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MDS Pharma Services, a leading provider of innovative drug discovery and development solutions, has launched the next generation of its proprietary ClinQuick(R) electronic system for Phase I study set-up, data capture, project tracking and personnel credential management. Aimed at improving client service, the new version of the ClinQuick(R) system extends a 15-year legacy of technical leadership in early clinical research. System enhancements include a more user-friendly interface, improved menu navigation and a more robust data platform. This new platform will enable faster and more flexible reporting and will ultimately allow clients to access their data via the internet.

“Since its implementation in 1993, ClinQuick(R) has been used successfully in more than 3,000 Phase I studies involving nearly 100,000 participants,” said MDS Pharma Services President David Spaight. “Our investment to enhance the ClinQuick(R) system builds on that legacy of success and will allow us to meet growing client demand for early clinical research services while maintaining our leadership position in Phase I. This next-generation ClinQuick(R) system will further improve our ability to deliver high quality Phase I services on time.”

About ClinQuick(R)

Designed and built by MDS Pharma Services for use in its Phase I clinical research centers, the fully integrated ClinQuick(R) system facilitates rapid data cleansing and client monitoring for seamless operation of both single and multi-site studies. ClinQuick(R) accelerates timelines, enables accurate direct data acquisition, and reduces costs by a third compared to traditional paper case report forms (CRFs) - the forms used by clients to collect and document data from each participating clinical research site. The system is fully CFR Part 11 compliant and can be used for study management and electronic data capture (EDC), either alone or in conjunction with a client-provided EDC system or paper CRFs. MDS Pharma Services offers one of the world’s largest capacities for conducting early-phase clinical studies, with some 1,100 beds in five state-of-the-art clinical research facilities in North America and Europe.

About MDS Pharma Services

MDS Pharma Services is committed to delivering quality service on time. We offer a full spectrum of resources to meet the drug discovery and development needs of the pharmaceutical and biotechnology industries. With numerous facilities strategically located around the world, we apply advanced scientific and technological expertise throughout the drug discovery and development process - from lead optimization, pre-IND research, early clinical research (bioequivalence, phases I-IIa) and bioanalysis through to global clinical development (phases IIb-IV), central lab and centralized cardiac services. For more information, visit our website at http://www.mdsps.com.

MDS Pharma Services is a business unit of MDS Inc. (TSX: MDS; NYSE: MDZ), a global life sciences company that provides market-leading products and services that our customers need for the development of drugs and diagnosis and treatment of disease. We are a leading global provider of pharmaceutical contract research, medical isotopes for molecular imaging, radiotherapeutics, and analytical instruments. MDS has more than 5,500 highly skilled people in 29 countries.

MDS Pharma Services
http://www.mdsps.com

The June 2008 issue of the Journal of Pharmaceutical Innovation (JPI) is publishing the first scientific papers outlining the progress made on ISPE’s Product Quality Lifecycle Implementation (PQLI) initiative. Written by subject matter experts representing the global pharmaceutical manufacturing industry, these papers present preliminary practical scientific and technological approaches to implementing ICH documents that address Pharmaceutical Development (Q8 and Q8(R)), Quality Risk Management (Q9), and Pharmaceutical Quality Systems (Q10). The June issue will be published in print and with Open Access on SpringerLink (available at www.springer.com/journal/12247) with the possibility to comment.

The Product Quality Lifecycle Implementation (PQLI) initiative was launched by ISPE in June 2007 to help industry find practical technical solutions to the challenges of implementing guidelines put forth by the ICH. The first three Task Teams formed focused on Criticality, Design Space and Control Strategy, and how these areas are linked; a Legacy Products Task team has also been formed as the fourth topical area.

Through PQLI, ISPE is providing technical frameworks to facilitate the implementation of Q8, Q9, and the imminent Q10 for new products and processes, as well as for existing approved products which could benefit. PQLI will provide better understanding of Quality by Design (QbD) applied to new products and processes, and is developing cross-functional tools valued by both the Industry and Regulatory Authorities worldwide. While the output is critical for industry application, the conclusions have been reached with input from global regulators. With the publication of these articles, the ISPE PQLI Task Teams are seeking additional feedback prior to developing their respective positions into technical documents.

