Overview of International Clinical Research Center Brno Project. Tomáš Kára, MD, PhD

Transcription

1 Overview of International Clinical Research Center Brno Project Tomáš Kára, MD, PhD

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3 International Research Centers CERN (Switzerland) European Organization for Nuclear Research ISS International Space Station ICRC Brno (Czech Republic) International Clinical Research Center Brno ITER (France 2010) International Thermonuclear Experimental Reactor

4 ICRC BRNO Combination of: Next-generation clinical research base State-of-the-art clinical center for treatment of cardiovascular and CNS diseases International educational center Technological cluster Integral part of St. Anne s University Hospital PLATFORM FOR MULTIDISCIPLINARY INTERNATIONAL COLLABORATION linking clinical research, clinical care, medical educaion and TT

5 ICRC Novel concept of clinical research Dynamic research teams Flexible laboratory tract system Pulsed type of research project International Space Station

6 Advantages of the ICRC Brno Concept Open platform for sharing know-how on international level MULTIDISCIPLINARY INTERNATIONAL TEAMS - New quality of research Acceleration of research process up to 50% in comparison to the GCRC concept (idea-proof of concept) Integration of collaboration of academic institutions with industry on local and international level in particular - new dimension of development of medical and biotech industry Acceleration of knowledge transfer from bench to bedsite Sophisticated model of education

7 ICRC Basic Operational Characteristics Key Departments/Units: Dpt. of Cardiovascular Diseases Dpt. of Neurology Integrated Research Platforms Centrum of R&D Support Budget: 140 million of E. No. of Employees: 450 Construction initiation: June 2010 Construction completed: June 2012 ICRC full operation: January 2013

8 Project Approved on March 8, 2006 by the Governmental Resolution No. 239/2006

9 Mayo Clinic Strategic Academic Partner of the ICRC Brno Project

10 Research Education Clinical Practice CP

11 MAYO CLINIC: STRATEGIC ACADEMIC PARTNER OF ICRC A non for profit profit, foundation based organisation, establishedin Rochester, Minnesota, in 1889 One of the largest university hospital in the world Employs over 56,000 people on 3 locations One of the largest center of medical research in the world The largest Technology Transfer Office for Medical Research Employsover56,000 peopleon 3 locations

12 Mayo Clinic Annual Research and Education Support Research appox. $ 400 million > 8,000 research projects > 3,000 grants/contracts Employees Education >$ 150 million > 300 courses/year

13 Comparison of Total Investment of Mayo Clinic and Czech Republic into Medical Research (2004) 400 Celkové investice ČR a Mayo Clinic do lékařského výzkumu (2004) Miliony USD ČR Mayo Zdroj: Úřad vlády (ČR) a Mayo Clinic Annual Report

14 Contribution of Mayo Clinic to ICRC Brno Project Essential collaboration to ICRC concept development Comprehensive Research Project Management and direct participation of leading Mayo specialists in R&D programs Substantial contribution to join research projects realization and financing Special educational programs

15 Memorandum of Understanding signed between Mayo Clinic, Ministry of Health and St. Anne s University Hospital

16 Collaboration with Minnesota Partnership for Biotechnology and Medical Genomics

17 ICRC Key Programs Research and Developemnt Cardiovascular Medicine Neurosciences Advanced Education Technology Transfer Clinical Care

18 ICRC Brno Education

19 Mayo CLINIC ICRC Brno Scientific Training Programs Long-term Training Programs (1-3 years) Funded by Mayo Clinic Short-term Training Programs (1-3 months) Funded by Mayo Clinic with contribution of Masaryk University and South Moravian Region MSc. and PhD Study Programs in preparation Simulation-Based Education Project of Mayo Brno Multidisciplinary Simulation Center

