TetraQ is a leading Australian preclinical contract research organization focused on providing a broad range of integrated preclinical drug development solutions in the disciplines of ADME, Bioanalytics, Efficacy, Toxicology and Pharmaceutics. TetraQ’s Toxicology, ADME and Bioanalytics laboratories are GLP recognised and in collaboration with NATA, TetraQ’s ADME team pioneered ISO17025-2005 (R&D) research & development accreditation becoming the first laboratory in Australia to obtain this accreditation in 2005. Each of our world-class facilities is equipped with state-of-the-art instrumentation including LC-MS/MS, HPLC & ELISA. Essentially, TetraQ is a one-stop-shop for early stage drug development and we are recognized as world leaders in bioanalytical method development & sample analysis of drugs / metabolites in biological fluids with both human and animal samples.

1. What is TetraQ?
A leading Australian contract research organisation (CRO)
providing integrated preclinical drug development
services to the biotech and pharmaceutical industries
where...
Quality, Performance, Reliability and Value are more
than just words to us...
It’s everything!
Quality Preclinical Drug Development Solutions

2. Where is TetraQ?
Brisbane
 Located at The University of Queensland in
Brisbane (UQ), Queensland
 Joint initiative of UQ, Qld Institute for Medical
Research (QIMR) and Q-Pharm
 Part funded by the Queensland Government
Smart State Research Facilities Fund
 8.1 M$ invested in State-of-the-art infrastructure
 GLP recognized
 Staffing – 30 FTE + casuals
Quality Preclinical Drug Development Solutions

3. How was TetraQ founded?
4 Founders
Professors Ron Dickinson, Istvan Toth, Rod
Minchin & Maree Smith
 Internationally recognized experts in the
four core preclinical disciplines –
• ADME
• Efficacy
• Toxicology
• Pharmaceutics
 100 yrs expertise & know-how amongst
founders
 60 yrs of commercialization experience
amongst founders
Quality Preclinical Drug Development Solutions

4. How is TetraQ structured?
Centre for Integrated Preclinical Drug Development (CIPDD)
Training
The Hub of Organics Research
Analysis
Short courses for
Targeted to bringing Commercial arm of
Industry CIPDD; Business
Bioanalysis Services innovation into Drug
Development “Toolkit” undertaking contract
for UQ researchers
R&D for biotech &
i.e. methods research
Preclinical Seminars Pharma clients
Modern GLP facilities
with the latest Funded by research
Training of PhD Registered business
equipment and highly grants: Govt + Industry
name of UniQuest -
students working on
trained technical staff
“toolkit research” contracting entity
for services to
University of QLD
researchers
Quality Preclinical Drug Development Solutions

5. What is the significance of TetraQ services?
 Assess potential therapeutic effects of the drug candidate in living
organisms
 Gather sufficient data to determine reasonable safety of the drug
candidate in humans through laboratory experimentation and
animal studies
 Determine whether the drug candidate is ever likely to be
developed as a pharmaceutical
“Fail early, fail cheap”
Quality Preclinical Drug Development Solutions

6. Why is this significant?
 Expensive exercise – $US 800 – 1200 million
 Long timelines – 10-15 yrs
 Huge risk of failure
 Only 1 in 5000 molecules from drug discovery will
make it to market and become a new product
Quality Preclinical Drug Development Solutions

7. What are the services TetraQ provide?
Assessment of:
 Efficacy:
 “Does it work?”
 Cell-based assays and animal models of human disease
 ADME - Pharmacokinetics and metabolism:
 “How can it be delivered and what does the body do to it?”
 Absorption, distribution, metabolism, elimination (ADME)
 Toxicology:
 “Is it safe?”
 Cell-based assays and animal testing
 Pharmaceutics:
 “Is its manufacture viable and controllable?”
 Physicochemical properties; formulation studies, stability
Quality Preclinical Drug Development Solutions

8. Where does TetraQ fit into the drug development phases?
Phase
Preclinical Phase I Phase II
III
Drug
Drug Discovery Clinical Clinical
Clinical
Development Trials Trails
Trails
Quality Preclinical Drug Development Solutions

9. Efficacy – Biological Services
Is the drug candidate effective against the target disease?
 Proof-of-concept studies in animal models of human disease
 Pain: nociceptive, inflammatory, neuropathic
 Arthritis
CNS Models - Multiple sclerosis, Parkinson‟s disease

