Nattha Kerdsakundee,Ph.D. Regional Manager Department of International Trials

Transcription

1 Nattha Kerdsakundee,Ph.D. Regional Manager Department of International Trials

2 Disclaimer These Power Point slides are the intellectual property of NCGM under the copyright laws. Used by permission. All rights reserved. NCGM and the NCGM logo are registered trademarks of the National Center for Global Health and Medicine. 2

3 Locate in the center of Southeast Asia with area around 513,115 sq.km Top 10 Tourist Attraction Countries in the World in 2018 Climate: Tropical and high humidity 3 seasons (only 2 in south) Hot: March-June Rainy: July-October Cool: November-February Temperature around C 3

4 Capital city: Bangkok 77 provinces Major language: Thai Population: 68.4 M Crude Birth rate 10.7 (per 1000) Crude Death rate 8.3 (per 1000) Total Fertility rate 1.58 Life expectancy: 75 year Transition into aged society (age>60 year: 17% of population; 2018 est) Source: Institute for Population and Social Research Major religion: Buddhism GDP Per Capita: 6,992 USD (2018 est) GDP growth rate: 3.87% (2018 est) Health expenditure approx. 4.1% of GDP (241 USD per capita) (Source: ceicdata) 4

5 Health status in Thailand The Non-communicable diseases are the major cause of death. The prevalence of NCD is also on the rise due to Source: WHO changing lifestyles: smokers, high in meat, salt, fat, and sugar content meal Aged society, the increasing of developing respiratory diseases, cancer, and diabetes Infectious diseases remain an issue of Thailand due to its tropical climate. - Nearly 450,000 people in Thailand are living with HIV/AIDS, but the number of new HIV cases per year decreased - Dengue fever affects tens of thousands annually - Other infectious diseases including influenza, tuberculosis, and malaria 5

6 Infectious diseases in Thailand Dengue Fever Dengue In 2013, Thailand experience the largest dengue epidemic in more than two decades No. of patients In 2018, the updated no. of Dengue cases are 25,408 case and Death 33 case 2018 est Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Source: Bureau of Vector-borne Disease, Department of disease control, Thailand, Polwiang, Sittisede Travel Medicine and Infectious Disease, Volume 14, Issue 4,

7 Infectious diseases in Thailand Malaria Malaria No. of Patients P. vivax 58% - P. Falciparum 41% - P. Malariae 0.1% - mixed Pv and Pf 0.7% Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Source: Bureau of Vector-borne Disease, Department of disease control, Thailand 7

8 Infectious diseases in Thailand Tuberculosis No. of registered patients Tuberculosis Source: Bureau of Tuberculosis Department of disease control, Thailand HIV- positive with TB is around 8.8% 2.2% of new cases with MDR/RR-TB 24% of previously treated cases with MDR/RR-TB Source: WHO Global TB report

9 Rabies outbreak, 2018 Rabies has once again raised its head in Thailand, killing many people in the country since last year. 8 people died in confirmed animals of rabies 9

10 Antimicrobial resistance in Thailand Distribution of MDR-TB Cases, Thailand Imipenem resistance Distribution of Artemisinin Resistance TIER I- areas with credible evidence of artemisinin TIER II- areas with significant inflows of mobile & migrant populations from tier I areas or shared borders with tier I areas TIER III- endemic areas without evidence of artemisinin resistance and have limited contact with tier I areas 10

11 Healthcare systems National Health Security Systems (public hospital only) Health Expenditure in Thailand 2014 Out of pocket 3% 12% Other Private Source: Thailand Health profile % Source: OECD Health Statistics 2016: WHO Global Health Expenditure Database11 Public

12 Healthcare market trend Source: PwC Health Industries Leader Source: EIC SCB, World Health Organization, BMI Thai government and tourism Authority of Thailand have promoted medical and health tourism policy Source: GlobalData 12

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14 Clinical research in Thailand Drug discovery Pre-Clinical IND submitted I II III FDA approval IV Research and development Vaccine - National Vaccine Institute, MOPH - Government Pharmaceutical Organization (GPO) - Produce over six million doses a year (diphtheria, pertussis, tetanus and encephalitis) - Joined with Sanofi Aventis to produce more than 20 million vaccine dose (encephalitis, hepatitis B, rabies and influenza - Center of Vaccine development, Mahidol University - Dengue - HIV - Influenza - JE - Chikungunya - Hepatitis Natural compou nd - Chula Drug Discovery and Development Research Center - Excellent Center for Drug Discovery, Mahidol University 14

15 Clinical research in Thailand Drug discovery Pre-Clinical IND submitted I II III FDA approval IV - National Laboratory Animal Center, Mahidol University - Center for Animal Research, Naresuan University Pre- Clinical In vivo (animal) testing - National Primate Research Center of Thailand, Chulalongkorn University 15

