Biotech Israel – HBI – The leading nonclinical development service provider in Israel, invites you to enjoy HARLANEWS.

Are you considering non clinical product development ? call Harlan now at 08-9409451 and share our expertise, scientific excellence , high quality nonclinical GLP studies, data interpretation, and regulatory support

TELEMETRIC PHYSIOLOGICAL MONITORING AT HARLAN The use of wirelessimplantable devices for monitoring and collecting physiological data today constitutes an integral part of any pre-clinical safety and toxicity test program. Use of implantable probes at Harlan Israel to evaluate temperature, blood pressure, ECG, EMG and physiological components, eliminates the use of older & traditional monitoring methodologies in the anesthetized animal preparation that interfere with the proper evaluation of the test animal’s physiologicalreactions

. HARLAN part of the BERESHIT STEM CELL CONSORTIUM

The consortium comprises Israeli companies and forefront academic

research institutions.

was admitted to the consortium to provide tools and techniques for GLP qualified pre-clinical models. We apply our expertise for the development of a preclinical program for the evaluation of cell therapies’ safety and efficacy.

DO YOU HAVE ALTERNATIVES TO ANIMAL TESTING FOR SCREENING AND LEAD COMPOUND OPTIMIZATION ?Concerns about animal welfare and interest in higher throughput testing have led researchers to develop alternative in-vitro test methods for current in-vivo safety and efficacy tests. Alternative tests may reduce the number of mammals in conventional testing and eliminate suffering associated with conventional animal test methods. In vitro testing is, cheaper, simple, rapid and easy to perform. Thus new approaches not only reduce suffering but also pave the way for R&D savings. Alternatives to animal testing has become increasingly important replacement for, or as complement to, traditional animal-based toxicology testing in the cosmetics, personal care, household products, and pharmaceutical industries. Alternative tests are integrated within HARLAN's activities for the screening of compounds and the selection of lead candidates based on their efficiency, toxicity and ADME properties.

HARLAN is well positioned to handle the episode of banning animal testing for cosmetics in Israel if the Jan 2007 Keneset proposal turns into law. Ask HARLAN for an alternative to animal testing model i.e. an in vitro system that might fit your requirements.

Immunodeficient

Model Selection

Immunodeficient mouse models are useful as hosts for propagation of malignant cells and tissues. Such models have been used for both allogeneic, xenogeneic transplantation studies. To select the best model for a study , which is not simple we consider the following 1.Characteristics of mutation including : Mechanism of action, Cell types affected, Immune defects secondary to mutation of interest, Effects of mutation on breeding and life span, phenotype effects 2.Characteristics of background strain including Related research studies, type of research, strain specific characteristics 3.Mutation strain interaction including : Effects on strain specific spontaneous disease, Associated phenotype effects, Strain dependent scid Leakiness resulting in some functional B and T cells, Thymic lymphoma development. For more information call HARLAN 08-9409451

Recently Harlan Israel has completed the GLP certification of specialized large animal units capable of housing pigs, sheep and goats. Harlan Israel now offers the full range of toxicology and pharmacology contract research services, including acute, sub-chronic, and chronic studies performed in large animals. Pigs having both anatomical and physiological similarities to man, are a species of an ever growing demand for the safety evaluation of pharmaceuticals and medical devices toxicity. Several unique pig features include : coronary artery distribution more similar to humans than any other animal, very similar heart output to humans, higher pulmonary pressure, and a similar to man lung size. Available large animals surgery capabilities at Harlan comprises simple minimally invasive as well as complex surgical procedures, on-line monitoring of major physiological vital signs, x-rays and fluoroscopy, and assessment of radio-labeled Test Items.

GENERAL KNOWLEDGE

Pharmcogenomic

14.12.06 a draft ICH guidance aimed at facilitating the development and approval of pharmacogenomic and pharmacogenetic drugs establishes consistent definitions of key terms in the disciplines.

Predictive Safety Testing Consortium

was established as a collaboration of industry, academia, and FDA to identify and clinically qualify safety biomarkers that will improve understanding of a compound's safety profile to cut a novel medical treatment time to market.

1.2.2007 Stem Cells Research Guidelines Released The main scientific group for stem cell scientists released 15 pages of ground rules governing human embryonic stem cell research but failed to reach a consensus on the issue of paying donors for their eggs. The International Society for Stem Cell Research is seeking to encourage uniform research practices, but its rules are not bindingervice.

Biocompatibility Testing and Toxicology Profiles for Medical Devices preclinical Development – The Harlan advantage

Biological evaluation of medical device is preformed to determine the potential toxicity resulting from contact of medical device component materials with the body. At Harlan safety evaluation studies in vitro and in vivo are conducted on a variety of biomaterials, medical devices and related products to identify the presence of toxins and harmful effects. The testing is performed to evaluate biocompatibility appropriate to an intended use of the device or component. Models applied for testing surface devices that include three categories : 1) devices in contact with the skin only 2) devices communicating with intact mucosal membranes and 3) devices that contact breached or otherwise compromised body surfaces, comprise less demanding test program than toxicological models for implanted devices that contact the blood. Over the last 20 years the rapid pace of the materials science has yielded a continuous updating of biocompatibility testing guidelines, published by the International Organization for Standardization. The ISO 10993 entails a series of standards for evaluating the biocompatibility of an implant prior to a clinical study. These standards are recognized by most international regulatory authorities, and include procedures for cytotoxicity, skin sensitization, dermal irritation and

Intracutaneous reactivity, acute systemic toxicity, subchronic toxicity, mutagenicity, implantation, hemocompatibility, chronic toxicity, carcinogenicity and reproductive/ developmental tests. When you are in need for a contract research organization be sure to select one that has avoided FDA enforcement activities. Such is Harlan Israel the sole provider in the country of Medical Device GLP Accredited Biocompatibility tests

JUST FOR FUN : 2 Hydrogens : The first one : Hey ! I think I have lost an electron. The second one replies : Are you sure ? The first one than says : Yeah ! I'm positive