TARGETED NANODELIVERY

for Therapeutics andMolecular Imaging

Addressing Safety, Regulatory, and Commercialization Issues Formerly BioMEMS and NANOtech World Conference

August 21-23, 2005 L'Enfant Plaza Hotel

Washington, D.C.

Cambridge Healthtech Institute’s 6th Annual

Cambridge Healthtech Institute1037 Chestnut Street Newton Upper Falls, MA 02464T: 617-630-1300 or toll-free in the U.S. 888-999-6288 F: 617-630-1325 • www.healthtech.com

• Extensive Focus on Delivery Strategies

• Regulatory and Safety Coverage

• Applications in Molecular Imaging

• New Nanotech Business Forum

• Nanoparticles in the Clinic

Scientific Advisory Board

Dr. Carol A. Dahl, Bill & Melinda Gates Foundation

Dr. Mauro Ferrari, The Ohio State University

Dr. Scott E. McNeil, NCI-Frederick

Dr. Celeste Null, Intel Corporation

Dr. Daniel C. Sullivan, National Cancer Institute

Dr. Stephen McCormack, NeuroSystec Corp.

Final Agenda

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

Register By May 27th and save up to $350

Corporate Support:

Nanotech Business Perspectives Forum*

Supporting Association:

Lead SponsoringPublications:

Sponsoring Publications: Web Partner:

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1:00-2:00pm Forum Registration

2:00-2:30 Nanotech Investment: Trends and ObservationsMr. Edward K. Moran, Director of Product Innovation/Leader, Nanotech Industry Practice Technology, Media & Telecommunications Group,Deloitte Services, LPAlthough there is the popular perception that nanotech is being “hyped,” and that products are still years from commercialization, investors are waking up to thepotential of nanotechnology. What sort of challenges do nanotechnology companies seeking financing face, what sort of metrics are VCs looking for, and what sortof exits can nanotech companies expect?

2:30-3:00 The New Face of Nanotechnology FinanceMr. Scott Livingston - Managing Director, The Livingston Group - Axiom Capital ManagementThe classical path for entrepreneurs commercializing advanced technology has undergone significant change as a result of the boom and bust of the late 90s. Thecurrent angel/VC/IPO path is being challenged by new corporate financing structures, the current leaders on Wall Street are being challenged by a new group offirms with specific expertise in nanotechnology, and the established players in early stage finance are being challenged by a new type of institutional investor. Whoare the new players and what are the new tools available to the nanotechnology entrepreneur and how will nanotechnology finance change over the next fewyears?

3:00-3:30 Refreshment Break

5:10-5:30 Closing Comments

5:30 Close of Day One

4:30-5:30 Early Registration for Targeted Nanodelivery

4th Annual SYSTEMS INTEGRATION IN BIODEFENSEAugust 24-25, 2005 • Loews L’Enfant Plaza Hotel • Washington, D.C.

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3:30-4:00 Drug Delivery to the Inner EarDr. Stephen McCormack, President and Chief Executive Officer, NeuroSystec Corp.NeuroSystec Corporation is a new combination therapy company that is developing unique, advanced products which deliver neuroactive compoundsusing pumps and formulation technologies to treat hearing disorders. By applying the advances in delivery systems to recently developed neuroactivecompounds, we are joining two areas of scientific discovery in order to bring relief to people suffering from previously untreatable conditions. Tinnitus,a condition associated with hearing loss and with no method of treatment, is our first target indication. According to a CDC report 50 million Americanssuffer from tinnitus and 2 million are disabled by the disease. This presentation will discuss the future of nanosystems for drug delivery and present anexamination of clinical targets for inner ear disorders.