PQLI is projected to be at least a five-year initiative that has started with highly interactive fact-gathering sessions held in the USA and Europe. Working groups will continue to collect and process information for distribution as white papers, articles to be published in ISPE’s Journal of Pharmaceutical Innovation and Pharmaceutical Engineering Magazine, leading to detailed technical documents, and training programs that will be produced by ISPE for the industry worldwide.

“The ISPE PQLI Task Teams are to be congratulated for their technical publications in JPI on criticality, design space, and control strategy, which embrace inputs from open, interactive global workshops that included participation from both industry and regulators,” said Moheb M. Nasr, Ph.D., Director, Office of New Drug Quality Assessment (ONDQA, CDER, FDA). “These papers, and the PQLI initiative, are important ‘next steps’ to facilitate the implementation of QbD and to answer the tangible challenges.”

Referring to the importance of understanding the future role of the EU Qualified Person within the frameworks of ICH Q8, 9 and 10, Jacques Morenas (AFSSAPS) and current chairman of the Pharmaceutical Inspection Cooperation Scheme (PIC/S) said “EU regulators are ready to work with ISPE on this topic taking into account it is a critical point. Work is already on progress as we can see with work made into PAT team at the EMEA level and we will be happy to continue.”

The Criticality article describes a mechanism for categorizing and delineating criticality for quality attributes, variables, material attributes and process parameters in accordance with a risk based approach reflective of QbD principles articulated in ICH Q8R. The article introduces the adoption of a Criticality Analysis Decision Tree to categorize criticality relative to a variable’s impact to quality and delineate levels of criticality with respect to relative risk.

Design Space discussions considered the linkage of the patient experience with product quality. It also focused on how risk assessment methodologies integrate with process design principles, provided perspective on selection of mechanistic versus empirical approaches, and clarified how they may be applied to legacy products, and biotech products. The team also discussed a number of useful methods for depicting design space. The team recognizes that organizations may choose different, scientifically defensible means to arrive at design space.

The Control Strategy team has proposed a Model process to enable a clear logic to be used on how a Control Strategy differentiates between patient and business requirements, as well as showing the linkage from Critical Quality Attributes, e.g. via Critical Process Parameters, to individual controls such as analytical, PAT, engineering, procedural or other controls. The Model illustrates how the Control Strategy embraces ICH requirements (product and systems). It will also provide a discussion bridge between disciplines such as development scientists and controls engineers.

The Legacy Products team has started work and will produce a paper later in 2008 in JPI. The team is considering how to derive business benefits by reviewing knowledge about a product and/or process and proposing opportunities for flexibility in a post approval regulatory application for an approved product. A suggested workflow process will be produced and supported by case studies.

“The publication of these papers is a milestone event as it will bring together an industry view of a risk and science based design approach for pharmaceuticals,” said James C. Spavins, Vice President, Global CMC, Pfizer. “The use of risk based analyses to determine design constraints and then determine appropriate controls is a foundational process for the advancement of science and technology - it is time for pharmaceutical professionals to have an aligned view.”

The Journal of Pharmaceutical Innovation (JPI) is an international, multidisciplinary peer-reviewed scientific journal dedicated to publishing high quality papers emphasizing innovative research and applied technologies within the pharmaceutical and biotechnology industries. JPI’s goal is to be the premier communication vehicle for the critical body of knowledge that is needed for scientific evolution and technical innovation. The journal brings together in a single source the most exciting work from a variety of fields - from R&D to market. JPI publishes Perspectives, Case Studies, Research Letters, Research Articles, and Reviews in the following categories: materials science; process design, optimization, automation, and control; product design; facilities; information management; regulatory policy and strategy; supply chain developments; and education and professional development. JPI is published by ISPE in collaboration with Springer.

About ISPE

ISPE, the International Society for Pharmaceutical Engineering, is the Society of choice for 25,000 pharmaceutical science and manufacturing professionals in 90 countries around the globe. ISPE aims to be the catalyst for “Engineering Pharmaceutical Innovation” by providing members with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies and industry leaders.

