called the PC-30 with a DOS operating system. The current product is called ďThe DirectorĒ, a Windows 95 or higher based system.
In 1998, SMI introduced the Piccola, the first table top rotary tablet press, into the US market. To date over 250 of these machines have been made and are sold throughout Europe, North and South America, and Asia.
Today SMI specializes in solid dosage machines with a complete line of tablet presses, high shear granulators, roller compactors, cone mills, and the latest addition, a fluid bed granulator. All of these products serve the needs of pre-formulation through R&D, pilot plant and production. These products reflect engineering and instrumentation excellence drawn from Garyís background and education.
President, Pharmaceutical Technologies International, Inc.
Dr. «elik 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. «elik 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. «elik 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. «elik 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. «elik'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. «elik 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. «elik 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. «elik 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. «elik is listed in "Who is who in science and engineering (1995)".
Professor of Pharmaceutics, College of Pharmacy,
University of Minnesota, Minneapolis, Minnesota, USA.
We are very sad to announce that Prof. David Grant passed away on December 8th, 2005. Dr. Harry Brittain has kindly accepted to present the subject matter given in Prof. Grant's lectures.
David Grant is a graduate of Oxford University, UK: B.A. in Chemistry in 1960; D.Phil. in Physical Chemistry in 1963; M.A. (Keble College, 1963); and D.Sc. for recognized published research on the physical chemistry of pharmaceutical systems (October 1990). He has held academic appointments at the University of Nottingham, UK, and University of Toronto, Canada. In 1988, he was appointed to the William and Mildred Peters Chair in Pharmaceutics, University of Minnesota. Since July 1998, he has served as Director of the Drug Delivery Center in the University. Since January 1994, David Grant has served as Associate Editor of the Journal of Pharmaceutical Sciences. He is also a member of the Editorial Advisory Board of the journals Pharmaceutical Development and Technology, Kona Powder and Particle and AAPSPharmSci. In April 1999 he was awarded the PhRMA Foundation Pharmaceutics Award in Excellence. David Grant teaches the physical chemistry of pharmaceuticals in which he is co-author of an undergraduate text. In 1978 and 1980 he worked on the intermolecular interactions of drugs in solution at the University of Kansas in the laboratory of the late Dr. Takeru Higuchi, with whom he is the co-author of a book on the solubility behavior of organic compounds. Since 1978 David Grant has been studying the crystal engineering of drugs and the properties of the solid state, particularly the thermodynamics, solvation, polymorphism, crystallization, compaction, solubility, and dissolution of drugs. His recent work has focused on doping, hydration, hydrogen bonding, and chirality in the solid state. He is the author or co-author of over 200 peer-reviewed scientific articles and reviews and serves as a consultant for numerous companies that manufacture fine chemicals and pharmaceuticals. David Grant is a Fellow of AAAS, AAPS, IUPAC and the Royal Society of Chemistry (Chartered Chemist, UK). Memberships also include ACA, ACS, AIChE, APhA, and Rho Chi.
Vice President, Process Technology at Glatt Air Techniques, Inc.
David M. Jones was appointed Vice President, Process Technology at Glatt Air Techniques, Inc. in Ramsey, New Jersey in June, 2001. Currently his assignments are in several directions. His primary responsibilities are as a process advisor in the Product Development Group (formulation, process development, scale-up and tech transfer) at Glatt. Secondly, he conducts processing seminars and assists existing and prospective customers in process development, troubleshooting and scale-up projects worldwide. Finally, Jones acts as a US user representative to the equipment development and engineering groups at Glatt, GmbH, a manufacturer of equipment for use in solid dosage form processing, with primary interests in the pharmaceutical industry (the parent company of Glatt Air Techniques, Inc). Studying electrical and mechanical engineering at the University of Delaware, prior to joining Glatt, he was on the Process Development staff at Stuart Pharmaceuticals (Astra-Zeneca Pharmaceuticals at present) in Newark, Delaware. In 1979, he joined Glatt as the feasibility laboratory supervisor. His responsibilities included testing of client's materials in laboratory, pilot and production scale fluidized bed systems, development of standard operating and equipment cleaning procedures and registration of Glatt with FDA as a food and pharmaceutical manufacturer. He has published more than 20 articles, three book chapters, and is the recipient of four U.S. patents (five pending).
Vice President, Pharmaceutical and Analytical R&D, Hoffmann-La Roche Inc.
