2014 CRS Annual Meeting Workshops

These workshops offer focused presentations on specific topics by noted speakers, and are open to a limited number of participants for an additional fee.

The workshops will be held at the 2014 CRS Annual Meeting & Exposition in Chicago, Illinois, U.S.A. on July 12-13, 2014. All workshops must be registered for in advance. You have the option to register for a workshop only, and not attend the CRS Annual Meeting.

Register for the CRS Annual Meeting to reserve your spot in a premeeting workshop.

Your organization is  invited to sponsor one or more workshops. All levels offer substantial recognition; certain levels of sponsorship include complimentary registration to the workshop.

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Albumin: The Next Generation Protein Therapeutic

Cosponsored by Novozymes Biopharma Inc.

Saturday, July 12, 08:45– 17:00

Organizers:  Kenneth Howard, Aarhus University, Denmark, and Daniel Shelly, Novozymes Biopharma US, Inc., U.S.A.

Albumin is the most abundant human plasma protein that exhibits prolonged circulatory half-life and a predominant role in extracellular and intracellular transport of nutrients. Exploitation of these properties can be utilized for delivery of drug cargos and a paradigm shift in control of drug extended half-life and targeted delivery. This workshop assembles global leaders from both academia and industry in a unique forum to present and discuss the application of albumin in drug delivery. Biological mechanisms relevant for albumin drug delivery capabilities such as molecule binding, cellular receptor engagement and recycling and its tuning through recombinant technology for modulation of pharmacokinetics are addressed. Clinical development and commercial albumin-based drug products such as albumin-binding prodrugs, genetic fusions, and nanoparticles are then described that highlight its emergence as the next-generation protein therapeutic.

Workshop Schedule and Invited Speakers

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Oral Delivery of Peptides and Proteins

Cosponsored by Catalent Pharma Solutions

Saturday, July 12, 08:00 – 17:00 and Sunday, July 13, 08:00 – 12:00

Organizers: David Brayden, University College Dublin, Ireland, and Randall Mrsny, University of Bath, United Kingdom

Oral delivery of peptides and proteins is regarded as one of the great challenges for drug delivery. After a slump in interest in the mid-1990s, at least 12 technologies with selected peptides are now in clinical trials. The workshop will assess the current status of this revitalized field, exploring how selected technologies work and whether they can be applied to a range of peptide and protein-based payloads. Key aspects to be discussed are the rationale for payload and technology selection, repeat oral dose toxicology, and arguments for parenteral-to-oral switching.

Workshop Schedule and Invited Speakers

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Nanotechnology – Process and Formulation, Characterization and Applications

Saturday, July 12, 08:00 – 17:00 and Sunday, July 13, 08:00 – 12:00

Organizers: Teresa Virgallito, Microtek Laboratories, Inc., U.S.A., and Nicole Papen-Botterhuis, TNO, The Netherlands

Nanotechnology is a broad term that covers many areas of science, research, and technology. In the next 20 years, nanotechnology will touch the life of nearly every person on the planet. The workshop will provide an overview of nanoencapsulation and a range of applications where nanotechnology is being utilized. Future applications of nanotechnology will be discussed. The workshop will also cover regulatory compliance for nanotechnology for consumer products. Nanotechnology can be found in cosmetics, sunscreens, clothing, and many other consumer products today.  

Workshop Schedule and Invited Speakers

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Computational Pharmaceutics – The Application of Computer Modeling in Drug Delivery

Sunday, July 13, 08:00 – 12:00

Organizers: Defang Ouyang, Aston University, United Kingdom, and Alex Bunker, University of Helsinki, Finland

This workshop will focus on the application of molecular modeling techniques in drug delivery—named as “computational pharmaceutics.” The workshop will discuss the modeling of different drug delivery systems, such as cyclodextrins, solid dispersions, liposomes, polymer coating of delivery systems, particulate media, protein/peptide formulations, nonviral gene delivery systems and surface modification, and three important methodological areas: pharmacokinetic modeling, molecular modeling, and synchrotron radiation micro-computed tomography (SR-μCT) combined with the in silico 3D reconstruction.

Workshop Schedule and Invited Speakers

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Locally Acting Dermal Drug Products – Global Challenges for Development and Registration

Sunday, July 13, 08:00– 12:00

Organizers: Howard Maibach, University of California, San Francisco, U.S.A., and Tapash Ghosh, ONDQA/CDER/FDA, U.S.A.

The workshop will bring a sound understanding of topical dermal products across multiple disciplines and multiple sectors with the goal of meeting the challenges of the 21st century. It will also discuss the challenges associated with demonstration of bioequivalence for topical products, from both new and generic drug perspectives, in light of the considerations for future regulatory submissions. Alternative and novel technologies for determining bioequivalence of topical drug products, as well as the value of in vitro drug release in semisolid dosage forms, will also be discussed.

Workshop Schedule and Invited Speakers

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