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?


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


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?


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

http://www.uq.edu.au/


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?


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?


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?


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?


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)


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


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


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


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?


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!


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?

http://images.google.com.au/imgres?imgurl=http://www.mnmprop.com/Pictures/House building procedures/Step 1 sales agreement.png&imgrefurl=http://www.mnmprop.com/The Building procedure.html&h=260&w=270&sz=52&hl=en&start=4&um=1&usg=__pUF-VA4dcn2NQhyRvDI94ONll4c=&tbnid=D17BKRbW6Y0wLM:&tbnh=109&tbnw=113&prev=/images?q=agreement&ndsp=18&um=1&hl=en&sa=N


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?


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

tetraq - integrated preclinical drug development solutions presentation

Health & Medicine