Founded in 1980, ISPE has worldwide headquarters in Tampa, Florida, with a European office in Brussels, Belgium, and an Asia Pacific office in Singapore.

www.ISPE.org

Inovio Biomedical Corporation (AMEX:INO), a leader in enabling the development of DNA vaccines using electroporation-based DNA delivery, announced that the team of Dr. Christian H. Ottensmeier, MD, PhD, Cancer Research UK Senior Clinical Research Fellow at the University of Southampton, will present interim data from a clinical study of an experimental DNA-based prostate cancer vaccine at the American Association for Cancer Research meeting in San Diego, USA, April 12 - 16, 2008. The data indicates that the combination of this DNA vaccine and electroporation DNA delivery was safe and well-tolerated. Patients treated using electroporation also displayed higher levels of antibody and anti-DOM CD4 responses.This academic study is a phase I/II study in 30 HLA A2+ patients with biochemical failure of prostate cancer. The study is testing a DNA fusion vaccine developed at Southampton. The vaccine encodes an immunostimulant sequence from tetanus linked to a sequence from prostate specific membrane antigen (PSMA27). PSMA is an attractive antigen as it is found in the vast majority of prostate cancers and its expression is increased after standard anti-androgen treatment. The study is also evaluating electroporation as a novel delivery strategy for DNA vaccines compared to DNA delivered without electroporation.

The study has completed recruitment of 30 patients and vaccination is ongoing at the third (highest) dose level. Monitoring of antibody responses has been completed for the 20 patients at the first and second dose levels to week 16. Monitoring of CD4 cellular immunity has been completed for the 10 patients at the lowest dose. These 10 patients have additionally been assessed for CD8 T-cell responses. Interim results to date include:

– Vaccination with and without electroporation has been safe and well tolerated.

– The tetanus sequence induced strong antibody responses and cellular immunity. The PSMA27 antigen induced CD8+ cytotoxic T-cells in a substantial number of the patients.

- 13 of 20 patients developed increases in anti-DOM (the immunostimulant sequence from tetanus) antibody by week 16 after three vaccinations. Of these increased responses, 4 of 10 were in the DNA arm; 9 of 10 were in the electroporation arm.
- In 9 of 10 patients in the low dose cohort, increases in CD4 responses were observed.
- 6 of 10 subjects in the low dose cohort developed PSMA27-specific CD8 responses not detected before vaccination.

– Antibody responses were generally higher in patients treated using electroporation compared to those treated with the DNA vaccine alone (without electroporation). The use of electroporation-based DNA delivery appears to also increase the level of anti-DOM CD4 responses.

“We are extremely pleased with these observations that our electroporation delivery technology is enhancing the level of antibody and T-cell responses from this novel DNA vaccine against prostate cancer,” said Avtar Dhillon, MD, president and CEO of Inovio. “Apart from assessing the safety and tolerability of electroporation, being able to also detect increased levels of immune response is one of the important outcomes that we are aiming to achieve with all of our five current clinical studies for DNA-based immunotherapies and DNA vaccines that are being advanced by our partners.”

The development of this DNA vaccine was supported by the UK cancer charities the Leukemia Research Fund and Cancer Research UK, and rights to the vaccine are owned by Cancer Research Technology Limited. The study was supported by Cancer Research UK funding, the Allan Willett Foundation, Inovio Biomedical Corporation, and the Experimental Cancer Medicine Centre in Southampton. The clinical study is a collaborative project between the University of Southampton/Southampton University Hospitals and the Institute of Cancer Research/Royal Marsden Hospital, Sutton, Surrey.

An abstract of the presentation (Abstract Number 2843) including CD8+ response data for the first three patients is now available at http://www.aacr.org. The presentation during the conference will include the data from the first ten patients referenced above.

About Inovio’s Immunotherapy Products

DNA-based immunotherapy products have the potential to by-pass inherent scientific obstacles of conventional vaccines that prevent their development for cancer and chronic infectious diseases such as HIV and hepatitis C. Pre-clinical and clinical data have indicated the potential ability of Inovio’s technologies to safely and effectively deliver and significantly enhance the potency of such immunotherapies.

Inovio’s DNA-based immunotherapy products consist of DNA plasmids and its electroporation-based intratumoral and intramuscular DNA delivery systems. A DNA plasmid is designed to express an antigen that can induce an immune response specific to a cancer or infectious disease-causing organism. The plasmid is synthetically created and readily manufactured using well-established bacterial fermentation and purification technology. After a plasmid is delivered into tumor or muscle cells, production of the antigen may then induce a preventive or therapeutic immune response against the targeted disease. Inovio’s advanced electroporation devices facilitate delivery and expression of such immunotherapies and have been shown in primate and human studies to safely and efficiently generate immune responses. Breast cancer, prostate cancer, melanoma, HIV and hepatitis C virus are among the current targets of therapies employing Inovio technology.

