Scientific Program Descriptions, Invited Speakers, and Moderators
Scientific Sessions offer an exciting lineup of invited speakers, several Research Highlight Talks (five-minute podium presentations), and a moderated discussion. The Research Highlight Talks are selected from submitted abstracts to that session and have a corresponding poster. This year, CRS has increased the number of Research Highlight Talks to provide more presentation opportunities and have added a Poster Pub session to further highlight the poster presentations.
View the session description and listing of speakers by clicking on the session name below. Speakers are subject to change.
Comparative Pharmacokinetics in Preclinical Sciences
Preclinical science and animal models are key components in determining pharmacokinetics and pharmacodynamics of new drugs and delivery systems. Preclinical data obtained across species drives initial candidate drug design/selection and resultant optimization of development procedures needed for regulatory approval. This session will address how to design preclinical studies in select animal species. First, in silico modeling of data from administration routes will be examined relative to the target species, and second, the increasing complexity of designing dissolution studies in media relevant to true intestinal conditions will be discussed.
Invited Speaker: Paul Walsh, Merck & Co., U.S.A.
Moderator: Marilyn Martinez
Delivery Technologies in Cosmetics, Personal Care, and Household Products
This session will cover all aspects of controlled release in personal and home care areas. Examples are cosmetics, cosmeceuticals, skincare, fragrances, deodorants and antiperspirants, hair care, mouth care, air fresheners, cleaning and sanitizing agents, and insect/pest/mold control agents and devices. This core area seeks to promote progress and applications across this diverse range of products, with particular emphasis on the research and manufacturing activities ongoing in the relevant industries.
Invited Speaker: Job Thijssen, University of Edinburgh, Scotland
Moderator: Ron Versic
Delivery Technologies in Nutraceuticals, Food, and Oral Products
This session will include all aspects of oral delivery science and product development, including immediate, sustained, delayed, and pulsed release. It includes oral delivery of drugs (from small molecules to biologics), food, feed, beverages, nutrients, nutraceuticals, flavors, probiotics, prebiotics, and supplements. Topics of interest are broad and include, but are not limited to, all aspects of systems that enhance oral absorption, introduce prolonged effect and stability of additives, product acceptability (including taste masking, rheology, etc.), targeted and/or more uniform delivery in the gastrointestinal tract, in vitro and in vivo models, analytical chemistry, formulation technology for poorly soluble agents, biopharmaceutics, equipment design, and computational modeling.
Invited Speaker: Robert Hans Tromp, NIZO Food Research, The Netherlands
Moderator: Yoav Blatt
Encapsulation and Controlled Release for Industrial Applications
This session focuses on advances in encapsulation and controlled release products in agrochemicals, agriculture, aquaculture, textiles, and other industrial applications. Topics include, but are not limited to, more efficient biomass production for biofuels, genetic engineering (release of genetically engineered materials, enhancing organisms), anticorrosive and/or antifouling coatings (e.g., fish farms or offshore installations), self-healing coatings and materials (e.g., textiles), water storage systems, technologies for high-rise systems (fertilizing, light control), and more traditional areas involving controlled release of nutrients, vaccines, fertilizers, and pesticides.
Invited Speaker: Kaimin Cai, University of Illinois at Urbana-Champaign, U.S.A.
Moderator: Jie Shen
Integration of Imaging and Drug Delivery
In recent years, there has been tremendous effort to integrate imaging and drug delivery in order to improve therapeutic response and clinical outcomes. In particular, emphasis has been placed on exploiting imaging to deepen our understanding of drug and delivery vehicle transport, to guide interventions that enhance drug delivery, and to identify subpopulations of patients that are likely to respond to a specific therapy. This session will highlight exciting advances in this area of research with an emphasis on approaches that have advanced to late-stage preclinical or clinical development. Challenges in the clinical translation and development of image-guided interventions will be discussed.
Invited Speaker: Katherine Ferrara, University of California-Davis, U.S.A.
Moderator: Ick Chan Kwan
Local Drug Delivery
With increasing awareness of challenges in systemic drug delivery and recent advances in imaging technologies, local drug delivery is revisited as a promising means to achieve target-specific drug delivery. This session covers new formulation technologies exploiting accessible local routes for target-specific drug delivery—such as lungs, eyes, nose, oral cavity, gastrointestinal tract, vagina, and peritoneal cavity—featuring clinical and industrial perspectives.
Invited Speaker: Kullervo Hynynen, Sunnybrook Health Sciences Centre, Canada
Moderator: Justin Hanes
Manufacture, Characterization, Stability, and Regulatory Aspects
This session will cover technology development through scale-up of commercially viable processes and methods to prepare and characterize products designed for controlled release of active materials. Some examples of process technologies include spray-drying, hot-melt extrusion, co-precipitation, supercritical fluid technology, fluid bed coating, complex coacervation, 3D printing, inkjet printing, electrospinning, microfluidics, powder layering techniques, high-shear granulation techniques, membrane processes, and emulsion-based processes. The use of quality-by-design (QbD) concepts, analytical technologies for process end-point and real-time monitoring of preparation processes, imaging methods, and other approaches to ensure commercial viability are also critical to this area.
