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News Article | February 28, 2017

BEIJING--(BUSINESS WIRE)--Pharmaron, a fully integrated contract research organization offering R&D services to the life sciences industry, today announced that it has signed a definitive agreement under which Pharmaron will acquire a majority stake in Shin Nippon Biomedical Laboratories Clinical Pharmacology Center, Inc. (“SNBL CPC”) in Baltimore, Maryland, USA. This clinical center is a leading provider of moderate and highly complex Phase I/II clinical development services for the life sciences sector. Current shareholder Shin Nippon Biomedical Laboratories, Ltd. (SNBL) (TSE:2395) will retain a minority stake in the business following the transaction. SNBL CPC is a full-service clinical CRO located on the campus of the University of Maryland BioPark. Since its inception in 2005, over 200 studies have been completed in the purpose-built, clinical pharmacology unit. Many of these completed clinical studies have been submitted in support of global regulatory filings for drug approval for marketing of both small and large molecules. This strategic acquisition allows Pharmaron to be one-step closer to offering a full spectrum of R&D services. Addition of this capability to the Pharmaron Group naturally complements and expands Pharmaron’s existing drug R&D services, further consolidating the clinical development capabilities, through synergistic integration with recently acquired radiolabelled science capabilities, including Quotient Bioresearch’s clinical metabolism in the UK and Xceleron’s AMS-based 14C-microtracer technology in the USA. Mr. Larry Lou, President and COO of Pharmaron commented: “We are delighted to have SNBL CPC join the Pharmaron Group. This is an important milestone for Pharmaron. Once integrated and further developed, the new clinical platform will fuel the corporate engine for business growth in a sustainable manner. This is another testimony of our determination to fully realize our mission to support our clients’ success in discovery, development and commercialization of important medicines and fulfill our vision to be a global leading organization in the life sciences service industry.” Dr. Ryoichi Nagata, Chairman and CEO of SNBL commented: “The mission of SNBL CPC has been to offer complex and innovative clinical pharmacology services in close proximity to leading university medical centers. Through this transaction, we look forward to seeing future growth of CPC as part of Pharmaron Group.” The financial terms of the transaction are not being disclosed. Teneo Capital served as financial advisor to Pharmaron; O’Melveny & Myers LLP served as Pharmaron’s legal advisor. SC&H Capital served as financial advisor to SNBL; Miles & Stockbridge P.C. served as legal advisor to SNBL. Pharmaron is a private, premier R&D service provider for the life sciences industry. Founded in 2003, Pharmaron has invested in its people and facilities, and established a broad spectrum of R&D service capabilities ranging from synthetic and medicinal chemistry, biology, DMPK, pharmacology, safety assessment, radiochemistry and radiolabelled metabolism, clinical analytical sciences to chemical & pharmaceutical development. With over 4,000 employees, and operations in China, the United States, and the United Kingdom, Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan and China. SNBL CPC is a clinical pharmacology facility located in the University of Maryland BioPark in Baltimore, Maryland, USA. The state of the art facility and equipment is bolstered by a vibrant research community. SNBL CPC specializes in complex Phase I-II trials, including TQT/Phase 1 QT de-risking, first-In-human (FIH), Japanese Bridging and Phase II Proof of Concept (POC) studies in therapeutics areas including immunology/infectious disease, neurology, respiratory, dermatology and more. SNBL CPC conducts clinical trials from multiple sectors, including biopharmaceutical and biotech industry, academia, and the government. SNBL CPC offers full service support of clinical trials through its in-house resources, expert partners from surrounding universities and practices. Proximity and the agreements that SNBL CPC has developed with the University of Maryland, Baltimore and Johns Hopkins University makes this facility best of its kind.

