News for Africa Doc

November 28, 2007 - WAYNE, PA - The Center for Professional Innovation &Education (CfPIE) is pleased to announce a new training program geared towards professionals involved with Pharmaceutical, Medical Device and Biotech Marketing and Advertising initiatives. The course, Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices is scheduled for January 14 &15, 2007 at The Desmond Hotel &Conference Center in Malvern, PA. This two-day program will give participants a comprehensive overview of the regulatory requirements binding Pharmaceutical and Medical Device marketers and insights on how to develop and maintain a successful marketing/advertising plan. Participants will also gain valuable perspective on how regulators and the courts view compliance and the issues inherent with staying compliant. “The compliance issues surrounding marketing and advertising of products in the life sciences are many, and the regulations continue to change and evolve.” said Bill Beyer, Director of Marketing for CfPIE. “By drawing on the experience of industry experts and those most closely connected with these issues, we have been able to develop a thorough, practical curriculum which will help Marketing and Regulatory personnel face even the toughest compliance strategies.” This course will be of benefit to anyone involved in Marketing, Advertising, Regulatory Affairs or those that need or want insight into the regulations and best practices for compliance. More information about this program or other CfPIE courses can be found by calling +1-610-765-1128, emailing info@cfpie.com or visiting www.cfpie.com. About CfPIE: CfPIE currently offers over 250 public courses in Malvern, PA, Costa Mesa, CA, Dublin, Ireland and Berlin, Germany each year and another 250 customized client-site programs annually. For personnel looking for professional advancement as well as technical/regulatory training, CfPIE offers convenient delivery options for the following course types: ? Pharmaceutical Training ? Medical Device Training ? Skin/Cosmetic Product Training ? Biotech Training Course topics include all regulatory, technical and compliance issues from product discovery, development, manufacturing and clinical trial concerns through post-approval challenges. CfPIE has been the preferred training partner for most of the top 100 life science firms globally and a critical component to personnel development efforts of smaller organizations and start-up companies. Press Inquiries: Morgan Litsky Marketing Coordinator The Center for Professional Innovation &Education 992 Old Eagle School Road, Suite 913 Wayne, PA 19087 Phone: 1-610-688-1708 Fax: 1-610-688-7817 Email: mlitsky@cfpie.com Web: www.cfpie.com

MTS Cryo Stores are an accredited off-site sample storage facility, with eight years history. Initially running under the banner of, ‘Cool Repair UK’, storing clinical specimens for universities, government departments and biotechnology and pharmaceutical facilities. MTS Cryo Stores is an original European company based in the heart of the UK, with an enthusiastic team making them a popular choice for bio-banking services. We hold the capacity to store your important archived samples in our two million sample storage facility at temperatures ranging from ambient to -150°C in mechanical refrigeration units; -196°C is also available with liquid nitrogen (LN2) storage. HTA licence 22499. BIO BANKING – CLINICAL SAMPLE BIOSTORAGE SERVICES We understand the limitations of storage space required to centralise your study specimens. Utilising off-site sample storage increases your laboratory workspace and the security of your samples for both temperature and access, enabling you to make more productive use of your valuable resources. By reducing the amount of freezers you reduce the risk of equipment failure and the associated costs. This service is also for the smaller user who just wants to secure their research and not lose samples due to equipment failure. To address this need, we offer the option of a comprehensive specimen storage management service at our facility with ItemTracker®, our sample tracking software developed to solve the challenges associated with specimen management, so in simple terms we know where and what your samples are. SAMPLE STORAGE REPOSITORY Our cGMP compliant repository for samples is designed to provide you with peace of mind by offering: High-security environment including access control system, motion detectors, smoke detectors, and CCTV surveillance Guaranteed temperature integrity with continuous monitoring by both electronic and paper chart recording Full emergency back up including power generators and storage units and optional liquid carbon dioxide back up systems A dedicated team of staff to ensure immediate response and remediation in emergency situations On-site workshop and technicians who proactively monitor equipment to provide preventive maintenance and rapid repair if necessary (most other sites, even the UK’s largest, rely on callout engineers) Full disaster recovery / business continuation planning with provision for dividing and storing critical core samples 'DISASTER RECOVERY' STORAGE MTS recognise the need for disaster recovery plans in the unfortunate event of a potential loss of samples.  We can now accommodate this as part of our client's contingency planning at MTS, as we have created this as an additional service disaster recovery contract with emergency couriers who can arrive at site with the right packaging and sufficient dry ice to pack all samples. This arrangement provides peace of mind for your critical materials and could also help reduce insurance premiums. MTS Cryo Stores provide at their site a cGMP compliant validation package for various temperature requirements, provided by using temperature controlled-cabinets. We offer storage capacity from a single shelf to a full storage cabinet throughout our range of storage temperatures. We supply the standard validation required for this industry or validation to your requirements utilising the latest technology.

IDBS have announced that the School of Pharmacy at The University of Nottingham (UK) has selected E-WorkBook to meet its data management requirements. The School of Pharmacy sought a solution that could meet three distinct requirements - adherence to good governance procedures, IP protection and visibility, and effective management of research activities. The University of Nottingham's School of Pharmacy is one of the world's highest ranking schools of pharmacy and has continued to significantly enhance the development of new medicines. The School is recognised for its forward thinking approach and has received a ranking of 'international excellence' for its research activities. E-WorkBook provides an efficient solution that will enable up to 300 researchers and managers within the School of Pharmacy to find and protect valuable IP assets, effectively manage all of the school's research activities, whilst also adhering to the highest standards of research governance. Professor Saul Tendler, Head of School, said: “I am really delighted to be working with IDBS on this exciting project. The E-WorkBook will help and support the school in maintaining its position as one of the world's leading Pharmacy Schools. Neil Kipling, founder and CEO of IDBS commented: “Universities are playing an increasingly important role in promoting global access to essential medicines and are a major contributor to health-related innovations. We are pleased to welcome the School of Pharmacy, University of Nottingham to our growing customer base. Following a rigorous tender process, IDBS was selected as the vendor of choice and we are very proud to be working with a leading school of pharmacy to help them become more responsive to the scientific landscape.”