Invited Speakers: Johan Paul, Flamac, Belgium, and Zhibing Zhang, University of Birmingham, U.K.
New Processes, New Materials, New Products
New manufacturing processes can lead to both new materials and new systems and hence new products. Sometimes new processes are, like electrospinning, old but have been more recently adopted because of the availability of appropriate materials and adapted technologies to produce new forms (such as fibers) with potential for drug delivery in more versatile ways. Two- and three-dimensional printing techniques are a case in point. This session will consider production techniques such as these but also new materials such as graphene and graphane analogues, magnetic surfactants, or other materials that allow more precise design and novel uses.
Invited Speaker: Khuloud Al-Jamal, King's College London, United Kingdom
Moderator: Ryan Donnelly
Ocular Drug Delivery
Ocular drug delivery has been a major challenge to drug delivery scientists owing to the complex anatomy and physiology of the eye. In addition, the demonstration of bioequivalence for generic ophthalmic products to their reference products can be challenging. This session will focus on the recent advances in ocular drug delivery with an emphasis on new materials for long-acting products that can be used to deliver both small and large molecules. This session will also highlight general recommendations for establishing bioequivalence of generic ocular drug products including in vitro approaches.
Invited Speakers: Stephanie Choi, FDA, U.S.A., Michael Sailor, University of California-San Diego, U.S.A., and Xiaoming Xu, FDA, U.S.A.
Moderator: Kannan Rangaramanujam
Oligonucleotide Delivery: New Applications and Opportunities
This session focuses on therapeutic approaches utilizing oligonucleotides including antisense oligonucleotides, siRNAs, and miRNAs. The session will highlight innovative chemistry (e.g., conjugate) and formulation-based delivery systems and therapeutic approaches requiring access to tissues and cell types outside of the liver. Novel approaches for targeting both actively (e.g., with targeting ligands) or passively (e.g., endogenous targeting approaches) will be discussed as well as approaches for efficient intracellular delivery. Immunomodulatory applications will also be highlighted.
Invited Speakers: Andrew Geall, Avidity Nano, U.S.A., and Pieter Cullis, University of British Columbia, Canada
Moderator: Pieter Cullis
This session focuses on advances in delivery science and technology for both systemically and locally acting oral formulations. This session will highlight the impact of key excipients on manufacturing, quality, and clinical performance of oral drug delivery systems. This session will also highlight the recent developments in locally acting gastrointestinal drugs with an emphasis on how to determine local drug dissolution. In addition, this session will highlight the efforts that have been made by industry, academia, and regulatory agencies to ensure the therapeutic performance of advanced oral drug delivery systems including amorphous solid dispersions and modified release drug products.
Invited Speakers: Mansoor Khan, Texas A&M Health Science Center, U.S.A. and Yihong Qiu, AbbVie, U.S.A.
Moderator: Cornell Stamoran
Overcoming Biological Barriers in Drug Delivery
Biological barriers were created during evolution to enable organisms to precisely control the interaction between inside and outside environments. The differentiation at interfaces to regulate water homeostasis, uptake of nutrition, gas exchange, or exchange of waste is manifold and constitutes a key hurdle in the field of drug delivery. This session will highlight advances in drug delivery through biological barriers that include, but are not limited to, the blood-brain barrier, blood-ocular barrier, mononuclear phagocyte system, tissue penetration barriers, cell uptake barriers, and intracellular barriers.
Invited Speaker: Murray Korc, Indiana University, U.S.A.
Moderator: Anand Subramony
Parenteral Systemic Delivery of Biopharmaceuticals: Overcoming Product Development and Regulatory Challenges
This session will include all aspects of oral delivery science and product This session will focus on current hot topics in the development of injectable biopharmaceutical products including formulation, delivery, stability, and regulatory considerations critical in advancing novel delivery based biopharmaceutical products to the clinic and commercialization. In addition, the session will highlight current approaches for the characterization of parenteral delivery systems and the bioactives contained within them, especially those of importance to regulatory agency approval.
Invited Speaker: Bruce Kerwin, Just Biotherapeutics, Inc., U.S.A., and Bill Lambert, Omeros Corp. U.S.A.
Moderator: Emmanuel Ho
Peptides, Proteins, and Vaccines
The global medicines market is undergoing a period of dramatic change, and it is forecast that by 2016 biopharmaceuticals will overtake small molecules’ domination of the market. While biopharmaceuticals (including peptides, proteins, and vaccines) offer unique modes of action, which are highly specific with far fewer side effects, their commercialization requires significant innovation. This session will focus on strategies to maximize therapeutic effectiveness of peptide, protein, and vaccine formulations, including topics on formulations/devices/technologies that (1) improve targeted delivery, (2) enhance immunization efficacy, (3) minimize delivery invasiveness or increase patient adherence, (4) extend and control release, (5) enhance stability, and (6) lower development and manufacturing costs.
Invited Speaker: Elizabeth Topp, Purdue University, U.S.A.
