236 Faunce Johns Hopkins April 07

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Information about 236 Faunce Johns Hopkins April 07

Published on March 6, 2008

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National Centre for Biosecurity:  National Centre for Biosecurity Nanotechnology in medicine and biosecurity: dilemmas for bioethics, public health law and international human rights Thomas Alured Faunce BA LLB (Hons) B Med PhD. Senior Lecturer Faculty of Medicine and College of Law, Australian National University, Director Globalisation and Health Project, Board Member National Centre for Biosecurity. Thomas.Faunce@anu.edu.au Johns Hopkins Bloomberg School of Public Health Hapton House Room 688 Johns Hopkins Bloomberg School of Public Health 624 N Broadway Baltimore, MD 21205 Tuesday, April 17, 2007 2:30 - 4:00 p.m. National Centre for Biosecurity:  National Centre for Biosecurity OVERVIEW Research background Introduction to nanotechnology in biosecurity Introduction to nanotechnology in medicine (with particular focus on Australian nano/bio-tech. companies and cost-effectiveness regulation) Related dilemmas for bioethics, public health law and international human rights Relevant Research and Professional Background:  Relevant Research and Professional Background Project Director of three year ARC trade and medicines grant (2005-2007) Project Director of three year ARC Discovery grant in regulation of nanotechnology in medicine (2007-2009) Founding Board Member Australian National Centre for Biosecurity (NCB) Former senior registrar in intensive care at Alfred Hospital (Melb) Consultant with UNESCO on its global data base of bioethics, health law and international human rights National Centre for Biosecurity:  National Centre for Biosecurity Australian National Centre for Bioecurity (NCB) aims: Facilitate academic and policy engagement with: 1)Fast-moving infectious disease outbreaks of natural origin 2) Biological weapons threats 3) Risks associated with research on pathogenic organisms 4) Implications of emerging technologies for biosecurity 5) Disease impact on health governance, state functioning and economy Nanotech. In Biosecurity:  Nanotech. In Biosecurity Biosecurity and the dilemma of medical chaos after terrorist bombings:  Biosecurity and the dilemma of medical chaos after terrorist bombings On 12 October 2002 a bomb containing approximately 500mg-1g TNT, and 80-120cm above the ground, exploded near the northern wall of a bar in Kuta, Bali. Survivors underwent debridement, removal of shrapnel and suturing of multiple lacerations under general anaesthetic at the Sanglah Central General Hospital in Denpasar, Bali, being further assessed by a team of Australian medical specialists on the tarmac. Transported by RAAF Hercules aircraft to Darwin and at Darwin Hospital resuscitated in the general ward, before being transferred to Australian ICUs via RAAF Hercules aircraft then helicopter transfer. TA Faunce, The Bali Disaster: Principles of Management for Australian Intensive Care Australian and New Zealand Anaesthesia and Intensive Care Scientific Meeting, Hobart May 2003 Primary, secondary and tertiary injuries from terrorist bombings:  Primary, secondary and tertiary injuries from terrorist bombings “Primary” terrorist bomb injuries: deriving from the blast wave itself: cerebral gas embolism and extensive pulmonary contusions as well as bilateral ruptured tympanic membranes. “Secondary” injuries from shrapnel, structural debris or heat propelled by the blast wave: severe and extensive burns as well as wounds which became ongoing sources of infection and sepsis “Tertiary” injuries from immediate displacement against solid objects or from building collapse or fire: simple fractures, contusions, abrasions and lacerations consistent with either being blown against a structure, or having it fall or burn upon them. Building collapse is a deliberate terrorist aim to maximise casualties from a bomb blast. Dilemmas with delayed deliberate terrorist post-blast injuries:  Dilemmas with delayed deliberate terrorist post-blast injuries Delayed deliberate post-blast injuries to create secondary hazards for victims, rescuers or medical staff: second bomb attached to a mock or pseudo-victim, or radiation or biologic vectors. The secondary targeting of hospitals by terrorists in this manner may be part of a tactic to disable disaster response plans. Our ICU patients developed complex gram negative