4:00-4:30 Polymerized Liposomal Nanoparticles (PLNs): New, Targetable Delivery Vehicles for Anti-Inflammatory,Vaccine and Cancer Chemotherapeutic Applications

Dr. Jon O. Nagy, Vice President and Director of Medicinal Chemistry, NanoMed Technologies, LLCNanoMed has developed a synthetic, non-viral nanoparticle technology embodying 1) a unique nanoparticle design platform, and 2) a cus-tomizable drug delivery system. The Polymerized Liposomal Nanoparticle (PLN) technology utilizes nanoparticles created using the self-assembling ability of a unique class of diacetylenic lipids that can be polymerized into stable, bimolecular membrane structures capable ofdelivering a drug payload. The PLN technology lends itself especially well to the display of multiple functionalities. These particles are com-prised of individual lipid monomers part of which are functionalized for the purpose of targeting, and may include additional moieties to con-trol other physical properties such as surface charge, polarity, and fluidity. Different functionalized lipids can be rapidly mixed and matchedin an infinite number of combinations and relative concentrations to create tailor-made particles with desirable targeting and circulationproperties. The nanoparticles are non-immunogenic, display no acute toxicity and can be highly concentrated. We are able to modulate theparticle intracellular degradation and excretion rates by controlling the degree of polymerization.

4:30-5:00 The Nanomechanics of Protiveris’s Cantilever Arrays and Biosensor SystemDr. Gregory Kellogg, CTO, R&D, Protiveris Inc.Nanomechanical cantilevers are extremely sensitive transducers of chemical and biological signals into mechanical motion. Protiveris’s VeriScan(tm)3000 Biosensor System is the first nanomechanical cantilever reader capable of tracking the movement of an array of cantilevers in multiple assayswells. It can detect the motion of up to 64 cantilevers individually and simultaneously with resolutions of less than 1 nanometer of bending.Significantly, using optical detection techniques, the VeriScan 3000 Biosensor System can measure both stress related and mass related cantileverdeflections. This technology offers real-time detection of biomolecular binding events, in a multiplex, label free format and at lower detection limitsthan existing techniques.

5:00 Close of Day one

SUNDAY, AUGUST 21

DON’T MISS!

** SSeeppaarraattee RReeggiissttrraattiioonn RReeqquuiirreedd..

NEW!

Cambridge Healthtech Institute’s 6th Annual

TARGETED NANODELIVERY for Therapeutics and Molecular Imaging

Addressing Safety, Regulatory, and Commercialization Issues

August 22-23, 2005 • Loews L’Enfant Plaza Hotel • Washington, D.C.

The goal of targeted therapeutics is to create drugs that by the specificity of their design and delivery will be more effective in treat-ing disease and less toxic. Nanotechnology offers the possibility of a device and a drug in one, with novel capabilities. It will be nec-essary to address the challenges that lie ahead: targeted delivery, safety, commercialization and regulatory issues. Nanotechnologypromises to create a new class of imaging agents that offer distinct advantages and can be used for the early detection and diagnosisof disease. Diagnostic molecules have the potential to act as biomarkers in drug development and diagnostics, and can be used inthe imaging of cancer in living subjects. This meeting will address the challenges in implementing nanotechnology for drug deliverysystems and imaging agents, and promote dialogue between diagnostic and therapeutic development.

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

OPPORTUNITIES AND CHALLENGES FOR NANOPARTICLES

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

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

10:30-11:00 The Bio-Legal Complexity of NanoparticleDevelopment

Dr. James L. Tatum, Special Assistant, Cancer Imaging Program,National Cancer Institute The use of commercially available nanoparticle constructs for both imagingand drug delivery in humans is not novel. However, the current enthusiasm fornanotech-based solutions extends far beyond simple particles to multi-modalplatforms that involve multiple active pharmaceutical ingredients (APIs).These new constructs present a higher level of complexity not only in manu-facturing but also in predicting their behavior in the human including such fun-

damental information as bio-distribution and biocompatibility. Thus go/no-godecision points are less well defined and decisions such as committingresources for scale up of GLP product for pre-clinical testing must be made onlimited data. In addition to the relative uncertainty of bio-interactions, devel-opment of these new constructs involves unique legal complexity. The modernnano-construct is the poster child of team science involving the conglomera-tion of multiple sub-units all with attached intellectual property interests lead-ing to complex licensing issues. It may be a more significant challenge to assurethat such legal issues do not become bigger obstacles to development than thecomplex bio systems these constructs are intended to interrogate and manip-ulate. In this presentation we will discuss some of the unique challenges innano-probe development aimed at producing a successful commercial productand possible strategies to reduce the uncertainty in risk analysis during thedevelopment 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 andBlood Institute Nanotechnology offers a broad range of opportunities for the diagnosis andtreatment of heart, lung and blood diseases. Areas that are particularly prom-ising include molecular imaging, drug delivery and therapeutics, tissue engi-neering and biomaterials, and biosensors and diagnostics. Facilitating theapplication of nanotechnology to disease diagnosis and treatment will requiremulti-disciplinary research teams bringing together individuals with bioengi-neering and nanotechnology skills with biological scientists and clinicians.

