Scientific Sessions

Scientific Sessions form the core of the annual meeting and are focused on various aspects within the extensive scope of controlled release and delivery. The 20 sessions highlight the latest information on bioactives, consumer & diversified products, and preclinical sciences & animal health. Each session features an invited speaker and includes four additional speakers to round out the session. These sessions offer an exciting lineup of top scientists representing the continuum of delivery science and technology.

The following are session topics and invited speakers for
the 2013 CRS Annual Meeting & Exposition.

Challenges Around Brain Delivery: Sampling Site Issues and Interspecies Extrapolations

This session will highlight the difficulties associated with estimating brain target site concentrations, errors associated with the use of cerebral spinal fluid concentrations to estimate concentrations in brain extracellular fluids, and the complications associated with interspecies extrapolation of drug delivery to the brain. Such complications can arise from interspecies differences in diffusion distance, transporter functions, fluid turnover, enzymatic processes, and bias associated with sampling site. Animal models will be discussed from the perspective of interpretation/extrapolation to the human patient. Novel drug delivery approaches for brain- and CNS-targeted therapeutic candidates will be presented.

Invited Speaker: Margareta Hammarlund-Udenaes, Uppsala University, Sweden

Food, Nutraceuticals and Personalized Diet

This session will cover recent developments in food research such as addition of health-promoting ingredients (probiotics, vitamins, fibers, high-intensity zero-calorie sweeteners, etc.), enhanced experience (long-lasting release or burst/delayed release of ingredients such as caffeine and other energy-providing ingredients), convenience (readability and portability of food through concentration, or transforming from liquid to solid and vice versa), natural and less-processed food (protection of ingredients in their natural form through micro/nano-encapsulation), novelty foods, personalized diet (in combination with genomics), and packaging development (pathogen detection, antimicrobial packaging).

Invited Speaker: Martin Kussmann, Nestlé Institute of Health Sciences SA, Switzerland

Modern Agriculture and Aquaculture

This session focuses on new possibilities for encapsulation and controlled release products in agriculture and aquaculture. Topic areas include but are not limited to more efficient biomass production for biofuels, genetic engineering (release of genetically engineered materials, enhancing organisms), anticorrosive coatings for fish farms, vaccine delivery and water storage systems, technologies for high-rise systems (fertilizing, light control), and the more traditional areas involving controlled release of nutrients, fertilizers, and pesticides

Invited Speaker: David Powell, ProFishent Inc., U.S.A.

Personal and Home Care

Controlled release strategies are used in many personal and home care areas such as cosmetics, cosmeceuticals, skin care (lotions, sunscreens, etc.), personal care (deodorants, antiperspirants, hair care), mouth care (toothpastes, mouth rinses, tooth whiteners), air fresheners, cleaning and sanitizing agents, and pest or mold control agents and devices. This session attempts to capture current work and applications across this diverse range of needs.

Invited Speaker: Jiten Dihora, Procter & Gamble, U.S.A.

Smart Building and Construction Materials and Coatings

How can we make building materials more sustainable? This session focuses on controlled release in new-age building materials and smart materials for construction and renovation. Topic areas include self-healing and self-cleaning building materials; controlled release of algicides, fungicides, and biocides; and encapsulation of phase change products.

Invited Speaker: Henk Jonkers, Delft University of Technology, The Netherlands

Drug Delivery for Developing Countries/Global Challenges

The present milieu of neglected global health (which encompasses 17 tropical diseases as identified by the World Health Organization) is one of hope and struggle. The WHO’s Millennium Development Goal 6 outlines goals for the control of HIV/AIDS, malaria, and tuberculosis (the big three) and includes all other neglected diseases. While the big three infectious diseases do affect a very large percentage of the poor populations, the deflection of focus from diseases that persist in conditions of poverty, as well as in rural areas, urban slums, or conflict zones, creates a cycle of poverty that is crippling the development of low-to-middle income countries. Overall, neglected diseases cause great suffering and are a leading cause of chronic disability, diminished quality of life, and premature death. This session will focus on novel drug delivery technologies that have been applied to address developing world diseases. This has also defined new challenges related to cost-effective manufacturing and the exploration of routes of administration that are more suitable for use in low-to-middle income countries.

Invited Speaker: Kim Woodrow, University of Washington, U.S.A. 

