PARTNERS PARTNERS. Beyond the Barrier. Network in the biomedical Ecosystem and Robust Support system

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1 PARTNERS Personalized & precision clinical trial consortium based on Advanced Research Tools, Network in the biomedical Ecosystem and Robust Support system PARTNERS Beyond the Barrier

2 P A R T N E R S P A R T N E R S Healthcare, drug development paradigm shift Personalized & precision medicine Targeted therapy & niche-buster We are committed to providing personalized & precision clinical trials with our specialized facilities & a team approach strategy Pharmaceutical industry has been changing Rational drug design, Advancing translational research From closed to open innovation Panomics Based Clinical Trial Samsung Genome Institute Bio Bank Stem Cell & Regenerative Medicine Center Institute for Innovative Cancer Medicine Stem Cell Clinical Trial Hospitals need to be the partner from the vendor Total innovation from basic, translational, clinical research to commercialization Connecting internal & external innovation with control tower Pharmacogenomic Research Center for Psychactive drugs Cancer Genomic Research Center Korea University Cancer Institute Genome Research Center Lee Gil Ya Cancer and Diabetes Institute Neuroscience Research Institute Human Biobank Global Stem Cell Clinical Trial Center CHA Bio Complex Laboratory of Pharmacometabolomics We are striving for PARTNERS to be a partner Image Biomarker Metabolite Biomarker Personalized & precision clinical trial based on Advanced Research Tools, Network in the biomedical Ecosystem and Robust Support system PARTNERS CONSORTIUM 2 3

3 P A R T N E R S P A R T N E R S Total Innovation from basic, translational, clinical research to commercialization Control Tower open innovation and true collaboration in the biomedical ecosystem Panomics based Clinical Trial All phase one-stop platform Panomics based N of 1 trial Target efficacy and safety evaluation Drug repositioning What W e Offer P-CREATS for coordination PARTNERS - Clinical REsearch And Translational research Support system Consulting Regulatory affairs Resource coordination Stem Cell Clinical Trial The unique clinical trial center dedicated to stem cells Stem cell trial global network Stem cell bank Image Biomarker Image biomarker based clinical trial Ultra-high resolution PET/MRI system Clinical trial using imaging-genetics Research Module Team Approach Support Module Matrix Organization ABLE for business Adding value through Business Linkage and Evolving system Business consulting Development & connection of innovative pipeline Commercialization support Metabolite Biomarker Metabolomics based clinical trial Metabolite biomarker discovery & evaluation Integrated OMICS analysis platform EXPERT for education EXcellent Programs for Education and ReTraining Customized & integrated program Open education platform Mentoring program Program QC/QA 4 5

4 P A R T N E R S 3,500 practicing clinicians with experience across all therapeutic areas and 330 specialists including clinical pharmacologist, CRC, CRA Diverse patient population with 5 million outpatients and 250,000 inpatients per year for disease-specific subject populations Completed 140 phase 1 and 373 phase 2 clinical trials for the last 5 years with full range of services including consulting, regulatory affairs and education Global infrastructure composed of 5 hospitals total of 158 beds for early and late phase clinical trials and 96 harmonized SOPs and integrated protocols for multisite trials Certified by AAHRPP and FERCAP for the highest subject safety Strong internal audit function to ensure QA/QC Full-scale emergency response team and MD coverage Business Card 6

5 PARTNERS-Clinical REsearch And Translational research Support system P-CREATS PARTNERS-Clinical REsearch And Translational research Support system P-CREATS designed to coordinate the open innovation among the industries, academia to medical center from developing fundamental technology to new drug approval based on the research capabilities of consortium. Consultation from experts in a variety of fields Clinician 74(Panomics 35, Stem cell 31, Image biomarker 4, Metabolite biomarker 4) Clinical pharmacologists 7, Basic researcher 21, Biostatistician 3 Legal/intellectual property 5, Regulatory affairs 5 P A R T N E R S

6 PARTNERS-Clinical REsearch And Translational research Support system SERVICE EXPERT CONSULTING Provides objective and professional advices about R&D process by configuring the advisory group of the relevant fields. Clinical development strategic advise & guidance Development of study design Pre-IND meeting RESOURCE COORDINATION Links the optimize resources in accordance with the needs of applicants using the research navigator Research collaboration with institutions Allocation of optimal core facility and connection Funding connection REGULATORY AFFAIRS Handles the approval of the clinical trial protocols following the professional licensing process IND preparation & maintenance Emergency use IND Risk management/ NDA support EXPERIENCE Tanibirumab Korea s first new antibody drug for cancer, FIH trial Drug development consulting & Developing protocol concept sheet Rituximab Biosimilar Drug development consulting & Developing protocol concept sheet Anti c-met Targeting Drug New antibody drug for cancer, FIH trial Protocol development, IND approval, study team organization, Safety Review Committee operation Contact information TEL FAX ahm0125.an@samsung.com