16 Clinical research in Thailand Drug discovery Pre-Clinical IND submitted I II III FDA approval IV Thailand 356 2,328 Singapore 412 2,029 Malaysia 185 1,050 Philippines Indonesia Total trial Vietnam Active recruiting trial Cambodia Myanmar 21 4 Lao 13 4 Brunei Number of Clinical Trials Source: NIH U.S. National Library of Medicine, ClinicalTrials.gov 16

17 Clinical research in Thailand Trial III II N/A IV Thailand has an ability to conduct all phase of clinical trial Most of Clinical trials are in III I Number of Clinical Trials Disease Type HIV 274 Respiratory infection 103 Clinical trials in Thailand covers a broad range of disease profiles including noncommunicable and communicable disease. Diabetic type 2 Lung Non-small cell Breast neoplasm GI neoplasm Hepatitis B Anemia Influenza Pain (postoperative) Malaria Asthma Number of Clinical Trials Source: NIH U.S. National Library of Medicine, ClinicalTrials.gov 17

18 Clinical research in Thailand Attracting factors Large treatment-naïve patient population Highly skilled workforce Broad range of disease profiles, including tropical diseases Biggest impediment The lengthened of the independent ethical approval Source: Deloitte process and the import license approval process 18

19 How to start clinical trial 19 Picture from rahlat.com

20 Regulator of Drug and Medical Device Thai FDA organization structure Hazardous Substances Committee National Drug Policy Committee National Coordinating Committee on Chemicals Management Ministry of Public Health Food and Drug Administration Secretary-General National Food Safety Committee Medical Device Committee Narcotic Control Committee Committee on Prevention against Abuse of Volatile Substances Psychotropic Substances Committee Internal Audit Group Public Sector Development Group Food and Drug Legal Group Narcotic Revolving Fund One Stop Service Center Information Center Cosmetic Committee Drug Committee Food Committee Complaint & Suppression Center Anti-corruption Center Deputy Secretaries General (3) Senior Experts Bureau of Cosmetic and Hazardous Substances Bureau of Import and Export Inspection Bureau of Drug Bureau of Food Narcotics Control Division Medical Devices Control Division Cosmetic Hazardous Substances Control Group Control Group Office of the Technical Planning Public &Consumer Rural and Local Consumer Health Product Secretary Division Affairs Division Protection and Promotion Division 20

21 Clinical Trial process Sequential process Parallel process 21

22 Clinical Trial process Sequential process Inspection Compliance with GCP Protocol Regulations 22

23 Clinical Trial process Parallel process 23

24 Hospitals conducting Clinical Trials Bangkok Province Central Hospital and others including specialized hospital (55) Regional hospitals (33) University Hospital (20) - Bangkok (8) - Northern (3) - Northeast (4) - Eastern (1) - Southern (4) Private hospital (321) Every hospital can conduct clinical trials depending on facility, infrastructure and staff. District Sub-district General hospitals (83) Community hospitals (723) Health center (9,768) Other public hospitals (120) Municipality Medical Center Private Clinic (17,671) Pharmacy (11,154) Most of clinical trials have been conducted in University hospital and Specialized hospital. More than 100 public hospital provide specialized medical services 24

25 20 IRB/IEC accredited by Thai FDA 25

26 Examples of Current Clinical Trials Topic Disease No. of particip ants Evaluating the Pharmacokinetics, Safety, and Tolerability of Doravirine (MK-1439) and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (MK-1439A) in HIV-1-Infected Children and Adolescents II Study of AZD9291 in Advanced Stage NSCLC With EGFR and T790M Mutations Detected in Plasma Ct-DNA (PLASMA) A Clinical Study to Evaluate the Safety and Immunogenicity of Inactivated Poliomyelitis Vaccine in Healthy Infants A Study of Epoetin Beta Treatment in Anemic Participants With Myelodysplastic Syndrome (MDS) I II III IV HIV infection Carcinoma, Non- Small-Cell Lung Poliomyeli tis Myelodysp lastic Syndromes 26 Site Sponsor 65 Siriraj Hospital National Institute of Allergy and Infectious Diseases (NIAID) 108 Ramathibodi Hospital National University Hospital, Singapore AstraZeneca 1,329 Siriraj Hospital Chiang Mai University Hospital 120 King Chulalongkorn Memorial Hospital Rajavithi Hospital Ramathibodi Hospital Siriraj Hospital Chiang Mai University Hospital Srinagarind Hospital Khonkean Regional Hospital Thammasart Chalermprakiert Hospital Naresaun University hospital Sapprasitthiprasong Hospital LG Chem Hoffmann-La Roche

27 Notes!! Leading conductor of clinical research in pharmaceuticals among all ASEAN Highly skilled workforce (15,509 FTEs) Large patient population (111,672 participant in 761 trials) Well developed medical equipment and facilities High incidence of Tropical Disease High cost-effective in hosting trials 27

28 28 Picture:

29 Thank you ありがとうございます ขอบค ณค ะ Picture: dreamstime