IDBS have announced that the School of Pharmacy at The University of Nottingham (UK) has selected E-WorkBook to meet its data management requirements. The School of Pharmacy sought a solution that could meet three distinct requirements - adherence to good governance procedures, IP protection and visibility, and effective management of research activities. The University of Nottingham's School of Pharmacy is one of the world's highest ranking schools of pharmacy and has continued to significantly enhance the development of new medicines. The School is recognised for its forward thinking approach and has received a ranking of “international excellence” for its research activities. E-WorkBook provides an efficient solution that will enable up to 300 researchers and managers within the School of Pharmacy to find and protect valuable IP assets, effectively manage all of the School's research activities, whilst also adhering to the highest standards of research governance. Professor Saul Tendler, Head of School, said “I am really delighted to be working with IDBS on this exciting project. The E-WorkBook will help and support the School in maintaining its position as one of the world's leading Pharmacy Schools. Neil Kipling, founder and CEO of IDBS commented, “Universities are playing an increasingly important role in promoting global access to essential medicines and are a major contributor to health-related innovations. We are pleased to welcome the School of Pharmacy, University of Nottingham to our growing customer base. Following a rigorous tender process, IDBS was selected as the vendor of choice and we are very proud to be working with a leading school of pharmacy to help them become more responsive to the scientific landscape.”

INC Research, a therapeutically-focused contract research organization (CRO) with a process for delivering reliable results, today announced that David Subich, MD has been named the senior director, Clinical Operations for Metabolic and Endocrine diseases. Based in Raleigh, he will be overseeing existing related trials currently being conducted and developing comprehensive services for this growing therapeutic area. Dr. Subich has 23 years of experience as an attending physician specialising in internal medicine with a focus on metabolic and endocrine diseases. His rich background includes starting his own practice group, North Central Ohio Clinic, serving as a hospitalist, and a role as medical director covering several area nursing homes. Since 1991, Dr. Subich was the principal investigator on more than 50 clinical trials, where he was responsible for staff and study oversight, patient exams and Good Clinical Practices (GCP) at the research site. He also served as an associate professor for clinical rotations for The Ohio State University School of Medicine where he was recognized for his teaching excellence. He has frequently presented on scientific and educational panels on a range of treatment, practice and clinical issues related to metabolic and endocrine diseases. Dr. Subich was trained at The Cleveland Clinic Foundation after an internship at Baylor College of Medicine in Houston. He received his medical degree from The Medical College of Ohio. “Dr. Subich has a unique combination of research experience and hands-on medical practice in a variety of environments. He has witnessed the rise of metabolic diseases as a physician and understands the benefits of developing safe and effective drugs to treat patients,” said John Potthoff, COO of INC Research. “Our trusted process methodology gives us the framework to efficiently expand into new therapeutic areas as drug development trends emerge. We are thrilled Dr. Subich has joined our team to establish our Metabolic and Endocrine division.” “Diabetes and obesity are among the more prevalent metabolic disorders, and we are seeing those greatly increase on a global basis,” said Dr. Subich. “I am excited to leverage the knowledge inside of INC Research to build a world-class team to address the unmet clinical needs for pharmaceutical and biotech companies, exploring current and future targets for metabolic and endocrine diseases.”

BIOQUELL's 'proactive' hydrogen peroxide vapour (HPV) decontamination service has been chosen to be one of only six technologies to be placed in seven NHS showcase hospitals. The HCAI technology innovation programme is a new initiative set up by the DoH to develop, promote and press forward new technologies into our hospitals that have the potential to make a real difference in the battle against HCAI's. BIOQUELL's experience in providing high level decontamination equipment and services has been rewarded with a DoH led contract that will see the patented Clarus(R) technology used as a proactive service within seven designated showcase hospitals over a four month trial period. Matthew Parks, head of room bio-decontamination services at the Hampshire based company commented, "We are confident that the proactive service will prove to be a great success, just as they have been in similar deployments throughout the UK, Europe and America. We look forward to reviewing and promoting the results, with a goal to be working alongside all British hospitals in the near future". BIOQUELL's unique decontamination technology is supported by robust scientific data and is the only technology of its kind to be awarded category One status by the DoH's expert rapid review panel. An article published online in July of this year (Boyce et al - Infection Control and Hospital Epidemiology 2008, in press.) proved a reduction in the acquisition of C. difficile infections whilst being operated within a busy healthcare setting. Benefits of BIOQUELL's HPV technology include: Safe to use with all sensitive electrical and electronic equipment An active distribution of penetrates into difficult to reach areas ensuring uniform bio-decontamination Proven biological efficacy against a wide range of nosocomial pathogens including methicillin-resistant Staphylococcus aureus (MRSA), Clostridium difficile, vancomycin-resistant enterococci (VRE) and Acinetobacter baumannii The process is rapid ensuring minimum disruption to any room, ward or facility. For example, a single side room can be decontaminated in less than two hours, an entire ward can be decontaminated in 12 hours. All adjacent areas can operate as normal during the procedure

In its continuous effort to strengthen ties with institutions devoted to research in translational medicine, HealthTwiSt has moved its offices to the prestigious biotech research campus, Berlin-Buch. Located in the northeast corner of Berlin, the campus combines basic research in molecular biology and genetics with clinical research so that the latest medical discoveries can be brought to the bedside as quickly as possible. As Dr. Busjahn stated; 'Being located in the very same building as the Experimental and Clinical Research Center clearly improves our ability to serve our customers and deliver clinical data and samples most sufficiently'. Among the most prominent new neighbours are the Max Delbrück Center for molecular medicine (MDC), the Leibniz-Institute for molecular pharmacology (FMP) and the Charité University Medicine Berlin. Beside those research institutions, around 30 biotech enterprises with more than 500 employees are situated on the Berlin-Buch Campus. The expertise and services they offer range from the development of bio-diagnostics and vectors for gene therapy to peptide synthesis, protein analysis, cell and tissue grafts, bioinformatics and genetics.