infections due to atypical organisms. The dominant organism was acinetobacter, but of a type not previously seen in our unit. What if it had been a form of the 1918 influenza virus, a deliberately mutated mousepox or smallpox? A protocol requiring use of nanotechnology rapid surveillance for such bio-hazards could be critical to minimizing injury in this phase. But what should be the form and content of laws and guidelines to control the response to a positive result? Nanotech in Biosecurity:  Nanotech in Biosecurity The United States Department of Justice (DOJ) National Institute of Justice (NIJ) has two separate biosecurity-related projects that incorporate nanotechnology - DNA Research: to develop a nanotechnology device that will be integrated into the current crime laboratory processes and protocols to rapidly and accurately analyze forensic DNA samples. 2) Chemical detection: developing a wearable, low-cost device to provide better warning of exposure to unanticipated chemical and biological hazards than current approach relying on vapor exposure of an immobilized enzyme surface. M.C.Roco.National Nanotechnology Investment in the FY 2003 Budget Request by the President. National Science and Technology Council's subcommittee on Nanoscale Science, Engineering and Technology Nanotech in Biosecurity:  Nanotech in Biosecurity The Forensic Science Center at Lawrence Livermore National Laboratory in the US aims to develop nanostructured materials for the collection, concentration and detection of chemical weapons or other related compounds : Silica-based nanomaterials, Molecular imprinted polymers and Silicon platforms Reynolds J.G.;Hart B.R Nanomaterials and Their Application to Defense and Homeland Security , 2004; 56 (1): 36-39 US Defense-funded basic research programs include 16 multimillion-dollar annual grants to university researchers as part of the defense university-research initiatives in nanotechnology and some 25 grants under the multidisciplinary university-research initiative. Dilemmas from US-China interests in military nanotechnology:  Dilemmas from US-China interests in military nanotechnology The Institute for Soldier Nanotechnologies (ISN), is a research collaboration between the United States Army and the Massachusetts Institute of Technology (MIT). The ISN combines basic and applied research into military applications of nanoscience and nanotechnology in: protection, performance improvement, injury intervention and cure. Strategists within China's People's Liberation Army (PLA) reportedly understand the strategic significance of such military nanotechnology research in the United States. The Center for Nanotechnologies at the Chinese Academy of Sciences (CAS) in Beijing opened in 2000. Uniting over a dozen CAS institutes and several university laboratories, the aim of the center was to upgrade scientific cooperation while accelerating nanotech industrial development in Beijing. Military research? Implications of “nano-war” rivalry for peace and fundamental freedoms? National Centre for Biosecurity:  National Centre for Biosecurity U.S. National Academies Globalization, Biosecurity, and the Future of the Life Sciences Focusing on known bio-weapon pathogens may miss the bigger picture of non-traditional attacks. Laws such as PATRIOT and the Bioterrorism Response Acts may discourage research that could be helpful to the U.S and humanity. Ethical guidelines and codes for scientists in nano/biosecurity research could be useful if combined with education programs Restrictive regulations and the imposition of constraints on the flow of life sciences information are unlikely to reduce risks of its malevolent use. Such restrictions will limit the potential for continuing advances in the life sciences and its related technologies to improve health, provide secure sources of food and energy, contribute to economic development in both resource-rich and resource-poor parts of the world. National Centre for Biosecurity:  National Centre for Biosecurity BWC and CWC and International Law “The 1972 Biological and Toxin Weapons Convention (BWC) and the 1993 Chemical Weapons Convention (CWC) serve as cornerstones of the global biological-chemical regime, which has expanded to include rules and procedures rooted in measures ancillary to the two treaties.” U.S. National Academies Globalization, Biosecurity, and the Future of the Life Sciences The Biological Weapons Convention (BWC) prohibits the