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21 The Mayo Clinic Brno Human Bridge 22 colleagues from Mayo Clinic visited Brno, namely Dr. Samuel Asirvatham, Dr. Charles Beaty, Dr. Yonas Geda, Dr.Bernard Gersh, Dr. David Holmes, Dr. Brooks Edwards, Dr. Paul Friedman, Dr. Sherine Gabriel, Dr. Christopher McGregor, Dr. Francesco Lopez-Jimenez, Dr. Alexander Schirger, Dr. Virend Somers, Dr. Zallem Temesgen, Dr. Santhi Vege, Dr.Eric Wieben and others The current CEO of St. Anne s Hospital Petr Koska as well as his predecessors have been guests at Mayo Several senior and junior colleagues from Brno visited Mayo Clinic as part of the collaboration Consultants: Dr. Jiri Vitovec, Dr. Jindrich Spinar, Dr. Lenka Spinarova, Dr. Miroslav Soucek, Dr. Jaroslav Meluzin, Dr. Petr Nemec, Dr. Robert Mikulik, Dr. Jan Sitar, Dr. Ota Hlinomaz, Dr. Ladislav Groch, cardiology Dr. Ivan Rektor, Dr. Robert Mikulik neurology Dr. Rostislav Vyzula, Dr. Martin Klabusay oncology Dr. Pavel Jurak, Ing. Josef Halamek, Dr. Vlastimil Vondra Biomedical Engineering Dr. Miroslav Svoboda, Dr. Michal Vlasin Veterinary medicine/animal research Dr. Jan Adam nanotech research Research fellows at CVD (Dr. Virend Somers): Ing. Jiri Nykodym, Dr. Marek Orban, Ing. Pavel Leinveber, Ing. Jan Bukartyk, Dr. Pavla Balcarkova, Dr. Vladimir Horvath, Dr. Frantisek Lehar, Dr. Viktor Musil, Dr. Martin Novak, Dr. Martin Plachy, Dr. Zbynek Pozdisek, Dr. Ondrej Toman, Research fellows at GI (Dr. Santhi Vege: Dr. Veronika Pribramska, Dr. Jan Trna Other Study stays: Dr. Ondrej Sochor, Dr. Martin Pesl Residents: Dr. Tomas Konecny, 3 rd year resident at Mayo Graduate School of Medicine and appointee in Mayo Cardiovascular Fellowship Training Program July 2010

22 ICRC Brno Research and Development

23 Cardiovascular Research CARDIO 1: Cardiovascular and transplant surgery, heart failure, and organ transplantions - development of novel strategies for advanced diagnostic and treatment CARDIO 2: Interventional cardiology, angiology and acute coronary syndromes - development of novel strategies for advanced diagnostic and treatment CARDIO 3: Cardiac electrophysiology and pacing - development of novel strategies for advanced diagnostic and treatment CARDIO4: Cardiovascular and metabolic disorders - identification of novel risk factors and development of novel diagnostic and therapeutic strategies CARDIO 5: Non-invasive cardiovascular imaging - development of novel methods and technologies CARDIO 6: Development of novel methods and interventions for prevention of cardiovascular diseases in the general population CARDIO 7: Tissue engineering in cardiovascular medicine

24 Neurosciences NEURO1: Cerebrovascular Diseases - development of novel strategies for early detection and advanced treatment NEURO2: Epilepsy and Parkinson Diseases - development of novel strategies for early detection and advanced treatment NEURO3: Defining new biomarkers and novel strategies for early detection of Alzheimer Disease and other types of dementia NEURO4: Brain and cerebrovascular imaging - development of novel methods and technologies NEURO5: Multiple Sclerosis - development of novel strategies for early detection and advanced treatment

25 MULTIDISCIPLINARY RESEARCH PLATFORMS: ENABLINGSYNERGY AND INTERDISCIPLINARY COLLABORATION IN ADVANCED MEDICAL RESEARCH Animal Research Center Center of Biomolecular and Cellular Enginereing Integrated Center of Cellular Therapy and Regenerative Medicine Center of Biomedical Engineering Center of Molecular Imaging Clinical Pharmacology Unit

26 CARDIO 1: Advancing the Treatment of End-Stage Heart Failure by Developing Mechanical and Biological Artificial Heart

27 Growing Epidemics of Heart Failure Heart failiure epidemiology forecasts to Datamonitor 2002

28 The Gap between Need for Organs Transplant vs. Donors Availability United Network for organ sharing UNOS 2006

29 The Gap between Need for Organs Transplant vs. Donors Availability Mechanical Heart Support Devices Biotechnologies United Network for organ sharing UNOS 2006

