Building a Globally Trusted Organization in Malaysia

Transcription

1 Building a Globally Trusted Organization in Malaysia

2 Outline Introduction Malaysia Clinical Research Environment Annual Report 2017 Moving forward towards a Global Trusted Organization Closing notes 1

3 Introduction 2

4 VISION To establish Malaysia as a Preferred Destination for Industry Sponsored Research (ISR) 2020 KPI TARGET 1000 ISR New & Ongoing Trials GNI RM 578 Million 1000 New High Skill Jobs 3

5 Board of Directors A non-profit company wholly owned by Ministry of Health to create a supportive environment and complete ecosystem to grow Industry Sponsored Research (ISR) YB Dr. Dzulkefly Ahmad Minister of Health, Malaysia Y. Bhg. Dato Seri Dr. Chen Chaw Min Secretary General in the Ministry of Health, Malaysia Y. Bhg. Datuk Dr. Shahnaz Murad Deputy Director General of Health (Research & Technical Support) in the Ministry of Health, Malaysia Prof Datuk Dr Adeeba Binti Kamarulzaman Dean of the Medical Faculty at Universiti Malaya Y. Bhg. Datuk Dr. Noor Hisham Director General of Health, Malaysia Y. Brs. Dr. Goh Pik Pin Director of the National Clinical Research Centre, Malaysia Mr Ewe Kheng Huat Executive Director of the Pharmaceutical Association of Malaysia 4

6 Management of CRM Dr. Akhmal Yusof CEO Dr. Khairul Faizi Head of Business Development Joanne Yeoh Head of Clinical Operations Yau Yit Huan Head of IT & Finance Zaleha Yusof Head of Human Resource 5

7 Scope of Services

8 Pulau Pinang 9 Kedah & Perlis 7 Kelantan 4 Terengganu 4 Placement of Study Coordinators 122 and growing Perak 12 Sabah 11 Selangor 24 Pahang 5 Kuala Lumpur & Putrajaya 23 Negeri Sembilan 3 Melaka 3 Johor 5 Sarawak 12 7

9 Malaysia Research Environment : The Opportunities

10 Malaysia Healthcare context Population 32.4 million 0 14 years: 24.1% years: 69.7% 65 years and over: 6.2% Source: Department of Statistics, Malaysia, 2017 Multiracial (English widely spoken and understood) Common diseases : Cardiovascular, Cancer, Diabetes Growing Public Healthcare spending- 4.54% GDP on Consistent timeline for Regulatory and Ethics approval 1 - Ministry of Health Malaysia: Health Facts

11 Malaysia: Best Healthcare In The World July 6 th 2017, International Living in its Annual Global Retirement Index 2017 honoured Malaysia for the third consecutive year of being named the country with the Best Healthcare in the World The ranking is based on: the price of medical procedures facilities available excellent hospitals highly trained doctors affordable care Source: 10

12 Huge Opportunity to Conduct Clinical Research in Malaysia *Number of industry initiated trials per million population Frost and Sullivan Asia clinical trials whitepaper- February

13 Competitive Costs of Conducting Clinical Research Frost and Sullivan Asia clinical trials whitepaper- February

14 Quick Startup time and Speedy Approval Parallel submission to Regulatory and Ethics. Regulatory Submission: 30-days approval 1 Ethics committee approval: 51 calendar days 2 1. George clinical, 2. MREC report 13

15 Malaysia is competitively positioned to attract more clinical trials! 14

16 Site Achievements in 2018 Top Recruiter 1. RESPECT-ESUS (Stroke Study): Hospital Seberang Jaya (PI: Dr. Irene Looi) 2. Prostate Cancer Registry: Hospital Kuala Lumpur (PI: Dr. Noor Ashani Md Yusoff) 3. RESPIRE (Respiratory Syncytial Virus in hospitalized Paediatrics): Hospital Sibu (PI: Dr Toh Teck Hock) 4. ELIGENT (Prostate Cancer Registry): Hospital Selayang (PI: Dato Dr. Rohan Malik) 5. Respiratory Syncytial virus in hospitalized adults: Hospital Miri (PI: Dr. Desmond Samuel) Global First Recruiter 1. ELIOS (Metastatic NSCLC): Hospital Umum Sarawak (PI: Dr. Voon Pei Jye) 2. VISTOR (Respiratory Syncytial Virus in hospitalized Paediatrics): Hospital Sibu (PI: Dr. Chieng Chae Hee) Malaysia First Recruiter 1. CHRONOS 3 (indolent B-cell Non-Hodgkin s Lymphoma) Hospital Raja Permaisuri Bainun (PI: Dr. Kamini K.) 2. Lupus Nephritis: Hospital Raja Permaisuri Bainun (PI: Dr. Loh Chek Loong) 15