 Obesity
 Diabetes
 Cancer (through partner)
Quality Preclinical Drug Development Solutions

10. Pharmaceutics
Does the drug candidate have the right physical, chemical &
biological properties to become a medicine for human use?
 Physicochemical characterization
 FTIR, UV,NMR,MS
 Formulation development
 Structure elucidation, solubility
 Stability trials & stability indicating method development
 Dissolution studies
 Lead compound optimisation
Quality Preclinical Drug Development Solutions

11. Toxicology
TetraQ-Toxicology facilities are GLP recognised
Is the drug candidate sufficiently safe to administer to humans in
early stage clinical trials ?
 Genotoxicity assays (Ames Test, Micronucleus, Mouse Lymphoma
Assay)
 In vivo acute & repeat dose (chronic) toxicity studies
 In vivo safety pharmacology (including hERG, respiratory and CNS)
 Cytotoxicity assessment
 In vivo – two species, rodent and non rodent (dog, primates)
Project Management Services
 Preclinical development plans
Quality Preclinical Drug Development Solutions

12. ADME – Bioanalytic Services
(absorption, distribution, metabolism elimination)
TetraQ-ADME is GLP recognised & has NATA ISO 17025, Research
& Development Accreditation
 World leaders in bioanalytical method development &
sample analysis of drugs/metabolites in biological
fluids, human and animal samples
 Validated bioanalytical methods
 HPLC, LC-MS/MS, ELISA
 Screening, partially validated, fully validated to
satisfy FDA requirements
 Bioavailability and pharmacokinetic studies
 Drug metabolism studies including metabolite
identification
 Biodistribution and plasma protein binding studies
 Toxicokinetics
Quality Preclinical Drug Development Solutions

13. What Clinical trail experience does TetraQ have?
HAHA Assay
 Transferred and validated HAHA assay (Human antibody/human antibody)
and anaylsed 100‟s of samples
ELISA Assay (Only Australian laboratory accredited for ELISA)
 Transferred and conducted partial validation of ELISA assay for major
Australian biotech organisations with analysis of 1500 plasma samples
 LC-MS/MS - 3 synthetic peptides in a single vaccine
 Fully validated in rat plasma to FDA requirements
 Analysis of samples from Toxicokinetic study
Small molecules - LC-MS/MS
Bioequivalence studies for generics
Quality Preclinical Drug Development Solutions

14. Quality is Key!
 Our Quality System is maintained by a full-time Quality
Assurance Manager who is supported by trained QA staff in
each facility
 TetraQ-ADME - NATA ISO 17025, Research & Development
Accreditation
 TetraQ-ADME and TetraQ-Toxicology are GLP recognised
facilities
 Data acceptable for Australian and international regulatory
submission
Quality Preclinical Drug Development Solutions

15. Who are TetraQ clients?
 Australian biotech and pharma companies
 ASX-listed & private companies
 International clients
 Based in USA, Europe, Asia & Japan
 Universities, Research Institutes, Big Pharma
 200 projects for 60 clients since inception in May 2005
 Frequent repeat business
 Indicates strong client satisfaction
Quality Preclinical Drug Development Solutions

16. Why use TetraQ Services?
 TetraQ offer Tailored solutions, not just a menu of choices
 Four world class facilities with quot;State of the art” equipment including
LC-MS/MS, HPLC and ELISA equipment
 Highly skilled scientific and management team,
Services backed by a leadership team with wealth experience in all
4 areas of preclinical drug development
Quality science behind all services (no short cuts)
 Modern PC2, SPF central animal breeding facilities
 We assist clients with data interpretation to facilitate and guide timely
decision-making
 A „one-stop shop‟ for early stage drug development
Quality Preclinical Drug Development Solutions

17. Thank you for your interest in TetraQ
We are focused to provide preclinical drug
Dean Simonsen
- Sales & Services Manager
development solutions to meet your needs
- Mb: 61 409 480 532
- Email: d.simonsen@tetraq.com.au
- PH: 61 7 3346 9933
- Fx: 61 7 3346 7391
Please feel free to ask questions to
Rose-marie Pennisi
better understand how we may assist
- Commercial Manager
- Mb: 61 437 112 549
your organisation
- Email: r.pennisi@tetraq.com.au
Quality Preclinical Drug Development Solutions