TetraQ - Integrated Preclinical Drug Development Solutions Presentation
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Transcript of TetraQ - Integrated Preclinical Drug Development Solutions Presentation
Quality Preclinical Drug Development Solutions
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!
What is TetraQ?
Quality Preclinical Drug Development Solutions
Brisbane
Where is TetraQ?
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
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
How was TetraQ founded?
Quality Preclinical Drug Development Solutions
How is TetraQ structured?
Commercial arm of
CIPDD; Business
undertaking contract
R&D for biotech &
Pharma clients
Registered business
name of UniQuest -
contracting entity
Centre for Integrated Preclinical Drug Development (CIPDD)
Training
Short courses for
Industry
Preclinical Seminars
Training of PhD
students working on
“toolkit research”
Research
Targeted to bringing
innovation into Drug
Development “Toolkit”
i.e. methods research
Funded by research
grants: Govt + Industry
The Hub of Organics
Analysis
Bioanalysis Services
for UQ researchers
Modern GLP facilities
with the latest
equipment and highly
trained technical staff
for services to
University of QLD
researchers
Quality Preclinical Drug Development Solutions
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”
What is the significance of TetraQ services?
Quality Preclinical Drug Development Solutions
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
Why is this significant?
Quality Preclinical Drug Development Solutions
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
Assessment of:
What are the services TetraQ provide?
Quality Preclinical Drug Development Solutions
Drug Discovery
Preclinical Drug
Development
Phase I Clinical Trials
Phase II Clinical Trails
Phase III
Clinical Trails
Where does TetraQ fit into the drug development phases?
Quality Preclinical Drug Development Solutions
Is the drug candidate effective against the target disease?
Efficacy – Biological Services
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
Physicochemical characterization
FTIR, UV,NMR,MS
Formulation development
Structure elucidation, solubility
Stability trials & stability indicating method development
Dissolution studies
Lead compound optimisation
Does the drug candidate have the right physical, chemical &
biological properties to become a medicine for human use?
Pharmaceutics
Quality Preclinical Drug Development Solutions
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)
Preclinical development plans
ToxicologyTetraQ-Toxicology facilities are GLP recognised
Project Management Services
Quality Preclinical Drug Development Solutions
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
ADME – Bioanalytic Services(absorption, distribution, metabolism elimination)
TetraQ-ADME is GLP recognised & has NATA ISO 17025, Research & Development Accreditation
Quality Preclinical Drug Development Solutions
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
What Clinical trail experience does TetraQ have?
Quality Preclinical Drug Development Solutions
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 is Key!
Quality Preclinical Drug Development Solutions
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
Who are TetraQ clients?
Quality Preclinical Drug Development Solutions
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
Why use TetraQ Services?
Quality Preclinical Drug Development Solutions
We are focused to provide preclinical drug
development solutions to meet your needs
Please feel free to ask questions to
better understand how we may assist
your organisation
Dean Simonsen
- Sales & Services Manager
- Mb: 61 409 480 532
- Email: [email protected]
Rose-marie Pennisi
- Commercial Manager
- Mb: 61 437 112 549
- Email: [email protected]
- PH: 61 7 3346 9933
- Fx: 61 7 3346 7391
Thank you for your interest in TetraQ