Waseem Malick, Ph.D. is Vice President, Pharmaceutical and Analytical R&D Department, Hoffmann-La Roche Inc., Nutley, NJ, 07110. Dr. Malick received his B.S. (Pharmacy) from Panjab University, M.S. (Pharmaceutics) from Columbia University and Ph.D. (Pharmaceutics) from University of Michigan in 1976. He was Assistant Professor of Pharmaceutics at Wayne State University, Detroit from 1975-1978. In 1978, he started his industrial research career at American Hospital Supply Corporation and subsequently joined Hoffmann-La Roche, USA in 1981. He has been involved in preformulation, formulation, analytical and drug delivery research and currently is Global Head of Pharmaceutical & Analytical R&D at Roche. He has published extensively and has been very active in professional organizations. He has in the past served as the General Chairperson of the American Association of Pharmaceutical Scientists (AAPS) Eastern Regional Meeting and as the Chairperson of the Pharmaceutical Development Subsection of the Pharmaceutical Research and Manufacturers of America. He is an AAPS Fellow. Dr. Malickís current responsibilities include global management and guidance of analytics, drug delivery research, preformulation, formulation and manufacture of clinical dosage forms, and package research.
Director, International Sales and Research and Development, Quadro Engineering Inc.
British/Canadian trained with more than twenty-eight (28) years of experience in Mechanical Engineering specializing in Machine and Process Design.
Over the past 12 years at Quadro, Ben has been successfully designing and developing process equipment for the Pharmaceutical, Food, Cosmetic and Chemical Industries specializing in milling.
Ben has been awarded three (3) USA/Worldwide patents for his novel inventions for the pharmaceutical industry. He is a Senior Member of the Society of Manufacturing Engineers and Institute of Industrial Engineers.
Ben is also a member of ISPE (International Society of Pharmaceutical Engineers) and the Ontario Certified Engineering Technicians and Technologists.
President, DPharma Group Inc.
Dilip M. Parikh is a President of Dpharma Group Inc., a pharmaceutiocal Technology consulting group. He is a Industrial Pharmacist by training, and has over 30 years of industry experience gained at major pharmaceutical companies in research and development, cGMP compliant facility planning and constructions, and manufacturing and operational management.
He is the editor of book:Handbook of Pharmaceutical Granulation Technology, second Edition published in 2005 (Taylor and Francis, NY) and author of numerous scientific publications. Mr. Parikh has been an invited speaker at various scientific conferences worldwide on various Pharmaceutical technologies.
President, PPT and Vice President, PTI, Inc
Dr. Porter is currently President, PPT, and Vice President, Pharmaceutical Technologies International, Inc., where he is involved with providing a variety of services (including product and process optimization, designing expert systems, presenting training seminars, and undertaking contract product development projects) to the global pharmaceutical industry. Previously, he was Vice President, Global Technical Support, for Colorcon, with responsibility for worldwide customer technical support and product applications development. Having spent more than 25 years with Colorcon, he directed the development of the wide variety of coating systems for which that company is renowned. Before joining Colorcon, he was a pharmaceutical product development scientist with Astra-Zeneca (formerly I.C.I. Pharmaceuticals Division) in the UK.
Additionally, he is President, Phoqus Pharmaceuticals, Inc., the subsidiary of UK-based company engaged in the development and application of electrostatic technology to oral solid dosage forms with a view to creating novel drug delivery systems and opportunities for novel imaging of such dosage forms.
Dr Porterís technical interests relate to film coating, tabletting, and fluid-bed technologies, with particular interest in modified-release drug-delivery systems, the application of statistical experiment design techniques to product and process optimization, and the development of expert systems for pharmaceutical oral solid dosage forms.
Dr Porter holds several patents relating to film coating, and is a renowned speaker at technical symposia and conferences around the world. He is a member of the Royal Pharmaceutical Society of Great Britain, the American Association of Pharmaceutical Scientists, the American Pharmaceutical Association, and the Controlled Release Society. He is also a visiting adjunct faculty at several Schools of Pharmacy in the United States
Dr Porter is a native of England, and received his B. Pharm. (with hons.) Degree from the Welsh School of Pharmacy, U.W.I.S.T., and his Ph.D. in Pharmaceutics from the School of Pharmacy, University of London.
Senior Consultant, Jenike & Johanson, Inc.
James K. Prescott is a Senior Consultant at Jenike & Johanson, Inc. in Westford, Massachusetts. As a consultant dealing with powder flow, primarily serving the pharmaceutical industry, he has addressed hundreds of projects, such as solving solid dosage form content uniformity problems, reducing product weight variations, specialized feeders for low feed rate/high accuracy applications, and corporate standardization of bin designs. He received his B.S. in Aeronautical Engineering from Rensselaer Polytechnic Institute in Troy, New York, and his M.E. in Mechanical Engineering from Worcester Polytechnic Institute in Massachusetts. Jim is a member of the PQRI Blend Uniformity Working Group.
