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On the cutting edge
January 2016
by Jeffrey Bouley  |  Email the author
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Our first roundup of the year for the hardware, software and materials that make life-sciences research and pharma/biotech R&D possible brings us an expansion in Singapore, the joining of a consortium for identification of treatment response predictors, a new interdisciplinary chemistry lab, the solving of an Ebola mystery, strengthening of clinical trials content management security/compliance and a new path to accessing full-text journals.
 
Thermo Fisher opens new clinical services facility in Asia hub
 
SINGAPORE—Thermo Fisher Scientific recently announced the official  opening of its new state-of-the-art GMP facility. Having established its first clinical services facility in Singapore in 2001, the move to this newly built facility will meet the growing demand for clinical supply services in the region. The new site will provide both regional and global pharmaceutical and biotech companies with a one-stop service for clinical supplies, including GMP storage, local labeling, secondary packaging, comparator sourcing, handling and distribution of ambient and cold chain supplies and returns management.
 
Located on Toh Guan Road in Jurong East, the hub for Singapore’s biomedical and pharmaceutical companies, the new facilitiy is nearly 70,000 square feet, which is more than 60 percent larger than the previous site and double the cold chain capacity.
 
The clinical services facility is also reportedly well-equipped with improved technologies and operational tools to serve a growing need for clinical supplies and trials in the region. This includes a larger storage system for its clinical supplies, a new climatic control energy consumption system that reduces the facility’s carbon footprint, and an overall building monitoring system that provides staff with timely updates on the facility’s conditions.
 
“Asia Pacific continues to be our fastest-growing market and a central contributor to our growth,” said Leon Wyszkowski, Thermo Fisher’s vice president of clinical services for North America and facility network. “For nearly 15 years, Singapore has been the central hub for our Asia-Pacific operations, due to its strategic location. With the opening of our larger and well-equipped facility, we aim to continue to build on our Singapore facility further and on the expertise of our local team, to strengthen our regional and global presence in the clinical supplies industry.”
 
Protagen AG joins MATURA Consortium
 
LONDON—Protagen AG, a company concerned with the development of advanced diagnostic tools to address some of the most severe autoimmune diseases, in early December announced that it will join the MATURA Consortium. The overarching mission of the MATURA Consortium is to improve patient care in Rheumatoid Arthritis (RA) by rationalizing therapy decisions through a stratified medicine approach.
 
MATURA (MAximising Therapeutic Utility for Rheumatoid Arthritis) aims to identify treatment response predictors which will allow the allocation of patients to subgroups defined by the therapy they are most likely to respond to, early in the disease process. RA provides the ideal setting for the introduction of a stratified medicine approach as the treatment is standardized, there is a significant non-responder rate to each marketed and commonly used drug, and early and effective therapy has consistently been shown to improve long-term outcomes, including joint damage, disability and employment.
 
Prof. Costantino Pitzalis from Queen Mary University of London, who leads the consortium, said: “We are delighted that Protagen has joined our consortium. There are currently a number of biologic treatments in RA and at the moment, we have no way of predicting favorable patient drug response before therapy selection and treatment.” Adds Prof: Anne Barton from the University of Manchester, who co-leads the consortium: “Being able to accurately predict whether a treatment will work or not, would lead to more targeted and individual treatments as well as greater efficacy and better quality of life for patients. Protagen and its unique, proprietary SeroTag platform is a new key asset to our group of established industry partners, and significantly support our quest for Treatment Response Predictors.”
 
“Our innovative SeroTag technology allows for the first time the systematic determination of response prediction markers to select the most appropriate drug and therapy for rheumatoid arthritis,” notes
 
Stefan Müllner, Protagen’s CEO. “In addition, it enables new approaches for successful drug development, and to support patients, rheumatologists, payers and the pharma industry in our combined effort to improve patient management by rationalizing treatment decision. This is exactly what MATURA is aiming for and we feel privileged to be part of the consortium and support these efforts.”
 
Shimadzu teams with UWM to form interdisciplinary chemistry lab
 
COLUMBIA, Md.—Shimadzu Scientific Instruments recently announced the opening of the Shimadzu Laboratory for Advanced Applied and Analytical Chemistry at the University of Wisconsin-Milwaukee (UWM). The new 2,000-square-foot laboratory and office suite is a hub for research across the entire UWM campus, as well as a classroom for teaching the theory and practice of mass spectrometry. The new lab, located inside of UWM’s Kenwood Interdisciplinary Research Complex, was made possible by a $1.13-million grant from Shimadzu Scientific Instruments.
 
