> 24 March 2015: 2:30 PM – 3:30 PM
Room 24B at the San Diego Convention Center.
> Reproductive and Juvenile Studies in minipigs
In this joint Citoxlab/Ellegaard session, we will present the reproductive biology of Göttingen minipigs, theory and practice of embryofetal toxicology studies in minipigs as well as theory and practice of juvenile toxicity studies. The session, illustrated with case histories based on Citoxlab’s extensive background in the use of minipigs for these types of study, should interest both specialists and generalists.
Citoxlab is proud to announce that Michael Pugsley has joined our global team of scientific experts in drug safety and efficacy assessments. Dr. Pugsley brings considerable expertise in the field of drug development with more than 20 years of experience in the Industry. He has occupied a wide range of leadership positions with overview of regulatory submissions for small molecules and biologics in numerous therapeutic areas including oncology, cardiovascular, metabolic and infectious diseases. Dr. Pugsley is also recognized for his very active contribution to multiple harmonization initiatives including with ILSI/HESI and the Safety Pharmacology Society (SPS). With a solid knowledge in the design and conduct of non-clinical programs, he will support Citoxlab clients from early exploratory assays to definitive IND-enabling GLP studies. More specifically, Dr. Pugsley will assist Citoxlab clients in achieving their goals through scientific advice on the design and conduct of critical non-clinical studies, bringing new therapies to patients.
To face the increase in demand for studies from the chemical, agrochemical and pharmaceutical industries, Citoxlab in Hungary has extended its inhalation capacity with the addition of a new, purpose-built rodent dosing suite containing five new exposure systems. This brings the capacity for rodents to a total of four suites with 16 isolated cabinets, each accommodating one exposure tower. The exposure system used is nose-only, dynamic, flow past and modular.
The rodents are held in circularly arranged polycarbonate restraint tubes, which allow only the nares to enter the exposure port. Tubes of different sizes are available to accommodate animals of various body weights to minimize stress. The special design of the tubes allows heat regulation of restrained animals.
Fresh aerosol from the generation system is constantly supplied to the inner plenum (distribution chamber) of the exposure system, which is under positive pressure. The aerosol is distributed to the individual exposure ports. After passing through the animal’s breathing zone, spent aerosol enters the outer cylinder from where it is exhausted through a suitable filter system.
The exposure system is equipped with flow controllers, pressure, temperature, relative humidity, oxygen and CO2 sensors, and the data are captured via a computerised control system.
In addition to rodent inhalation, exposure of dogs is performed using individual exposure masks in the dog inhalation unit. The dog exposure system consists of 4 complete units allowing simultaneous exposure of 4 dogs in each. There is an additional unit dedicated to the control group. The units each consist of two anodised aluminium chambers, individual exposure masks and are equipped with flow controllers, pressure, temperature, RH, oxygen and CO2 sensors and a computer controlled system.
The facility has performed more than 300 studies via the inhalation route over the past 5 years ranging in duration from acute to 6 months. The Principal Scientist, for inhalation has over 20 years of experience in inhalation toxicology with a range of chemical and pharmaceutical materials. Other scientific and technical staff in the inhalation group have an average of 8 years’ experience each.
Leveraging your non-clinical data for better decision-making
Central nervous system (CNS) and neurological indications are the second most frequent in clinical trials after oncology drugs. CNS drugs are the most frequently associated with polysomnographic perturbations. The incidence of sleep disorders increases proportionally with age in the patient population and identification of a drug-induced sleep disorder can have an important impact on the prescription rate of a novel therapy. Sleep disorders are also considered as an emerging cardiac risk factor in aging populations. Non-clinical studies conducted during drug development provide a unique opportunity to investigate potential effects of a test article on sleep architecture. Furthermore, polysomnography can be added to existing non-clinical studies in some cases enabling an ethical and economical strategy to assess drug safety and the impact on the sleep cycle. Computerized sleep scoring methodologies have been well-established by our team and allow for accurate and reproducible quantification of normal and post-dose sleep characteristics (1, 2, 3). Our team has developed integrative analysis procedures using electroencephalograms (EEG), electromyograms (EMG) and electrooculograms (EOG) for optimal output, enabling rapid decision-making on drug candidates with potential sleep disturbance effects.
Figure: Spectral analysis illustrating the effects of diazepam in a non-rodent model (red dots; p<0.05)
1: Rachalski A, Authier S, Bassett L, Pouliot M, Tremblay G, Mongrain V. Sleep electroencephalographic characteristics of the Cynomolgus monkey measured by telemetry. J Sleep Res. 2014 Dec;23(6):619-27.
2: Bassett L, Troncy E, Pouliot M, Paquette D, Ascah A, Authier S. Telemetry video-electroencephalography (EEG) in rats, dogs and non-human primates: Methods in follow-up safety pharmacology seizure liability assessments. J Pharmacol Toxicol Methods. 2014 Nov-Dec;70(3):230-40.
Citoxlab is delighted to announce the appointment of Dr. Pramila Singh, who joins the company with over 15 years of diversified experience in toxicology research and development. Dr. Singh brings a wealth of experience and years of commitment to building customized toxicology programs across a broad spectrum of drug and chemicals applications in various regions.
Dr. Singh previously conducted original research in allergy-related respiratory disease at the U.S. Environmental Protection Agency and has a PhD in Pharmaceutical Sciences. She has held leadership positions at Makhteshim Agan Industries and Syngenta (USA), where she managed required toxicology programs for new compound development.
Dr. Singh previously worked at Pharmaceutical Product Development (PPD, USA), supporting small, mid and large-size drug and medical device companies in a wide range of pre-IND activities and during clinical development. She has broad experience working with global regulatory authorities and in synthesizing preclinical study programs that fulfill both scientific and regulatory requirements. One of her missions will be to support the Departments of Reproductive and Developmental Toxicology and Safety Pharmacology as well as General Toxicology Services at Citoxlab, France.
As a leading scientist in our global team of scientific experts, Dr. Singh will bring positive value to clients at Citoxlab.
U.S. FDA and French ANSM (National Agency for Drug Safety) conduct a joint international inspection in the context of routine overseas inspection. This inspection involved 5 inspectors (3 from the U.S. FDA and 2 from ANSM) over 5 days and included full audits of 4 general toxicology studies and the associated analytical studies. The inspectors’ report following this joint inspection concluded that the audited studies were conducted in full accordance with GLP requirements without any major observations. This joint international inspection was a success and the first of its kind for Citoxlab in France.
BOOTH no. 2327. San Diego, US, 22-26 March 15
BOOTH on the BLOCK no. 6M60 / Hall 6.
BOOTH no. 12. Solihull, UK, 20-22 April 2015
You can access the posters presented and all the details about the events where we will be participating by clicking here.