Inovio is poised to deliver advanced DNA-based immunotherapies, devices and know-how in this rapidly advancing field. The company is actively licensing its technology to pharmaceutical and biotechnology companies and supporting early stage clinical studies arising from its own research efforts or through academic collaborations.

About the University of Southampton

The University of Southampton is a leading UK teaching and research institution with a global reputation for leading-edge research and scholarship. It is one of the UK’s top 10 research universities, offering first-rate opportunities and facilities for study and research across a wide range of subjects in humanities, health, science and engineering. The University has over 22,000 students and 5000 staff. Its annual turnover is in the region of £325 million. http://www.soton.ac.uk

About Royal Marsden Hospital

The Royal Marsden Hospital was the first hospital in the world dedicated to cancer treatment and research into the causes of cancer. Today the hospital with its academic partner, The Institute of Cancer Research, forms the largest comprehensive cancer centre in Europe with over 40,000 patients from the UK and abroad seen each year. It provides inpatient, day care and outpatient services for all areas of cancer treatment.

About Cancer Research Technology

Cancer Research Technology Limited (CRT) is a specialist commercialization and development company, which aims to develop new discoveries in cancer research for the benefit of cancer patients. CRT works closely with leading international cancer scientists and their institutes to protect intellectual property arising from their research and to establish links with commercial partners. CRT facilitates the discovery, development and marketing of new cancer therapeutics, vaccines, diagnostics and enabling technologies. CRT is wholly owned by Cancer Research UK, the largest independent funder of cancer research in the world. Further information about CRT can be found at http://www.cancertechnology.com.

About Cancer Research UK

Together with its partners and supporters, Cancer Research UK’s vision is to beat cancer. The charity carries out world-class research to improve understanding of the disease and find out how to prevent, diagnose and treat different kinds of cancer. It ensures that its findings are used to improve the lives of all cancer patients. Cancer Research UK helps people to understand cancer, the progress that is being made and the choices each person can make. The charity works in partnership with others to achieve the greatest impact in the global fight against cancer. For further information about Cancer Research UK’s work or to find out how to support the charity, visit http://www.cancerresearchuk.org.

About Leukaemia Research

Leukaemia Research is the only national UK charity devoted exclusively to improving treatments, finding cures and learning how to prevent leukaemia, Hodgkin’s lymphoma and other lymphomas, myeloma and the related blood disorders. Leukaemia Research receives no government grants and urgently needs to raise over £100 million in the next five years to commit to new research. From basic laboratory research to clinical trials with patients, Leukaemia Research is committed to saving lives by funding high quality, carefully selected research throughout the UK. Further information, including patient information booklets, is available at http://www.lrf.org.uk.

Leukaemia Research currently supports 30 Specialist Programmes in which the groups undertake long-term intensive research into relevant areas of leukaemia and the related diseases, often working closely with diagnosis and treatment; more than 200 project grants, which provides short-term funding, usually two-three years, for work on a specific problem; 25 clinical fellowships for the training of outstanding junior doctors in both the treatment and research of leukaemia and more than 20 studentships, lectureships and senior fellowships.

About Inovio Biomedical Corporation

Inovio Biomedical (AMEX: INO)is focused on developing multiple DNA-based immunotherapies and DNA vaccines. Inovio is a leader in developing human applications of electroporation using brief, controlled electrical pulses to increase cellular uptake of a useful biopharmaceutical. Human data has shown that Inovio’s electroporation-based DNA delivery technology can significantly increase gene expression and immune responses from DNA vaccines. Immunotherapy partners include Merck, Wyeth, Vical, University of Southampton, Moffitt Cancer Center, the U.S. Army, National Cancer Institute, and International Aids Vaccine Initiative. Inovio’s technology is protected by an extensive patent portfolio covering in vivo electroporation. More information is available at http://www.inovio.com.

This press release contains certain forward-looking statements relating to our plans to develop our electroporation drug and gene delivery technology. Actual events or results may differ from our expectations as a result of a number of factors, including the uncertainties inherent in clinical trials and product development programs (including, but not limited to, the fact that pre-clinical results referenced in this release may not be indicative of results achievable from testing in humans and that results from one study may necessarily not be reflected or supported by the results of other similar studies), the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of Inovio’s technology as a delivery mechanism, the availability or potential availability of alternative therapies or treatments for the conditions targeted by Inovio or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that Inovio and its collaborators hope to develop, evaluation of potential opportunities, issues involving patents and whether they or licenses to them will provide Inovio with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether Inovio can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2006, our 10-Q for the nine months ended September 30, 2007,and other regulatory filings from time to time. There can be no assurance that any product in our product pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proved accurate.