Equipped with an array of Shimadzu’s analytical instruments, the lab is able to support diverse programs in drug discovery, freshwater science, food and beverage, environmental science and other basic life-sciences and chemistry studies. The facility features six state-of-the-art mass spectrometers, sample preparation tools, UV-visible and FTIR spectrometers, liquid and gas chromatography systems and a fully equipped tissue culture suite to enable discovery and toxicology research.
 
The Milwaukee Institute for Drug Discovery (MIDD), part of UWM’s Department of Chemistry and Biochemistry, is the primary user of the lab. The institute uses the lab to conduct NIH-funded research on new drugs for pain, schizophrenia and asthma, as well as anti-infective and anticancer drugs. MIDD frequently uses the instrumentation for structural analysis of newly synthesized drug compounds, assessment of drug metabolism and stability and assesment of pharmacokinetics and biodistribution. Neuroscientists at the university have adopted the MALDI-TOF MS for studies on central nervous system development, pain processes and learning. 
 
“Our relationship with Shimadzu allows us ready access to the market’s latest analytical innovations,” said Dr. Douglas Stafford, director of MIDD. “In the future, we hope that this lab will be used to host user workshops on new applications and instruments. This will help to keep our scientists ahead of the curve by staying connected to the wide network of MS users.”
 
“The University of Wisconsin-Milwaukee, in conjunction with MIDD, is a vibrant, growing research community, supporting interdisciplinary applications in numerous scientific programs,” said Terry Adams, vice president of marketing at Shimadzu Scientific Instruments. “Shimadzu is proud to have our name associated with such an outstanding institution and we are eager to work with the many researchers and students utilizing this impressive laboratory.”
 
Illumina NGS helps solve Ebola mystery
 
SAN DIEGO—Next-generation sequencing (NGS) has helped researchers solve an Ebola mystery out of Liberia. The case, which was published in an issue of the New England Journal of Medicine late last year, provided molecular evidence of Ebola virus transmission between a man who had the Ebola virus and his female partner. The mystery: The man’s blood had tested free of Ebola 155 days prior to the transmission.
 
Illumina Distinguished Scientist Dr. Gary Schroth was a co-author on the recent paper, and he explained that in this situation, a case of sexual transmission of the Ebola virus in Liberia was confirmed using the Illumina MiSeq System and a custom version of the TruSeq RNA Access Kit. Contributing to the work were scientists from the U.S. Army Medical Research Institute of Infectious Diseases, the Liberian Institute for Biomedical Research, the Centers for Disease Control and Prevention, the World Health Organization, the National Institutes of Health and the Ministry of Health & Social Welfare in Liberia.
 
On Sept. 23, 2014, a man in Liberia entered a hospital with the Ebola virus and was treated. By Sept. 29, his blood was Ebola negative and on Oct. 7 he left the hospital. Five months later he had unprotected intercourse with a woman who died 20 days later from Ebola. Following the woman’s death on March 27, 2015, public health officials tested a semen sample from the man by quantitative RT-PCR and it was found positive. However, the test indicated that the level of viral RNA was barely detectable and researchers couldn’t tell much more than the man’s semen was positive for Ebola.
 
At that point scientists realized they need a more advanced method to provide direct genomic evidence of whether the woman was indeed infected by this man and if the infection was caused by the same virus that infected him months earlier.
 
According to Schroth, “Illumina’s TruSeq RNA Access Kit, in conjunction with the MiSeq, was the only technique available that could provide a nearly complete full genome viral sequence from the semen sample that had barely detectable levels of Ebola when using qPCR. All they had to work with was this barely detectable virus level—probably 100- to 1,000-fold lower concentration than what they could even hope to get a genome using conventional methods. That’s where the RNA Access technology was critical to this project.”
 
The study findings have significant public health implications. The Centers for Disease Control and Prevention and the World Health Organization, for example, changed their recommendations for convalescent patients regarding sexual contact until more definitive information is obtained about how long Ebola virus can persist in semen.
 