7 Integrated Services for Your Entire Trial R&D One Stop Platform for Open Research Collaboration Bio Specimen Global Relationship Active research collaborations with global pharmas and research institutions Genome matched clinical trial Excellence in clinical trial site Pfizer CORE Research Site Oncology Center of Excellence Premier Research Site Onco Alliance Center Clinical Trials Genomics Pre-clinical Research Meet the Investigators Lung cancer, head and neck cancer Lung cancer study, ICGC(International Cancer Genome Consortium) AVATASCAN Neuroimaging study for alzheimer's cardiology knee surgery, osteoarthritis of knee ' for knee cartilage defects P A R T N E R S

8 Resource Biospecimen collection in our biobank Prostate Pancreas Bioinformatic solution optimized to the clinical actions Personal cancer & rare disease genome analysis solution CDW Gateway QC infomation Variants Variants Software Fastq Sequencing Drug Repositioning Tract Cancer Simvastatin for Gastrointestinal Cancer clear cell Renal Cell Carcinoma maintenance for Small Cell Lung Cancer Cell Lung Cancer A-CRO Experiences Tel Fax

9 Global Clinical Trial Center of Excellence The World Best Global Clinical Trial Center KU-KIST KUMC KU College of Pharmacy JCI Hongneung Valley Drug Discovery & Development Group Science Global Pharmaceutical Company CRO HRPC Safety FERCAP Industry-University Collaboration Network & Open-Innovative Research Platform The Leader of Clinical Trial Center in Asia with Top Global Standards Patient safety as Top priority by high ethical standards, QI and transparency EXPERT Excellence in the translational research Patient-oriented, leading-edge clinical trial Establishment of global standards Responsibility for society Teamwork & collaboration Personalized and integrated education system Infections and Respiratory diseases GI and Liver diseases Musculoskeletal diseases Neurologic / Psychiatric diseases Art Providing the best environment for clinical trials High quality experts, knowledge and experiences Disease-specific Medi -cluster working groups Endocrine diseases Cardiovascular diseases Cancer BEST Business model, Education, Support and Translational network Supporting full life cycle of Clinical Trial VALUE-DRIVEN CLINICAL TRIAL The Value of Clinical Trial and beyond KU-Global CTC is dedicated to providing optimal research environment for the human welfare through clinical trials based on unmet medical needs from society. Global Center of Excellence in Clinical Trials P A R T N E R S

10 Main research areas and capacity of KU Global CTC Panomics based clinical trials, providing personalized clinical trial New drug development based on Bed-side Panomics through the realtime evaluation of efficacy and safety New Drug Development for Neuropsychiatric Diseases based on ipsc Supporting Whole Life-cycle of Clinical Trials by BEST (Business model, Education, Support and Translational network) Education Training Monitoring Commercial CRO Cooperation Academic KUMC CTC CRO Experts Research Planning Laboratory Analysis From Drug Discovery Dual-CRO To New Drug Development BIOMEDICAL Cluster based Open Research Platform -Matchmaking between researchers -Supporting validation of New drug target -Bridging preclinical experiments to clinical trials -Consultation for new drug development -The first medical holding company in Korea Commercialization of open clinical trials Bio Venture, Pharmaceutical companies, CRO etc.. Clinical Trial Center with a competitiveness and self-reliance as a cooperative partner in global trial market Contact information Tel Fax irbadmin@kumc.or.kr

11 Genomics / Metabolomics based Clinical Trial Center At Genomics/Metabolomics based Clinical Trial Center (CTC), we provide high quality and customized genomics / metabolomics analyses and biomarker discovery & evaluation for companies and research groups. The CTC presents fully validated, integrated OMICS analysis platforms that cover a part of the human metabolism, disease, and health. Our mission is to apply efficiently our technology and knowledge in order to offer quality services in a timely, convenient, and cost-effective manner. Services at the Genomics/Metabolomics CTC Consulting on the design of genomics/metabolomics experiments Development of novel spectroscopic and chemometric tools for investigating human metabolic pathways and disease Mass spectrometry-based metabolic profiling LC-MS small molecule target analysis Pharmacogenomic/Pharmacometabolomic assay and study Biomarker discovery and evaluation Personalized healthcare through metabolic phenotyping Whole Metabolic Pathway P A R T N E R S

