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Held immediately following the
4th Annual Systems Integration in Biodefense, August 24-25, 2005

Day 1

Monday, August 22

7:30-8:30 Registration, Poster Set-Up, Coffee


8:30-8:40 Chairperson’s Opening Comments
Dr. Daniel C. Sullivan, Associate Director, Cancer Imaging Program, National Cancer Institute
FDA Presentations

8:40-9:00 Navigating the Regulatory Pathway for Nanotechnology: First Steps and Challenges
Drs. Wendy R. Sanhai, Senior Scientific Advisor, Office of the Commissioner, FDA and George Mills Director, Division of Medical Imaging and Radiopharmaceutical Drug Products. Office of New Drugs, CDER, FDA
The pathway for regulation of nanotechnology-based medical products remains to be fully elucidated. However, we are proceeding along this path with a battery of evaluative tools/questions that can be effectively applied to these products; Therapeutics, Diagnostics, Combination Products and their incorporation into imaging modalities, as they move through pre-clinical and clinical development, and incorporating new knowledge as this field evolves. In an effort to stimulate discussion, some case studies and thought-provoking questions will be presented.

9:00-9:30 FDA Regulatory Considerations for Nanotechnology Products
Dr. Nakissa Sadrieh, Associate Director for Research Policy and Implementation, FDA/CDER/OPS
Nanotechnology is an emerging area of science that is expected to significantly impact the types of products regulated by the FDA. The FDA believes that the existing battery of toxicology tests is adequate for most nanotechnology products that will be regulated. However, as new toxicological risks that derive from new materials and/or new configurations of existing materials are identified, new tests may be required. The FDA expects that many of the nanotechnology products will span the regulatory boundaries between drugs, medical devices and biologicals. However, it is likely that many nanotechnology products will be regulated as “Combination Products” for which the regulatory pathway has been established by statute.

9:30-9:50 TBA
George Mills Director, Division of Medical Imaging and Radiopharmaceutical Drug Products. Office of New Drugs, CDER, FDA

9:50-10:30 Coffee Break, Poster & Exhibit Viewing

10:30-11:00 The Bio-Legal Complexity of Nanoparticle Development
Dr. James L. Tatum, Special Assistant, Cancer Imaging Program, National Cancer Institute 
The use of commercially available nanoparticle constructs for both imaging and drug delivery in humans is not novel. However, the current enthusiasm for nanotech-based solutions extends far beyond simple particles to multi-modal platforms that involve multiple active pharmaceutical ingredients (APIs). These new constructs present a higher level of complexity not only in manufacturing but also in predicting their behavior in the human including such fundamental information as bio-distribution and biocompatibility. Thus go/no-go decision points are less well defined and decisions such as committing resources for scale up of GLP product for pre-clinical testing must be made on limited data. In addition to the relative uncertainty of bio-interactions, development of these new constructs involves unique legal complexity. The modern nano-construct is the poster child of team science involving the conglomeration of multiple sub-units all with attached intellectual property interests leading to complex licensing issues. It may be a more significant challenge to assure that such legal issues do not become bigger obstacles to development than the complex bio systems these constructs are intended to interrogate and manipulate. In this presentation we will discuss some of the unique challenges in nano-probe development aimed at producing a successful commercial product and possible strategies to reduce the uncertainty in risk analysis during the development process.

11:00-11:30 The Promise of Nanotechnology for Heart, Lung and Blood Diseases
Dr. Denis Buxton, Associate Director, Heart Research Program, Division of Heart and Vascular Diseases, National Heart, Lung and Blood Institute 
Nanotechnology offers a broad range of opportunities for the diagnosis and treatment of heart, lung and blood diseases. Areas that are particularly promising include molecular imaging, drug delivery and therapeutics, tissue engineering and biomaterials, and biosensors and diagnostics. Facilitating the application of nanotechnology to disease diagnosis and treatment will require multi-disciplinary research teams bringing together individuals with bioengineering and nanotechnology skills with biological scientists and clinicians. 