30 Brno Artificial Heart Project Prototypes TNS Brno II-VIII Longest EU survival in cows 314 days

31 Left Ventricle Assist Device Developing next generation with physiological regulatory feedback system Heartmate II

32 Mayo-Brno Project of Fully Implantable Heart Assist Device

33 Advanced Biotechnologies in Treatment of Heart Failure

34 Advanced Biotechnologies in Treatment of Heart Failure Xenotransplant Engineering Collaboration with Team of Dr. Christopher McGregor (Mayo Clinic/UC London) Cardiac Stem Cell Engineering Collaboration with Dr. Dan Kaufman from Minnesota Stem Cell Research Institute Developed original clone of human mocardial tissue

35 Dr. Mc Gregor and Dr. ICRC 2007 Conference

36 Cardiac Stem Cell Engineering Collaboration with Dr. Dan Kaufman from Minnesota Stem Cell Research Institute Developed original clone of human myocardial tissue

37 ICRC Brno Science Without Borders

38 St. Anne s Hospital - ICRC Collaborating Industrial Partners

39 Comparison of Investment in Research and Development of the Czech Republic and Potential Industrial Partners 16 Investice do výzkumu ČR a strategických partnerů ICRC (2004) M iliardy USD ČR GE IBM J&J Mayo Pfizer Zdroj: Úřad vlády (ČR) a Annual Reports

40 St Anne s University Hospital ICRC Brno Transparent Legal and Ethical Environment for Collaboration with Industry Yes.

41 St. Anne s University Hospital Implementing E.U. and U.S. Legal and Ethical Standards for Collaboration with Industry Conflict of Interest Office Clinical Trials Center Technology Transfer Office

42 BRNO Biotech Partnership SYNERGY ICRC Brno translational research, international collaboration UT ISI CEITEC TECHNOLOGY RIS III University Campus basic research CARS* preclinical research and development *Cardiovascular Animal Research Center

43 Cardiovascular Animal Research Center State of the Art Animal Research Facility School of Veterinary Medicine Brno

44 Installation of high-end Nuclear Magnetic Scanner from GE

45 Dr. Asirvatham (Mayo Clinic) is collaborating with Brno Team on Development of Novel Technology for Stroke, Epilepsy and Brain Tumors Treatment (Co-Funded by IGA MH)

46 Minnesota Partnership for Biotechnology and Medical Genomics

47 ICRC Brno and Brno Biotech Partnership

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49 Application to Program Research and Development for Innovations

50 Cardiovascular Research CARDIO 1: Cardiovascular and transplant surgery, heart failure, and organ transplantions - development of novel strategies for advanced diagnostic and treatment CARDIO 2: Interventional cardiology, angiology and acute coronary syndromes - development of novel strategies for advanced diagnostic and treatment CARDIO 3: Cardiac electrophysiology and pacing - development of novel strategies for advanced diagnostic and treatment CARDIO4: Cardiovascular and metabolic disorders - identification of novel risk factors and development of novel diagnostic and therapeutic strategies CARDIO 5: Non-invasive cardiovascular imaging - development of novel methods and technologies CARDIO 6: Development of novel methods and interventions to decrease risk factors and incidence of cardiovascular diseases in the general population CARDIO 7: Tissue engineering in cardiovascular medicine

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52 Cardiovascular Research CARDIO 1: Cardiovascular and transplant surgery, heart failure, and organ transplantions - development of novel strategies for advanced diagnostic and treatment CARDIO 2: Interventional cardiology, angiology and acute coronary syndromes - development of novel strategies for advanced diagnostic and treatment CARDIO 3: Cardiac electrophysiology and pacing - development of novel strategies for advanced diagnostic and treatment CARDIO4: Cardiovascular and metabolic disorders - identification of novel risk factors and development of novel diagnostic and therapeutic strategies CARDIO 5: Non-invasive cardiovascular imaging - development of novel methods and technologies CARDIO 6: Development of novel methods and interventions to decrease risk factors and incidence of cardiovascular diseases in the general population CARDIO 7: Tissue engineering in cardiovascular medicine

