Translational Research in Korea
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1 Translational Research in Korea In-Jin Jang, MD, PhD Department of Pharmacology, Clinical Pharmacology & Clinical Trials Center, Seoul National University College of Medicine & Hospital 12 September 2009
2 Agenda Government grants for translational research Industry initiatives Private sectors Example: Seoul National University Hospital
3 R&D Programs of Korean Ministry of Health, Welfare & Family Affairs R&D focused on Disease Prevention Disease oriented R&D Infrastructure development for disease oriented research: Medical Cluster, Korea National Enterprise for Clinical trials (KoNECT) Focused investment for productivity Innovative Research Hospital: technology transfer & commercialization Human Resource Development
4 Translational Research Programs of Ministry of Health, Welfare & Family Affairs Category Programs Disease Overcome Disease Oriented Research Hospital for Specialized Research Capability Clinical Scientist Support Translational Research Scientists Grant; seed grant for junior faculties, 35 million KRW for 1 year Translational Research Grant for Individual Investigators; 60 million KRW for 2 yr Translational Research Grant for M.D.-Ph.D. Collaboration; 200 million KRW for 2 yr Translational Research Center Grant for Practical Outcomes/Products; 500 million KRW for 4 yr Specialized Dx Tx Technology Development Support infrastructure building for research capacity of Hospital (clinical basic scientists) 1 billion KWR for 5 yr, 15 centers by 2012 Support & train future clinical scientists with capability of clinical and basic research 10 million KRW for 1 yr
5 Ministry of Health, Welfare & Family Affairs: Innovative Research Institute Program Hospital based cluster for new treatment & product development Support IND from Translational Research of basic and clinical scientists Research capacity building in Hospital: dedicated research faculty, research support for clinician, etc 4 billion KRW per year for 5 years each center, select 6 centers by 2010 Clinical R&D, facilitate & network for commercialization Univ./Lab. Hospital Industry Infra: personnel, capital, facility, regulation
6 Innovative Research Institute Program at SNUH
7 Innovative Research Institute Program at AMC 1. Targeted anticancer drug development 2. Drug delivery using nanotechnology 3. Molecular imaging for tumor
8 Innovative Research Institute Program of Severance Hospital 1. Diagnostic development 7.0T MRI base, monitoring of atherosclerosis, nanotechnology base imaging dye 2. Therapeutic agent development Vascular acting agents (repair, new vessel formation, etc) Magnetic nano-particle based thrombolytic agent, innovative stent, etc.
9 Translational Research Grant of Ministry of Education, Science and Technology Development of Fusion Technology of Medicine & Innovative Technology Clinician driven identification of research topic and collaboration with PhD scientists Superior and creative technology development by fusion of medicine and innovative techniques such as BT, NT, IT, CT, etc. Clinician will take the role of PI with 1 ~ 3 PhD subpi s. 500 million KRW per year for 5 years
10 Agenda Government grants for translational research Industry initiatives Private sectors Example: Seoul National University Hospital
11 Partnerships for Early Phase Clinical Trials and Translational Research Asia Phase I Center - Chinese, Japanese subjects - Dedicated staff member: Chinese speaking, Japanese speaking - Collaboration with Japan based CRO Pfizer, Core Research Site Consortium Dedicated staff member, steering committee Astra Zeneca: oncology translational research collaboration, Virtual Research Institute for diabetes, obesity and atherosclerosis
12 Agenda Public initiatives Industry initiatives Private sectors Example: Seoul National University Hospital
13 History of SNUH Jejungwon(1885) Daehan Hospital(1907) The Affiliate Hospital of Gyeongseoung Imperial University(1928) Corporation SNUH(1978) The Affiliate Hospital of SNU(1946)
14 Branch Hospitals Staff: 3,902 Beds: 1355 Inpatients: 558,325 (2007) Outpatients: 1,778,143 (2007) SNUH SNUCH Staff: 641 Beds: 270 Inpatients: 210 Outpatients: 715 Open: Boramae Staff: 799 Beds: 561 Inpatients: 457 Outpatients: 1,579 Open: Consignment: Staff: 1,474 Beds: 909 Inpatients: 845 Outpatients: 2,783 Open: Healthcare System SNUBH Location: Finance Center Staff: 150 Customer : 100 person/day Open:
15 Clinical Research Institute GLP Laboratory
16 SNUH Clinical Trials Center Since June 15, 1997 Support Clinical Research and Trials: translation of basic research into clinical practice Support investigator and sponsors with space, facility, expert staffs, softwares, etc.