FiT is the leading homegrown regional freight logistics group, with offices and representation throughout Eastern Africa (Kenya, Tanzania, Uganda, Rwanda, Burundi, and South Sudan) and a worldwide network of leading international freight logistics partners. Blending our local experience and our global network, we use modern infrastructure and facilities to provide customers with unique solutions to all their logistic needs. FiT is an ISO 9001: 2000 certified company. Key features of Freight-In-Time Group include: Over 100 employees in five countries 15 facilities totaling over 4,500m² Third highest ranked air freight forwarder in East Africa GSA for over five airlines Market leader in project logistics GLOBAL TRANSPORTATION FREIGHT As East Africa's leading providers of incoming and outgoing airfreight services, handling over 10,000 shipments and over 15,000 tons annually, FiT can manage the movement of a single shipment or a complex freight management program. These products and services include: FiT provides services in the following areas: Air freight Sea freight Road transport Inter-regional co-ordination FiT express Customs brokerage GSAs and charters Project management Key products FiT handle both regionally and internationally include: Perishables Manufacturing goods Electronic and IT products Textiles Motor industry Airlines Diplomatic services Distribution of relief goods, NGO and AID products REGIONAL PLANNING AND PROJECT CARGO Our scope of work is not only limited to freight, but also includes warehousing, pick and pack and regional distribution. With an increasing focus on investment within Africa, in particular in, or through East Africa, FiT is getting more and more involved with the planning and movement of project cargo through the region. ARV DRUG DISTRIBUTION AND PEPFAR PROJECT FiT are the authorised service providers for UPS-SCS (supply chain solutions) with whom we actively participate in the US government funded PEPFAR (Presidential Emergency Plan For Aids Relief) project for the distribution of ARV Drugs within Africa. In addition, FiT is also actively participating in the regional distribution of other US government funded projects, through USAID, such as avian flu, influenza and malaria prevention programs. Within the IT industry, FiT have launched a similar initiative for the re-distribution of IT equipment and accessories within the region. Discussions are currently ongoing with both Hewlett Packard and Dell (the two leading global IT manufacturers) for proposals of a regional distribution solution. CHINA DEVELOPMENT FiT have a dedicated Chinese speaking route development manager situated in China with the sole purpose of marketing and developing traffic with China, acting as the link between the East African region and the Far East. We are able to source for goods and supplies from China, negotiate favourable prices and follow up with suppliers for quality and delivery time. FiT offer unrivaled sea and air freight rates from China and south east Asia, to East Africa. We are also involved in Bi-annual trips we organize to the Canton Fair, which is the largest Chinese commodity export trade fair. Our partner UPS-SCS have offices located in all the major towns in China, thus allowing for one point of contact anywhere within the country. GSA EXPERTISE Freight-In-Time Group has also represented various airlines in a GSA capacity, particularly in those regions where an airline's cargo uplift capacity / flight frequency does not justify its own offices. Areas we have had (or currently provide) GSA services include Nairobi, Kilimanjaro, Mombasa, Zanzibar, Mwanza, Entebbe and Dar es Salaam. FiT is a member of EGSAC (European General Sales Agents Cargo Ltd), that is a consortium of independent GSA companies which are leaders in their own market. EGSAC membership is a growing network of highly-professional, well-established, proudly-independent cargo companies that provide airlines with representation of the highest calibre with over 30 members, covering over 35 countries in, over 60 locations world wide. Coverage is available selectively station-by-station, country-by-country, or system wide through a single point of contact.

Procool are temperature controlling specialists; they aim to include everything you need, from initial concept right through installation, to commissioning of a fully working air cooling system and beyond. TEMPERATURE CONTROL SYSTEMS All of our air cooling system designs are fully illustrated so that you know exactly what to expect, and our service includes all installation works; both mechanical and electrical. We understand that your production schedule cannot be disrupted, so manage our projects and train our installation teams with that in mind. The key stages in our process are: Design and installation Initial survey Design and proposal Design development Installation Commissioning Document issue Maintenance TEMPERATURE CONTROLLING PRODUCTS Pharmacool is a unique range of temperature controlling products designed specifically to meet the needs of the pharmaceutical distribution industry. Based on a very clear understanding of the MHRA recommendations for the storage of drugs at controlled room temperature, Pharmacool is the only solution on the market that comes with a full compliance guarantee, giving you complete piece of mind. Each Pharmacool system is designed to suit the nature of your individual building, but all offer the same guarantee, low-cost installation and low operating costs. SMALL BUILDING AIR COOLING SYSTEMS Ideally suited to smaller distribution warehouses, or on site pharmacy stores, our Pharmacool Bronze temperature control system features fully automatic control, free cooling, and hassle free low-maintenance operation. WAREHOUSE TEMERATURE CONTROL SYSTEMS Great in medium sized warehouses, or larger premises that already have a monitoring and mapping system in place, Pharmacool Silver adds centralized electronic controls, with fail-safe manual overrides, to the more basic Pharmacool Bronze. LARGE WAREHOUSE AIR COOLING SYSTEMS Combining centralised electronic controls with sophisticated wireless temperature monitoring and reporting software, the Pharmacool Gold solution is ideal for large warehouses. In large spaces, considerable time can be saved through automatic monitoring of the MKT and absolute temperatures in order to demonstrate compliance. Integrating the temperature monitoring and control systems with each other avoids duplicated hardware, allowing the cooling system to respond to the actual parameters required for compliance, and reduces maintenance costs. COMPLETE ENVIRONMENTAL CONTROL SYSTEMS Both air cooling systems Pharmacool Silver and the Pharmacool Gold can be extended to provide complete automatic control of all your environmental systems, whether existing or new. This can include cooling, ventilation, heating, economiser fans, door curtains and cold room systems. Pharmacool Gold offers fully integrated centralised control and monitoring, with more consistent temperatures throughout the year and reduced energy bills.

