HEALTH. Institute for Biomedicine and Health Sciences

Transcription

1 The Innovation Company HEALTH Institute for Biomedicine and Health Sciences

2 Our central activity is innovative applied research that bridges the gap between basic research and industrial applications. We are therefore well placed to meet the needs of both science and business. High quality standards, fast decisions, excellent communication and strong team work make us a valued partner for the pharmaceutical industry, medical device manufacturers and health system institutions. Thomas Pieber, MD, Professor of Medicine Director Contact JOANNEUM RESEARCH Forschungsgesellschaft mbh HEALTH Institute for Biomedicine and Health Sciences Elisabethstrasse Graz Phone Fax health@joanneum.at 2

3 HEALTH Institute for Biomedicine and Health Sciences BRIDGING BOUNDARIES No other field is as dependent on interdisciplinary collaboration to bring new ideas to market as medicine. We work in a close strategic alliance with the Medical University Graz and our director, Prof Thomas Pieber MD, is also the director of the clinical department for endocrinology and metabolism at the University. Our team consists of around 60 technical and scientific employees. We work closely with a further 80 medically oriented specialist personnel from the Medical University Graz. Together, we work to translate ideas and technologies from medicine, pharmaceutical science and health services research into marketable products and services. Services Tissue-specific pharmacokinetic and pharmacodynamic studies Bio- and pharma ceutical analysis Metabolomics Health technology consulting services for the medical industry Data management and statistics for clinical research Medical devices Medical sensors ehealth technologies: Supporting medical decision making Integrated health care planning ehealth systems for integrated care Research effectiveness & economic evaluations 3

4 Tissue-specific PK and PD We investigate the actions of drugs, nanoparticles and various delivery systems in vivo and ex vivo. We perform tissue-specific pre-clinical and clinical pharmacokinetic (PK) and pharmacodynamic (PD) studies using continuous sampling techniques (microdialysis and open-flow microperfusion - OFM). We also investigate bioavailability and bioequivalence and perform metabolomics studies in vivo and ex vivo. Our services LL preparing study protocols LL submitting ethical applications LL executing pre-clinical and clinical studies LL performing and validating bioanalytical procedures LL statistically analyzing the data Tissues - We focus on the target tissue level LL Dermal OFM dofm: dermatology; transport over and into the corneal layer; e.g. antibodies LL Cerebral OFM cofm: neurology; transport over blood-brain-barrier (BBB), dose-response with bypassing BBB; e.g. highly lipophilic psycho- and neuropharmaceuticals LL Adipose tissue OFM aofm: endocrinology; e.g. insulins Advantages We are able to sample unchanged interstitial fluid. We can sample any substances independent of their molecular size (even cells), lipophilicy or protein binding. OFM-Material CE-labeled catheters and small, wearable, multi-channel pumps for clinical dofm and aofm-studies High-end laboratory GLP certified We are specialized on microliter sample volumes and picomolar analyte concentrations. Dr Frank Sinner frank.sinner@joanneum.at 4

5 Bio- and pharmaceutical analysis We develop, validate, optimise and automate innovative bioanalytical methods for high-throughput analysis for medical research and the pharmaceutical industry. We can analyse microliter sample volumes and picomolar analyte concentrations with state-of-the-art bioanalytical methods. We offer our services GLP compliant - if required. Bioanalysis is performed on human and animal blood and tissue samples. Pharmaceutical analysis is performed on pharmaceutical raw materials and formulations, e.g. drug analysis, cleaning validation, quantitative testing, testing for impurities. Chromatography four dual-pump systems, valve switching, online SPE, reversed phase LC, hydrophilic interaction LC, doublecolumn switching, available from nano to conventional scale Mass spectrometry (MS) exactive Orbitrap (benchtop), LTQ Orbitrap (FTMS), two triple-quadrupole MS, GCMS, LCMS Immunochemical methods ELISA, Multiplex Assays (e.g. cytokines) Enzymatic/photochemical methods Automated assays for clinical laboratory parameters Analyte expertise Acyl-CoAs, polyamines, vitamin D metabolites (reference methods), various metabolic products, drug analysis Dr Christoph Magnes christoph.magnes@joanneum.at 5

6 Metabolomics The application and optimization of innovative analytical services for the investigation of metabolic processes is our focus. We combine medical, biological, biochemical, bioanalytical, information technology and statistical expertise for basic research, drug development, diagnostics and personalised medicine. Study design medical as well as biological and statistical expertise Sampling Freeze clamp tissue samples, serum, plasma, cell culture, yeast Sample storage, sample preparation LC/FTMS-analysis Data analysis data conversion, peak detection, alignment, grouping, data filtering Statistics multivariate statistical methods, regression models, neural networks Metabolite database Determination of unknown substances Dr Christoph Magnes

7 FOTOLIA, Rebel FOTOLIA, Chad Mc Dermott Health technology consulting services for the medical industry With our interdisciplinary approach and extensive research methodologies toolbox, we can offer independent evidence-based support at various stages of product (drug or device) development, launch and improvement. We can help provide you with support in assessing potential demand, conducting cost-effectiveness and/or budget impact analyses for reimbursement purposes and improving your long-term market position. Q Q Assessment of clinical utility and patient demand support in establishing indications and market potential, extensive clinical networks Health economics research cost studies, Markov models, cost-effectiveness research Systematic literature reviews and meta-analyses using standardised best-practice processes Satisfaction and acceptance studies among patients and health care providers Horizon scanning for continued demand and trend analyses to forecast market changes Dr Wolfgang Habacher wolfgang.habacher@joanneum.at 7

