The mazda pharma Guide 5th August to 11th August 2013 | Page 77

? ? MACHINERY ARTICLE common cancers among women in the world, and HPV is responsible for more than 99 per cent of all cervical cancers. The Aptima HPV test is performed with Hologic's ThinPrep liquid cytology specimens, which are routinely used for Pap testing. Other Hologic diagnostic tests that use ThinPrep specimens and are cleared by the FDA for use on the Panther system include the Aptima Combo 2 assay for chlamydia and gonorrhea, and the Aptima Trichomonas vaginalis assay. The Aptima HPV assay has been approved for two uses: to screen women 21 years and older with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results to determine the need for referral to colposcopy; to use adjunctively with cervical cytology to screen women 30 years and older to assess the presence or absence of high-risk HPV types; the Aptima HPV assay was CE-marked in 2008 and received FDA approval on the Hologic high- throughput Tigris system in 2011. Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products, with an emphasis on serving the healthcare needs of women. ENTERPRISE-READY MULTI-CHANNEL MARKETING FRAMEWORK FOR PHARMA : The information Business Technology Services (iBTS) business unit of Indegene which is a leading provider of R&D, commercial and marketing solutions to top global pharmaceutical and healthcare organisations has launched a robust and innovative Enterprise-ready Multi-channel Marketing Framework (iMCM) for pharmaceutical organisations. iMCM will help clients to deploy enterprise-ready consistent, multi-message MCM programmes across brands efficiently and cost-effectively. iMCM has the additional advantages of being an out-of-the-box, multi-platform and mobile-ready platform, Dr Rajesh Nair, president – Indegene said, “After the acquisition and integration of Aptilon in November 2012, we have accelerated our investments in the multi-channel technology R&D, and iMCM is the first of a suite of new solutions we will be launching in the market place.” Its sales and marketing departments at global pharmaceutical organisations are under increased pressures arising from shrinking pipeline, patent cliffs, increasing compliance requirements from regulatory bodies, dwindling med-rep effectiveness, and surge of digital channels to engage physicians. Companies have started to look to IT to help exploit inherent opportunities as well as mitigate new risks arising from these market shifts. This has also put unconventional pressures on CIO offices to meet these changing business needs and to deploy enterprise-wide solutions that enable new commercial models. Indegene's iMCM framework provides CIOs with an enterprise-wide architecture that services all pharma stakeholders effectively. The framework puts HCPs at the center of focus and increases the effectiveness of engagement through optimizations, resulting from the integration of applications within the technology stack. The framework effectively combines Customer Relationship Management (CRM), analytics, multi-platform connectivity, multichannel/ multi-device/ multi-content interfaces, digital asset management, message publishing systems and external systems including social collaboration platforms, and blog systems in an open and expandable architecture. Dr Nair added, “This novel approach allows clients to deploy stable and customizable MCM architecture across the enterprise effectively while providing the necessary flexibility that is critical to effective MCM deployment.” IDRI'S VACCINE CANDIDATE FOR VISCERAL LEISHMANIASIS :Zydus Group and Infectious Disease Research Institute (IDRI), a Seattle-based non-profit research and product development organization, have decided to collaborate on the production and clinical development of IDRI's visceral leishmaniasis (VL) vaccine candidate, designed to prevent the deadly parasitic disease. Zydus & IDRI will collaborate to conduct clinical development activities in India with the goal of developing, registering and marketing this vaccine candidate for the prevention of VL, which will achieve the objective of global access - that is, ensuring the vaccine is affordable to and accessible by all people in need. Conducting trials in India, where there are real-life situations of disease exposure, is critical to determining the effectiveness of IDRI's VL vaccine candidate and ensuring it is approved and available within endemic countries. Pankaj R Patel, chairman and managing director, Zydus group, said, “Zydus has always been committed to working with partners and collaborating to bridge unmet healthcare needs. By partnering with IDRI on this very important mission, we will be taking an all important step to eradicate visceral leishmaniasis which is a huge healthcare burden.” VL, known as kala-azar in India, is transmitted by the bite of an infected sand fly. There are over 5 lakh new VL cases and 50,000 associated deaths each year. VL is the most severe form of leishmaniasis, affecting vital organs, and, if left untreated, the disease can be fatal. A vaccine is considered essential to control and eliminate the disease. Currently, leishmaniasis occurs in four continents and is considered to be endemic in 88 countries; 72 of those are developing countries, with the disease being most common in India, Nepal, Bangladesh, Sudan and Brazil. While there are drugs to treat the disease, they are expensive and often toxic. To date, a safe and efficacious vaccine to prevent this disease does not exist. IDRI's VL vaccine candidate, LEISHF3+GLA-SE, is the product of more that 20 years of research and development supported by the US National Institutes of Health (NIH) and the Bill & Melinda Gates Foundation. The defined, purified, recombinant vaccine comprises two fused leishmania parasitie proteins and an adjuvant to stimulate a protective immune response against the parasite. After completion of a Phase 1 clinical trial of 36 US adult volunteers to test safety and immunogenicity, the vaccine was shown to be safe and to induce potent immune responses in healthy volunteers. ?M?????I?????%I$?????????????????????????q???????????????????????????????????????????????????????????????i????????????????????????????????%I$??Y0???????????????????????????????????]??????????????????i????????????????????????????Q????????????????????????????????????????????????????????????????????????????????????????????????%I$??????????????????????????????????????????t?I0?Q%5?A H?-%P?=H? =IQ11?AIQUMM%L???AIAIQUMM%L??? ?????????????????????????????????????????????????????? ?? ?????????????????? ??????????? ?????????????????????????????????????????????M??????????????????????????????????????????I????Q????A H????????????????????????????????????????? ??????????????????????????????????????????? ?5`????????Q???I????Q????A H?-????? ?????????????????????????????????????????????????????? ???????????()Q!?5i?A!I5?U%???????????????????((??((0