“Expediting the Regulatory Pathway” 

12:00-1:30 Lunch on your own
(Technology Workshop Sponsorship Available)


1:30-1:40 Chairperson’s Comments
Mr. Alex W. Kawczak, Vice President, BioProducts and Nanostructured Materials, Laboratory Operations/ Commercial Business, Battelle Memorial Institute

1:40-2:10 Photonic Nano-Explorers for BioAnalysis, Cellular Imaging and NanoMedicine
Dr. Raoul Kopelman, The Kasimir Fajans Collegiate Professor of Chemistry, Physics and Applied Physics, and Member of Biophysics, The Center for Bio-Nanotechnology and Ultra Fast Optics, The University of Michigan 
PEBBLEs (Photonic Explorers for Biomedical use with Biologically Localized Embedding) are sub-micron sized optical sensors and effectors specifically designed for minimally invasive analyte monitoring in viable, single cells with applications for real time analysis of drug, toxin, and environmental effects on cell function or, alternatively, for intracellular intervention. The main classes of PEBBLE nanosensors are based on matrices of cross-linked polyacrylamide, cross-linked poly (decyl methacrylate), sol-gel silica and ormosil. These matrices have been used to fabricate sensors for H+, Ca2+, K+, Na+, Mg2+, Zn2+, Fe3+, Cu+, Cu2+, Cl-, O2, NO, OH and glucose that range from 20 nm to 600 nm in diameter. A number of techniques have been used successfully to deliver PEBBLE nanosensors into mouse oocytes, rat alveolar macrophages, rat C6-glioma, and human neuroblastoma cells. The PEBBLE matrix protects the cell biochemistry from the sensors chemicals and protects the sensor chemistry from the cell’s biochemicals. It also enables synergistic sensing schemes. With microsecond response times, zeptomolar absolute detection limits, chemical and physical targeting as well as fluorescence background rejection techniques, these nanosensors are playing an increasing role in live cell chemical imaging and analysis. The nanoeffectors can produce chemical activation inside live cells, e.g., with singlet oxygen. Both nanosensors and nanoeffectors are targetable for in vivo applications of optochemical imaging, diagnostic imaging and therapy. For instance, nano-effector platforms provide a new paradigm for cancer therapy: Targeted nano-platforms improve photodynamic therapy of cancer. Specifically, rats with brain cancer (9L-gliosarcoma) show a very significant extension of survival time, following a protocol of 5 minutes of red laser irradiation. Simultaneously these nanoplatforms enable MRI monitoring of tumor shrinkage. Toxicity, bio-distribution, bio-degradation and bio-elimination are parameters in the design and fabrication of these multifunctional nanoplatforms.

2:10-2:40 Virus-Based Nanoparticles: Novel Biomolecular Sensors for Targeting Cancer
Dr. Marianne Manchester, Associate Professor, Department of Cell Biology, Center for Integrative Molecular Biosciences, Scripps Research Institute 
Viruses are unique materials for nanotechnology because of their size, multivalent assembly, and uniformity. We use the cowpea mosaic virus (CPMV) as a nanoparticle platform. CPMV is an icosahedral, 31nm proteinaceous particle. The structure of the CPMV capsid, defined at the atomic level yields a uniform particle size that can be engineered to display peptides or proteins in controlled orientations on particle surfaces, either by genetic manipulation of the viral genome or by chemical attachment to the particle surface. CPMV also demonstrates favorable bioavailability and is non-toxic in vivo. We have developed CPMV nanoparticles as novel anti-tumor and vascular imaging reagents.

