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Deasy R.E.,University College Cork | Moody T.S.,Almac | Maguire A.R.,University College Cork
Tetrahedron Asymmetry | Year: 2013

Hydrolase-catalysed kinetic resolutions to provide enantioenriched α-substituted 3-aryl alkanoic acids are described. (S)-2-Methyl-3- phenylpropanoic acid (S)-1a was prepared in 96% ee by Pseudomonas fluorescens catalysed ester hydrolysis, while, Candida antarctica lipase B (immob) resolved the α-ethyl substituted 3-arylalkanoic acid (R)-1b in 82% ee. The influence of the position of the substituent relative to the ester site on the efficiency and enantioselectivity of the biotransformation is also explored; the same lipases were found to resolve both the α- and β-substituted alkanoic acids. Furthermore, the steric effect of substituents at the C2 stereogenic centre relative to that for their C3 substituted counterparts on the efficiency and stereoselectivity is discussed.


News Article | December 6, 2016
Site: www.prweb.com

Almac Clinical Technologies, part of the Almac Group, the world’s largest privately-held contract pharmaceutical development and manufacturing organisation, today announced the formation of a strategic partnership with inVentiv Health, a leading biopharma outsourcing company combining a leading CRO and the industry’s only Contract Commercial Organization (CCO). The partnership presents an opportunity for both organisations to provide clients and sites with streamlined access to best-in-class clinical trial Interactive Response Technology (IRT) solutions. Through the strategic partnership, Almac Clinical Technologies will now provide IRT solutions to inVentiv clients, including its market-leading IXRS® technology. This technology has been used in over 2,000 trials and provides sponsors with the visibility and control needed to make data-driven decisions. inVentiv Health’s IRT specialists will also join Almac Clinical Technologies’ 500+ person expert consultancy team. This team and technology transition will allow Almac and inVentiv to seamlessly service current inVentiv Health IRT clients. “We’re committed to accelerating clinical trials and see tremendous value in applying leading technology solutions to streamline the process. This partnership will enable inVentiv Health to enhance its clinical services continuum by offering clients access to Almac’s comprehensive, best-in-class IRT services to unlock further efficiencies in trial study configuration and deployment.” inVentiv Health selected Almac as a partner based on Almac’s dedication to customer focus, quality, expertise and innovation. These factors align with inVentiv Health’s commitment to accelerating client success. "This partnership reaffirms Almac’s position as the global leader in clinical technology solutions, like IRT. We’re thrilled to partner with inVentiv Health as their organisational mission aligns seamlessly with the ethos and priorities of the Almac Group. We look forward to our exciting new venture together and the opportunity to offer clients an expanded array of choices to help support the critical work they do every day.” Almac Clinical Technologies and inVentiv Health will be exhibiting at the 8th annual SCOPE Summit for Clinical Operations Executives on 24-26 of January 2017. Representatives from both organisations will be available to discuss the partnership in greater detail. The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture. The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 4,500 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo). inVentiv Health is a global professional services organization designed to help the biopharmaceutical industry accelerate the delivery of therapies to market. Our combined Clinical Research Organization (CRO) and Contract Commercial Organization (CCO) offer a differentiated suite of services, processes and integrated solutions designed to improve client performance. With approximately 15,000 employees and the ability to support clients in 90 countries, our global scale and deep therapeutic expertise enable inVentiv Health to help clients navigate an increasingly complex environment. For more information, visit http://www.inVentivHealth.com. For information about Almac and this Press Release, please contact Matt Cocking at 1.215.660.8500 For information about inVentiv Health and this Press Release, please contact Danielle DeForge 1.781.425.4624.


