updates on id needs: amr and vaccinesupdates on id needs: amr and vaccines dr. anton...

Updates on ID needs: AMR and vaccines

Dr. Anton アンㇳン Villanueva, Dept. of International Trials

Focus: Quality & Risk and the Philippines

© 2018 National Center for Global Health and Medicine 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 registeredtrademarks of the National Center for Global Health and Medicine.

©2018 NCGM | CCS | Department of International Trial

3

© 2018 National Center for Global Health and Medicine

Targets

• 1. Intro to ASEAN

• 2. Infectious disease trends

• 3. AMR and Vaccines

Intramuros


ASEAN health market

Country-specific:

• Application:

• GCP: IRB LTO Risk Sites Pilipino (Informed Consent)

• IB: CPR PCIU Import Permit

• (MOU) MOA MTA

• Fees: FDA Php 2500, IRB Php 15-60k or %

5

ACTD=ASEAN Common Technical DossierGCP=Good Clinical PracticeIB=Investigator’s Brochure

IRB=Institutional Review Board (Ethics)LTO=License to OperateCPR=Certificate of Product RegistrationPCIU=Permit for Clinical Investigational Use

Contracts: MOU=Memorandum of UnderstandingMOA=Memorandum of AgreementMTA=Material Transport/Transfer Agreement

Pacific Bridge Medical (2014)

harmonization


6


Targets




Department of Health


‘Pilipinas’‘Maharlika’Health Burden

• Emerging economy with triple burden of diseases• Infectious Diseases

(tropical)

• Non-communicable

• Mental health

7


http://www.wpro.who.int/philippines/areas/communicable_diseases/ continuation_communicable_diseases/en/https://www.cdc.gov/globalhealth/countries/Philippines/https://www.doh.gov.ph/populationhttps://www.doh.gov.ph/mortalityhttps://www.doh.gov.ph/morbidityhttps://pharmaboardroom.com/country_reports/philippines-pharma-report/Philippine health research registry

Clinical trials on drugsPhilippine General Healthcare Market Gap:

- High morbidity due to infections, therefore need improved screening, diagnosis, and prevention including vaccines

- Already much on diabetes; cardiovascular lacking

http://www.wpro.who.int/philippines/areas/communicable_diseases/continuation_communicable_diseases/en/

https://www.cdc.gov/globalhealth/countries/Philippines/

https://www.doh.gov.ph/population

https://www.doh.gov.ph/mortality

https://www.doh.gov.ph/morbidity

https://pharmaboardroom.com/country_reports/philippines-pharma-report/


9


Targets




Global City


Need new regimen and more vaccineshttp://www.wpro.who.int/philippines/areas/communicable_diseases/continuation_communicable_diseases/en/https://www.cdc.gov/globalhealth/countries/Philippines/Research Institute of Tropical Medicine (2016). Antimicrobial Resistance Surveillance Program Data Summary Report. Available at: http://arsp.com.ph/wp-content/uploads/2017/06/2016_annual_report_summary.pdf

AMR

Japanese Encephalitis

http://www.wpro.who.int/philippines/areas/communicable_diseases/continuation_communicable_diseases/en/

https://www.cdc.gov/globalhealth/countries/Philippines/


Philippine Infectious Diseases Market Gap:

- Highly endemic to many seasonal, epidemic-prone, as well as neglected tropical diseases, including recurring global infections like measles and chicken pox

- AMR: also Sexually-Transmitted Infections

MDR-TB/HIV

Emerging/Re-emerging


Required Vaccines

12


Recommended Vaccines Gap

13


Arigatǭ gozaimasu!ありがとうございます！

Maraming salamat po

VIET NAM

Nguyen Tam


Table of content

Recent need of infectious diseases in Vietnam

Vaccine manufacturing in Vietnam

Recent updates on Vietnam Pharmaceutical Sectors

16


Recently needs of infectious diseases in Vietnam

Emergence of infectious diseases

• Un-controlled Antimicrobial Resistance based on current controlling program

• Difficult of differential diagnosis and technology of diagnosis

• Meningococcal infection and Encephalitis, except for Encephalitis by Herpes and Japanese Encephalitis

Expectation from Pharmaceuticals

• Evidence-based for usage of antibiotic combination of

• ceftazidim/avibactam

• meropenem/vaborbactam

• Anti-fungal medicine

• Echinocandins: The product (Caspofungin) is licensed in Vietnam. However, the safety and efficacy data are not sufficient for medical needs.

