Regional Manager Department of International Trials · 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

Nattha Kerdsakundee,Ph.D.Regional Manager

Department of International Trials

© 2018 National Center for Global Health and Medicine 2

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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 19-38°C

https://www.drivingdirectionsandmaps.com/thailand-google-map/


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

Capital city: Bangkok

77 provinces

Major language: Thai

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)


Health status in Thailand

Source: WHO

• The Non-communicable diseases are the major cause of

death.

The prevalence of NCD is also on the rise due to

• 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


Infectious diseases in ThailandDengue Fever

0

20000

40000

60000

80000

100000

120000

140000

160000

180000

2012 2013 2014 2015 2016 2017

No.

of p

atie

nts

Dengue 2012-2017

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 , 398 - 406

In 2018, the updated no. of Dengue cases are 25,408 case and Death 33 case

In 2013, Thailand experience the largest dengue epidemic in more than two decades

2018 est.

2017

© 2018 National Center for Global Health and Medicine

0

5000

10000

15000

20000

25000

30000

35000

40000

2012 2013 2014 2015 2016 2017

No.

of P

atie

nts

Malaria 2012-2017

7

Malaria

Infectious diseases in Thailand

- P. vivax 58% - P. Falciparum 41%- P. Malariae 0.1%- mixed Pv and Pf 0.7%

Source: Bureau of Vector-borne Disease, Department of disease control, Thailand

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec


Infectious diseases in Thailand

0

10000

20000

30000

40000

50000

60000

70000

80000

2012 2013 2014 2015 2016 2017

No.

ofr

egis

tere

d pa

tient

s

Tuberculosis 2012-2017Tuberculosis

• 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 2017

Source: Bureau of Tuberculosis Department of disease control, Thailand


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 2018

• 359 confirmed animals of rabies


Antimicrobial resistance in Thailand

Imipenem 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

Distribution of MDR-TB Cases, Thailand

Distribution of Artemisinin Resistance


Healthcare systems

Source: Thailand Health profile 2008-2010

National Health Security Systems (public hospital only)

Source: OECD Health Statistics 2016: WHO Global Health Expenditure Database

Health Expenditure in Thailand 2014Out of pocket

Other Private

Public

85%

12%3%


Source: PwC Health Industries Leader

Thai government and tourismAuthority of Thailand havepromoted medical and healthtourism policy

Healthcare market trend

Source: GlobalData

12

Source: EIC SCB, World Health Organization, BMI


- 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

- Chula Drug Discovery and Development Research Center

- Excellent Center for Drug Discovery, Mahidol University

Research and development

Vaccine

Phase I

Phase II

Phase III

Phase IV

14

Clinical research in Thailand

Drug discovery

IND

subm

itted

FDA

appr

oval

- Dengue- HIV- Influenza- JE- Chikungunya- Hepatitis

Natural compou

nd

Pre-Clinical Phase


Pre-Clinical Phase

Phase I

Phase II

Phase III

Phase IV

15


Drug discovery

IND

subm

itted

FDA

appr

oval

Pre-Clinical Phase

In vivo (animal) testing

- National Laboratory Animal Center, Mahidol University

- Center for Animal Research, Naresuan University

- National Primate Research Center of Thailand,

Chulalongkorn University


1

4

4

12

78

54

92

185

412

356

2

13

21

73

374

381

890

1,050

2,029

2,328

0 500 1000 1500 2000 2500

Brunei

Lao

Myanmar

Cambodia

Vietnam

Indonesia

Philippines

Malaysia

Singapore

Thailand

Total trial

Active recruiting trial

16

Phase I

Phase II

Phase III

Phase IV

Drug discovery

Pre-Clinical Phase

IND

subm

itted

FDA

appr

oval


Source: NIH U.S. National Library of Medicine, ClinicalTrials.govNumber of Clinical Trials


Clinical trials in Thailand covers a broad

range of disease profiles including non-

communicable and communicable

disease.