The global specialty active pharmaceutical ingredients (API) market is anticipated to record a year-over-year growth rate of 7.9% and reach a market value of US$ 119,513.1 Mn in 2016. Small molecules will continue to account for the leading market revenue share by product type, accounting for over two-thirds share in 2016. Staggering increase in the manufacturing of HPAPI (high potency API) will continue to influence the adoption of API positively. Popularity of peptide-based drugs and the patent expiry of blockbuster branded drugs in the near future is also expected to boost the growth of the market. However, complex manufacturing guidelines and stringent regulatory processes will continue to pose challenges to widespread adoption. By product type, growth of the small molecules segment will be positively impacted by increasing outsourcing of active pharmaceutical ingredients manufacturing from European to Asian countries. In addition, rising preference for HPAPI to treat cancer will play a crucial role in the growth of small molecule segment of the global specialty API market. Based on the consumption pattern, the outsourced segment will continue to dominate market revenues, accounting for nearly 65% share in 2016. New pharmaceutical companies are increasingly entering the market with authorized and approved HPAPI, but lack of manufacturing facility infrastructure is providing an impetus to the outsourcing trend in terms of manufacturing. This factor is currently more pronounced in U.S.-based companies. Furthermore, the tendency of established pharmaceutical companies to curtail the operational and financial load of HPAPI manufacturing is anticipated to play a key role in elevating the outsourcing segment, boosting the growth of SMEs in the market. FMI’s report has segmented the global specialty active pharmaceutical ingredient market on the basis of region into North America, Europe, and Rest of the World (ROW). The ROW is the leading region in terms of global revenue share, closely followed by Europe and North America. European API manufacturers are competing on the basis of high quality standards, advanced manufacturing installations, and high purity of intermediates (API), whereas ROW CMOs are focusing on bulk API manufacturing. The key players in the small molecule active pharmaceutical ingredients segment include Johnson Matthey, Almac, and Siegfried Holding AG, which follow advanced manufacturing technology, premium promotion strategies, and provide a range of development and diagnostic services. Notable companies in the peptide API segment are PolyPeptide Laboratories, Corden Pharma International GmbH (International Chemical Investors Group), Pepscan Holding, Provence Technologies Group, BCN Peptides S.A., and Senn Chemicals AG. They are characterized on the basis of expertise in development and manufacturing, strong client base, and activity in a wide range of industries. Major HPAPI players in the market are Ash Stevens, Inc., Orion Corporation, Farmhispania Group, S.L., Olon S.p.A., and AmbioPharm, Inc., based on widespread market presence, government approvals, and strong distribution channels. Long-term Outlook: The global specialty API market is expected to witness a CAGR of 8.8% during the forecast period 2016-2024. ROW will continue to be the leading region in terms of revenues during the forecast period.


CARY, NC--(Marketwired - February 08, 2017) - The 2nd edition of Industry Standard Research's (ISR's) Drug Product Contract Manufacturer Quality Benchmarking report reveals that buyers of outsourced drug product manufacturing services value a strong regulatory history and reliable on-time delivery more than low cost when selecting a CMO for drug product manufacturing. The report includes information on respondents' outsourcing philosophies and practices, CMO perceptions and interactions and CMO selection drivers before diving into a series of in-depth performance analyses specific to the drug product offerings of 70 contract manufacturing organizations. 302 respondents provide rating assessments on 673 service encounters. "A strong regulatory track record topped the list of attributes as the most important factor influencing drug product CMO selection," said Kate Hammeke, Vice President, Market Research at Industry Standard Research. "Reliable on-time delivery placed second and a track record for meeting quality performance metrics came in third. Low cost had fewer than one-in-ten respondents mention it as the most important selection driver. We are hearing this more and more from service buyers. Cost is not necessarily becoming less important, but that multiple factors beyond project price impact overall costs and consequently those attributes outweigh 'low cost' as a selection criterion." The report provides a Consumer Reports-style analysis where each of the 70 CMOs included in the research is evaluated across 27 service quality attributes, making this report the most comprehensive assessment of quality in the contract manufacturing space. These performance metrics are categorized into four 'scorecards': Delivery Factors, Organization Factors, Capabilities and Staff Characteristics. From these performance evaluations, respondents indicated how well the manufacturers performed with respect to expectations specific to their experience working with the manufacturer(s). For buyers of outsourced services, the report includes highly valuable information to help guide CMO selection for drug product manufacturing projects. There are several stand-out CMOs this year: Pfizer CentreOne placed among the leaders across each of the four scorecards (Delivery, Organizational, Capabilities and Staff Characteristics) and Samsung BioLogics received top scores for its Organization Factors and Capabilities. Fareva received top marks for its Delivery Factors and among emerging market CMOs, Wuxi AppTec appeared among the leaders for its Organization Factors. CMO performance attributes evaluated by respondents include Full range of manufacturing for the dosage forms we require, Reliable on-time delivery, Regulatory History, Quality performance metrics, Scale-up and tech transfer abilities, Scientific knowledge, Right-first-time measurements, and many others. Data include an in-depth analysis of 20 of the 70 featured contract manufacturers, including AbbVie Contract Manufacturing, Albany Molecular Research Inc. (AMRI), Almac, Baxter BioPharma Solutions, Boehringer Ingelheim, Capsugel, Catalent, Dr. Reddy's CPS, Evonik, Fareva, GSK Contract Manufacturing, Patheon, PCI Pharma Services, Pfizer CentreOne, Piramal Pharma Solutions, Samsung BioLogics, Sandoz, Sanofi CEPiA, Vetter and Wuxi AppTec. For more information on ISR's "Drug Product Contract Manufacturer Quality Benchmarking" report, please visit ISR's report page at https://www.isrreports.com/reports/drug-product-contract-manufacturer-quality-benchmarking-2nd-edition/. Industry Standard Research is the premier, full service market research provider to the pharma and pharma services industries. With over a decade of experience, ISR delivers an unmatched level of domain expertise. For more information about ISR's off-the-shelf intelligence and custom research offerings, please visit the company's website at www.isrreports.com, email info@isrreports.com or follow ISR on Twitter @ISRreports.


