West Africa Doctors Network News Portal

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

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.

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.

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.

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.

Antibodies Incorporated is a long standing manufacturer of antibodies, antibody based diagnostic kits and reagents under its own label and as a contract manufacturer. Through its long history in the industry it has established not only a sterling reputation as a high quality, rapid response producer of antibodies, but as a versatile, teamwork oriented service provider. We adhere to the strict quality guidelines of ISO 13485 as certified by BSI. NEUROMABS MONOCLONAL ANTIBODIES We are currently the exclusive distributor of NeuroMabs. These are a series of high quality, fully characterized monoclonal antibodies that can be used for research purposes within the research community, including the pharmaceutical industry, biotech, or other research institutions, as long as they are willing to supply us with appropriate MTAs. No reach through royalties are asked, only that their use is for research. These monoclonals are being developed at a rapid rate by highly qualified scientists in the neuroscience area. Only after they are proven to work in WB, ELISA, and IHC are they called NeuroMabs. IMMUNOGENICITY TESTING SERVICES Because of our history as scientists and manufacturers of diagnostic reagents and as custom developers of antibodies and diagnostic assays, we also continue to serve the early therapeutic / vaccine development sector of the industry with both immunogenicity and immunopotency testing services. Immunogenicity is the property of a therapeutic entity that gives rise to an immune response in patients. In the pharmaceutical industry, this patient immune response is viewed negatively as it can lead to potential side effects as well as to diminished efficacy. Measurement of immunogenicity is usually done at the low end of sensitivity as this is where the FDA and other regulatory bodies will show concern for new drugs in the early stages of testing. IMMUNOPOTENCY TESTING SERVICES Immunopotency is the property of vaccines that causes an immune response in patients, and unlike immunogenicity, it is viewed positively within the vaccine industry. The immune response may be either humoral, as measured by assays that detect an antibody (like ELISA), or cellular, as measured by T-cell responses and cytokines (interleukins, interferons, or growth factors), or both. We are capable and skilled at measurements in these areas as part of our long-standing relationship with vaccine manufacturers who have come to rely on us to track the efficacy of their products in animal models. These measurements are also important to the industry for purposes of stability of formulations and lot reproducibility. COLLABORATORS Antibodies Incorporated is looking for clients in the European pharmaceutical and biotechnology industries who want to collaborate in one or more of the following areas: Production of monoclonal antibodies (or polyclonal) Assay development Custom reagent manufacturing (GMP) Custom antibody production for diagnostic assays (large scale) Assay service in immunopotency or immunogenicity.

Peak Scientific, with its 10 years of experience specializing in the development and production of laboratory Gas Generators, has worked closely with most of the world's leading instrument manufacturers, such as Applied Biosystems/ MDS SCIEX, to produce products that not only meet their requirements but also to provide the user of their applications with a consistent, safe and cost effective supply of gas on-site in the laboratory. Peak Scientific offers the largest choice of products to meet the gas demand of API LC/MS/MS. The NM20Z is the standard solution, providing courtain, source and exhaust gas to any Applied Biosystems/ MDS SCIEX LC/MS/MS up to and including the API5000. The generator is easy to install, wall mountable and requires little maintenance, whilst being connected to an existing source of dry, clean and oil- free compressed air. Should you not have an existing source of suitable in-house air, the NM20ZA may be the solution to your API LC/MS/MS requirements. The NM20ZA produces Nitrogen and Zero Air in quantities sufficient to operate API LC/MS up to and including the API4000, whilst being a stand alone solution containing two internal air compressors. If you require a stand alone solution for any API LC/MS up to and including the API5000 or work in a laboratory where downtime is absolutely unacceptable, the N300DR may be the right choice for you. In addition to these systems, Peak Scientific has now also launched two more models to meet the demands of our customers: the NM40Z and the NM20ZL. Much like the NM20Z, the NM40Z requires a source of compressed air for operation, however as opposed to the NM20Z, the NM40Z can offer sufficient flows of Nitrogen and Zero Air to supply gas to up to two API LC/MS in full flow. The NM20ZL has been specifically designed to operate API LC/MS in either Electrospray/ Standard Mode or Photospray Mode. A simple turn switch on the face of the generator, enables the customer to easily switch between Nitrogen and Zero Air supply for standard modes or all Nitrogen supply for Photospray Applications. Peak Scientific is proud to offer the most complete range of products to Applied Biosystems/ MDS SCIEX LC/MS/MS users and are confident that our products will not only meet the applications' requirements, but also meet your expectations in terms or reliability and product quality.