Farrell D.J.,Quotient BioResearch | Krause K.M.,Theravance | Benton B.M.,Theravance
Diagnostic Microbiology and Infectious Disease | Year: 2011

The in vitro activity of telavancin was determined for 94 diverse Staphylococcus spp. Telavancin had MIC 90 values of 0.5 μg/mL for methicillin-susceptible, methicillin-resistant, and vancomycin-susceptible Staphylococcus aureus, and coagulase-negative staphylococci isolates. Telavancin MICs were 0.5-1 μg/mL for vancomycin-intermediate S. aureus isolates and 2-4 μg/mL for vancomycin-resistant S. aureus strains. © 2011 Elsevier Inc.

Neville D.,Quotient Bioresearch | Houghton R.,Quotient Bioresearch | Garrett S.,King's College London
Bioanalysis | Year: 2012

Background: Several new products have been marketed with the specific capability of removing phospholipids. These products were evaluated alongside more traditional extraction techniques, using UHPLC and precursor-ion scanning (pre m/z 184), which detects glycerophosphocholines (GPCho), lyso-GPCho and sphingomyelins. Using this technique the plasma GPCho profile of human, dog and rat plasma is briefly compared. Results: Precursor-ion scanning detected more of the phospholipid profile in extracts than a SRM experiment (m/z 184-184). Products designed for the purpose were the most efficient at removing phospholipids and reversed-phase SPE was better than mixed-mode cation exchange. A comparison of different UHPLC columns demonstrated that C 8 or phenyl phases would help manage the elution of GPChos. Conclusion: Phospholipid removal plates are useful where no sample concentration is required; however for more challenging LOD it will be necessary to enrich the original sample. In these cases build-up of phospholipids can be avoided with a thoughtful choice of UHPLC column. © 2012 Future Science Ltd.

Kruger A.,University of Cambridge | Kruger A.,Max Planck Institute for Molecular Genetics | Vowinckel J.,University of Cambridge | Mulleder M.,University of Cambridge | And 6 more authors.
EMBO Reports | Year: 2013

Cells counteract oxidative stress by altering metabolism, cell cycle and gene expression. However, the mechanisms that coordinate these adaptations are only marginally understood. Here we provide evidence that timing of these responses in yeast requires export of the polyamines spermidine and spermine. We show that during hydrogen peroxide (H 2 O 2) exposure, the polyamine transporter Tpo1 controls spermidine and spermine concentrations and mediates induction of antioxidant proteins, including Hsp70, Hsp90, Hsp104 and Sod1. Moreover, Tpo1 determines a cell cycle delay during adaptation to increased oxidant levels, and affects H 2 O 2 tolerance. Thus, central components of the stress response are timed through Tpo1-controlled polyamine export. © 2013 EUROPEAN MOLECULAR BIOLOGY ORGANIZATION.

Coelho J.R.,University of Lisbon | Carrico J.A.,University of Lisbon | Knight D.,Quotient Bioresearch | Knight D.,University of Western Australia | And 4 more authors.
PLoS ONE | Year: 2013

Background: The rise of antibiotic resistance in pathogenic bacteria is a significant problem for the treatment of infectious diseases. Resistance is usually selected by the antibiotic itself; however, biocides might also co-select for resistance to antibiotics. Although resistance to biocides is poorly defined, different in vitro studies have shown that mutants presenting low susceptibility to biocides also have reduced susceptibility to antibiotics. However, studies with natural bacterial isolates are more limited and there are no clear conclusions as to whether the use of biocides results in the development of multidrug resistant bacteria. Methods: The main goal is to perform an unbiased blind-based evaluation of the relationship between antibiotic and biocide reduced susceptibility in natural isolates of Staphylococcus aureus. One of the largest data sets ever studied comprising 1632 human clinical isolates of S. aureus originated worldwide was analysed. The phenotypic characterization of 13 antibiotics and 4 biocides was performed for all the strains. Complex links between reduced susceptibility to biocides and antibiotics are difficult to elucidate using the standard statistical approaches in phenotypic data. Therefore, machine learning techniques were applied to explore the data. Results: In this pioneer study, we demonstrated that reduced susceptibility to two common biocides, chlorhexidine and benzalkonium chloride, which belong to different structural families, is associated to multidrug resistance. We have consistently found that a minimum inhibitory concentration greater than 2 mg/L for both biocides is related to antibiotic non-susceptibility in S. aureus. Conclusions: Two important results emerged from our work, one methodological and one other with relevance in the field of antibiotic resistance. We could not conclude on whether the use of antibiotics selects for biocide resistance or vice versa. However, the observation of association between multiple resistance and two biocides commonly used may be of concern for the treatment of infectious diseases in the future. © 2013 Coelho et al.