121

335

386

388

827

0 100 200 300 400 500 600 700 800 900

I

IV

N/A

II

III

Trial Phase

17


Number of Clinical Trials

Thailand has an ability to conduct all phase of

clinical trial

Most of Clinical trials are in Phase III

Source: NIH U.S. National Library of Medicine, ClinicalTrials.gov

39

45

46

52

61

63

66

69

80

84

103

274

0 50 100 150 200 250 300

Asthma

Malaria

Pain (postoperative)

Influenza

Anemia

Hepatitis B

GI neoplasm

Breast neoplasm

Lung Non-small cell

Diabetic type 2

Respiratory infection

HIV

Disease Type

Number of Clinical Trials



Source: Deloitte

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

process and the import license

approval process


How to start clinical trial

Picture from rahlat.com

http://rahlat.com/


Regulator of Drug and Medical DeviceThai FDA organization structure

Ministry of Public Health

Food and Drug Administration Secretary-General

National Food Safety Committee

National Drug Policy Committee

National Coordinating Committee on Chemicals

ManagementHazardous Substances Committee

Narcotic Control Committee

Committee on Prevention against Abuse

of Volatile Substances

Psychotropic Substances Committee

Medical Device Committee

Cosmetic Committee

Drug Committee

Food Committee

Food and Drug Legal Group

Narcotic Revolving Fund

One Stop Service Center

Information Center

Complaint & Suppression Center

Anti-corruption Center

Internal Audit Group

Public Sector Development Group

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 Control Group

Hazardous Substances Control Group

Office of the Secretary

Technical Planning Division

Public &Consumer Affairs Division

Rural and Local Consumer Health Product Protection and Promotion Division


Clinical Trial process

• Sequential process

• Parallel process



• Sequential process

InspectionCompliance with •GCP •Protocol•Regulations



• Parallel process


Hospitals conducting Clinical Trials

• Every hospital can conduct clinical trials depending on facility, infrastructure and staff.

• Most of clinical trials have been conducted in University hospital and Specialized hospital.

• More than 100 public hospital provide specialized medical services

Bangkok

Province

District

Sub-district

Regional hospitals (33)

Central Hospital and others including

specialized hospital (55)

Community hospitals

(723)

Health center (9,768)

Municipality Medical Center

Private Clinic

(17,671)

Pharmacy(11,154)

University Hospital (20)- Bangkok (8)- Northern (3)- Northeast (4)

- Eastern (1)- Southern (4)

Private hospital

(321)

General hospitals (83)

Other public

hospitals (120)


20 IRB/IEC accredited by Thai FDA


Examples of Current Clinical TrialsTopic Phase Disease No. of

participants

Site Sponsor

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

I HIV infection

65 • Siriraj Hospital • National Institute of Allergy and Infectious Diseases (NIAID)

Phase II Study of AZD9291 in Advanced Stage NSCLC With EGFR and T790M Mutations Detected

in Plasma Ct-DNA (PLASMA)

II Carcinoma, Non-Small-Cell Lung

108 • Ramathibodi Hospital • National University Hospital, Singapore

• AstraZeneca

A Clinical Study to Evaluate the Safety and Immunogenicity of Inactivated Poliomyelitis

Vaccine in Healthy Infants

III Poliomyelitis

1,329 • Siriraj Hospital• Chiang Mai University

Hospital

• LG Chem

A Study of Epoetin Beta Treatment in Anemic Participants With Myelodysplastic Syndrome

(MDS)

IV Myelodysplastic Syndromes

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

• Hoffmann-La Roche


Notes!!

Leading conductor of clinical research in pharmaceuticals among all ASEAN

Highly skilled workforce (15,509 FTEs)

Well developed medical equipment

and facilities

High incidence of Tropical Disease

High cost-effective in hosting trials

Large patient population (111,672 participant in 761 trials)

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Documents

Regional Manager Department of International Trials · 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