Shaping the Future Industry Sponsored Research in Malaysia. College Physician 12 Nov 2017 Dr Akhmal Yusof CEO Clinical Research Malaysia

Transcription

1 Shaping the Future Industry Sponsored Research in Malaysia College Physician 12 Nov 2017 Dr Akhmal Yusof CEO Clinical Research Malaysia 1

2 Outline Introduction Meeting socio-economic demand of the country CRM Strategies: Where are we heading? Closing notes

3 Oncology ISR provide at least RM17 million worth of medication since 2013 to MoH

4 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 Datuk Seri Dr. S. Subramaniam Minister of Health, Malaysia YB Senator Datuk Prof Dr. Sim Kui Hian Senior Consultant Cardiologist Y. Bhg. Dato Seri Dr. Chen Chaw Min Secretary General in the Ministry of Health, Malaysia Y. Bhg. Datuk Dr. Noor Hisham Director General of Health, Malaysia Y. Bhg. Datuk Dr. Shahnaz Murad Deputy Director General of Health (Research & Technical Support) in the Ministry 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 Prof Dr Adeeba Binti Kamarulzaman Dean of the Medical Faculty at Universiti Malaya 4

5 Adhere to We will gain TRUST TRUST need to be maintain

6 Building a Trusted Organisation 1. Respect diversities whistleblowing policy 2. Integrity ABAC/FCPA 3. Professional Business Conduct No Gifts policy 4. Protecting company assets-ip protection 5. Behaving in community

7 Good Legal Review System Standard Operating Procedure in place reviewed and approved within 14 days reviewed by PUU Min of Health Transparent with presentation to PUU office quarterly Governed by Malaysia law Arbitration in Kuala Lumpur Indemnity to cover Institution and Study Team

8 Good Financial Control System Standard Operating Procedure reviewed and approved by KSU office reviewed by Integriti Transparent with statement of account Audited by external auditor

9 Scope of Services

10 CRM believes in delivering Deliver the commitment : I am Aware campaign, Clinical Trial Day, Clinical Trial List in CRM website Relia bility Spee d Quality Quick Startup time : Improve internal timeline Feasibility, Budget Negotiation, Fast recruitment within 100 days Quality Data Delivery : Protocol Deviation Workshop & GCP Refresher

11 How are we performing?

12 Where does Malaysia stand in SEA ( ) Country Number of ISRs* ( /12/2016) Thailand 741 Singapore 600 Malaysia 311 Philippines 207 Vietnam 154 Indonesia 111 Source: ClinicalTrials.gov, 20 th January2017 * Studies received from 01/01/2013 to 12/31/

13 THERAPEUTIC AREA No. of Approved Trials Classification of Trials approved by ECs in 2016 (Jan Dec 2016, n=162) No. of Trials approved by ECs in Malaysia in 2016 according to Therapeutic Area (Jan-Dec 2016, n=162) Interventional (Drug) 52 Observational/Non-Interventional Jan- Dec16 Yr BABE Studies Medical Device Phases of the Trials approved in 2016 (n=162) BE Cardiology / Vascular Diseases Oncology Endocrinology Pulmonary / Respiratory Disease Infectious Disease Paediatrics Neurology Hematology Dermatology Rheumatology Opthalmology Nephrology Hepatology Gastroenterology Vaccine Urology Psychiatry Orthopedic Nutrition Anaesthesiology Public Health / Epidemiology O&G Immunology Epidemiology Advanced Therapy Medicinal Product (ATMP) No. of Trials Approved in NO. OF TRIALS

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15 Speed : Quick start up time Countries Regulatory Timeline Ethics Submission Singapore Approx. 30 days Approx. 30 days Parallel MALAYSIA Approx. 30 business days Approx. 50 business days Parallel South Korea Approx. 30 days Approx. 50 days Parallel Hong Kong business days days Parallel Japan Approval is by default if no objections within 30 days 4 8 weeks Sequential Taiwan Approx. 30 business days Approx business days Both Philippines 8-12 weeks 8-12 weeks Both Source: George Clinical India 15

16 Meeting socio-economic demands of the country

17 CRM s 2020 KPI Targets 1000 ISRs (new & ongoing) (GNI) RM 578 million 1000 New Hi-Skill Jobs new & ongoing ISRs GNI of RM mil 1118 skill jobs 2017 (Sep) 1055 new & ongoing ISRs GNI of RM mil 1491 skill jobs 17