“The public health concern is: What’s going to be the long term effect of this concept of a ‘cleared Ebola infection?’ This study has not only shown Ebola is detectable after long periods of time, but even with low viral loads—when it’s barely detectable—it still can kill someone,” says Schroth. “My group has been doing research into how to use the RNA Access method. Right now the kit we have is used to enrich for human genes, but we realized that if we just changed the probes from human probes to virus probes, this kit and protocol could be used in virology. So, we made this Ebola panel to use in collaboration with these organizations, but there is no Illumina ‘Ebola RNA Access kit’.”
 
Exostar’s Life Sciences Identity Hub now includes Veeva Vault
 
HERNDON, Va.—Exostar, whose cloud-based solutions help companies in life sciences, healthcare, aerospace and defense mitigate risk and solve their identity and access challenges, late last year announced a partnership agreement with Veeva Systems Inc., a leader in cloud-based software for the global life-sciences industry. Veeva Vault, a content management platform and suite of applications that reduces IT complexity and increases business agility, now can be accessed through Exostar’s Life Sciences Identity Hub.  The connection enables life-sciences organizations and their partners to prepare, exchange, and store clinical trials documentation with the ease and security of a single credential.
 
Exostar and Veeva are working together to streamline the provisioning process of creating Vault accounts with appropriate roles and permissions for all individuals participating in a clinical trial, regardless of their affiliation. Exostar’s Secure Access Manager (SAM) delivers an added layer of security when authenticating individuals. With SAM credentials, individuals enjoy a single sign-on experience to Vault and other applications connected to the Life Sciences Identity Hub. These credentials also support the inclusion of validated electronic signatures as documents are shared in Vault throughout clinical trials workflow processes.
 
“Bringing Vault and SAM together allows clinical trials personnel throughout our life-sciences community to fully benefit from the strengths of both solutions in a seamlessly integrated environment,” said Vijay Takanti, vice president of security and collaboration solutions at Exostar.  “Vault enables global business processes and serves as a single source of truth for content, while SAM provides the access control and document signature security necessary for information protection and compliance.”
 
“Being part of the Exostar Life Sciences Identity Hub allows easy single sign-on for companies using Vault eTMF and the other Vault applications,” said Kathryn King, vice president of Vault Clinical.  “The seamless integration Exostar has created helps companies more effectively and securely work with multiple Vault applications across their partner or client ecosystem.”
 
The Exostar Life Sciences Identity Hub gives over 1,000 sponsors, CROs, investigators, academic institutions, application providers and other industry organizations a highly-secure, connect-once environment that reduces redundancy and expenditures while speeding integration and onboarding. More than 20,000 individuals productively collaborate with one another, accessing applications and data, as defined by asset owners and controlled by SAM.
 
“The value Exostar and Veeva together are delivering perfectly illustrates the whole being greater than the sum of the parts,” said Daniel Pfeifle, Exostar’s Vice President of Sales and Marketing.  “Now that Vault is connected to the Life Sciences Identity Hub, we look forward to replicating this value throughout the industry.”
 
Better access to scientific data
 
IPSWICH, Mass.—In early December,  EBSCO Information Services (EBSCO) introduced a new information resource for researchers in the biotechnology and pharmaceutical industries. Biotechnology Source provides access to industry-leading, full-text journals from a single platform and is designed to help companies gain a competitive edge by providing fast access to relevant, current and accurate information.
 
Biotechnology Source is said to have a versatile, fully-customizable platform and content that includes more than 8,700 full-text journals, including many unique titles reportedly available only through this tool. In addition, current journals are complemented by an extensive backfile.
 
Biotechnology Source is said to be easily integrated into a company’s workflow for increased visibility and usage, and it can conveniently be accessed via mobile devices. It provides increased discoverability to reliable information via top industry journals, helping ensure that researchers are returning search results of value to their organizations. 
 
Joe Tragert, senior director of product management, says Biotechnology Source helps researchers of all experience levels navigate an increasingly complex landscape of medical and pharmaceutical literature, while surfacing reliable information, noting: “Results-oriented organizational researchers and corporate librarians don’t have time for complex and laborious search engines. They want answers and information fast. Biotechnology Source gives researchers immediate, one-click access to full-text primary literature that has been carefully vetted, so they know they can trust it to be reliable and relevant.”
Our first roundup of the year for the hardware, software and materials that make life-sciences research and pharma/biotech R&D possible brings us an expansion in Singapore, the joining of a consortium for identification of treatment response predictors, a new interdisciplinary chemistry lab, the solving of an Ebola mystery, strengthening of clinical trials content management security/compliance and a new path to accessing full-text journals.
 