Procool are temperature controlling specialists; they aim to include everything you need, from initial concept right through installation, to commissioning of a fully working air cooling system and beyond. TEMPERATURE CONTROL SYSTEMS All of our air cooling system designs are fully illustrated so that you know exactly what to expect, and our service includes all installation works; both mechanical and electrical. We understand that your production schedule cannot be disrupted, so manage our projects and train our installation teams with that in mind. The key stages in our process are: Design and installation Initial survey Design and proposal Design development Installation Commissioning Document issue Maintenance TEMPERATURE CONTROLLING PRODUCTS Pharmacool is a unique range of temperature controlling products designed specifically to meet the needs of the pharmaceutical distribution industry. Based on a very clear understanding of the MHRA recommendations for the storage of drugs at controlled room temperature, Pharmacool is the only solution on the market that comes with a full compliance guarantee, giving you complete piece of mind. Each Pharmacool system is designed to suit the nature of your individual building, but all offer the same guarantee, low-cost installation and low operating costs. SMALL BUILDING AIR COOLING SYSTEMS Ideally suited to smaller distribution warehouses, or on site pharmacy stores, our Pharmacool Bronze temperature control system features fully automatic control, free cooling, and hassle free low-maintenance operation. WAREHOUSE TEMERATURE CONTROL SYSTEMS Great in medium sized warehouses, or larger premises that already have a monitoring and mapping system in place, Pharmacool Silver adds centralized electronic controls, with fail-safe manual overrides, to the more basic Pharmacool Bronze. LARGE WAREHOUSE AIR COOLING SYSTEMS Combining centralised electronic controls with sophisticated wireless temperature monitoring and reporting software, the Pharmacool Gold solution is ideal for large warehouses. In large spaces, considerable time can be saved through automatic monitoring of the MKT and absolute temperatures in order to demonstrate compliance. Integrating the temperature monitoring and control systems with each other avoids duplicated hardware, allowing the cooling system to respond to the actual parameters required for compliance, and reduces maintenance costs. COMPLETE ENVIRONMENTAL CONTROL SYSTEMS Both air cooling systems Pharmacool Silver and the Pharmacool Gold can be extended to provide complete automatic control of all your environmental systems, whether existing or new. This can include cooling, ventilation, heating, economiser fans, door curtains and cold room systems. Pharmacool Gold offers fully integrated centralised control and monitoring, with more consistent temperatures throughout the year and reduced energy bills.

FiT is the leading homegrown regional freight logistics group, with offices and representation throughout Eastern Africa (Kenya, Tanzania, Uganda, Rwanda, Burundi, and South Sudan) and a worldwide network of leading international freight logistics partners. Blending our local experience and our global network, we use modern infrastructure and facilities to provide customers with unique solutions to all their logistic needs. FiT is an ISO 9001: 2000 certified company. Key features of Freight-In-Time Group include: Over 100 employees in five countries 15 facilities totaling over 4,500m² Third highest ranked air freight forwarder in East Africa GSA for over five airlines Market leader in project logistics GLOBAL TRANSPORTATION FREIGHT As East Africa's leading providers of incoming and outgoing airfreight services, handling over 10,000 shipments and over 15,000 tons annually, FiT can manage the movement of a single shipment or a complex freight management program. These products and services include: FiT provides services in the following areas: Air freight Sea freight Road transport Inter-regional co-ordination FiT express Customs brokerage GSAs and charters Project management Key products FiT handle both regionally and internationally include: Perishables Manufacturing goods Electronic and IT products Textiles Motor industry Airlines Diplomatic services Distribution of relief goods, NGO and AID products REGIONAL PLANNING AND PROJECT CARGO Our scope of work is not only limited to freight, but also includes warehousing, pick and pack and regional distribution. With an increasing focus on investment within Africa, in particular in, or through East Africa, FiT is getting more and more involved with the planning and movement of project cargo through the region. ARV DRUG DISTRIBUTION AND PEPFAR PROJECT FiT are the authorised service providers for UPS-SCS (supply chain solutions) with whom we actively participate in the US government funded PEPFAR (Presidential Emergency Plan For Aids Relief) project for the distribution of ARV Drugs within Africa. In addition, FiT is also actively participating in the regional distribution of other US government funded projects, through USAID, such as avian flu, influenza and malaria prevention programs. Within the IT industry, FiT have launched a similar initiative for the re-distribution of IT equipment and accessories within the region. Discussions are currently ongoing with both Hewlett Packard and Dell (the two leading global IT manufacturers) for proposals of a regional distribution solution. CHINA DEVELOPMENT FiT have a dedicated Chinese speaking route development manager situated in China with the sole purpose of marketing and developing traffic with China, acting as the link between the East African region and the Far East. We are able to source for goods and supplies from China, negotiate favourable prices and follow up with suppliers for quality and delivery time. FiT offer unrivaled sea and air freight rates from China and south east Asia, to East Africa. We are also involved in Bi-annual trips we organize to the Canton Fair, which is the largest Chinese commodity export trade fair. Our partner UPS-SCS have offices located in all the major towns in China, thus allowing for one point of contact anywhere within the country. GSA EXPERTISE Freight-In-Time Group has also represented various airlines in a GSA capacity, particularly in those regions where an airline's cargo uplift capacity / flight frequency does not justify its own offices. Areas we have had (or currently provide) GSA services include Nairobi, Kilimanjaro, Mombasa, Zanzibar, Mwanza, Entebbe and Dar es Salaam. FiT is a member of EGSAC (European General Sales Agents Cargo Ltd), that is a consortium of independent GSA companies which are leaders in their own market. EGSAC membership is a growing network of highly-professional, well-established, proudly-independent cargo companies that provide airlines with representation of the highest calibre with over 30 members, covering over 35 countries in, over 60 locations world wide. Coverage is available selectively station-by-station, country-by-country, or system wide through a single point of contact.