development and acquisition of biological weapons and is the foundation of international efforts to prevent their use. Member states meet every five years in Geneva, Switzerland to review and improve the operation of the Convention. The Sixth Review Conference of the BWC took place from November 20 through December 8, 2006, seventh Review Conference takes place in 2011. Article X (2) This Convention shall be implemented in a manner designed to avoid hampering the economic or technological development of States Parties to the Convention Universality, national implementation, confronting non-compliance. National Centre for Biosecurity:  National Centre for Biosecurity UNESCO Universal Declaration on Bioethics and Human Rights Assume: Nano-computer power for face recognition, speech recognition, and object tracking on ubiquitous public cameras: Article 8 – Respect for human vulnerability and personal integrity In applying and advancing scientific knowledge, medical practice and associated technologies, human vulnerability should be taken into account. Individuals and groups of special vulnerability should be protected and the personal integrity of such individuals respected. Article 15 – Sharing of benefits 1. Benefits resulting from any scientific research and its applications should be shared with society as a whole and within the international community, in particular with developing countries. In giving effect to this principle, benefits may take any of the following forms: Article 16 – Protecting future generations The impact of life sciences on future generations, including on their genetic constitution, should be given due regard. Nanotech. in Medicine:  Nanotech. in Medicine Nanomedicine Research is Developing Rapidly:  Nanomedicine Research is Developing Rapidly The research budget of every major pharmaceutical company now has a considerable component devoted to nanotechnology. Nanomedicine is a major area of interest for Australian bio-tech. companies Nanotherapeutics: new challenges for safety and cost-effectiveness regulation in Australia Thomas Alured Faunce — Med J Aust 2007; 186 (4): 189-191 (free on-line). Nanomedicine:  Nanomedicine Nanoparticles may provide an efficient delivery system for DNA vaccines and gene therapy. They may assist speedier and more efficient delivery of drugs to diseased cells with less pain. They have been investigated in neurosurgery, cardiac surgery and blood disorders. Peptide nanotubes have been investigated as the next generation of antibiotics and as immune modulators. Nanogenerators are being engineered that utilise an antibody to direct a caged radioactive atoms to destroy cancer cells. Mumper RJ and Cui Z Genetic Immunization by Jet Injection of Targeted pDNA-coated Nanoparticles (2003) 31 Methods 255-262 Roy I, Ohulchanskyy TY, Bharali DJ et al Optical Tracking of Organically Modified Silica Nanoparticles as DNA Carriers: A Nonviral, Nanomedicine Approach for Gene Delivery (2005) 102(2) Proc. Nat. Acad. Sci 279-284. Kreuter J, Nanoparticulate Systems for Brain Delivery of Drugs(2001) 47 Adv Drug Deliv 65-81. Shaffer C. Nanomedicine transforms drug delivery. (2005) 10(23-24) Drug Discov Today 1581-2. Leary SP, Liu CY, Yu C et al Toward the Emergence of Nanoneurosurgery: Part I-Progress in Nanoscience, Nanotechnology and the Comprehension of Events in the Mesoscale Realm (2005) 57 (4) Neurosurgery 606-633 Kong DF, Goldschmidt-Clermont PJ. Tiny Solutions for Giant Cardiac Problems (2005) 15(6) Trends Cardiovasc Med 207-11. Hulstein JJ et al A Novel Nanobody that Detects the Gain-of-function Phenotype of von Willebrand Factor in ADAMTS13 Deficiency and von Willebrand Disease Type 2B (2005)106(9) Blood 3035-42. Vinogradov S. The second annual symposium on nanomedicine and drug delivery: exploring recent developments and assessing major advances 2004 1(1) Expert Opin Drug Deliv 181-4 Ghadiri MR Antibacterial Agents Based on the Cyclic D, L Peptide Architecture (2001) 412 Nature 451-455 Bottini, MBruckner S, Nika K et al, Multi-Walled Carbon Nanotubules Induce T Lymphocyte Apoptosis (2006) 160 Toxicology Letters 121-126. Scheinberg DA et al Tumor Therapy with Targeted Atomic Nanogenerators (2001) 294 Science 1537-1542 Nano Vic:  Nano Vic Nanotechnology Victoria. Not-for-profit collaboration between RMIT, CSIRO, Monash Uni. and Swinburne IT. $28 million govt. funding to drive commercial outcomes from Victoria’s strong nanocapability base. Pulmonary drug delivery: