Contract Research

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Contract Research

• Canadian Trade Consulate
• Denver, CO October 2006

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CANTEST Overview

• Founded in 1969
• Head office in Burnaby, British Columbia
• Over 300 employees
• Strong history and consistent growth
• 6L 1000E 9F 2011

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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
full-time functions
1989 One of the first laboratories to use Liquid
Chromatograph / Mass Spectometer (LC/MS)
1999 Relocation to current facility
2001 Joint Venture with Axelson BioPharma
Research (ABR) Opening of Winnipeg Lab
1996 Formal Laboratory Accreditation from
Standards Council of Canada (SCC)
2005 ABR becomes CANTEST BioPharma CANTEST
Victoria moves to new location
2003 CANTEST acquires equity position in
Vancouver Clinical Trial Facility
2006 CANTEST acquires Elemental Research Inc.
(ERI) and Vizon Scitec
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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

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Corporate Overview

• Corporate Services
• Financial
• Facility Management
• Quality Assurance
• Marketing and Communications
• Human Resources
• Information Technology
• Information Systems

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Geographic Representation
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Accomplishments in 2005/2006
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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

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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

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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

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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

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Analytical Services

• Pharmaceuticals in the Environment
• Ecotoxicology
• Aquatic Terrestrial Toxicity Testing
• Bioaccumulation
• Biodegradation /extractables
• Mass balance studies
• OECD GLP studies

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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

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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

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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

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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
  (radio-labelled, QT prolongation)

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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

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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

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Life Sciences - Operations
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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

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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

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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

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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
  (ISO90012000)
• Rapid turnaround for QAd results
• Customized templates, data export and reports

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CANTEST Ltd.

• To discuss your project requirements, please
  contact
• Catherine McGuinness cmguinness_at_cantest.com 60
  4 307 7620
• To learn more about CANTEST visit
• www.cantest.com

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Contract Research