Drug Targeting, Pharmacokinetics and Biodistribution: Differences Between Species

While animal models are often used to explore the potential therapeutic application of targeted therapeutics, little information is available on the potential pitfalls associated with interspecies extrapolations; including differences in pharmacokinetics, biodistribution and target structure/function. For example, cell-surface hyaluronan (HA)-binding proteins such as CD44 and RHAMM have been implicated in cell migration, inflammation, lymphocyte activation, and tumor progression. Therefore, they are being explored as therapeutic targets for a number of diseases. Differences between species used in the preclinical development of therapeutics against this target will create challenges. This session will highlight the challenges encountered when using animal models for therapeutics designed for use in humans. The challenges of optimizing the predictive capabilities of these animal model studies to support the development of human therapeutics and imaging products will be emphasized.

Invited Speaker: Jim Klostegaard, University of Texas, U.S.A.

Emerging Technologies

Recent advances in materials science and biological science are creating new opportunities for technology development in controlled release. This session highlights such novel approaches. As examples, exosomes are naturally occurring nanovesicles that are important for cell–cell communication and that perhaps can be harnessed for controlled delivery of miRNA or other agents; DNA self-assembly methods (sometimes called DNA origami) can be used for making novel materials for bioactive agent delivery; and disease-targeting bacteria have been engineered to deliver therapeutics. Another interesting example would include metal–organic frameworks being developed for drug delivery and imaging purposes.

Invited Speaker: Dan Luo, Cornell University, U.S.A.

Imaging and Characterization Techniques for Drug Delivery: Systems and Targeted Drug Delivery

Although standard characterization techniques remain important for a proper analysis of drug delivery systems, and abstracts about improvements in these techniques are certainly welcome in this session, the main focus of this session is on new imaging technologies. There are many exciting developments in this field, both in the imaging analysis of the drug delivery systems and in imaging for diagnosis in combination with targeted drug delivery (so-called theragnostics, for instance with ultrasound or magnetic nanoparticles).

Invited Speaker: Karsten Mäder, Martin-Luther University Halle-Wittenberg, Germany

Micro- and Nanoparticle Design

This session will explore the relationship between the design of micro- and nanoparticles and their functionality with respect to the delivery of agents. Topics include techniques for incorporation of novel agents, modeling of particles, design issues related to nanomedicine, such as methods for attachment of targeting ligands to nanomaterials, regulation of biodistribution by modification of particle size, shape, and mechanical properties, and other methods for regulation of nanoparticle interactions with cellular and tissue structures.

Invited Speaker: David Weitz, Harvard University, U.S.A.

Oral CR - Pharmaceutical Formulations, Technologies and Development Strategies

This session will highlight current global research, development, and commercialization of oral controlled release technology and bring together professionals from large pharma, CROs/CMOs, excipient companies, and academia. Submissions are sought that advance knowledge in the area of oral CR, whether they are related to 1) novel formulations, technologies, or strategies, or 2) scientific investigations of established technologies, including troubleshooting and Quality-by-Design case studies. One cornerstone of this session is oral CR technology for poorly soluble compounds, in particular those requiring solubilization, motivated by the increasing industry needs and opportunities in this area.

Invited Speaker: Peter Timmins, Bristol-Myers Squibb, U.K.

Oral CR - Predictive Tools (In Vitro/In Vivo/In Silico)

The intent of this session is to provide a current snapshot of the global research, development, and application of predictive tools for oral controlled release product development and to bring together professionals with backgrounds in analytical chemistry, formulation technology, biopharmaceutics, equipment design, and computational modeling. Submissions are sought that advance knowledge in the area of controlled release product performance prediction, with particular emphasis on in vitro and in silico technologies and in vitro–in vivo relationships. Key topics are the prediction of drug release and product robustness issues, especially with respect to the impact of food constituents, which are critical enablers of a Quality-by-Design development strategy.

Invited Speaker: Sandra Klein, UNI Greifswald, Germany

Parenteral Sustained Release Drug Delivery

This session will provide a global overview of the research, development, and commercialization of parenteral sustained release drug delivery. Key stakeholders from large pharma, drug delivery CROs/CMOs, excipient companies, and academia will take part. Submissions can relate to 1) novel materials, dosage forms/devices, processes, or development strategies; 2) fundamental understanding of established technology, including modeling and characterization; or 3) industrial product development case studies. Examples of discovery-to-development transitions and bench- to full-scale commercial manufacture are within the scope of this session.

Invited Speaker: Steven Schwendeman, University of Michigan, U.S.A.

