CRS EDUCATIONAL WORKSHOPS
July 7-8, 2007, Long Beach, California
Watch for more details to come on these exciting educational offerings.
Micro and Nanoencapsulation: Formulation, Applications, and Processes
Generously Sponsored by Bio Invigor Corporation and Lipo Chemicals, Inc.
Chairs:Paul Richardson, Balchem Corporation, U.S.A.; J. Chris Soper, Givaudan Flavors, U.S.A.; and Ronald Versic, Ronald T. Dodge Company, U.S.A.
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- Applications in Controlled Release
Ronald Versic, Ronald T. Dodge, U.S.A.
- Atomization Processes
Irwin Jacobs, Particle and Coating Technologies, U.S.A.
- Coacervation in Controlled Release
Ronald Versic, Ronald T. Dodge Company, U.S.A.
- Diffusion Performance of Microcapsules
Robert Wieland, Givaudan Flavors, U.S.A.
- Encapsulation by Fluid Bed Processing
Michael Valazza, Cardinal Health, U.S.A.
- Encapsulation for Foods
Gary Reineccius, University of Minnesota, U.S.A.
- Flavor Encapsulation
Birgit Schleifenbaum, Firminich Geneva, Switzerland
- Lipid Nanoparticles for Encapsulation of Actives: Dermal and Oral Formulations
Rainer Mueller, University of Berlin, Germany
- Mechanisms and Factors in Controlled Release
Robert Sparks, Particle and Coating Technologies, U.S.A.
- Microcapsule Process Selection Criteria
Niraj Vasisht, BDS International, U.S.A.
- Nano and Microencapsulation for Controlled Release
Joerg Kreuter, J.W. Goethe University, Germany
- Nanoparticles and Capsules from Emulsions
Ruth Schmid, SINTEF, Norway
- Application of Lipid Encapsulates
Paul Richardson, Balchem Corporation, U.S.A.
- Functional Nanosystems for Pharmaceuticals
Ijeoma Uchegbu, University of London, U.S.A.
This two-day workshop will provide an introduction to basic concepts of various controlled release technologies. It will offer information on release mechanisms and behaviors of key technologies in commercial use. A nanoencapsulation segment in the workshop will present overviews of nanocapsule and nanocrystal processes and their applications in pharmaceutical and polymer fields.
After attending this workshop, attendees should be able to examine a planned commercial product and determine initially the usefulness of encapsulation, the most likely encapsulation dosage form, the cost of encapsulation and the manufacturing method to put encapsulation into the product.
Molecular Imaging and Drug Delivery
Generously Sponsored by Mylan Technologies Inc., and SOLIQS - The global drug delivery business of Abbott
Chairs: Zheng-Rong Lu, University of Utah, U.S.A., and Alexei Bogdanov, University of Massachusetts, U.S.A.
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- How Molecular Imaging Could Assist in Drug Development and Translational Research
Alexei Bogdanov, University of Massachusetts Medical School, U.S.A.
- PET Imaging in Drug Discovery and Development
Kathryn Morton, University of Utah, U.S.A.
- Microbubbles for Targeted Imaging and Drug Delivery
Alexander Klibanov, University of Virginia, U.S.A.
- Non-invasive Visualization of "In Vivo" Drug Delivery and Evaluation of Therapeutic Efficacy with Contrast Enhanced MRI
Zheng-Rong Lu, University of Utah, U.S.A.
- MicroPET and Bioluminesence Imaging in Small Animals
Jung-Joon Min, Chonnam University, South Korea
- Bioconjugated Nanoparticles for Molecular Imaging and Drug Delivery
Shuming Nie, Emory University and George Institute of Technology, U.S.A.
- Imaging of Apoposis "in Vivo"
Eyk Schellenberger, Charte Berlin, Germany
- Perspective: Targeted Delivery and Molecular Imaging Vladimir Torchilin, Northeastern University, U.S.A.
This one-day workshop will address the hot topics in molecular imaging and drug delivery. You will learn how molecular imaging could assist in drug development and translational research. The workshops will also cover non-invasive issues such as evaluating therapeutic response with dynamic MRI and visualization of in vivo drug delivery with polymers. Presentations on targeted delivery will be given – from microbubbles to nanomaterials to enzyme-sensitive optical imaging agents. The workshop will provide information on gene expression imaging in assessing gene delivery and therapy.
Sustained Release Parenteral Products: In Vitro and In Vivo Considerations
Generously Sponsored by InterAg, DURECT Corporation, and SOTAX Corporation
Chairs: Marilyn Martinez, FDA Center for Veterinary Medicine, U.S.A. and Michael Rathbone, InterAg, New Zealand
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Morning Session :DEVELOPING IN VITRO TEST METHODS AND SETTING IN VITRO RELEASE SPECIFICATION
- Human Parenteral Sustained Release Formulations: Examples and Regulatory Challenges
Mansoor Khan, FDA/CDER, U.S.A.
- Veterinary Parenteral Sustained Release Formulations: Examples and Regulatory Challenges
Mai Huynh, FDA/CVM, U.S.A.
- Microspheres: Developing "In Vitro" Test Methods and Setting "In Vitro" Release Specification & Liposomes:
Diane Burgess, University of Connecticut, U.S.A.
- Subcutaneous Implants: Developing In Vitro Test Methods and Setting In Vitro Specifications
Jeremy Wright, Durect, U.S.A.
- Liposomes: Developing In Vitro Test Methods and Setting In Vitro Release Specifications
Diane Burgess, University of Connecticut, U.S.A.
- Lipophilic Solutions and Suspensions: Developing In Vitro Test Methods and Setting In Vitro Release Specifications
Susan Weng Larsen, University of Copenhagen, Denmark
- "In Vitro-In Vivo" Correlations: Human Examples
Jaymin C. Shah, Pfizer, U.S.A.
Afternoon Session: THE IMPACT OF HOST PHYSIOLOGY ON "IN VIVO" PRODUCT PERFORMANCE
- Physiological Variables Influencing Product Performance
Natalie Medlicot, University of Otago, New Zealand
- Factors Influencing "In Vivo" Drug Release: Microspheres, Nanoparticles and Implants
Uday Kompella, University of Nebraska, U.S.A.
- Unique "In Vivo" Challenges with Parenteral Liposomal Preparations: Describing Pharmacokinetic Behavior
Daryl C. Drummond, Hermes Biosciences, Inc., U.S.A.
- Human Safety Considerations
Patrick Marroum, FDA/CDER, U.S.A.
- Veterinary Safety Considerations
Marilyn Martinez, FDA/CVM, U.S.A.
This one-day workshop will discuss the considerations and challenges associated with the development of discriminative and biologically relevant in vitro methods for assessing drug release for parenteral products, identify the critical biopharmaceutical issues such as the important physiological variables influencing drug release, the impact of altering injection volume and concentration, and address the possibility of establishing in vitro and in vivo correlations. Presentations will also provide an overview of experiences in correlating specific types of test procedures with category of parenteral controlled release product – implant, microspheres, and suspensions. These insights are intended to be used by both drug sponsors and by regulators for setting in vitro release test specifications that can insure product quality and performance and can be used in lieu of very long and expensive in vivo studies to support the chemistry and manufacturing changes likely to occur over the lifespan of a pharmaceutical product.
Human and veterinary medicine share similar challenges when trying to establish biologically relevant in vitro release methods and specifications for parenteral controlled release products. This workshop will provide an opportunity for an exchange from both experiences – human and veterinary – and of the corresponding challenges encountered in establishing discriminative and standardized in vitro methods, and the experiences with efforts to correlate the results of these in vitro tests with in vivo product performance.
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