Inovio Biomedical Corporation

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MedicalNewsToday.com

Research, led by a Virginia Tech chemist, may someday help natural-products chemists decrease by years the time it takes to develop certain types of medicinal drugs. The research by T. Daniel Crawford, associate professor of chemistry, involves computations of optical rotation angles on chiral non-superimposable molecules

Many chiral molecules are important for medical treatment for illnesses ranging from acid-reflux to cancer. The term “chiral” means that two mirror images of a molecule cannot be superimposed onto each other. In other words, some are “left-handed” and some are “right-handed.”

“Most drugs have this handedness property,” Crawford said, “and for many of these drugs, even though both hands can cause a reaction, it is a situation where one hand does a good thing and one does a bad thing.” He used thalidomide as an example. A mixture of both hands of the drug was used in the late 1950s and early 1960s to treat morning sickness in pregnant women. Later studies revealed that, while one of the two hands acted as the desired sedative, the other hand was found to cause significant birth defects. Thalidomide was never approved by the FDA in the United States and was eventually taken off the market in Europe.

For chemists, therefore, it is often vital to determine which hand of a molecule they are using. In other words, when you have a sample of a chiral molecule, how do you distinguish between the left and right hand?

This is where a technique called polarimetry comes in to play. By shooting plane-polarized light through a sample of one hand, the chiral molecule in question will rotate to a characteristic angle either clockwise or counterclockwise, and the two hands of a chiral molecule produce opposite rotations.

“So if we figure out the direction and rotation of the light or each hand, we have a frame of reference for determining whether we have the left or right hand of a molecule,” Crawford said.

The problem with this method is that synthesizing the two hands of chiral molecules is often extremely time consuming. “It can take anywhere from weeks to years,” Crawford said.

Crawford’s research applies the theory of quantum mechanics to devise computational methods in order to eliminate having to create a synthetic molecule. “The hope is that this will allow us to calculate things like optical rotation very accurately,” he said. “So when an organic chemist has a molecule and doesn’t know if it is left- or right-handed, we can calculate that directly on the computer.”

Crawford said the ultimate goal in his research is to be able to provide organic chemists with computational tools to determine the handedness of a particular molecule they are working with. He said that such tools could speed up the drug development process by years.

The research titled, The Current State of ‘Ab Initio’ Calculations of Optical Rotation and Electronic Circular Dichcoism Spectra, by Crawford and Mary C. Tam of Virginia Tech and Mica Abrams of the University of Central Arkansas, appeared as the cover article in the November 2007 Journal of Physical Chemistry A. Get the complete article at: http://pubs.acs.org/cgi-bin/article.cgi/jpcafh/2007/111/i48/html/jp075046u.html

About the College of Science

The College of Science at Virginia Tech gives students a comprehensive foundation in the scientific method. Outstanding faculty members teach courses and conduct research in biology, chemistry, economics, geosciences, mathematics, physics, psychology, and statistics. The college is dedicated to fostering a research intensive environment and offers programs in many cutting edge areas, including those in nanotechnology, biological sciences, information theory and science, and supports the university’s research initiatives through the Institute for Critical Technologies and Applied Sciences, and the Institute for Biomedical and Public Health Sciences. The College of Science also houses programs in intellectual property law and pre-medicine.

Virginia Tech (Virginia Polytechnic Institute and State University)
Room 1, Media Bldg. (0109)
Blacksburg, VA 24061
United States
http://www.vt.edu

Carnegie Mellon University’s Nadine Aubry and colleague Pushpendra Singh of the New Jersey Institute of Technology (NJIT) are leading a research team to develop a manufacturing strategy that could improve technologies used in tissue engineering and information technology.

Aubry, head of Carnegie Mellon’s Mechanical Engineering Department, and Singh, an engineering professor at NJIT, have developed a new way of herding nano/micro-particles into highly ordered two-dimensional lattices (monolayers) with adjustable spacing between the particles.

The team’s research, reported last month in the Proceedings of the National Academy of Sciences USA journal (http://.pnas.org/egi/content/full/105/10/3695), shows how the use of electric fields and fluid- fluid interfaces can be judiciously used to develop new materials with special properties to increase the efficiency of drug delivery patches, solar cells and the next generation of high-performance computing.

