Citoxlab President Keynote
Dear Valuable Customers,
The first half of 2015 confirmed and reinforced the trend seen in 2014 when we recorded increased numbers of projects entrusted to us by our clients. This positive trend comes from two key segments of our customers, large to midsize pharma as well as biotech companies. Indeed, the dramatic increase in biotech funding, initiated during Q4 2011-Q1 2012 and continuing to rise gradually over 2013, reached more than 54 billion USD in 2014, the highest recorded figure since 2000. This is of course a benefit shared by the entire CRO industry. A market survey by William Blair analysts updated in March of this year, just after the annual SOT meeting, confirmed this positive industry trend and the first two quarters of 2015 have seen new records in biotech funding.
For Citoxlab Group this translates into sales figures which increased at all 5 of our centres (Evreux and Saint-Nazaire, France; Montréal, Canada; Copenhagen, Denmark and Veszprem, Hungary). Globally, sales for Citoxlab Group increased by 22% over the first 6 months of 2015 compared to last year (54.2 vs. 44.5 Mi Euros). To face this increased demand from our customers, several of our sites hired new staff, and today our group employs more than 900 people.
Another trend to be noted is the increased complexity of the studies requested by our clients, which include evaluations like multiplex biomarkers analysis, diverse panels of cytometry, immunogenicity tests sometimes linked with cell-based assays, immunohistochemistry and multiplatform genomics investigations using Affymetrix gene chips or Illumina NGS. Our ability to offer a very large spectrum of biomarkers has become a driver for many of our customers.
I also would like to highlight our recent focus in safety pharmacology where, in addition to the classic studies to investigate cardiovascular function, we have been asked to perform more studies to assess effects on the central nervous system. We have collected validation data (in rats, dogs and NHPs) and we took the opportunity to share and publish these data in papers which were read by many colleagues (see below).
In early safety pharmacology, it is my pleasure to announce that we have decided to set up in vitro ion channel models in our Montreal facility, as we think that this service will become more necessary in the future after the recent CiPA analysis from the USFDA.
I hope that this Newsletter helps to keep you informed about the continued development of Citoxlab Group and about the services we provide with our best efforts to meet your needs, in particular in terms of scientific expertise, relevance and quality of the data and evaluation on the products you are committed to develop.
Citoxlab hires board-certified clinical-pathologists in France and North-America
We are pleased to announce the appointment of 2 Board-certified clinical pathologists at Citoxlab France (Evreux) and Citoxlab North-America (Montreal).
Myriam Defontis, DMV, IPSAV, DECVCP is a Doctor of Veterinary Medicine and Diplomate of the European College of Veterinary Clinical Pathology (ECVCP). She worked for 3 years as head of clinical pathology and immunology department at Labéo Frank Duncombe (Caen, France). She has completed residencies in preclinical safety at Novartis AG (Switzerland), and the Justus-Liebig University (Giessen, Germany), where she specialized in clinical pathology techniques such as hematology, immunology, cytology, urinalysis, biochemistry, flow cytometry, multiplexing, hemostasis and endocrinology.
Virginie Allegret, DVM, IPSAV, DES, DACVP is also a Doctor of Veterinary Medicine and Diplomate of the American College of Veterinary Pathologists (ACVP). Before joining Citoxlab, Virginie worked at Charles River (Canada) for 5 years where she gained expertise in hematology, biochemistry, cytology, urinalysis and hemostasis.
Joining the Citoxlab pathology team of 15 experienced board-certified pathologists; Myriam Defontis and Virginie Allegret will supervise and coordinate all activities in clinical pathology, oversee analyses, evaluate and write clinical pathology reports. Myriam and Virginie will be valuable assets to Citoxlab as they will be offering our clients and teams the benefits of their scientific and technical expertise.
“To keep pace with the growing interest in exploring immunology during the safety assessment of vaccines, adjuvants and immune therapies, Myriam Defontis and Virginie Allegret will be actively supporting the emergence of the immunomonitoring platform while ensuring the development and validation of new biomarkers in particular in flow cytometry .”, said Bernard Palate, Director of Pathology and Veterinary Services.