ACE Pharmaceuticals offers a full range of custom-designed development services with professional standards. Further to that ACE offers manufacturing and packaging of clinical trial medication. We specialize in solid, semi-solid and liquid pharmaceutical products. In a strategic alliance with other companies we can offer you parenteral formulations: ampoules, vials, lyophilised and terminally sterilized processes for single and multi-dose products, small molecules and peptides / proteins and sterility assurance / process validation. The solutions we offer are tailored to our customers' exact needs, modular services with the overriding objective of accelerating commercial success. Our expertise covers API characterization, pre-formulation, formulation development, validation and analytical method development. Our GMP-license states that ACE is authorised to manufacture and supply (worldwide) investigational medicinal products for clinical trial purposes. Our track record includes over 20 products, which have either performed development work, and/or manufactured clinical trial medication, which are now registered products. ANALYTICAL SERVICES Our laboratory is a certified, independently operating analytical laboratory, providing advanced and sophisticated analytical services with experienced professionals and state-of-the-art instrumentation (Certificate 103441 EL, issued by the Ministry of Health). The ACE laboratory has a strong commitment towards quality assurance and provides quality and excellence in analytical support. ACE operates cGMP guidelines and ICH-guidelines. METHOD DEVELOPMENT AND VALIDATION CHEMISTRY Our development methods include: Analysis of active ingredients as such, in blends and finished products such as soft and hard gel caps, tablets and capsules Quantitative and qualitative characterization of impurities, residual solvents etc Assays and dissolution tests of finished products according to EP, BP, USP and JP-guidelines Analytical method validation and method development services Clinical trial analytical support Pharmaceutical equivalence studies Finished product stability studies CLINICAL TRIAL SUPPLIES - CLINICAL MANUFACTURE TO DRUG DESTRUCTION Our service covers the clinical supply process from clinical manufacture to drug destruction in quantities ranging from Phase I and compassionate use requests to large-scale Phase III/IV studies involving multinational centres. It includes packaging, labelling and distribution services for patient administration at investigational sites worldwide. When it comes to driving project completion, ACE Pharmaceuticals provides unsurpassed attention to detail. We deliver always on time, at the right place, in the right quality and the requested quantity for a fair price. CONTRACT CLINICAL SUPPLIES MANAGEMENT Creation of clinical trial pack design or pack design according to requirement of customer are processed under a number of sections. Our primary packaging includes blinding by over-encapsulation, manufacturing of placebo capsules, blister packaging (PVC, PVDC, PVC/PE/PVDC, Aclar, Aluminium, etc), mixed fill blisters and bottling of tablets and capsules. Our secondary packaging includes various and complex pack assemblies (open, single blind, double blind, double dummy), cold seal walleting / carding of blisters and coding by inkjet printer (invisible ink). Finally our labelling services cover the design and generation of labels, multilingual labels, labels printed by thermal transfer, coloured labels or coloured printing, over labelling and design and generation of code break envelopes. SOURCING OF COMPARATIVE DRUG PRODUCTS Storage, distribution and returns: GMP storage facilities: at room temperature or between 2°C and 8°C Monitoring of temperature and humidity Worldwide distribution (to clinical centres, investigators and/or sponsors) Receipt, evaluation and reconciliation of returns Destruction of returns PROJECT MANAGEMENT Full project management includes randomisation of treatments, protocol development, advice and consultation worldwide; dynamic and GMP/GCP experimented staff. QUALITY ASSURANCE Permanent training of operators and the maintenance of our quality system have allowed us to reach an excellent level of quality and to obtain the manufacturer authorisation (license 3103A/d) issued by the Dutch Ministry of Health. This certificate is based on the application of Good Manufacturing Practices and ICH-guidelines dedicated to clinical supplies.