insulin, erythropoietin In vivo diagnostics: nanoparticle contrast agents for coronary atheroscelosis In vitro diagnostics: gold nanoparticles coated with diagnostic antibodies-contact with antigen causes them to aggregate and change colour (to blue) Miconisers:  Miconisers Manufactures bulk nanoproducts for sunscreens, diagnostics and targeted drug delivery MicrosunTM Nano sized Zinc Oxide powder, (30nm) and blends of Nano sized Zinc Oxide with Nano particles of Titanium Oxide, Iron, Aluminium, Zirconium, Silver and Manganese Concentrated dispersions of Nano sized Zinc & Titanium with a range of solids from 40-80% in water, esters (IPP, IPM, Capric/caprylic), mineral oil (paraffin, white oil) and Silicones (Dimethicones, cyclomethicones, etc) Micronised high quality cosmetic grades of talc coated with Boron Nitride, Ceramide, Chitin, Siloxane, Stearic Acid, Vitamin C, Vitamin E and Betacarotene. Zinc Oxide has been used for many years in a wide range of cosmetic products; eg, moisturisers lip products, foundations, make-up bases, face powders, hand creams, etc. The availability of Micronisers transparent Nano-sized Zinc Oxide (NanosunTM) has enhanced the effectiveness of Zinc Oxide and overcome the “whitening” aspect of normal Zinc Oxide powder. pSivida:  pSivida pSivida has developed the only two FDA approved sustained release treatments for chronic eye disease – Vitrasert ® and Retisert™. Both manufactured and sold by global ophthalmology company, Bausch & Lomb (B&L). Medidur™ in Phase III clinical trials, is licensed to Alimera Sciences for the treatment of Diabetic Macular Edema. Modified form (porosified or nano-structured) of silicon BioSilicon™, for drug delivery, wound healing, orthopedics, and tissue engineering (exclusive licenses to subsidiaries, AION Diagnostics Limited and pSiNutria Limited, to develop and commercialize) BrachySil™, a brachytherapy product in Phase IIb clinical trials, for the treatment of inoperable primary liver cancer. Licensing agreement with Beijing Med-Pharm Corporation for the clinical development, marketing and distribution of BrachySil™ in China. Four evaluation agreements for its drug delivery technologies with three of the world’s largest pharmaceutical companies. Listed on NASDAQ (PSDV), Australian (PSD), and Frankfurt (PSI) stock exchanges and is a member of the NASDAQ Health Care Index (Nasdaq: IXHC) and the Merrill Lynch Nanotechnology Index. In 2005 pSivida acquired Controlled Delivery Systems from Boston. Starpharma:  Starpharma Specialist in dendritic nanotechnology Dow Chemical’s 8.6% ownership in Starpharma Holdings and recent acquisition of Dendritic Nanotechnologies from US (focus on life sciences and industrial applications (research reagents, industrial chemicals and fine chemicals). Starpharma focus on dendritic nanotechnologies: pharmaceutical (viva gel, protein PK modifications and cancer therapies) and life sciences (medical diagnostics, drug optimisation, drug delivery). Viva Gel is bottom up technology. Well-defined synthetic polymer, made in vat by adding monomers. “Can decorate the surface with functionality.” Has same electrical charge as receptors on T cells, so “gums” up HIV before it can get to T cells, in dose-response manner. Starpharma has collaborations with Qiagen, Dadebehring and EMD Bioseciences (Merck (Germany))). Also has sought and obtained funding from US NIH. Advanced Nanotechnologies (WA):  Advanced Nanotechnologies (WA) Mechanochemical Processing (MCP) technology is a novel, patented solid-state process for the manufacture of a wide range of nanopowders. Dry milling is used to induce chemical reactions through ball-powder collisions (low temperature chemical reactor) that result in nanoparticles formed within a salt matrix. Particle size is defined by the chemistry of the reactant mix, milling and low heat treatment conditions. Particle size distribution curve for MCP ~30nm zinc oxide nanopowder shows a mean particle size of 30nm with a standard deviation of less than 4nm. Alusion™ - the latest in soft focus effect pigments for hiding the effects of ageing. ZinClear™ - for the first time enabling transparent SPF 30+ sunscreens containing only zinc oxide as the UV absorber. Zinc Oxide “is ideal for all cosmetic and industrial transparent UV absorbing applications, and antibacterial functions”. Commercialisation arrangements with Samsung Corning Ceramisphere:  Ceramisphere Commercialising sol-gel (Si02) encapsulation technology