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Biopta company presentation

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Ethically-donated fresh, functional human tissues can be used to better predict the likely effect of drugs during clinical trials. As the closest possible model of drug function in patients, fresh human tissues are playing an increasingly important role in de-risking the drug discovery process, helping pharmaceutical and biotechnology companies to make earlier go/no-go decisions based on human data.

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Biopta company presentation

  1. 1. The Use of Fresh Human Tissues to Predict Drug Efficacy, Safety and Absorption
  2. 2. Human Tissues Predict Clinical Safety and Efficacy • Functional data produced in ex vivo human tissue • Provide information to pharmaceutical and biotechnology companies about the behaviour of their compounds in human relevant systems • Efficacy • Do compounds work in human tissue • Absorption • Are compounds permeable through human gut, skin, bronchi • Safety Pharmacology • Do compounds show adverse effects in human tissue – e.g. human coronary arteries • Comparative studies with other species strengthens this capability
  3. 3. Biopta- Leaders in Fresh Human Tissue Research Beltsville, Maryland Glasgow, UK• HQ and lab in Glasgow, UK • Lab facility in Maryland • Founded 2002 • First, and currently only, GLP compliant functional human tissue CRO • Experts in human tissue research and procurement • 50% of scientists at PhD level • Pharma and Biotech customers worldwide • Tailored human functional studies with responsive and flexible collaboration to achieve clients’ goals
  4. 4. Biopta’s Tissue Network: Fresh Human Tissues Sourced 24/7 in USA and UK Surgical residual tissues Nontransplantable organs • Biopta receives ethically donated fresh tissues via two main routes: - Surgical residual tissues (mainly UK) -Non-transplantable organs (mainly USA) • Biopta’s facilities are open 24/7 to receive the tissues, dissect and conduct experiments – Laboratories ( ) placed strategically to minimise transport time • Biopta is an ethically approved Research Tissue Bank
  5. 5. Biopta’s Scientific Expertise: Techniques to Assess Human Tissue Pharmacology • Biopta has a track record of producing high quality decision-making data from human and animal tissue in a variety of functional assay systems • Experience with addressing complex issues across a broad range of therapeutic areas and mechanistic pathways • Staffed with highly trained laboratory scientists skilled in tissue dissection and experimentation, and with experienced study directors with a track record of coordinating complex programs of work
  6. 6. Biopta – How we work Fresh Human Tissue Pharmacology Techniques Scientific Experience Scientific Question BioptaClient Protocol design e.g. Blood pressure change e.g. Resistance arteries e.g. Tissue baths -10 -9 -8 -7 -6 -5 0 25 50 75 100 log M [acetylcholine] %Relaxation -9 -8 -7 -6 -5 -4 0 25 50 75 100 log M [phenylephrine] %Constriction Decision-making data Relaxation to Acetylcholine Constriction to Phenylephrine Raw data traces Analysed data Interim and final reports
  7. 7. Tissue baths Ussing Chambers Wire myographs Perfusion myographs Ex vivo cultures Biopta Techniques • Contractility and relaxation of tissues • vascular and myocardial tissue • lung tissue • gastrointestinal tissue • genitourinary tissue • Inflammation, cytokine and gene exp. analysis • lung tissue • gastrointestinal tissue • Compound penetration and metabolism • gastrointestinal tissue • lung tissue • skin tissue • Ion channel activity • lung tissue • gastrointestinal tissue
  8. 8. Biopta Human Tissues Blood Vessels: Gastrointestinal: Others: - resistance arteries - large intestine - skin - coronary arteries - small intestine - skeletal muscle - renal arteries - oesophagus - pulmonary arteries - stomach - cerebral arteries Cardiovascular: Genitourinary: Respiratory: - atrial appendage - bladder - bronchus - ventricular muscle - urethra - trachea - uterus From both healthy and diseased patients: heart failure, asthma, COPD, diabetes, atherosclerotic tissue, ischaemic limbs, psoriatic and atopic dermatitis skin biopsies Other tissues are available from Biopta’s wide tissue network. Contact us to check availability: info@biopta.com
  9. 9. Constriction ↑ blood pressure Relaxation ↓ blood pressure 0 min 10 min 15 min 20 min 25 min5 min Fresh human tissue (heart shown here but many tissue and organ types used) Tissue transported immediately to laboratory Scientist isolates the tissues of interest The “living” tissues are exposed to drugs Small blood vessels isolated from tissue sample A Biopta project: patient > lab > translational data
  10. 10. Using human tissues de-risks development by avoiding species differences Sensitivity differences to the vasoconstrictor 5-HT (serotonin) in subcutaneous resistance arteries of dogs and humans -10 -9 -8 -7 -6 -5 -4 0 25 50 75 100 Canine Human 5-HT log [M] %constriction (ofKPSSresponse) Where there are clear species differences between humans and animals, human isolated tissues can avoid such differences Relaxation CRC to PDE2 inhibitor in canine and human subcutaneous resistance arteries -7.0 -6.5 -6.0 -5.5 -5.0 -4.5 -4.0 -10 15 40 65 90 ** ** ** canine sc arteries human sc arteries Log M [PDE2 inhibitor] Relaxationasa%of 300nMU46619preconstriction Biopta collaboration with J&J demonstrating the involvement of PDE2 in the control of subcutaneous artery tone (results published at the Safety Pharmacology Society Meeting, 2009)
  11. 11. Biopta’s data impacts across the whole drug development process Clinical trials Discovery phase Development phase Clinical trials Phase 1 II III IV Lead optimisation Lead identification Hit identification Target validation Nomination phase Target validation Compound characterisation DMPK Safety Clinical observations
  12. 12. Why Biopta? • Add commercial value and reduce risk of clinical failure • Efficacy and safety data generated in target species eliminating species differences • Conduct experiments to directly compare animal and human data • Biopta is the world leading GLP-compliant laboratory for testing in fresh, functional human tissues Email: KeithBowers@biopta.com Tel: +44 141 330 3831 www.biopta.com

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