BioXpr provides bioinformatics expertise in genomic, proteomic, metabolomic and database design for the biotechnology and pharmaceutical industries. Our company provides innovative commercial packages for: Primers / probes prediction Molecular network visualisation Project management LIMS GENOMICS As the challenge of genome discovery is shifting from the generation of new sequence data to the identification and understanding of gene products and their functions, efficient data interpretation and integration of diverse public and proprietary databases are becoming critical tasks. Our company offers expertise in building R&D support systems for primer / probe predictions, DNA microarray design and analysis, genome annotation, and SNP analysis. PROTEOMICS To know the structure of a protein is useful for the design and optimisation of many pharmaceutical products. BioXpr has developed its expertise around the comparative modelling of proteins, achieving high rankings in international CASP5 and EVA evaluations. Our team can tackle any projects involving protein modelling, docking, sequence alignments, mass spectrometry or protein engineering. METABOLOMICS Metabolomics needs for bioinformatics encompass data and information management, raw analytical data processing and ontology, statistical analysis and data mining, data integration, and mathematical modelling of metabolic networks within a framework of systems biology. Our team has successfully developed and validated a series of critical tools to merge several sources of data, rebuild the pathways and visualise the resulting information efficiently. DESIGN OF CUSTOM SOFTWARE BioXpr’s expertise in developing algorithms and software can be used to create a dedicated solution for specific problems requiring high computing power and smart automated data processing. Our expertise also includes the design of on-board software for controlling novel lab equipment. DESIGN OF CUSTOM INFORMATION SYSTEMS Thanks to its appropriate knowledge and smart handling of database systems, BioXpr can design, build and maintain strong and evolutive custom databases. We can also provide robust data mining solutions, generating powerful information systems for your R&D team. BIOXPRESS - OLIGONUCLEOTIDES DESIGN SOFTWARE BioXpress is an innovative oligonucleotides design software. Using its highly flexible software architecture, BioXpress can receive specific plug-ins to predict multiplex primers, long oligos, taqman probes, molecular beacons, scorpions probes, miRNA, siRNA, PNA, MLPA and LNA. Each prediction plug-in can be easily customised to suit your prediction methods and parameters. NAMEK - VISUALISATION TOOL FOR METABOLIC NETWORKS Namek is a visualisation tool for metabolic networks that is compatible with Hupo-PSI-Mi formats and able to import / export data in XML or from online databases. The networks displayed by Namek can be superimposed with gene differential expression or mass-spec data to show the variations of pathway balances in specific situations. Unlike similar software, Namek can manage up to 50,000 nodes in a single network. TURBO PILOT - ONLINE PROJECT MANAGEMENT TOOL Turbo Pilot© is a powerful and user-friendly online project management tool resulting from a collaboration with GSK-Biologicals. This software is designed to help project managers assign tasks to distant teams (R&D labs in multinational companies, multi-partners research projects, etc.) and to control the progress of the project using easy-to-read dashboards and statistics. For team-mates, the software provides objectives and day-to-day planning of the assigned tasks. SIBIOCLé - MANAGEMENT AND TRACKING OF RESEARCH PROCESSES Sibio offers customisable software solution for the management and tracking of research processes. The SibioClé is a combination of electronic lab notebook and a very complete LIMS. It supports the typical experimentation of a biotech laboratory as a standard feature and it can be adapted to very specific procedures using robots and programmable instruments. SibioClÉ is a product from Sibio which is distributed in Benelux by BioXpr.

INC Research, a therapeutically-focused contract research organization (CRO) with a process for delivering reliable results, today announced that David Gill and William Hall have been elected to its Board of Directors. Both new members bring necessary expertise to help guide the company's strategic growth plans. David Gill, former CFO of NxStage Medical, will also serve as the chairman of INC Research's Audit Committee, which has the responsibility to ensure the integrity of financial statements and performance of internal and external audits. Gill has held various executive roles with emerging medtech and information technology companies, where during his tenure revenue and shareholder value significantly increased. Gill has been a frequent presenter at investment conferences and is well known within the healthcare industry. Hall is co-founder and chairman of Procyon Technologies, Inc., a Chicago-based holding company. He also currently serves as an adjunct professor at the Ross School of Business Administration and as a member of the Leadership Council of the Life Sciences Institute at the University of Michigan. Previously Hall served as chairman and CEO of Falcon Building Products, a subsidiary of Eagle Industries, a privately held US$2.4 billion diversified manufacturing company founded by investor, Sam Zell. "We are privileged to welcome such strong talent to our Board during this exciting period of growth," said James Ogle, CEO of INC Research. "David brings a tremendous amount of financial expertise and executive experience from the life sciences industry, and Bill provides a unique strategic perspective based on his background in both academic and business leadership roles. After our extensive search, with the addition of David and Bill, we feel we have the right people in place to truly take INC Research to the next level."