developed at the federally funded Australian Nuclear Science and Technology Organisation (ANSTO). Ceramisphere is fully owned subsidiary of ANSTO CeramiSphere™ can produce a range of ceramic particles from materials such as silica, titania, alumina and zirconia. Particle sizes from 10 nanometers to 100 microns depending on the application. The particle surface is hydrophilic and may be functionalised, microporous or mesoporous. Applicable to hydrophilic and hydrophobic molecules, drugs, proteins, enzymes, fragrance and DNA can be encapsulated No need for reformulation for different target molecules True controlled release by diffusion, release rate (hours to months) independent of particle size (10 nm – 100 microns) High mechanical resistance, chemical inertness and biocompatibility SiO2 is already an FDA approved material for oral and topical use Wide range of potential applications including drug delivery, encapsulation of biocides, pesticides and insecticides, food and fragrance encapsulation and veterinary applications Alchemia:  Alchemia Alchemia has developed and applied to patent a new and efficient process for the preparation of Synthetic Heparin. The Company intends to commercialise Alchemia's Synthetic Heparin with its partner, The Dow Chemical Company (Dow). In the US market, approval will be sought through the ANDA route (Abbreviated New Drug Application). The cGMP pilot scale production of Synthetic Heparin has been successfully completed at Dow's US facilities. VAST technology: nanoscale drug discovery technique for systematically scanning molecular diversity space. Eiffel Technologies:  Eiffel Technologies Eiffel's focus is on modification and re-engineering of pharmaceutical compounds and supercritical fluid research. Supercritical Fluid technologies can be used to produce uniform, very small drug particles. Drugs produced in this way have the potential to be delivered in more convenient and effective dose forms. For example, a drug previously administered via injection could be re-engineered to be delivered via an inhaler. Supercritical Fluid technology is therefore well placed to enable the development of line extension products with superior performance to protect market share once patent life of branded pharmaceuticals expires. Eiffel sponsors continuing research in pharmaceutical processing at its Pharmaceutical Re-engineering Facility, located at the University of NSW. Pharmaceutical development and scale-up activities are conducted at the Company’s headquarters in North Ryde, Sydney, Australia. Other Australian nanomedicine capabilities:  Other Australian nanomedicine capabilities Nanotechnology and biomaterials centre Uni Qld (Nanomic Biosystems): rapid DNA sequencing using colloidal practicles ANU Dept. Applied Mathematics: ‘Fibrin Lite’ radio-labelled nanoparticle for diagnosis of fibrin deposition diseases and DVT Centre for Nanoscience and Nanotechnology Uni Melb: polymer encapsulation for cotrolled release of Doxorubicin Monash University, Dept. Biochemistry and molecular biology and school of physics and materials engineering and synchrotron research program Flinders University, School of Chemistry, Physics and Earth Sciences: nanotech. Polymers, sol-gels, silicon materials, biosensors, carbon nanotubes, surface characterisation and bio-sensors University of Technology Sydney (UTS): researching artificial membranes to improve the bio-compatibility of implanted tissue and cells Dilemmas for Bioethics and Health Law :  Dilemmas for Bioethics and Health Law Safety assessment of therapeutic goods (medicines and medical devices) is a relatively data rich field with considerable capacity in regulators to require additional targeted studies where novel concerns are identified Safety assessment of nanotechnology industrial chemical production is a relatively data poor environment Dilemmas for Bioethics and Health Law:  Dilemmas for Bioethics and Health Law Are there likely to be “class” nanotech. effects in medicine and biosecurity? Or will these be confined to uniquely engineered nanomaterials with novel surface binding properties? Nanotherapeutics: new challenges for safety and cost-effectiveness regulation in Australia Thomas A Faunce — Med J Aust 2007; 186 (4): 189-191. Dilemmas for regulation of nanomedicine:  Dilemmas for regulation of nanomedicine Terminological definitions and standards used in differing nanotherapeutic assessments need to be clarified. Long-term safety of