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

NANOPARTICLES FOR TARGETED DELIVERY

1:30-1:40 Chairperson’s CommentsMr. Alex W. Kawczak, Vice President, BioProducts andNanostructured Materials, Laboratory Operations/ CommercialBusiness, Battelle Memorial Institute

1:40-2:10 Photonic Nano-Explorers for BioAnalysis,Cellular Imaging and NanoMedicine

Dr. Raoul Kopelman, The Kasimir Fajans Collegiate Professor ofChemistry, Physics and Applied Physics, and Member of Biophysics,The Center for Bio-Nanotechnology and Ultra Fast Optics, TheUniversity of Michigan PEBBLEs (Photonic Explorers for Biomedical use with Biologically LocalizedEmbedding) are sub-micron sized optical sensors and effectors specificallydesigned for minimally invasive analyte monitoring in viable, single cells withapplications for real time analysis of drug, toxin, and environmental effects oncell function or, alternatively, for intracellular intervention. The main classesof PEBBLE nanosensors are based on matrices of cross-linked polyacrylamide,cross-linked poly (decyl methacrylate), sol-gel silica and ormosil. These matri-ces 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 600nm in diameter. A number of techniques have been used successfully to deliv-er PEBBLE nanosensors into mouse oocytes, rat alveolar macrophages, rat C6-glioma, and human neuroblastoma cells. The PEBBLE matrix protects the cellbiochemistry from the sensors chemicals and protects the sensor chemistryfrom the cell’s biochemicals. It also enables synergistic sensing schemes. Withmicrosecond response times, zeptomolar absolute detection limits, chemicaland physical targeting as well as fluorescence background rejection tech-niques, these nanosensors are playing an increasing role in live cell chemicalimaging and analysis. The nanoeffectors can produce chemical activationinside live cells, e.g., with singlet oxygen. Both nanosensors and nanoeffectors

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11:30-12:00 “Expediting the Regulatory Pathway”

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8:40-9:00 Navigating the Regulatory Pathway forNanotechnology: First Steps andChallenges

Drs. Wendy R. Sanhai, Senior Scientific Advisor, Office of theCommissioner, FDA The pathway for regulation of nanotechnology-based medicalproducts remains to be fully elucidated. However, we are pro-ceeding along this path with a battery of evaluative tools/ques-tions that can be effectively applied to these products;Therapeutics, Diagnostics, Combination Products and theirincorporation into imaging modalities, as they move throughpre-clinical and clinical development, and incorporating newknowledge as this field evolves. In an effort to stimulate discus-sion, some case studies and thought-provoking questions will bepresented.

9:00-9:30 FDA Regulatory Considerations forNanotechnology Products

Dr. Nakissa Sadrieh, Associate Director for Research Policyand Implementation, FDA/CDER/OPSNanotechnology is an emerging area of science that is expected to sig-nificantly impact the types of products regulated by the FDA. The FDAbelieves that the existing battery of toxicology tests is adequate formost nanotechnology products that will be regulated. However, as newtoxicological risks that derive from new materials and/or new configu-rations of existing materials are identified, new tests may be required.The FDA expects that many of the nanotechnology products will spanthe regulatory boundaries between drugs, medical devices and biologi-cals. However, it is likely that many nanotechnology products will beregulated as “Combination Products” for which the regulatory pathwayhas been established by statute.

