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Contract Research Canadian Trade Consulate Denver, CO October 2006 CANTEST Overview Founded in 1969 Head office in Burnaby, British Columbia Over 300 employees Strong history and consistent growth 6L + 1000E + 9F = 2011 12-Dec-08 2 Company History – Highlights 1969 7 employees Drug testing in horses 1970/71 Testing expanded into Environment, Food & Industrial Chemistry 1973 One of the first laboratories to use Gas Chromatograph / Mass Spectometer (GC/MS) 1979 Acquired first personal computer (a Commodore PET) 1980 Introduction of first Laboratory Information Management System (LIMS) 1987 Quality Assurance & Quality Control become fulltime functions 1989 One of the first laboratories to use Liquid Chromatograph / Mass Spectometer (LC/MS) 1996 1999 2001 Joint Venture with Axelson BioPharma Research (ABR) Opening of Winnipeg Lab 2003 CANTEST acquires equity position in Vancouver Clinical Trial Facility 2005 ABR becomes CANTEST BioPharma CANTEST Victoria moves to new location 2006 CANTEST acquires Elemental Research Inc. (ERI) and Vizon Scitec Formal Relocation Laboratory to current Accreditation facility from Standards Council of Canada (SCC) 12-Dec-08 3 CANTEST Overview Primary Lines of Business Life Sciences GMP Analytical GLP Bioanalytical GCP Clinical Research Industry and Government Food Safety Material Sciences Forensic Drug Equine Testing Environmental Quality PIE – Pharmaceuticals in the Environment Environmental Industrial Hygiene & Microbiology 12-Dec-08 4 Corporate Overview Corporate Services Financial Facility Management Quality Assurance Marketing and Communications Human Resources Information Technology Information Systems 12-Dec-08 5 Geographic Representation 12-Dec-08 6 Accomplishments in 2005/2006 12-Dec-08 7 Focus on Technology Liquid Chromatography Tandem Mass Spectrometry 8 LC-MS/MS Inductively Coupled Plasma Mass Spectrometry 6 ICPMS Ion Chromatography –trace anion/cation analysis (e.g. Chloride, Fluoride, Acetate) Conventional LC & GC UV/FID/Mass Spectrometry 35 GC-MS 17 LC-MS Chromatography-ICPMS (LC-ICPMS) – speciation & protein binding Information Technology 20 servers in a centralized & redundant modular server system Redundant storage, weekly & daily incremental back-ups all data Over 200 networked PCs on a distributed network 12-Dec-08 8 Life Sciences Initiatives Jan. 2006 Biopharmaceutics Services API 5000 LC-MS/MS – trace level analysis March 2006 PI/II Clinical Research Services April 2006 Trace Elemental Analytical Services June 2006 $9.5 M Physical Expansion July 2006 Pharmaceuticals in the Environment (PIE) Services 12-Dec-08 9 Life Sciences Analytical Services New product API registration GMP analytical development Pharmaceutics in the Environment (PIE) Non-clinical & Clinical Services Drug discovery support GLP Bioanalytical method development & validation Biopharmaceutics Services (PK design & Stats) GCP Phase I/IIa clinical research 12-Dec-08 10 Analytical Services GMP Compliant • • • • • Batch Release testing (ie peptides) Residual catalyst analysis (ie. Palladium) Heavy metal analysis (API, excipients) Raw material/impurity characterization Stability/Forced Degradation testing Extractables/leachables in containers, packaging, medical devices(Catheters, Implantable Lenses, Syringes etc.) • • Medical device bio-compatability testing 12-Dec-08 11 Analytical Services Pharmaceuticals in the Environment Ecotoxicology Aquatic & Terrestrial Toxicity Testing Bioaccumulation Biodegradation /extractables Mass balance studies OECD GLP studies 12-Dec-08 12 Bioanalytical Services Drug Discovery Support Method development, transfer & optimization Method qualification across matrices Metabolite identification and profiling Early Pharmacokinetic bio-analysis Protein binding studies (free/bound assessments) Tissue cross section microprobe analysis 12-Dec-08 13 Bioanalytical Services Non-clinical and Clinical Support Bioanalytical Validation, cross-validation across species, tissue