RAD001 (everolimus) is a macrolide antibiotic derived from rapamycin that is being investigated by Novartis as a potential treatment for various solid tumours, including advanced kidney cancer. "Novartis hopes to submit an NDA in 2008 for the use of RAD001 as a treatment for metastatic renal cell carcinoma." Rapamycin is an interesting drug because of its diverse clinical applications. Indeed, marketed under the brand name Certican®, Novartis' everolimus is already an approved medication for the prevention of organ rejection in patients undergoing heart and kidney transplantation. Besides potent immunosuppressant effects, everolimus also inhibits mTOR protein. It is this property that is being exploited in the development of RAD001 (everolimus) as a potential anti-cancer medication. If the outcome of current trials proves successful Novartis hopes to submit an NDA in 2008 for the use of RAD001 as a treatment for metastatic renal cell carcinoma (RCC). TARGETING mTOR Mammalian target of rapamycin, or mTOR, is a protein kinase that regulates cell growth, cell proliferation, cell motility and cell survival, as well as protein synthesis. Studies suggest that the mTOR growth pathway may be hyperactive in some cancers making it a potentially attractive cancer therapy target. Novartis' RAD001 (everolimus) is a serine-threonine kinase inhibitor of mTO that continuously inhibits the mTOR protein and so acts to prevent tumour cell division and blood vessel cell growth. If approved, RAD001 will join Wyeth's mTOR inhibitor temsirolimus (ToriselÒ), which was approved for the treatment of advanced RCC in 2007. At present it is the only marketed cancer therapy that specifically inhibits mTOR. RAD001 SHOWS EFFICACY IN RCC The efficacy and safety of RAD001 (everolimus) has been demonstrated in the phase III RECORD-1 (REnal Cell cancer treatment with Oral RAD001 given Daily) trial, which enrolled more than 400 patients with advanced RCC whose cancer had progressed despite prior treatment with a range of first-line therapies. This included treatment with two of the newest drugs for RCC, sorafenib and sunitinib. Interim results from RECORD-1, a multicentre randomised, double-blind, placebo-controlled, showed that treatment with RAD001 more than doubled the time to tumour progression after failure of first-line therapy. In fact, the independent data monitoring committee stopped the trial once the interim results were released. Median progression-free survival (primary endpoint) was 4 months for patients in the RAD001 arm compared with 1.9 months in the placebo arm (p&t;0.0001), a 70% reduction in the risk of cancer progression. No significant differences were observed with respect to secondary efficacy endpoints, which included overall survival and objective response rate. A central review of the patients evaluable for best percentage change in target lesions showed evidence of tumour shrinkage in 50% of RAD001-treated patients during the double-blind phase, compared with 8% of placebo recipients. RAD001 appeared generally well tolerated by patients in this study, with 6% prematurely discontinuing because of adverse effects. POTENTIAL IN OTHER CANCERS In addition to RCC, RAD001 is also being investigated for its potential to treat other cancers. Studies are ongoing to see whether it can bring therapeutic benefit to patients with pancreatic endocrine tumours, the results for which are expected towards the end of 2008. Other cancers for which RAD001 is being explored include carcinomas of the breast, stomach, and lung. "Other cancers for which RAD001 is being explored include carcinomas of the breast, stomach, and lung." MARKETING COMMENTARY RCC, which develops in the renal tubules, is the most common cancer of the kidney. It accounts for about 2‐3% of all new cancers. Surgery to remove the tumour is standard treatment and can be effective if the tumour is confined to the kidney. However, if the tumour recurs following surgery prognosis is often poor. Generally resistant to radiotherapy and chemotherapy, RCC has proved one of the more difficult cancers to treat once the disease has spread. Some important advances have been seen in the treatment of RCC with the arrival of targeted therapies such as the multi-kinase inhibitors sorafenib and sunitinib. Although not curative, they can significantly prolong progression free survival in advanced RCC. As results from the RECORD-1 trial demonstrate, treatment with RAD001 may further extend progression-free survival in patients with metastatic RCC after failure with these newer drugs.