9:30-9:50 TBAGeorge Mills Director, Division of Medical Imaging andRadiopharmaceutical Drug Products. Office of New Drugs,CDER, FDA

MONDAY, AUGUST 22

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are targetable for in vivo applications of optochemical imaging, diagnosticimaging and therapy. For instance, nano-effector platforms provide a new par-adigm for cancer therapy: Targeted nano-platforms improve photodynamictherapy of cancer. Specifically, rats with brain cancer (9L-gliosarcoma) show avery significant extension of survival time, following a protocol of 5 minutes ofred laser irradiation. Simultaneously these nanoplatforms enable MRI monitor-ing of tumor shrinkage. Toxicity, bio-distribution, bio-degradation and bio-elimination are parameters in the design and fabrication of these multifunc-tional nanoplatforms.

2:10-2:40 Virus-Based Nanoparticles: NovelBiomolecular Sensors for Targeting Cancer

Dr. Marianne Manchester, Associate Professor, Department of CellBiology, Center for Integrative Molecular Biosciences, ScrippsResearch 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 pro-teinaceous particle. The structure of the CPMV capsid, defined at theatomic level yields a uniform particle size that can be engineered to dis-play peptides or proteins in controlled orientations on particle surfaces,either by genetic manipulation of the viral genome or by chemical attach-ment to the particle surface. CPMV also demonstrates favorable bioavail-ability and is non-toxic in vivo. We have developed CPMV nanoparticlesas novel anti-tumor and vascular imaging reagents.

2:40-3:10 Nanoparticle-Aptamer Bioconjugates forTargeted Drug Delivery

Omid C. Farokhzad, M.D., Assistant Professor of Anesthesia, HarvardMedical School, Laboratory of Nanomedicine and Biomaterials,Department of Anesthesiology, Brigham and Women’s Hospital Nucleic acid ligands (aptamers) are potentially well suited for the therapeutictargeting of drug encapsulated controlled release polymer particles in a cell- ortissue-specific manner. We synthesized a bioconjugate comprised of controlledrelease polymer nanoparticles and aptamers which bind to the ProstateSpecific Membrane Antigen (PSMA), and examined its efficacy for targeteddelivery to Prostate Cancer (PCa) cells. We demonstrated that these bioconju-gates can efficiently target and get taken up by PCa cells which express thePSMA 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 thePSMA protein.

3:10-3:40 Refreshment Break, Poster & ExhibitViewing

4:10-4:40 Drug Delivery Strategies UsingSupramolecular Gels

Dr. Menno R. de Jong, Research Scientist, Biomade TechnologyFoundationSupramolecular gels in water or other solvents are formed by the self-assemblyof low molecular weight compounds into nanofibrous networks. The non-cova-lent nature of these gels has allowed Biomade Technology to create gelator sys-tems responsive to physiologically acceptable triggers like temperature, pH, orion concentrations, offering exciting opportunities for targeted drug release.Currently, we are developing modified release systems and matrices for thecontrolled formation and stabilization of nanoparticulate formulations of poor-ly water soluble drugs based on biocompatible supramolecular gels. Using thelatter technology, we have found good increases in bioavailibility for severaldrugs. Advantages of the use of supramolecular gels include ease of formulation,excellent scalability, and broad applicability, rendering them interesting toolsin the drug discovery phase and beyond.

4:40-5:10 Inorganic Biohybrid Nanoparticles forTargeted Drug Delivery

Dr. Sandwip K. Dey, Department of Chemical and MaterialsEngineering & Electrical Engineering, Arizona State UniversityTo date, polymeric, lipid, magnetic, and metal nanoparticle systems have beenthe focus of intense research. However, inorganic ceramic nanoparticles arealso an appealing class of material due to its inherent physiological stability inbiological environments. One example is the layered double-hydroxide (LDH)structure, in which an ionically bonded anion resides between two layers ofcationic hydroxides to maintain charge balance. By utilizing this structure,negatively charged therapeutic agents can be readily intercalated within LDHby exchange with the LDH anion to form a biohybrid nanoparticle. To date, thesuccessful intercalation of biofunctional molecules (e.g., antisense-DNA andATP, as well as the cancer therapeutic agents such as folinic acid andmethotruxate) have been reported. Additionally, functionalization of such bio-hybrid nanoparticles, for the purpose of cellular recognition, may be achievedby immobilizing polyethylene glycol (PEG) or dextran onto the surface of thenanoparticles, followed by specific ligand attachment to the end of the PEG ordextran. Here we begin with a brief overview of the state of the art and futurebarriers in the processing of ceramic nanoparticles having the LDH structure,and its potential to target liver cancer cells. Specifically, co-precipitation, bio-hybridization, and functionalization, as well as the physiological responsetowards the nanoparticles, cellular toxicity, and efficacy of cellular targetingwill be outlined. The central theme of this presentation will be on the synthe-sis of LDH nanoparticles (50 - 150 nm dia) by the co-precipitation method, cou-pled with a variety of characterization methods including X-ray diffraction,Infrared spectroscopy, and high-resolution scanning electron microscopy andtransmission electron microscopy.