matrices for IND applications and Phase I/IIa studies GLP Sample Bioanalysis (including Metallo-Drugs) Dose confirmation/homogeneity testing for non-clinical studies Bioanalysis of parent compounds plus major/unique metabolites Drug/drug interaction (DDI) studies, bio-availablity (BA) and bio-equivalence (BE) studies 12-Dec-08 14 Biopharmaceutics Services Study Design and Consultation Support for both non-clinical (TK) and clinical pharmacokinetic studies (BE/BA) Literature review Study design and protocol writing Regulatory body communications Pharmacokinetic (PK) Statistical Analysis Pharmacokinetic (PK) statistical analysis, review and data interpretation using WinNonLin PK report writing (including QA review for ICH/FDA studies) Final submission preparation 12-Dec-08 15 Clinical Research Services First in man; First in patients clinical facility 36 bed facility for overnight stays; close to hospital campus Only confined clinical unit in Vancouver Administration office for screening/recruitment on hospital campus Large healthy normal population (pharmacogenomic data available) Access to special populations studies (Japanese bridging, hepatic/renal impaired) Focus on speciality /intensive monitoring studies (radiolabelled, QT prolongation) 12-Dec-08 16 Clinical Research Services Phase I Healthy PK Studies First in Man, single dose/multiple dose BA/BE, Pharmacodynamics (PD)/biomarker evaluation Drug-drug interaction studies (DDI) Mass Balance/metabolism Pharmaco-genomic studies (poor metabolizers) QTc Prolongation studies 12-Dec-08 17 Clinical Research Services Phase IIa Patient PK Studies First in Patients, single dose/multiple dose Dose ranging, dose regimen Renal & hepatic insufficiency Biomarker evaluation, proof of concept Experimental & confirmatory designs Therapeutic populations Hepatitis C Rheumatoid Arthritis Asthma/COPD Alzheimer Disease Diabetes Psoriasis 12-Dec-08 18 Life Sciences - Operations Life Sciences Clinical Research Pharmaceutical Biopharmaceutics GxP Production Research & Development Client Services 12-Dec-08 19 Life Sciences - Facilities Expanded clinical facility Jan 2007 9.5M expansion planned, 50,000 ft2 May 2007 Custom designed laboratory facilities Temporary archive facilities Long-term sample storage Back-up generator 12-Dec-08 20 Life Sciences – Quality Focus Independent Quality Assurance (QA) Independent Quality Control team for Life Sciences Division QA Manager, Vesna Janic, B.Sc. Team of 6 qualified QA auditors Regulators Successful FDA Site – Project and Process Inspection (July 2000, ERI site 2001) FDA audit expected in 2006/7 from the Office of Generic Drugs ISO9001 registration, Health Canada Establishment license Audits conducted routinely by a number of sponsor QA groups & independent GLP consultants 12-Dec-08 21 Life Sciences – Core Values Innovation & Integrity Special emphasis on stability during sample collection and processing Experienced with trace level analysis – pg/mL Expertise in validation of parent plus multiple metabolites – emphasis on selectivity and specificity Validation process exceeds FDA-BMV guidelines Innovative solutions arising from: Study designs/ predicting outcomes Method development / transfers Production analysis/ bioanalysis 12-Dec-08 22 Life Sciences – Core Values Commitment and Co-operation Broad scope of services Drug discovery through clinical research Consultative & collaborative project management approach Single point of contact Study Team – PI or Study Director, Project Management/Business Development, Sample logistics, data management, technical writers, QC, QA auditors Consistent history of meeting timelines & budgets Use of metrics to assess continuous improvement (ISO9001:2000) Rapid turnaround for QA’d results Customized templates, data export and reports 12-Dec-08 23 CANTEST Ltd. To discuss your project requirements, please contact: Catherine McGuinness cmguinness@cantest.com 604 307 7620 To learn more about CANTEST visit: www.cantest.com 12-Dec-08 24 Contract Research