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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.
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'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 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 past chair of the AAPS Excipients Focus Group. Dr. Çelik is listed in "Who is who in science and engineering (1995)".
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.
Senior Manager in the Product Development Group at Colorcon
Charlie Cunningham is currently a Senior Manager in the Product Development Group at Colorcon where he is responsible for the development of new film coating technologies and applications. Before assuming his current role, Charlie held the positions of North America Technical Services Manager and Global Technical Manager for excipients. In these roles, he provided technical support for film-coating processes and solid oral dose formulation using immediate and modified release technologies supplied by Colorcon. In his 17 year career at Colorcon, Charlie has focused on coating process applications and the scale-up and optimization of aqueous film-coating processes. Charlie has published several articles in the areas of immediate release and delayed release film coating technologies as well as solid oral dose formulation and excipient technologies. He holds three patents related to novel film-coating and excipient formulations. Prior to joining Colorcon, Charlie was employed by Niro and was involved in the development of spray-drying, fluid-bed coating and granulation processes.
Linda A. Felton, Ph.D. is an Associate Professor of Pharmaceutics at the University of New Mexico. She earned a B.S. in Pharmacy and a Ph.D. in Pharmaceutics from the University of Texas at Austin. Her research interests are focused on polymeric film coating technology, modified release systems, and topical/transdermal drug delivery. She has presented her work at national and international conferences and has published extensively in peer-reviewed journals.
Dr. Felton is a reviewer for a number of pharmaceutical journals, an editorial board member of Drug Development and Industrial Pharmacy, and the co-editor for the 3rd edition of “Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms” text. Dr. Felton has a joint appointment with the Department of Veteran’s Affairs Cooperative Studies Program where she oversees the formulation development of clinical trials materials. She is a current member of AAPS, CRS, ISPE, and AACP.
After a 28 year career at Glatt Air Techniques, Inc. David M. Jones departed at the end of June, 2007 to begin a practice as an independent consultant (launch date July 1, 2008). As Vice President for the Pharmaceutical Services Division at Glatt, his assignments were in multiple directions. These included supporting existing and prospective customers in process development, scale-up projects, troubleshooting and operator training programs globally. Jones was the organizer and course director for the Glatt Air Techniques, Inc. hands-on Process Training Seminars, semi-annual events attracting an average of 70 attendees. He also was responsible for developing and presenting more than 50 custom training seminars for industry clients. A frequently invited speaker, he has spoken at AAPS Symposia (national and regional meetings); the Philadelphia and New Jersey Pharmaceutical Discussion Groups; the TTC (Technology Training Center) in Germany as well as for several vendor organized symposia (Degussa-Huls, Colorcon, Lasentech, etc.). A second area of responsibility was as a process consultant for the formulation development group at Glatt. For the equipment division, he was an initiator of Glatt’s global standard for machine and insert configuration, and routinely was the process representative for the design and specification of machinery for clients of the company. He studied mechanical and electrical engineering at the University of Delaware. Prior to joining Glatt, he was on the Process Development staff at Stuart Pharmaceuticals (then a division of ICI Americas) in Newark, Delaware. He has published more than 15 articles, three book chapters, and is the recipients of seven U.S. patents, including the technique known as the Wurster HS (patented by Glatt Air Techniques, 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. Malick’s current responsibilities include global management and guidance of analytics, drug delivery research, preformulation, formulation and manufacture of clinical dosage forms, and package research.
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 Technologist.
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.
Dr. Porter is currently Senior Science Fellow with International Specialty Chemicals (ISP), where he has responsibility for the development, on a global basis, of film-coating systems and providing customer technical support. Prior to joining ISP, he was a technical consultant to the Pharmaceutical Industry, specializing in formulation and process design associated with broad strategies relating to oral drug delivery, particularly as these embrace application of the film-coating process. His expertise also involves designing approaches for formulation and process optimization using design of experiment (D.O.E.) techniques. He has been, and continues to be, associated with Pharmaceutical Technologies International, Inc., in presenting training seminars to the pharmaceutical industry. Until early 1999, Dr. Porter was Vice President, Global Technical Support, for Colorcon where he had responsibility for customer technical support and product applications development on a worldwide basis. For more than 25 years, Dr Porter held several positions within Colorcon, and was responsible for the development of the film-coating systems for which that company is renowned. Dr. Porter formerly had experience in the UK with I.C.I. (now AstraZeneca) Pharmaceuticals Division as a formulation scientist. He is a native of England and received his B.Pharm. (with honors) Degree from the Welsh School of Pharmacy, U.W.I.S.T. (U.K.), and his Ph.D. Degree from the School of Pharmacy, University of London. Dr. Porter holds several patents relating to film coating, and has published extensively on this subject. He is a well-recognized presenter at technical conferences around the world. He is a member of the Royal Pharmaceutical Society of Great Britain, American Association of Pharmaceutical Scientists, American Pharmacists Association, and the Controlled Release Society. He is a visiting adjunct faculty at the Philadelphia College of Pharmacy, University of the Sciences in Philadelphia.
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.
Executive Director Novartis Pharmaceuticals Corporation
Dr. Ruegger received a BS in Pharmacy from Rutgers College of Pharmacy and a Ph.D. in Pharmaceutical Science from Rutgers University. She currently works as a Pharmaceutical Development Unit Head at Novartis Pharmaceuticals Corporation in East Hanover, NJ where she is responsible for product development, clinical manufacturing and technology transfer. Her current interests include the application of LEAN processes for pharmaceutical development, Quality by Design, compaction simulation, and formulation development of poorly soluble compounds.
Dr. Ruegger is a member of the American Association of Pharmaceutical Scientists and is the chair of the Manufacturing, Science and Engineering section of AAPS.
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. John’s 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.
Dr. Somma has more than 30 years of experience working in the pharmaceutical industry, specifically in the areas of production troubleshooting, dosage form development, manufacturing scale up, technology transfer and project management. He has a particular technical interest in the area of solid dosage forms and the physical pharmacy associated with them. Dr. Somma has utilized his technical and managerial talents within cross- and multi-functional teams, mentoring colleagues and direct reports alike. He has had direct responsibility for senior staff, both domestically and internationally, as well as technical development and life cycle management support for a variety of oral solid dosage,novel formulations and therapeutic groups. Additionally, he has served as an invited investigator trainer and liaison for the FDA on various projects and initiatives, affording a unique perspective within Pharmaceutical Regulatory Affairs. At SommaTech, Dr. Somma’s focus is on pharmaceutical technology and helping clients achieve their FDA regulated product goals for a fast submission and seamless approval, as well as assuring a cost effective product and secure supply chain. He has a strong background in implementation of SUPAC IR/MR equipment guidance with society associates and colleagues within FDA/CDER, and will work to share his expertise with IPS’ clients. Dr. Somma has been a welcomed keynote speaker and presenter at many pharmaceutical industry association meetings. Among them is the FDA/s Pharmaceutical cGMPs and Process Analytical Technology (PAT) Symposium, where his topic was “Current Industry Practices in Manufacturing Process Validation.” Other topics include “Technology Transfer or Knowledge Transfer for Products and Processes: Which Expedites the Process Most?”, “Life Cycle Management – the Way of the Future?” and “Aspects of Technology Transfer.” Additionally, Dr. Somma has written and co-authored several technical papers and studies, most recent being “In vitro Dissolution and In vivo Bioavailability of Methylphenidate from a Bi-modal Release Formulation and an Immediate Release Formulation in Healthy Volunteers,” with L. Lee, et al.
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