5:40-6:45 Networking Reception

6:45 Close of Day One

MOLECULAR IMAGING

8:00-8:30 Morning Coffee

8:30-8:40 Chairperson’s CommentsDr. Carol Dahl, Director for Global Health Technologies, Bill and Melinda Gates Foundation

8:40-9:10 Nanoparticle-Based Molecular Imaging Agentfor Diagnosis in Neovascular Diseases

Dr. Shelton D. Caruthers, Senior MR Clinical Scientist, Philips MedicalSystems and Associate Director, Cardiovascular MagneticResonance Laboratories, Washington University School of Medicine As biotechnology advances, in vivo imaging is rapidly incorporating microscop-ic and biochemical information. Similarly, the evolving paradigms of medicineare growing toward the in vivo characterization of the molecular mechanismsof disease with high-affinity, targeted ligands affording a targeted diagnosis.Utilizing these converging technologies, the nanoparticle-based molecularimaging agent presented here provides a high-affinity, target-directed diagnos-tic imaging agent with the potential of additionally monitoring drug deliveryand response. Based on a perfluorocarbon emulsion, this nanoparticle systemhas been applied successfully in models of neovascular disease such as athero-sclerosis and tumor growth.

9:10-9:40 Quantum Dots Co-Localize with GliomaSteven A. Toms, MD, MPH, Director, Section of Metastatic Disease,Brain Tumor Institute, Cleveland Clinic FoundationThe use of fluorescent semiconductor nanocrystals (Quantum Dots) for in vitroand in vivo biological applications has been rapidly evolving. A major difficul-ty with nanoparticles is phagocytosis by components of the reticuloendothelialsystem, which limits circulation half-life of nanoparticles and impedes specifictissue targeting by conjugated nanocrystals. Surface coating of the nanocrystalswith long chains of polyethylene glycol (PEG) improves the circulation half-lifeand permits phagocytosis of the circulating nanocrystals by tissuemacrophages. Tissue macrophages and microglia infiltrate experiment gliomaand accurately outline tumor borders. Intravenous delivery long chain PEGcoated Quantum Dots is accompanied by phagocytosis by macrophages andmicroglia, allowing the optical imaging of brain tumors which may allow moreaccurate biopsy and resection of gliomas.

9:40-10:10 In Vivo Optical Imaging Enabled by Soft-MatterAnalogues of the Quantum Dots

Dr. Michael J. Therien, Alan G. MacDiarmid Professor of Chemistry,University of Pennsylvania In aqueous solution, hydrophobic conjugated-multi(porphyrin)-based near-infrared fluorophores (NIRFs) cooperatively self assemble with amphiphilicdiblock copolymers to form polymersomes (100 nm diameter polymer vesi-cles). The thick membranes of these synthetic vesicles uniquely segregate anduniformly disperse large numbers of high emission dipole strength NIRFs.