17 RENOVATION, 2007
18 Clinical Trials Center, SNUH Committee on General Affairs Director Prof. KU Min (Allergy) Acting Committee Prof. KS Yu (Clinical Pharmacology) Prof. SI Oh (Cardiology) Division of Clinical Research Prof. DW Kim (Oncology) Division of Clinical Research Support Prof. IJ Jang (Clinical Pharmacology) Division of Medical Device Eval. Prof. W. S. Ahn (Anesthesiologist) Clinical Research Manager (Head Nurse) Administrative Manager QA (1 Registered Nurse) Research Ward (7 sections, 46 beds) Outpatient Clinic (7 rooms) 12 Registered Nurses, 4 Nurse Aides, 1 Administrative Staff Pharmacy (6 Pharmacists) Core Lab (5 Laboratory Medical Technicians) Faculties: 7 In house staff: 34 Research coordinators: 26 Admin. & Technologist Administrative Office (4 Persons) Reception (1 Person)
19 SNUH CTC Core lab. : sample processing/storage Research ward: 46 trial beds Outpatient clinic: 7+1 units Pharmacy Pharmacodynamics lab. Medical Device Evaluation Neuropsychopharmacology (128 channel EEG, portable EEG, psychomotor, thermal pain, etc) Dermatology, ophthalmology, etc. CV (QT, ABP, IC, etc),capable of thorough QT study: MAC5000 & MAC5500 (4), MUSE & SW Sample processing and testing - Pharmacogenomics laboratory Bioanalysis: GLP compliant LC MS/MS (6 sets), HPLC (5), Drug screening, etc.
20 CTC Expansion Oncology center (2010) Oncology trials: 20 dedicated beds and other facilities 1,000 m 2 space
21 CTC Expansion (cont.) Brain, Heart, & Diabetes Center (2012) - Cardiovascular/metabolic disease research & trials - Innovative treatment dev beds, 5 OPD office, etc. Research Oriented Hospital in IFEZ - Global regulations and standard Under construction
22 Clinical Trial & Research Technology Development PET imaging biomarkers Microdosing / exploratory IND Pharmacogenomics Metabolomics Modeling & simulation
![C]Raclopride Simulate Clinical Trial in silico Occupancy](/docs-images/84/89661549/images/23-3.jpg "(Putamen, %) 90 80 70 60 50 40 C 30 20 100 mg (N=3) 200 mg")
23 PK-PD Modeling & Simulation of Functional Imaging (PET) Data in Phase I Trial of a Novel Antipsychotic, for Later Phase Dose Estimation Before 2 hour 6 hour Dopamine (D 2 ) receptor occupancy of a new antipsychotic drug using PET & [ 11 C]Raclopride Simulate Clinical Trial in silico Occupancy (Putamen, %) C mg (N=3) 200 mg (N=3) mg (N=3) Prediction line by sigmoid Emax model Effect Site Concentration (ng/ml) PK-PD(D 2 occupancy) modeling with NONMEM At steady-state, 12 h post-dose 1. Occupancy median; 42 ~ 47.5% 2. Occupancy 10 percentile value; 32 ~ 37.5 % 3. Occupancy 90 percentile value; 52.3 ~ 58.4% Optimum Design for Phase II KS Lim, KS Yu, IJ Jang, SG Shin et al. CPT Feb
24 EMR Capability More than 1 million patients data: diagnosis, laboratory data, medication, image, etc. Excellent tool for translational research Feasibility check Electronic data capturing ADR signal detection Genetic research for rare phenotypes
25 Research Groups Pharmacogenomics Innovative Research Institute for Cell Therapy Xenotransplantation Research Center Regional Clinical Trial Center Nuclear Medicine Molecular Imaging Center Clinical Research Center for Stroke Genome Research Center for Diabetes and Endocrine disease Facility of GLP(Good Laboratory Practice) AAALAC(Association for Assessment and Accreditation of Laboratory Animal Care) International Achievement of Accreditation
26 Globally Competitive Research Area Brain Research: Alzheimer s & Parkinson disease Psychiatry: genomic, imaging and neurological evaluation Genetics: pharmaco-, population, etc. Cardiovascular: stem cell, vascularization research Immunology: NKT, regulatory T cell, RA, pulmonary fibrosis, etc. Endocrine: molecular mech., role of mitochondria in insulin resistance Pharmacology: HIF, hypoxia related disease Oncology: personalized therapy based on molecular biomarker, translational research Surgery: genetics Radiology: molecular image, interventional radiology, etc.
27 SCI Publications at SNU MC & SNUH 1,427 in
28 Research Grants 100 million USD in 2008 at SNU MC & SNUH Intramural Grant for Translational Research Multidisciplinary grant: collaboration with School of Engineering and Natural Sciences Grant for collaborative research between basic and clinical medicine USD Medical School Hospital Others
29 Thank you for kind attention.
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