“This new manufacturing strategy could revolutionize the way we design two-dimensional nanomaterials with adaptable microscopic structures and desired properties,” said Aubry, who was recently named a fellow of the American Association for the Advancement of Science (AAAS) for her outstanding contributions to the field of fluid dynamics.

The research team found they could control the particle distribution, particularly uncharged particles, at a fluid-fluid interface by applying an electric field. Without an electric field, particles self assemble. But they self assemble under capillary action, which make particles attract one another at the free-surface of a liquid. This is the same action we experience when our cereal flakes regroup at the surface of a bowl of milk.

This self-assembly via capillary action has serious flaws. Some of those flaws include an inability to manipulate small-sized particles and adjust the porosity of the resulting material. There are also inherent defects in the particle patterns.

“What is fascinating, is that the presence of an electric field can remedy all these deficiencies,” Aubry said. “The key is that when we apply the electric field, we can expand or shrink the lattice, and we can do it dynamically. The explanation is all in the subtle interplay between the forces - both electrostatic and hydrodynamic - acting on the particles.”

The research team shows that their new technique creates forces capable of assembling micron-sized particles and theoretically predicts that the method should apply to nanoparticles as well.

“We are extremely excited about the new self-assembly method because it offers flexibility, precision and simplicity,” Aubry said.

Researchers have developed a new method for presenting clinical trial survival data that includes data from all trial participants unlike the standard method, according to a commentary published online January 8 in the Journal of the National Cancer Institute.

In clinical studies, “time-to-event” data represents the time from the start of a study to an event, such as disease recurrence or death. But often many participants in a study do not experience an event before the study is over, so their survival time is not known. To overcome this data gap, the standard statistical method for presenting time-to-event results, known as the Kaplan-Meier survival curve, involves plotting the proportion of individuals surviving without an event over the period of the study. Using this method, researchers get an estimate of the median survival times. However, these plots also tend to make differences in survival between groups visually appear larger than they actually are.

To address this problem, Patrick Royston, D.Sc., of the Medical Research Council Clinical Trials Unit in London and colleagues developed a new method for plotting survival as a bar graph and tested it on data from a kidney cancer trial. In cases where a participant had not experienced an event, the researchers estimated that person’s survival by using their prognosis and length of time in the trial.

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Medicalnewstoday.com

Computer analysis of existing drugs may be key to fighting new infectious agents and antibiotic-resistant pathogens like deadly tuberculosis strains and staph ’superbugs.’ Researchers in Canada say the use of such “emergency discovery” technology could save time, money and lives during a sudden outbreak or a bioterrorism attack. They reported at the 234th national meeting of the American Chemical Society.

Drug ‘repurposing’ or ‘reprofiling’ is not new: Pharmaceutical companies have been seeking new uses of old drugs to extend patent protections and whenever new, off-label uses of the drugs are found. But reprofiling to deliberately develop emergency drugs is a new concept, made possible by advances in chemoinformatics, a new field that merges chemistry with computer science, according to study presenter Artem Cherkasov, Ph.D., of the University of British Columbia in Vancouver, Canada.

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Medicalnewstoday.com

Older patients and people taking multiple medications are set to benefit from better packaging of their medicines by pharmacists.

The Commonwealth Government has provided up to $72.9 million to the Pharmacy Guild of Australia through the Fourth Pharmacy Agreement for the Dose Administration Aids program.

The program provides support to community pharmacists to help patients manage their medication by packaging it into individual doses that are arranged according to the dose schedule throughout the day. The packaging can be either a unit-dose pack (one single type of medication per compartment) or a multi-dose pack (different types of medication per compartment).

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Medicalnewstoday.com

The National Community Pharmacists Association (NCPA), the American Pharmacists Association (APhA), the National Alliance of State Pharmacy Associations (NASPA) and Mirixa Corporation announced the beta launch of http://www.RxWiki.com, the first Web 2.0 medication therapy management encyclopedia for consumers, written and edited by pharmacists. RxWiki is a free website publishing pharmaceutical, over-the-counter, and nutraceutical medication information. RxWiki also serves as a community network for pharmacists to create and share information for their patients and consumers at large, and to collaborate in the advancement of Medication Therapy Management (MTM).