News Article | February 15, 2017
Site: www.marketwired.com

CARY, NC--(Marketwired - February 09, 2017) - The 2nd edition of Industry Standard Research's (ISR's) Small Molecule API Contract Manufacturer Quality Benchmarking report reveals that the top performing CMOs relative to expectations, and based off customer feedback on recent service encounters, are contract manufacturers with a drug innovator as its parent company. "For the second year in a row, Pfizer CentreOne has been a top performer across all four scorecards," explained Kate Hammeke. "This year, AbbVie Contract Manufacturing placed among the leaders in three of the four scorecards. This is a sign that customers working with embedded CMOs are having their expectations exceeded, but so are respondents who outsource to small and midsize CMOs. Aesica, SAI Life Sciences and Wockhardt received top marks across two scorecards each, which is a sign that regardless of project size or company budget, one can find a CMO whose quality matches your organization's needs." The report includes information on buyers' outsourcing philosophies and practices, CMO perceptions and interactions, and CMO selection drivers before diving into a series of in-depth performance analyses specific to the small molecule offerings of 36 contract manufacturing organizations. 241 respondents provide rating assessments on 689 service encounters. The report provides a Consumer Reports-style analysis where each of the 36 CMOs included in the research is evaluated across 27 service quality attributes, making this report the most comprehensive assessment of quality in the contract manufacturing space. These performance metrics are categorized into four 'scorecards': Delivery Factors, Organization Factors, Capabilities and Staff Characteristics. From these performance evaluations, respondents indicated how well the manufacturers performed with respect to expectations specific to their experience working with the manufacturer(s). For buyers of outsourced services, the report includes highly valuable information to help guide CMO selection for small molecule projects from early clinical stages to commercialization. CMO performance attributes evaluated by respondents include Ability to manufacture small molecule API, Reliable on-time delivery, Regulatory history, Quality performance metrics, Scale-up and tech transfer abilities, Scientific knowledge, Right-first-time measurements, and many others. Data include an in-depth analysis of 27 of the 36 featured contract manufacturers, including AbbVie Contract Manufacturing, Aesica, Albany Molecular Research Inc. (AMRI), Alcami, Almac, AMPAC Fine Chemicals, Aptuit, Ash Stevens, Cambrex, Dr. Reddy's CPS, Evonik, GSK Contract Manufacturing, Halo Pharma, Lonza, Novasep, Patheon, Pfizer CentreOne, PharmaCore, Piramal Pharma Solutions, Recipharm, SAFC, SAI Life Sciences, Sanofi CEPiA, Siegfried, Wockhardt and Wuxi AppTec. For more information on ISR's "Small Molecule API Contract Manufacturer Quality Benchmarking" report, please visit ISR's report page at https://www.isrreports.com/reports/small-molecule-api-contract-manufacturer-quality-benchmarking-2nd-edition/ Industry Standard Research is the premier, full service market research provider to the pharma and pharma services industries. With over a decade of experience, ISR delivers an unmatched level of domain expertise. For more information about ISR's off-the-shelf intelligence and custom research offerings, please visit the company's website at www.isrreports.com, email info@isrreports.com or follow ISR on Twitter @ISRreports.