Moderator: Steven Schwendeman
Physical Oncology: Modulating Tumor Microenvironment for Drug Delivery
The discrepancy between preclinical and clinical outcomes arises, in part, owing to the failure of conventional model systems to recapitulate the complexity of solid tumor tissues. One major factor in the complexity of tumors is their fibroinflammatory component (stroma), which increases tumor interstitial fluid pressure, blocking the delivery of anticancer therapies to tumor cells, and contributes generally to chemoresistance. This session focuses on advances in the delivery of drugs deep into tumor tissues achieved through modulation of components of the tumor microenvironment. Efforts that target the biophysical barriers to perfusion, diffusion, and convection imposed by the desmoplastic reaction will be highlighted.
Invited Speaker: Youngbro Byun, Purdue University, U.S.A.
Moderator: Hamid Ghandehari
Preclinical Science Challenges to Drug Delivery
How drug distribution occurs in different species is related in part to structure and function of drug transporters, and these can have a bearing on behavior of drug delivery systems in preclinical animal models. An alternative approach in preclinical research is the advances made in 3D cell culture models as well as organ-on-a-chip models of human and animal tissue. Apart from contributing positively to the three Rs (replacement, reduction, and refinement), these models have improved metabolism predictive capacity and also can be used to interrogate drug target interactions, as well as to screen drug candidates efficiently.
Invited Speaker: Katrina Mealey, Washington State University, U.S.A.
Moderator: David Brayden
Predictive Modeling in Delivery and Targeting (Scaling: Mouse to Man; Probability of Reaching Targets; Stochastic Process in System Distribution)
This session will include all aspects of oral delivery science and product Mathematical modeling of drug delivery and targeting provides opportunities to reduce empiricism in our science. To achieve this we must have predictive models of the behavior of systems such as nanoparticles in vivo. There is a need for understanding the scaling factors in extrapolation from animal models to humans, and for evaluation of the mathematical probability of issues such as extravasation and binding to receptors, including a realization of the stochastic nature of many of the processes in targeting. This session will survey some approaches to allow the next generation of delivery systems to be designed more rationally.
Invited Speaker: You Han Bae, University of Utah, U.S.A.
Moderator: Ping Lee
Taking Stock of Progress and Challenges in Drug Delivery and Targeting
It is crucial after decades of research into new drug delivery and targeting systems that we reflect on true progress and define honestly the challenges that lie ahead. This session asks two questions: “where are we now?” and “are we telling it straight?” These questions apply not only to nanotechnology but also to instances wherein our science has translated into false promises. There is often a lack of quantitative data on the delivery of the active let alone the carrier to putative targets, and few papers discuss target pharmacokinetics let alone particokinetics. Contributions that address these issues are welcome.
Invited Speaker: David Grainger, University of Utah, U.S.A.
Moderator: David Stepensky
“Thinking Outside the Box” Delivery Technologies: Nanocarriers from Nature
Living creatures have developed diverse bioactive materials with unique structures to survive and adapt to changing environments. This session will highlight two groups of natural nanocarriers, namely, exosomes and protein nanocages. Exosomes are nanometer-sized membranous vesicles that play a major role in intercellular communication owing to the ability to transfer proteins and nucleic acids from one cell to another. As a result, there has been significant interest in exploiting exosomes for applications in drug delivery. Nature in its wonders presents the most intricate and delicate protein structures, including those of cage-like architecture. Perfect and complex symmetry is ubiquitous in protein nanocages, and they can be engineered for applications in drug delivery. This session will largely highlight exosome and protein nanocage-based delivery strategies, with additional emphasis on drug delivery technologies formed from other natural materials.
Invited Speaker: Yong Song Gho, Pohang University of Science and Technology, Korea
Moderator: Alexander "Sandy" Florence
Tissue engineering that aims to recreate functional tissues and organs has emerged as a promising strategy to treat a series of tissue defects, to create in vitro cell culture platforms, and to engineer biological machinery. Despite the impressive results reported over the past decades, there is still a real need to improve the quality of engineered tissue by regulating transport and bioactivity of regenerative medicine, including incorporation of synthetic drug molecules, growth factors, DNA, and so on. To this end, this session will discuss current efforts and future directions to utilize and further modify advanced drug delivery technologies for enhanced tissue engineering in both academia and industry.
Invited Speakers: Eben Alsberg, Case Western Reserve University, U.S.A. and Buddy Ratner, University of Washington, U.S.A.
Moderator: Buddy Ratner
Transdermal delivery constitutes a popular alternative route of administering drugs. This session will cover new developments in all aspects of transdermal drug delivery, including understanding of transdermal permeation pathways, especially for macromolecules. Contributions on the development of devices and formulations to enhance transdermal drug delivery are welcome. Contributions reporting clinical translation of technologies are of particular interest. Novel analytical tools to study transdermal drug delivery and mathematical models for describing transport are also welcome. This session will also include new developments in topical drug delivery methods that focus on localized delivery of small and large molecules such as peptides and nucleic acids.
Invited Speaker: Zhen Gu, North Carolina State University, U.S.A.
Moderator: Mark Prausnitz