TUESDAY, AUGUST 23

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5:10-5:40 “Breakthroughs in Nanotech Drug Delivery”

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NATIONAL LABORATORIES PERSPECTIVE

3:40-4:10 Controlled Synthesis andProcessing of MultifunctionalCarbon NanoVectors for TargetedDrug Delivery, Radiotherapy andImaging

Drs. David Geohegan, Oak Ridge National Laboratory,Anna Gutowska, Pacific Northwest National Laboratory,Jim Misewich,Materials Science & Condensed MatterPhysics,Brookhaven National Lab and BarbaraTarasevich, Senior Research Scientist, Pacific NorthwestNational Lab

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HOTEL INFORMATIONLL''EEnnffaanntt PPllaazzaa HHootteell480 L’Enfant Plaza SW, Washington, DC 20024Tel: 202-484-1000 • Fax: 202-646-4456Rm Rate: $153 S/D • Cutoff: July 30, 2005

TRAVEL INFORMATION

Special Airline Discounts Available

Discount fares are available on United, United Express, United codeshare flights (UA*) operated by US Airways, and US Airways Express.You can receive up to a 15% discount if you or your travel agent callsUnited’s toll-free number 1-800-521-4041 and refer to the Meeting IDNumber 579YS.

EXHIBIT AND SPONSOR INFORMATIONShowcase your company’s expertise, brand your solutions and developrevenue opportunities with qualified decision-makers by becoming anExhibitor or Sponsor of TARGETED NANODELIVERY! Contract exhib-it booth space by MMaayy 2200,, 22000055 and you will save $300! If you want to discuss sponsoring or exhibiting at TARGETED NANODELIV-ERY, please contact Suzanne Carroll at 617-630-1352 orscarroll@healthtech.com.

PRESENT A POSTER AND SAVE $50

Reasons You Should Present Your Research Poster at TARGETEDNANODELIVERY• Receive $50 off your registration fee • Your poster abstract will be published in our

conference proceedings• Your research will be seen by leaders from top biotech,

academic and government institutes

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Extrusion methods enable isolation of NIR-emissive polymersomes havinghomogeneous, nanoscale, size distributions. Long-wavelength optical excita-tion of such assemblies generates intense, highly localized emissive signalscapable of penetrating through the dense tumor tissue of a live animal. The sta-bility of these synthetic vesicles, coupled with the ability to modulate theiremission over a 600-to-950 nm wavelength domain, define a family of nanome-ter-sized emissive soft matter that offers an intriguing complement to in vivoimaging platforms based on quantum dots, with exceptional potential to facili-tate deep-tissue diagnostic and drug-delivery applications.

10:10-10:40 Coffee Break, Poster & Exhibit Viewing

10:40-11:10 Nanoshells for Molecular Targeted Imagingand Therapy of Cancer

Dr. Rebekah Drezek, Stanley C. Moore Assistant Professor,Bioengineering, Rice UniversityWe describe initial results of our work towards the development of target-ed gold nanoshells for combined imaging and therapy applications. Metalnanoshells consist of a silica core coated with a thin layer of gold. Theseparticles provide an ideal material for many biomedical imaging and ther-apy applications because the optical resonance can be precisely tuned todesired wavelengths through the visible and near infrared spectral regionsby varying the core/shell thickness ratio. In a proof-of-principle study, wedemonstrate that it is possible to fabricate biocompatible immunotargetedgold nanoshells which exhibit favorable scattering properties for imaging atone wavelength and a high absorption cross-section required for pho-tothermal therapy at a second wavelength. The results of initial in vitro cellstudies and in vivo animal experiments will be presented.

11:10-11:40 Nanosensors and Biochips: From ResearchBench to Clinical Settings

Dr. Tuan Vo-Dinh, Corporate Research Fellow, Group Leader,Advanced Biomedical Science and Technology Group (ABSTG),Director, Center for Advanced Biomedical Photonics (CABP), Oak Ridge National LaboratoryThis presentation discusses the development and application of advancednanosensors, nanoprobes, and biochips for biomedical diagnostics.Combining the exquisite specificity of biological recognition probes andthe excellent sensitivity of laser-based optical detection, nanoprobess arecapable of detecting and differentiating biochemical constituents of com-plex systems for bioimaging. The development of nanosensors opens newhorizons to biomolecular research at the single-cell level, and permits theability to probe the intact cellular architecture. Recently, we have devel-oped a novel integrated Multi-functional Biochip (MFB) which allowssimultaneous detection of several disease end-points using different biore-ceptors such as DNA, antibodies, enzymes, cellular probes) on a singlebiochip system. The biochip has recently been developed to detect thegene fragments of Tuberculosis and the HIV gene system as well as the p53and FHIT proteins. The biochip could be used to diagnose genetic suscep-tibility and diseases, or to monitor exposure to bioactive environmentalsamples. Technology transfer activities of the MFB technology to the pri-vate companies (HealthSpex, Nanodetection Technologies) for the devel-opment of a new, Inexpensive System for the simultaneous detection ofmultiple genetic mutations in a range of clinical and non-clinical settingswill be discussed.