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18 Annual Report 2017

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20 2020 TARGET GNI of RM 578 million 1000 New Skilled Jobs 1000 New and ongoing ISRs 2017 scorecard 2015 RM125++ million 1118 skill jobs 777 New and ongoing ISRs 2/3 KPI Achieved! 2016 RM196++ million 1491 skill jobs 939 New and ongoing ISRs RM240++ million skill jobs New and ongoing ISRs

21 The therapeutic areas of clinical trials conducted in Malaysia 2017 Cardiology/Vascular Diseases Oncology Gastroenterology / Hepatology Rheumatology Pediatrics/Neonatology Nephrology Neurology Infections and Infectious Diseases Hematology Pulmonary/Respiratory Diseases Psychiatry/Psychology Obstetrics/Gynecology (Women s Health) Dermatology Urology Orthopedics/Orthopedic Surgery Ophthalmology Nutrition and Weight Loss Genetic Disease Endocrinology Pathology Wound Care Surgical Anaesthesiology NO. OF TRIALS Note: Of the 19 oncology trials, 1 is a pre-clinical trial 20

22 Classifications of clinical trials conducted in Malaysia in 2017 Composition of interventional trials Medical device, 18 Others, 3 Observational 27 16% Interventional % Bioequivalence studies, 51 New IP, 72 21

23 Breakdown of Interventional studies according to phases (n=144) Phase IV, 8 Bioequivalence, 51 Phase III, 64 Phase I, 5 Phase II, 15 22

24 Growth of Sponsors and CROs SPONSORS CRO 150 more than 400% growth since more than 200% growth since

25 Building A Global Trusted Research Organisation

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28 C1:RESPECTING OTHERS C5: COMMUNITY AROUND US CRM CODE OF CONDUCT C2: DILIGENCE & INTEGRITY C4: PROTECTION OF COMPANY PROPERTIES & ASSETS C3: CONDUCTING BUSINESS 27

29 5Key Strategies 28

30 ISO 9001:2015 Accreditation Project Phase 1 Planning & Gap analysis Phase 2 Design and Development of QMS Phase 3 Training and Implementation Phase 4 Stage -Documentation Audit Stage 2 - Compliance Audit Jan Feb 2018 Mar - Apr 2018 May Jul 2018 Aug Jan 2019 Expected to be certified by January 2019 Ongoing Pending 29

31 Where Are We Heading?

32 The Next Way forward, UPSTREAM movement into Early Phase, Preclinical Pre -Clinical Project ACCELERATE P1RP Phase I Phase II,III,IV 31

33 Phase I Realization Project : Launch of Malaysia Phase I Guidelines 32

34 Phase 1 Realisation Project (P1RP) Updates Guidelines for Phase 1 Clinical Trial People Development Capability Development Preparation of Sites Risk Management Guideline launched in Nov 2017 Sponsorship of NPRA officers to The Christie Manchester (Oct ) Scientific Review Panel members approved by YBMK Ampang CTU and Sarawak GH Phase I Unit ready Crisis Manual Completed 33

35 Attracting Global Interests and Partnership 34

36 MOU with C&R Research, South Korea Dr. Akhmal Yusof of CRM and Yoon Moon Tae of C&R Research, Yoon Moon Tae 18 th January

37 Korean Visit 2017 Visit to Yonsei Global Clinical Trial Centre Showcasing to Daewoong our capabilities- 1 SGLT2i in Phase I 36

38 2017 1st Medical Korea Academy invitation to Dr Abdullah Mohd Razali by KHIDI 37

39 Visit by Samsung Bioepis, May

40 MoU Signing with DNDi - Public Health Approach to Hepatitis C in Malaysia 13th January

41 Aurigene Collaboration for Translational work MoU Signing between IMR & Aurigene for Novel Anti-Cancer Compounds & Associated Biomarkers 40

42 MOU With Taipei Medical University 41

43 MOU with ZheJiang University, China CRM and the First Affiliated Hospital of ZheJiang University Memorandum of Understanding (MoU) January

44 MOU with Intellim Corporation Japan 43

45 MOU with Hematogenix to set up Central oncology clinical trials Lab and Novotech the Asia Pacific CRO 44

46 NHAM-CRM Research Track April

47 Industry Dialogue April

48 International Presence and Awareness campaign

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50 3 Million visits to date since Feb Million in 2016 alone 49

51 Bulletins 50

52 I am AWARE campaign aims to raise patient and public awareness in clinical trials by providing the necessary means for patients and public to get information on clinical trials or to participate in any ongoing trials. 43 sites activations nationwide More than 3000 registered volunteers 51

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54 Creating World Class TEAM in CRM Making a Difference : NEW VALUE PROPOSITION Training & Development Recalibrate & Manage Performance Clearer Career Development 53

55 Conclusion and moving forward CRM is a unique model to facilitate ISR in Malaysia Our 5 years strategic focus on Pre-Clinical, Phase I and Sustained Quality We invite more Korean Biopharmaceuticals and Clinial trial related institutions to Collaborate with Malaysia 54

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