• Flucytosine is not available in Vietnam although it is available in current guidelines

• New drug development on anti-biotic and anti-fungal

17


Vaccine manufacturing in VietnamVietnamese vaccine companies seek new collaborations to expand new technology and market by allowing higher percentage of foreigner-own

1960 (tOPV)

1990s (DTP and VAT Vaccine in 1990;BCG Vaccine in 1992; Cholera vaccine in 1993; JEV in 1997)

2000s (Hep B-2001; Td Vaccine in 2002; Hep A in 2003; Measles in 2009)

2010s (Rotavirus in 2012; bOPV in 2017; Measles and Rubella in Mar 2017; 2018 phase III Trial for seasonal influenza vaccine, H5N1; completed phase II for IPV Vaccine)

2020: projected to manufacture 5 in 1 Vaccine

❖ Manufactured 11 out of 12 vaccines for Expanded Program on Immunization

❖ Manufacturing volumes enough for the country’s need and exported to countries under WHO’s program

• Vietnamese vaccine companies IVAC

• POLYVAC

• VABIOTECH

• DAVAC

• Supporting from other international organization (WHO, Pasteur Paris, NIH Japan, JICA Japan, BARDA, etc.)


Recent updates on Regulation in Vietnam in pharmaceutical sectors

Opening foreign –owners for

pharmaceutical companies and

public companies

• No limitation on percentage of owners

• M&A (Taisho Japan-DHG VN)

CPTPP

• Reducing tariff on pharmaceutical products

• Reduce the timeframe for New Drug Registration

New Circular on

Clinical Trials

• GCP Inspection to promote standard of clinical trials

• Shorten the review timeline

19


ありがとうございます。Cảm ơn

A wink on R&D targets for DRCongo:

“from vaccines to Cure”

Muchanga Sifa MJ, MD, PhD


Population Trends

22

UN estimates on November 5, 2018 Population: 84,874,826 (1.1% world population)Growth rate: 3.28%Population density: 37per km240.5% of the population is urban.Median age is 16.8 years

The data are in thousands or millions and represent the population in each age group.https://population.un.org/wpp/DataQuery/

79.3678.4376.63

74.8773.15

69.868.2

2010201120122013201420162017

Dea

ths/

1,0

00

live

bir

ths

Year

< 5y Mortality rate


Vaccination Coverage and Infant Mortality Rate

10 Most common causes of infant

mortality (2016)

1. Malaria

2. Tuberculosis

3. Lower respiratory infection

4. Diarrheal diseases

5. Cerebrovascular diseases

6. Ischemic heart disease

7. Protein-energy malnutrition

8. HIV/AIDS

9. Neonatal preterm birth

10. Neonatal encephalopathy

All cannot be preventable by the current available vaccines.

Need new molecules!!!!!

Needs


All-Causes Mortality

No death 2016

Malaria

Lower respiratory infection

Tuberculosis

Diarrheal diseases

Protein-energy

malnutrition

Neonatal preterm birth

Neonatal encephalopathy

Congenital defects

HIV/AIDS

Neonatal sepsis

Malaria has replaced diarrheal diseases as first. Tuberculosis is shifting, maybe due to resistance. All causes are mainly infectious.

Malaria Burden

Percentage of estimated malaria deaths attributable to the 18 countries with nearly 80% of global malaria deaths in 2017


% MDR/RR-TB in previously treated TB

cases

Tuberculosis Burden


Yellow feverJune 2016

700 cases

63 deaths

CholeraFeb 2018

83 cases 43 deaths

Vaccine derived

PolioJuly 2017

4 cases

Measles28506 suspects

386 deaths

Monkey Pox

Jan 2017-May 2018

2585 cases 42 deaths

Ebola

10th

August 2018

…cases…deaths

Outbreaks

Dec 19thTotal :542Deaths: 329Cured: 192Suspects: 86

EBOLA( Aug.2018)

Dec 17thTotal :531Deaths: 313Cured: 184Suspects: 86


Referenceshttps://www.analyticsvidhya.com/blog/2016/06/bayesian-statistics-beginners-simple-english/https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)00115-4/fulltexthttps://reliefweb.int/report/democratic-republic-congo/democratic-republic-congo-epidemics-yellow-fever-cholera-measleshttp://www.healthdata.org/democratic-republic-congohttp://www.who.int/gho/countries/cod.pdf?ua=1https://www.severemalaria.org/countries/democratic-republic-of-congohttps://www.precisionvaccinations.com/democratic-republic-congo-cdc-travel-alerts-include-ebola-measles-polio https://www.precisionvaccinations.com/democratic-republic-congo-cdc-travel-alerts-include-ebola-measles-polio

Nattha Kerdsakundee, Ph.D.