2:40-3:10 Nanoparticle-Aptamer Bioconjugates for Targeted Drug Delivery 
Omid C. Farokhzad, M.D., Assistant Professor of Anesthesia, Harvard Medical School, Laboratory of Nanomedicine and Biomaterials, Department of Anesthesiology, Brigham and Women’s Hospital 
Nucleic acid ligands (aptamers) are potentially well suited for the therapeutic targeting of drug encapsulated controlled release polymer particles in a cell- or tissue-specific manner. We synthesized a bioconjugate comprised of controlled release polymer nanoparticles and aptamers which bind to the Prostate Specific Membrane Antigen (PSMA), and examined its efficacy for targeted delivery to Prostate Cancer (PCa) cells. We demonstrated that these bioconjugates can efficiently target and get taken up by PCa cells which express the PSMA protein (77 fold increase in binding vs. control, N=150 cells per group) whereas no detectable uptake was observed in cells that do not express the PSMA protein.

3:10-3:40 Refreshment Break, Poster & Exhibit Viewing

National Laboratories Perspective
3:40-4:10 Capabilities for the Controlled Synthesis and Processing of Multifunctional Nanovectors
Drs. David Geohegan, Oak Ridge National Laboratory, Anna Gutowska, Pacific Northwest National Laboratory, Jim Misewich,Materials Science & Condensed Matter Physics,Brookhaven National Lab and Barbara Tarasevich, Senior Research Scientist, Pacific Northwest National Lab

4:10-4:40 Drug Delivery Strategies Using Supramolecular Gels
Dr. Menno R. de Jong, Research Scientist, Biomade Technology Foundation
Supramolecular gels in water or other solvents are formed by the self-assembly of low molecular weight compounds into nanofibrous networks. The non-covalent nature of these gels has allowed Biomade Technology to create gelator systems responsive to physiologically acceptable triggers like temperature, pH, or ion concentrations, offering exciting opportunities for targeted drug release. Currently, we are developing modified release systems and matrices for the controlled formation and stabilization of nanoparticulate formulations of poorly water soluble drugs based on biocompatible supramolecular gels. Using the latter technology, we have found good increases in bioavailibility for several drugs. Advantages of the use of supramolecular gels include ease of formulation, excellent scalability, and broad applicability, rendering them interesting tools in the drug discovery phase and beyond.

4:40-5:10 Inorganic Biohybrid Nanoparticles for Targeted Drug Delivery 
Dr. Sandwip K. Dey, Department of Chemical and Materials Engineering & Electrical Engineering, Arizona State University
To date, polymeric, lipid, magnetic, and metal nanoparticle systems have been the focus of intense research. However, inorganic ceramic nanoparticles are also an appealing class of material due to its inherent physiological stability in biological environments. One example is the layered double-hydroxide (LDH) structure, in which an ionically bonded anion resides between two layers of cationic hydroxides to maintain charge balance. By utilizing this structure, negatively charged therapeutic agents can be readily intercalated within LDH by exchange with the LDH anion to form a biohybrid nanoparticle. To date, the successful intercalation of biofunctional molecules (e.g., antisense-DNA and ATP, as well as the cancer therapeutic agents such as folinic acid and methotruxate) have been reported. Additionally, functionalization of such biohybrid nanoparticles, for the purpose of cellular recognition, may be achieved by immobilizing polyethylene glycol (PEG) or dextran onto the surface of the nanoparticles, followed by specific ligand attachment to the end of the PEG or dextran. Here we begin with a brief overview of the state of the art and future barriers in the processing of ceramic nanoparticles having the LDH structure, and its potential to target liver cancer cells. Specifically, co-precipitation, biohybridization, and functionalization, as well as the physiological response towards the nanoparticles, cellular toxicity, and efficacy of cellular targeting will be outlined. The central theme of this presentation will be on the synthesis of LDH nanoparticles (50 - 150 nm dia) by the co-precipitation method, coupled with a variety of characterization methods including X-ray diffraction, Infrared spectroscopy, and high-resolution scanning electron microscopy and transmission electron microscopy.

“Breakthroughs in Nanotech Drug Delivery”

5:40-6:45 Networking Reception

6:45 Close of Day One


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