Thermo Fisher opens new clinical services facility in Asia hub
 
SINGAPORE—Thermo Fisher Scientific recently announced the official  opening of its new state-of-the-art GMP facility. Having established its first clinical services facility in Singapore in 2001, the move to this newly built facility will meet the growing demand for clinical supply services in the region. The new site will provide both regional and global pharmaceutical and biotech companies with a one-stop service for clinical supplies, including GMP storage, local labeling, secondary packaging, comparator sourcing, handling and distribution of ambient and cold chain supplies and returns management.
 
Located on Toh Guan Road in Jurong East, the hub for Singapore’s biomedical and pharmaceutical companies, the new facilitiy is nearly 70,000 square feet, which is more than 60 percent larger than the previous site and double the cold chain capacity.
 
The clinical services facility is also reportedly well-equipped with improved technologies and operational tools to serve a growing need for clinical supplies and trials in the region. This includes a larger storage system for its clinical supplies, a new climatic control energy consumption system that reduces the facility’s carbon footprint, and an overall building monitoring system that provides staff with timely updates on the facility’s conditions.
 
“Asia Pacific continues to be our fastest-growing market and a central contributor to our growth,” said Leon Wyszkowski, Thermo Fisher’s vice president of clinical services for North America and facility network. “For nearly 15 years, Singapore has been the central hub for our Asia-Pacific operations, due to its strategic location. With the opening of our larger and well-equipped facility, we aim to continue to build on our Singapore facility further and on the expertise of our local team, to strengthen our regional and global presence in the clinical supplies industry.”
 
Protagen AG joins MATURA Consortium
 
LONDON—Protagen AG, a company concerned with the development of advanced diagnostic tools to address some of the most severe autoimmune diseases, in early December announced that it will join the MATURA Consortium. The overarching mission of the MATURA Consortium is to improve patient care in Rheumatoid Arthritis (RA) by rationalizing therapy decisions through a stratified medicine approach.
 
MATURA (MAximising Therapeutic Utility for Rheumatoid Arthritis) aims to identify treatment response predictors which will allow the allocation of patients to subgroups defined by the therapy they are most likely to respond to, early in the disease process. RA provides the ideal setting for the introduction of a stratified medicine approach as the treatment is standardized, there is a significant non-responder rate to each marketed and commonly used drug, and early and effective therapy has consistently been shown to improve long-term outcomes, including joint damage, disability and employment.
 
Prof. Costantino Pitzalis from Queen Mary University of London, who leads the consortium, said: “We are delighted that Protagen has joined our consortium. There are currently a number of biologic treatments in RA and at the moment, we have no way of predicting favorable patient drug response before therapy selection and treatment.” Adds Prof: Anne Barton from the University of Manchester, who co-leads the consortium: “Being able to accurately predict whether a treatment will work or not, would lead to more targeted and individual treatments as well as greater efficacy and better quality of life for patients. Protagen and its unique, proprietary SeroTag platform is a new key asset to our group of established industry partners, and significantly support our quest for Treatment Response Predictors.”
 
“Our innovative SeroTag technology allows for the first time the systematic determination of response prediction markers to select the most appropriate drug and therapy for rheumatoid arthritis,” notes
 
Stefan Müllner, Protagen’s CEO. “In addition, it enables new approaches for successful drug development, and to support patients, rheumatologists, payers and the pharma industry in our combined effort to improve patient management by rationalizing treatment decision. This is exactly what MATURA is aiming for and we feel privileged to be part of the consortium and support these efforts.”
 
Shimadzu teams with UWM to form interdisciplinary chemistry lab
 
COLUMBIA, Md.—Shimadzu Scientific Instruments recently announced the opening of the Shimadzu Laboratory for Advanced Applied and Analytical Chemistry at the University of Wisconsin-Milwaukee (UWM). The new 2,000-square-foot laboratory and office suite is a hub for research across the entire UWM campus, as well as a classroom for teaching the theory and practice of mass spectrometry. The new lab, located inside of UWM’s Kenwood Interdisciplinary Research Complex, was made possible by a $1.13-million grant from Shimadzu Scientific Instruments.
 