engineered nanoparticles (ENPs) in humans needs to be established. ENPs in isolated cell experiments have caused DNA damage. Short-term ENP exposure in animals has produced dose-dependent inflammatory responses and pulmonary fibrosis. Chronic in-vivo exposure studies (in particular, of reproductive toxicity) are yet to be published. Some ENPs preferentially accumulate in mitochondria and inhibit function. Others may become unstable in biological settings and release elemental metals. Gaps in nanotherapeutic safety data need to be systematically determined, and government support needs to be directed to the relevant fields of nanotoxicological research. Workable and consistent standards and guidelines for therapeutic ENP use and handling, monitoring and labelling need to be developed. Individual nanotherapeutic applications may overlap different classifications of medicines, medical devices, and diagnostic and therapeutic risk assessment classifications and pathways. Potential or actual weaknesses in the existing regulatory framework need to be located and addressed. Dilemmas for Nanomedicine Regulation:  Dilemmas for Nanomedicine Regulation Any revised regulatory system needs to factor in the likely high cost for “innovative” nanotherapeutics, as well as difficulties in classifying nanotech versions of existing off-patent pharmaceuticals as “generic”. Reimbursement for new and often “innovative” pharmaceuticals and medical devices (such as those likely to use ENPs) is a significant and increasing component of government health care expenditure. In this context, cost-effectiveness assessment of allegedly innovative medical products, linked to a central government price negotiation, is internationally becoming an accepted part of the health techno-logy regulatory approval process. Pharmaceutical “innovation” may be achieved either through the operation of “competitive markets” (requiring a greater role for competition regulators) or through expert evaluations of “objectively demonstrated therapeutic significance” Dilemmas for Regulation of Nanomedicine:  Dilemmas for Regulation of Nanomedicine One of the first nanomedical devices approved by the United States Food and Drug Administration (FDA) bypassed the requirement for a lengthy and costly clinical study because regulators deemed that its constituent nanoscale calcium phosphate fitted a category of existing approved macroscale products. Similarly, a nanoparticulate reformulation of an existing drug has been deemed by the FDA not to require an Abbreviated New Drug Application because bioequivalence was established. Gathering, analysing, categorising and characterising safety data for individual nanotherapeutic products may be unusually difficult. Recently Australian TGA regulators reviewing the scientific literature on nanoparticulate titanium dioxide and zinc oxide in sunscreens found evidence, from isolated cell experiments, of DNA-damaging free radical formation on light exposure, but apparent lack of penetration below surface layers of the skin Should FDA be the global benchmark for safety regulation? Dilemmas For Bioethics, Health Law and International Human Rights:  Dilemmas For Bioethics, Health Law and International Human Rights UNESCO Universal Declaration of Bioethics and Human Rights Article 2. This Declaration is addressed to States. As appropriate and relevant, it also provides guidance to decisions or practices of individuals, groups, communities, institutions and corporations, public and private. Article 14 – Social responsibility and health 2. Taking into account that the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition, progress in science and technology should advance: access to quality health care and essential medicines, especially for the health of women and children, because health is essential to life itself and must be considered to be a social and human good; Bioethics and International Human Rights as calibration systems for health law: Faunce TA, Who Owns Our Health? Medical Professionalism, Law and Leaderhip Beyond the Age of the Market State. UNSW Press 2007 National Centre for Biosecurity:  National Centre for Biosecurity CONCLUSION Introduction to nanotechnology in biosecurity Introduction to nanotechnology in medicine (with particular focus on Australian nano/bio-tech. companies) Related dilemmas for bioethics, public health law and international human rights

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