Proteogenix supplies a comprehensive range of molecular biology and immunology services like custom monoclonal antibody and custom polyclonal antibody development, recombinant protein production and purification in E coli bacteria and K lactis yeast, gene synthesis, peptide synthesis, antibody conjugation and fragmentation, PCR and RT-PCR, cloning, DNA purification, and target validation on Tissue MicroArrays (TMA) in immunohistochemistry. Proteogenix also distributes antibodies, proteins, ELISA kits, tissue microarrays, DNA and RNA purification kits, and 2100 retrievers for antigen unmasking in immunohistochemistry. PROTEIN PRODUCTION AND PURIFICATION Proteogenix's experienced scientists offer protein production and purification in prokaryotic systems (E coli bacteria) as well as in eukaryotic systems (K lactis yeast). We can start synthesizing the gene if necessary and clone it into our expression vectors to produce and purify the corresponding recombinant protein. Conditions are first optimised to offer the highest production yield and purity before the scale-up. The resulting high-purity protein can be used for many applications, like protein-protein interaction studies, custom antibody development, structural and functional studies (crystallography, RMN, enzymatic activity), immunoassays and antibody purification. CUSTOM ANTIBODY PRODUCTION Proteogenix provides custom polyclonal antibody production and custom monoclonal antibody production from an extensive range of animals, such as mice, rats, rabbits, chickens, guinea pigs, Chinese hamsters, goats and sheep. Our great experience is very important for immunization, screening and cloning, but also for ascites production and purification, antibody fragmentation, and conjugation to fluochromes and enzymes. ELISA, western-blot and immunohistochemistry protocols can be developed with the produced antibodies. Monoclonal and polyclonal antibodies / antiserum can be raised against various antigens, including peptides, phospho peptides, purified proteins, haptens, cells and protein extracts. GENE SYNTHESIS Our gene synthesis service allows us to synthesize double-stranded DNA of a very large size in a short period of time from client-specified nucleotidic sequences. A free option of codon optimization can be performed for any system to increase the production efficiency. PEPTIDE SYNTHESIS We offer peptide synthesis services useful for custom monoclonal or polyclonal antibody development, as well as for therapeutic molecule development. We offer a large choice of modifications, such as phosphorylation or acetylation. CUSTOM TARGET-VALIDATION ON TISSUE MICROARRAYS Proteogenix has a division in charge of epidemiologic antibody characterization on tissue microarrays. Our TMAs gather more than 50,000 samples selected for the quality of the tissues, and for which we have an incomparable amount of clinical information. It is one of the largest tissue collections in the world, with more than 120 tumor types available. 20 anatomical pathologists work in this division to validate your antibodies on paraffin TMA or frozen TMA. ANTIBODIES, PROTEINS, ELISA KITS AND TMA PRODUCTS Proteogenix distributes an extensive range of antibodies, proteins and ELISA kits covering the fields of cell cycle; apoptosis; CD markers; anti-HLA; tags; interleukins; viral proteins; energy metabolism and body-weight regulation; diabetology; cytokines, chemokines and related molecules; bone and cartilage metabolism; cardiovascular disease; and growth hormone and factor-related products, enzymes and hormones. TMA provide an excellent method to perform large-scale immunohistostainings, since each TMA can contain several hundred frozen or paraffin tissue spots. Large-scale studies can be performed on normal-tissue, breast, prostate, lung, colon, bladder, kidney and pancreatic cancer, as well as on more rare cancers like head and neck.