Peptide and Protein Delivery

This session is intended to capture current activity in the area of therapeutic peptide and protein delivery. Injectable or implantable dose forms are often employed in this domain because of various concerns including API instability in the harsh conditions of the gut, inadequate uptake from the gut related to solubility and size constraints, or delivery logistics. Nevertheless, continuing research with solubility/uptake enhancers and stabilizing strategies opens potential avenues to viable oral delivery for a wider array of these molecules. Submissions involving new or enhanced knowledge in the area of peptide or protein delivery via oral, injectable, or other applicable routes are sought.

Invited Speaker: Tarek Fahmy, Yale University, U.S.A.

Processing Technology/Manufacturability

The translation of a useful drug delivery technology from laboratory proof-of-concept to clinical assessment and market introduction/supply requires a number of steps and innovations. Integral to this evolution is the selection of pharmaceutical manufacturing technology that is appropriate for the characteristics of the compound, its drug delivery needs, and commercial criteria. For the successful design, development, and control of a manufacturing process, a thorough understanding of the underlying science and engineering is essential, especially in a Quality-by-Design environment. Submissions are sought that advance knowledge in this area, whether they are related to novel process concepts or case studies of established process technology.

Invited Speaker: Beth Hill, Johnson & Johnson, U.S.A.

Regional Delivery: Challenges in Ocular Delivery and Pulmonary Delivery

This session will feature presentations on new advances in drug and gene delivery to the eye and to or via the lung. These organs offer opportunities for highly targeted regional delivery based on their ready availability following application of drops or injections for the eye or inhalation for the lung. Also, pulmonary delivery is a patient-friendly alternative for delivery of sensitive components that would not survive an oral administration route. This session welcomes abstracts on all relevant aspects of ocular delivery and pulmonary delivery including, but not limited to, new biomaterials and devices, safety and efficacy in animal disease models, and all classes of bioactives, including biologics and nucleic acids.

Invited Speaker: Samir Patel, Clearside Biomedical, U.S.A.

Rising Suns in Asia

(session sponsored by Japanese Society of Drug Delivery System)

This session is sponsored by the Japanese Society of Drug Delivery System (JSDDS) for supporting talented young researchers in Asia. According to the research papers in the field of drug delivery systems, the quality and number of papers from Asia are continuously increasing. JSDDS wants to support talented young researchers, especially in Asian regions such as China, Korea, Singapore, and so on, to encourage them to be leaders in the next generation. We would like to select candidates from submitted abstracts by requiring candidates to list their papers in JCR (an official journal of CRS) so that we can evaluate their quality of research in depth.

Invited Speaker: Yukio Nagasaki, University of Tsukuba, Japan

RNAi and DNA Delivery

Our understanding of complex diseases has increased tremendously through the application of research tools that can selectively manipulate the expression of genes within defined cell populations. Validation of how selected genes influence disease development and progression is commonly based on experiments that ask what happens to a cell population when the selected gene is introduced or silenced. Importantly, research tools being used to define the role of genes in disease progression have the potential to transition seamlessly into therapeutic products. This session will focus on approaches used to achieve effective nucleic acid delivery in models of disease, with an emphasis on the use of materials or technologies that facilitate sustained gene expression, gene knockdown, or gene modification. Because the goal is to define treatments for disease in humans or animals, the session will also include discussions of safety of these therapeutic candidates.

Invited Speaker: Chae-Ok Yun, Hanyang University, Korea

Solubilization Technology - A Key Enabler for the Delivery of Poorly Soluble Drugs

This session will provide a current picture of the global research, development, and commercialization of solubilization technology for drug delivery and bring together key stakeholders from large pharma, CROs/CMOs, excipient companies, and academia. Submissions can relate to 1) novel ingredients, processes, or development strategies; 2) fundamental understanding of established technology; or 3) industrial troubleshooting and development case studies. Amorphous drug dispersion technology is central to the session because of its importance to the pharmaceutical industry as a means of enhancing the bioavailability of insoluble compounds.

Invited Speaker: Ravi Shanker, Pfizer, U.S.A.

Topical/Transdermal Drug Delivery

Topical and transdermal delivery of important drugs and drug candidates represents an important formulation trajectory with a number of marketed examples. Delivery to or through the skin can be passive or induced by a number of energetic processes. The goal of this session is to provide a forum for the presentation of novel delivery systems and formulations as well as analytical assessments of these systems. Proof-of-concept studies in both preclinical and clinical settings also fall within the scope of this session, as do novel materials and excipients that may facilitate topical or transdermal delivery.

Invited Speaker: Rainer Müller, Freie University Berlin, Germany

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