Equipped with an array of Shimadzu’s analytical instruments, the lab is able to support diverse programs in drug discovery, freshwater science, food and beverage, environmental science and other basic life-sciences and chemistry studies. The facility features six state-of-the-art mass spectrometers, sample preparation tools, UV-visible and FTIR spectrometers, liquid and gas chromatography systems and a fully equipped tissue culture suite to enable discovery and toxicology research.
 
The Milwaukee Institute for Drug Discovery (MIDD), part of UWM’s Department of Chemistry and Biochemistry, is the primary user of the lab. The institute uses the lab to conduct NIH-funded research on new drugs for pain, schizophrenia and asthma, as well as anti-infective and anticancer drugs. MIDD frequently uses the instrumentation for structural analysis of newly synthesized drug compounds, assessment of drug metabolism and stability and assesment of pharmacokinetics and biodistribution. Neuroscientists at the university have adopted the MALDI-TOF MS for studies on central nervous system development, pain processes and learning. 
 
“Our relationship with Shimadzu allows us ready access to the market’s latest analytical innovations,” said Dr. Douglas Stafford, director of MIDD. “In the future, we hope that this lab will be used to host user workshops on new applications and instruments. This will help to keep our scientists ahead of the curve by staying connected to the wide network of MS users.”
 
“The University of Wisconsin-Milwaukee, in conjunction with MIDD, is a vibrant, growing research community, supporting interdisciplinary applications in numerous scientific programs,” said Terry Adams, vice president of marketing at Shimadzu Scientific Instruments. “Shimadzu is proud to have our name associated with such an outstanding institution and we are eager to work with the many researchers and students utilizing this impressive laboratory.”
 
Illumina NGS helps solve Ebola mystery
 
SAN DIEGO—Next-generation sequencing (NGS) has helped researchers solve an Ebola mystery out of Liberia. The case, which was published in an issue of the New England Journal of Medicine late last year, provided molecular evidence of Ebola virus transmission between a man who had the Ebola virus and his female partner. The mystery: The man’s blood had tested free of Ebola 155 days prior to the transmission.
 
Illumina Distinguished Scientist Dr. Gary Schroth was a co-author on the recent paper, and he explained that in this situation, a case of sexual transmission of the Ebola virus in Liberia was confirmed using the Illumina MiSeq System and a custom version of the TruSeq RNA Access Kit. Contributing to the work were scientists from the U.S. Army Medical Research Institute of Infectious Diseases, the Liberian Institute for Biomedical Research, the Centers for Disease Control and Prevention, the World Health Organization, the National Institutes of Health and the Ministry of Health & Social Welfare in Liberia.
 
On Sept. 23, 2014, a man in Liberia entered a hospital with the Ebola virus and was treated. By Sept. 29, his blood was Ebola negative and on Oct. 7 he left the hospital. Five months later he had unprotected intercourse with a woman who died 20 days later from Ebola. Following the woman’s death on March 27, 2015, public health officials tested a semen sample from the man by quantitative RT-PCR and it was found positive. However, the test indicated that the level of viral RNA was barely detectable and researchers couldn’t tell much more than the man’s semen was positive for Ebola.
 
At that point scientists realized they need a more advanced method to provide direct genomic evidence of whether the woman was indeed infected by this man and if the infection was caused by the same virus that infected him months earlier.
 
According to Schroth, “Illumina’s TruSeq RNA Access Kit, in conjunction with the MiSeq, was the only technique available that could provide a nearly complete full genome viral sequence from the semen sample that had barely detectable levels of Ebola when using qPCR. All they had to work with was this barely detectable virus level—probably 100- to 1,000-fold lower concentration than what they could even hope to get a genome using conventional methods. That’s where the RNA Access technology was critical to this project.”
 
The study findings have significant public health implications. The Centers for Disease Control and Prevention and the World Health Organization, for example, changed their recommendations for convalescent patients regarding sexual contact until more definitive information is obtained about how long Ebola virus can persist in semen.
 