12:10-1:30 Lunch on your own(Technology Workshop Sponsorship Available)

DRUG DELIVERY SYSTEMS IN THE CLINIC

1:30-1:40 Chairperson’s CommentsChairperson: Dr. Mauro Ferrari, Associate Vice President for HealthSciences, Technology, and Commercialization, and AssociateDirector, Dorothy M. Davis Heart and Lung Research Institute,The Ohio State University

1:40-2:10 Delivery Strategies for Targeted TherapyDr. Barrett E. Rabinow, Director of Strategic Development, BaxterHealthcare Delivery strategies of nanoparticles for targeted therapy involve passive andactive modes following injection, as well as direct delivery to particular sites.Examples will be discussed involving monocyte phagocytic system targeting ofslow dissolving nanoparticles for the purpose both of altering pharmacokinet-ics of the drug, as well as for targeting of liver and macrophage mediated-dis-eases. Prolonged circulation time enabled by coating with hydrophilic surfac-tants permits passive targeting to sites of tumor, infection, and inflammation.Coating of nanoparticles with particular ligands permits active targeting to spe-cific cell types, such as brain endothelial cells, hepatocytes or tumor cells; andto intracellular regions such as cytoplasmic space vs. endosomal vesicles; aswell as to regions of the body affected by local heating or irradiation. Directdelivery to the ventricles of the brain and the pulmonary space, as well as theprospects for nanoparticulate targeting following oral delivery will also be dis-cussed.

2:10-2:40 Nanotech Constructs in Drug DeliveryDr. William Van Antwerp, Distinguished Scientist, Corporate Science& Technology, Medtronic MiniMed We will discuss the applicability of nanotechnology constructs in drug delivery.

Our view is that nano-based materials will be prominent in drug delivery in 5years, while self assembly-based construct will be much longer out.

2:40-3:10 A Dendrimer in the Clinic: A Dendrimer-Based Microbicide Targeted at Prevention of HIV

Dr. Jeremy Paull, Regulatory Affairs and QA Manager, StarpharmaPty Ltd.Starpharma is developing defined and precise dendrimer nanostructures as tar-geted drugs, and has just completed the world’s first clinical trials under USFDA regulations of its lead development candidate, the dendrimer, SPL7013 forprevention of HIV infection in women. SPL7013 is a poly-anionic, lysine den-drimer with a molecular weight of 16.5 KDa. The development of SPL7013 hasbeen supported by the development of regulatory standard analytical and bio-analytical methods. The dendrimer is designed to have efficacy against HIVand other sexually transmitted infections, while being safe to the user. In theclinical trial, SPL7013 Gel (VivaGel) when applied intravaginally in healthywomen was shown to be safe and well tolerated, and there was no systemicabsorption. The study shows that the dendrimer is localised at the site of deliv-ery for optimum disease targeting and safety profile.

3:10-3:40 Refreshment Break, Poster & ExhibitViewing

5:00 End of Conference

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3:40-5:00 STRATEGIC DISCUSSION: GettingNanoparticles Ready for the Clinic

Chairperson: Dr. Mauro FerrariGlaxoSmithKline (invited)Mr. Alex W. Kawczak, Vice President, BioProducts and Nanostructured Materials, LaboratoryOperations/Commercial Business, Battelle Memorial Institute Mr. Bob Root, Chief Executive Officer, Orion Group Inc. Dr. Lloyd L. Tran, President, International Association ofNanotechnology

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11:40-12:10 “Advantages of Nanoparticles forMolecular Imaging”

PRESENT A POSTER AND SAVE $50Cambridge Healthtech Institute encouragesattendees to gain further exposure by pre-senting their work in the poster sessions. Tosecure a poster board and inclusion in theconference CD, your abstract must be sub-mitted, accepted and registration paid in fullby August 1, 2005. Register online to use thePoster Abstract Submission form or, if you reg-ister by phone, fax, or mail, you will receivePoster Abstract Submission guidelines viaemail.

