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Beyond the BarrierPARTNERS

We are committed to providing personalized & precision clinical trialswith our specialized facilities & a team approach strategy

Panomics Based Clinical Trial

Metabolite Biomarker

Stem Cell Clinical Trial

Samsung Genome Institute Stem Cell & Regenerative

Medicine Center

Institute for Innovative Cancer Medicine

Human Biobank

Laboratory of Pharmacometabolomics

Bio Bank

Pharmacogenomic Research Centerfor Psychactive drugs

CHA Bio Complex

Global Stem Cell Clinical Trial CenterCancer Genomic Research Center

Genome Research Center

Lee Gil Ya Cancer and Diabetes Institute

Neuroscience Research Institute

Korea University Cancer Institute

Image Biomarker

Healthcare, drug development paradigm shift

Personalized & precision medicineTargeted therapy & niche-buster

Pharmaceutical industry has been changing

Rational drug design, Advancing translational researchFrom closed to open innovation

Hospitals need to be the partner from the vendor

Total innovation from basic, translational, clinical research to commercializationConnecting internal & external innovation with control tower

PARTNERS CONSORTIUM

We are striving for PARTNERS to be a partnerPersonalized & precision clinical trial based onAdvanced Research Tools,Network in the biomedical Ecosystem andRobust Support system

P A R T N E R S

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P A R T N E R S

3

What W e Offer

ABLE for businessAdding value through Business Linkage and Evolving system

• Business consulting• Development & connection of

innovative pipeline• Commercialization support

EXPERT for educationEXcellent Programs for Education and ReTraining

• Customized & integrated program• Open education platform• Mentoring program• Program QC/QA

Panomics based Clinical Trial• All phase one-stop platform • Panomics based N of 1 trial• Target efficacy and safety evaluation• Drug repositioning

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

Metabolite Biomarker• Metabolomics based clinical trial• Metabolite biomarker discovery & evaluation• Integrated OMICS analysis platform

Research Module

Team Approach

Support Module

Matrix Organization

P-CREATS for coordinationPARTNERS - Clinical REsearch AndTranslational research Support system

• Consulting• Regulatory affairs• Resource coordination

Total Innovationfrom basic, translational, clinical research to commercialization

Control Toweropen innovation and true collaboration in the biomedical ecosystem

P A R T N E R S

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P A R T N E R S

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Business Card

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

P A R T N E R S

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P-CREATSPARTNERS-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 fieldsClinician 74 (Panomics 35, Stem cell 31, Image biomarker 4, Metabolite biomarker 4)Clinical pharmacologists 7, Basic researcher 21, Biostatistician 3Legal/intellectual property 5, Regulatory affairs 5

PARTNERS-Clinical REsearch And Translational research Support system

P A R T N E R S

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

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

Tanibirumab Korea’s first new antibodydrug 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

Handles the approval of the clinical trial protocols following the professional licensing process

• IND preparation & maintenance• Emergency use IND• Risk management/ NDA support

SERVICE

EXPERIENCE

EXPERT CONSULTING

RESOURCE COORDINATION

REGULATORY AFFAIRS

PARTNERS-Clinical REsearch And Translational research Support system

Contact information TEL 82-2-3410-6853 FAX 82-2-3410-0958 E-mail ahm0125.an@samsung.com

P A R T N E R S

Integrated Services for Your Entire Trial

Excellence in clinical trial site Pfizer CORE Research Site

Oncology Center of Excellence Premier Research Site

Onco Alliance Center

Active research collaborations with global pharmas and research institutionsGlobal Relationship

R&D One Stop Platform for Open Research Collaboration

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

Genome matched clinical trial

Bio Specimen Clinical

Trials

Genomics

Pre-clinicalResearch

ResourceBiospecimen collection in our biobank

Personal cancer & rare disease genome analysis solution

®

Bioinformatic solution optimized to the clinical actions

Pancreas

Prostate

QC infomation

Variants

Variants

Fastq

Gateway Software

Sequencing

CDW

Tract CancerSimvastatin for Gastrointestinal Cancer clear cell Renal Cell

Carcinomamaintenance for Small Cell Lung Cancer Cell Lung Cancer

Drug Repositioning

A-CRO Experiences

Tel Fax

P A R T N E R S

Global Clinical Trial Center of Excellence The World Best Global Clinical Trial Center