“Today, 34% of all US online consumers use Wikipedia, and 7% of US online consumers with medical conditions used peer-edited health information in the past 12 months. The mission of RxWiki is to become the Web’s most trusted source of medication information,” said NCPA Executive Vice President and CEO Bruce Roberts. “NCPA, APhA and NASPA all believe our member pharmacists will gain tremendous professional satisfaction from contributing to this new medium knowing it will be one more way they improve consumers’ use of medications.”

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Medicalnewstoday.com

Healthcare organizations involved in the manufacturing, distribution and dispensing of pharmaceutical products came together to announce the creation of RxResponse, - a program designed to help support the continued delivery of medicines during a severe public health emergency. The partnership includes the American Hospital Association, American Red Cross, Biotechnology Industry Organization, Healthcare Distribution Management Association, National Association of Chain Drug Stores, National Community Pharmacists Association and the Pharmaceutical Research and Manufacturers of America.

“During a disaster, it is vital that systems are in place to assist with the continued delivery of medicines to hospitals, healthcare providers and patients in need,” said Billy Tauzin, president and CEO, Pharmaceutical Research and Manufacturers of America (PhRMA). “Rx Response is a partnership dedicated to assist with the delivery of critical medicines to patients whose health is threatened during a crisis.”

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Medicalnewstoday.com

IBM on Thursday launched an electronic “pedigree” system that will help fight prescription drug counterfeiting using radio-frequency identification tags, the AP/Houston Chronicle reports. The ePedigree system allows drug companies to create electronic certificates of authenticity for drugs and track them through the supply chain and into the hands of consumers. The tags also will keep track of expiration dates, batch numbers to be used in case of a recall and other information.

Chris Clauss, IBM Software’s director of sensor information management, said the RFID tags are not a guarantee against counterfeiting, but they will “raise the bar” and make such activity more difficult. A California law scheduled to take effect in 2009 will mandate that any drug distributed in the state has its pedigree attached, according to the AP/Chronicle. Past attempts to combat fake drugs — including holograms and watermarks — often were illegally “reproduced within months, to the point where brand managers could not tell the difference between the counterfeit and the real thing,” the AP/Chronicle reports (Ortutay, AP/Houston Chronicle, 8/9).

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Medicalnewstoday.com

Manhattan Research, a healthcare market research services firm, today announced the leading pharmaceutical product website destinations for physicians from its new physician research study, “ePharma Physician(R) v7.0: The Future of Professional eMarketing.”

Top 10 Pharma Product Websites Among Physicians in 2007 Ranked by Number of U.S. Primary Care Physician Visitors

1. Januvia

2. Singulair

3. Advair

4. Chantix

5. Adderall XR

6. Byetta

7. Gardasil

8. Vytorin

9. Avandia

10. Concerta

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Medicalnewstoday.com

CENiMED GmbH, BioTeZ Berlin-Buch GmbH and Invitek Gesellschaft für Biotechnik & Biodesign mbH (company for biotechnology and bio-design) announce their cooperation in the development, production and marketing of Recovery-ELISAs for therapy control of a new group of therapeutics, the so called humanised antibodies.

Humanised antibodies offer unforeseen potentialities in cancer therapy, e. g. for the treatment of mamma carcinoma. Previous therapy control methods, however, could not avoid overdoses which had caused adverse reactions with the patients. Recovery-ELISA (R-ELISA) is an innovative, patented ELISA technique for the determination of the exact efficacy concentration of the therapeutic antibodies and the therapy control. The automation of this technique will be established by a renowned platform manufacturer and then will be made available for the patients and the pharmaceutical industry.

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Medicalnewstoday.com

Anticipating the need for patient-friendly technologies that can deliver therapeutic doses of prescribed drugs with minimal reliance on the patient, drug developers continue to explore noninvasive routes of administration. Delivering drugs through the skin - transdermal delivery - possesses several attractive attributes, but as work with passive transdermal patches has progressed, so too has the realization of the true extent of the barrier to drug delivery presented by the stratum corneum, the skin’s outer layer of dead, hydrophobic, keratinized cells. By using a variety of energy and mechanical approaches, active transdermal delivery expands the potential for delivering drugs noninvasively by actively transporting the drug across and through the skin.

Led by established technology companies including Alza/J&J, Becton Dickinson, and 3M, combination microporation drug delivery products will dominate the active transdermal sector for the next three years, representing almost two-thirds of the market in 2009. Other important active transdermal segments include iontophoresis and heat-assisted transdermal products. Products based on electroporation, ultrasound and lasers will also compete for market share.