I am interested in presenting a poster at:❒ TARGETED NANODELIVERY❒ SYSTEM INTEGRATION IN BIODEFENSE

and will submit a completed one-pageabstract by August 1, 2005 (Please Note:Registration must be paid in full to presentposter.)Title

CHA ADVANCES REPORTSAffiliate authors collaborate with CHA experts to pro-vide a series of reports that evaluate the salienttrends in pharmaceutical technology, business, andtherapy markets. For more information, visitwww.advancesreports.com, or contact CindyOhlman at cohlman@chadvisors.com or 781-547-0202.

ADDITIONAL REGISTRATION DETAILSEach registration includes all conference sessions,posters and exhibits, food functions, and a copy ofthe conference CD.

GROUP DISCOUNTSSpecial rates are available for multiple attendeesfrom the same organization. Contact DavidCunningham at 617-630-1372 to discuss your optionsand take advantage of the savings.

HANDICAPPED EQUAL ACCESSIn accordance with the ADA, CambridgeHealthtech Institute is pleased to arrange specialaccommodations for attendees with special needs.All requests for such assistance must be submitted inwriting to CHI at least 30 days prior to the start ofthe meeting.

SUBSTITUTION/CANCELLATION POLICYIn the event that you need to cancel a registration, you may:• Transfer your registration to a colleague within

your organization• Credit your registration to another Cambridge

Healthtech Institute program• Request a refund minus a $100 processing fee per

conference• Request a refund minus the cost ($250) of order-

ing a copy of the CDNOTE: Cancellations will only be accepted up totwo weeks prior to the conference.

Program and speakers are subject to change.

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TARGETED NANODELIVERY for Therapeutics and Molecular Imaging

Addressing Safety, Regulatory, and Commercialization Issues Formerly BioMEMS and NANOtech World Conference

August 21-23, 2005 • Loews L’Enfant Plaza Hotel • Washington, D.C.

YES! Register me for TARGETED NANODELIVERY 521 F

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PRICING INFORMATIONCommercial Academic, Government,

OPENING FORUM Hospital-Affiliated❒ Nanotech Business Perspectives Forum ❒ $375 ❒ $225

SINGLE CONFERENCE (Choose One):❒❒ Targeted Nanodelivery OR ❒❒ Systems Integration in Biodefense Early Registration Deadline until May 27, 2005 ❒ $1045 ❒ $545Advance Registration Deadline until July 15, 2005 ❒ $1195 ❒ $620Registrations after July 15, 2005 and on-site ❒ $1395 ❒ $695❒❒ Poster Discount ❒❒ $50 off ❒❒ $50 off

BOTH CONFERENCES❒❒ Targeted Nanodelivery AND ❒❒ Systems Integration in Biodefense Early Registration Deadline until May 27, 2005 ❒ $1545 ❒ $840Advance Registration Deadline until July 15, 2005 ❒ $1770 ❒ $925Registrations after July 15, 2005 and on-site ❒ $1995 ❒ $1030❒❒ Poster Discount ❒❒ $50 off ❒❒ $50 off

❒ I cannot attend but would like to purchase the conference CD for $250 (plus shipping). Massachusetts delivery will include 5% sales tax.

❒❒ Please send information on exhibiting and opportunities to present workshops.

PAYMENT INFORMATION❒ Enclosed is a check or money order payable to Cambridge Healthtech Institute, drawn on a U.S. bank, in U.S.

currency.❒ Invoice me, but reserve my space with credit card information listed below.

Invoices unpaid two weeks prior to conference will be billed to credit card at full registration rate. Invoices mustbe paid in full and checks received by the deadline date to retain registration discount. If you plan to register onsite, please check with CHI beforehand for space availability.

❒ Please charge: ❒ AMEX (15 digits) ❒ Visa (13-16 digits) ❒ MasterCard (16 digits) ❒ Diners Club (14 digits)

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IHDPlease refer to the Keycode below:

Register By May 27th and save up to $350

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