Patient safety as Top priority by high ethical

standards, QI and transparency

HRPC FERCAP

JCI

Safety

KU-KIST

CRO

KUMC

ScienceDrug Discovery &

Development Group

Hongneung Valley

KU College of Pharmacy

Global Pharmaceutical Company

Industry-University Collaboration Network &

Open-Innovative Research Platform

The Leader of Clinical Trial Center in Asia with Top Global

Standards

Providing the best environment for clinical trials

High quality experts, knowledge and experiences

Disease-specific Medi-cluster working groups

ArtMusculoskeletal diseases

GI and Liver diseases

Infections and Respiratory diseases

Neurologic /Psychiatric diseases

Cardiovascular diseases

Cancer

Endocrine diseases

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 Supporting full life cycle of Clinical Trial

BEST Business model,

Education,

Support and

Translational network

VALUE-DRIVEN CLINICAL TRIALThe Value of Clinical T r i a l a n d b e y o n d

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

Main research areas and capacity of KU Global CTCFor the actualization of cutting edge medicine Genome, IT Convergence, Stem cell study to create practical synergy and achieve industrialization

Panomics based clinical trials, providing personalized

clinical trial

New drug development based on Bed-side Panomics through the real-time evaluation of efficacy and safety

New Drug Development for Neuropsychiatric Diseases

based on iPSC

Supporting Whole Life-cycle ofClinical Trials by BEST

(Business model, Education, Support and Translational network)

Establishing of Business Model by One-step processing system

From Drug Discovery

To New Drug DevelopmentDual-CRO

Commercial CRO

Academic

CRO

Contact information Tel 82-2-920-6466 Fax 82-2-920-6465 E-mail irbadmin@kumc.or.kr

ExpertsResearch PlanningLaboratory Analysis

Education TrainingMonitoring

New Drug Discovery Research Team

Center of New Drug Development

KU Holdings

-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

Commercializationof 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

KUMCCTC

Cooperation

BIOMEDICAL Cluster based Open Research Platform

Services at the Genomics/Metabolomics CTC

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.

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

Genomics / Metabolomics based Clinical Trial Center

Whole Metabolic Pathway

P A R T N E R S

Clinical Pharmacological Services

Biostatistical/Data Management Services

research results

Services at the KNUH CTC

KNUH CTC Linkage Projects with other institutes An opportunity for collaborative research with New Drug

Development Center, Daegu-Gyeongbuk Medical Innovation Foundation Radiolabeled ADME study for drug development with Molecular

Imaging Research Center, Research Institute of Radiological & Medical Sciences

Clinical Trial Clinical trials related to new drug development :

Phase 1 ~ Phase 4 Microdosing clinical trials : Phase 0 Investigator Initiated Trials

Clinical Research Coordinator Service Provision of highly trained and dedicated Clinical Research

Coordinators Full services for subject recruitment, project management and

documentation Preparation of monitoring, audit, and inspection

Contact information Tel 82-53-200-6356 Fax 82-53-420-5218 E-mail ctc@knu.ac.kr

Global Clinical Trials Center with Advanced Imaging Technology

P A R T N E R S

Imaging BiomarkerDiscovery

Personalized Clinical Trialsbased on Imaging-Genomics

Early Phase Efficacy /Safety Evaluation

From Macroscopic to Microscopic Image

The need for a new accurate quantitative method

1.5TBrainstem Image

7TBrainstem Image

11.7TMolecular Image

HRRT-PET / 7.0T MRI Fusion Imaging

Neuroscience Research Institute

Animal researchPET & MRI

Human research PET & MRI

Quantization of Molecular Fusion Imaging

Micro-PET

HRRT-PET

7.0T MRI

Micro-CT

7.0T MRI

PET & MRIFusion

PET/CT

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

Impossible to detect< 1-2% difference by traditional methods

Fat measurement using 1H MRS

Clinical Facilities of Gachon Clinical Trials CenterGachon 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 82-32-460-9460 Fax 82-32-460-9443 E-mail kyh@gilhospital.com

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

CHA Clinical Trials CenterGlobal Center of Excellence in Clinical Trials

P A R T N E R S

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.

Current clinical trials are including retinal pigmentated epithelial cells, autologous killer cells, cord blood cells, neuronal precursor cells, etc for various regenerative diseases.

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

Contact information Tel 82-32-780-5322/5176 Fax 82-32-780-5305 E-mail ctc@chamc.co.kr