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Medicalnewstoday.com

In her Brown University laboratory, Edith Mathiowitz makes tiny particles coated in polymers. These microcapsules, some as small as the point of a pin, can carry medicines, genes, paints, pesticides — any molecule that needs protection or controlled release.

Mathiowitz developed her technique as a drug delivery system, but her microcapsules are now being put to a very different use — to make ink for the first permanent removable tattoo. Under a new intellectual property licensing agreement signed by Brown University and Freedom-2 Holdings Inc., the company has the right to make and sell their ink based on research Freedom-2 has funded in the Mathiowitz lab.

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Medicalnewstoday.com

The Wall Street Journal on Wednesday examined prescription drug data mining, a process by which sophisticated software enables health officials to search through large databases looking for possible drug dangers. Data mining software allows health authorities to identify “rare side effects that didn’t show up in clinical trials,” the Journal reports. However, “it can also raise false alarms and force regulators to divert time and money from more pressing dangers,” according to the Journal.

The Journal profiled the experience of World Health Organization Drug Monitoring Center Director Ralph Edwards. Edwards and his team in the mid-1990s developed software to mine drug data, and national drug agencies, including FDA, in 2002 allowed the center to publish and share data mining findings without permission. Edwards, who receives about 200,000 adverse-event reports and identifies about 60 serious signals annually, last year discovered a possible link between cholesterol-lowering statins and amyotrophic lateral sclerosis, or Lou Gehrig’s disease.

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“Resources on Youth Reproduce Health and HIV/AIDS,” Interagency Youth Working Group: The new Web site provides resources aimed at people working with youth in developing countries on HIV/AIDS and reproductive health issues. The site includes guidance on program areas and best practices; publications; a database of more than 900 recent resources; research tools; training materials; and links to other youth Web sites. More than 15 organizations worked together to create the Web site (IYWG release, 6/29).

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Mobile healthcare specialist iPLATO has developed a new text messaging service which provides Britons travelling abroad with free travel health information regarding malaria. The service, funded by GlaxoSmithKline Travel Health as part of the Malaria Awareness Campaign, allows travellers to text in the name of their destination country to receive relevant information about the malaria prevalence in that country.

Despite the fact that malaria is a preventable disease every year approximately 2,000 British travellers return home with malaria, making the UK one of the biggest importers of malaria among industrialised countries. It is hoped that by making it easier for travellers to access important health advice via their mobile phone that this number will be reduced. The service is designed so that once a traveller has been informed about the level of malaria risk at their destination they will be encouraged to contact a healthcare professional for expert advice on protection. Travellers using the service are charged their standard operator rates and the service is available over all networks.

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Metabolon, Inc., the leader in metabolomics solutions for drug development and the discovery of new diagnostic markers today announced the launch of mVision, an integrated service providing the biomarker discovery, biochemical pathway analysis, and biological effect intelligence needed by scientists to confidently and effectively advance their research programs.

Based on Metabolon’s advanced analytic and informatics platforms, mVision is designed to identify biochemical biomarkers from numerous chemical classes and various sample matrices including: plasma, serum, urine, cerebrospinal fluid (CSF), cell extracts, and tissues. mVision’s unbiased and non-targeted approach to biomarker discovery allows scientists to observe drug- or disease- induced biochemical changes over virtually the entire spectrum of biochemical pathways. This global screening can be accomplished without hypotheses of the biologic or biochemical effects of disease or the investigational drug.

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To develop selective measurement techniques for diagnostics, drug research, and the detection of poisons, researchers would like to combine the high specificity of biochemical reactors with universal microelectronics. Now, researchers at the Max Planck Institute for Biochemistry in Martinsried/Munich have shown that such bioelectronic hybrid systems are no longer just a utopian vision. In the journal Angewandte Chemie, they describe the coupling of a receptor to a silicon chip by means of a cell-transistor interface.

Many receptors are coupled to ion channels within cell membranes. When the corresponding ligand binds to its receptor, the channel is opened, allowing ions to stream into the cell. With a few tiny electrodes (the patch-clamp technique), this stream of ions can be measured; however, this technique destroys the cell. A team headed by Peter Fromherz has now proven that things can be different. Their novel, noninvasive sensor involves coupling of the ion stream directly to a microelectronic device by means of a direct cell-chip contact.

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