1. REACTA Forum 2014 참가후기 2014.11.21 세브란스병원 연구원 최청암

2. Outline REACTA Forum 2014 Collaboration in industry (NonTransCelerate) 제약회사 (Daiichi Sankyo) 임상시험 센터 ( 삼성서울병원 CTC) CRO (INC Research Korea)

3. REACTA (REgional Asian Clinical Trial Association) CTC ( 주로 Asia 지역 ) 의 모임 –Korea, Japan, Taiwan, HK, US, and Malaysia REACTA Forum 2014 부산 동아대에서 개최 2014.11.6-7 Guiding purpose – 상호 협력 – 교육 –Regulatory harmonization

8. OPTIMIZING THE CLINICAL TRIAL PROCESS THROUGH COLLABORATION 1. Yoon-Duk Han, TransCelerate

9. TransCelerate A non-profit organization focused on advancing innovation in –R&D –Improving patient safety –Delivering more high quality medicines Discusses issues facing the industry and solution for addressing common challenges Support of the original 10 founding biopharmaceutical company members

10. Source: TransCelerate, 2014 ARCS Scientific Congress

16. EFFICIENT MULTINATIONAL CLINICAL TRIALS FOR PATIENTS IN ASIA 2. Koichi Miyazaki, Daichi Sankyo Co., Ltd

17. Increasing trend of clinical trial activity in Asia Source: REACTA Forum 2014

18. The number of studies per 100 M people Source: REACTA Forum 2014 Sufficient capacity available in Asia for increased demend

19. Protocol deviation (deviation/patient) Source: REACTA Forum 2014

20. Proposed investigator grant for completed case Clinical trial in Asia is cost effective Source: REACTA Forum 2014

21. Enrollment speed (enrollment/sites) Source: REACTA Forum 2014

22. Clinical trial by phase Source: REACTA Forum 2014

23. Contribution from each region … small region should contribute at least 21.3% of the patients… …guarantee reasonable power of … at least 20% Asian authorities may request more data from Asia Source: REACTA Forum 2014

24. Development strategy (past) Source: REACTA Forum 2014

25. Development strategy Source: REACTA Forum 2014

26. Clinical study in Asia Quality, cost and speed of Asia study are competitive Asia should be involved from early stage trial to consider ethnic differences Ideally, each region should contribute at lease 20% of the patients to ensure the consistency across regions Source: REACTA Forum 2014

27. SAMSUNG MEDICAL CENTER CLINICAL TRIAL CENTER 3. YoungSuk Park, SAMSUNG Medical Center CTC

28. SMC CTC Introduction 1995 1 상 임상시험 실시기 관 지정 2001 美보건아시아 최초로 실시기관 및 IRB 등록 2006 AAHRPP 전면인증 2007 Pfizer CORE Research Site 지정 2008 보건복지부 지역임상 시험센터 및 3 개부문 지정 2010 미래의학센터 설립 2012 BMS Oncology Center of Excellence Sanofi Premier Site 지정 2013 보건복지부 연구중심 병원 지정 Source: 삼성서울병원 임상시험센터 website

29. SMC CTC Introduction Phase 1252030 Phase 2757671 Phase 3113112119 Phase 456 50 Source: REACTA Forum 2014

30. Phase 1 Unit Team at CTC ResearcherNumber Pharmacologist6 Pharmacist2 Operation1 CRC Oncology 6 Healthy Volunteer 6 Nurse2 PK6 Phase 1 Study –Single ascending dose –Multiple ascending dose –Drug-Drug Interaction –BA/BE Proof of Concept Study with New Biomarkers Through QT/QTc Study Multi Omics (Genomics/Proteomics/Metabolomics) PK/PD M&S New Statistical Tools for Innovative Design □ Member □ Technology for early phase trials Source: REACTA Forum 2014

31. Personalized Tx Clinical at ICMI Source: REACTA Forum 2014

32. SMC & Industry Collaboration Cases Source: REACTA Forum 2014

33. Translational CRO Functions Source: REACTA Forum 2014

34. SITE SELECTION 3. Hailey Chae, INC Research Korea

35. Site Selection Process Potential Investigators Evaluate Criteria Feasibility Study Pre-study Visit Source: REACTA Forum 2014

36. Identifying Potential Investigators Literature Review Medical Society Directories Investigator Database Reference from Investigator Professional Colleagues Regulatory Lists Source: REACTA Forum 2014

37. Site Evaluation Experience with similar trials Interest Level (Prompt response for feasibility & any queries) Patient pool Competing trials Resources (study coordinator/Sub-I/Rater) EC (SOP/approval timeline/contract process) Source: REACTA Forum 2014

38. Site Evaluation Staff –Study coordinator/Sub-I/Rater –General interest & attitude –Training Facility –Storage for study supplies –Archiving practices: study documents –Device calibration: Freezer/Blood pressure Source: REACTA Forum 2014

39. Criteria Source: REACTA Forum 2014 Certification Competition Compliance Contract Cost Expertise Experience Equipment Ethics committee Local lab Logistics Language Subject Staff Space & storage Time Training

40. Selection of site is both the Art and Science of Investigating Investigator Source: REACTA Forum 2014

41. Factors influencing clinical trial site selection in Europe Applications to run clinical trials in Europe fell 25% between 2007 and 2011 19 factors explored: across investigator-driven, hospital-driven and environment-driven criteria, and costs. It also surveyed perceptions of the European trial environment Investigator-dependent, environment-dependent and hospital- dependent factors were rated highly important, costs being less important Within environment-driven criteria, pool of eligible patients, speed of approvals and presence of disease-management networks were significantly more important than costs or government financial incentives Source: REACTA Forum 2014

42. Investigator-driven criteria in the selection of phase II-III trial sites CriteriaMean Investigator recruitment/retention track record27.3 Investigator experience in previous trials22.7 Investigator interest22.4 Investigator concurrent workload17.2 Investigator publication track record10.4 Source: REACTA Forum 2014

43. Environment-driven criteria in the selection of phase II-III trial sites CriteriaMean Size of marketing/eligible patients in a region23.8 Speed of MoH/Ethics committees approval23.4 Disease management system/networks18.9 Cost of running trial15.2 Presence of country on ‘core country list’11.8 Source: REACTA Forum 2014

44. Hospital-driven criteria in the selection of phase II-III trial sites CriteriaMean Site personnel experience and training22.0 Previous experience with site20.0 Facilities/equipment required by trial19.7 Hospital approval/contracting system17.4 Site personnel language proficiency10.8 Source: REACTA Forum 2014

46. Institutional Considerations to procure more projects Expand experience and qualified investigator pool by active involvement of sub-investigator group Establish and maintain qualified and well- trained study coordinator resource via clinical trial center Update regular trial experience and patient pool (Web-based/Newsletter) Streamline and control feasibility process Obtain regular feedback from industry Source: REACTA Forum 2014

47. 끝 ! 감사합니다.