“The public health concern is: What’s going to be the long term effect of this concept of a ‘cleared Ebola infection?’ This study has not only shown Ebola is detectable after long periods of time, but even with low viral loads—when it’s barely detectable—it still can kill someone,” says Schroth. “My group has been doing research into how to use the RNA Access method. Right now the kit we have is used to enrich for human genes, but we realized that if we just changed the probes from human probes to virus probes, this kit and protocol could be used in virology. So, we made this Ebola panel to use in collaboration with these organizations, but there is no Illumina ‘Ebola RNA Access kit’.”
 
Exostar’s Life Sciences Identity Hub now includes Veeva Vault
 
HERNDON, Va.—Exostar, whose cloud-based solutions help companies in life sciences, healthcare, aerospace and defense mitigate risk and solve their identity and access challenges, late last year announced a partnership agreement with Veeva Systems Inc., a leader in cloud-based software for the global life-sciences industry. Veeva Vault, a content management platform and suite of applications that reduces IT complexity and increases business agility, now can be accessed through Exostar’s Life Sciences Identity Hub.  The connection enables life-sciences organizations and their partners to prepare, exchange, and store clinical trials documentation with the ease and security of a single credential.
 
Exostar and Veeva are working together to streamline the provisioning process of creating Vault accounts with appropriate roles and permissions for all individuals participating in a clinical trial, regardless of their affiliation. Exostar’s Secure Access Manager (SAM) delivers an added layer of security when authenticating individuals. With SAM credentials, individuals enjoy a single sign-on experience to Vault and other applications connected to the Life Sciences Identity Hub. These credentials also support the inclusion of validated electronic signatures as documents are shared in Vault throughout clinical trials workflow processes.
 
“Bringing Vault and SAM together allows clinical trials personnel throughout our life-sciences community to fully benefit from the strengths of both solutions in a seamlessly integrated environment,” said Vijay Takanti, vice president of security and collaboration solutions at Exostar.  “Vault enables global business processes and serves as a single source of truth for content, while SAM provides the access control and document signature security necessary for information protection and compliance.”
 
“Being part of the Exostar Life Sciences Identity Hub allows easy single sign-on for companies using Vault eTMF and the other Vault applications,” said Kathryn King, vice president of Vault Clinical.  “The seamless integration Exostar has created helps companies more effectively and securely work with multiple Vault applications across their partner or client ecosystem.”
 
The Exostar Life Sciences Identity Hub gives over 1,000 sponsors, CROs, investigators, academic institutions, application providers and other industry organizations a highly-secure, connect-once environment that reduces redundancy and expenditures while speeding integration and onboarding. More than 20,000 individuals productively collaborate with one another, accessing applications and data, as defined by asset owners and controlled by SAM.
 
“The value Exostar and Veeva together are delivering perfectly illustrates the whole being greater than the sum of the parts,” said Daniel Pfeifle, Exostar’s Vice President of Sales and Marketing.  “Now that Vault is connected to the Life Sciences Identity Hub, we look forward to replicating this value throughout the industry.”
 
Better access to scientific data
 
IPSWICH, Mass.—In early December,  EBSCO Information Services (EBSCO) introduced a new information resource for researchers in the biotechnology and pharmaceutical industries. Biotechnology Source provides access to industry-leading, full-text journals from a single platform and is designed to help companies gain a competitive edge by providing fast access to relevant, current and accurate information.
 
Biotechnology Source is said to have a versatile, fully-customizable platform and content that includes more than 8,700 full-text journals, including many unique titles reportedly available only through this tool. In addition, current journals are complemented by an extensive backfile.
 
Biotechnology Source is said to be easily integrated into a company’s workflow for increased visibility and usage, and it can conveniently be accessed via mobile devices. It provides increased discoverability to reliable information via top industry journals, helping ensure that researchers are returning search results of value to their organizations. 
 
Joe Tragert, senior director of product management, says Biotechnology Source helps researchers of all experience levels navigate an increasingly complex landscape of medical and pharmaceutical literature, while surfacing reliable information, noting: “Results-oriented organizational researchers and corporate librarians don’t have time for complex and laborious search engines. They want answers and information fast. Biotechnology Source gives researchers immediate, one-click access to full-text primary literature that has been carefully vetted, so they know they can trust it to be reliable and relevant.”
 
Code: E011629

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