Alpha Diagnostic provides a comprehensive range of services related to protein or gene sequence analyses for the purpose of selecting antigenic peptides, synthesis of custom peptides, antibodies to peptides and proteins. PHOSPHOPEPTIDE, PEPTIDE AND PROTEIN ANTIBODIES ADI specializes in producing antibodies to phosphopeptides and acetylated peptides or proteins. ELISA testing of antibodies and affinity purification of antibodies is also available. ADI has been one of the most cited commercial sources for these services for the last 15 years. PRIMARY ANTIBODIES ADI has also produced thousands of primary antibodies for tumour markers, drug metabolizing enzymes, membrane receptors, growth factors, and drug transporter proteins. ELISA KITS FOR SERUM PROTEINS ADI has hundreds of ELISA kits for human and animal proteins, and it is the most comprehensive sources of autoimmune ELISA kits for animal research. ADI has recently produced recombinant proteins, antibodies, and ELISA kits for anthrax vaccine research. ADI is also the source of monkey-specific antibodies and ELISA kits for IgG, IgA, IgM, IgE and other serum proteins. Highly economical ELISA readers and washers are also available. CUSTOM PEPTIDE SYNTHESIS, ANTIBODIES AND PURIFICATION ADI uses the latest technology in peptide synthesis using fmoc / tboc chemistries to synthesize custom peptides to your specification (purity, quantities, etc.). We perform rigorous quality controls (mass specs, hplc, amino acid analyses, etc.) at various stages of peptide synthesis. Most common peptide modifications (phosphorylation, acetylating etc) are available. ADI can also synthesize long peptides (~100 AA). ADI offers one of the most comprehensive services for the selection of antigenic peptides, BLAST searches, and identification of signal peptide, trans-membrane domains, sequence alignment, and other common structural motifs. Antigenic peptides can then be used for antibody production. ADI has its own USDA-approved animal research facility for custom production of antibodies in rabbits, goats, mice, pigs and chickens. Purified peptides proteins (recombinant GST, His-tag, etc.) are used for antibody production. Antibodies are tested by ELISA or other techniques (Western, IHC, etc.) upon request. ADI specializes in producing antibodies to modify peptides (phosphorylated and acetylated peptides, etc.). PRIMARY AND COMMON FUSION TAG ANTIBODIES ADI produces and distributes an extensive range of antibodies, covering the fields of obesity, circadian rhythm, ageing, cell cycle, apoptosis, drug metabolizing enzymes and drug transporters, DNA repair, viral proteins; energy metabolism and body-weight regulation; dialectology; cytokines, chemokines and related molecules; bone and cartilage metabolism; cardiovascular disease; and growth hormone and factor-related products, enzymes and hormones, and allergens. ADI provides the most extensive collection of common fusion tag antibodies (GST, His, MBP, Myc-tag, etc.). Recombinant proteins containing the appropriate tags are also available for control studies.

Semagacestat (LY-450139) is a gamma secretase inhibitor under development by Eli Lilly as a treatment for Alzheimer's disease (AD). Now in advanced-stage development, it is hoped that this new anti-dementia drug will help delay the onset of severe AD and thereby help preserve cognitive and executive functioning and in turn improve patient quality of life. MOVING BEYOND SYMPTOM RELIEF IN AD AD is a devastating neurodegenerative disease and the most common form of dementia to affect the elderly. From early symptoms of memory loss, the disease runs a progressive course of steady cognitive decline accompanied by severe behavioural problems. "There is an urgent need to find drugs that can address the underlying pathology of Alzheimer's disease." Although specific anti-dementia drugs are available for patients with AD, they provide at best only modest symptomatic improvement. Moreover, their effects on cognition, executive functioning and behaviour are only temporary. None is considered to have disease-modifying effects that can halt the progression of the disease and stop cognitive decline ‐ the hallmark of AD. Many patients also fail treatment with first-line anti-dementia drugs because of poor efficacy and tolerability. There is an urgent need to find drugs that can address the underlying pathology of AD and help halt the inexorable rise in the prevalence of the disease as the world's elderly population rises. GAMMA SECRETASE INHIBITORS TARGET BETA-AMYLOID Pathologically, AD is characterised by the presence of amyloid plaques (neuritic or senile plaques) and neurofibrillary tangles in the brain. The amyloid plaques result from the accumulation of insoluble toxic beta-amyloid (b-amyloid42), derived from amyloid precursor protein (APP). The production of toxic beta-amyloid is believed to trigger a series of secondary events, giving rise to the so-called amyloid cascade hypothesis. This has spurred the search for drugs to prevent b-amyloid42 formation. Lilly's semagacestat (LY-450139) is designed to inhibit gamma secretase, an enzyme that is involved in the cleavage of APP to beta-amyloid. By decreasing production of beta-amyloid, it is hoped that gamma secretase inhibitors will exert a disease-modifying effect in AD and thus slow or halt the destruction of nerve cells ‐ the final stage in the amyloid cascade hypothesis. PHASE III IDENTITY TRIAL Semagacestat (LY-450139) has now advanced to phase III development, where it will be evaluated in the IDENTITY (Interrupting Alzheimer's Dementia by EvaluatiNg Treatment of AmyloId PaThologY) trial, the first phase III trial for this new anti-dementia drug. IDENTITY, an international multicentre randomised, double-blind, placebo-controlled trial, will enrol 1,500 patients with mild-to-moderate AD. Integral to the design of this 21-month long study is a randomised delayed start, so that patients initially assigned placebo will receive active drug at some stage before the end of the double-blind treatment period. All patients completing the initial 21-month study period will be eligible to continue open-label therapy. Several different tests will be used on a proportion of patients in the IDENTITY trial to measure the effect of semagacestat (LY-450139) on both A-beta amyloid and amyloid plaques. For example, a new brain scan capable of taking images of amyloid plaques will be used to measure the build up of amyloid plaques, while other tests will measure brain size and functioning. These additional tests will help to further determine the effect of semagacestat (LY-450139) on AD pathology. MARKETING COMMENTARY "It is hoped that semagacestat will help delay the onset of severe AD and thereby help preserve cognitive and executive functioning." Recent estimates suggest that worldwide between 12 and 15 million people have AD, with about 5 million people affected in the US alone. Primarily a disease of the elderly, prevalence is projected to rise significantly as the proportion of elderly in the world's population increases. By 2050 there are likely to be more than three times as many people with AD than there are today, unless more effective treatments are discovered. While the search for curative AD therapies continues, any drug that can significantly address underlying disease pathology and slow disease progression would constitute a major advance. Costs of care increase dramatically as patients advance to severe AD, when they are no longer able to function independently and often become bedridden. Not surprisingly, the current market for anti-dementia therapies is in its infancy with among the highest growth dynamics in the CNS market.