Next-generation sequencing technologies are increasingly being applied in clinical settings, however the data are characterized by a range of platform-specific artifacts making downstream analysis problematic and error- prone. One major application of NGS is in the profiling of clinically relevant mutations whereby sequences are aligned to a reference genome and potential mutations assessed and scored. Accurate sequence alignment is pivotal in reliable assessment of potential mutations however selection of appropriate alignment tools is a non-trivial task complicated by the availability of multiple solutions each with its own performance characteristics. Using targeted analysis of BRCA1 as an example, we have simulated and mutated a test dataset based on Illumina sequencing technology. Our findings reveal key differences in the abilities of a range of common commercial and open source alignment tools to facilitate accurate downstream detection of a range of mutations. These observations will be of importance to anyone using NGS to profile mutations in clinical or basic research. © 2012 Oliver GR.


Kitson S.L.,Almac
Current radiopharmaceuticals | Year: 2013

Targeted alpha therapy (TAT) is an investigational procedure which utilises monoclonal antibodies (mAbs), peptide conjugates and/or other chemical compounds. These bio-vectors are able to transport a dose of alpha particles to destroy cancer cells. Radionuclide antibody-conjugates (RACs), labelled with beta emitters, have already been used in humans. More recently, TAT has been introduced to treat oncological diseases mainly leukaemia and lymphoma. Encouraging results have also been obtained in solid neoplasms with the administration of anti-tenascin. This chimeric antibody labelled with astatine-211 was delivered in patients with recurrent brain tumours into a surgically created cavity. Conversely, a clinical trial using a standard TAT approach to treat patients with metastatic melanoma, observed the shrinkage of the solid tumour mass. This response in melanoma may lead to an alternative mechanism for TAT, called tumour-antivascular- alpha-therapy (TAVAT), and forms the basis of a novel approach to the treatment of cancer disease states. In this paper, we will concentrate mainly on the application of TAT using antibodies. In particular, an investigation into the major general features connected with the use of alpha emitters in cancer therapy will be discussed. The prospective role of TAT with RACs will also be outlined briefly, especially focussing on the most important therapeutic strategies to date based on antibodies radiolabelled with beta emitters.


Caswell J.M.,Almac | O'Neill M.,Almac | Taylor S.J.C.,Almac | Moody T.S.,Almac
Current Opinion in Chemical Biology | Year: 2013

Cytochrome P450 monoxygenase (P450s or CYPs) allow access to drug metabolites, necessary for approval of new therapeutics in one step, with increased success being demonstrated using bacterial and fungal P450s. Moreover, 12 of the 13 products of the human metabolism of verapamil can be accessed through engineered and chimeric bacterial P450s. These P450s are also used in the synthesis of pharmaceuticals themselves, including the semi-synthetic production of artemisinin in an engineered cell. The integration of new technologies including ultrasound and polyfluorinated hydrocarbon solvents offers an attractive means by the true synthetic potential of ubiquitous P450s can be fully realised. © 2013 Elsevier Ltd.