Regional Manager, Department of International Trials


Outline

❖Update Infectious Disease in 2018

❖Antimicrobial Resistance Situation

❖Pharmaceutical Market in Thailand


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

• Aging 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


No. Disease No. of case No. of death

% of death

1 Diarrhea 1,055,271 8 < 0.01

2 Pneumonia 247,683 199 0.08

3 Influenza 156,280 30 0.02

4 H.conjunctivitis 82,196 - -

5 Tuberculosis 74,940 4,971 6.63

6 Dengue 78,762 105 0.13

7Hand, foot and mouth

disease58,182 1 < 0.01

8 Chickenpox 53,984 - -

9 Scrub Typhus 8,249 4 0.05

10 Hepatitis B 6,246 - -

11 Malaria 6,329 1 0.02

12 Measles 4,030 15 0.37

13 Scarlet fever 2,813 - -

14 Leptospirosis 2,507 30 1.20

15 Melioidosis 2,344 5 0.21

Infectious disease in 2018

Thailand’s health ministry has confirmed 2 infectious disease outbreak in 2018• Dengue• Measles

Re-emerging Infectious Diseases by WHO definition

Source: Department of disease control, Thailand


Dengue outbreak

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

In 2018, the updated no. of Dengue cases are 78,762 case and Death 105 case

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

2018 est.

2017

0

20000

40000

60000

80000

100000

120000

140000

160000

2013 2014 2015 2016 2017 2018

No

. of

Susp

ects

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


Measles outbreak

❑Measles outbreak in the southern provinces

❑ The morbidity rate in Yala province is 132.61 /

100,000 population

❑ Low vaccination rates in the South

❑Misunderstanding about vaccinations that

spread around Muslim communities


Tuberculosis

• HIV- positive with TB is around 10%

• 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

0

10000

20000

30000

40000

50000

60000

70000

80000

90000

100000

2014 2015 2016 2017 2018

No

. ofr

egis

tere

d p

atie

nts

Thailand is among the 30 high-burden TB countries globally


Malaria

- P. vivax 80% - P. Falciparum 20%- 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

0

5000

10000

15000

20000

25000

30000

35000

2014 2015 2016 2017 2018

No

. of

Susp

ects

Number of malaria patients in Thailand gradually decrease every year


Outline





Antimicrobial Resistance

(Average) every 15 minute; 1 Thai people death from AMR= 100 people per day= 20,000-38,000 people per year

Economic lost around 46,000 mil. baht

Misuse or excessive use of antibiotics81% in public hospital25-91% in university hospital64-80% in drug store

About 88,000 infections were attributed to antimicrobial resistance (AMR) in Thailand

At least 3.24 million additional days in hospital

Source: National Antimicrobial Resistance Surveillance Center, Thailand


Important resistant pathogens

• Imipenem resistant Acinetobacter spp.

• Imipenem resistant Pseudomonas aeruginosa

• Vancomycin resistant enterococci

• Carbapenem resistant Enterobacteriaceae

• Extended spectrum β-lactamase producing Enterobacteriaceae

• Multidrug resistant and extensive drug resistant tuberculosis



Rate of Imipenem resistance Acinetobacter spp.

Distribution of MDR-TB Cases, Thailand(639 cases in 2018)

Source: Bureau of Tuberculosis Department of disease control, Thailand

Percent resistance of E. faecium, E. faecalis to vancomycin



Causes of AMR in Thailand

❑Misused antibiotics as medicines to fight inflammation or

cold symptom

❑ Improper use of antibiotics by medical personnel, public

health agencies, veterinarians and agriculturalist



Policies for AMR in Thailand

Lower the number of drug resistance-related deaths by 50%

within the year 2021

❑Monitor cases of antibiotic resistance

❑ Control the distribution of antibiotics

❑ Prevent drug resistance in the farming sector and pets

❑ Offer related education to the public

❑ Developing mechanism to steer forward all attempts to fight it



Outline





Pharmaceutical Market in Thailand

Share of Pharmaceutical Expenditure (2013-17 average)

The market in medicines now accounts for

approximately a quarter of all domestic

medical expenses with the majority of this

being distributed through hospitals.

Source of Import (2017)

In 2017, the value of the Thai pharmaceuticals

market was THB 169 bn, 5.3% growth YoY(Source: Business Monitor International)


Leading Categories Market Share

❑ Anti-infective drug is around 20% of

drug market in Thailand

❑ Antibiotic value is around 50% of Anti-

infective drug

❑ In 2012, the value of antibiotic drug

(manufacture and import) was THB

17,000 mil.(Source: Thai FDA)


Source: PwC Health Industries Leader

Thai government and tourismAuthority of Thailand havepromoted medical and healthtourism policy

Healthcare market trend

45

Source: EIC SCB, World Health Organization, BMI

Pharmaceutical Market Trend


Thank you

ありがとうございます

ขอบคณุคะ่Picture: dreamstime

INDONESIA

Marlinang D. Siburian, MSc.