8 Data management and statistics for clinical research We provide a comprehensive set of services and tools from study planning, electronic data capture, data management and statistical analysis through to publication of results. Electronic data capture and management: We perform data management from ecrf-design through to data release with validated systems. In heterogeneous environments we develop interfaces and provide additional tools to facilitate research with your data. Statistical analysis: With our profound understanding of challenges and questions in the medical domain and an extensive set of statistical methods we support planning, analysis, modelling, interpretation and publication. Q Q Data management for clinical studies in accordance with good clinical practice (GCP) Electronic data capture and management supporting regulatory guidelines (according to 21 CFR Part 11) Interfaces Development and validation of interfaces between systems in clinical research Study planning and statistics for clinical studies (sample size calculation, mixed effect models, PK/PD models, reporting) Q Q Biobank information systems data flow in biobanks, pseudonymisation, traceability, automation Dr Peter Beck peter.beck@joanneum.at 8

9 Medical devices We support the development of medical devices that meet medical needs, high demands of medical staff and patients as well as stringent regulatory, safety and quality requirements. With our interdisciplinary approach, we are able to offer support through all stages of the medical device life cycle, from the ideas stage through to improvement of market position. We aim to help you develop products that are best placed to meet patient needs for long term success. Assessment and evaluation market/ disease profiling, feasibility, reimbursement potential, IPRs, business-plan development Design-Development-Verification user-requirements, prototypes, ex vivo/in vitro studies, technical documentation (EN ISO compliant) Clinical data and evaluation statistics, data management, systematic literature appraisals, modeling Market launch & production QM support, analyses for reimbursement Market and technology surveillance demand and trend analyses, technology roadmaps, satisfaction studies Quality and risk management (QM / RM) implementation of QM / RM systems, workshops, according to EN ISO and EN ISO Dr Frank Sinner frank.sinner@joanneum.at 9

10 Medical sensors We focus on implementing various sensor technologies into applications for the clinical environment. We drive the development of new sensing methods from fundamental ideas to experimental models and prototypes for preclinical and clinical testing. Our portfolio includes: Sensors for in vivo and ex vivo monitoring Point of care systems Home monitoring Optical sensors based on fluorescence Electrochemical sensors amperometric and potentiometric Bioimpedance measurements Miniaturisation of sensor geometries and integration into microfluidic structures Evaluation of sensor systems preclinically and clinically Workflow-analysis to support system development for clinical applications Dr Frank Sinner

11 ehealth technologies: Supporting medical decision making We develop smart software systems to support complex clinical processes focussing on usability. It is our aim to support professional medical decision making and adequate patient care. Our services range from supporting work-flow and decision making with software solutions for mobile devices, by implementing clinical protocols and algorithms, to information extraction from medical free-text documents, thus utilizing their content as valuable source of relevant information. Solutions for clinical practice transfer of clinical processes to electronic systems, focusing on optimum usability In-depth skills natural language processing (NLP) and machine learning Software development as medical device according to IEC (certification in progress) Usability studies with patients and clinical professionals Clinical studies for software validation (particularly decision support) Dr Peter Beck

12 FOTOLIA, nyul Integrated health care planning Health care systems require continuous restructuring and reform to meet current and future needs and challenges. We can assist these processes by developing multisectoral and integrated strategies for improving care. Our aim is to achieve maximum patient-focused health gain combined with an efficient use of health care resources, via: Incisive analysis of current care situation Evidence-based development of new/improved processes and structures Health Technology Assessment Pilot testing, standardised implementation and continuous monitoring Long time experience In health care planning and establishing integrated care services Professional networks for several medical areas and different care sectors A comprehensive package of tools for standardising documentation and implementing high quality information retrieval processes Integration of patients perspectives into processes surveys and focus groups In-depth skills in conducting Health Technology Assessments Dr Wolfgang Habacher wolfgang.habacher@joanneum.at 12

13 FOTOLIA, Alexander Raths FOTOLIA, Michael Nivelet ehealth systems for integrated care We develop tailored e-health systems to support medical and administrative processes in innovative service concepts for patient care, medical documentation and quality management. Our systems are easy to use for both medical and administrative personnel. Customised IT solutions design, development, testing, operation and maintenance High quality software development process A broad network of technical experts from a variety of healthcare sectors Links to expertise in care planning and evaluation Many years of experience in the development of integrated care concepts Hosting of server-based IT solutions Dr Peter Beck peter.beck@joanneum.at 13

14 FOTOLIA, samaneh Research effectiveness & economic evaluations Whether you want to know if your intervention, service or program is working, or you have already collected data but now need help analysing it, we can help you with our expertise at any stage of your evaluation process. We provide connected thinking and incisive insights into complex health care processes. Project outset establishing research question and hypotheses; systematic information gathering; exploration of potential methods of evaluation; individualised evaluation concept and study design Main process developing practical and efficient standardized data collection methods; collection and management of study-specific data; preparation and maintenance of large pre-existing datasets; statistical analyses Final stage interpretation of results; final report and documentation; recommendations for service and technology improvement Dr Wolfgang Habacher

15 Quality We set high quality standards for our services and products. As our partner, you can rely on the application of international quality standards right from placing your order up to delivery of the final product/service. We operate according to the following guidelines: EN ISO 9001:2008 EN ISO GLP Our customers are welcome to assess our facilities and quality standards on-site at any time. The key factors in our QM systems are: Regular training of personnel Qualification and maintenance of quality-relevant laboratory equipment Validation of analytical methods according to international guidelines Traceability of sample and data management Long-term archiving of documents Risk management Deviation management Change control Corrective and Preventative Action (CAPA) Dr Frank Sinner

16 JOANNEUM RESEARCH Forschungsgesellschaft mbh HEALTH Institute for Biomedicine and Health Sciences Elisabethstrasse Graz Phone Fax health@joanneum.at oefpbf The Innovation Company