Agency: European Commission | Branch: FP7 | Program: CP-FP | Phase: KBBE-2008-2-4-02 | Award Amount: 4.40M | Year: 2009

Biocides have been in use for hundreds of years for antisepsis, disinfection and preservation. Despite this widespread and ever increasing use most bacterial and fungal species remain susceptible to biocides. The dramatic increase and spread of resistance to antibiotics linked to reports of co- and cross-resistance between antibiotics and biocides raised speculations on potential hazard of biocide use. The overarching question which BIOHYPO is aimed to address is: has the use of biocides contributed to the development and spread of clinically significant antibiotic resistance in human pathogens? Core of BIOHYPO are a high throughput screening approach on collections of thousands of well characterized microorganisms and an interactive web based data analysis platform. Phenotypic screening for reduced susceptibility to biocides, detection of novel resistance genes and mobile elements, and screening for their molecular epidemiology and metagenomics will be accompanied by methodological innovation for testing, risk evaluation and registration of biocides. Altogether BIOHYPO aims to provide solid data and analysis to direct future issuing of guidelines for safe environmental, medical and industrial use of biocides.

Howard J.W.,Quotient Bioresearch | Kay R.G.,Quotient Bioresearch | Pleasance S.,Quotient Bioresearch | Creaser C.S.,Loughborough University
Bioanalysis | Year: 2012

There is increasing interest within the pharmaceutical industry in the development of proteins and peptides as drugs in addition to their use as biomarkers. Immunochemistry-based techniques have been traditionally used for the quantitation of proteins and peptides; however, LC-MS-based methodologies are being increasingly adopted as they offer several advantages. UHPLC is well established within the small-molecule community as a means to increase resolution and/or the speed of separations prior to MS detection; however, it is rarely applied to proteins or peptides separations. In this paper, current applications of UHPLC to such separations are reviewed, as well as considerations with regard to the effect of altering various chromatographic parameters. © 2012 Future Science Ltd.

McEwen A.,Quotient Bioresearch | Henson C.,Quotient Bioresearch
Bioanalysis | Year: 2015

Traditional bioanalytical measurements determine concentrations of drug and metabolites in plasma; however, most drugs exert their effects in defined target tissues. As there is no clear relation between concentrations in plasma and those in tissue, alternative methods must be employed to study the absorption, distribution, metabolism and excretion properties of new therapeutic agents. Quantitative whole-body autoradiography is used in the drug development process to determine the distribution and concentrations of radiolabeled test compounds in laboratory animals. Quantitative whole-body autoradiography can provide information on tissue PKs, penetration, accumulation and retention. Although the technique is considered the industry standard for performing preclinical tissue distribution studies, it is perhaps timely, 60 years after the first reported use of the method, to re-assess the technique against modern alternatives. © 2015 Future Science Ltd.

A simple, low cost system for the backflushing of capillary gas chromatography (GC) columns has been investigated and integrated into a method for the detection of anabolic steroids in equine urine. The modification to the method was simple to make and quick to setup and optimize. The use of backflushing technology was found to offer significant benefits in terms of sample throughput and improved system robustness. © 2010 Elsevier B.V.

Kingsley C.,Quotient Bioresearch
Sp2 | Year: 2010

The Bioanalytical Sciences division of Quotient Bioresearch was set up in response to the needs of the marketplace and has developed a range of technologies and services in the areas of immunogenicity testing for biotherapeutics; measuring immune response to new drugs coming to market; cell-based neutralising antibody assays; bioanalytical testing; and other services related to biopharmaceuticals.

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