Rubella2017 Sept- 2018 Jan : Asmat, Papua651 cases, 75 died

Facts:• Indonesia is one of the

10th countries with the highest measles and rubella cases

• 2014-2018 : ✓ 5737 Rubella cases✓ 1660 suspect CRS

(Congenital Rubella Syndrome) (surveyed from 12 sentinel hospitals)

• 1982 : Measles vaccine as national program for children age 9 mo

• 2017 : Rubella vaccine was added to national program given in together with measles vaccine → Measles Rubella (MR) vaccine

• Rubella vaccine produced by Serum Institute of India (SII), containing enzyme derived from porcine

• HARAM – against religious law (considered as a sin)

• 50-95% of the society rejected the vaccination

• Threat of coming outbreaks!!

OUTBREAKS

Diphtheriae2017 Jan-Nov :

Nationwide, 596 cases, 32 died

Aceh, 76 casesEast Java, 271 cases

Banten, 81 casesWest Sumatera, 30 cases

West Java, 95 cases

Hepatitis A2018 Sept :

Singkawang, West Kalimantan

189 cases

Hepatitis A2017 Nov-2018 Jan : Lamongan, East Java 33 cases

Hepatitis A2015 Dec: Bogor, West Java28 cases, 1 died

Chikungunya2015 Dec-2018 Jan : Buleleng, Bali96 cases

Dengue 2016 Jan-Feb :

In 15 cities of 11 Provinces608 cases, 34 diedNationwide, 8487 cases, 108 died.Facts: Number of cases >> since 2015 (more in patients age >15 yo)

MERSNo case found in

Indonesia.Two Indonesians got

infected and were hospitalized in Saudi Arabia. Returned to

Indonesia after recovered.

Facts:• One million

Indonesian people travel to Saudi

Arabia every year for religious trip.

• High risk for MERS!!

Facts:Vaccination coverage >> Number of cases >>→AMR (penicillin and

erythromycin)New vaccine?!!

Nati

on

al

Pro

gra

m InfluenzaTetanus, Diphtheriae, Pertussis (Td/Tdap)Varicella, HPV , Zoster, Measles, Rubella, Mumps, Hep A, Hep BHep A and BTyphoidPneumococcal Polysaccharide (PPSV23)/PneumoniaPneumococcal conjugate 13-valent (PCV13)/PneumoniaMeningitis MeningococcalYellow fever

Available Vaccines:

Vaccine suppliers:

1. Bio Farma (since 1890), now supplies

Pentavalent and Measles vaccines for

National Program2. Glaxo Smith Kline (GSK)

3. Novartis4. Sanofi

Vaccination

in Indonesia

76.1 67.8 69.8 75.3 74.1 79.3 83.0 82.7 82.280.0 85.0 90.0 95.0 100.0

84.0

0.0

50.0

100.0

150.0

-30.0

20.0

70.0

120.0

2007 2008 2009 2010 2011 2012 2013 2014 2015

National vaccination coverage

Coverage

Source: Information and Data Center MOH

0-4 yo20,945,43122,953,246

Indonesian Population

2010 2050

#1 Great need for HALAL vaccine supplies

• Measles

59,000 death/year

• Rabies• Diphtheria 7,097 cases in 2016(India (~50%), Madagascar, Indonesia, Nepal, Myanmar)

• Rubella22,361 cases in 2016(India (~37%), China, Indonesia, Sudan, South Africa)

186,605 cases in 2016(India (~38%), Mongolia, China, Nigeria, Indonesia)

25,000 death/year

Infectious Diseases and Muslim

population

• Dengue

Muslim Population: 1.6 billion (2010) ~ 21.9% of the world population

• Since 2012, when the virus was first identified in Saudi Arabia, there have been 2081 laboratory-confirmed cases of MERS-CoV infection reported to WHO from 27 countries, with at least 722 deaths - a fatality rate of 35%

• MERS-CoV is one of the high threat pathogens included in the WHO’s Research & Development Blue Print which provides a road map for research and development of diagnostic, preventive and therapeutic products for prevention, early detection and response

• More than 2 million Muslim people travel every year to Mecca for Hajj pilgrimage

• Many infectious diseases cases occur in countries with Muslim majority including Indonesia (disbelief in vaccination and/or

uninformed)• High demand for halal medical products ~

>1.6 billion people • Pharmaceutical companies should start to

consider halal-haram aspects• Clinical trials for halal recommendation

can be done in countries with Muslim population to get halal certification

• Endorsement from Religious leaders on medical products are required in

countries with Muslim Majority such as Indonesia

• National health program in countries with Muslim majority should be disseminated through well-informed religious leaders

Middle-East respiratory syndrome

coronavirus (MERS-CoV)


ありがとうございます。Terima kasih

updates on id needs: amr and vaccinesupdates on id needs: amr and vaccines dr. anton...

Documents