Showing the efficacy of its HTS screening systems and successful collaboration with Academia, Bioalvo managed to file its first IP on products eight months after having the technology platform up and running. Bioavlo filed two PCT patent applications covering the therapeutic use of a compound identified using its proprietary drug screening technology, already protected by two earlier filed PCT applications. Relevant data regarding toxicity, efficacy and physiological behaviour (like ability to cross the blood brain barrier - BBB), that were key information for the IP filing, were obtained under the aegis of a successful collaboration with Professor Miguel Castanho's team at UL. The PCTs were filed covering therapeutic use for indications such as pain and CNS diseases. Bioalvo acquired full commercial and IP rights regarding the products to UL, who will receive royalties on Bioalvo's net revenues regarding the product sales. The relevance of the existing data already attracted the attention of key international players in the fields of pain and CNS. Helena Vieira, Bioalvo's CEO said, "We are very happy we've been able to show that industry and academia can work quite well together in Portugal and that is the way to value the good science we have within our universities. Filing our first IP around products give us a great feeling of accomplishment since this is a relevant landmark in the planned roadmap for the company development. These are the first of many that will follow, technology is up and running successfully as we have reassured with this IP filing, so it is only a question of time and resources." Luis Amado, Bioalvo's CBDO mentioned, "Having products with relevant data as in this case is a great asset to foster partnerships and licensing deals, not only on product front but also for the use of technology that can see its value considerably increased by those." Professor Miguel Castanho declared, "this is an important step in technology transfer and industry-academia partnerships in Portugal. It is certainly an encouraging event to cross the old boundaries that still separate the two sectors. It is also inspiring to have the perspective that our academic work may one day revert in direct favour of suffering patients. Without a strong and committed industrial partner like Bioalvo this goal would be elusive. About Bioalvo S.A. Bioalvo is the first Portuguese biotech company working on early stages of drug discovery. Bioalvo designs and develops innovative drug development programmes that generate potent and efficient drugs aimed at central nervous system and neurodegenerative disorders. Through its proprietary innovative platforms Bioalvo can accelerate and increase the efficiency of drug discovery through HTS and generate true and potent drug candidates for its pipeline and of its partners that will ultimately lead to treatments and cures for human diseases with dramatic social impacts such as amyloidosis, Huntington's, Alzheimer's, Parkinson's or cancer. The company operates an alliance-based R&D business model and relies on partnerships to fill its pipeline and bring its products to the market. Bioalvo is fully committed in building value by developing a diverse pipeline of products to address un-met healthcare needs.

Pradaxa (dabigatran etexilate) is a new oral anticoagulant under development by Boehringer Ingelheim. Its primary indication is for prevention of venous thromboembolism (VTE) following orthopaedic surgery, such as operations for total hip and total knee replacement. Within a year of filing for regulatory approval with the EMEA in early 2007, the company received positive news that the Committee for Medicinal Products in Human Use (CHMP) had recommended Pradaxa's approval for thromboprophylaxis. Subsequent authorisation to market Pradaxa followed and it is now in the process of being launched in countries throughout Europe. THE BURDEN OF VTE VTE is the formation of a blood clot or thrombus in the vein, which may occlude the vein or rupture and lodge elsewhere in the body, such as an artery. VTE encompasses both deep-vein thrombosis (DVT) and pulmonary embolism (PE), in which clots formed in the deep veins of the leg rupture and become lodged in the pulmonary artery. After heart attack and stroke, it is the third most common cardiovascular disease. "In the US alone, it is estimated that 2 million people are affected by VTE." In the US alone, it is estimated that 2 million people are affected by VTE. Of these 60,000 die from PE, which occurs when a clot in the deep veins of the leg breaks away and becomes lodged in the pulmonary artery. In the majority of cases VTE is a silent disease, producing no overt symptoms and as a consequence probably under-diagnosed. Patients undergoing major orthopaedic surgery (hip or knee replacements and hip fracture) are at an especially high risk of developing VTE. Without anticoagulant therapy, between 40% and 50% of patients undergoing hip replacement surgery suffer VTE. This rises to 70‐80% in hip fracture surgery. ALTERNATIVES TO WARFARIN NEEDED In clinical use for some 50 years, the vitamin K antagonist warfarin remains the standard long-term oral anticoagulant. Although effective when well managed, it has a number of significant drawbacks that can have potential thrombotic and haemorrhagic consequences. Thromboprophylaxis with warfarin is influenced by genetic differences in metabolism, concurrent medication use, vitamin K intake, drug interactions, and alcohol consumption among others. Thus, to keep patients within the International Normalised Ratio (INR) target range, daily maintenance doses of warfarin can vary from less than 1 to over 20mg/day. This necessitates regular coagulation monitoring and dosage adjustments. Warfarin is an indirect thrombin inhibitor and depletes vitamin K-dependent clotting factors, particularly prothrombin, when exerting its antithrombotic effect. Pharmacologically this results in a slow onset of action. Thus, when rapid anticoagulation is indicated, patients have to take overlapping parenteral antithrombin therapy with heparins. Finally, warfarin has a long half-life, which together with the half-life of the vitamin K-dependent clotting factors slows its offset of action. The drawbacks associated with warfarin have spurred the search for alternative orally administered drugs that more closely meet the ideal criteria for anticoagulant therapy. These include: Once or twice-daily oral administration High therapeutic index with standardised dosages Rapid onset and offset of action No requirement for routine coagulation monitoring Minimal interaction with food or drugs Studies on Pradaxa indicate that this new oral anticoagulant has a rapid onset and offset of action and predictable anticoagulation action, removing the need for coagulation monitoring. There is also no evidence to suggest it interacts with food, while its potential to interact with other drugs is considered low. PRADAXA IN VTE PREVENTION Clinical data from the RE-NOVATETM and RE-MODELTM trials, included in regulatory submissions to the EMEA, support the clinical efficacy of Pradaxa in VTE prevention. At doses of 150 or 220 mg, orally administered Pradaxa proved as safe and effective as the injectable LMW heparin, enoxaparin 40mg, in preventing VTE and all cause mortality following total hip and knee replacement surgery. "Studies on Pradaxa indicate that this new oral anticoagulant has a rapid onset and offset of action and predictable anticoagulation action." Incidence of major bleeding, the main safety concern with thromboprophylaxis, was comparable between treatment arms and low in both trials (range 1.3‐2.0%). Likewise, the incidence of raised hepatic enzyme levels was similar between treatment arms. Pradaxa's first indication is for VTE prevention. The company is also exploring the drug&squo;s potential in stroke prevention in patients with atrial fibrillation (AF), where Pradaxa is being evaluated in the 18,000-patient RE-LY trial. MARKETING COMMENTARY Developing a suitable alternative to warfarin has been the driving force of anticoagulant research for years. Hopes were first raised at the end of 2003 when Exanta (ximelagatran), an oral direct thrombin inhibitor, was approved in Europe. However, they were subsequently dashed when it was withdrawn from the market in 2006 because of hepatic toxicity. Hopes have now been raised again with EMEA approval of Pradaxa. Also waiting in wings are two other oral anticoagulants that are likely to challenge Pradaxa in the market for thromboprophylaxis, Bayer's Xarelto (rivaroxaban) and BMS/Pfizer's apixaban.