53 ANNAlab MI-2 Testing in EP MAYO

54 Other Prototypes Developed in Collaboration between Institute of Scientific Instruments, Mayo Clinic and St. Anne s University Hospital Non-invasive cardiac output monitor ANNAlab CO 1+2 Spirometric systems ANNAlab SM 1-3 System for digital photoplethysmography ANNAlab SGP 1

55 Cardiovascular Research CARDIO 1: Cardiovascular and transplant surgery, heart failure, and organ transplantions - development of novel strategies for advanced diagnostic and treatment CARDIO 2: Interventional cardiology, angiology and acute coronary syndromes - development of novel strategies for advanced diagnostic and treatment CARDIO 3: Cardiac electrophysiology and pacing - development of novel strategies for advanced diagnostic and treatment CARDIO4: Cardiovascular and metabolic disorders - identification of novel risk factors and development of novel diagnostic and therapeutic strategies CARDIO 5: Non-invasive cardiovascular imaging - development of novel methods and technologies CARDIO 6: Development of novel methods and interventions to decrease risk factors and incidence of cardiovascular diseases in the general population CARDIO 7: Tissue engineering in cardiovascular medicine

56 0s 30s 1min 3 min 10 min 30 min Quantitative cardiology PET-single tracer The power of PET is quantification, but it is problematic due to image noise. Unique hemodynamic information is inherently available in dynamic PET, if we can perform quantification of functional parameters and maximize information from a single scan using full automation Single scan What to measure? Venous blood Lung tissue Arterial blood Right myocard Left myocard Cardiac Output Stroke Volume Transit times Central blood volume Syst. Vascular Resistance CCT LV pressure Lung water Regional lung blood vol. LVEF EDV ESV Wall motion Wall thickening Perfusion Oxygen consumption Tissue characterization Cardiac Efficiency What to measure in the future? Functional component tissue segmentation: MVW-PCA on Dynamic PET 11 C-Acetate PC1-myocard PC3 arterial blood pool PC2 venous blood pool PC4

57 KEY INDUSTRIAL PARTNERS

58 Key Advantages of ICRC Brno Project Unique Concept of ICRC World widely respected strategic academic partner Mayo Clinic Proven concept with strong history of collaboration International Teams with world widely respected leaders

59 Brno Mayo Clinic

60 MAYO CLINIC CONTRIBUTION Methodology /Know-how/Training Foresight defined research programs Team Leaders for each program Projects in progress (IP, knowledge, financing) Education short term, MSc, PhD, joint programs Established Trademark (Mayo Clinic name) Individualized medicine Network

61 St Anne s Hospital - ICRC Research Management

62 ICRC Brno Research Management ICRC International Steering Committee operational management- international collaboration ICRC Brno International Scientific Advisory Boards (3) Strategic decisions ICRC Brno Scientific Working Groups Responsible for management of individual research programs (13) ICRC Brno Working Groups for Advanced education Technology transfer and industrial research Conflict of Interest Policy

63 ICRC Brno Project Realization

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65 St. Anne s Hospital - ICRC Focus on Applied Medical Research

66 Summary of Research Collaboration Mayo & ISI/St. Anne s Hospital ( ) 18 completed research projects 28 papers [IF >130], 2 book chapters and 1 book published 5 manuscripts in preparation/submission 6 functional prototypes and 4 software packages developed for high- resolution data acquisition and processing 1 U.S. Patent Awarded 3. U.S. Patent Applications pending/ in preparation (Mayo Medical Venture) Contribution to Mayo Clinic Hewlett-Packard monitoring technology development 3 scientific awards (ISH, CSH, Mayo Outstanding Research Award )

67 ICRC Brno Key Directions of Research Prevention and early detection of cardiovascular, oncological and neurovascular diseases Development of novel diagnostic and therapeutic strategies/technologies for targeted and individualised treatment of cardiovascular, oncological and neurovascular diseases Ongoing international research projects funded by NIH/EU/CR

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