News Article | December 19, 2016
Site: www.prweb.com

Almac Clinical Technologies, part of the Almac Group, the world’s largest privately-held contract pharmaceutical development and manufacturing organisation, today announced a collaboration with Exostar, whose cloud-based solutions help companies in highly-regulated industries mitigate risk and solve their identity and access challenges. The companies are working together to provide Single Sign-On (SSO) and Federated-Authentication access to eClinical applications used to support clinical trials, including Interactive Response Technology (IRT). In its first eClinical proof-of-concept collaboration with Exostar, Almac successfully integrated its market-leading IXRS® 3 IRT with Exostar’s identity and access management platform for life sciences. As a result, Almac’s global client base is set to benefit substantially through simplified credential management for both clinical sites and trial sponsors - ultimately helping to streamline clinical trial workflows. The SSO functionality eliminates the need for site personnel and patients to maintain multiple credentials. When combined with fast credential de-provisioning, the solution enhances the controls and security surrounding trial-sponsor intellectual property. The user-authentication functionality extends to other federated partners of Exostar, including TransCelerate, Merck and AstraZeneca, further augmenting the value of the platform. “The clinical trials process is dynamic and complex. With IXRS® 3, Almac expedites drug development by bringing constituents, materials, and data together so the right people have access to the right information and supplies at the right time,” said Kenny Kong, Exostar’s Director of Life Sciences and Health IT. “By federating to the Exostar platform, Almac is furthering the value of their solution by enabling SSO for their clinical application, which eases the access burden on study sponsors, improves the site user experience, and raises the level of security.” “Protecting sensitive data and securely conducting clinical trial operations are critical functions, yet can prove immensely challenging for sponsors. Exostar’s cloud-based platform provides a perfect solution to enable our clients to overcome these challenges. We’re excited about Exostar’s dedication to streamlining identity management in the highly-regulated industry we work in, and we firmly believe that combining best-in-class technology solutions like IXRS® 3 with Exostar’s identity and access management platform for life sciences will inherently unlock new value and reduce burden for the biopharmaceutical clients we serve.” The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IRT) through to commercial-scale manufacture. The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 4,500 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo). Exostar, named a Cool Vendor for 2016 by Gartner, offers cloud-based solutions that help companies in highly-regulated industries mitigate risk and solve identity and access challenges. Nearly 125,000 organizations leverage Exostar to help them collaborate securely, efficiently, and compliantly with their partners and suppliers. By offering connect-once, single sign-on access, Exostar strengthens security, reduces expenditures, and raises productivity so customers can better meet contractual, regulatory, and time-to-market objectives. http://www.exostar.com.


News Article | February 15, 2017
Site: www.prweb.com

Matthew Regulski, D.P.M., the Director of the Wound Care Institute of Ocean County, announces a new clinical trial for those suffering from chronic venous leg ulcers. Those interested in participating in the study should call the Wound Care Institute of Ocean County immediately at 732-736-5509. The study, officially titled “A Prospective, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial Comparing Two Doses of VF001-DP to Placebo as an Adjunct to Standard Care in Patients with Chronic Venous Leg Ulcers,” is being sponsored by Factor Therapeutics Ltd., alongside the following collaborators: Parexel, ARANZ Medical and Almac Clinical Services LLC. “The objective of this study is to demonstrate the effectiveness and safety of VF001-DP as an adjunct to standard care (SC) in the treatment of chronic venous leg ulcers (VLUs) compared to placebo with SC over the course of the 12-week Treatment Phase,” according to ClinicalTrials.gov (Identifier: NCT02973893). This clinical trial is targeted at the following conditions: Ulcers, leg ulcers, varicose ulcers, pathologic processes, skin ulcers, skin diseases, varicose veins, vascular diseases and cardiovascular diseases, and will consist of three phases: Screening (two weeks), treatment (12 weeks and follow-up (12 weeks). Only patients whose study ulcer does not exhibit more than 30 percent change (increase or decrease) in ulcer size post-debridement between the screening phase visit (S1) and the treatment phase visit (T1) and who continue to meet eligibility criteria at the treatment phase visit (T1) will be randomized to receive either the Active Treatment Group (VF001-DP low or high dose plus standard care) or the Control Treatment Group (placebo plus standard care) in a ratio of 1:1:1, according to ClinicalTrials.gov. “This study will help us determine if this new course of treatment improves wound healing in chronic venous leg ulcers compared to standard care alone,” said Regulski. “Anyone with an ulceration between their knee and their ankle may be a candidate for this study and is encouraged to contact our office immediately to discuss this exciting new biological treatment.” This clinical trial plans to recruit 168 patients (56 per treatment group) at 26 centers in the United States, including the Wound Care Institute of Ocean County. To enroll in this study or to check eligibility requirements, please call the Wound Care Institute of Ocean County at 732-736-5509. About the Wound Care Institute of Ocean County The Wound Care Institute of Ocean County is the leader in wound care management, and is dedicated to the diagnosis and successful treatment of chronic and debilitating wounds. The Wound Care Institute follows the highest levels of evidence-based medicine and offers various treatment algorithms using the most advanced cellular therapies, as well as vascular services and surgical reconstruction. The Wound Care Institute of Ocean County is also involved in multiple clinical trials that have tremendous impact on the way wound healing is performed. To learn more, visit http://www.woundcareinstituteofoceancounty.com.

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