IDBS is today proud to announce Neil Kipling, founder and CEO, has been awarded an honorary doctorate (DUniv) from the University of Surrey. Since being founded by Neil Kipling in 1989, IDBS has grown to become one of the world's leading providers of data management software to the pharmaceutical and biotechnology industries. The company has been trading for almost 20 years in a highly competitive marketplace and boasts an enviable customer base that includes 18 of the top 20 global pharmaceutical companies. Neil believes that a number of key factors have contributed to the companies continuous success story - including IDBS' location on The Surrey Research Park, his personal association with the local community and University, as well as the company's partnership approach and ability to support a diverse customer base. Dr. Malcolm Parry, director of The Surrey Research Park, who proposed Neil for this award, commented: “Neil's career reflects his versatility as an outstanding entrepreneur who has continued to contribute to building the knowledge-based economy not just regionally, but internationally.” He added: “IDBS has remained profitable and has continued to report excellent sales and revenue growth. The Surrey Research Park provides an innovative environment upon which IDBS has built its success. All of us at The Surrey Research Park and at the University would like to congratulate him on his doctorate, as well as for his many other successes, and the triumphs still to come.” Neil Kipling, founder and CEO, commented: “This is a great honour, not just for me, but for the whole team here at IDBS. Seeing the company evolve to what it is today inspires me to achieve ever greater levels of success for IDBS. As a company, we have already achieved so many good things, but there is still so much still to come!”

We are proud to present you our new ultra high purity nitrogen gas generator for Gas Chromatography systems. The NG10L-HP is designed to deliver high volume, high pressure, clean, dry, Nitrogen at a flow rate of 10l/min for the use with multiple Laboratory Analytical Instruments as a source of carrier gas. This system utilizes carbon molecular sieve technology to selectively remove oxygen, moisture and other gases to leave clean, dry, phthalate free, ultra high purity nitrogen. Due to the simplicity of the design and the small number of moving parts the Nitrogen Generator will have a long and trouble free life. The Generator only needs to be connected to a clean dry source of compressed air and therefore the installation is straightforward and maintenance minimal. Peak Scientific Instruments is an international company focussed on producing and supporting high quality Gas Generators for the analytical instrument market. Our gas generators provide a safe and economical alternative to combustible bottled gas and cylinders and offer a constant purity resulting in accurate analysis.

Guildford, UK - ID Business Solutions Ltd (IDBS), a provider of drug discovery data management solutions, is proud to be awarded the 2008 Frost & Sullivan European Bioinformatics Service Differentiation Innovation Award. Analysts from Frost & Sullivan perform extensive market research in order to determine potential award recipients. Their research indicated that 'IDBS provides real value to the life sciences industry through its consulting services.' By enabling the companies in the life sciences market to integrate research and business data, IDBS is helping organisations to make intelligent business decisions in a market that is characterised by budgetary restrictions and strong competition. IDBS' willingness to partner with pharmaceutical and biotechnology companies to achieve scientific and business excellence, and the contribution of its highly skilled staff who possess extensive scientific and IT expertise, were identified as two key differentiators that have helped IDBS achieve an average of 15% growth per year in a highly competitive and fragmented market. "IDBS, with its innovative range of product services, has demonstrated a strong understanding of the bioinformatics market,” notes Frost & Sullivan analyst E. Sujith. “With a highly service-oriented model, IDBS displays its commitment to give real value to its customers. Beyond its superiority in various product solutions, the range of services catering to the life sciences industry makes IDBS a worthy recipient of this award." Neil Kipling, founder and CEO of IDBS, commented: "We at IDBS are very honoured to be given this prestigious award. We would also like to take this opportunity to thank all our customers for their continued support and loyalty."

As part of ASINEX's suite of ADMET screens, ASINEX is able to provide affordable, efficient non-GLP tests for Liver S9 stability (human, rat), stability in hepatocytes (human, rat), plasma protein binding (rat) and plasma stability (rat).The tests are carried out at ASINEX's laboratory in Moscow where turnaround time is typically from 4-10 days depending on the test. ASINEX is able to provide special offers for first time users. ASINEX's Bioscreening dept. was founded in 2001 and provides a range of services including custom screening (against panel of kinases, GPCRs or proteases) and other ADMET tests including physiochemical properties, in-vitro absorption, cytotoxicity, proliferation and apoptosis, drug transport assay, and PK in vivo.