Distinguished Research Leader, Pharmaceutical R&D, Hoffmann-La Roche.
Navnit H. Shah is a Distinguished Research Leader in the Pharmaceutical R&D Department at Hoffmann-La Roche Inc. Nutley, N.J. He is heading the oral dosage form development group. He has received his B.S. in Chemistry and Pharmacy from the Bombay University in India and M.S. and a Ph.D. in Pharmaceutics from St. Johnís University in New York. Dr. Shah has accumulated over 25 years of experience on the research and development of oral dosage forms and published and presented over 50 papers in the field of development of controlled release drug delivery, oral absorption improvement of poorly soluble drugs, powder technology and solid dosage forms technology. He is the holder of 14 patent in drug delivery systems encompassing controlled release and oral absorption improvement area. Dr. Shah has published extensively on the solid dosage form development and powder technology affecting content uniformity and dissolution of drugs. Dr. Shah was an invited speaker for Preformulation and formulation of solid dosage form development , lipid delivery systems and controlled delivery area at various national and international conferences. He is a member of the American Association of Pharmaceutical Scientists and Controlled Release Society. He is AAPS fellow and served AAPS in various capacities as a chairman of PT section program committee for eastern regional meeting, and chairman of paper screening committee for AAPS annual meeting. He is also an adjunct associate professor at the University of Rhode Island and responsible for mentoring two Ph.D. students.
Director of Pharmaceutics and Pharmaceutical Technology in the Process Technology Solutions area of IPS.
He has been involved in production support, scale-up, pilot plant as well as early and full development activities of pharmaceutical products, which include novel as well as traditional dosage forms for the past 29 years with Novartis.
Within the scope of his development efforts a practical application of novel product engineering concepts have been merged with the regulatory needs and production requirements demanded for bulk pharmaceuticals. These unique products have been delivered as robust, validated commercial processes.
He has provided expert guidance, and support for 21 NDAs in the chemistry, manufacturing and control area from submission through the pre approval inspection phase.
His current role with IPS focuses on pharmaceutical technology and helping clients achieve their FDA regulated product goals for a fast submission, seamless approval as well as assuring a cost effective product and a secure supply chain.
His research interests include unique process control applications, physics of tablet compression events and the characterization of films applied to solid dosage forms.
He is the past chairman of ISPEís SUPAC Equipment Guidance Steering Committee. The efforts of this committee were awarded former Vice President Al Goreís ďHammer AwardĒ. The Hammer Award was given to federal employees and their partners who had advanced the Vice Presidentís National Performance Review goals of building a better government.
Russ earned his PhD in Pharmaceutical Technology under N.G. Lordi at Rutgers University College of Pharmacy in 1987. Prior to this he earned his BS degree in Pharmacy in 1974 and an MS degree in 1980 from Rutgers University.
Contact Information: IPS, 3 Executive Drive, Somerset, NJ, 08873
732-748-1990 Ex 203,FAX 732-748-1993
Senior Principal Scientist, Hoffman La Roche
Dr Duksoon Choi is a senior principal scientist, heading preformulation and solid state characterization group at Hoffman La Roche in Nutley. Dr. Choi and his team collaborate closely with the discovery chemists, biologists, formulation scientists and process chemists in identifying compounds with optimal physicochemical, ADME and solid state properties for development and manufacture. His research focuses on the understanding the principles and applications of physics and chemistry in dealing with pharmaceutics, drug delivery, synthesis and process scale up. He received his B.S. in chemistry from Kyung Hee University at Seoul in 1976, and a Ph.D in analytical chemistry with environmental toxicology as minor from Louisiana State University in 1988. After his Ph.D. he had worked in discovery, early clinical development and analytical development area before he joined Hoffman La Roche in 1999.
Assistant professor, Department of Industrial and Physical Pharmacy at Purdue University.
Lynne S. Taylor is currently an assistant professor in the Department of Industrial and Physical Pharmacy at Purdue University. Prior to moving to academia, she spent 5 years working at AstraZeneca in Sweden where she was an associate principle scientist within the Solid State Analysis group. Lynne obtained a Bachelor of Pharmacy degree from the University of Bath (1990) and a PhD from the School of Pharmacy, University of Bradford, UK (1996). Lynne also held a postdoctoral research position at the School of Pharmacy, University of Wisconsin-Madison, USA. Her research interests center on the investigation of polymorphs, hydrates and amorphous materials, dosage form characterization and the application of vibrational spectroscopy to investigate the solid state.