Citoxlab invests for new ophthalmology treatments
Many Pharma and Biotech companies are currently interested in the treatment of diseases of the eye and defects of vision. Consequently, clients have come to Citoxlab with numerous ocular projects. One important target for new therapeutic approaches is macular degeneration, where small molecules, monoclonal antibodies and other therapeutic modalities are under evaluation. Gene therapy constructs are being developed to correct genetic deficiencies that are the basis of some inherited conditions affecting eyesight. As with other medicinal products, preclinical safety studies are required on these products involving an evaluation of tolerance and potential toxicity as well as studies to evaluate biodistribution using qPCR to trace the distribution and elimination of the product. Preclinical studies for ocular products are typically performed in rabbits, dogs, minipigs or monkeys and should follow the intended clinical route of administration. These studies often involve intravitreal injection, but may require more complex administration techniques such as retinal implantation or the use of sophisticated ocular devices. Follow-up of treated animals to demonstrate good tolerance of the drug can involve not only standard ophthalmological evaluations by trained veterinarians and histopathology performed by experienced pathologists, but also the evaluation of ocular function by electroretinography and detailed observations by optical coherence tomography (OCT). At Citoxlab, we offer each of these services and have started building reference data for OCT in dogs and monkeys. OCT is a non-invasive technique and offers several advantages for structural and functional evaluation of the retina. We hope that providing these tools for our clients will result in important clinical benefits for patients. We would be happy to discuss your projects in the area of ocular disease.
Citoxlab leads In Situ hybridization studies
Citoxlab offers a wide range of comprehensive immunohistochemistry (IHC) and in situ hybridization (ISH) services. These services allow you to rapidly visualize one or multiple proteins or to localize specific RNA sequences in human and animal tissues or cells using fluorescent or chromogenic methods. Multiple proteins may be localized at the same time in a tissue or cell using carefully selected fluorophores or chromogens. Multiplexing is a powerful tool when co-localization of proteins is needed.
The Citoxlab IHC & ISH platform is equipped with 4 Ventana automated staining machines, which makes workflow efficiency and flexibility easier. Aside from the panels of markers already available, such as those associated with inflammatory cell characterization and viral detection in monkeys, Citoxlab has the capabilities to develop many new markers, in oncology for example.
Citoxlab also has broad experience with Tissue Cross-Reactivity (TCR) and different types of antibodies including classical Ab, Fab fragment, biotinylated Ab, IgG4 Ab, Peg-Fab, bispecific Ab, human single chain variable fragment (scFv), cytotoxic – conjugated Ab (ADC) and vaccine induced Abs.
Citoxlab proposes a broad range of established protocols for over 100 different biomarkers in human and various lab animal tissues. Other staining protocols may be developed on request.
Dedicated board certified pathologists provide proficient scientific advice, best practices regarding documentation and cost effective solutions in the development of efficient methods to meet your expectations.
Publication of Citoxlab safety pharmacology articles viewed 4176 times!
Science is the main focus of our daily research activities and the Citoxlab team is pleased to see that this passion for innovation in drug development is shared worldwide. Our team published three articles related to safety pharmacology last year and the scientific community responded very positively.
The central nervous system (CNS) was of major interest, with one article on sleep studies (including polysomnography with EEG, EOG and EMG)1 and another addressing seizure liability assessments across a range of species2. Both articles discuss important considerations during drug development and the interest of translational value from non-clinical research to patient populations.
The third article focuses on a non-invasive model for respiratory investigations in toxicology studies3.
As expected, regulatory aspects of drug safety testing remain a major theme in scientific discussions within our team, and the publications aimed to share ideas and concepts applied to drug discovery and development in the field of non-clinical regulatory studies. Our team remains committed to excellence in drug development, and we are pleased to share knowledge acquired in the exciting area of safety pharmacology.