18 CRM strategies : Where are we heading?

19 Early Phase trials via P1RP 1000 ISR by 2020 Optimizing Oncology ISR via 3P-O and CRM-IKN support First PI growth since 2010 ( 185 in 2016 vs 69 In 2015) New collaboration with DNDi, Univesities (Glasgow, Lancaster, Birmingham, Newcastle, Warwick, Cambridge & Melbourne) 1.4 Million hit for website, Media presence in print media, 6 International missions Fastest growing site managers with 30% increase headcounts providing resources in public & private sectors

20 CRM 5 year strategies (2017 to 2020) Clinical Research Excellence and Advancement Centre Malaysia (CREAM) To manage own dedicated centre specializing on early phase development and oncology To complete the Clinical/Scientific ecosystem and drive research that matters for Healthcare solutions Project Accelerate 5 year Blue print Sustainable Value Proposition (SVP) Project To create research training academy that is respectable in the SEA region

21 Phase 1 Realisation Project (P1RP) Updates Pillar 1 Pillar 2 Pillar 3 Pillar 4 Pillar 5 Guidelines for Phase 1 CT People Development Capability Development Preparation of Sites Risk Management Launch November 2017 NPRA officer sponsored by CRM to study at Christie Manchester Oct 2017 Scientific Review Panel lists finalized and awaiting appointment by YBMK Ampang CTU and Sarawak GH Phase I Unit ready Crisis Manual Completed NPRA = National Pharmaceutical Regulatory Agency

22 Phase 1 Guideline available in CRM website

23 ACCELERATE Pre Clinical projects with Clinical/Scientific organization Collaboration with local Universities/MoH for Bench to Bedside Projects P1RP Centralized Lab for the region DNDi Translational Head visit to CRM and Sarawak Biodiversity Corporation in April 2017 IMR & Aurigene work for Novel Anti-Cancer Compounds & Associated Biomarkers recruitment started in October 2017

24 ACCELERATE Pre Clinical projects with Clinical/Scientific organization Collaboration with local Universities/MoH for Bench to Bedside Projects P1RP Centralized Lab for the region NHAM CRM Research Track showcased basic science, translational research as well as late stage clinical research from various institutions in Malaysia including all universities in the areas of Cardiology

25 ACCELERATE Pre Clinical projects with Clinical/Scientific organization Collaboration with local Universities/MoH for Bench to Bedside Projects P1RP Centralized Lab for the region

26 ACCELERATE Pre Clinical projects with Clinical/Scientific organization Collaboration with local Universities/MoH for Bench to Bedside Projects P1RP Centralized Lab for the region Visit to Hematogenix- Planning to Open lab to cater for Asian Clinical Trials sites in Malaysia

27 Growth of Sponsors (Aug) 142 CAGR 44%

28 FULL FEASIBILITY COUNT FULL FEASIBILITY STUDY GROWTH CAGR 12% YEAR Higher Full feasibility in Aug 2017 compared to full year Average conversion rate of 12% currently vs 10% in 2016

29 Creating Awareness About Clinical Research

30 I AM AWARE ROADSHOW LOCATIONS Upcoming:

31 16 th MAY 2017 INSTITUT KANSER NEGARA (IKN), PUTRAJAYA

32 The launching of Clinical Trials Day Officiated by the Minister of Health, Datuk Seri Dr. S. Subramaniam at National Cancer Institute, PUTRAJAYA -(16 May 2017). To celebrate the Clinical Trials Day launch, 33 satellite hospitals across Malaysia, conducted the I Am Aware roadshow to further drive awareness among public.

33 What could ISR contribute?

34 The intangible value of ISR TECHNOLOGY TRANSFER DESIGN STUDY PROTOCOL STUDY METHODOLOGY DATA MANAGEMENT EXPANDING RESOURCES INCREASE TREATMENT OPTIONS FOR THE PEOPLE PROVIDE RESOURCES TO STUDY SITES PROVIDE NEW KNOWLEDGE GLOBAL RECOGNITION CONSISTENT TIMELINE RELIABILITY & QUALITY PUBLICATION

35 2016 : 1 ISR 2017 : 7 ISRs

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37 MN companies Local companies

38 We believe CRM provides global health solutions for the people through clinical research Our deep understanding of the local clinical research landscape with the international standards of operations coupled with fundamental backing of the MoH provide us an incomparable advantage to deliver research and create high skilled job opportunities

39 Thank you Visit w w w. c l i n i c a l r e s e a r c h. my 39