1. Where is TetraQ?
Located at The University of Queensland in Brisbane
Brisbane (UQ), Queensland
Joint initiative of UQ, Queensland 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
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2. Who founded TetraQ?
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
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3. How is TetraQ structured?
Centre for Integrated Preclinical Drug Development (CIPDD)
Research Training The Hub of Organics
Analysis
Commercial arm of Targeted to bringing Short courses for
CIPDD; Business innovation into Drug Industry Bioanalysis Services
undertaking contract R&D Development “Toolkit” for UQ researchers
for biotech & Pharma i.e. methods research
clients Preclinical Seminars
Modern GLP facilities
Funded by research with the latest equipment
Registered business
grants: Govt + Industry Training of PhD students and highly trained
name of UniQuest - working on “toolkit technical staff for
contracting entity research” services to University of
QLD researchers
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4. 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”
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5. 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
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6. Where does TetraQ fit into the drug development phases?
Preclinical Phase I Phase II Phase III
Drug Discovery Drug Clinical Clinical Clinical
Development Trials Trails Trails
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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
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8. 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
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9. 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
Solubility studies
Stability trials & stability indicating method development
Dissolution studies
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10. 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
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11. 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
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12. What Clinical trial 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 ISO-17025 R&D 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
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13. 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
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14. 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
300 projects for 70 clients since inception in May 2005
Frequent repeat business
Indicates strong client satisfaction
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15. Why use TetraQ Services?
TetraQ offer Tailored solutions, not just a menu of choices
Four world class facilities with "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
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16. Thank you for your interest in TetraQ
Dean Simonsen We are focused to provide
- Sales & Services Manager
- Mb: 61 409 480 532 preclinical drug development
solutions to meet your needs
- 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
- Commercial Manager
better understand how we may
- Mb: 61 437 112 549
- Email: r.pennisi@tetraq.com.au assist your organisation
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