TetraQ Services Presentation


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TetraQ Services Presentation

  1. 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 Quality Preclinical Drug Development Solutions
  2. 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 Quality Preclinical Drug Development Solutions
  3. 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 Quality Preclinical Drug Development Solutions
  4. 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” Quality Preclinical Drug Development Solutions
  5. 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 Quality Preclinical Drug Development Solutions
  6. 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 Quality Preclinical Drug Development Solutions
  7. 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. 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 Quality Preclinical Drug Development Solutions
  9. 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 Quality Preclinical Drug Development Solutions
  10. 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 Quality Preclinical Drug Development Solutions
  11. 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 Quality Preclinical Drug Development Solutions
  12. 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 Quality Preclinical Drug Development Solutions
  13. 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 Quality Preclinical Drug Development Solutions
  14. 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 Quality Preclinical Drug Development Solutions
  15. 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 Quality Preclinical Drug Development Solutions
  16. 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 Quality Preclinical Drug Development Solutions