Access a copy (2) for free: http://www.sciencedirect.com/science/article/pii/S105687191400238X
1: Sleep electroencephalographic characteristics of the Cynomolgus monkey measured by telemetry. Rachalski A, Authier S, Bassett L, Pouliot M, Tremblay G, Mongrain V. J Sleep Res. 2014 Dec;23(6):619-27. doi: 10.1111/jsr.12189. Epub 2014. Aug 11. PubMed PMID: 25109588.
2: Telemetry video-electroencephalography (EEG) in rats, dogs and non-human primates: methods in follow-up safety pharmacology seizure liability assessments. Bassett L, Troncy E, Pouliot M, Paquette D, Ascah A, Authier S. J Pharmacol Toxicol Methods. 2014 Nov-Dec;70(3):230-40.
3: Effects of amphetamine, diazepam and caffeine on polysomnography (EEG, EMG, EOG)-derived variables measured using telemetry in Cynomolgus monkeys. Authier S, Bassett L, Pouliot M, Rachalski A, Troncy E, Paquette D, Mongrain V. J. Pharmacol Toxicol Methods. 2014 Jul-Aug;70(1):86-93.
Biomarkers included in Acute Radiation Syndrome studies
Biomarkers offer several advantages including longitudinal evaluations of biological progression in the same individuals and also a high translational value when the same biomarkers can be applied to the clinic. C-Reactive Protein (CRP) and Citrulline are well established diagnostic tools with solid scientific foundations to assess inflammation and gastrointestinal function, respectively. Our team has applied biomarker analysis technologies including ELISA and LC-MS/MS to characterize time course plasma concentrations in non-clinical studies. These biomarkers were qualified in normal individuals but also in efficacy models of acute radiation syndrome (ARS) for drug development. Normal values for these biomarkers were evaluated and compared across a range a species including rodents and non-rodents. Interestingly, circadian cycle effects were observed in the absence of drug treatment and also changes associated with feeding and other experimental conditions such as anaesthesia. Moreover, the kinetics of the changes were correlated with body surface area (BSA) providing a robust framework for results interpretation. This extensive characterization of clinically relevant biomarkers can be applied to non-clinical safety and efficacy studies to increase sensitivity in drug development. Our results will be presented at the 61st Annual Meeting of the Radiation Research Society (RRS) in Weston Florida, 2015 Sept 19-22.
atlanbio successfully renewed its GLP/GMP certification
Following an inspection by the French National Agency for Medicines and Health Products (ANSM) in March 2015, the GLP compliance certification of atlanbio was successfully renewed. Quality systems are a key element of the services atlanbio offers to clients. All the regulatory studies adhere to international GLP standards as required.
Philippe Couerbe, President of atlanbio commented: “The successful renewal of our GLP certification is an essential element for our ongoing business and reflects our continued focus on our quality systems and its improvement.”
Moreover, atlanbio is proud to announce that the company is fully compliant with GCP expectations. The QA organization has been completed by the end of 2014 and all clinical studies performed in 2015 receive an official QA statement for this compliance. The choice of atlanbio has been to put in place the highest compliance standards, based on the GLP experience of the company.
Within Citoxlab Group, atlanbio is a flexible, high-technology organization dedicated to preclinical and clinical bioanalysis, and offering a large panel of techniques including mass spectrometry for small and large molecules, immunoassays, immunogenicity testing and cell-based assays.
Atlanbio GLP statement: http://www.atlanbio.com/images/organization/quality/Certificat_BPL_2015.pdf
· 5th Infusion Meeting (ITO) – Germany, Cologne – 2015 September, 7-8
· 51st Congress of the European Societies of Toxicology – Porto, Portugal – 2015 September, 13-16
Booth 27 & 28
· 61st Annual Meeting of the Radiation Research Society – Weston, Florida – September 19-22, 2015
· 13th ESTP and BSTP – Guldford, UK – 2015 September, 22-25
· Chemical Industry Regulation Meeting (CIR) – Barcelona, Spain – 2015 September, 23-24
· 15th Annual meeting of Safety Pharmacology Society – Czech Republic, Pragues – 2015 September, 29 – October, 1st
Citoxlab Newsletter September 2015