Epistem announced today that Exponential Biotherapies, Inc (EBI). of Virginia, USA, have contracted Epistem to provide their specialised preclinical efficacy testing services for agents likely to protect the gastrointestinal tract against radiation damage. The first compound that Epistem will assess is EBI's lead candidate drug, EA-230, which is a small peptide immunoregulator, which has shown the potential to treat (minimise) radiation insult and could therefore be administered following a terrorist nuclear attack to reduce the level of intestinal related radiation sickness. Epistem is a world leader in supplying assays that measure qualitatively and quantitatively the effects of radiation damage on the stem cells in the gut. Epistem's assays show the effects of agents developed to protect the very sensitive cells of the gut. These assays were chosen by the National Institutes of Health (NIH) Medical Countermeasures against Radiological and Nuclear Threats (MCART) programme and Epistem also works with a number of pharmaceutical companies developing new drugs candidates with the potential to treat mucositis, the erosion of the lining of the mouth and gut, which is a very common side effect of radiation therapy used during cancer treatment. The assays provide quantitative and mechanism of action data to assess the efficacy of novel drug candidates, and help define optimum dose scheduling for progression to the clinical phases in this very important area of oncology supportive care. Dr Zsolt Harsanyi, the Chairman and Chief Executive of Exponential Biotherapies, said: "Epistem's well established assays and unrivalled expertise in the field of gastrointestinal epithelial radiation toxicity are extremely valuable to us in confirming the potential of EA-230 as a therapeutic treatment for radionuclear attack". Dr Catherine Booth, head of Epistem's contract research division commented: "We are looking forward to working with EBI to assess the therapeutic potential of EA-230. If it is able to improve gastrointestinal wound healing following radiation exposure it may have widespread applications in biodefence, oncology supportive care (the area for which we first developed and validated these assays), and possibly in other related intestinal wound healing situations, such as inflammatory bowel disease."

Epistem announced today that it had successfully completed a preliminary study with AstraZeneca for the use of its proprietary, minimally invasive plucked human hair biomarker technology to help steer oncology drug development. The technology includes analysing gene expression change in RNA extracted from the bulb of cells located at the base of a single human plucked hair. Changes in gene expression can be used to identify biomarkers ('core gene sets') to aid decision making in the drug development process. The companies have demonstrated that single plucked hairs sampled over multiple time points provide effective levels of RNA for gene expression measurement. The study also showed that the process was well tolerated by subjects and samples proved robust during shipment and storage. Over 85% of hairs sampled were evaluable for measurement. Further analysis of single hairs also established reliable detection of over 13,000 genes in single hairs, which can be used to establish 'core gene sets' for biomarker drug discovery, validation and patient selection. A joint scientific abstract of the study was recently presented at the AACR-NCI-EORTC meeting in San Francisco. The hair biomarker provides the industry with a potentially powerful tool to measure the effects of new cancer treatments and their translation from preclinical through to clinical phases, enabling more informed go/no go decisions to be undertaken at an earlier stage. The identification of appropriate biomarkers within drug development is gaining greater importance with the launch last year of The Biomarkers Consortium founded by The Foundation for the National Institutes of Health (FNIH), the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and the Pharmaceutical Research and Manufacturers of America (PhRMA). AstraZeneca is an active member of the consortium, with the consortium's aim to identify new biomarkers that could accelerate the delivery of new clinical treatments and medicines for prevention, early diagnosis, and treatment of disease. Epistem and AstraZeneca plan to explore hair follicle core gene sets based on drug-induced gene expression in pathways of interest for specific therapeutics. Identified gene expression changes in the hair follicle will be linked to changes in tumours to determine drug exposure, toxicity and dose response leading to patient selection. Matthew Walls, CEO, Epistem stated: "We are excited at the initial results that our companies have made in developing an RNA based biomarker for drug development. AstraZeneca was the first of the top tier pharmaceutical companies to begin feasibility studies for the use of our hair biomarker platform and the successful completion of these studies bodes well for the proposed next steps in our joint development collaboration." Professor Andrew Hughes, Clinical Director of Discovery Medicine, AstraZeneca commented: "Epistem are clearly at the forefront of understanding gene expression profiling in plucked human hair and its utility to drug development. Our published results clearly demonstrate that the method is both feasible and practical; and offers the promise of providing insights into both dose and patient selection."