12 Services at the KNUH CTC KNUH CTC Linkage Projects with other institutes Clinical Pharmacological Services ť An opportunity for collaborative research with New Drug Development Center, Daegu-Gyeongbuk Medical Innovation Foundation ť Radiolabeled ADME study for drug development with Molecular Imaging Research Center, Research Institute of Radiological & Medical Sciences ťȴ,;a=fla>a;ȴ9f<ȴe=<a;9dȴ;gfkmdl9lagf ťȴ )JGLG;GDȴ<=KA?Fȴ9F<ȴ<=N=DGHE=FL ťȴ )$ ȴ9F9DQKAK ťȴ )$ )ʆȴEG<=DAF? ťȴ -ʆ&ȴ ťȴ &=<A;9Dȴ/JALAF?ȴ )JGLG;GDK ȴ+=HGJLK ȴ + ȴ9F<ȴE9FMK;JAHLK ȴ=L; Clinical Trial Biostatistical/Data Management Services ť Clinical trials related to new drug development : Phase 1 ~ Phase 4 ť Microdosing clinical trials : Phase 0 ť Investigator Initiated Trials ťȴ,l9lakla;9dȴ;gfkmdl9lagfȴ>gjȴlja9dȴ<=ka?fȴ ťȴ,l9lakla;9dȴ F9DQKAKȴ)D9Fȴ9F<ȴKL9LAKLA;9DȴAFL=JHJ=L9LAGFȴ>GJȴ research results ťȴ ʆ9L9:9K=ȴ<=N=DGHE=FL ȴ<9L9ȴ=FLJQȴ9F<ȴJ=NA=O Clinical Research Coordinator Service ť Provision of highly trained and dedicated Clinical Research Coordinators ť Full services for subject recruitment, project management and documentation ť Preparation of monitoring, audit, and inspection Contact information Tel Fax ctc@knu.ac.kr

13 Global Clinical Trials Center with Advanced Imaging Technology From Macroscopic to Microscopic Image HRRT-PET / 7.0T MRI Fusion Imaging Neuroscience Research Institute 1.5T Brainstem Image 7T Brainstem Image 11.7T Molecular Image Animal research PET & MRI Micro-PET Micro-CT Human research PET & MRI HRRT-PET 7.0T MRI PET/CT Quantization of Molecular Fusion Imaging 7.0T MRI PET & MRI Fusion Segmented 7.0T MRI Lee Gil Ya Cancer and Diabetes Institute Metabolic Monitoring System, CLAMS In vitro/ex-vivo fat oxidation analyzer LC/MS/MS Minispec GC/MS The need for a new accurate quantitative method Impossible to detect < 1-2% difference by traditional methods Fat measurement using 1 H MRS Early Phase Efficacy / Safety Evaluation Imaging Biomarker Discovery Personalized Clinical Trials based on Imaging-Genomics P A R T N E R S

14 Clinical Facilities of Gachon Clinical Trials Center Gachon Clinical Trials Center is capable of conducting any clinical research project involving healthy volunteers or patients, from bioavailability/bioequivalence studies to first-in-human trials. On top of that, we offer comprehensive research support and consultation services at every facet from planning for execution to interpreting results. In particular, we are committed to provide a full portfolio of early phase clinical trials to our clients that encompass local and international pharmaceutical industries, biotech companies, and CROs. Early Phase Clinical Trials First-in-human study Pilot study Proof-of-concept study Pharmacokinetic/Pharmacodynamic study Clinical Research Supports Research pharmacy Research coordinator IRB submission Clinical study report Consultation Services Clinical trial design Bridging strategy Bioanalysis consultation Contact information Tel Fax kyh@gilhospital.com

15 CHA Clinical Trials Center Global Center of Excellence in Clinical Trials Full Service for Clinical Trials Study design / protocol development Regulatory submission Subject recruitment Clinical conduct IP management / pharmacy Sample management Study report Early Phase Clinical Pharmacology Studies First-in-human study Comparative pharmacokinetic study Drug-drug interaction study Bridging study Special population(hepatic/renal impairment) study P A R T N E R S

16 World's only specialized clinical trial center for'stem cell' Global Stem Cell Clinical Trials Center provides one stop service with a full suite of facilities for cell manufacturing, operation and hospitalization for efficient service delivery and patient's satisfaction. 1. Systematic care is available in all-in-one facilities for patients. 2. Modernized and patient-oriented in-hospitalization facility (single rooms and VIP rooms) 3. The conquest of intractable and rare diseases based on the cell research technology for 50 years in CHA Group Current clinical trials are including retinal pigmentated epithelial cells, autologous killer cells, cord blood cells, neuronal precursor cells, etc for various regenerative diseases. Contact information Tel /5176 Fax ctc@chamc.co.kr